Names and pronunciation
PegIntron, Pegintron Redipen, Sylatron
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Drug reference
PegIntron, Pegintron Redipen, Sylatron
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Func. class.: Immunomodulator
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ACTION: Stimulates genes to modulate many biologic effects, including the inhibition of viral replication; inhibits ion cell proliferation, immunomodulation; stimulates effector proteins; decreases leukocyte, platelet counts
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USES: Chronic hepatitis C infections in adults with compensated liver disease; chronic hepatitis B in adults who are HBe AG positive, HBe AG negative; HCV patients coinfected with HIV; nonresponders or relapsers with chronic hepatitis C, malignant melanoma
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Unlabeled uses: Adenovirus, coronavi- rus, encephalomyocarditis virus, herpes simplex types 1 and 2, hepatitis D, acute hepatitis C, HIV, HPV, polio virus, rhinovi- rus, varicella zoster, variola, vesicular stomatitis
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CONTRAINDICATIONS: Neo nates, infants, sepsis; hypersensitivity to interferons, benzyl alcohol, Escherichia coli protein Precautions: Pregnancy, breastfeeding, children <18 yr, geriatric patients, thy- roid disorders, myelosuppression, renal/ hepatic disease, suicidal/homicidal ide- ation, preexisting ophthalmologic disor- ders, pancreatitis, hemodialysis
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Black Box Warning: Cardiac disease, depression, autoimmune disease, infec- tion, use with ribavirin
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SIDE EFFECTS CNS: Headache, insomnia, dizziness, anxiety, hostility, lability, nervousness, depression, fatigue, poor concentration, pyrexia, suicidal ideation, homicidal ide- ation, relapse of drug addiction, emo- tional lability, mania, psychosis CV: Ischemic CV events ENDO: Hypothyroidism, diabetes GI: Abdominal pain, nausea, diarrhea, anorexia, vomiting, dry mouth, fatal colitis, fatal pancreatitis HEMA: Thrombocytopenia, neutropenia, anemia, lymphopenia INTEG: Alopecia, pruritus, rash, dermatitis MISC: Blurred vision, inj-site reaction, rigors MS: Back pain, myalgia, arthralgia RESP: Cough, dyspnea
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INTERACTIONS • Use caution when giving with theophyl- line, myelosuppressive agents Increase: hepatic damage—NNRTIs, NRTIs, protein inhibitors Drug/Lab Test Increase: triglycerides, ALT Decrease: HB, platelets, WBCs, neutrophils Abnormal: thyroid function test
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DOSAGE AND ROUTES Pegasys • Adult: SUBCUT 180 mcg weekly × 48 wk; if poorly tolerated, reduce dose to 135 mcg weekly; in some cases, reduc- tion to 90 mcg may be needed Peg-Intron (chronic hepatitis C with compen- sated liver disease) • Adult >105 kg: SUBCUT 1.5 mcg/kg/wk plus ribavirin 600 mg in am and 800 mg in pm plus a HCV NS3/4A protease inhibitor; 86- 105 kg: 150 mcg/0.5 mL (0.5 mL of 150 P mcg vial or Redipen) per wk plus ribavirin 1200 mg/day in 2 divided doses plus a HCV NS3/4A protease inhibitor; 81-85 kg: 120 mcg/0.5 mL (0.5 mL of 120 mcg vial or Redipen) per wk plus ribavirin 1200 mg/day in 2 divided doses plus a HCV NS3/4A prote- ase inhibitor; 76-80 kg: 120 mcg/0.5 mL (0.5 mL of 120 mcg vial or Redipen) per wk plus ribavirin 400 mg in am and 600 mg in pm plus a HCV NS3/4A protease inhibitor; 66- 75 kg: 96 mcg/0.4 mL (0.4 mL of 120 mcg vial or Redipen) per wk plus ribavirin 400 mg in am and 600 mg in pm plus a HCV NS3/4A protease inhibitor; 61-65 kg: 96 mcg/0.4 mL (0.4 mL of 120 mcg vial or Redipen) per wk plus ribavirin 800 mg/day in 2 divided doses plus a HCV NS3/4A prote- ase inhibitor; 51-60 kg: 80 mcg/0.5 mL (0.5 mL of 80 mcg vial or Redipen) per wk plus ribavirin 800 mg/day in 2 divided doses plus a HCV NS3/4A protease inhibitor; 40- 50 kg: 64 mcg/0.4 mL (0.4 mL of 80 mcg vial or Redipen) per wk plus ribavirin 800 mg/day in 2 divided doses plus a HCV NS3/4A protease inhibitor; <40 kg: 50 mcg/0.5 mL (0.5 mL of 50 mcg vial or Redipen) per wk plus ribavirin 800 mg/day in 2 divided doses plus a HCV NS3/4A protease inhibitor Malignant melanoma (Sylatron only) • Adult: SUBCUT 6 mcg/kg/wk × 8 wk then 3 mcg/kg/wk × ≤5 yr, premedicate with acetaminophen 500-1000 mg 30 min before first dose, prn for subsequent doses
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Available forms: Pegasys: inj 135, 180 mcg/0.5 mL; Pegintron: 50, 80, 120, 150 mcg/0.5 mL; Sylatron 200, 300, 600 mcg powder for inj
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Administer: • In evening to reduce discomfort, to allow patient to sleep through some side effects • Continue pediatric dose in those who turn 18 yr Interferon alfa-2a • Use prefilled syringes; store in refrig- erator Interferon alfa-2b SUBCUT/IM route • Reconstitute with 1 mL of provided di- luent/10-, 18-, or 50-million unit vials, swirl; sol for inj vials do not need recon- stitution
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Assess: • Neuropsychiatric symptoms: severe depression with suicidal ideation; monitor q3wk then 8 wk, then q6mo • B/P, blood glucose, ophthalmic exam, pulmonary function • ALT, HCV viral load; patients who show no reduction in ALT, HCV unlikely to show benefit of treatment after 6 mo • Platelet counts, heme concentration, ANC, serum creatinine concentration, al- bumin, bilirubin, TSH, T4, AFP • Myelosuppression: hold dose if neu- trophil count is <500 × 106/L or if plate- lets are <50 × 109/L • Hypersensitivity: discontinue immedi- ately if hypersensitivity occurs • Infection: vital signs, increased WBCs, fever; product may need to be discontinued • Colitis/pancreatitis: may be fatal; diarrhea, fever, nausea, vomiting, severe abdominal pain; if these occur, product should be discontinued • Pregnancy/breastfeeding: may cause birth defects if alfa-2b is used with riba- virin; do not use in pregnancy, contracep- tion is needed; do not breastfeed
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Evaluate: • Therapeutic response: decreased chronic hepatitis C signs, symptoms; un- detectable viral load
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • Provide patient or family member with written, detailed information about product • Use 2 forms of effective contraception throughout treatment and for 6 mo after treatment (men and women) (combina- tion therapy with ribavirin) • To avoid driving, other hazardous ac- tivity if dizziness, confusion, fatigue, som- nolence occur • To use puncture-resistant container for disposal of needles/syringes if using at home • To report suicidal/homicidal ideation, visual changes, bleeding/bruising, pulmo- nary symptoms
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PHARMACOKINETICS Half-life 15-80 hr, large variability in other pharmacokinetics
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• Adult: SUBCUT 180 mcg weekly × 48 wk; if poorly tolerated, reduce dose to 135 mcg weekly; in some cases, reduc- tion to 90 mcg may be needed Peg-Intron (chronic hepatitis C with compen- sated liver disease)
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• Adult >105 kg: SUBCUT 1.5 mcg/kg/wk plus ribavirin 600 mg in am and 800 mg in pm plus a HCV NS3/4A protease inhibitor; 86- 105 kg: 150 mcg/0.5 mL (0.5 mL of 150 P mcg vial or Redipen) per wk plus ribavirin 1200 mg/day in 2 divided doses plus a HCV NS3/4A protease inhibitor; 81-85 kg: 120 mcg/0.5 mL (0.5 mL of 120 mcg vial or Redipen) per wk plus ribavirin 1200 mg/day in 2 divided doses plus a HCV NS3/4A prote- ase inhibitor; 76-80 kg: 120 mcg/0.5 mL (0.5 mL of 120 mcg vial or Redipen) per wk plus ribavirin 400 mg in am and 600 mg in pm plus a HCV NS3/4A protease inhibitor; 66- 75 kg: 96 mcg/0.4 mL (0.4 mL of 120 mcg vial or Redipen) per wk plus ribavirin 400 mg in am and 600 mg in pm plus a HCV NS3/4A protease inhibitor; 61-65 kg: 96 mcg/0.4 mL (0.4 mL of 120 mcg vial or Redipen) per wk plus ribavirin 800 mg/day in 2 divided doses plus a HCV NS3/4A prote- ase inhibitor; 51-60 kg: 80 mcg/0.5 mL (0.5 mL of 80 mcg vial or Redipen) per wk plus ribavirin 800 mg/day in 2 divided doses plus a HCV NS3/4A protease inhibitor; 40- 50 kg: 64 mcg/0.4 mL (0.4 mL of 80 mcg vial or Redipen) per wk plus ribavirin 800 mg/day in 2 divided doses plus a HCV NS3/4A protease inhibitor; <40 kg: 50 mcg/0.5 mL (0.5 mL of 50 mcg vial or Redipen) per wk plus ribavirin 800 mg/day in 2 divided doses plus a HCV NS3/4A protease inhibitor Malignant melanoma (Sylatron only)
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• Adult: SUBCUT 6 mcg/kg/wk × 8 wk then 3 mcg/kg/wk × ≤5 yr, premedicate with acetaminophen 500-1000 mg 30 min before first dose, prn for subsequent doses
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