Ribavirin

Dosing

Genotypes 1 and 4, with Peginterferon alfa-2aGenotypes 1 and 4, with Peginterferon alfa-2bGenotypes 2 and 3, with Peginterferon alfaIn combination with interferon alfa-2bGenotype 2, treatment-naïve on HD, in combination with Peginterferon alfa-2aCombination therapy in interferon alfa-naïve patients with compensated liver disease - HIV infection- BW ≤75 kg: 1,000 mg PO daily (2 divided doses) x48w

  • BW >75 kg: 1,200 mg PO daily (2 divided doses) x48w- BW <65 kg: 800 mg PO daily (2 divided doses) x48w

  • BW 66-85 kg: 1,000 mg PO daily (2 divided doses) x48w

  • BW 86-105 kg: 1,200 mg PO daily (2 divided doses) x48w

  • BW >105 kg: 1,400 mg PO daily (2 divided doses) x48w800 mg PO daily (2 divided doses) x24w- BW ≤75 kg: 400 mg PO qAM + 600 mg PO qPM x24-48w

  • BW >75 kg: 600 mg PO twice daily x24-48w200 mg PO once daily + Peginterferon alfa-2a 135 mcg/week x24w800 mg PO daily (2 divided doses) + Peginterferon alfa-2a 180 mcg SUBQ once weekly x48w

Chronic HCV, in combination with interferon alfa-2b or Peginterferon alfa-2a, -2b- BW<65kg: 하루 800mg(아침 400mg, 저녁 400mg)

  • BW 65-85kg: 하루 1000mg(아침 400mg, 저녁 600mg)

  • BW>85kg: 하루 1200mg(아침 600mg, 저녁 600mg)

  • 혈색소수치가 10g/dL 미만인 환자는 1일 600mg으로 감량하고, 8.5g/dL 미만인 환자는 치료를 중단함

  • 안정형 심혈관질환 병력이 있는 환자에서 치료기간 중 어떤 때라도 4주 이내에 혈색소수치가 2g/dL 이상 감소하는 경우 1일 600mg으로 감량하고, 감량복용 4주 이후에도 12g/dL 미만이면 치료를 중단함

국내허가사항: 18세 이하의 소아에 대한 안전성 및 유효성은 확립되지 않음

Chronic HCV, with compensated liver diseaseRespiratory syncytial virus infectionAge ≥2y: 15 mg/kg PO daily x48w + Peginterferon alfa-2b20 mg/mL solution aerosolized over 12-18h once daily x3-7d

CrCl <50Use not recommended

General Information

Hepatitis C, chronic, combination therapy in interferon alfa-naïve patients with compensated liver disease. Respiratory syncytial virus infection.

Black Box Warning: Ribavirin monotherapy is ineffective for treatment of chronic hepatitis C virus infection. The primary toxicity is hemolytic anemia, which may result in worsening of cardiac disease and fatal and nonfatal myocardial infarctions. Avoid use in patients with significant or unstable cardiac disease. Ribavirin is contraindicated in women who are pregnant and in male partners of women who are pregnant. Use 2 reliable forms of contraception and avoid pregnancy during therapy and for 6 months after completion of treatment in both female patients and in female partners of male patients who are taking ribavirin.

Test CBC prior to initiating therapy, at weeks 2 and 4, more frequently if clinically warranted, and periodically thereafter.

Perform pregnancy test in women of childbearing potential prior to initiating treatment on a monthly basis during therapy and for 6 months after discontinuation.

Perform thyroid stimulating hormone test (TSH) prior to initiating therapy and periodically thereafter.

Perform renal function prior to initiation and periodically during therapy.

Perform eye exam at baseline in all patients and periodically during therapy.

Assess ECG in patients with preexisting heart disease prior to initiating therapy and periodically thereafter.

Common

  • Diarrhea

  • Nausea

  • Vomiting

  • Neutropenia

  • Asthenia

  • Dizziness

  • Headache

  • Insomnia

  • Fatigue

  • Pruritus

Severe

  • Myocardial infarction

  • Hemolytic anemia

  • Thrombotic thrombocytopenic purpura

  • Liver failure

  • Hepatotoxicity

  • Hyperammonemia

  • Hyperbilirubinemia

  • Respiratory complication

  • Suicide

Contraindications:

  • Didanosine: increased risk of toxicity

Drug-drug interactions:

  • Warfarin- fluctuations in INR

  • Azathioprine

  • Abacavir

  • Zalcitabine

  • Zidovudine

  • Stavudine

Antimicrobial class: Antiviral agent, Guanosine nucleoside analog, Viral RNA polymerase inhibitor

Pregnancy category: Contraindicated; do NOT use in pregnancy

Average serum half life: 298 hours (oral), 9.5 hours (inhalation)

Precautions:

  • Patients with chronic HCV and cirrhosis may have increased risk of hepatic decompensation and death during combination therapy with interferon; monitoring recommended and discontinue if decompensation occurs with use of oral tablets.

  • Discontinue if serious skin reactions or hypersensitivity reactions occur.

  • Use oral tablets with caution in patients with baseline risk of severe anemia; monitoring recommended.

  • Discontinue if pancreatitis, ophthalmologic disorders, or pulmonary function impairment occur.

  • Pancytopenia and bone marrow suppression have been reported during combination therapy with interferon plus azathioprine; discontinue all agents and do not reintroduce with concomitant azathioprine.

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