Sonidegib
Generic Name: sonidegib
Brand Names:
Odomzo
11 DESCRIPTION Sonidegib is a Hh pathway inhibitor. The molecular formula for sonidegib phosphate is C 26 H 26 F 3 N 3 O 3 • 2H 3 PO 4 . The molecular weight is 681.49 daltons. The chemical name is N-[6-(cis-2,6-dimethylmorpholin-4-yl)pyridine-3-yl]-2-methyl-4’-(trifluoromethoxy) [1,1’-biphenyl]-3-carboxamide diphosphate. The molecular structure is shown below: Sonidegib phosphate is a white to off-white powder. Sonidegib freebase is practically insoluble.
Overview
11 DESCRIPTION Sonidegib is a Hh pathway inhibitor. The molecular formula for sonidegib phosphate is C 26 H 26 F 3 N 3 O 3 • 2H 3 PO 4 . The molecular weight is 681.49 daltons. The chemical name is N-[6-(cis-2,6-dimethylmorpholin-4-yl)pyridine-3-yl]-2-methyl-4’-(trifluoromethoxy) [1,1’-biphenyl]-3-carboxamide diphosphate. The molecular structure is shown below: Sonidegib phosphate is a white to off-white powder. Sonidegib freebase is practically insoluble.
Uses
1 INDICATIONS AND USAGE 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. 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
2 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 ) 2.1 Important Safety Information Verify the pregnancy status of females of reproductive potential prior to initiating ODOMZO [see Use in Specific Populations (8.1 , 8.3 )] . 2.2 Recommended Dosage The recommended dosage of ODOMZO is 200 mg taken orally once daily on an empty stomach, at least 1 hour before or 2 hours after a meal, administered until disease progression or unacceptable toxicity [see Clinical Pharmacology (12.3) ]. Obtain serum creatine kinase (CK) levels and renal function tests prior to initiating ODOMZO in all patients [see Dosage and Administration (2.2) and Warnings and Precautions (5.2) ].
Side Effects
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Musculoskeletal Adverse Reactions [see Warnings and Precautions (5.2) ] . 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. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-406-7984 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Interactions
7 DRUG INTERACTIONS CYP3A inhibitors: Avoid strong CYP3A inhibitors. Avoid long-term (greater than 14 days) use of moderate CYP3A inhibitors. ( 7.1 ) CYP3A inducers: Avoid strong and moderate CYP3A inducers. ( 7.1 ) 7.1 Effects of Other Drugs on ODOMZO Strong and Moderate CYP3A Inhibitors Avoid concomitant administration of ODOMZO with strong CYP3A inhibitors [see Clinical Pharmacology (12.3) ]. Avoid concomitant administration of ODOMZO with moderate CYP3A inhibitors. If a moderate CYP3A inhibitor must be used, administer the moderate CYP3A inhibitor for less than 14 days and monitor closely for adverse reactions particularly musculoskeletal adverse reactions [see Clinical Pharmacology (12.3) ].
Warnings
WARNING: EMBRYO-FETAL TOXICITY ODOMZO can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. ODOMZO is embryotoxic, fetotoxic, and teratogenic in animals [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ] . Verify the pregnancy status of females of reproductive potential prior to initiating therapy. 5 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 of musculoskeletal adverse reactions. ( 2.2 , 5.2 ) Premature fusion of the epiphyses ( 5.3 , 8.4 ) 5.1 Embryo-Fetal Toxicity ODOMZO can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. 4 CONTRAINDICATIONS None. None. ( 4 )
Pregnancy
8.1 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 [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).
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING 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].
Frequently Asked Questions
What is Sonidegib used for?▼
1 INDICATIONS AND USAGE 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. 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 )
What are the side effects of Sonidegib?▼
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Musculoskeletal Adverse Reactions [see Warnings and Precautions (5.2) ] . 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. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc. at 1-800-406-7984 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Can I take Sonidegib during pregnancy?▼
8.1 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 [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).
What are the important warnings for Sonidegib?▼
WARNING: EMBRYO-FETAL TOXICITY ODOMZO can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. ODOMZO is embryotoxic, fetotoxic, and teratogenic in animals [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ] . Verify the pregnancy status of females of reproductive potential prior to initiating therapy. 5 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 of musculoskeletal adverse reactions. ( 2.2 , 5.2 ) Premature fusion of the epiphyses ( 5.3 , 8.4 ) 5.1 Embryo-Fetal Toxicity ODOMZO can cause embryo-fetal death or severe birth defects when administered to a pregnant woman. 4 CONTRAINDICATIONS None. None. ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.