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Harvoni Oral Pellets Generic Name & Formulations
Legal Class
Rx
General Description
Ledipasvir, sofosbuvir; 33.75mg/150mg, 45mg/200mg.
Pharmacological Class
HCV NS5A inhibitor + HCV NS5B polymerase inhibitor.
See Also
How Supplied
Tabs, pellets—28
Manufacturer
Generic Availability
Tabs (YES); pellets (NO)
Harvoni Oral Pellets Indications
Indications
Chronic hepatitis C virus (HCV) infection in patients with: genotype 1, 4, 5, or 6 without cirrhosis or with compensated cirrhosis; genotype 1 with decompensated cirrhosis, in combination with ribavirin; or genotype 1 or 4 who are liver transplant recipients without cirrhosis or with compensated cirrhosis, in combination with ribavirin.
Harvoni Oral Pellets Dosage and Administration
Adults and Children
<3yrs: not established. Test for HBV infection prior to initiation. ≥3yrs (<17kg): 33.75mg/150mg (pellets) once daily; (17–<35kg): 45mg/200mg (tabs or pellets) once daily; (≥35kg): 90mg/400mg (tabs or pellets) once daily. ≥18yrs: 90mg/400mg (tabs) once daily. Genotype 1: Treatment-naïve without cirrhosis or with compensated cirrhosis (Child-Pugh A), or treatment-experienced without cirrhosis: treat for 12 weeks; treatment-naïve without cirrhosis who have pre-treatment HCV RNA <6 million IU/mL: can be considered for 8 weeks. Treatment-experienced with compensated cirrhosis: treat for 24 weeks; can be considered for 12 weeks with concomitant ribavirin (if eligible). Treatment-naïve and -experienced with decompensated cirrhosis (Child-Pugh B or C): treat for 12 weeks with ribavirin (see full labeling). Genotype 1 or 4: Treatment-naïve and -experienced liver transplant recipients without cirrhosis or with compensated cirrhosis: treat for 12 weeks with ribavirin. Genotype 4, 5, 6: Treatment-naïve and -experienced without cirrhosis or with compensated cirrhosis: treat for 12 weeks. HCV/HIV-1 co-infection: follow same dosage schedule. See full labeling.
Harvoni Oral Pellets Contraindications
Contraindications
When co-administered with ribavirin, its contraindication also apply to this combination regimen (eg, Pregnancy Cat.X).
Harvoni Oral Pellets Boxed Warnings
Boxed Warning
Risk of HBV reactivation in patients coinfected with HCV and HBV.
Harvoni Oral Pellets Warnings/Precautions
Warnings/Precautions
Risk of HBV reactivation in patients coinfected with HCV/HBV. Test all patients for HBV infection by measuring HBsAg and anti-HBc; if positive serologic evidence, monitor for hepatitis flare or HBV reactivation during and at post-treatment follow-up; treat if clinically indicated. Increased risk of symptomatic bradycardia when concomitant amiodarone esp. patients also taking beta blockers or with cardiac comorbidities and/or advanced liver disease. Decompensated cirrhosis: monitor hepatic function. Pregnancy. Nursing mothers.
Harvoni Oral Pellets Pharmacokinetics
See Literature
Harvoni Oral Pellets Interactions
Interactions
Concomitant amiodarone: not recommended; if no alternatives, monitor cardiac function (see full labeling). Concomitant P-gp inducers (eg, rifampin, St. John’s wort), other sofosbuvir-containing products, carbamazepine, phenytoin, phenobarbital, oxcarbazepine, rifabutin, rifapentine, elvitegravir, cobicistat, emtricitabine, tenofovir DF, tipranavir/ritonavir, simeprevir, or rosuvastatin: not recommended. Concomitant certain immunosuppressants or chemotherapeutic agents: may increase risk of HBV reactivation. May increase absorption of concomitant P-gp and BCRP substrates. Separate dosing of antacids by 4hrs. May give H2-antagonists simultaneously or 12hrs apart (comparable to max famotidine 40mg twice daily). May give PPI doses (comparable to omeprazole ≤20mg) simultaneously under fasted conditions. May potentiate digoxin, atorvastatin (myopathy); monitor. Concomitant tenofovir DF regimens without a HIV protease inhibitor/ritonavir or cobicistat; monitor. Concomitant atazanavir/ritonavir or cobicistat + emtricitabine/tenofovir DF, darunavir/ritonavir or cobicistat + emtricitabine/tenofovir DF, or lopinavir/ritonavir + emtricitabine/tenofovir DF: consider alternatives; or if coadmin necessary, monitor. Monitor INR with warfarin.
Harvoni Oral Pellets Adverse Reactions
Adverse Reactions
Fatigue, headache, asthenia, nausea, diarrhea, insomnia.
Harvoni Oral Pellets Clinical Trials
See Literature
Harvoni Oral Pellets Note
Notes
For ribavirin specific dosing and safety information, refer to the full prescribing information.
Harvoni Oral Pellets Patient Counseling
See Literature
