Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
SONIDEGIB PHOSPHATE (UNII: W421AI34UW) (SONIDEGIB - UNII:0RLU3VTK5M)
Novartis Pharmaceuticals Corporation
SONIDEGIB PHOSPHATE
SONIDEGIB 200 mg
PRESCRIPTION DRUG
New Drug Application
ODOMZO- SONIDEGIB CAPSULE NOVARTIS PHARMACEUTICALS CORPORATION ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE ODOMZO SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ODOMZO. ODOMZO (SONIDEGIB) CAPSULES, FOR ORAL USE INITIAL U.S. APPROVAL: 2015 WARNING: EMBRYO-FETAL TOXICITY _SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._ ODOMZO CAN CAUSE EMBRYO-FETAL DEATH OR SEVERE BIRTH DEFECTS WHEN ADMINISTERED TO A PREGNANT WOMAN AND IS EMBRYOTOXIC, FETOTOXIC, AND TERATOGENIC IN ANIMALS. (5.1, 8.1) VERIFY THE PREGNANCY STATUS OF FEMALES OF REPRODUCTIVE POTENTIAL PRIOR TO INITIATING THERAPY. ADVISE FEMALES OF REPRODUCTIVE POTENTIAL TO USE EFFECTIVE CONTRACEPTION DURING TREATMENT WITH ODOMZO AND FOR AT LEAST 20 MONTHS AFTER THE LAST DOSE. (5.1, 8.3) ADVISE MALES OF THE POTENTIAL RISK OF EXPOSURE THROUGH SEMEN AND TO USE CONDOMS WITH A PREGNANT PARTNER OR A FEMALE PARTNER OF REPRODUCTIVE POTENTIAL DURING TREATMENT WITH ODOMZO AND FOR AT LEAST 8 MONTHS AFTER THE LAST DOSE. (5.1, 8.3) INDICATIONS AND USAGE ODOMZO is a hedgehog pathway inhibitor indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy. (1) DOSAGE AND ADMINISTRATION Recommended dose: 200 mg orally once daily taken on an empty stomach, at least 1 hour before or 2 hours after a meal. (2.1) DOSAGE FORMS AND STRENGTHS 200 mg capsules (equivalent to 281 mg of diphosphate salt of sonidegib) (3) CONTRAINDICATIONS None. (4) WARNINGS AND PRECAUTIONS Blood donation: Advise patients not to donate blood or blood products during treatment with ODOMZO and for at least 20 months after the last dose. (5.1) Musculoskeletal adverse reactions: Obtain serum creatine kinase (CK) and creatinine levels prior to initiating therapy, periodically during treatment, and as clinically indicated. Temporary dose interruption or discontinuation o Lees het volledige document