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Drug overview for ODOMZO (sonidegib phosphate):
Generic name: SONIDEGIB PHOSPHATE (SOE-ni-DEG-ib)
Drug class: Antineoplastic - Hedgehog Pathway Inhibitors
Therapeutic class: Antineoplastics
Sonidegib, a hedgehog signaling pathway inhibitor, is an antineoplastic agent.
No enhanced Uses information available for this drug.
Generic name: SONIDEGIB PHOSPHATE (SOE-ni-DEG-ib)
Drug class: Antineoplastic - Hedgehog Pathway Inhibitors
Therapeutic class: Antineoplastics
Sonidegib, a hedgehog signaling pathway inhibitor, is an antineoplastic agent.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for ODOMZO (sonidegib phosphate) have been approved by the FDA:
Indications:
Basal cell carcinoma of skin
Professional Synonyms:
Basal cell epithelioma
Basalioma
Indications:
Basal cell carcinoma of skin
Professional Synonyms:
Basal cell epithelioma
Basalioma
The following dosing information is available for ODOMZO (sonidegib phosphate):
No enhanced Dosing information available for this drug.
Sonidegib is administered orally once daily on an empty stomach, at least 1 hour before or 2 hours after a meal.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| ODOMZO 200 MG CAPSULE | Maintenance | Adults take 1 capsule (200 mg) by oral route once daily |
No generic dosing information available.
The following drug interaction information is available for ODOMZO (sonidegib phosphate):
There are 0 contraindications.
There are 3 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Cobimetinib; Olaparib; Sonidegib/Moderate CYP3A4 Inhibitors SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Agents which inhibit the CYP3A4 enzyme may inhibit the metabolism of cobimetinib, olaparib, and sonidegib.(1-4) CLINICAL EFFECTS: Concurrent use of moderate CYP3A4 inhibitors may increase systemic exposure and the risk for adverse effects from cobimetinib, olaparib, or sonidegib.(1-4) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: When possible, avoid the use of moderate CYP3A4 inhibitors in patients receiving cobimetinib, olaparib, or sonidegib.(1-4) For patients taking cobimetinib 60 mg daily, if concurrent short term use (14 days or less) of a moderate CYP3A4 inhibitor cannot be avoided, reduce cobimetinib dose to 20 mg daily. After discontinuation of the moderate CYP3A4 inhibitor resume the previous 60 mg dose. Patients who are taking cobimetinib 40 mg or 20 mg daily should not receive a moderate or strong CYP3A4 inhibitor.(1) If concomitant use with olaparib cannot be avoided, reduce the olaparib dose. Dosage adjustments are specific to the formulation of olaparib.(2,3) Reduce the dosage of the CAPsule formulation to 200 mg (four 50 mg CAPsules) taken twice daily.(2) Reduce the dosage of the TABlet formulation to 150 mg (one 150 mg TABlet) twice daily). If the CYP3A4 inhibitor is discontinued, resume the dose of olaparib taken prior to initiation of the CYP3A4 inhibitor after 3 to 5 half-lives.(3) If sonidegib and a moderate CYP3A4 inhibitor must be used, administer the moderate CYP3A4 inhibitor for less than 14 days and monitor closely for adverse effects, particularly musculoskeletal adverse reactions.(4) DISCUSSION: In an interaction study, itraconazole (a strong CYP3A4 inhibitor) given 200 mg once daily for 14 days followed by a single dose of cobimetinib 10 mg increased mean cobimetinib AUC 6.7-fold (90% CI 5.6, 8.0). Subsequent simulations showed that predicted steady-state concentrations of cobimetinib at a reduced daily dose of 20 mg given with short term use of a moderate CYP3A4 inhibitor were similar to observed steady-state concentrations at the 60 mg dose without an inhibitor.(1) In simulations using physiologically-based pharmacokinetic (PBPK) models, concurrent use of fluconazole, a moderate CYP3A4 inhibitor, may increase the area-under-curve (AUC) of olaparib by 2.2-fold.(2,3) Based upon PBPK simulations, sonidegib mean steady-state AUC would increase 1.8-fold if administered with a moderate CYP3A4 inhibitor for 14 days and would further increase to 2.8-fold if the moderate CYP3A4 inhibitor is coadministered with sonidegib for 4 months.(4) Moderate CYP3A4 inhibitors linked to this monograph include: aprepitant, avacopan, berotralstat, clofazimine, conivaptan, crizotinib, diltiazem, dronedarone, duvelisib, erythromycin, fedratinib, fluconazole, fluvoxamine, fosnetupitant, imatinib, isavuconazonium, ledipasvir, lenacapavir, letermovir, netupitant, nilotinib, schisandra, tofisopam, treosulfan and verapamil.(5) |
AKYNZEO, APONVIE, APREPITANT, CARDIZEM, CARDIZEM CD, CARDIZEM LA, CARTIA XT, CINVANTI, CLOFAZIMINE, CONIVAPTAN-D5W, COPIKTRA, CRESEMBA, DANZITEN, DIFLUCAN, DILT-XR, DILTIAZEM 12HR ER, DILTIAZEM 24HR ER, DILTIAZEM 24HR ER (CD), DILTIAZEM 24HR ER (LA), DILTIAZEM 24HR ER (XR), DILTIAZEM HCL, DILTIAZEM HCL-0.7% NACL, DILTIAZEM HCL-0.9% NACL, DILTIAZEM HCL-NACL, DILTIAZEM-D5W, E.E.S. 200, E.E.S. 400, EMEND, ERY-TAB, ERYPED 200, ERYPED 400, ERYTHROCIN LACTOBIONATE, ERYTHROCIN STEARATE, ERYTHROMYCIN, ERYTHROMYCIN ESTOLATE, ERYTHROMYCIN ETHYLSUCCINATE, ERYTHROMYCIN LACTOBIONATE, FLUCONAZOLE, FLUCONAZOLE-NACL, FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE ER, GLEEVEC, GRAFAPEX, IMATINIB MESYLATE, IMKELDI, INREBIC, MATZIM LA, MULTAQ, NILOTINIB HCL, ORLADEYO, PREVYMIS, SUNLENCA, TASIGNA, TAVNEOS, TIADYLT ER, TIAZAC, TRANDOLAPRIL-VERAPAMIL ER, VAPRISOL-5% DEXTROSE, VERAPAMIL ER, VERAPAMIL ER PM, VERAPAMIL HCL, VERAPAMIL SR, XALKORI |
| Sonidegib/Strong CYP3A4 Inhibitors SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Agents that inhibit the CYP3A4 isoenzyme may inhibit the metabolism of sonidegib.(1) CLINICAL EFFECTS: Concurrent use of strong CYP3A4 inhibitors may increase levels of and effects from sonidegib, including musculoskeletal adverse reactions (elevated creatine kinase) or rhabdomyolysis.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Avoid the use of strong CYP3A4 inhibitors in patients undergoing therapy with sonidegib.(1) Consider alternatives with no or minimal enzyme inhibition. DISCUSSION: In a study, 15 healthy subjects received a single sonidegib 800 mg alone or after ketoconazole 200 mg twice daily for 14 days. Mean area-under-curve (AUC) and concentration maximum (Cmax) increased by 2.2-fold and 1.5-fold respectively.(1) Strong inhibitors of CYP3A4 include: adagrasib, boceprevir, ceritinib, clarithromycin, cobicistat, idelalisib, indinavir, itraconazole, josamycin, ketoconazole, lonafarnib, lopinavir, mibefradil, mifepristone, nefazodone, nelfinavir, nirmatrelvir/ritonavir, paritaprevir, posaconazole, ribociclib, saquinavir, telaprevir, telithromycin, tipranavir, troleandomycin, tucatinib, or voriconazole.(2,3) |
APTIVUS, CLARITHROMYCIN, CLARITHROMYCIN ER, EVOTAZ, GENVOYA, ITRACONAZOLE, ITRACONAZOLE MICRONIZED, KALETRA, KETOCONAZOLE, KISQALI, KORLYM, KRAZATI, LANSOPRAZOL-AMOXICIL-CLARITHRO, LOPINAVIR-RITONAVIR, MIFEPREX, MIFEPRISTONE, NEFAZODONE HCL, NOXAFIL, OMECLAMOX-PAK, PAXLOVID, POSACONAZOLE, PREZCOBIX, RECORLEV, SPORANOX, STRIBILD, SYMTUZA, TOLSURA, TUKYSA, TYBOST, VFEND, VFEND IV, VIRACEPT, VOQUEZNA TRIPLE PAK, VORICONAZOLE, ZOKINVY, ZYDELIG, ZYKADIA |
| Sonidegib/Strong & Moderate CYP3A4 Inducers SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Agents that induce the CYP3A4 isoenzyme may induce the metabolism of sonidegib.(1) CLINICAL EFFECTS: Concurrent use of strong or moderate CYP3A4 inducers may decrease the levels and effectiveness of sonidegib.(1) PREDISPOSING FACTORS: Induction effects may be more likely with regular use of the inducer for longer than 1-2 weeks. PATIENT MANAGEMENT: Avoid the concurrent use of strong or moderate CYP3A4 inducers in patients receiving therapy with sonidegib.(1) Consider the use of alternatives with little to no induction potential. DISCUSSION: In an interaction study, 16 healthy subjects received a single dose of sonidegib 800mg alone or 5 days after receiving rifampin 600 mg daily for 14 days. Mean sonidegib area-under-curve (AUC) was decreased by 75% and maximum concentration (Cmax) decreased 54% when taken with rifampin. Based upon population based pharmacokinetic (PBPK) simulations, a moderate CYP3A4 inducer such as efavirenz given for 14 days is predicted to decrease sonidegib AUC 56% in cancer patients taking sonidegib 200 mg daily. Coadministration with a moderate CYP3A4 inducer for 4 months is predicted to decrease sonidegib exposure (AUC) by 69%.(1) Strong inducers of CYP3A4 include: apalutamide, barbiturates, carbamazepine, encorafenib, enzalutamide, fosphenytoin, ivosidenib, lumacaftor, mitotane, phenobarbital, phenytoin, primidone, rifampin, rifapentine, and St. John's wort. Moderate inducers of CYP3A4 include: bosentan, cenobamate, dabrafenib, efavirenz, elagolix, etravirine, lesinurad, lorlatinib, mavacamten, mitapivat, modafinil, nafcillin, pacritinib, pexidartinib, repotrectinib, rifabutin, sotorasib, telotristat ethyl, thioridazine, and tovorafenib.(2-3) |
ASA-BUTALB-CAFFEINE-CODEINE, ASCOMP WITH CODEINE, AUGTYRO, BOSENTAN, BRAFTOVI, BUTALB-ACETAMINOPH-CAFF-CODEIN, BUTALBITAL, BUTALBITAL-ACETAMINOPHEN, BUTALBITAL-ACETAMINOPHEN-CAFFE, BUTALBITAL-ASPIRIN-CAFFEINE, CAMZYOS, CARBAMAZEPINE, CARBAMAZEPINE ER, CARBATROL, CEREBYX, DILANTIN, DILANTIN-125, DONNATAL, DUZALLO, EFAVIRENZ, EFAVIRENZ-EMTRIC-TENOFOV DISOP, EFAVIRENZ-LAMIVU-TENOFOV DISOP, EPITOL, EQUETRO, ERLEADA, ETRAVIRINE, FIORICET, FIORICET WITH CODEINE, FOSPHENYTOIN SODIUM, INTELENCE, LORBRENA, LUMAKRAS, LYSODREN, MITOTANE, MODAFINIL, MYSOLINE, NAFCILLIN, NAFCILLIN SODIUM, OJEMDA, ORIAHNN, ORILISSA, ORKAMBI, PENTOBARBITAL SODIUM, PHENOBARBITAL, PHENOBARBITAL SODIUM, PHENOBARBITAL-BELLADONNA, PHENOBARBITAL-HYOSC-ATROP-SCOP, PHENOHYTRO, PHENYTEK, PHENYTOIN, PHENYTOIN SODIUM, PHENYTOIN SODIUM EXTENDED, PRIFTIN, PRIMIDONE, PROVIGIL, PYRUKYND, RIFABUTIN, RIFADIN, RIFAMPIN, SEZABY, SYMFI, SYMFI LO, TAFINLAR, TALICIA, TEGRETOL, TEGRETOL XR, TENCON, THIORIDAZINE HCL, THIORIDAZINE HYDROCHLORIDE, TIBSOVO, TRACLEER, TURALIO, VONJO, XCOPRI, XERMELO, XTANDI |
There are 0 moderate interactions.
The following contraindication information is available for ODOMZO (sonidegib phosphate):
Drug contraindication overview.
The manufacturer states that there are no known contraindications to the use of sonidegib.
The manufacturer states that there are no known contraindications to the use of sonidegib.
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Lactation |
There are 3 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Myalgia |
| Myopathy with CK elevation |
| Pregnancy |
There are 0 moderate contraindications.
The following adverse reaction information is available for ODOMZO (sonidegib phosphate):
Adverse reaction overview.
Adverse effects reported in 10% or more of patients with advanced basal cell carcinoma receiving sonidegib in the principal efficacy study include muscle spasms, alopecia, dysgeusia, fatigue, nausea, diarrhea, musculoskeletal pain, weight loss, decreased appetite, myalgia, abdominal pain, headache, pain, vomiting, pruritus, and arthralgia. Laboratory abnormalities reported in more than 15% of patients receiving sonidegib include elevated concentrations of serum creatinine, elevated concentrations of serum CK, hyperglycemia, elevated concentrations of lipase, anemia, lymphopenia, elevated concentrations of aminotransferases (i.e., AST, ALT), and elevated concentrations of amylase. Amenorrhea lasting at least 18 months also has been reported in 2 of 14 premenopausal women receiving sonidegib (200 or 800 mg once daily).
Adverse effects reported in 10% or more of patients with advanced basal cell carcinoma receiving sonidegib in the principal efficacy study include muscle spasms, alopecia, dysgeusia, fatigue, nausea, diarrhea, musculoskeletal pain, weight loss, decreased appetite, myalgia, abdominal pain, headache, pain, vomiting, pruritus, and arthralgia. Laboratory abnormalities reported in more than 15% of patients receiving sonidegib include elevated concentrations of serum creatinine, elevated concentrations of serum CK, hyperglycemia, elevated concentrations of lipase, anemia, lymphopenia, elevated concentrations of aminotransferases (i.e., AST, ALT), and elevated concentrations of amylase. Amenorrhea lasting at least 18 months also has been reported in 2 of 14 premenopausal women receiving sonidegib (200 or 800 mg once daily).
There are 1 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. | None. |
| Rare/Very Rare |
|---|
|
Rhabdomyolysis |
There are 19 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Acute abdominal pain Alopecia Anemia Anorexia Diarrhea Dysgeusia Fatigue Headache disorder Lymphopenia Muscle spasm Musculoskeletal pain Myalgia Nausea Pruritus of skin Vomiting Weight loss |
General weakness Pain |
| Rare/Very Rare |
|---|
|
Amenorrhea |
The following precautions are available for ODOMZO (sonidegib phosphate):
Safety and efficacy of sonidegib have not been established in pediatric patients. Data in animals suggest possible adverse effects on bone, teeth, reproductive tissues, and nerve fibers in juvenile rats receiving sonidegib at exposure levels of approximately 1.2 times the human exposure at the recommended dosage. Epiphyseal disorders were reported in pediatric patients exposed to sonidegib in a clinical trial.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Sonidegib may cause fetal harm if administered to pregnant females based on its mechanism of action and animal findings. Verify pregnancy status in all females of reproductive potential prior to initiation of sonidegib therapy. If a female patient or female partner of a male patient receiving sonidegib therapy becomes pregnant during therapy or within 20 or 8 months, respectively, after discontinuance of the drug, the clinician should notify the manufacturer at 800-406-7984.
It is not known whether sonidegib is distributed into milk. Because of the potential for serious adverse reactions to sonidegib in breast-fed infants, women should be advised to discontinue breast-feeding while receiving sonidegib and for at least 20 months after discontinuance of therapy. The effects of the drug on breast-fed infants or on milk production are unknown.
In the BOLT study, 54% of patients receiving sonidegib (200 or 800 mg once daily) were 65 years of age or older and 28% were 75 years of age or older. No overall differences in efficacy were observed between geriatric and younger adults; however, grade 3 or 4 adverse effects, serious adverse effects, or adverse effects requiring interruption or discontinuance of therapy occurred more frequently in patients 65 years of age or older compared with younger adults. The manufacturer makes no specific dosage recommendations for geriatric patients.
The following prioritized warning is available for ODOMZO (sonidegib phosphate):
WARNING: Sonidegib is not recommended for use during pregnancy because it may cause serious harm (possibly death) to an unborn baby. Women of childbearing age must have a pregnancy test before starting this medication. They must also use reliable forms of birth control while taking sonidegib and for 20 months after the last dose of this medication.
It is unknown if sonidegib passes into semen. Because of the possible risk of passing the drug on to a partner, men taking sonidegib (including men who have had a vasectomy) must use condoms during sex with women who are pregnant or of childbearing age, both during treatment with sonidegib and for 8 months after the last dose of this medication. Men should also not donate sperm during this time. If you or your partner become pregnant or think you may be pregnant, tell your doctor right away.
WARNING: Sonidegib is not recommended for use during pregnancy because it may cause serious harm (possibly death) to an unborn baby. Women of childbearing age must have a pregnancy test before starting this medication. They must also use reliable forms of birth control while taking sonidegib and for 20 months after the last dose of this medication.
It is unknown if sonidegib passes into semen. Because of the possible risk of passing the drug on to a partner, men taking sonidegib (including men who have had a vasectomy) must use condoms during sex with women who are pregnant or of childbearing age, both during treatment with sonidegib and for 8 months after the last dose of this medication. Men should also not donate sperm during this time. If you or your partner become pregnant or think you may be pregnant, tell your doctor right away.
The following icd codes are available for ODOMZO (sonidegib phosphate)'s list of indications:
| Basal cell carcinoma of skin | |
| C44.01 | Basal cell carcinoma of skin of lip |
| C44.11 | Basal cell carcinoma of skin of eyelid, including canthus |
| C44.111 | Basal cell carcinoma of skin of unspecified eyelid, including canthus |
| C44.112 | Basal cell carcinoma of skin of right eyelid, including canthus |
| C44.1121 | Basal cell carcinoma of skin of right upper eyelid, including canthus |
| C44.1122 | Basal cell carcinoma of skin of right lower eyelid, including canthus |
| C44.119 | Basal cell carcinoma of skin of left eyelid, including canthus |
| C44.1191 | Basal cell carcinoma of skin of left upper eyelid, including canthus |
| C44.1192 | Basal cell carcinoma of skin of left lower eyelid, including canthus |
| C44.21 | Basal cell carcinoma of skin of ear and external auricular canal |
| C44.211 | Basal cell carcinoma of skin of unspecified ear and external auricular canal |
| C44.212 | Basal cell carcinoma of skin of right ear and external auricular canal |
| C44.219 | Basal cell carcinoma of skin of left ear and external auricular canal |
| C44.31 | Basal cell carcinoma of skin of other and unspecified parts of face |
| C44.310 | Basal cell carcinoma of skin of unspecified parts of face |
| C44.311 | Basal cell carcinoma of skin of nose |
| C44.319 | Basal cell carcinoma of skin of other parts of face |
| C44.41 | Basal cell carcinoma of skin of scalp and neck |
| C44.51 | Basal cell carcinoma of skin of trunk |
| C44.510 | Basal cell carcinoma of anal skin |
| C44.511 | Basal cell carcinoma of skin of breast |
| C44.519 | Basal cell carcinoma of skin of other part of trunk |
| C44.61 | Basal cell carcinoma of skin of upper limb, including shoulder |
| C44.611 | Basal cell carcinoma of skin of unspecified upper limb, including shoulder |
| C44.612 | Basal cell carcinoma of skin of right upper limb, including shoulder |
| C44.619 | Basal cell carcinoma of skin of left upper limb, including shoulder |
| C44.71 | Basal cell carcinoma of skin of lower limb, including hip |
| C44.711 | Basal cell carcinoma of skin of unspecified lower limb, including hip |
| C44.712 | Basal cell carcinoma of skin of right lower limb, including hip |
| C44.719 | Basal cell carcinoma of skin of left lower limb, including hip |
| C44.81 | Basal cell carcinoma of overlapping sites of skin |
| C44.91 | Basal cell carcinoma of skin, unspecified |
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