Rydapt

Rydapt is a prescription medication used with other chemotherapy drugs to treat certain types of acute myeloid leukemia (a type of cancer of the white blood cells) in adults. Rydapt is also used to treat certain types of mastocytosis (a blood disorder in which there are too many mast cells, a certain kind of white blood cells) in adults.

Rydapt belongs to a group of drugs called kinase inhibitors. These work by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop the spread of mast and cancer cells.

This medication comes in a capsule form and is taken orally twice daily, with food.

Common side effects of Rydapt include nausea, vomiting, diarrhea, and headache.

Rydapt is a prescription medication used with other chemotherapy drugs to treat certain types of acute myeloid leukemia (a type of cancer of the white blood cells) in adults.

Rydapt is also used to treat aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL) in adults. These disorders cause mastocytosis (too many mast cells, a certain kind of white blood cell).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Novartis Pharmaceuticals Corporation

Serious side effects have been reported with Rydapt. See the “Rydapt Precautions” section.

The most common side effects of Rydant in people with Acute myeloid leukemia (AML) include:

• low white blood cell counts with fever (febrile neutropenia)  
• nausea
• vomiting
• redness, pain or ulcers on the inside your mouth (mucositis)
• headache
• nosebleeds
• bruising
• high blood sugar levels (hyperglycemia)
• upper respiratory tract infection
• muscle or bone pain

The most common side effects of Rydant in people with aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL) include:

• vomiting 
• diarrhea   
• swelling of hands, feet, or ankles
• tiredness
• upper respiratory tract infections
• fever
• constipation
• headache
• muscle or bone pain
• stomach pain                    

This is not a complete list of Rydapt side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medications that block a protein in the body (CYP3A4) such as some macrolide antibiotics (clarithromycin, telithromycin), some HIV protease inhibitors (indinavir, nelfinavir, ritonavir, saquinavir), some HCV protease inhibitors (boceprevir, telaprevir), some azole antifungals (ketoconazole, itraconazole, posaconazole, voriconazole), delavirdine (Rescriptor), and nefazodone. Increased Rydapt concentrations may increase the risk of toxicity.

• medications that increase the activity of the enzyme CYP3A4 such as carbamazepine (Tegretol, Equetro, Carbatrol), phenobarbital, phenytoin (Dilantin), rifampin (Rifadin), and St John's wort. Decreased Rydapt concentrations may reduce efficacy.

This is not a complete list of Rydapt drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Rydapt including the following: 

• Serious allergic reactions. Do not take Rydapt if you are allergic to any of the ingredients in Rydapt. Symptoms of a serious allergic reaction to Rydapt may include:
  • rash
  • raised red patches on your skin (hives)
  • swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing
• Harm to your unborn baby. Rydapt can harm unborn baby or cause baby's death when taken during pregnancy
• Lung damage. Rydapt may cause lung problems that may lead to death. Tell your healthcare provider right away if you have some or all of the following symptoms:
  • new cough
  • chest discomfort
  • shortness of breath
• Problems becoming pregnant (infertility).

Grapefruit and grapefruit juice may interact with Rydapt and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before taking Rydapt, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Rydapt, any other medications, or any of the ingredients in Rydapt capsules.
• have any lung or breathing problems.
• are pregnant or plan to become pregnant. Rydapt may cause harm to your unborn baby. Tell your healthcare provider right away if you become pregnant during treatment with Rydapt or think you may be pregnant. 
  • If you are able to become pregnant, your healthcare provider may perform a pregnancy test within 7 days before you start Rydapt.
  • Females who are able to become pregnant should use effective birth control (contraception) during treatment with Rydapt and for at least 4 months after the last dose of Rydapt.
  • Males who have female partners that are able to become pregnant should use effective birth control during treatment with Rydapt and for at least 4 months after the last dose of Rydapt.

• are breastfeeding or plan to breastfeed. It is not known if Rydapt passes into your breast milk. You should not breastfeed during treatment with Rydapt and for at least 4 months after the last dose of Rydapt.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant. 

Based on the way it works, Rydapt may cause harm to your unborn baby. Rydapt should never be used by pregnant women.

• Females who are able to become pregnant should use effective birth control (contraception) during treatment with Rydapt and for at least 4 months after the last dose of Rydapt.
• Males who have female partners that are able to become pregnant should use effective birth control during treatment with Rydapt and for at least 4 months after the last dose of Rydapt.

Tell your doctor if you are breastfeeding or plan to breastfeed. 

It is not known if Rydapt crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Rydapt.

Take Rydapt exactly as prescribed.

Rydapt comes in a capsule form and is taken orally twice daily with food.

Do not open or crush Rydapt capsules.

If you miss a dose of Rydapt, take your next dose at your scheduled time. Do not take an extra dose to make up for a missed dose.

If you vomit after taking a dose of Rydapt, do not take an extra dose. Take your next dose at your scheduled time.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

The recommended dose of Rydapt for the treatment of Acute myeloid leukemia (AML) is 50 mg orally twice daily with food on Days 8 to 21 of each chemotherapy cycle of induction with cytarabine and daunorubicin and on Days 8 to 21 of each chemotherapy cycle of consolidation with high-dose cytarabine.

The recommended dose of Rydapt for the treatment of aggressive systemic mastocytosis (ASM), systemic mastocytosis with associated hematological neoplasm (SM-AHN), or mast cell leukemia (MCL) is 100 mg orally twice daily with food. Treatment is continued until disease progression or unacceptable toxicity occurs.

Anti-emetics (medications that are used for nausea and/or vomiting) are usually given before treatment with Rydapt to reduce the risk of nausea and vomiting.

If you take too much Rydapt, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Rydapt is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if an overdose is suspected, seek emergency medical attention.

Keep this medication in the container it came in, tightly closed, and out of reach of children.

Store it at room temperature, 15°C to 30°C (59°F to 86°F) and away from excess heat and moisture (not in the bathroom).