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Odomzo

Generic Name: sonidegib (SOE ni DEG ib)
Brand Names: Odomzo

What is Odomzo?

Odomzo (sonidegib) 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.

Important information

Do not use Odomzo 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 Odomzo 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.

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

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

To make sure Odomzo 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 Odomzo.

Do not use this medicine if you are pregnant. Odomzo 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 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.

For Men: If a man fathers a baby while taking Odomzo, 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 Odomzo.

How should I take Odomzo?

Take Odomzo exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

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

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 Odomzo at room temperature away from moisture and heat.

Odomzo 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.

See also: Dosage Information (in more detail)

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 Odomzo?

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

Do not donate semen (sperm) while taking this medicine 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.

Odomzo 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 this medicine);

  • muscle weakness;

  • little or no urinating;

  • dark colored urine; or

  • fever, unusual tiredness.

Common Odomzo 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.

See also: Side effects (in more detail)

What other drugs will affect Odomzo?

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 Odomzo.
  • 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.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2016 Cerner Multum, Inc. Version: 1.01. Revision Date: 2015-09-02, 1:59:39 PM.

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