sonidegib

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Pronunciation: SOE ni DEG ib

Brand: Odomzo

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

Do not use this medicine if you are pregnant. Sonidegib can cause severe birth defects or stillbirth if the mother or the father is taking this medicine at the time of conception or during pregnancy.

Use birth control to prevent pregnancy, whether you are a man or a woman. For women: Use birth control while taking sonidegib and for at least 20 months after you take your last dose. For Men: Use condoms during sex while you are taking sonidegib and for at least 8 months after you take your last dose. Use condoms even if you had a vasectomy, or if your partner is already pregnant or able to become pregnant.

Sonidegib 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.

What is sonidegib?

Sonidegib is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

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?

You should not use sonidegib if you are allergic to it, or if you are pregnant or breast-feeding a baby.

To make sure sonidegib is safe for you, tell your doctor if you have:

  • kidney disease; or
  • a past or present muscle disorder.

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

Do not use this medicine if you are pregnant. Sonidegib can cause severe birth defects or stillbirth if the mother or the father is taking this medicine at the time of conception or during pregnancy. 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.

For Men: If a man fathers a baby while taking sonidegib, the baby may have birth defects. Use condoms during sex while you are taking this medicine, and for at least 8 months after your treatment ends. 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.

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.

It is not known whether sonidegib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine and for at least 20 months after your final dose of sonidegib.

How should I take sonidegib?

Your doctor will perform blood tests to make sure you do not have conditions that would prevent you from safely using sonidegib.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

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 missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

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 tenderness (even if this occurs after you have stopped taking sonidegib);
  • muscle weakness;
  • little or no urinating;
  • dark colored urine; or
  • fever, unusual tiredness.

Common side effects may include:

  • stomach pain, nausea, vomiting, diarrhea;
  • loss of appetite, weight loss;
  • muscle spasms;
  • headache;
  • missed menstrual periods;
  • 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?

Other drugs may interact with sonidegib, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about sonidegib.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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