Loading…
PLEGRIDY is a brand name for Peginterferon Beta-1a, supplied as a liquid. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 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…
Verbatim from this product's HC label. Tap a section to expand.
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.
). 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.
, 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.
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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Know a brand we are missing in Canada? 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.
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.
• 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 […]
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.
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 […]