ODOMZO sonidegib capsule

Land: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

SONIDEGIB PHOSPHATE (UNII: W421AI34UW) (SONIDEGIB - UNII:0RLU3VTK5M)

Fáanlegur frá:

Novartis Pharmaceuticals Corporation

INN (Alþjóðlegt nafn):

SONIDEGIB PHOSPHATE

Samsetning:

SONIDEGIB 200 mg

Gerð lyfseðils:

PRESCRIPTION DRUG

Leyfisstaða:

New Drug Application

Vara einkenni

ODOMZO- SONIDEGIB CAPSULE
NOVARTIS PHARMACEUTICALS CORPORATION
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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