Names and pronunciation
(ro-peg-in-ter-feer′on alfa) Besremi
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Drug reference
(ro-peg-in-ter-feer′on alfa) Besremi
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Func. class.: Immunostimulating agent
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ACTION: Binds to interferon alfa receptor (IFNAR) in the bone marrow
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USES: Polycythemia vera
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CONTRAINDICATIONS Hypersensitivity to interferon, severe psy- chiatric disorders, severe depression, suicidal ideation/attempt, hepatic disease Child-Pugh B or C, active serious/ untreated autoimmune disease, immuno- suppressed transplant patients Precautions: Endocrine/CV/pulmonary/ ophthalmologic toxicity, pancreatitis, colitis, hyperlipidemia
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INTERACTIONS Increased: myelosuppression—myelo- suppressive agents, monitor for increased myelosuppression Increased: CNS toxicity—narcotics, opi- oids, hypnotic sedatives, avoid use Increased: adverse reactions—CYP 450 substrates (NTI), dose adjustment may be needed
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DOSAGE AND ROUTES • Adult: SUBCUT 100 mcg q2wk, increase by 50 mcg q2wk to a max 500 mcg until hematocrit <45%, platelets <400 × 109 cells/L, leukocytes <10 × 109 cells/L, continue for at least 1 yr at the dosage that achieves hematologic sta- bility, then the dosing interval may be extended to q4wk (not receiving a hydroxyurea); SUBCUT 50 mcg q2wk with hydroxyurea, gradually taper hydroxyurea by reducing the total biweekly dose by 20%-40% q2wk during weeks 3-12; discontinue hydroxyurea by week 13; increase ropeginterferon alfa- 2b dose by 50 mcg q2wk to a max dose of 500 mcg until hematocrit <45%, platelets <400 × 109 cells/L, leukocytes <10 × 109 cells/L; continue for at least 1 yr at the dosage that achieves hemato- logic stability, then the dosing interval may be extended to q4wk (with hydroxyurea)
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Available forms: Solution for injection 500 mcg/mL prefilled syringe Administer SUBCUT route: • Visually inspect for particulate matter/ discoloration before use • Allow the refrigerated product to warm to room temperature for 15-30 min; keep the syringe in the carton, at- tach the covered needle, move air bub- bles to the top • Discard some of the medication to achieve the prescribed dose; push the syringe plunger to align the top of the gray stopper to the correct syringe dose R line/numbered markings • Use the lower stomach/abdomen (at least 2 inches away from the belly button) or the top of thighs as injection sites; ro- tate sites; do not inject into skin that is ir- ritated, red, bruised, infected, or scarred • Do not recap the needle; dispose of the used prefilled syringe with the needle still attached into a sharps disposal con- tainer • Store in a refrigerator at 36°F-46°F (2°C-8°C) in the original carton to pro- tect from light, do not freeze
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Assess: • Assess for history of severe psychiatric disorders, in particular severe depression, suicidal ideation, or suicide attempt; monitor closely for symptoms, change in mood, and need for treatment • Assess for hypersensitivity reactions; if occurs, stop treatment and manage as needed • Identify hepatic impairment (Child- Pugh B or C), monitor LFTs and hepatic function baseline and during treatment; reduce dose or discontinue depending on severity • Monitor blood counts baseline, q2wk during titration, ≥q3-6mo during main- tenance • Pancreatitis: Assess for signs/symp- toms of pancreatitis, including nausea/ vomiting, right upper abdominal pain, may need to be discontinued • Pulmonary toxicity: Discontinue if pulmonary infiltrates or pulmonary func- tion impairment occurs • Ophthalmologic toxicity: Advise pa- tients to have eye examinations before and during treatment. Evaluate eye symp- toms promptly and discontinue if needed
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • Dental and periodontal toxicity: Advise patients to use good oral hygiene and to have regular dental exams • Driving/operating machinery: Ad- vise patients to avoid driving or using machinery if they experience dizziness, hallucinations • Depression/suicide: Inform pa- tients, caregivers, family that suicidal ideation/behavior, new onset/worsening depression may occur. Advise them to be aware of any unusual changes in mood or behavior, new onset or worsening of depression, or the emergence of suicidal thoughts or behavior. Instruct them to report signs or symptoms of depression to their health care provider right away, to discontinue product immediately, and seek immediate medical attention if sui- cidal ideation or attempts occur • To notify the health care provider of signs/symptoms of diabetes or thyroid dysfunction, CV adverse reactions, weak- ness, fever, bruising, nosebleeds, itching, alopecia or rash, trouble breathing, se- vere diarrhea • Hyperlipidemia: Advise patients that product may increase blood triglycerides and that they will need blood testing to monitor for this toxicity • Hepatotoxicity: Advise patients to report signs or symptoms of hepatic tox- icity to their health care provider: yellow- ing of skin, eyes, abdominal pain, clay- colored stools • Renal toxicity: Advise patients to re- port signs or symptoms of kidney dis- ease, change in urinary patterns • Pregnancy/breastfeeding: Advise women to use an effective method of contraception and not to breastfeed dur- ing and ≥8 wk after the final dose • Teach patient, caregiver storage, prep- aration, and administration techniques
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PHARMACOKINETICS Half-life 7 days, onset, peak, duration unknown
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• Adult: SUBCUT 100 mcg q2wk, increase by 50 mcg q2wk to a max 500 mcg until hematocrit <45%, platelets <400 × 109 cells/L, leukocytes <10 × 109 cells/L, continue for at least 1 yr at the dosage that achieves hematologic sta- bility, then the dosing interval may be extended to q4wk (not receiving a hydroxyurea); SUBCUT 50 mcg q2wk with hydroxyurea, gradually taper hydroxyurea by reducing the total biweekly dose by 20%-40% q2wk during weeks 3-12; discontinue hydroxyurea by week 13; increase ropeginterferon alfa- 2b dose by 50 mcg q2wk to a max dose of 500 mcg until hematocrit <45%, platelets <400 × 109 cells/L, leukocytes <10 × 109 cells/L; continue for at least 1 yr at the dosage that achieves hemato- logic stability, then the dosing interval may be extended to q4wk (with hydroxyurea)
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