China's Coblopasvir(盐酸可洛派韦胶囊):Pictures,Uses,Dosage,Side Effects,Warnings-SEAGULL HEALTH

Introduction of Coblopasvir

Coblopasvir Hydrochloride Capsules (Trade Name: Kailiwei) is a domestic Class 1 innovative anti-hepatitis C virus drug developed by Kain Green, a subsidiary of Beijing Kain Technology Co., Ltd. It was approved for marketing through priority review by the National Medical Products Administration (NMPA) in February 2020, and is China’s first independently developed innovative hepatitis C virus (HCV) NS5A inhibitor.

Indication

Coblopasvir Hydrochloride Capsules, in combination with Sofosbuvir, is indicated for the treatment of adult patients with chronic hepatitis C virus (HCV) infection of genotypes 1, 2, 3 and 6 who are treatment-naive or interferon-experienced, with or without concomitant compensated cirrhosis.

Overview

Generic Name

Coblopasvir Hydrochloride Capsules,盐酸可洛派韦胶囊

Brand Name

凯力唯

Drug Type

Rx Drug

Approval No.

国药准字H20200001

Active Ingredient

Coblopasvir Hydrochloride

Dosage Form

60mg*28capsules

Specification

Capsules

Description

This product is a hard capsule, the contents of which are white or off-white granules and powder.

Expiry Date

24 months

Manufacturer

Beijing Kain Technology Co., Ltd.

Storage

Keep sealed and store below 30℃.

Dosage and Administration

Recommended Dose

For oral administration, 60mg once daily for 12 consecutive weeks, which can be taken on an empty stomach or with food.

Sofosbuvir should be taken orally at the same time, 400mg once daily for 12 consecutive weeks, either on an empty stomach or with food.

Missed Dose

If a dose of Coblopasvir Hydrochloride Capsules is missed, the patient should be instructed to take the missed dose as soon as possible on the same day, and then resume taking the medication at the usual time for the next dose. If the missed dose is not taken on the same day, the patient should be instructed to take the next dose at the usual time on the following day, and the dose should not be increased. For missed doses of other medications in the treatment regimen, refer to their respective package inserts.

Contraindications

Coblopasvir Hydrochloride Capsules are contraindicated in patients with a previous hypersensitivity to this product or any of its ingredients.

Concomitant use with strong CYP3A inducers or inhibitors should be avoided, including but not limited to Carbamazepine, Phenytoin Sodium, Rifampicin, St John's Wort, Clarithromycin, Itraconazole and others. Such medications may decrease or increase the plasma concentration of coblopasvir, thereby affecting the efficacy or safety of Coblopasvir Hydrochloride Capsules.

For contraindications related to the concomitant use of this product with other medications, refer to the package inserts of the respective medications.

Adverse Reactions

Main adverse reactions include decreased neutrophil count, asthenia, hypoalbuminemia, headache, hyperuricemia, dizziness, diarrhea, decreased platelet count, nausea, abdominal pain, fatigue, hepatic steatosis.

Special Populations

Pregnancy and Lactation

Pregnancy

Insufficient human data are available to evaluate the safety risks of Coblopasvir Hydrochloride Capsules in pregnant women. Pregnant women or women of childbearing potential not using contraception should not take Coblopasvir Hydrochloride Capsules. Effective contraceptive measures should be continued for 5 weeks after completion of treatment with Coblopasvir Hydrochloride Capsules.

Combination with Other HCV Medications

When Coblopasvir Hydrochloride Capsules are used in combination with Sofosbuvir Tablets, the contraindications and warnings for Sofosbuvir Tablets also apply to this combination regimen. For information on the use of other medications in the treatment regimen during pregnancy and lactation, refer to their respective package inserts.

Lactation

Insufficient human data are available to evaluate the safety risks of Coblopasvir Hydrochloride Capsules in lactating women. Breastfeeding is not recommended for mothers taking Coblopasvir Hydrochloride Capsules.

It is unknown whether coblopasvir is excreted into human milk. Coblopasvir is present in the milk of lactating rats, with concentrations in rat milk 2.9 to 3.9 times those in maternal plasma. Coblopasvir was detected in the plasma of offspring rats in the high-dose group at 200mg/kg/day.

Refer to the relevant prescribing information for other medications in the regimen simultaneously.

Pediatric Use

The safety and efficacy of Coblopasvir Hydrochloride Capsules in pediatric patients under 18 years of age have not been established.

Geriatric Use

The safety and efficacy of Coblopasvir Hydrochloride Capsules in geriatric patients aged 70 years and above have not been established through research.

For more detailed drug information, please consult the official package leaflet.