lished.
Neonates
Sfety and efficacy not established.
DOSING CONSIDERATIONS
Hepatic Impairment
No dosage adjustments are needed for patients with mild, moderate, or severe hepatic impairment (Child-Pugh Class A, B, or C).
Renal Impairment
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed for mild or moderate renal impairment. Safety and efficacy have not been established in patients with severe renal impairment (eGFR less than 30 mL/min/1.73 m2) or end stage renal disease requiring hemodialysis. No dosage recommendations can be given for these patients.
ADMINISTRATION
Oral Administration
Oral Solid Formulations
Take sofosbuvir; velpatasvir with or without food.
If administered with ribavirin, take ribavirin with food.
STORAGE
Epclusa :
- Store and dispense in original container
- Store below 86 degrees F
CONTRAINDICATIONS / PRECAUTIONS
General Information
Sofosbuvir; velpatasvir may be used in combination with ribavirin; therefore, any contraindication to ribavirin also applies to the combination regimen. See ribavirin monographs for additional information regarding contraindications and warnings associated with these products.
Male-mediated teratogenicity, pregnancy
No adequate human data are available to establish whether or not sofosbuvir; velpatasvir poses a risk to pregnancy outcomes. In animal studies, no adverse effects on fetal development were observed with either sofosbuvir or velpatasvir. Because animal studies are not always predictive of human response, use of the drug during pregnancy should only be considered if the benefits justify the potential risk to the fetus. In certain patient populations, sofosbuvir; velpatasvir is administered with ribavirin. The use of sofosbuvir; velpatasvir in combination with ribavirin is contraindicated in pregnant women and in the male partners of women who are pregnant. Ribavirin may cause birth defects and death of the exposed fetus. Ribavirin therapy also may cause male-mediated teratogenicity and is contraindicated for use during pregnancy, in females who may become pregnant, or in men whose female partners are pregnant. Studies of ribavirin indicate teratogenic (e.g., malformations of skull, palate, eye, jaw, limbs, skeleton, and GI tract) or embryocidal properties in all of the animal species tested. Patients and their partners are required use 2 reliable forms of effective contraception during treatment and for 6 months after use of these combination therapies. Patients who are not willing to practice strict contraception should not receive sofosbuvir; velpatasvir with ribavirin. Females must also undergo a pregnancy test immediately prior to initiation of therapy, monthly during therapy, and for 6 months post-therapy. To monitor maternal-fetal outcomes of pregnancies in female patients and female partners of male patients exposed to ribavirin during treatment and for 6 months following cessation of treatment, health care providers are encouraged to report any cases to the Ribavirin Pregnancy Registry; telephone (800) 593-2214. For patient who are also infected with HIV and taking concomitant antiretroviral agents, an Antiretroviral Pregnancy Registry is available at (800) 258-4263.
Breast-feeding
According to the manufacturer, it is not known if sofosbuvir; velpatasvir or their metabolites are excreted in human milk, affect milk production, or have a |
