Sirolimus (with albumin) Injection

WHY is this medicine prescribed?

Sirolimus (with albumin) injection is used to treat a certain type of epithelioid cell tumor (soft tissue cancer that can form in any part of the body) that has spread to nearby tissues or to other parts of the body or can not be removed by surgery. Sirolimus is in a class of medications called kinase inhibitors. It works by blocking the action of the abnormal protein that tells the cancer cells to multiply. This may help slow the growth of tumors.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

Sirolimus (with albumin) injection comes as a suspension (liquid) to be given by intravenous infusion (slow injection into a vein) over 30 minutes. It is usually given by a doctor or nurse in a doctor's office or infusion center. Sirolimus (with albumin) injection is usually given on days 1 and 8 of a 21 day cycle.

Your doctor may need to interrupt your treatment, reduce your dose, or stop your treatment depending on your response to the medication and any side effects that you experience. Be sure to tell your doctor how you are feeling during your treatment.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What SPECIAL PRECAUTIONS should I follow?

Before receiving sirolimus (with albumin) injection,

• tell your doctor and pharmacist if you are allergic to sirolimus (Fyarro, Rapamune), other rapamycin derivatives such as everolimus (Afinitor, Zortress) or temsirolimus (Torisel), any other medications, or any of the ingredients in sirolimus (with albumin) injection. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: boceprevir, bromocriptine, carbamazepine, cimetidine, cisapride, clarithromycin, clotrimazole, cyclosporine, danazol, diltiazem, erythromycin, indinavir, itraconazole, ketoconazole, metoclopramide, nicardipine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, ritonavir, telaprevir, telithromycin, troleandomycin, verapamil, or voriconazole. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with sirolimus (with albumin) injection, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

• tell your doctor what herbal products you are taking, especially St. John's wort.

• tell your doctor if you have or have ever had diabetes, high cholesterol, high levels of potassium in your blood, or liver or kidney problems.

• you should know that sirolimus (with albumin) injection may interfere with sperm production in men. However, you should not assume that you cannot get someone else pregnant. Tell your doctor if you are pregnant or plan to become pregnant. Your doctor may perform a pregnancy test to be sure that you are not pregnant when you begin receiving sirolimus (with albumin) injection. Use a reliable method of birth control to prevent pregnancy during your treatment with sirolimus (with albumin) injection and for 3 months after your final dose. Talk to your doctor about birth control methods that will work for you. If you become pregnant while receiving sirolimus (with albumin) injection, call your doctor. Sirolimus (with albumin) injection may harm the fetus.

• if you have diabetes, you should know that sirolimus (with albumin) injection may increase glucose levels. Your doctor may ask you to monitor your blood glucose more frequently during your treatment with (with albumin) injection.

• if you are having surgery, including dental surgery, tell the doctor or dentist that you are receiving sirolimus (with albumin) injection.

• do not have any vaccinations without talking to your doctor.

What SPECIAL DIETARY instructions should I follow?

Do not eat large amounts of grapefruit or drink grapefruit juice while receiving this medication.

What SIDE EFFECTS can this medicine cause?

Sirolimus(with albumin) injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• vomiting
• diarrhea
• stomach pain
• constipation
• dry mouth
• hemorrhoids
• change in taste
• fatigue
• headache
• hair loss
• decreased appetite
• weight loss
• muscle, back, or neck pain
• difficulty sleeping

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately or get emergency medical treatment:

• sores in or around the mouth or lips
• fever, sore throat, chills, or other signs of infection
• cough, shortness or breath or painful breathing
• pain or burning on urination, pain in lower back, or difficulty urinating
• unusual bleeding or bruising; red or black, tarry stools; coughing up or vomiting blood or brown material that looks like coffee grounds
• swollen, red, cracked, scaly skin
• hives
• rash
• itching
• difficulty breathing or swallowing
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• hoarseness

Sirolimus (with albumin) injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to sirolimus (with albumin) injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.