ropeginterferon alfa-2b

Contraindicated in:

Hypersensitivity;
Presence or history of severe psychiatric disorders, particularly severe depression, suicidal ideation, or suicide attempt;
Moderate or severe hepatic impairment;
Severe renal impairment;
Presence or history of active serious or untreated autoimmune disease;
Immunosuppressed transplant recipients;
Uncontrolled hypertension, New York Heart Association Class II–IV HF, ventricular arrhythmias, recent MI, significant coronary artery disease, unstable angina, or recent stroke;
OB: Pregnancy;
Lactation: Lactation.

Use Cautiously in:

Hypothyroidism or hyperthyroidism;
Retinopathy;
Rep: Women of reproductive potential;
Pedi: Safety and effectiveness not established in children;
Geri: ↑risk of adverse reactions.

Adv. Reactions/Side Effects ⬆ ⬇

CV: edema, hypertension, atrial fibrillation, HF, MI, myocardial ischemia

Derm: ↑sweating, alopecia, pruritus, rash, erythema, hyperkeratosis, psoriasis

EENT: nasopharyngitis, cataract, dry eye, retinal artery/vein occlusion, retinal detachment, retinal exudate, retinal hemorrhage, retinopathy

Endo: autoimmune thyroiditis, hyperthyroidism, hypothyroidism, type 1 diabetes

GI: ↑liver enzymes, abdominal pain, diarrhea, nausea, dry mouth, COLITIS, PANCREATITIS

GU: menstrual disorders, renal impairment

Hemat: leukopenia, neutropenia, thrombocytopenia, anemia

Local: injection site reactions

Metab: ↓appetite, hyperlipidemia, hypertriglyceridemia

MS: arthralgia, muscle spasms, periodontal disorders

Neuro: depression, dizziness, fatigue, headache, sleep disorder, vertigo, aggression, bipolar disorder, confusion, mania, SUICIDAL BEHAVIORS/THOUGHTS, transient ischemic attack

Resp: dyspnea, INTERSTITIAL PNEUMONITIS, PULMONARY HYPERTENSION, pulmonary infiltrates

Misc: flu-like syndrome, HYPERSENSITIVITY REACTIONS (INCLUDING ANAPHYLAXIS AND ANGIOEDEMA), INFECTION

Interactions ⬆ ⬇

Drug-drug:

May suppress CYP450 enzymes, which can ↑ levels and risk of toxicity of various CYP450 substrate.
May cause additive myelosuppression when used with other myelosuppressive agents.
↑risk of CNS depression with opioids, sedatives, and hypnotics.

Availability ⬆ ⬇

Solution for injection (prefilled syringes): 500 mcg/mL

Route/Dosage ⬆ ⬇

SC (Adults ): Not previously receiving hydroxyurea: 100 mcg every 2 wk; ↑ by 50 mcg every 2 wk until Hct <45%, platelets <400 × 10⁹/L, and WBC <10 × 10⁹/L. After 1 yr of therapy, may expand dosing frequency to every 4 wk. Transitioning from hydroxyurea: 50 mcg every 2 wk in combination with hydroxyurea; ↑ dose of ropeginterferon alfa-2b by 50 mcg every 2 wk until Hct <45%, platelets <400 × 10⁹/L, and WBC <10 × 10⁹/L. Taper hydroxyurea therapy by ↓ total biweekly dose by 20–40% every 2 wk during Week 3–12 and then discontinue hydroxyurea by Week 13. After 1 yr of ropeginterferon alfa-2b therapy, may expand dosing frequency to every 4 wk.

US Brand Names ⬆ ⬇

Action ⬆ ⬇

Binds to interferon alfa receptor and activates several kinases, including Janus kinase 1 and tyrosine kinase 2; specific mechanism of benefit in polycythemia vera unknown.

Therapeutic effects:

Improvement in hematological parameters and spleen size and reduction in thromboembolic events.

Classifications ⬆ ⬇

Therapeutic Classification: immune modifiers

Pharmacologic Classification: interferons

Pharmacokinetics ⬆ ⬇

Absorption: 27% absorbed following SUBQ administration.

Distribution: Minimally distributed to tissues.

Metabolism/Excretion: Unknown.

Half-Life: 7 days.

Time/Action Profile ⬆ ⬇

(plasma concentrations)

ROUTE	ONSET	PEAK	DURATION
SUBQ	unknown	2–5 days	unknown

Patient/Family Teaching ⬆ ⬇

Explain purpose and side effects of medication to patient. Advise patient to read Patient Information before starting therapy.
Instruct patient or caregiver on proper storage, preparation, administration, and disposal.
Advise patient to notify health care professional immediately if hypersensitivity symptoms (rash or acute difficulty breathing) occur.
Advise patient to have eye examinations before and during therapy, specifically in those with retinopathy-associated disease such as diabetes mellitus or hypertension, and to promptly notify health care professional of visual changes.
Inform patient that phlebotomy to normalize blood hyperviscosity may be necessary during the titration phase of ropeginterferon alfa-2b.
Advise patient to maintain good oral hygiene and regular dental exams to avoid dental and periodontal disorders (loss of teeth, dry mouth).
Advise patient and caregivers to notify health care professional of changes in mood or behavior or new or worsening depression. If suicidal ideation or attempts occur, advise patient to immediately stop therapy and seek medical attention.
Advise patient to notify health care professional if signs or symptoms of diabetes, thyroid disease, cardiac toxicity (difficulty breathing with exercise or sleep, fatigue), infection, easy bruising or bleeding, abdominal pain, nausea or vomiting, bloody stools, alopecia, or pruritus occur.
Caution patient to avoid driving or other activities requiring alertness until response to drug is known.
Advise patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult health care professional before taking other medications.
Rep: May cause fetal harm. Advise women of reproductive potential to use effective contraceptive method and to avoid breastfeeding during therapy and for ≥8 wk after final dose.

section name header

Indications ⬇

Contraind./Precautions ⬆ ⬇