Ravida

Ravida Dosage/Direction for Use

Manufacturer:

Pharmaniaga Manufacturing Berhad

Distributor:

Pharmaniaga Logistics
Full Prescribing Info
Dosage/Direction for Use
Treatment with Ravida should be initiated and monitored by a physician experienced in the management of patients with chronic hepatitis C.
Posology: Adults: The recommended dose of Ravida is 200 mg once daily, to be taken orally with or without food (see Pharmacology: Pharmacokinetics under Actions).
Ravida must be used in combination with other medicinal products indicated for the treatment of chronic hepatitis C. The monograph for the co-administered medicinal products should be referred to before initiation of therapy with Ravida. (See Table 8.)

Click on icon to see table/diagram/image

For HCV genotype information, see Precautions.
Dose interruption and discontinuation: If treatment interruption or discontinuation of the other medicinal products in the regimen is necessary, Ravida must not be given as monotherapy.
Vomiting and missed doses: Patients should be instructed that if vomiting occurs within 2 hours of dosing, an additional tablet should be taken. If vomiting occurs more than 2 hours after dosing, no additional dose for the day is needed. These recommendations are based on the absorption kinetics of ravidasvir, which are suggestive that the majority of the dose is absorbed within 2 hours after dosing.
Patients should be instructed that, if they miss a dose of Ravida, the dose should be taken as soon as possible if remembered within 18 hours of the scheduled dose time. However, if the missed dose is remembered more than 18 hours after the scheduled dose, the dose should be skipped and the next dose taken at the appropriate time.
Special populations: Elderly: There is limited clinical experience with Ravida in patients aged ≥ 65 years. Treatment with Ravida in accordance with the recommended posology should be guided by an assessment of the potential benefits and risks for the individual patient.
Renal impairment: No studies have been conducted with Ravida in patients with serum creatinine > 1.5 x ULN or end stage renal disease. Treatment with Ravida in accordance with the recommended posology should be guided by an assessment of the potential benefits and risks for the individual patient.
Hepatic impairment: No dose adjustment of Ravida is required for patients with mild hepatic impairment. The safety and efficacy of Ravida have been assessed in patients with compensated cirrhosis but not in patients with decompensated cirrhosis. The safety and efficacy of Ravida administration in patients with severe hepatic impairment have not been assessed (see Precautions, Adverse Reactions and Pharmacology: Pharmacokinetics under Actions).
Liver transplant patients: The safety and efficacy of Ravida in the treatment of HCV infection in patients who are post-liver transplant have not been assessed. Treatment with Ravida in accordance with the recommended posology should be guided by an assessment of the potential benefits and risks for the individual patient.
Patients co-infected with human immunodeficiency virus (HIV): The safety and efficacy of Ravida in this population have been assessed and no significant differences were observed when compared to patients not co-infected with HIV. For dosing recommendations for HIV antiviral agents co-administered with Ravida, see Interactions.
Paediatric population: The safety and efficacy of Ravida in children and adolescents aged below 18 years have not yet been assessed.
Method of administration: Ravida is to be taken orally with or without food. Patients should be instructed to swallow the tablets whole. The tablets should not be chewed, crushed or split.
Route of Administration: Oral.
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