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Rydapt

Generic Name: midostaurin (MYE doe STAW rin)
Brand Names: Rydapt

What is Rydapt?

Rydapt (midostaurin) is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Rydapt is used together with other cancer medicines to treat acute myeloid leukemia.

Rydapt is also used to treat certain rare blood disorders, including systemic mastocytosis with mast cell leukemia or other cancers affecting the blood, bone marrow, or lymphatic tissue.

Rydapt may be used only if your tumor has a specific genetic marker, for which your doctor will test.

Important information

Use birth control to prevent pregnancy, whether you are a man or a woman. Rydapt use by either parent may cause birth defects. Avoid pregnancy and breast-feeding for at least 4 months after you stop using this medicine.

Before taking this medicine

You should not use Rydapt if you are allergic to midostaurin.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

  • lung disease or breathing problems.

Rydapt can harm an unborn baby or cause birth defects, whether the mother or father is taking this medicine.

  • If you are a woman, do not use Rydapt if you are pregnant. You may need to have a negative pregnancy test before starting this treatment. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 4 months after your last dose.

  • If you are a man, use effective birth control if your sexual partner is able to get pregnant. An unborn baby can be harmed if a man fathers the child while he is using Rydapt. Keep using birth control for at least 4 months after your last dose.

  • Tell your doctor right away if a pregnancy occurs while either the mother or the father is taking Rydapt.

You should not breast-feed while using this medicine and for at least 4 months after your last dose.

How should I take Rydapt?

Take Rydapt 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.

Rydapt is usually taken 2 times per day (once every 12 hours) with food.

Take your doses at regular intervals to keep a steady amount of the drug in your body at all times.

You may be given medication to prevent nausea or vomiting while you are receiving Rydapt.

If you vomit shortly after taking Rydapt, do not take an extra dose. Wait until your next scheduled dose time to take the medicine again.

Do not crush or open a capsule.

While using Rydapt, you may need frequent blood tests (every 1 to 4 weeks). This medicine is usually given until your body no longer responds to the medication.

Use all medications as directed by your doctor. Read the instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.

Store Rydapt in the original container at room temperature, away from moisture and heat.

Rydapt dosing information

Usual Adult Dose for Acute Myeloid Leukemia:

50 mg orally twice a day at approximately 12 hour intervals on Days 8 to 21 of each cycle of induction AND on Days 8 to 21 of each cycle of consolidation.

Comments:
-This drug is not indicated as a single-agent induction therapy for acute myeloid leukemia (AML) patients.
-Information on FDA-approved tests for the detection of FLT3 mutation in AML is available at: http://www.fda.gov/CompanionDiagnostics.

Use: In combination with standard cytarabine and daunorubicin induction and high-dose cytarabine consolidation, treatment of newly diagnosed AML who are FLT3 mutation-positive as detected by a FDA approved test.

Usual Adult Dose for Systemic Mastocytosis:

100 mg orally twice a day at approximately 12 hour intervals
Duration of Therapy: Until disease progression or unacceptable toxicity occurs.

Comments: Monitor for toxicity at least weekly for the first 4 weeks, every other week for the next 8 weeks, and monthly thereafter while on treatment.

Uses: Treatment of aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL).

Usual Adult Dose for Leukemia:

100 mg orally twice a day at approximately 12 hour intervals
Duration of Therapy: Until disease progression or unacceptable toxicity occurs.

Comments: Monitor for toxicity at least weekly for the first 4 weeks, every other week for the next 8 weeks, and monthly thereafter while on treatment.

Uses: Treatment of aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL).

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 Rydapt?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Rydapt side effects

Get emergency medical help if you have signs of an allergic reaction to Rydapt: hives, warmth, redness, or tingly feeling; chest pain, difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • pain or sores in or around your mouth, redness inside your mouth, sore throat;

  • sudden chest pain or discomfort, wheezing, dry cough, feeling short of breath;

  • high blood sugar - increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss; or

  • low blood cell counts - fever, chills, flu-like symptoms, swollen gums, mouth sores, skin sores, rapid heart rate, pale skin, easy bruising, unusual bleeding, feeling light-headed.

Common Rydapt side effects may include:

  • fever, flu-like symptoms;

  • mouth sores;

  • unusual bleeding or bruising;

  • cold symptoms such as stuffy nose, sneezing, sore throat;

  • trouble breathing;

  • nausea, vomiting, stomach pain, constipation, diarrhea;

  • muscle or joint pain;

  • headache, feeling tired; or

  • swelling.

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 Rydapt?

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 midostaurin, 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 pharmacist can provide more information about Rydapt.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Rydapt 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 1996-2017 Cerner Multum, Inc. Version: 1.01.

Date modified: July 02, 2017
Last reviewed: June 08, 2017

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