Sirolimus protein-bound is used to treat adults with a certain type of perivascular epithelioid cell tumor (PEComa).

Sirolimus protein-bound may also be used for purposes not listed in this medication guide.

Both men and women using sirolimus protein-bound should use effective birth control to prevent pregnancy. Sirolimus protein-bound can harm an unborn baby if the mother or father is using this medicine.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Sirolimus protein-bound is injected into a vein by a healthcare professional over a 30-minute period on days 1 and 8 of each 21-day treatment cycle.

Your blood sugar will need to be checked on a regular basis, and you may need other medical tests.

Usual Adult Dose for Malignant perivascular epithelioid cell neoplasm:

Recommended dose: 100 mg/m2 as an IV infusion over 30 minutes on Days 1 and 8 of each 21-day cycle.
Duration of therapy: Until disease progression or unacceptable toxicity

Use: Adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa)

You should not use sirolimus protein-bound if you are allergic to it, other rapamycin derivatives, or albumin.

Tell your doctor if you have ever had:

• liver disease;

• diabetes;

• breathing problems; or

• bleeding problems.

Both men and women using this medicine should use effective birth control to prevent pregnancy. Sirolimus protein-bound can harm an unborn baby if the mother or father is using this medicine.

Keep using birth control for at least 12 weeks after your last dose. Tell your doctor right away if a pregnancy occurs.

You will need to have a negative pregnancy test before starting this treatment.

Sirolimus protein-bound may affect fertility in men or women. Pregnancy could be harder to achieve while either parent is using this medicine.

Do not breastfeed while using this medicine, and for at least 2 weeks after your last dose.

Call your doctor for instructions if you miss a dose.

In a medical setting an overdose would be treated quickly.

Avoid receiving a "live" vaccine. The vaccine may not work as well while you are using sirolimus protein-bound. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), and zoster (shingles).

Grapefruit may interact with sirolimus protein-bound and cause side effects. Avoid consuming grapefruit products.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Sirolimus protein-bound may cause serious side effects. Call your doctor at once if you have:

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

• nosebleeds, bleeding gums, abnormal vaginal bleeding, any bleeding that will not stop;

• low blood potassium--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling;

• signs of infection--fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding; or

• low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Common side effects of sirolimus protein-bound may include:

• blisters or ulcers in your mouth, red or swollen gums, trouble swallowing;

• fever, chills, sore throat, body aches, loss of appetite, bruising or bleeding;

• tiredness;

• cough;

• altered sense of taste;

• rash;

• nausea, diarrhea, vomiting;

• swelling;

• muscle, bone, or joint pain; or

• loss of weight and appetite.

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.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Other drugs may affect sirolimus protein-bound, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.