TM Owner Sun Pharma
Odomzo 200mg Capsule
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Indications & Clinical Uses
- Odomzo 200mg is the brand name for sonidegib, an oral hedgehog pathway inhibitor capsule taken once daily.
- It is approved for the treatment of adult patients with locally advanced basal cell carcinoma that has recurred after surgery or radiation therapy, or that is not suitable for surgery or radiation.
- Odomzo works by blocking the smoothened protein in the hedgehog signaling pathway, which is abnormally active in basal cell carcinoma.
- It is not indicated for metastatic basal cell carcinoma and is not used for any other type of skin cancer.
- Odomzo was originally developed by Novartis and its US and Canadian rights were acquired by Sun Pharmaceutical Industries in December 2016, so the same medicine may still appear under older Novartis-branded packaging in some regions.
- Treatment is prescribed and monitored by a specialist familiar with hedgehog pathway inhibitors and continues until disease progression or unacceptable side effects occur.
Side Effects
- Odomzo carries a boxed warning for embryo-fetal toxicity: it can cause fetal death or severe birth defects if taken during pregnancy, so pregnancy status must be confirmed before starting treatment.
- Musculoskeletal reactions are very common, affecting more than half of patients, including muscle spasms, musculoskeletal pain, and myalgia; blood tests often show elevated creatine kinase, and rare but serious muscle breakdown (rhabdomyolysis) with kidney injury has occurred.
- Other very common effects include hair loss, altered or lost taste, fatigue, nausea, diarrhea, decreased appetite, and unintended weight loss.
- Seek urgent medical attention for severe or worsening muscle pain, weakness, dark urine, or reduced urination, as these can signal rhabdomyolysis.
- Report any possibility of pregnancy immediately.
- Because effects on growing bone are a concern, Odomzo is not given to children or adolescents whose bones are still developing.
Precautions & Warnings
- Because of the risk of severe birth defects and fetal death, females of reproductive potential must have a negative pregnancy test before starting Odomzo and use effective contraception during treatment and for 20 months after the last dose; males must use condoms during treatment and for 8 months afterward, even with a vasectomy, and should not donate sperm.
- Odomzo must not be taken by pregnant women.
- Creatine kinase should be checked periodically, and treatment should be interrupted or stopped for significant muscle symptoms or kidney injury.
- Odomzo can cause premature fusion of bone growth plates, so it must not be used in children or adolescents with open growth plates.
- Blood donation should be avoided during treatment and for 20 months afterward because of possible fetal exposure.
- The capsule must be taken on an empty stomach, at least one hour before or two hours after food, to ensure proper absorption.
Avoid Interactions
- Odomzo levels rise substantially with strong CYP3A4 inhibitors, such as ketoconazole, itraconazole, clarithromycin, and ritonavir, and these combinations must be avoided because of the increased risk of musculoskeletal toxicity.
- Moderate CYP3A4 inhibitors, including diltiazem, erythromycin, and fluconazole, may be used only for short courses of 14 days or less, with close monitoring for muscle-related side effects.
- Strong or moderate CYP3A4 inducers, such as rifampin, carbamazepine, phenytoin, and St. John's wort, reduce sonidegib levels and should also be avoided, as they may reduce effectiveness.
- Grapefruit and grapefruit juice can increase drug exposure and should be avoided.
- Odomzo must be taken on an empty stomach, since food significantly increases absorption and drug levels.
- Patients should tell their healthcare provider about every prescription medicine, over-the-counter drug, and herbal supplement they take, since many common drugs interact through the same liver enzyme pathway.
References
Frequently Asked Questions
Odomzo (sonidegib) treats adults with locally advanced basal cell carcinoma that has come back after surgery or radiation, or that cannot be treated with surgery or radiation. It blocks a signaling pathway that drives this skin cancer's growth. It is not used for metastatic basal cell carcinoma or other cancers.
Take one 200 mg Odomzo capsule by mouth once daily, on an empty stomach, at least one hour before or two hours after eating. Food increases how much drug your body absorbs, which can raise the risk of side effects. Swallow capsules whole.
Most patients get muscle spasms, muscle pain, fatigue, nausea, hair loss, or taste changes. Odomzo has a boxed warning for severe birth defects and fetal death if taken in pregnancy. Rare but serious muscle breakdown (rhabdomyolysis) can occur - get urgent care for severe muscle pain, weakness, or dark urine.
Avoid strong CYP3A4 inhibitors like ketoconazole and clarithromycin, which raise Odomzo levels and muscle-toxicity risk. Avoid grapefruit juice for the same reason. Avoid CYP3A4 inducers like rifampin and St. John's wort, which lower its effect. Never take Odomzo with food, since it increases absorption unpredictably.
Your healthcare provider checks creatine kinase levels periodically to watch for muscle injury and confirms you are not pregnant before starting. Report new or worsening muscle pain, weakness, or dark urine right away, since this can signal rhabdomyolysis, a rare but serious muscle-breakdown reaction.
No. Odomzo can cause fetal death or severe birth defects and must never be taken during pregnancy. Women must use effective contraception during treatment and for 20 months after the last dose; men must use condoms for 8 months after stopping, even after a vasectomy.
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