Loading…
HARVONI is a brand name for Sofosbuvir, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: HARVONI (ledipasvir/sofosbuvir) is indicated for the treatment of chronic hepatitis C virus (CHC) infection in adults (≥ 18 years of age). HARVONI is indicated for the treatment of CHC genotype 1 infection in pediatric patients ≥ 12 years of age, without cirrhosis or with compensated cirrhosis. Liver Transplant…
Verbatim from this product's HC label. Tap a section to expand.
and 14 CLINICAL TRIALS). Patients Co-infected with Human Immunodeficiency Virus (HIV-1) Efficacy with HARVONI has been established in adult CHC genotype 1 or 4 patients, with or without cirrhosis, co-infected with HIV-1 (see 4 DOSAGE AND ADMINISTRATION and 14 CLINICAL TRIALS).
1 Pediatrics (< 18 years of age) Safety and efficacy with HARVONI have been established in pediatric patients ≥ 12 years of age with genotype 1 CHC (see 14 CLINICAL TRIALS). Safety and efficacy in pediatric patients infected with other CHC genotypes or in patients who are < 12 years of age have not been established (see 7 WARNINGS AND PRECAUTIONS).
7% of total number of patients in clinical trials) aged 65 and over. The response rates observed for patients over 65 years of age were similar to that of younger patients across treatment groups. HARVONI can be administered in geriatric patients (see 10 CLINICAL PHARMACOLOGY).
2 CONTRAINDICATIONS HARVONI is contraindicated in patients with known hypersensitivity to any of the components of the product. For a complete listing, see the
, 10 CLINICAL PHARMACOLOGY and 14 CLINICAL TRIALS). 5 Missed Dose If a patient misses a dose of HARVONI within 18 hours of the time it is usually taken, the patient should take HARVONI as soon as possible, and then take the next dose of HARVONI at the regularly scheduled time.
If a patient misses a dose of HARVONI and it is after 18 hours of the time it is usually taken, the patient should not take the missed dose, but resume the usual dosing schedule. A double dose of HARVONI must not be taken. If a patient vomits less than 5 hours after taking a dose of HARVONI, the patient should take another dose of HARVONI.
If a patient vomits more than 5 hours after taking a dose of HARVONI, the patient should take the next dose at the regularly scheduled time. Product Monograph HARVONI (ledipasvir/sofosbuvir) tablets Page 8 of 71 5 OVERDOSAGE For management of a suspected drug overdose, contact your regional poison control centre.
No specific antidote is available for overdose with HARVONI. If overdose occurs the patient must be monitored for evidence of toxicity. Hemodialysis is unlikely to result in significant removal of ledipasvir since ledipasvir is highly bound to plasma prote in.
Hemodialysis can efficiently remove (53% extraction ratio) the predominant circulating metabolite GS-331007. Administration of activated charcoal may also be used to aid in the removal of unabsorbed active substance. General supportive measures including monitoring of vital signs as well as observation of the clinical status of the patient are recommended.
The highest documented doses of ledipasvir and sofosbuvir were 120 mg twice daily for 10 days and a single dose of 1200 mg, respectively. In these trials, there were no untoward effects observed at this dose level, and adverse events were similar in frequency and severity to those reported in the placebo groups.
). 7% of total number of patients in clinical trials) aged 65 and over. The response rates observed for patients over 65 years of age were similar to that of younger patients across treatment groups. HARVONI can be administered in geriatric patients (see 10 CLINICAL PHARMACOLOGY).
2 CONTRAINDICATIONS HARVONI is contraindicated in patients with known hypersensitivity to any of the components of the product. For a complete listing, see the 4 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING section of the Product Monograph.
When HARVONI is administered with RBV, the contraindications to RBV also apply to this combination regimen. Refer to the RBV Product Monograph for a list of contraindications for RBV. 1 Pregnant Women). 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions Potential for Hepatitis B Virus (HBV) Reactivation Screen all patients for evidence of current or prior HBV infection before initiating HARVONI treatment.
Cases of HBV reactivation, including those resulting in fulminant hepatitis , hepatic failure, and death, have been reported during HCV treatment and/or post -treatment with regimens containing direct acting antivirals (DAAs) in patients co-infected with HBV (see 7 WARNINGS AND PRECAUTIONS, Potential for HBV Reactivation).
1 Dosing Considerations The treatment duration of HARVONI is fixed and is not guided by a patient’s HCV RNA levels (ie, no response guided therapy). 2 Recommended Dose and Dosage Adjustments in Adults (≥ 18 years of age) HARVONI is a fixed dose single tablet regimen.
No dosage adjustments are possible for HARVONI. The recommended dose of HARVONI is one tablet of 90 mg/400 mg ledipasvir/sofosbuvir, taken orally, once daily with or without food (see 10 CLINICAL PHARMACOLOGY, Pharmacokinetics). The recommended treatment duration for HARVONI in adult patients (≥ 18 years of age) is provided in Table 1.
HARVONI is contraindicated in patients with known hypersensitivity to any of the components of the product. For a complete listing, see the 4 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING section of the Product Monograph. When HARVONI is administered with RBV, the contraindications to RBV also apply to this combination regimen.
Refer to the RBV Product Monograph for a list of contraindications for RBV. 1 Pregnant Women).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Sofosbuvir in Canada.
Know a brand we are missing in Canada? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
The effects of higher doses/exposures are not known. 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING Table 2. Dosage Forms, Strengths, Composition and Packaging HARVONI is a fixed-dose single tablet regimen containing ledipasvir and sofosbuvir for oral administration.
HARVONI is available as an orange colored, diamond shaped, film-coated tablet debossed with “GSI” on one side and “7985” on the other side of the tablet. Each bottle contains 28 tablets, a silica gel desiccant, polyester coil, and closed with a child resistant closure.
7 WARNINGS AND PRECAUTIONS Please see 3 SERIOUS WARNINGS AND PRECAUTIONS BOX. General Treatment with HARVONI should be initiated and monitored by a physician experienced in the management of CHC. Route of Administration Dosage Form / Strength/Composition Non-medicinal Ingredients Oral Tablet 90 mg ledipasvir/ 400 mg sofosbuvir Colloidal silicon dioxide, copovidone, croscarmellose sodium, lactose monohydrate, magnesium stearate, and microcrystalline cellulose.
The tablets are film-coated with a coating material containing the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and FD&C Yellow #6/sunset yellow FCF aluminum lake. Product Monograph HARVONI (ledipasvir/sofosbuvir) tablets Page 9 of 71 The safety and efficacy of HARVONI in combination with other anti-HCV medicines have not been studied.
The sustained virologic response (SVR) of HARVONI is reduced in t reatment- experienced patients with HCV containing certain NS5A baseline mutations (see 15 MICROBIOLOGY). The safety and efficacy of HARVONI have not been studied in patients who have failed previous therapy with HARVONI.
Use with P-gp Inducers Medicinal products that are P-glycoprotein (P-gp) inducers [eg, rifampin, St. John’s wort (Hypericum perforatum)] may significantly decrease ledipasvir and sofosbuvir plasma concentration leading to reduced therapeutic effect of HARVONI and potential loss of virologic response.
Rifampin and St. John’s wort should not be used with HARVONI (see
Table 1. Treatment Duration for HARVONI in HCV-infected Adult Patients Patient Population Treatment Regimen and Duration Genotype 1 Treatment-naïvea with or without cirrhosisb HARVONI 8 or 12 weeksc Treatment-experiencedd without cirrhosisb HARVONI 12 weeks Treatment-experiencedd with cirrhosisb HARVONI 24 weekse Product Monograph HARVONI (ledipasvir/sofosbuvir) tablets Page 6 of 71 Patient Population Treatment Regimen and Duration Treatment-naïvea and treatment-experiencedd with decompensated cirrhosis (Child-Pugh B or C) HARVONI + RBVg 12 weeks Genotype 1 or 4 Treatment-naïvea and treatment-experiencedd liver transplant recipients without cirrhosis, or with compensated cirrhosis (Child-Pugh A) HARVONI + RBVf 12 weeks Genotype 1 or 4 Treatment-naïvea and treatment-experiencedd HCV/HIV-1 co-infected patients, with or without cirrhosisb HARVONI 12 weeksh Genotype 2, 4, 5 or 6 Treatment-naïvea and treatment-experiencedd, with or without cirrhosisb HARVONI 12 weeks Genotype 3 Treatment-naïvea with or without cirrhosisb HARVONI + RBVf 12 weeks Treatment-experiencedd with or without cirrhosisb HARVONI + RBVf 24 weeks a.
Treatment-naïve is defined as no prior exposure to any interferon, RBV, or other approved or experimental HCV-specific direct acting antiviral agent at the time of treatment initiation. b. 75 and an aspartate aminotransferase (AST): platelet ratio index (APRI) of > 2.
c. HARVONI for 8 w eeks can be considered in treatment-naïve genotype 1 patients w ithout cirrhosis w ho have pre-treatment HCV RNA less than 6 million IU/mL (see 14 CLINICAL TRIALS). d. Treatment-experienced is defined as those w ho failed prior therapy w ith an interferon-based regimen, including regimens containing an HCV protease inhibitor.
e. HARVONI+RBVf for 12 w eeks can be considered in treatment-experienced genotype 1 patients w ith cirrhosis w ho are eligible for RBV. f. The daily dose of RBV is w eight based (<75 kg = 1000 mg; ≥75 kg = 1200 mg) and administered orally in tw o divided doses w ith food.
Refer to RBV PM for information on dose modification. g. Administer ribavirin at a starting daily dosage of 600 mg in tw o divided doses w ith food. If the starting dosage is w ell-tolerated, the dosage can be titrated up to a maximum of 1000-1200 mg daily divided (<75 kg = 1000 mg; ≥75 kg = 1200 mg) and administered tw ice daily w ith food If the starting dosage is not w ell-tolerated, the dosage should be reduced as clinically indicated based on hemoglobin levels.
Refer to RBV PM for information on dose modifications. h. 4 Drug-Drug Interactions). Product Monograph HARVONI (ledipasvir/sofosbuvir) tablets Page 7 of 71 Special Populations Pediatrics (< 18 Years of age) In pediatric patients ≥ 12 years of age with genotype 1 CHC without cirrhosis or with compensated cirrhosis, the recommended dose of HARVONI is one tablet of 90 mg/400 mg ledipasvir/sofosbuvir, taken orally once daily with or without food for 12 weeks (see 14 CLINICAL TRIALS and 10 CLINICAL PHARMACOLOGY).
No data are available to make a dose recommendation for pediatric patients < 12 years or ≥ 12 years of age with other genotypes. HARVONI is not indicated for use in pediatric patients < 12 […]