Loading…
Plegridy is a brand name for Peginterferon Beta-1a. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Plegridy is indicated in adult patients for the treatment of relapsing remitting multiple sclerosis (see section 5.1).
Verbatim from this product's EMA label. Tap a section to expand.
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.
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.
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.
1. 8).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Know a brand we are missing in European Union? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
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 […]
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 […]
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.
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, […]