Names and pronunciation
(soe-fos′bue-vir) Sovaldi
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Individual generic drug information
Extracted information for sofosbuvir only.
(soe-fos′bue-vir) Sovaldi
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Func. class.: Antiviral, antihepatitis agent
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Chem. class.: Nucleotide analog polymerase inhibitor
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ACTION: Inhibits hepatitis C virus RNA polymerase by incorporating the polymerase into the viral RNA; also acts as a chain terminator
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USES: Chronic hepatitis C (genotypes 1, 2, 3, 4) with compensated liver disease in combination
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Extracted information for sofosbuvir only.
CONTRAINDICATIONS: Hyper- sensitivity, pregnancy in combination; male-mediated teratogenicity Precautions: Breastfeeding, children, hepatic/renal disease
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Black Box Warning: Hepatitis B exacer- bation Black Box Warning: Hepatitis B exac- erbation: monitor HBsAg, HBV DNA, he- patic enzymes, bilirubin • Pregnancy: if planned or suspected; if pregnant, call the Antiretroviral Pregnancy Registry, 1-800-258-4263; obtain preg- S nancy test before starting treatment; women who have HIV-1 and HCV who are taking antiretrovirals also should enroll with the registry Black Box Warning: Hepatitis B ex- acerbation: to notify prescriber im- mediately of liver toxicity: yellow eyes or skin, fatigue, weakness, loss of ap- petite, nausea/vomiting, light-colored stools
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SIDE EFFECTS CNS: Headache, chills, weakness, fatigue, fever, insomnia GI: Diarrhea, hyperbilirubinemia, nausea MISC: Rash, pruritus, neutropenia, ane- mia, myalgia
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INTERACTIONS Decrease: sofosbuvir-P-glycoprotein (P-gp) inducers (carBAMazepine, PHENobarbital, phenytoin, rifAMPin); OXcarbazepine, rifabutin, rifapentine, tipranavir; avoid concurrent use Increase: bradycardia—amiodarone; avoid using together Increase: sofosbuvir level—carvedilol, cobicistat Drug/Herb Decrease: sofosbuvir level—St. John’s wort; do not use together
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Extracted information for sofosbuvir only.
DOSAGE AND ROUTES Chronic hepatitis C Genotype 1, 4 • Adult: PO 400 mg daily with peginter- feron alfa and ribavirin × 12 wk; may con- sider use for genotype 1 with only ribavirin × 24 wk Chronic hepatitis C Genotype 2 • Adult: PO 400 mg daily with ribavirin × 12 wk Chronic hepatitis C Genotype 3 • Adult: PO 400 mg daily with ribavirin or daclatasvir × 24 wk Chronic hepatitis C with hepatocel- lular carcinoma in those waiting for liver transplant • Adult: PO 400 mg daily with ribavirin × 48 wk or until transplant
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Available forms: Tabs 400 mg
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Administer: • By mouth without regard to food • Do not use as monotherapy • Do not crush, break tabs
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Extracted information for sofosbuvir only.
Assess: • Heart rate, B/P; severe bradycardia may occur with amiodarone used concurrently • Serum HCV-RNA baseline and periodi- cally • Severe renal disease/GFR <30 mL/ min/1.73 m2: monitor BUN, creatinine • Closer monitoring in geriatric patients; may develop renal, cardiac symptoms more rapidly • HBV reactivation: test is required before beginning therapy; monitor throughout, monitor coinfected patients closely
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Evaluate: • Therapeutic response: decreased symptoms of chronic hepatitis C
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • That optimal duration of treatment is unknown; that product is not a cure; that transmission may still occur • To avoid use with other medications unless approved by prescriber • Not to stop abruptly unless directed; worsening of hepatitis may occur, not to use alone, keep in original container • Pregnancy/breastfeeding: to notify prescriber if pregnancy is planned or suspected; to use two forms of reliable contraception; to avoid breastfeeding
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Extracted information for sofosbuvir only.
PHARMACOKINETICS PO: Peak ½-2 hr, excreted by kidneys 80%, 61%-65% protein binding; half-life 0.4-27 hr
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Filter the extracted dose blocks for this individual drug.
Chronic hepatitis C Genotype 1, 4
• Adult: PO 400 mg daily with peginter- feron alfa and ribavirin × 12 wk; may con- sider use for genotype 1 with only ribavirin × 24 wk Chronic hepatitis C Genotype 2
Candidate age grouping · source page 1217
Chronic hepatitis C Genotype 1, 4
• Adult: PO 400 mg daily with ribavirin × 12 wk Chronic hepatitis C Genotype 3
Candidate age grouping · source page 1217
Chronic hepatitis C Genotype 1, 4
• Adult: PO 400 mg daily with ribavirin or daclatasvir × 24 wk Chronic hepatitis C with hepatocel- lular carcinoma in those waiting for liver transplant
Candidate age grouping · source page 1217
Chronic hepatitis C Genotype 1, 4
• Adult: PO 400 mg daily with ribavirin × 48 wk or until transplant
Candidate age grouping · source page 1217