Sonidegib
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From MedlinePlus, U.S. National Library of Medicine
Boxed warning
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. Advise females of reproductive potential to use effective contraception during treatment with ODOMZO and for at least 20 months after the last dose [see Warnings and Precautions (5.1) and Use in Specific Populations (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 [see Warnings and Precautions (5.1) and Use in Specific Populations (8.3) ] . 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 )
Handling and access
NIOSH hazardous drug
Table 2NIOSH lists sonidegib as a hazardous drug. AHFS class: 10:00 antineoplastic agents.
- Meets the NIOSH definition of a hazardous drug (carcinogenicity, developmental or reproductive toxicity, organ toxicity at low doses, or genotoxicity) without MSHI or a Group 1 or 2A carcinogen classification.
- Only a developmental and/or reproductive hazard: precautions matter most for workers who are pregnant, breastfeeding, or trying to conceive.
Handle with the precautions your facility uses for hazardous drugs (USP <800>). NIOSH's Managing Hazardous Drug Exposures lists controls by drug form and activity.
Dosing in kidney impairment
Obtain serum creatine kinase (CK) levels and renal function tests prior to initiating ODOMZO in all patients [see Dosage and Administration and Warnings and Precautions ]. If a dose of ODOMZO is missed, resume dosing with the next scheduled dose. 2.3 Dosage Modifications for Adverse Reactions Interrupt ODOMZO for Severe or intolerable musculoskeletal adverse reactions.
First occurrence of serum CK elevation between 2.5 and 10 times upper limit of normal (ULN). Recurrent serum CK elevation between 2.5 and 5 times ULN. Resume ODOMZO at 200 mg daily upon resolution of clinical signs and symptoms. Permanently discontinue ODOMZO for Serum CK elevation greater than 2.5 times ULN with worsening renal function.
Drug interactions
Check sonidegib against a medication listLabel text (2 paragraphs)
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) ]. Strong and Moderate CYP3A Inducers Avoid concomitant administration of ODOMZO with strong and moderate CYP3A inducers [see Clinical Pharmacology (12.3) ].
Contraindications
None. None. ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
E*Likelihood score E*: Unproven but suspected cause of clinically apparent liver injury.
Sonidegib is a small molecule kinase inhibitor that blocks signaling in the hedgehog pathway and is used in the therapy of unresectable or metastatic basal cell carcinoma. Sonidegib therapy is associated with a low rate or transient serum aminotransferase elevations during therapy, but has not been linked to instances of clinically apparent acute liver injury.
ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.
Pregnancy and lactation
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). 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.
Breastfeeding (LactMed)
No information is available on the clinical use of sonidegib during breastfeeding. Because sonidegib is 97% bound to plasma proteins, the amount in milk is likely to be low. However, its half-life is about 28 days and it might accumulate in the infant. The manufacturer recommends that breastfeeding be discontinued during sonidegib therapy.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
Not the price at the counterThese are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.