ODOMZO*
Manufacturer DetailsNOVARTIS PHARMACEUTICALS CORP.
Compositions:
Sonidegib-mg,
Sonidegib-mg,
| Strength | Rate | Packing Style |
|---|---|---|
| mg | 0.00 | unit |
List of Related Indications:
- For the treatment of Patients with Locally Advanced Basal Cell Carcinoma(BCC) that has occurred following surgery or radiation therapy, or those who are not candidates for Surgery or Radiation Therapy
List Of Drugs:
- Sonidegib-Odomzo -@- (July 2015)- Anti-cancer
Indication Type Description:
Drug Interaction
Indication
Adverse Reaction
Contra-Indications
Dosages/ Overdosage Etc
Patient Information
Pharmacology/ Pharmacokinetics
Pregnancy and lactation
Drug Interaction:
CYP3A inhibitors: Avoid strong CYP3A inhibitors. Avoid long-term
(greater than 14 days) use of moderate CYP3A inhibitors.
CYP3A inducers: Avoid strong and moderate CYP3A inducers.
Indication:
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)
Proprietary Name- ODOMZO*
Established Name- Sonidegib
Applicant- Novartis Pharmacuticals corpn.
Indication- For the treatment of Patients with Locally Advanced Basal Cell
Carcinoma(BCC) that has occurred following surgery or radiation
therapy, or those who are not candidates for Surgery or Radiation
Therapy
Approval Date- July 24,2015
Approved by U.S.FDA as on 24-7-2015 (Ref- FDA approved List- 2015)
NEW MOLECULAR ENTITY AND NEW THERAPEUTIC BIOLOGICAL
PRODUCTS APPROVED FOR 2015
Certain drugs are classified as New molecular Emtities- NME- for FDA review
Many of these products contain active moieties that have not been approved
by FDA previously, either as a single ingredient or as part of a combination
products; these products frequently provide important new therapies for the
patients.
Some drugs are characterized as NMEs for administrative purposes ,but
nonetheless contain certain active moieties in products that have been
previously approved by FDA. For example, CDER classifies biological
products submitted in an application under section 351(a) of the Public
Service Act as NME for purposes of FDA review, regardless of whether
the agency previously approved a related active moiety in a different
product.
FDAs classification of a drug as an -NME- for review purposes is distinct
from FDAs determination of whether a drug is a - New Chemical Entity or - NCE-
within the meaning of the Federal Food,Drug, and Cosmetic Act
No.19
Drug Name - Sonidegib
Active Ingredient- Odomzo
Date of approval - 7/24/2015
FDA-approved use - To treat patients with locally advanced Basal Cell
Carcinoma that has recurred following surgery or
radiation therapy, or who are not candidates for
for surgery or radiation therapy.
Approved by US FDA on 7/24/2015- (Ref- FDA approved List- 2015)
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.
Adverse Reaction:
The most common adverse reactions occurring in .10% of patients are
muscle spasms, alopecia, dysgeusia, fatigue, nausea, musculoskeletal pain,
diarrhea, decreased weight, decreased appetite, myalgia, abdominal pain,
headache, pain, vomiting, and pruritus.
Contra-Indications:
CONTRAINDICATIONS
None.
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.
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 of musculoskeletal adverse reactions.
Dosages/ Overdosage Etc:
Indication- For the treatment of Patients with Locally Advanced Basal Cell
Carcinoma(BCC) that has occurred following surgery or radiation
therapy, or those who are not candidates for Surgery or Radiation
Therapy
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.
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.
DOSAGE FORMS AND STRENGTHS
200 mg capsules
Patient Information:
PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Embryo-Fetal Toxicity.
1. Advise female patients of the potential risk to a fetus.
2,Advise females of reproductive potential to use effective contraception during
treatment with ODOMZO and for at least 20 months after the last dose.
3.Advise males, even those with prior vasectomy, to use condoms, to avoid potential
drug exposure in both pregnant partners and female partners of reproductive
potential during treatment with ODOMZO and for at least 8 months after the last dose.
4.Advise female patients and female partners of male patients to contact their
healthcare provider with a known or suspected pregnancy.
5. Advise females who may have been exposed to ODOMZO during pregnancy,
either directly or through seminal fluid, to contact the Novartis Pharmaceuticals
Corporation at 1-888-669-6682.
6.Blood Donation
Advise patients not to donate blood or blood products while taking ODOMZO and
for 20 months after stopping treatment.
7.Musculoskeletal Adverse Reactions
Advise patients to contact their healthcare provider immediately for new or worsening
signs or symptoms of muscle toxicity, dark urine, decreased urine output, or the
inability to urinate
8.Administration Instructions Advise patients to take ODOMZO on an empty stomach,
at least 1 hour before or 2 hours after a meal
9.Lactation Advise women not to breastfeed during treatment with ODOMZO and for
up to 20 months after the last dose
Pharmacology/ Pharmacokinetics:
CLINICAL PHARMACOLOGY
1. Mechanism of Action
Sonidegib is an inhibitor of the Hedgehog pathway. Sonidegib binds to and inhibits
Smoothened, a transmembrane protein involved in Hedgehog signal transduction.
2. Pharmacokinetics- Absorption
Less than 10% of an oral dose of ODOMZO is absorbed. Following the administration
of a single ODOMZO dose (100 mg to 3000 mg) under fasted conditions in patients
with cancer, the median time-to-peak concentration (Tmax) was 2 to 4 hours.
Sonidegib exhibited dose-proportional increases in the area under the curve (AUC)
and the maximal concentration (Cmax) over the dose range of 100 mg to 400 mg,
but less than dose-proportional increases at doses greater than 400 mg.
Steady-state was reached approximately 4 months after starting ODOMZO and the
estimated accumulation at steady-state was 19-fold.
Following a dose of 200 mg once daily, the estimated mean steady-state Cmax is
1030 ng/mL, AUC0-24h is 22 ìg*h/mL and minimal concentration (Cmin) is 890 ng/mL.
A high-fat meal (approximately 1000 calories with 50% of calories from fat) increased
exposure to sonidegib (geometric mean AUCinf and Cmax) by 7.4-to 7.8-fold .
Distribution
The estimated apparent steady-state volume of distribution (Vss/F) was
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1. Pregnancy
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
There are no available data on the use of ODOMZO in pregnant women.
Advise pregnant women of the potential risk to a fetus
2. Lactation
No data are available regarding the presence of sonidegib in human milk, the effects
of the drug on the breast fed infant, or the effects of the drug on milk production.
Because of the potential for serious adverse reactions in breastfed infants from
sonidegib, advise a nursing woman not to breastfeed during treatment with
ODOMZO and for 20 months after the last dose
3. Pediatric Use
The safety and effectiveness of ODOMZO have not been established in pediatric patients.
4. Geriatric Use
Of the 229 patients who received ODOMZO (79 patients receiving 200 mg daily and
150 patients receiving 800 mg daily) in Study 1, 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 events, Grade 3 and 4 adverse
events, and adverse events 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.
