Combination Therapy Dose Reduction Guidelines

Dose modification guidelines for combination therapy (with ribavirin)

Discontinue
Reduce only Reduce only
combination
Laboratory values ribavirin dose to PegIntron™
therapy if:
600 mg/day* if: dose to one-half dose if:

Haemoglobin < 10 g/dl - < 8.5 g/dl

Haemoglobin in:
≥2 g/dl decrease in haemoglobin during any < 12 g/dl after four
Patients with history
four week period during treatment weeks of dose
of stable cardiac
(permanent dose reduction) reduction
disease

White blood cells - < 1.5 x 109/l < 1.0 x 109/l

Neutrophils - < 0.75 x 109/l < 0.5 x 109/l
Platelets - < 50 x 109/l < 25 x 109/l
Bilirubin – direct - - 2.5 x ULN**
> 4 mg/dl
Bilirubin - indirect > 5 mg/dl -
(for > 4 weeks)
Creatinine - - > 2.0 mg/dl
2 x baseline and
ALT/AST - - > 10 x ULN**

* Patients whose dose of ribavirin is reduced to 600 mg daily receive one 200 mg capsule in the
morning and two 200 mg capsules in the evening.
** Upper limit of normal