ropeginterferon alfa-2b

ROUTE	ONSET	PEAK	DURATION
SUBQ	unknown	2–5 days	unknown

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.

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.

Availability ⬆ ⬇

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

Assessment ⬆ ⬇

Monitor for psychiatric changes. For mild depression without suicidal ideation, consider psychiatric consultation if symptoms for >8 wk. For moderate depression without suicidal ideation, consider psychiatric consultation and dose ↓. For severe depression or any severity with suicidal ideation, permanently discontinue ropeginterferon alfa-2b and consult psychiatry.
Monitor patient for endocrine toxicities. If endocrine disorders that cannot be adequately managed occur, permanently discontinue ropeginterferon alfa-2b.
Monitor for cardiovascular toxicities.
Assess for infection and signs of easy bleeding.
Monitor for hypersensitivity reactions. If acute, serious symptoms occur, permanently discontinue ropeginterferon alfa-2b and provide appropriate medical treatment. A transient rash may not necessitate interruption of therapy.
Monitor for nausea, upper abdominal bloating or pain, and fever. If pancreatitis suspected, hold therapy and evaluate promptly. If confirmed, consider discontinuing ropeginterferon alfa-2b.
Monitor for signs and symptoms of colitis, occurring as early as 12 wk after initiation of therapy. If abdominal pain, bloody diarrhea, and fever occur, permanently discontinue ropeginterferon alfa-2b. Colitis may resolve 1–3 wk after discontinuation.
Monitor for pulmonary toxicity. If pulmonary infiltrates or respiratory impairment occur, permanently discontinue ropeginterferon alfa-2b.
Monitor for ophthalmologic toxicity (retinal hemorrhage, exudates, detachment, artery or vein occlusion, retinopathy). If new or worsening ophthalmic symptoms occur, discontinue ropeginterferon alfa-2b promptly.
Monitor for hepatotoxicity (jaundice, ascites, encephalopathy, hepatorenal syndrome, variceal hemorrhage). If symptoms occur, permanently discontinue ropeginterferon alfa-2b.

Lab Test Considerations:

Verify negative pregnancy status prior to initiating therapy.
Monitor CBC every 2 wk during titration and dose modification phase, every 3–6 mo during maintenance phase, and as clinically indicated. If Hgb <8 g/dL, platelets 25,000–<50,000/mm³, or WBC 1000–<2000/mm³,↓ dose by 50 mcg biweekly. If no improvement, continue to ↓ dose biweekly until Hgb >10.0 g/dL, platelets >75,000/mm ³, and WBC >3000/mm ³. If interrupted dose is 50 mcg, hold therapy until recovery. If life-threatening anemia, platelets <25,000/mm³, or WBC <1000/mm³, hold therapy until Hgb >10 g/dL, platelets >75,000/mm ³, and WBC >3000/mm ³. Consider permanent discontinuation if toxicity persists for >4 dose modifications.
Evaluate thyroid function tests as clinically indicated.
May ↑ lipase and amylase.
Monitor serum creatinine at baseline and during therapy. If severe renal impairment occurs, permanently discontinue ropeginterferon alfa-2b
Monitor serum triglycerides at baseline and intermittently during therapy. Consider discontinuation if hypertriglyceridemia is persistent.
Monitor liver enzymes and bilirubin at baseline and during therapy. If liver enzymes > baseline with concomitant bilirubin ↑ or other sign of hepatic decompensation, hold therapy until recovery; then ↓ dose by 50 mcg biweekly. If interrupted dose is 50 mcg, hold until recovery. If liver enzymes >5 times upper limit of normal (ULN) but ≤20 times ULN,↓ dose by 50 mcg biweekly until ALT and AST <3 times ULN or 3 times baseline, and GGT <2.5 times ULN or 2.5 times baseline. If interrupted dose is 50 mcg, hold until recovery. If liver enzymes >20 times upper limit of normal, hold therapy until ALT and AST <3 times ULN or 1.5 times baseline and GGT <2.5 times ULN or 2 times baseline. Consider permanent discontinuation if any of the above toxicities persist for ≥4 dose modifications.

Implementation ⬆ ⬇

SC: Bring single-dose prefilled syringe to room temperature for 15–30 min. Inspect solution; do not use if cloudy, discolored, or contains particulates. Administer SUBQ to lower abdomen (≥2 inches from umbilicus) or top of thigh and only into skin that is clean, dry, and intact. Rotate injection sites.

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.

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Contraind./Precautions ⬆ ⬇