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IMPORTANT SAFETY INFORMATION

Do not use FYARRO if you have had a severe allergic reaction to sirolimus or other medications that work similarly to sirolimus (eg, everolimus, temsirolimus), or human albumin.

FYARRO can cause the following serious side effects; depending on the severity, your doctor may decide to decrease your dose or stop treatment with FYARRO:

• Mouth ulcers and sores are common during treatment with FYARRO and can be severe. If you develop pain, discomfort, or open sores in your mouth, tell your doctor.
• Decreased blood cell counts (red blood cells, platelets, and white blood cells). Your doctor should do blood tests before you start and during treatment with FYARRO.
• Infections. FYARRO can make you more susceptible to infections. Tell your doctor right away if you develop a fever, chills, or do not feel well.
• Low potassium, which can affect your heart rhythm if severe. Your doctor should do blood tests to check your potassium levels before you start and during treatment with FYARRO.
• Increased blood sugar levels in blood. Your doctor should do blood tests before you start and during treatment with FYARRO. Diabetic patients should monitor their blood sugar more frequently.
• Lung inflammation. If you develop a persistent cough, chest pain, or shortness of breath, tell your doctor right away.
• Bleeding, which can lead to death. If you develop bleeding, tell your doctor right away.
• Allergic reactions, which can be severe and life-threatening. Tell your doctor or get medical help right away if you develop swelling of your face, lips, tongue, or throat; a rash, itching, or flushing of your skin; hives; difficulty breathing or swallowing; chest pain; or dizziness.
• Harm to an unborn baby. Tell your doctor right away if you become pregnant or think you might be pregnant during treatment with FYARRO. Exposure to FYARRO during pregnancy or within 12 weeks before becoming pregnant can cause harm to your baby. If you are able to become pregnant, your doctor should do a pregnancy test before you start treatment with FYARRO. Birth control should be used while receiving FYARRO and for 12 weeks after your last dose of FYARRO. Men with a female partner should use effective birth control during treatment and for 12 weeks after the last dose of FYARRO.
• Infertility in woman and men. FYARRO may affect your ability to become pregnant if you are female, or your ability to father a child if you are male.
• Vaccinations may be less effective while being treated with FYARRO. In addition, you should not receive a live vaccine or be around people who have recently received a live vaccine during your treatment with FYARRO.

Before taking FYARRO, tell your doctor if you are breast feeding. It is not known if FYARRO could pass into breast milk and harm your baby. You should not breast feed during treatment with FYARRO and for 2 weeks after the last dose. Tell your doctor about all your medical conditions and the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Using FYARRO with certain other medicines can cause serious side effects. Tell your doctor before you start taking any new medicine. You should not drink grapefruit juice or eat grapefruit during your treatment with FYARRO. It may make the amount of FYARRO in your blood increase to a harmful level.

The most common side effects with FYARRO include the following: mouth ulcers or sores; feeling weak or tired; rash; infection; nausea; swelling of arms, hands, feet, ankles, face, or other parts of the body; diarrhea; body pain; decreased weight and appetite; cough; vomiting; and altered taste.

These are not all the possible side effects of FYARRO. Tell your doctor if you have any side effect that bothers you or does not go away. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see full Prescribing Information.