peginterferon beta-1a

Absorption: Extent of absorption following SUBQ or IM administration unknown.

Distribution: Widely distributed to tissues.

Metabolism/Excretion: Undergoes catabolism; excretion is mainly renal.

Half-Life: 78 hr.

Time/Action Profile ⬆ ⬇

(reduction in relapse rate)

ROUTE	ONSET	PEAK	DURATION
SUBQ	within one mo	24–36 wk	unknown
IM	unknown	unknown	unknown

Contraind./Precautions ⬆ ⬇

Contraindicated in:

Hypersensitivity to natural or recombinant interferon beta or peginterferon.

Use Cautiously in:

History of depression or suicidal ideation;
Latex allergy;
History of seizures;
Renal impairment (risk of adverse reactions may be ↑);
OB: Use during pregnancy only if potential maternal benefit justifies potential fetal risk;
Lactation: Use while breastfeeding only if potential maternal benefit justifies potential risk to infant;
Pedi: Safety and effectiveness not established in children;
Geri: Safety and effectiveness not established in older adults.

Adv. Reactions/Side Effects ⬆ ⬇

CV: HF

Derm: pruritus

GI: HEPATOTOXICITY, nausea, vomiting

Hemat: ↓peripheral blood counts, HEMOLYTIC UREMIC SYNDROME, THROMBOTIC THROMBOCYTOPENIC PURPURA

Local: injection site reactions

MS: arthralgia, myalgia

Neuro: depression, headache, SEIZURES, SUICIDAL IDEATION, weakness

Resp: PULMONARY ARTERIAL HYPERTENSION (PAH)

Misc: chills, fever, flu-like symptoms, AUTOIMMUNE DISORDERS, HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS)

Interactions ⬆ ⬇

Drug-drug:

↑myelosuppression may occur with other myelosuppressives including antineoplastics.
Concurrent use of hepatotoxic agents may ↑ the risk of hepatotoxicity (↑ liver enzymes).

Drug-Natural Products:

Avoid concomitant use with immunomodulating natural products such as astragalus, echinacea, and melatonin.

Route/Dosage ⬆ ⬇

IM SC (Adults ): 63 mcg on Day 1, then 94 mcg on Day 15, then 125 mcg every 14 days.

Availability ⬆ ⬇

Solution for injection (prefilled pens and prefilled syringes): 63 mcg/0.5 mL; 94 mcg/0.5 mL; 125 mcg/0.5 mL

Assessment ⬆ ⬇

Assess frequency of exacerbations of symptoms of MS periodically during therapy.
Monitor patient for signs of depression during therapy. If depression occurs, notify health care professional immediately.
Monitor for injection site reactions (erythema, pain, pruritus, edema, bruising, drainage, necrosis). Avoid injecting near area of reaction.
Monitor patient with significant cardiac disease for worsening symptoms during initiation and periodically during therapy.
Assess patients who develop unexplained symptoms (dyspnea, new or increasing fatigue) for PAH. If other causes have been ruled out and a diagnosis of PAH is confirmed, discontinue therapy.

Lab Test Considerations:

Monitor serum AST, ALT, and bilirubin periodically during therapy.
- Monitor CBC with differential and platelet counts periodically during therapy. May cause anemia, ↓ lymphocyte, ↓ neutrophil, and ↓ platelet counts.

Implementation ⬆ ⬇

Administer prophylactic analgesics and/or antipyretics to prevent or minimize flu-like symptoms. Incidence of injection site reactions may be less with IM than with SUBQ dosing.
Remove syringe from refrigerator and allow to warm to room temperature for 30 min before injection. Do not use warm water to warm. Solution is clear to slightly opalescent and colorless to slightly yellow. Do not administer solutions that are cloudy, discolored, or contain particulate matter.
SC: Inject SUBQ in abdomen, back of upper arm, or thigh every 14 days; rotate sites. Prefilled pens are for single dose; discard after use.
- For patients using SUBQ dosing for the first time, titrate using the Plegridy Starter Pack for use with the prefilled syringe. Kit is supplied separately and contains two titration devices (Dose 1 for Day 1: 63 mcg, orange clip; Dose 2 for Day 15: 94 mcg, blue clip; Dose 3 for Day 29 and every 14 days after: 125 mcg, gray clip) to be used only with prefilled syringes for SUBQ use.
IM: Rotate injection sites between left and right thighs.
- Protective cover of prefilled syringe for IM use contains latex. Avoid handling by latex-sensitive individuals. Monitor for allergic reactions.
- For patients using IM dosing for the first time, titrate using the Plegridy Titration Kit for use with the prefilled syringe. Kit is supplied separately and contains two titration devices (Dose 1 for Day 1: 63 mcg, yellow clip; Dose 2 for Day 15: 94 mcg, purple clip; Dose 3 for Day 29 and every 14 days after: 125 mcg, no clip) to be used only with prefilled syringes for IM use.

Patient/Family Teaching ⬆ ⬇

Instruct patient in correct technique for injection and care and disposal of equipment. Avoid injecting into areas of skin irritation, redness, bruising, infection, or scarring. Check injection site 2 hr after injection for redness, swelling, and tenderness. Notify health care professional if skin reaction does not clear in a few days. Caution patient not to reuse needles or syringes and provide patient with a puncture-resistant container for disposal.
Instruct patient to take medication as directed; do not change dose or schedule without consulting health care professional. Advise patient to read Medication Guide prior to starting therapy and with each Rx refill in case of changes.
Inform patient that flu-like symptoms (headache, fever, chills, myalgia, sweating, malaise, tiredness) may occur during therapy. Acetaminophen may be used for relief of fever and myalgias. Flu-like symptoms are not contagious.
Advise patient to notify health care professional immediately if signs and symptoms of liver disease (yellowing of skin or whites of eyes, nausea, loss of appetite, tiredness, bleeding easily, confusion, sleepiness, dark-colored urine, pale stools), depression, suicidal thoughts, seizures, allergic reactions (itching; swelling of face, eyes, lips, tongue, throat; trouble breathing; feeling faint; anxiousness; rash; hives) or autoimmune diseases (easy bleeding or bruising, thyroid gland problems, autoimmune hepatitis) occur.
Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding.

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇