Odomzo
Generic name: sonidegib [ SOE-ni-DEG-ib ]
Drug class: Hedgehog pathway inhibitors
What is Odomzo?
Odomzo is a cancer medicine that interferes with the growth and spread of cancer cells in the body.
Odomzo is used to treat basal cell carcinoma (a type of skin cancer).
Odomzo is usually given when surgery or radiation cannot be used, or have been used without success.
Warnings
Odomzo can cause severe birth defects or stillbirth if the mother or father is taking this medicine at the time of conception or during pregnancy. Both men and women using this medicine should use effective birth control to prevent pregnancy.
If you are a woman, do not use sonidegib if you are pregnant. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 20 months after your last dose.
If you are a man, always use a condom during sex with a woman who is pregnant or is able to get pregnant, even if you have had a vasectomy. Keep using condoms while you are taking Odomzo and for at least 8 months after your last dose.
Odomzo can cause a condition that results in the breakdown of skeletal muscle tissue. Call your doctor right away if you have unexplained muscle pain or weakness.
Before taking this medicine
To make sure Odomzo is safe for you, tell your doctor if you have ever had:
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kidney disease; or
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a muscle disorder called rhabdomyolysis or myopathy.
You will need to have a negative pregnancy test before you start taking Odomzo.
Sonidegib can cause severe birth defects or stillbirth if the mother or father is taking this medicine at the time of conception or during pregnancy. Both men and women using this medicine should use effective birth control to prevent pregnancy.
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If you are a woman, do not use this medicine if you are pregnant. Use effective birth control to prevent pregnancy while you are taking this medicine and for at least 20 months after your last dose. Stop using Odomzo and call your doctor at once if you quit using birth control, if your period is late, or if you think you might be pregnant.
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If you are a man, always use a condom during sex with a woman who is pregnant or is able to get pregnant, even if you have had a vasectomy. Keep using condoms while you are taking this medicine and for at least 8 months after your last dose.
Call your doctor if you have unprotected sex or if you believe your form of contraception has failed, whether you are a man or a woman.
Do not breastfeed while using this medicine, and for at least 20 months after your last dose.
Related/similar drugs
fluorouracil topical, imiquimod topical, Efudex, Aldara, Libtayo, cemiplimab
How should I take Odomzo?
Take Odomzo exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.
Take Odomzo on an empty stomach, at least 1 hour before or 2 hours after a meal.
You will need frequent medical tests to be sure this medicine is not causing harmful effects. Your cancer treatments may be delayed based on the results of these tests.
Store at room temperature away from moisture and heat.
Dosing information
Usual Adult Dose for Basal Cell Carcinoma:
200 mg orally once a day
Duration of therapy: Until disease progression or unacceptable toxicity
Comments:
-This drug should be taken on an empty stomach at least 1 hour before or 2 hours after a meal.
-Prior to treatment initiation, serum creatinine kinase (CK) levels and renal function tests should be obtained from all patients, and the pregnancy status of females of reproductive potential should be verified.
Use: 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.
What happens if I miss a dose?
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What to avoid
Do not donate blood while you are taking Odomzo and for at least 20 months after your final dose.
Do not donate semen (sperm) while taking Odomzo and for at least 8 months after your final dose.
Odomzo side effects
Get emergency medical help if you have signs of an allergic reaction to Odomzo: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Sonidegib can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have:
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severe or unexplained muscle pain or weakness (even if this occurs after you have stopped taking this medicine);
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little or no urinating; or
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dark colored urine.
Common Odomzo side effects may include:
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loss of appetite, weight loss;
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tiredness;
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itchy skin, hair loss; or
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changes in your sense of taste.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Odomzo?
Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.
Other drugs may interact with sonidegib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.
Popular FAQ
How does Odomzo work?
Odomzo is classified as a Hedgehog pathway inhibitor and helps to block this molecular pathway which is active in basal cell (skin) cancers. By suppressing the Hedgehog pathway, Odomzo may stop or slow the growth of cancer lesions. Specifically, Odomzo binds to and inhibits Smoothened, a protein involved in this pathway. Continue reading
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Further information
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Odomzo only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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