Nanoparticle Albumin-Bound Sirolimus Injection

What is this medication?

NANOPARTICLE ALBUMIN-BOUND SIROLIMUS (Na no PAHR ti kuhl al BYOO muhn-bound sir OH li mus) is an immunosuppressant. It treats perivascular epithelioid cell tumor.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Fyarro

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Diabetes (high blood sugar)
• Infection
• Liver disease
• Low levels of potassium in the blood
• An unusual or allergic reaction to sirolimus, albumin, other medicines, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This medicine is injected into a vein. It is given by a health care provider in a hospital or clinic setting.

Talk to your health care provider about the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

Keep appointments for follow-up doses. It is important not to miss your dose. Call your health care provider if you are unable to keep an appointment.

What may interact with this medication?

• Certain antibiotics like clarithromycin, erythromycin, telithromycin
• Grapefruit juice
• Live vaccines
• Medicines for fungal infections like itraconazole, ketoconazole, posaconazole, voriconazole
• Mifepristone, RU-486
• Rifampin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Your condition will be monitored carefully while you are receiving this medicine.

You may need blood work done while you are taking this medicine.

This medicine may increase your risk of getting an infection. Call your health care provider for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

Do not become pregnant while taking this medicine or for 12 weeks after stopping it. Women should inform their health care provider if they wish to become pregnant or think they might be pregnant. Men should not father a child while taking this medicine and for 12 weeks after stopping it. There is a potential for serious side effects to an unborn child. Talk to your health care provider for more information. Do not breast-feed an infant while taking this medicine and for 2 weeks after the last dose.

This medicine may make it more difficult to get pregnant or father a child. Talk to your health care provider if you are concerned about your fertility.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• Allergic reactions (skin rash; itching or hives; swelling of the face, lips, or tongue)
• Bleeding (bloody or black, tarry stools, red or dark brown urine, spitting up blood or brown material that looks like coffee grounds, red spots on the skin;, unusual bruising or bleeding from the eyes, gums or nose)
• High blood sugar (increased hunger, thirst or urination, unusually weak or tired, blurry vision)
• Infection (fever, chills, cough, sore throat, pain or trouble passing urine)
• Low potassium levels (chest pain, dizziness, fast heartbeat, feeling faint or lightheaded, falls, muscle cramp or pain)
• Low red blood cell counts (feeling faint, lightheaded, falls, unusually weak or tired)
• Mouth sores
• Trouble breathing

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• Constipation
• Diarrhea
• Hair loss
• Lack or loss of appetite
• Nausea
• Swelling of the ankles, feet, hands or other unusual swelling
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

This medicine is given in a hospital or clinic. It will not be stored at home.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.