What is Rydapt?
Rydapt is an anti-cancer medicine that inhibits the growth and spreading of cancerous cells. Rydapt can be used in conjunction with other cancer drugs to treat acute leukemia. Rydapt can also be used to treat rare blood disorders such as mastocytosis accompanied by mast cell leukemia and other cancers that affect the blood, lymphatic tissue, bone marrow, or lymphatic tissues.
Warnings
Women and men who use Rydapt are encouraged to use birth control methods that prevent pregnancy. A mother or father taking Midostaurin may harm the unborn child.
Before you take this drug
If you have an allergy to midostaurin, then Rydapt should be avoided.
Notify your doctor of any of the following issues:
- Lung disease or breathing problems
Before starting the treatment, you may need a negative pregnancy result.
Midostaurin may cause birth defects or harm to an unborn child if either the mother or father uses Rydapt.
- Do not take midostaurin while pregnant if you're a woman. You should use effective birth control during the time you are taking this medication and for 4 months following your last dose. You may find your name on a registry if you are pregnant to monitor the effects of midostaurin.
- Use effective birth control if you're a man and your partner can get pregnant. Continue to use birth control for at least four months after your last dose.
- If you or your partner become pregnant while using Rydapt, tell your doctor immediately.
Rydapt can affect both men's and women's fertility. It is still important to use birth control to avoid pregnancy because midostaurin may harm the unborn child. While using Rydapt, you should not breastfeed for 4 months following your last dose. Rydapt should not be used by anyone under the age of 18.
How to take Rydapt?
Rydapt should be taken exactly as directed by your doctor. Your doctor will test Rydapt to ensure it is the best treatment for you. Read all instructions or guides that come with your medication and follow all directions. Follow the directions on the label. Rydapt can be taken twice a day with food (once every twelve hours). To ensure that you have a constant amount of drug in your system, take your doses regularly. While taking this medication, you may receive medication to prevent nausea and vomiting. Do not take another dose of Rydapt if you vomit soon after taking it. Do not take another dose of Rydapt until you have taken your next scheduled dose. Rydapt capsules should not be crushed or opened. Blood tests may be required every 1 to 4 weeks. Rydapt should be given until the body stops responding to it. As soon as taking any medication prescribed by your physician, always follow his or her directions carefully. Each medication comes with instructions. You should not alter your medication or doses without consulting your doctor. Store the capsules at room temperature, away from moisture or heat.
Details on dosage
Adult dose for acute myeloid leukemia:
On Days 8–21 of each cycle, take 50 mg twice daily at intervals of approximately 12 hours.
Comments:
This drug is not recommended as an induction therapy with a single agent for patients with acute myeloid lymphoma (AML).
Use: Combination of standard cytarabine, daunorubicin, and high-dose cytarabine induction for newly diagnosed AML patients who have FLT3 mutations as detected by an FDA-approved test.
Adult dose for systemic mastocytosis:
Take 100 mg twice daily at intervals of approximately 12 hours.
Duration of Treatment: Until disease progression occurs or unacceptable toxicities occur.
Comment: Check for toxicity every two weeks for the first four weeks, then weekly for the following eight weeks, and finally monthly while you are on treatment.
Uses: Treatment for aggressive systemic mastocytosis, systemic matomatocytosis associated with hematological neoplasms (SM-AHN), or mast cell lymphoma (MCL).
Adult dose for leukemia:
Take 100 mg twice daily at intervals of approximately 12 hours.
Duration of Treatment: Until disease progression occurs or unacceptable toxicities occur.
Comment: Check for toxicity every two weeks for the first four weeks, then weekly for the following eight weeks, and finally monthly while you are on treatment.
Uses: Treatment for aggressive systemic mastocytosis, systemic matoma with associated hematological neoplasms (SM-AHN), or mast cell lymphoma (MCL).
What happens if I miss the dose?
If you are almost due for your next dose, skip the missed one. Never take two doses of the same medicine at once.
What happens if I overdose?
Call 1-800-222-1222 for poison help or seek immediate medical attention.
What should be avoided?
If your doctor prescribes any restrictions regarding food, beverage, or activity, follow their instructions.
Side effects of Rydapt
If you experience any of the following symptoms of an allergic reaction: hives; chest pain; difficulty breathing; swelling in your face, lips, or throat; or warmth, redness, or tingly feelings, seek immediate medical attention.
If you experience:
- Sore throat, pain or sores around the mouth or inside, or redness in your mouth
- Feeling short of breath, chest discomfort or pain, dry cough, or wheezing
- Signs that you have an infection where the needle was used to inject other medications: bruising or swelling, redness, warmth, oozing or bleeding, and warmth around the needle.
- High blood sugar: increased thirst, increased urination, and dry mouth; or
- Low blood cell counts: fever, chills, and tiredness; mouth sores or skin sores; easy bruising; unusual bleeding. Pale skin, cold feet, and cold hands
Rydapt may cause side effects such as:
- Low blood cell count and fever
- Bruising, nosebleeds;
- High blood sugar
- Infection around an injection needle
- Mouth sores;
- Cold symptoms like stuffy noses, sneezing, and sore throats;
- Trouble breathing
- Nausea, vomiting, stomach pain, constipation, diarrhea;
- Muscle or bone pain
- Headache, feeling tired
- Swelling in the hands, feet, or ankles
There may be other side effects.Call your doctor immediately if experiencing side effects; for additional advice contact the FDA at 1-800-FDA-1088; to report adverse events you can reach them by dialing this number as well.
Interaction with other drug
It is sometimes not safe to take certain medications together. Some drugs may affect the blood levels of drugs that you are taking, causing side effects or making them less effective. Midostaurin may also interact with other drugs, such as prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor of all the medicines you are taking and those that you stop or start using.
