Mitotane

Mitotane

Mitotane

What is Mitotane?

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

Mitotane side effects

If necessary, get emergency medical helpSigns of an allergic reaction: hives; difficult breathing; Swelling of your face, lips, tongue, or throat.

Mitotane can cause serious side effects. Call your doctor immediately if you have:

• blurred or double vision;

• confusion, problems with speech, balance, or walking;

• a light-headed feeling, as if you were going to faint;

• pelvic pain, vaginal bleeding;

• easy bruising or bleeding (nosebleeds, bleeding gums); or

• any bleeding that doesn't stop.

Common side effects of mitotane can include:

• nausea, vomiting, loss of appetite;

• Diarrhea;

• depressed mood;

• dizziness, feeling dizzy; or

• rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You can report side effects to FDA at 1-800-FDA-1088.

Warnings

You may need to take steroid medications or stop taking mitotane for a short time if you have a serious injury or medical emergency. Your doctor will decide when you can start taking mitotane again.Do not change your dosage or medication schedule without your doctor's advice.

You must remain under the care of a doctor while taking Mitotane.

Before you take this medicine

Tell your doctor if you have ever had:

• recent infection, surgery, or trauma;

• liver disease; or

• if you are taking a blood thinner (warfarin, Coumadin, Jantoven).

Do not use mitotane if you are pregnant.This medicine could harm the unborn baby or cause miscarriage or premature birth. Use effective contraception to prevent pregnancy while using mitotane.

Do not breast-feed while using this medicine.

Follow your doctor's instructions about how long after stopping treatment to avoid pregnancy and breastfeeding.Mitotane may remain in your bloodstream long after you stop using it.

How should I take mitotane?

Follow all instructions on your prescription label and read any medication guides or instructions for use. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Frequent medical examinations may be required. Even if you don't have any symptoms, your doctor can use tests to determine whether mitotane is effective.

You may need to take steroid medications or stop taking mitotane for a short time if you have a serious injury or medical emergency. Your doctor will decide when you can start taking this medicine again.Do not change your dosage or medication schedule without your doctor's advice.

You must remain under the care of a doctor while taking Mitotane.

Store mitotane at room temperature, away from moisture and heat.

Ask your pharmacist how to handle mitotane tablets safely. You may need to wear latex gloves when handling this medicine. Don't use a broken tablet.

Mitotane dosage information

Usual adult dose for adrenocortical carcinoma:

Initial dose: 2 to 6 g orally per day, divided into 3 to 4 doses

Comments:
-Increase dose gradually to achieve a blood concentration of 14 to 20 mg/L or as tolerated.

Use: For the treatment of patients with unresectable, functional or nonfunctional adrenocortical carcinoma.

What happens if I miss a dose?

Take the medicine as soon as possible, but skip the missed dose if it is almost time for the next dose. Do not take two doses at the same time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help hotline at 1-800-222-1222.

What should I avoid while taking Mitotane?

Avoid driving and dangerous activities until you know how mitotane affects you. Your reactions may be affected.

Avoid activities that could increase the risk of bleeding or injury. Be especially careful to avoid bleeding when shaving or brushing your teeth.

What other drugs affect mitotane?

Sometimes it is not safe to take certain medications at the same time. Some medications can affect the blood levels of other medications you are taking, which may increase side effects or make the medications less effective.

Other medications can affect mitotane, including prescription and over-the-counter medications, vitamins, and herbal products. Tell your doctor about all medications you are currently taking and any medications you are taking or stopping.

More information

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