2. DOSAGE AND ADMINISTRATION
- 400 mg orally once daily with food. (2.1)
- If patient is intolerant to therapy, the dose may be reduced to 300 mg orally once daily with food. If necessary, the dose may be further reduced to 300 mg once daily with food for 5 consecutive days each week. (2.2, 5)
2.1 Dosing Information
The recommended dose is 400 mg orally once daily with food.
Treatment may be continued as long as there is no evidence of progressive disease or unacceptable toxicity.
ZOLINZA capsules should not be opened or crushed [see How Supplied/Storage and Handling (16) ].
2.2 Dose Modifications
If a patient is intolerant to therapy, the dose may be reduced to 300 mg orally once daily with food. The dose may be further reduced to 300 mg once daily with food for 5 consecutive days each week, as necessary.
2.3 Dosing in Special Populations
No information is available in patients with renal or hepatic impairment [see Pharmacokinetics (12.3) ].
3. DOSAGE FORMS AND STRENGTHS
100 mg white, opaque, hard gelatin capsules with “568” over “100 mg” printed within radial bar in black ink on the capsule body.
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