peginterferon beta-1a (Rx)

Brand and Other Names:Plegridy
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

injection solution, prefilled syringe

  • 63mcg/0.5mL and 94mcg/0.5mL starter pack
  • 125mcg/0.5mL

injection solution, prefilled pen for autoinjector

  • 63mcg/0.5mL and 94mcg/0.5mL starter pack
  • 125mcg/0.5mL

Multiple Sclerosis

Indicated for relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease

Administer SC q2wk with the following initial titration schedule

  • Day 1: 63 mcg SC once
  • Day 15: 94 mcg SC once
  • Beginning on day 29 and thereafter: 125 mcg SC q2wk

Safety and efficacy not established

Safety and efficacy not established

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Adverse Effects

>10%

Injection site reactions (66%)

Injection site erythema (62%)

Influenzalike illness (47%)

Pyrexia (45%)

Headache (44%)

Myalgia (19%)

Chills (17%)

Asthenia (13%)

Injection site pruritus (13%)

Arthralgia (11%)

1-10%

Nausea (9%)

Depression (8%); not different from placebo

CHF, cardiomyopathy (7%); not different from placebo

Decreased WBCs (7%)

Increased ALT (6%)

Vomiting (5%)

Pain (5%)

Hyperthermia (4%)

Pruritus (4%)

Increased AST (4%)

Increased GGT (3%)

Injection site edema (3%)

Injection site warmth (3%)

Injection site hematoma (3%)

Injection site rash (2%)

Increased ALT, >5 x ULN (2%)

<1

Increased AST, >5 x ULN

Seizures

Anaphylaxis, angioedema, urticaria

Autoimmune disorders

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Warnings

Contraindications

History of hypersensitivity to natural or recombinant interferon beta or peginterferon

Cautions

Severe hepatic injury, including hepatitis, autoimmune hepatitis, and rare cases of severe hepatic failure, reported; monitor liver function tests and consider discontinuing if hepatic injury occurs

Depression, suicidal ideation, and suicide occur more frequently in patients receiving interferon beta than in patients receiving placebo; advise patients to report immediately any symptom of depression and consider discontinuing if depression occurs

Seizures are associated with the use of interferon beta (<1%)

Anaphylaxis and other allergic reactions reported (rare); discontinue if a serious allergic reaction occurs

Injection site reactions reported, including site necrosis; change injection site; if multiple injection lesions occur, discontinue until healing occurs

Congestive heart failure and/or cardiomyopathy reported (7% in both peginterferon beta-1a- and placebo-treated patients)

Decreased peripheral blood counts reported in all cell lines, including rare instances of pancytopenia and severe thrombocytopenia; monitor for symptoms of infections, bleeding, and anemia; monitor CBC counts, differential WBC counts, and platelet counts

Autoimmune disorders of multiple target organs, including idiopathic thrombocytopenia, hyper- and hypothyroidism, and autoimmune hepatitis, have been reported

In patients with renal impairment, monitor for adverse reactions because of increased systemic exposure

Cases of thrombotic microangiopathy, including thrombotic thrombocytopenic purpura and hemolytic uremic syndrome, some fatal, reported; some cases have been reported several weeks to years after starting interferon beta products; discontinue therapy if clinical symptoms and laboratory findings consistent with TMA occur, and manage as clinically indicated

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Pregnancy & Lactation

Pregnancy Category: C

Encourage patients to enroll in pregnancy exposure registry that monitors pregnancy outcomes in women exposed to drug during pregnancy (1-866-810-1462 or visiting https://www.plegridypregnancyregistry.com/)

Lactation: Unknown if distributed in human breast milk

Pregnancy Categories

A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA: Information not available.

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Pharmacology

Mechanism of Action

The exact mechanism by which peginterferon beta-1a exerts its effects in patients with multiple sclerosis is unknown; interferons are thought to alter response to surface antigen and may enhance immune cell activities

Absorption

Does not accumulate in serum after multiple doses

Peak plasma concentration: 280 pg/mL

Peak plasma time: 1-1.5 days

AUC over 14 day interval: 34.8 ng•hr/mL

Distribution

481 L

Metabolism

Not extensively metabolized in the liver

Elimination

Half-life: 78 hr

Steady state clearance: 4.1 L/hr

Excretion: Mostly in urine

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Administration

SC Preparation

Prophylactic use of analgesics and/or antipyretics may prevent/ameliorate flulike symptoms associated with treatment

Remove from refrigerator and allow to warm to room temperature (~30 min) before injection (do not use external heat sources, such as warm water)

SC Administration

Train patients in the proper technique for self-administering SC injections

Patient should check the injection site for redness, swelling, and tenderness 2 hr after administering

Rotate sites for SC injections between the abdomen, back of the upper arm, and thigh

Storage

Store in the closed original carton to protect from light until ready for injection

Refrigerate between 2-8°C (36-46°F)

Do not freeze; discard if frozen

If refrigeration unavailable, may be stored between 2-25°C (36-77°F) for up to 30 days, protected from light

Can be removed from, and returned to, a refrigerator if necessary

Do not exceed a total combined time out of refrigeration of 30 days within a temperature range of 2-25°C (36-77°F)

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Images

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Formulary

FormularyPatient Discounts

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The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

Tier Description
1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
NC NOT COVERED – Drugs that are not covered by the plan.
Code Definition
PA Prior Authorization
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
QL Quantity Limits
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
ST Step Therapy
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
OR Other Restrictions
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.