peginterferon beta-1a (Rx)

Brand and Other Names:Plegridy
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Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

injectable solution for SC, prefilled syringe or pen

  • 63mcg/0.5mL and 94mcg/0.5mL titration kit
  • 125mcg/0.5mL; each syringe has attached 29-ga, 0.5-inch needle

injectable solution for IM, prefilled syringe

  • 63mcg/0.5mL and 94mcg/0.5mL titration kit
  • 125mcg/0.5mL; supplied with separate 23-ga, 1.25-inch needles

Multiple Sclerosis

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

Day 1: 63 mcg SC or IM x 1 dose

Day 15: 94 mcg SC or IM x 1 dose

Day 29 and thereafter: 125 mcg SC or IM once and q14 days thereafter

Dosage Modifications

Renal impairment

  • Mild, moderate, or severe: Increased peak plasma concentration and AUC observed in pharmacokinetic study; prolonged half-life also reported
  • Monitor for adverse reactions owing increased drug exposure in patients with severe renal impairment

Dosing Considerations

Switching between SC and IM administration

  • Not studied
  • Not expected that dose titration should be repeated to ameliorate flu-like symptoms

Safety and efficacy not established

Clinical studies did not include sufficient numbers of patients aged ≥65 years to determine whether they respond differently from younger subjects

Other reported clinical experience has not identified differences in responses compare to younger patients

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Adverse Effects

>10%

IM

  • Chills (36%)
  • Headache (36-41%)
  • Pain (22%)
  • Injection site pain (11%)

SC

  • Injection site erythema (25-62%)
  • Influenza like illness (47%)
  • Pyrexia (45%)
  • Headache (41%)
  • Chills (17-27%)
  • Injection site pain (15%)
  • Asthenia (13%)
  • Injection site pruritus (13%)

1-10%

IM

  • Injection site erythema (2%)

SC

  • Body temperature increased (6%)
  • ALT increased (6%)
  • Pain (5%)
  • AST increased (4%)
  • Pruritus (4%)
  • Hyperthermia (4%)
  • Gamma-glutamyl-transferase increased (3%)
  • Injection site edema (3%)
  • Injection site warmth (3%)
  • Injection site hematoma (3%)
  • Injection site rash (2%)

Postmarketing Reports

Serious hypersensitivity reactions (eg, anaphylaxis)

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Warnings

Contraindications

Hypersensitivity to natural or recombinant interferon beta or peginterferon, or any other excipients

Cautions

Depression, suicidal ideation, and suicide may occur; advise patients to report immediately any symptom of depression and consider discontinuing if depression 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

Serious allergic reactions

  • Serious allergic reactions (eg, angioedema, urticaria) reported
  • Treat allergic reaction appropriately and promptly with antihistamines or corticosteroids
  • Discontinue if a serious allergic reaction occurs
  • Protective rubber cover of prefilled syringe for IM administration contains natural rubber latex; avoid IM use in patients that allergic or sensitive to latex; safety of prefilled syringes in latex-sensitive individuals not studied

Hepatic injury

  • Severe hepatic injury, including hepatitis, autoimmune hepatitis, and rare cases of severe hepatic failure, reported
  • Elevated hepatic enzymes and hepatic injury reported; recurred in some patients upon rechallenge
  • Monitor for signs and symptoms of hepatic injury
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Pregnancy & Lactation

Pregnancy

There is pregnancy exposure registry that monitors pregnancy outcomes in women exposed to drug during pregnancy; encourage patients to enroll by calling 1-866-810-1462 or visiting https://www.plegridypregnancyregistry.com/.

Data from large population-based cohort study, as well as other published studies over several decades, have not identified drug-associated risk of major birth defects with use of interferon beta products during early pregnancy; findings regarding potential risk for low birth weight or miscarriage with use of interferon beta products in pregnancy have been inconsistent; in a study in pregnant monkeys, administration of interferon beta during pregnancy resulted in an increased rate of abortion

Lactation

Limited published literature has described the presence of interferon beta-1a products in human milk at low levels; there are no data on effects of interferon beta-1a on milk production

Consider developmental and health benefits of breastfeeding along with mother’s clinical need for drug and any potential adverse effects on breastfed infant from therapy or from underlying maternal condition

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 or IM Preparation

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 or IM Administration

May be administered SC or IM

Use analgesics and/or antipyretics prophylactically or concurrently to prevent/ameliorate flulike symptoms associated with treatment

Train the proper technique for self-administering injections via SC or IM

Advise to check injection site for redness, swelling, and tenderness 2 hr after administering

Prefilled syringes and pens are for single-use only; discard after use

Sites of injection

  • SC: Rotate injection sites between abdomen, back of upper arms, and thighs
  • IM: Rotate injection sites between left and right thigh

Storage

Prefilled pen or syringes

  • Store in closed original carton to protect from light until ready for injection
  • Refrigerate between 2-8ºC (36-46ºF)
  • Do not freeze; discard if frozen
  • If refrigeration unavailable, store at 2-25ºC (36-77ºF) for up to 30 days; can be removed from, and returned to, a refrigerator if necessary; not to exceed a total combined time out of refrigeration of 30 days at 2-25ºC (36-77ºF)
  • IM prefilled syringe contains natural rubber latex
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Images

BRAND FORM. UNIT PRICE PILL IMAGE
Plegridy subcutaneous
-
63 mcg/0.5 mL- 94 mcg/0.5 mL injection
Plegridy subcutaneous
-
125 mcg/0.5 mL injection
Plegridy subcutaneous
-
63 mcg/0.5 mL- 94 mcg/0.5 mL solution
Plegridy subcutaneous
-
125 mcg/0.5 mL solution

Copyright © 2010 First DataBank, Inc.

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Patient Handout

A Patient Handout is not currently available for this monograph.
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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.
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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.
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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.