Chrocee®

Ribavirin
Chrocee®

Prescribing Details



Description

Chrocee® is a guanosine (ribonucleic) analog used to stop viral RNA synthesis and viral mRNA capping, thus, it is a nucleoside inhibitor.

Chrocee® is a prodrug, which when metabolized resembles purine RNA nucleotides. In this form it interferes with RNA metabolism required for viral replication.


Uses

No Data


Indications

Chrocee® in combination with peginterferon alfa-2a is indicated for the treatment of patients 5 years of age and older with chronic hepatitis C (CHC) virus infection who have compensated liver disease and have not been previously treated with interferon alpha.


Dosage and administration

Adult dose:

Hepatitis C Virus Genotype Dose of PEG interferon alfa-2a Dose of Chrocee® Duration
Genotype 1, 4 180 mcg <75 kg = 1000 mg 48 weeks
≥75 kg = 1200 mg 48 weeks
Genotype 2, 3 180 mcg 800 mg 24 weeks

Pediatric dose:

Body Weight
(kg)		 Chrocee® Daily Dose* Number of capsules
23 – 33 400 mg/day 1 x 200 mg capsule A.M. 1 x 200 mg capsule P.M.
34 – 46 600 mg/day 1 x 200 mg capsule A.M. 2 x 200 mg capsule P.M.
47 – 59 800 mg/day 2 x 200 mg capsule A.M. 2 x 200 mg capsule P.M.
60 – 74 1,000 mg/day 2 x 200 mg capsule A.M. 3 x 200 mg capsule P.M.
≥75 1,200 mg/day 3 x 200 mg capsule A.M. 3 x 200 mg capsule P.M.

* Approximately 15 mg/kg/day


Use in pregnancy & lactation

Chrocee® may cause birth defects and/or death of the exposed fetus. Ribavirin has demonstrated significant teratogenic and/or embryocidal effects in all animal species in which adequate studies have been conducted. These effects occurred at doses as low as one twentieth of the recommended human dose of Ribavirin. Ribavirin treatment should not be started until a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy.


Geriatric use
No Data

Precautions

Renal impairment patients: Dose should be reduced in patients with creatinine clearance less than or equal to 50 mL/min.


Side effects
The most common adverse reactions (frequency greater than 40%) in adults receiving combination therapy are fatigue/asthenia, pyrexia, myalgia, and headache.

Contraindications

No Data


Drug interactions
  • Nucleoside analogues: Closely monitor for toxicities. Discontinue nucleoside reverse transcriptase inhibitors or reduce dose or discontinue Interferon, Ribavirin or both with worsening toxicities.
  • Azathioprine: Concomitant use of Azathioprine with Ribavirin has been reported to induce severe pancytopenia and may increase the risk of Azathioprine-related myelotoxicity.

Overdose
No Data

Preparation

No Data


Pharmaceutical precautions

Store in a cool (below 30° C) and dry place. Protect from light.


Presentation

Chrocee® 200 mg capsule: Each capsule contains Ribavirin BP 200 mg.


Package quantities

Chrocee® 200 mg capsule: Carton of 20 capsules in blister pack.