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nilutamide
generic
Black Box Warnings .
Interstitial Pneumonitis
2% incidence in clinical trials, though 17% incidence in small study of Japanese pts; rare post-marketing cases of pulmonary fibrosis leading to hospitalization and death; presentation incl. exertional dyspnea, cough, chest pain, fever, interstitial or alveo-interstitial x-ray changes, and restrictive pattern on PFTs w/ decr. CO2 diffusion capacity (DLco); most cases w/in 1st 3mo, most reversed when D/C tx; perform baseline chest x-ray, consider baseline PFTs; if sx occur immediately D/C tx to determine if drug-related
Adult Dosing .
Dosage forms: TAB: 150 mg
prostate CA, metastatic
- [150 mg PO qd]
- Start: 300 mg PO qd x30 days; Info: D/C if ALT >2x ULN
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- severe impairment: contraindicated
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.