sonidegib

Pronunciation: SOE ni DEG ib

Brand: Odomzo

Odomzo

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200 mg, capsule, pink, imprinted with NVR, SONIDEGIB 200MG

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What is the most important information I should know about sonidegib?

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.

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 sonidegib and for at least 8 months after your last dose.

What is sonidegib?

Sonidegib is used to treat basal cell carcinoma (a type of skin cancer).

Sonidegib is usually given when surgery or radiation cannot be used, or have been used without success.

Sonidegib may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking sonidegib?

Tell your doctor if you have ever had:

  • kidney disease; or
  • a muscle disorder called rhabdomyolysis or myopathy.

You will need to have a negative pregnancy test before you start taking sonidegib.

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.

  • If you are a woman, do not use sonidegib 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 sonidegib 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.
  • 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 sonidegib 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.

How should I take sonidegib?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take sonidegib 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.

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 should I avoid while taking sonidegib?

Do not donate blood while you are taking sonidegib and for at least 20 months after your final dose of sonidegib.

Do not donate semen (sperm) while taking sonidegib and for at least 8 months after your final dose.

What are the possible side effects of sonidegib?

Get emergency medical help if you have signs of an allergic reaction: 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:

  • severe or unexplained muscle pain or weakness (even if this occurs after you have stopped taking sonidegib);
  • little or no urinating; or
  • dark colored urine.

Common side effects may include:

  • stomach pain, nausea, vomiting, diarrhea;
  • loss of appetite, weight loss;
  • tiredness;
  • itchy skin, hair loss; or
  • 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 sonidegib?

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 affect 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.

Where can I get more information?

Your doctor or pharmacist can provide more information about sonidegib.

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