ODOMZO- sonidegib capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Sun Pharmaceutical Industries, Inc.

INN (International Name):

SONIDEGIB PHOSPHATE

Composition:

SONIDEGIB 200 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

ODOMZO (sonidegib) is 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. None. Risk Summary Based on its mechanism of action and data from animal reproduction studies, ODOMZO can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ]. There are no available data on the use of ODOMZO in pregnant women. In animal reproduction studies, oral administration of sonidegib during organogenesis at doses below the recommended human dose of 200 mg resulted in embryotoxicity, fetotoxicity, and teratogenicity in rabbits (see Data). Teratogenic effects observed included severe midline defects, missing digits, and other irreversible malformations. Advise pregnant women of the potential risk to a fetus. Report pregnancies to Sun Pharmaceutical Industries, Inc. at 1-800-406-7984. In the U.S. general population, the estimated background risk of major birth defects is 2-4% and of miscarriage in clinically recognized pregnancies is 15-20%. Data Animal Data Daily oral administration of sonidegib to pregnant rabbits resulted in abortion, complete resorption of fetuses, or severe malformations at ≥ 5 mg/kg/day (approximately 0.05 times the recommended human dose based on AUC). Teratogenic effects included vertebral, distal limb and digit malformations, severe craniofacial malformations, and other severe midline defects. Skeletal variations were observed when maternal exposure to sonidegib was below the limit of detection. No data are available regarding the presence of sonidegib in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production. Because of the potential for serious adverse reactions in breastfed infants, advise women not to breastfeed during treatment with ODOMZO and for 20 months after the last dose. Based on its mechanism of action and animal data, ODOMZO can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1) ] . Pregnancy Testing Verify the pregnancy status of females of reproductive potential prior to initiating ODOMZO treatment. Contraception Females Advise females of reproductive potential to use effective contraception during treatment with ODOMZO and for at least 20 months after the last dose. Males It is not known if sonidegib is present in semen. Advise male patients to use condoms, even after a vasectomy, to avoid potential drug exposure to pregnant partners and female partners of reproductive potential during treatment with ODOMZO and for at least 8 months after the last dose. Advise males not to donate semen during treatment with ODOMZO and for at least 8 months after the last dose. Infertility Based on findings from animal studies, female fertility may be compromised with ODOMZO [see Nonclinical Toxicology (13.1) ] . The safety and effectiveness of ODOMZO have not been established in pediatric patients. Epiphyseal disorders, including premature fusion of the epiphyses, have been reported in pediatric patients exposed to ODOMZO in a clinical trial. In some cases, pediatric patients treated with other Hh pathway inhibitors have experienced progression of epiphyseal fusion despite discontinuation of the Hh pathway inhibitor. Juvenile Animal Data In a 5-week juvenile rat toxicology study, effects of sonidegib were observed in bone, teeth, reproductive tissues, and nerves at doses ≥10 mg/kg/day (approximately 1.2 times the recommended human dose based on AUC). Bone findings included thinning/closure of bone growth plate, decreased bone length and width, and hyperostosis. Findings in teeth included missing or fractured teeth, and atrophy. Reproductive tissue toxicity was evidenced by atrophy of testes, ovaries, and uterus, partial development of the prostate gland and seminal vesicles, and inflammation and aspermia of the epididymis. Nerve degeneration was also noted. Of the 229 patients who received ODOMZO (79 patients receiving 200 mg daily and 150 patients receiving 800 mg daily) in BOLT, 54% were 65 years and older, while 28% were 75 years and older. No overall differences in effectiveness were observed between these patients and younger patients. There was a higher incidence of serious adverse reactions, Grade 3 and 4 adverse reactions, and adverse reactions requiring dose interruption or discontinuation in patients ≥65 years compared with younger patients; this was not attributable to an increase in any specific adverse event.

Product summary:

Each ODOMZO capsule has an opaque pink color with ‘SONIDEGIB 200MG’ printed on the capsule body and ‘NVR’ printed on the cap in black ink. ODOMZO capsules are supplied as follows: Bottle of 30 capsules                                   NDC 47335-303-83 Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Authorization status:

New Drug Application

Patient Information leaflet

Sun Pharmaceutical Industries, Inc.
----------
MEDICATION GUIDE
ODOMZO® (o-DOM-zo)
(sonidegib)
capsules
What is the most important information I should know about ODOMZO?
ODOMZO can cause your baby to die before it is born (be stillborn) or
cause your baby to have severe
birth defects.
For females who can become pregnant:
•
You should talk to your healthcare provider about the risks of ODOMZO
to your unborn child.
•
Your healthcare provider will do a pregnancy test before you start
taking ODOMZO.
•
In order to avoid pregnancy, you should use birth control during
treatment, and for at least 20
months after your final dose of ODOMZO. Talk to your healthcare
provider about what birth
control method is right for you during this time.
•
Talk to your healthcare provider right away if you have unprotected
sex or if you think your birth
control has failed.
•
Tell your healthcare provider right away if you become pregnant or
think that you may be
pregnant.
For males:
•
It is not known if ODOMZO is present in semen. Do not donate semen
while you are taking
ODOMZO and for at least 8 months after your final dose.
•
You should always use a condom, even if you have had a vasectomy,
during sex with female
partners who are pregnant or who are able to become pregnant, during
treatment with ODOMZO
and for at least 8 months after your final dose to protect your female
partner from being exposed
to ODOMZO.
•
Tell your healthcare provider right away if your partner becomes
pregnant or thinks she is
pregnant while you are taking ODOMZO.
Exposure to ODOMZO during pregnancy:
If you think that you or your female partner may have been exposed to
ODOMZO during pregnancy, talk
to your healthcare provider right away. If you become pregnant during
treatment with ODOMZO, you or
your healthcare provider should report your pregnancy to Sun
Pharmaceutical Industries, Inc. at 1-800-
406-7984.
What is ODOMZO?
ODOMZO is a prescription medicine used to treat adults with a type of
skin cancer, called basal cell
carcinoma, that has com

Summary of Product characteristics

ODOMZO- SONIDEGIB CAPSULE
SUN PHARMACEUTICAL INDUSTRIES, INC.
----------
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 dosage: 200 mg orally once daily taken on an empty
stomach, at least 1 hour before or 2
hours after a meal. (2.2)
DOSAGE FORMS AND STRENGTHS
200 mg capsules (3)
CONTRAINDICATIONS
None. (4)
WARNINGS AND PRECAUTIONS
Embryo-Fetal Toxicity: 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 of ODOMZO may be required based on the severity o