Finished product reference

Peginterferon Beta-1a

Injection · Parenteral · 125 µg/0.5mL

List code
52219
Pharmacologic class
Interferon beta

What it is and how it works

Mechanism of Action The mechanism by which PLEGRIDY exerts its effects in patients with multiple sclerosis is unknown.

Indications

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

Dosage and administration (summary)

For subcutaneous or intramuscular use only Recommended dose: 125 micrograms every 14 days PLEGRIDY dose should be titrated, starting with 63 micrograms on day 1, 94 micrograms on day 15, and 125 micrograms (full dose) on day 29 A healthcare professional 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 Analgesics and/or antipyretics on treatment days may help ameliorate flu-like symptoms Dosing Information PLEGRIDY may only be administered subcutaneously (SC) or intramuscularly (IM).

Contraindications

is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta or peginterferon, or any other component of PLEGRIDY . History of hypersensitivity to natural or recombinant interferon beta or peginterferon, or any other component of PLEGRIDY

Warnings and precautions

Hepatic injury: monitor liver function tests; monitor patients for signs and symptoms of hepatic injury; consider discontinuation of PLEGRIDY if hepatic injury occurs Depression and suicide: advise patients to report immediately any symptom of depression or suicidal ideation to their healthcare provider; consider discontinuation of PLEGRIDY if depression occurs Anaphylaxis and other allergic reactions: Discontinue PLEGRIDY if a serious allergic reaction occurs Injection site reactions: Do not administer PLEGRIDY into affected area until fully healed.

Pregnancy

Pregnancy Risk Summary Data from a large population-based cohort study, as well as other published studies over several decades, have not identified a drug-associated risk of major birth defects with the use of interferon beta products during early pregnancy.

Storage and supply

Storage and Handling Store PLEGRIDY prefilled pens and prefilled syringes in a refrigerator between 2°C to 8°C (36°F to 46°F) in the closed original carton to protect from light until ready for injection. Do not freeze. Discard if frozen.

Source: Peginterferon Beta-1A (Plegridy Pen) — US FDA prescribing information, 2025-11-12, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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