Sirolimus Protein-Bound (sir-OH-li-mus PROE-teen - bownd)

Treats perivascular epithelioid cell tumor (PEComa).

Brand Name(s):

Fyarro

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through an IV placed in a vein. It must be given slowly, so the needle will have to remain in place for at least 30 minutes.
• You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.
• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control to keep from getting pregnant during treatment and for at least 12 weeks after the last dose. Males with female partners must use effective birth control during treatment and for at least 12 weeks after the last dose.
• Do not breastfeed during treatment and for at least 2 weeks after the last dose.
• Tell your doctor if you have liver disease or diabetes.
• This medicine may cause the following problems:
  • Stomatitis (swelling of the mouth)
  • Serious infections
  • Hyperglycemia (high blood sugar level)
  • Lung or breathing problems, including interstitial lung disease, pneumonitis
  • Serious bleeding problems
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• This medicine is made from donated human blood. Some human blood products have transmitted viruses (including Creutzfeldt-Jacob disease), although the risk is low because donors and blood are both tested for viruses. Talk with your doctor if you are concerned.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Bloody or cloudy urine, change in how much or how often you urinate, difficult or painful urination, lower back or side pain
• Chest pain, trouble breathing
• Dry mouth, fruit-like breath odor, increased thirst, muscle cramps, nausea, vomiting, stomach pain, tiredness, uneven heartbeat
• Fever, chills, cough, runny or stuffy, sore throat, body aches
• Rapid weight gain, swelling in your hands, ankles, or feet
• Sores or white patches on your lips, mouth, or throat
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Change or loss of taste
• Diarrhea, loss of appetite, weight loss
• Muscle or bone pain

If you notice other side effects that you think are caused by this medicine, tell your doctor

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