Peginterferon Beta-1a is an active pharmaceutical ingredient in the Interferons group (L03AB). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
CAOfficial regulatory label· revised December 22, 2025[1]
PLEGRIDYTM (peginterferon beta-1a) is indicated for: • treatment of relapsing remitting multiple sclerosis (RRMS) for adult patients o to reduce the frequency of clinical exacerbations o to slow the progression of disability. The safety and efficacy of PLEGRIDYTM have not been established in patients with primary and secondary progressive multiple sclerosis.
1 Pediatrics Pediatrics (< 18 years of age): The safety and efficacy of PLEGRIDYTM in patients below 18 years of age has not been studied (see 7 WARNINGS AND PRECAUTIONS, Special Populations). 2 Geriatrics Geriatrics (> 65 years of age): The safety and efficacy of PLEGRIDYTM in patients over the age of 65 have not been sufficiently studied due to the limited number of such patients included in clinical trials.
Refer to 7 WARNINGS and PRECAUTIONS, Special population.
GBUnited Kingdom· MHRA
3 products
Uses
GBOfficial regulatory label· revised May 1, 2026[2]
1).
How to take
GBOfficial regulatory label· revised May 1, 2026
USUnited States· FDA
1 product
Uses
USOfficial regulatory label· revised October 21, 2025[3]
1 INDICATIONS AND USAGE PLEGRIDY is indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
PLEGRIDY is an interferon beta indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults ( 1 )
How to take
EUEuropean Union· EMA
1 product
Uses
EUOfficial regulatory label· revised March 17, 2026[4]
1).
How to take
EUOfficial regulatory label· revised March 17, 2026
Drug interactions
Known interactions involving Peginterferon Beta-1a. Select one for details. This list is informational and not a complete interaction checker.
Showing 240 of 262. Type above to find a specific drug.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
[1]Health Canada (DPD) · 02444372 · revised December 22, 2025
[2]MHRA (UK) · PLGB224070016 · revised May 1, 2026
[3]FDA DailyMed · 08f0ea03-4e6d-19… · revised October 21, 2025 [PDF]
[4]European Medicines Agency · EMEA/H/C/002827 · revised March 17, 2026
[5]OpenFDA adverse-event reports (US), 12 months ending June 4, 2026.
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.
How to take
CAOfficial regulatory label· revised December 22, 2025[1]
1 Dosing Considerations • Intended for use under the guidance and supervision of a physician. • Patients may self-inject only: o If their physician determines that it is appropriate. o Appropriate medical follow-up is provided. PLEGRIDYTM (peginterferon beta-1a) Page 5 of 47 o After proper training in SC injection technique for either PLEGRIDYTM PS/PLEGRIDYTM PEN.
• Injection sites should be rotated. The usual sites for subcutaneous injections include thigh, abdomen, and upper arm. Avoid injection into an area of skin that is sore, red, infected or otherwise damaged. • Before initiating a patient on PLEGRIDYTM PS/PLEGRIDYTM PEN therapy, note the Contraindications.
• Review the 7 WARNINGS AND PRECAUTIONS section and ensure appropriate monitoring of patients with depression, hepatic dysfunction, a history of seizures, cardiac disease, thyroid dysfunction, myelosuppression, and female patients of child-bearing potential.
• Patients should be advised of the side-effects of PLEGRIDYTM PS/PLEGRIDYTM PEN and instructed on the use of aseptic technique when administering PLEGRIDY PS/PLEGRIDY PEN. The Patient Medication Information should be carefully reviewed with all patients, and patients should be educated on self-care and advised to continue to refer to Part III during treatment with PLEGRIDYTM PS/PLEGRIDYTM PEN.
2 Recommended Dose and Dosage Adjustment PLEGRIDYTM (peginterferon beta-1a) is administered subcutaneously using a single-use, pre-filled syringe/pen. The recommended dosage of PLEGRIDYTM is 125 micrograms injected subcutaneously every 2 weeks.
Treatment initiation It is generally recommended that patients start treatment with 63 micrograms at dose 1 (on day 0) increasing to 94 micrograms at dose 2 (on day 14) reaching the full dose of 125 micrograms by dose 3 (on day 28) and continuing with the full dose (125 micrograms) every 14 days (2 weeks) thereafter (Table 1).
Table 1 – Titration Schedule at Initiation Dose Time* Amount (micrograms) Syringe/Pen Label Dose 1 On Day 0 63 Orange Dose 2 On Day 14 94 Blue Dose 3 On Day 28 125 (full dose) Grey * Dosed once 14 days (2 weeks) A Starter Pack is available containing the first 2 doses, 63 micrograms (dose 1, orange labeled syringe/pen) and 94 micrograms (dose 2, blue labeled syringe/pen) for day 0 and day 14 respectively.
Patients should use the Administration Dose Pack containing the full dose of 125 micrograms (full dose, grey labeled syringe/pen) from day 28 onwards (dosing every 14, days). Pediatrics Health Canada has not authorized an indication for pediatric use.
Renal Impairment No dosage adjustments are necessary in patients with renal impairment based on study data in mild, moderate, and severe renal impairment and end stage renal disease. 4 Administration • It is recommended that a health care professional trains patients in the proper technique for self-administering subcutaneous injections using the pre-filled syringe/pen.
Patients should be advised to rotate sites for subcutaneous injections. The usual sites for subcutaneous injections include thigh, abdomen, and upper arm. • Each PLEGRIDYTM pre-filled syringe/pen is provided with the needle pre-attached.
Pre-filled syringes/pens are for single use only and should be discarded after use. Dose titration at the initiation of treatment may help to ameliorate flu-like symptoms that can occur at treatment initiation with interferons. Prophylactic and concurrent use of analgesics and/or antipyretics may prevent or ameliorate flu-like symptoms sometimes experienced during interferon treatment.
5 Missed Dose If a dose of PLEGRIDYTM is missed, it should be administered as soon as possible: • If 7 days or more to the next planned dose: Patients should administer their missed dose immediately. Treatment can then continue with the next scheduled dose as planned.
• If less than 7 days to the next planned dose: Patients should begin a new 2 week dosing schedule starting from when they administer their missed dose. A patient should not administer two doses of PLEGRIDYTM within 7 days of each other.
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
CAOfficial regulatory label· Adverse reactions· revised December 22, 2025[1]
). These symptoms tend to be most prominent at the initiation of therapy and decrease in frequency and severity with continued treatment. Dose titration at the initiation of treatment may help to ameliorate flu- like symptoms that can occur at treatment initiation with interferons.
Concurrent use of analgesics and/or antipyretics may help reduce flu-like symptoms on treatment days. • Immediately report any symptoms of depression and/or suicidal ideation. • The risk of decreased blood counts including white blood cells and platelet counts and of the requirement for periodic laboratory testing.
Patients should be advised to report immediately any clinical symptoms associated with blood cell count abnormalities and laboratory testing should be performed according to standard medical practice. Patients with myelosuppression may require more intensive monitoring of complete blood cell counts, with differential and platelet counts.
• The potential risk of liver injury with interferon beta therapy, and of the requirement for frequent laboratory testing. Patients should be informed of the symptoms of suggestive liver dysfunction, such as loss of appetite accompanied by other symptoms such as nausea, vomiting, and jaundice, and advised to consult with their physician immediately should such symptoms arise.
• To report any symptoms of thyroid dysfunction (hypo or hyperthyroidism) and thyroid function tests should be performed according to standard medical practice. • Female patients should be advised about the abortifacient potential of PLEGRIDYTM and instructed to take adequate contraceptive measures.
Patients should be advised to discuss with their health care provider the potential risks and benefits of continued treatment while attempting to conceive. It is not known if interferons alter the efficacy of hormonal contraceptives.
• When a physician determines that PLEGRIDY PS/PLEGRIDY PEN can be used outside the physician’s office, persons who will be administering PLEGRIDY PS/PLEGRIDY PEN should receive instruction in reconstitution and/or injection, including the review of the injection procedures (see PATIENT MEDICATION INFORMATION).
If a patient is to self-administer, the physical ability of the patient to self-inject subcutaneously should be assessed. If home use is chosen, the first injection should be performed under the supervision of a qualified health care professional.
Patients should be advised of the importance of rotating sites of injection with each dose, to minimize the likelihood of injection site reactions. A puncture-resistant container for disposal of needles, syringes and autoinjectors should be used.
Patients should be instructed in the technique and importance of proper syringe, needle and autoinjector disposal and be cautioned against reuse of these items. • Thrombotic microangiopathy (TMA): Cases of thrombotic microangiopathy, manifested as thrombotic thrombocytopenic purpura (TTP) or haemolytic uraemic syndrome (HUS), including fatal cases, have been reported with interferon beta products.
Events were reported at various PLEGRIDYTM (peginterferon beta-1a) Page 9 of 47 time points during treatment and may occur after several weeks to several years after starting treatment with interferon beta. g. confusion, paresis) and impaired renal function.
If clinical features of TMA are observed, testing of blood platelet levels, serum lactate dehydrogenase (LDH), schistocytes (erythrocyte fragmentation) on a blood film with negative Coombs test and renal function is recommended. Prompt treatment of TTP/HUS is required and immediate discontinuation of treatment with PLEGRIDYTM is recommended.
Carcinogenesis and Mutagenesis No carcinogenicity data for interferon beta-1a are available in animals or humans. Interferon beta-1a was not mutagenic when tested in the Ames bacterial test and in an in vitro cytogenetic assay in human lymphocytes in the presence and absence of metabolic activation.
Cardiovascular Worsening of cardiac disease has been reported in patients receiving interferon beta. Patients with pre-existing significant cardiac disease, such as congestive heart failure, coronary artery disease or arrhythmia should be monitored for worsening of their cardiac condition, particularly during initiation of treatment (see 8 ADVERSE REACTIONS).
Driving and Operating Machinery No studies on the effects on the ability to drive and use machines have been performed. Endocrine and Metabolism Endocrine Disorders: hyperthyroidism Metabolism and Nutrition Disorders: hypercholesterolaemia, vitamin B12 deficiency, vitamin D deficiency, hypernatraemia, hypoglycaemia, hypokalaemia, increased appetite, malnutrition Hematologic Decreased Peripheral Blood Counts: Decreased peripheral blood counts in all cell lines, including rare pancytopenia and severe thrombocytopenia, have been reported in patients receiving interferon beta.
Cytopenias, including rare severe neutropenia and thrombocytopenia, have been observed in patients treated with PLEGRIDYTM. Patients should be monitored for symptoms or signs of decreased peripheral blood counts (see 8 ADVERSE REACTIONS).
Hepatic/Biliary/Pancreatic Severe hepatic injury, including elevated serum hepatic transaminase levels, hepatitis, and autoimmune hepatitis, and rare cases of severe hepatic failure, has been reported with interferon beta. Elevations in hepatic enzymes, noninfectious hepatitis and hepatic injury have been observed with the use of PLEGRIDYTM.
Patients should be monitored for signs and symptoms of hepatic injury. (see 8 ADVERSE REACTIONS). Treatment with PLEGRIDYTM should be stopped if icterus or other clinical symptoms of hepatic dysfunction appear.
Patients with Hepatic Impairment:
Caution should be used and close monitoring considered when administering PLEGRIDYTM to patients with severe hepatic impairment. Patients should […]
CAOfficial regulatory label· Warnings and precautions· revised December 22, 2025[1]
, Special Populations). 2 Geriatrics Geriatrics (> 65 years of age): The safety and efficacy of PLEGRIDYTM in patients over the age of 65 have not been sufficiently studied due to the limited number of such patients included in clinical trials.
Refer to 7 WARNINGS and PRECAUTIONS, Special population. 2 CONTRAINDICATIONS PLEGRIDYTM (peginterferon beta-1a) is contraindicated in: • patients with a history of hypersensitivity to natural or recombinant interferon beta or peginterferon • patients with a history of hypersensitivity to, any other component of the formulation or the container.
• Patients with current severe depression and/or suicidal ideation (see 7 WARNINGS and PRECAUTIONS). For a complete listing, see the 6 DOSAGE FORMS, STRENGTHS, COMPOSITION and PACKAGING section of the product monograph. 1 Dosing Considerations • Intended for use under the guidance and supervision of a physician.
• Patients may self-inject only: o If their physician determines that it is appropriate. o Appropriate medical follow-up is provided. PLEGRIDYTM (peginterferon beta-1a) Page 5 of 47 o After proper training in SC injection technique for either PLEGRIDYTM PS/PLEGRIDYTM PEN.
• Injection sites should be rotated. The usual sites for subcutaneous injections include thigh, abdomen, and upper arm. Avoid injection into an area of skin that is sore, red, infected or otherwise damaged. • Before initiating a patient on PLEGRIDYTM PS/PLEGRIDYTM PEN therapy, note the Contraindications.
• Review the 7 WARNINGS AND PRECAUTIONS section and ensure appropriate monitoring of patients with depression, hepatic dysfunction, a history of seizures, cardiac disease, thyroid dysfunction, myelosuppression, and female patients of child-bearing potential.
• Patients should be advised of the side-effects of PLEGRIDYTM PS/PLEGRIDYTM PEN and instructed on the use of aseptic technique when administering PLEGRIDY PS/PLEGRIDY PEN. The Patient Medication Information should be carefully reviewed with all patients, and patients should be educated on self-care and advised to continue to refer to Part III during treatment with PLEGRIDYTM PS/PLEGRIDYTM PEN.
2 Recommended Dose and Dosage Adjustment PLEGRIDYTM (peginterferon beta-1a) is administered subcutaneously using a single-use, pre-filled syringe/pen. The recommended dosage of PLEGRIDYTM is 125 micrograms injected subcutaneously every 2 weeks.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
CAOfficial regulatory label· Contraindications· revised December 22, 2025[1]
PLEGRIDYTM (peginterferon beta-1a) is contraindicated in: • patients with a history of hypersensitivity to natural or recombinant interferon beta or peginterferon • patients with a history of hypersensitivity to, any other component of the formulation or the container.
• Patients with current severe depression and/or suicidal ideation (see 7 WARNINGS and PRECAUTIONS). For a complete listing, see the 6 DOSAGE FORMS, STRENGTHS, COMPOSITION and PACKAGING section of the product monograph.
This is not medical advice. Consult a qualified healthcare professional.
Treatment should be initiated under supervision of a physician experienced in the treatment of multiple sclerosis. Plegridy may be administered subcutaneously (SC) using a single-use pre-filled pen or pre- filled syringe or intramuscularly (IM) using a single use pre-filled syringe.
Efficacy of peginterferon beta-1a administered subcutaneously has been demonstrated over placebo. Direct comparative data for peginterferon beta-1a versus non-pegylated interferon beta or data on efficacy of peginterferon beta-1a after switching from a non-pegylated interferon beta are not available.
1). Posology The recommended dose of Plegridy is 125 micrograms injected SC or IM every 2 weeks (14 days). Treatment initiation It is generally recommended that patients start SC or IM treatment with 63 micrograms at dose 1 (on day 0), increasing to 94 micrograms at dose 2 (on day 14), reaching the full dose of 125 micrograms by dose 3 (on day 28) and continuing with the full dose (125 micrograms) every 2 weeks (14 days) thereafter (see Table 1a for SC use or Table 1b for IM use).
Subcutaneous route An initiation pack is available containing the first 2 doses (63 micrograms and 94 micrograms).
Table 1a:
Titration schedule at initiation via SC route Dose Time* Amount (micrograms) Syringe label Dose 1 Day 0 63 Orange Dose 2 Day 14 94 Blue Dose 3 Day 28 125 (full dose) Grey *Dosed every 2 weeks (14 days) Intramuscular route An administration dose pack contains the full 125 microgram dose in 1 pre-filled syringe.
The Plegridy titration clips, designed for use with the pre-filled syringe are intended to limit the dose that is administered to 63 micrograms (dose 1 (1/2 dose), yellow titration clip) and 94 micrograms (dose 2 (3/4 dose), purple titration clip), for day 0 and day 14 respectively.
Each Plegridy titration clip should be used once, and then discarded along with any remaining medicinal product. Patients should use the full dose of 125 micrograms (no clip required) from day 28 onwards (dosing every 14 days). Table 1b Titration schedule at initiation via IM route Dose Time* Amount (micrograms) Titration clip Dose 1 Day 0 63 Yellow Dose 2 Day 14 94 Purple Dose 3 Day 28 125 (full dose) No clips needed *Dosed every 2 weeks (14 days) Dose titration at the initiation of treatment may help to ameliorate flu-like symptoms that can occur at treatment initiation with interferons.
8). Switching between the SC and IM routes of administration and vice versa has not been studied. 2). If a dose is missed, it should be administered as soon as possible. • If 7 days or more to the next planned dose: Patients should administer their missed dose immediately.
Treatment can then continue with the next scheduled dose as planned. • If less than 7 days to the next planned dose: Patients should begin a new 2 week dosing schedule starting from when they administer their missed dose. A patient should not administer two doses of peginterferon beta-1a within 7 days of each other.
Special populations Elderly population The safety and efficacy of peginterferon beta-1a in patients over the age of 65 have not been sufficiently studied due to the limited number of such patients included in clinical trials. 2). 4).
Paediatric population The safety and efficacy of peginterferon beta-1a in children and adolescents aged 10 to less than 18 years have not been established in multiple sclerosis. 2 but no recommendation on a posology can be made. The safety and efficacy of peginterferon beta-1a in children below 10 years of age have not been established.
No data are available. Method of administration It is recommended that a healthcare professional trains patients in the proper technique for self—administering SC injections using the SC pre-filled syringe/pre-filled pen or IM injections using the IM pre-filled syringes as appropriate.
Patients should be advised to rotate sites for SC or IM injections every two weeks. The usual sites for subcutaneous injections include abdomen, arm, and thigh. The usual site for intramuscular injection is the thigh. Each Plegridy pre-filled pen/syringe for SC is provided with the needle pre-attached.
Plegridy prefilled syringe for IM use is supplied as a prefilled syringe with a separate needle for IM use. Both IM and SC pre-filled syringes and SC pre-filled pens are for single use only and should be discarded after use. Precautions to be taken before handling or administering the medicinal product Once removed from the refrigerator, Plegridy should be allowed to warm to room temperature (up to 25 oC) for about 30 minutes prior to injection.
External heat sources such as hot water must not be used to warm the medicinal product. Plegridy pre-filled syringe must not be used if the liquid is coloured, cloudy, or contains floating particles. The liquid in the syringe must be clear and colourless.
Plegridy pre-filled pen must not be used unless the green stripes are visible in the pen injection status window. Plegridy pre-filled pen must not be used if the liquid is coloured, cloudy, or contains floating particles. The liquid in the […]
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
GBOfficial regulatory label· Adverse reactions· revised May 1, 2026[2]
Summary of safety profile The most common adverse drug reactions (ADR) (at a higher incidence than placebo) for Peginterferon beta-1a 125 micrograms subcutaneously every 2 weeks were injection site erythema, influenza like illness, pyrexia, headache, myalgia, chills, injection site pain, asthenia, injection site pruritus, and arthralgia.
The most commonly reported adverse reaction leading to discontinuation in patients treated with peginterferon beta-1a 125 micrograms subcutaneously every 2 weeks was influenza-like illness (<1%). Tabulated list of adverse reactions via subcutaneous route of administration In clinical studies, a total of 1,468 patients received peginterferon beta-1a SC for up to 278 weeks with an overall exposure equivalent of 4,217 person -years.
1,285 patients received at least 1 year, 1,124 patients have received at least 2 years, 947 patients received at least 3 years, and 658 patients received at least 4 years of treatment with peginterferon beta-1a. The experience in the randomised, uncontrolled phase (year 2) of the ADVANCE study and in the extension study ATTAIN (treatment received for up to 4 years) was consistent with the experience in the 1 year placebo-controlled phase of the ADVANCE study.
Table 2 summarizes ADRs (incidence above placebo and with a reasonable possibility of causality) from 512 patients treated with peginterferon beta-1a 125 micrograms SC every 2 weeks and 500 patients who received placebo for up to 48 weeks and post-marketing data.
The ADRs are presented as MedDRA preferred terms under the MedDRA System Organ Class. 4). ┼ Class label for interferon products, see below Pulmonary arterial hypertension $ Class label for interferon products 1 Adverse reactions derived only during post marketing experience Description of selected adverse reactions via subcutaneous route of administration Flu-like symptoms Influenza -like illness was experienced by 47% of patients receiving peginterferon beta-1a 125 micrograms every 2 weeks and 13% of patients receiving placebo.
g. influenza -like illness, chills, hyperpyrexia, musculoskeletal pain, myalgia, pain, pyrexia) was highest at the initiation of treatment and generally decreased over the first 6 months. Of the patients who reported flu-like symptoms 90% reported them as mild or moderate in severity.
None were considered serious in nature. Less than 1% of patients who received peginterferon beta-1a during the placebo-controlled phase of the ADVANCE study discontinued treatment due to flu-like symptoms. An open -label study in patients switching from interferon beta therapy to peginterferon beta-1a evaluated the onset and duration of prophylactically treated flu-like symptoms.
In patients experiencing flu-like symptoms, the median time to onset was 10 hours (interquartile range, 7 to 16 hours) after injection, and the median duration was 17 hours (interquartile range, 12 to 22 hours). g. injection site erythema, pain, pruritus, or oedema) were reported by 66% of patients who received peginterferon beta-1a 125 micrograms every 2 weeks compared to 11% of patients receiving placebo.
Injection site erythema was the most commonly reported injection site reaction. Of the patients who experienced injection site reactions 95% reported them as mild or moderate in severity. One patient out of 1,468 patients who received peginterferon beta-1a in clinical studies experienced an injection site necrosis which resolved with standard medical treatment.
Hepatic transaminase abnormalities The incidence of hepatic transaminase increases was greater in patients receiving peginterferon beta-1a compared to placebo. The majority of enzyme elevations were <3 times the upper limit of normal (ULN).
Elevations of alanine aminotransferase and aspartate aminotransferase (>5 times ULN), were reported in 1% and <1% of placebo-treated patients and 2% and <1% of patients treated with peginterferon beta-1a respectively. Elevations of serum hepatic transaminases combined with elevated bilirubin were observed in two patients who had pre-existing liver test […]
GBOfficial regulatory label· Warnings and precautions· revised May 1, 2026[2]
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Hepatic injury Elevated serum hepatic transaminase levels, hepatitis, autoimmune hepatitis and rare cases of severe hepatic failure have been reported with interferon beta medicinal products.
Elevations in hepatic enzymes have been observed with the use of peginterferon beta-1a. 8). 3). Depression occurs with increased frequency in the multiple sclerosis population and in association with interferon use. Patients should be advised to immediately report any symptoms of depression and/or suicidal ideation to their prescribing physician.
Patients exhibiting depression should be monitored closely during therapy and treated appropriately. 8). Hypersensitivity reactions Serious hypersensitivity reactions including cases of anaphylaxis have been reported as a rare complication of treatment with interferon beta, including peginterferon beta-1a.
Patients should be advised to discontinue treatment with peginterferon beta-1a and seek immediate medical care if they experience signs and symptoms of anaphylaxis or severe hypersensitivity. 8). Injection site reactions Injection site reactions, including injection site necrosis, have been reported with the use of subcutaneous interferon beta.
To minimise the risk of injection site reactions patients should be instructed in the use of an aseptic injection technique. The procedure for the self-administration by the patient should be reviewed periodically especially if injection site reactions have occurred.
If the patient experiences any break in the skin, which may be accompanied by swelling or drainage of fluid from the injection site, the patient should be advised to speak with their doctor. One patient treated with peginterferon beta-1a in clinical trials experienced an injection site necrosis with SC peginterferon beta-1a.
8). Decreased peripheral blood counts Decreased peripheral blood counts in all cell lines, including rare pancytopenia and severe thrombocytopenia, have been reported in patients receiving interferon beta. Cytopenias, including rare severe neutropenia and thrombocytopenia, have been observed in patients treated with peginterferon beta-1a.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
GBOfficial regulatory label· Contraindications· revised May 1, 2026[2]
1. 8).
This is not medical advice. Consult a qualified healthcare professional.
USOfficial regulatory label· revised October 21, 2025[3]
1 Dosing Information PLEGRIDY may only be administered subcutaneously (SC) or intramuscularly (IM). Recommended Maintenance Dosage After initial titration (see Table 1 and Table 2 ), the recommended dosage of PLEGRIDY is 125 micrograms injected every 14 days.
For subcutaneous injection:
Patients may rotate injection sites between the abdomen, back of the upper arm, or thigh.
For intramuscular injection:
Patients may rotate injection sites between the left and right thighs. Treatment Initiation Dose titration at the initiation of treatment may help to ameliorate flu-like symptoms that can occur at treatment initiation with interferons.
Prophylactic and concurrent use of analgesics and/or antipyretics may prevent or ameliorate flu-like symptoms sometimes experienced during treatment with PLEGRIDY. Switching between the subcutaneous and intramuscular routes of administration and vice versa has not been studied.
It is not expected that dose titration should be repeated to ameliorate flu-like symptoms if switching between subcutaneous and intramuscular routes of administration, or vice versa based upon bioequivalence demonstrated between the two routes of administration.
Subcutaneous Administration of PLEGRIDY Patients using PLEGRIDY for the first time should start treatment with 63 micrograms on day 1. On day 15 (14 days later), the dose is increased to 94 micrograms, reaching the full dose of 125 micrograms on day 29 (after another 14 days).
Patients continue with the full dose (125 micrograms) every 14 days thereafter (see Table 1 ). A PLEGRIDY Starter Pack is available containing two prefilled pens or syringes: 63 micrograms (dose 1) and 94 micrograms (dose 2).
Table 1:
Schedule for Subcutaneous Dose Titration Dose Time a Amount (micrograms) Color of Pen or Syringe Label a Dosed every 14 days Dose 1 On day 1 63 Orange Dose 2 On day 15 94 Blue Dose 3 On day 29 and every 14 days thereafter 125 (full dose) Grey Intramuscular Administration of PLEGRIDY For patients using PLEGRIDY injected intramuscularly for the first time, PLEGRIDY should be titrated using the PLEGRIDY Titration Kit designed for use with the prefilled syringe.
The PLEGRIDY Titration Kit is supplied separately and contains two titration devices to be used only with PLEGRIDY prefilled syringes for intramuscular use. Patients should start treatment with 63 micrograms (yellow clip) on day 1. On day 15 (14 days later), the dose is increased to 94 micrograms (purple clip), reaching the full dose of 125 micrograms on day 29 (after another 14 days).
Patients continue with the full dose (125 micrograms) every 14 days thereafter (see Table 2 ). 2 Important Administration Instructions (All Dosage Forms) Healthcare professionals should train patients in the proper technique for self-administering subcutaneous injections using the prefilled pen or syringe or intramuscular injections using the prefilled syringe.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. 4 ) ]. Once removed from the refrigerator, PLEGRIDY should be allowed to warm to room temperature (about 30 minutes) prior to injection.
Do not use external heat sources such as hot water to warm PLEGRIDY. Each PLEGRIDY pen and syringe for subcutaneous injection is provided with the needle pre-attached. PLEGRIDY prefilled syringe for intramuscular injection is supplied as a prefilled syringe with a separate needle.
Both intramuscular and subcutaneous prefilled syringes and subcutaneously administered prefilled pens are for one-time use in one patient only and should be discarded after use. 3 Premedication for Flu-like Symptoms Prophylactic and concurrent use of analgesics and/or antipyretics may prevent or ameliorate flu-like symptoms sometimes experienced during treatment with PLEGRIDY.
This is not medical advice. Consult a qualified healthcare professional.
Most-reported reactions to the US regulator (12 mo to June 4, 2026): 391 reports total. [5]
Drug Delivery System Malfunction 96
Influenza Like Illness 30
Drug Dose Omission By Device 26
Injection Site Erythema 21
Multiple Sclerosis Relapse 19
Multiple Sclerosis 14
Death 13
Device Delivery System Issue 13
Fatigue 12
Headache 12
Product Dose Omission Issue 12
Injection Site Pain 11
Side effects & warnings
USOfficial regulatory label· Adverse reactions· revised October 21, 2025[3]
gov/medwatch. 1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of PLEGRIDY cannot be directly compared to rates in clinical trials of other drugs and may not reflect the rates observed in practice.
PLEGRIDY Via Subcutaneous Administration In clinical studies (Study 1 and Study 2), a total of 1468 patients with relapsing multiple sclerosis received PLEGRIDY by subcutaneous injection for up to 177 weeks (41 months), with an overall exposure equivalent to 1932 person-years.
A total of 1093 patients received at least 1 year, and 415 patients at least 2 years of treatment with PLEGRIDY. A total of 512 and 500 patients, respectively, received PLEGRIDY 125 micrograms every 14 days or every 28 days during the placebo-controlled phase of Study 1 (year 1).
The experience in year 2 of Study 1 and in the 2-year safety extension study (Study 2) was consistent with the experience in the 1-year placebo-controlled phase of Study 1. In the placebo-controlled phase of Study 1, the most common adverse drug reactions for PLEGRIDY 125 micrograms subcutaneously every 14 days were injection site erythema, influenza-like illness, pyrexia, headache, myalgia, chills, injection site pain, asthenia, injection site pruritus, and arthralgia (all had incidence more than 10% and at least 2% more than placebo).
The most commonly reported adverse event leading to discontinuation in patients treated with PLEGRIDY 125 micrograms subcutaneously every 14 days was influenza-like illness (in less than 1% of patients). Table 3 summarizes adverse reactions reported over 48 weeks from patients treated in the placebo-controlled phase of Study 1 who received subcutaneous PLEGRIDY 125 micrograms (n=512), or placebo (n=500), every 14 days.
Table 3:
Adverse Reactions in the 48-Week Placebo-Controlled Phase of Study 1 with an Incidence 2% Higher for PLEGRIDY Than for Placebo PLEGRIDY (N=512) % Placebo (N=500) % Nervous System Disorders Headache 44 33 Gastrointestinal Disorders Nausea 9 6 Vomiting 5 2 Musculoskeletal and Connective Tissue Disorders Myalgia 19 6 Arthralgia 11 7 General Disorders and Administration Site Conditions Injection site erythema 62 7 Influenza like illness 47 13 Pyrexia 45 15 Chills 17 5 Injection site pain 15 3 Asthenia 13 8 Injection site pruritus 13 1 Hyperthermia 4 1 Pain 5 3 Injection site edema 3 0 Injection site warmth 3 0 Injection site hematoma 3 1 Injection site rash 2 0 Investigations Body temperature increased 6 3 Alanine aminotransferase increased 6 3 Aspartate aminotransferase increased 4 2 Gamma-glutamyl-transferase increased 3 1 Skin and Subcutaneous Tissue Disorder Pruritus 4 1 Flu-Like Symptoms Influenza-like illness was experienced by 47% of patients receiving PLEGRIDY 125 micrograms every 14 days and 13% of patients receiving placebo.
Fewer than 1% of PLEGRIDY-treated patients in Study 1 discontinued treatment due to flu-like symptoms. Comparison Between Subcutaneous and Intramuscular Administration An open-label, crossover study analyzed findings from 130 healthy volunteers to assess the bioequivalence of single doses of 125 micrograms of PLEGRIDY administered as a subcutaneous and intramuscular injection (Study 3).
The most commonly reported adverse reactions (with >10% incidence in either arm) across both treatment periods were chills (36% in IM vs 27% in SC), pain (22% in IM vs 14% in SC), headache (36% in IM vs 41% in SC), injection site pain (11% in IM vs 15% in SC), and injection site erythema (2% in IM vs 25% in SC).
Overall, injection site reactions were reported in 14% via IM route as compared to 32% via SC route. 2 Immunogenicity As with all therapeutic proteins, there is a potential for immunogenicity. The detection of antibody formation is highly dependent on the sensitivity and specificity of the assay.
Additionally, the observed incidence of antibody (including neutralizing antibody) positivity in an assay may be influenced by several factors including assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease.
For these reasons, comparison of the incidence of antibodies in the studies described below with the incidence of antibodies in other studies or to other interferon beta-1a products may be misleading. In Study 1, fewer than 1% of patients treated with PLEGRIDY SC every 14 days for 1 year developed neutralizing antibodies.
Approximately 7% of PLEGRIDY SC-treated patients developed antibodies to the polyethylene glycol moiety. No formal studies have been conducted with regards to immunogenicity of the intramuscular route of administration of PLEGRIDY. 3 Postmarketing Experience The following adverse reactions have been identified during post-approval use of PLEGRIDY.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. 3 )]. 1 )] . 8 )] .
USOfficial regulatory label· Warnings and precautions· revised October 21, 2025[3]
6 ) Thrombotic Microangiopathy: Cases of thrombotic microangiopathy have been reported with interferon beta products. 7 ) Pulmonary Arterial Hypertension: Cases of pulmonary arterial hypertension (PAH) have been reported in patients treated with interferon beta products, including PLEGRIDY.
1 Hepatic Injury Severe hepatic injury, including hepatitis, autoimmune hepatitis, and rare cases of severe hepatic failure, have been reported with interferon beta. Asymptomatic elevation of hepatic transaminases has also been reported, and in some patients has recurred upon rechallenge with interferon beta.
Elevations in hepatic enzymes and hepatic injury have been observed with the use of PLEGRIDY in clinical studies. The incidence of increases in hepatic transaminases was greater in patients taking PLEGRIDY than in those taking placebo.
The incidence of elevations of alanine aminotransferase above 5 times the upper limit of normal was 1% in placebo-treated patients and 2% in PLEGRIDY-treated patients. The incidence of elevations of aspartate aminotransferase above 5 times the upper limit of normal was less than 1% in placebo-treated patients and less than 1% in PLEGRIDY-treated patients.
Elevations of serum hepatic transaminases combined with elevated bilirubin occurred in 2 patients. Both cases resolved following discontinuation of PLEGRIDY. Cases of noninfectious hepatitis have been reported in the postmarketing setting with use of PLEGRIDY.
Monitor patients for signs and symptoms of hepatic injury. 2 Depression and Suicide Depression, suicidal ideation, and suicide occur more frequently in patients receiving interferon beta than in patients receiving placebo. In clinical studies, the overall incidence of adverse events related to depression and suicidal ideation in multiple sclerosis patients was 8% in both the PLEGRIDY and placebo groups.
The incidence of serious events related to depression and suicidal ideation was similar and less than 1% in both groups. Advise patients to report immediately any symptom of depression or suicidal ideation to their healthcare provider.
If a patient develops depression or other severe psychiatric symptoms, consider stopping treatment with PLEGRIDY. 3 Anaphylaxis and Other Allergic Reactions Serious allergic reactions are rare complications of treatment with interferon beta; anaphylaxis has been reported with use of PLEGRIDY in the postmarketing setting.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
USOfficial regulatory label· Contraindications· revised October 21, 2025[3]
3 )] . History of hypersensitivity to natural or recombinant interferon beta or peginterferon, or any other component of PLEGRIDY ( 4 )
This is not medical advice. Consult a qualified healthcare professional.
Treatment should be initiated under supervision of a physician experienced in the treatment of multiple sclerosis. Plegridy may be administered subcutaneously (SC) using a single-use pre-filled pen or pre-filled syringe or intramuscularly (IM) using a single use pre-filled syringe.
Efficacy of peginterferon beta-1a administered subcutaneously has been demonstrated over placebo. Direct comparative data for peginterferon beta-1a versus non-pegylated interferon beta or data on efficacy of peginterferon beta-1a after switching from a non-pegylated interferon beta are not available.
1). Posology The recommended dose of Plegridy is 125 micrograms injected SC or IM every 2 weeks (14 days). Treatment initiation It is generally recommended that patients start SC or IM treatment with 63 micrograms at dose 1 (on day 0), increasing to 94 micrograms at dose 2 (on day 14), reaching the full dose of 125 micrograms by dose 3 (on day 28) and continuing with the full dose (125 micrograms) every 2 weeks (14 days) thereafter (see Table 1a for SC use or Table 1b for IM use).
Subcutaneous route An initiation pack is available containing the first 2 doses (63 micrograms and 94 micrograms).
Table 1a:
Titration schedule at initiation via SC route Dose Time* Amount (micrograms) Syringe label Dose 1 Day 0 63 Orange Dose 2 Day 14 94 Blue Dose 3 Day 28 125 (full dose) Grey *Dosed every 2 weeks (14 days) Intramuscular route An administration dose pack contains the full 125 microgram dose in 1 pre-filled syringe.
The Plegridy titration clips, designed for use with the pre-filled syringe are intended to limit the dose that is administered to 63 micrograms (dose 1 (1/2 dose), yellow titration clip) and 94 micrograms (dose 2 (3/4 dose), purple titration clip), for day 0 and day 14 respectively.
Each Plegridy titration clip should be used once, and then discarded along with any remaining medicinal product. Patients should use the full dose of 125 micrograms (no clip required) from day 28 onwards (dosing every 14 days). Table 1b Titration schedule at initiation via IM route Dose Time* Amount (micrograms) Titration clip Dose 1 Day 0 63 Yellow Dose 2 Day 14 94 Purple Dose 3 Day 28 125 (full dose) No clips needed *Dosed every 2 weeks (14 days) 4 Dose titration at the initiation of treatment may help to ameliorate flu-like symptoms that can occur at treatment initiation with interferons.
8). Switching between the SC and IM routes of administration and vice versa has not been studied. 2). If a dose is missed, it should be administered as soon as possible. • If 7 days or more to the next planned dose: Patients should administer their missed dose immediately.
Treatment can then continue with the next scheduled dose as planned. • If less than 7 days to the next planned dose: Patients should begin a new 2 week dosing schedule starting from when they administer their missed dose. A patient should not administer two doses of peginterferon beta-1a within 7 days of each other.
Special populations Elderly population The safety and efficacy of peginterferon beta-1a in patients over the age of 65 have not been sufficiently studied due to the limited number of such patients included in clinical trials. 2). 4).
Paediatric population The safety and efficacy of peginterferon beta-1a in children and adolescents aged 10 to less than 18 years have not been established in multiple sclerosis. 2 but no recommendation on a posology can be made. The safety and efficacy of peginterferon beta-1a in children below 10 years of age have not been established.
No data are available. Method of administration It is recommended that a healthcare professional trains patients in the proper technique for self— administering SC injections using the SC pre-filled syringe/pre-filled pen or IM injections using the IM pre-filled syringes as appropriate.
Patients should be advised to rotate sites for SC or IM injections every two weeks. The usual sites for subcutaneous injections include abdomen, arm, and thigh. The usual site for intramuscular injection is the thigh. Each Plegridy pre-filled pen/syringe for SC is provided with the needle pre-attached.
Plegridy prefilled syringe for IM use is supplied as a prefilled syringe with a separate needle for IM use. Both IM and SC pre-filled syringes and SC pre-filled pens are for single use only and should be discarded after use. Precautions to be taken before handling or administering the medicinal product Once removed from the refrigerator, Plegridy should be allowed to warm to room temperature (up to 25 °C) for about 30 minutes prior to injection.
External heat sources such as hot water must not be used to warm the medicinal product 5 Plegridy pre-filled syringe must not be used if the liquid is coloured, cloudy, or contains floating particles. The liquid in the syringe must be clear and colourless.
Plegridy pre-filled pen must not be used unless the green stripes are visible in the pen injection status window. Plegridy pre-filled pen must not be used if the liquid is coloured, cloudy, or contains floating particles. The liquid in […]
This is not medical advice. Consult a qualified healthcare professional.
Side effects & warnings
EUOfficial regulatory label· Adverse reactions· revised March 17, 2026[4]
Summary of safety profile The most common adverse drug reactions (ADR) (at a higher incidence than placebo) for Peginterferon beta-1a 125 micrograms subcutaneously every 2 weeks were injection site erythema, influenza like illness, pyrexia, headache, myalgia, chills, injection site pain, asthenia, injection site pruritus, and arthralgia.
The most commonly reported adverse reaction leading to discontinuation in patients treated with peginterferon beta-1a 125 micrograms subcutaneously every 2 weeks was influenza-like illness (<1%). Tabulated list of adverse reactions via subcutaneous route of administration In clinical studies, a total of 1,468 patients received peginterferon beta-1a SC for up to 278 weeks with an overall exposure equivalent of 4,217 person -years.
1,285 patients received at least 1 year, 1,124 patients have received at least 2 years, 947 patients received at least 3 years, and 658 patients received at least 4 years of treatment with peginterferon beta-1a. The experience in the randomised, uncontrolled phase (year 2) of the ADVANCE study and in the extension study ATTAIN (treatment received for up to 4 years) was consistent with the experience in the 1 year placebo-controlled phase of the ADVANCE study.
Table 2 summarizes ADRs (incidence above placebo and with a reasonable possibility of causality) from 512 patients treated with peginterferon beta-1a 125 micrograms SC every 2 weeks and 500 patients who received placebo for up to 48 weeks and post-marketing data.
The ADRs are presented as MedDRA preferred terms under the MedDRA System Organ Class. 4). ┼ Class label for interferon products, see below Pulmonary arterial hypertension $ Class label for interferon products 1 Adverse reactions derived only during post marketing experience Description of selected adverse reactions via subcutaneous route of administration Flu-like symptoms Influenza -like illness was experienced by 47% of patients receiving peginterferon beta-1a 125 micrograms every 2 weeks and 13% of patients receiving placebo.
g. influenza -like illness, chills, hyperpyrexia, musculoskeletal pain, myalgia, pain, pyrexia) was highest at the initiation of treatment and generally decreased over the first 6 months. Of the patients who reported flu-like symptoms 90% reported them as mild or moderate in severity.
None were considered serious in nature. Less than 1% of patients who received peginterferon beta-1a during the placebo-controlled phase of the ADVANCE study discontinued treatment due to flu-like symptoms. An open -label study in patients switching from interferon beta therapy to peginterferon beta-1a evaluated the onset and duration of prophylactically treated flu-like symptoms.
In patients experiencing flu-like symptoms, the median time to onset was 10 hours (interquartile range, 7 to 16 hours) after injection, and the median duration was 17 hours (interquartile range, 12 to 22 hours). g. injection site erythema, pain, pruritus, or oedema) were reported by 66% of patients who received peginterferon beta-1a 125 micrograms every 2 weeks compared to 11% of patients receiving placebo.
Injection site erythema was the most commonly reported injection site reaction. Of the patients who experienced injection site reactions 95% reported them as mild or moderate in severity. One patient out of 1,468 patients who received peginterferon beta-1a in clinical studies experienced an injection site necrosis which resolved with standard medical treatment.
Hepatic transaminase abnormalities The incidence of hepatic transaminase increases was greater in patients receiving peginterferon beta-1a compared to placebo. The majority of enzyme elevations were <3 times the upper limit of normal (ULN).
Elevations of alanine aminotransferase and aspartate aminotransferase (>5 times ULN), were reported in 1% and <1% of placebo-treated patients and 2% and <1% of patients treated with peginterferon beta-1a respectively. Elevations of serum hepatic transaminases combined with elevated […]
EUOfficial regulatory label· Warnings and precautions· revised March 17, 2026[4]
Traceability In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded. Hepatic injury Elevated serum hepatic transaminase levels, hepatitis, autoimmune hepatitis and rare cases of severe hepatic failure have been reported with interferon beta medicinal products.
Elevations in hepatic enzymes have been observed with the use of peginterferon beta-1a. 8). 3). Depression occurs with increased frequency in the multiple sclerosis population and in association with interferon use. Patients should be advised to immediately report any symptoms of depression and/or suicidal ideation to their prescribing physician.
Patients exhibiting depression should be monitored closely during therapy and treated appropriately. 8). Hypersensitivity reactions Serious hypersensitivity reactions including cases of anaphylaxis have been reported as a rare complication of treatment with interferon beta, including peginterferon beta-1a.
Patients should be advised to discontinue treatment with peginterferon beta-1a and seek immediate medical care if they experience signs and symptoms of anaphylaxis or severe hypersensitivity. 8). Injection site reactions Injection site reactions, including injection site necrosis, have been reported with the use of subcutaneous interferon beta.
To minimise the risk of injection site reactions patients should be instructed in the use of an aseptic injection technique. The procedure for the self-administration by the patient should be reviewed periodically especially if injection site reactions have occurred.
If the patient experiences any break in the skin, which may be accompanied by swelling or drainage of fluid from the injection site, the patient should be advised to speak with their doctor. One patient treated with peginterferon beta-1a in clinical trials experienced an injection site necrosis with SC peginterferon beta-1a.
8). 6 Decreased peripheral blood counts Decreased peripheral blood counts in all cell lines, including rare pancytopenia and severe thrombocytopenia, have been reported in patients receiving interferon beta. Cytopenias, including rare severe neutropenia and thrombocytopenia, have been observed in patients treated with peginterferon beta-1a.
This is not medical advice. Consult a qualified healthcare professional.
Who should not take it
EUOfficial regulatory label· Contraindications· revised March 17, 2026[4]
1. 8).
This is not medical advice. Consult a qualified healthcare professional.
Treatment initiation It is generally recommended that patients start treatment with 63 micrograms at dose 1 (on day 0) increasing to 94 micrograms at dose 2 (on day 14) reaching the full dose of 125 micrograms by dose 3 (on day 28) and continuing with the full dose (125 micrograms) every 14 days (2 weeks) thereafter (Table 1).
Table 1 – Titration Schedule at Initiation Dose Time* Amount (micrograms) Syringe/Pen Label Dose 1 On Day 0 63 Orange Dose 2 On Day 14 94 Blue Dose 3 On Day 28 125 (full dose) Grey * Dosed once 14 days (2 weeks) A Starter Pack is available containing the first 2 doses, 63 micrograms (dose 1, orange labeled syringe/pen) and 94 micrograms (dose 2, blue labeled syringe/pen) for day 0 and day 14 respectively.
Patients should use the Administration Dose Pack containing the full dose of 125 micrograms (full dose, grey labeled syringe/pen) from day 28 onwards (dosing every 14, days). Pediatrics Health Canada has not authorized an indication for pediatric use.
Renal Impairment No dosage adjustments are necessary in patients with renal impairment based on study data in mild, moderate, and severe renal impairment and end stage renal disease. 4 Administration • It is recommended that a health care professional trains patients in the proper technique for self-administering subcutaneous injections using the pre-filled syringe/pen.
Patients should be advised to rotate sites for subcutaneous injections. The usual sites for subcutaneous injections include thigh, abdomen, and upper arm. • Each PLEGRIDYTM pre-filled syringe/pen is provided with the needle pre-attached.
Pre-filled syringes/pens are for single use only and should be discarded after use. Dose titration at the initiation of treatment may help to ameliorate flu-like symptoms that can occur at treatment initiation with interferons. Prophylactic and concurrent use of analgesics and/or antipyretics may prevent or ameliorate flu-like symptoms sometimes experienced during interferon treatment.
5 Missed Dose If a dose of PLEGRIDYTM is missed, it should be administered as soon as possible: • If 7 days or more to the next planned dose: Patients should administer their missed dose immediately. Treatment can then continue with the next scheduled dose as planned.
• If less than 7 days to the next planned dose: Patients should begin a new 2 week dosing schedule starting from when they administer their missed dose. A patient should not administer two doses of PLEGRIDYTM within 7 days of each other.
5 OVERDOSAGE No case of overdose has been reported. In case of over dosage, appropriate supportive treatment should be given. In case of overdose with PLEGRIDYTM, the patient should be advised to seek medical attention. For management of a suspected drug overdose, contact your regional poison control centre.
Eur, Glacial PLEGRIDYTM (peginterferon beta-1a) Page 7 of 47 […]
8). Renal and urinary disorders Nephrotic syndrome (class effects) Cases of nephrotic syndrome with different underlying nephropathies including collapsing focal segmental glomerulosclerosis (FSGS), minimal change disease (MCD), membranoproliferative glomerulonephritis (MPGN) and membranous glomerulopathy (MGN) have been reported during treatment with interferon-beta products.
Events were reported at various time points during treatment and may occur after several years of treatment with interferon beta. g. oedema, proteinuria and impaired renal function is recommended, especially in patients at higher risk of renal disease.
Prompt treatment of nephrotic syndrome is required and discontinuation of treatment with peginterferon beta-1a should be considered. Severe renal impairment Caution should be used when administering peginterferon beta-1a to patients with severe renal impairment.
Thrombotic microangiopathy (TMA) (class effects) Cases of TMA, manifested as thrombotic thrombocytopenic purpura (TTP) or haemolytic uraemic syndrome (HUS), including fatal cases, have been reported with interferon beta products. Events were reported at various time points during treatment and may occur several weeks to several years after starting treatment with interferon beta.
g. confusion, paresis) and impaired renal function. Laboratory findings suggestive of TMA include decreased platelet counts, increased serum lactate dehydrogenase (LDH) due to haemolysis and schistocytes (erythrocyte fragmentation) on a blood film.
Therefore if clinical features of TMA are observed, further testing of blood platelet levels, serum LDH, blood films and renal function is recommended. If TMA is diagnosed, prompt treatment is required (considering plasma exchange) and immediate discontinuation of peginterferon beta-1a is recommended.
Laboratory abnormalities Laboratory abnormalities are associated with the use of interferons. g. aspartate aminotransferase (AST), alanine aminotransaminase (ALT)), are recommended prior to initiation and at regular intervals following introduction of peginterferon beta-1a therapy and then periodically thereafter in the absence of clinical symptoms.
Patients with myelosuppression may require more intensive monitoring of complete blood cell counts, with differential and platelet counts. Hypothyroidism and hyperthyroidism have been observed with the use of interferon beta products.
Regular thyroid function tests are recommended in patients with a history of thyroid dysfunction or as clinically indicated. Seizure Peginterferon beta-1a should be administered with caution to patients with a history of seizures, to those receiving treatment with anti-epileptics, particularly […]
Less than 1% of PLEGRIDY-treated patients experienced a serious allergic reaction such as angioedema or urticaria. Those who did have serious allergic reactions recovered promptly after treatment with antihistamines or corticosteroids.
Discontinue PLEGRIDY if a serious allergic reaction occurs. The protective rubber cover of the PLEGRIDY prefilled syringe for intramuscular administration contains natural rubber latex which may cause allergic reactions and should not be handled by latex-sensitive individuals.
The safe use of PLEGRIDY prefilled syringe in latex-sensitive individuals has not been studied. 4 Injection Site Reactions Including Necrosis Injection site reactions, including injection site necrosis, can occur with the use of interferon beta, including PLEGRIDY.
, injection site erythema, pain, pruritus, or edema) was 66% in the PLEGRIDY group and 11% in the placebo group; the incidence of severe injection site reactions was 3% in the PLEGRIDY group and 0% in the placebo group. One patient out of 1468 patients who received PLEGRIDY in clinical studies experienced injection site necrosis.
The injury resolved with standard medical treatment. , injection site erythema, pain, pruritus, or edema) was 14% in the intramuscular PLEGRIDY group and 32% in the subcutaneous PLEGRIDY group. Injection site abscesses and cellulitis have been reported in the postmarketing setting with use of interferon beta.
Some cases required treatment with hospitalization for surgical drainage and intravenous antibiotics. Periodically evaluate patient understanding and use of aseptic self-injection techniques and procedures, particularly if injection site necrosis has occurred.
Decisions to discontinue therapy following necrosis at a single injection site should be based on the extent of the necrosis. For patients who continue therapy with PLEGRIDY after injection site necrosis has occurred, avoid administration of PLEGRIDY near the affected area until it is fully healed.
If multiple lesions occur, change injection site or discontinue PLEGRIDY until healing occurs. 5 Congestive Heart Failure Congestive heart failure, cardiomyopathy, and cardiomyopathy with congestive heart failure occur in patients receiving interferon beta.
In clinical studies, the incidence of cardiovascular events was 7% in both PLEGRIDY and placebo treatment groups. No serious cardiovascular events were reported in the PLEGRIDY group. Monitor patients with significant cardiac disease for worsening of their cardiac condition during initiation and continuation of treatment with PLEGRIDY.
6 Decreased Peripheral Blood Counts Interferon beta can cause decreased peripheral blood counts in all cell lines, including rare instances of pancytopenia and severe thrombocytopenia. 0 x 10 9 /L occurred in 7% of patients receiving PLEGRIDY and in 1% receiving placebo.
There is no apparent association between decreases in white blood cell counts and an increased risk of infections or serious infections. 0 x 10 9 /L), and platelet counts (below 100 x 10 9 /L) were all less than 1% and similar in both placebo and PLEGRIDY groups.
5 x 10 9 /L). In both patients, cell counts recovered after discontinuation of PLEGRIDY. Compared to placebo, there were no significant differences in red blood cell counts in patients treated with PLEGRIDY. Monitor patients for infections, bleeding, and symptoms of anemia.
Monitor complete blood cell counts, differential white blood cell counts, and platelet counts during treatment with PLEGRIDY. Patients with myelosuppression may require more intensive monitoring of blood cell counts. 7 Thrombotic Microangiopathy Cases of thrombotic microangiopathy (TMA), including thrombotic thrombocytopenic purpura and hemolytic uremic syndrome, some fatal, have been reported with interferon beta products.
Cases have been reported several weeks to years after starting interferon beta products. Discontinue PLEGRIDY if clinical symptoms and laboratory findings consistent with TMA occur, and manage as clinically indicated. 8 Pulmonary Arterial Hypertension Cases of pulmonary arterial hypertension (PAH) have been reported in patients treated with interferon beta products, including PLEGRIDY.
PAH has occurred in patients treated with interferon beta products in the absence of other contributory factors. Many of the reported cases required hospitalization, including one case with interferon beta in which the patient underwent a lung transplant.
PAH has developed at various time points after initiating therapy with interferon beta products and may occur several years after starting treatment. , dyspnea, new or increasing fatigue) should be assessed for PAH. If alternative etiologies have been ruled out and a diagnosis of PAH is confirmed, discontinue treatment and manage as clinically indicated.
9 Autoimmune Disorders Autoimmune disorders of multiple target organs including idiopathic thrombocytopenia, hyper- and hypothyroidism, and autoimmune hepatitis have been reported with interferon beta. In clinical studies, the incidence of autoimmune disorders was less than 1% in both PLEGRIDY and placebo treatment groups.
If patients develop a new autoimmune disorder, consider stopping PLEGRIDY. 10 Seizures Seizures are associated with the use of interferon beta. The incidence of seizures in multiple sclerosis clinical studies was less than 1% in patients receiving PLEGRIDY and placebo.
Exercise caution when administering PLEGRIDY to patients with a seizure disorder.
8). Renal and urinary disorders Nephrotic syndrome (class effects) Cases of nephrotic syndrome with different underlying nephropathies including collapsing focal segmental glomerulosclerosis (FSGS), minimal change disease (MCD), membranoproliferative glomerulonephritis (MPGN) and membranous glomerulopathy (MGN) have been reported during treatment with interferon-beta products.
Events were reported at various time points during treatment and may occur after several years of treatment with interferon beta. g. oedema, proteinuria and impaired renal function is recommended, especially in patients at higher risk of renal disease.
Prompt treatment of nephrotic syndrome is required and discontinuation of treatment with peginterferon beta-1a should be considered. Severe renal impairment Caution should be used when administering peginterferon beta-1a to patients with severe renal impairment.
Thrombotic microangiopathy (TMA) (class effects) Cases of TMA, manifested as thrombotic thrombocytopenic purpura (TTP) or haemolytic uraemic syndrome (HUS), including fatal cases, have been reported with interferon beta products. Events were reported at various time points during treatment and may occur several weeks to several years after starting treatment with interferon beta.
g. confusion, paresis) and impaired renal function. Laboratory findings suggestive of TMA include decreased platelet counts, increased serum lactate dehydrogenase (LDH) due to haemolysis and schistocytes (erythrocyte fragmentation) on a blood film.
Therefore if clinical features of TMA are observed, further testing of blood platelet levels, serum LDH, blood films and renal function is recommended. If TMA is diagnosed, prompt treatment is required (considering plasma exchange) and immediate discontinuation of peginterferon beta-1a is recommended.
Laboratory abnormalities Laboratory abnormalities are associated with the use of interferons. g. aspartate aminotransferase (AST), alanine aminotransaminase (ALT)), are recommended prior to initiation and at regular intervals following introduction of peginterferon beta-1a therapy and then periodically thereafter in the absence of clinical symptoms.
Patients with myelosuppression may require more intensive monitoring of complete blood cell counts, with differential and platelet counts. Hypothyroidism and hyperthyroidism have been observed with the use of interferon beta products.
Regular thyroid function tests are recommended in patients with a history of thyroid dysfunction or as clinically indicated. Seizure Peginterferon beta-1a should be administered with caution to patients with a history of seizures, to 7 those receiving treatment with anti-epileptics, […]