Pronunciation:

sir-OH-li-mus PROE-teen - bownd

Brand Names:

• Fyarro

Dosage Forms:

• Powder for Suspension

Classifications:

Therapeutic—

Immune Suppressant

Uses of This Medicine:

Sirolimus protein-bound injection is used to treat perivascular epithelioid cell tumor (PEComa) that has spread or grown and cannot be removed by surgery.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of sirolimus protein-bound injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sirolimus protein-bound injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Amiodarone
• Amprenavir
• Apalutamide
• Aprepitant
• Atazanavir
• Boceprevir
• Carbamazepine
• Carvedilol
• Cimetidine
• Ciprofloxacin
• Clarithromycin
• Cobicistat
• Conivaptan
• Crizotinib
• Cyclosporine
• Darunavir
• Delavirdine
• Diltiazem
• Dronedarone
• Elagolix
• Enzalutamide
• Erythromycin
• Flibanserin
• Fluconazole
• Fluvoxamine
• Fosamprenavir
• Fosaprepitant
• Fosnetupitant
• Fosphenytoin
• Idelalisib
• Imatinib
• Indinavir
• Itraconazole
• Ivacaftor
• Ketoconazole
• Lapatinib
• Larotrectinib
• Letermovir
• Lomitapide
• Lopinavir
• Lumacaftor
• Mibefradil
• Mifepristone
• Mitotane
• Nefazodone
• Nelfinavir
• Netupitant
• Nilotinib
• Palbociclib
• Phenytoin
• Posaconazole
• Quinidine
• Ranitidine
• Ranolazine
• Rifampin
• Ritonavir
• Saquinavir
• St John's Wort
• Telaprevir
• Telithromycin
• Tipranavir
• Vemurafenib
• Verapamil
• Voriconazole
• Voxelotor

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Diabetes or
• Liver disease, mild to moderate—Use with caution. May increase the risk of serious side effects.

• Liver disease, severe—Use is not recommended in patients with this condition.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. It is given through a needle placed into one of your veins. It must be given slowly, so the needle will have to remain in place for at least 30 minutes. The infusion will be given on Days 1 and 8 of each 21-day cycle.

Do not eat grapefruit or drink grapefruit juice while you are receiving this medicine.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Receiving this medicine while you are pregnant can harm your unborn baby. 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 with this medicine 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 of this medicine. If you think you have become pregnant while receiving the medicine, tell your doctor right away.

Stomatitis (swelling or inflammation of the mouth) may occur during treatment with this medicine. Tell your doctor right away if you have sores, ulcers, or white spots on the lips or tongue or inside the mouth.

This medicine lowers the number of some types of blood cells in your body. Because of this, you may bleed or get infections more easily. To help with these problems, avoid being near people who are sick or have infections. Wash your hands often. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

This medicine may cause serious infections (eg, urinary tract infections, upper respiratory tract infections, and sinusitis). Check with your doctor right away if you have bladder pain, bloody or cloudy urine, chest tightness, chills, cough, difficult, burning, or painful urination, ear congestion, fever, frequent urge to urinate, headache, loss of voice, lower back or side pain, pain or tenderness around eyes and cheekbones, sneezing, sore throat, stuffy or runny nose, trouble breathing, or unusual tiredness or weakness.

Check with your doctor right away if you have decreased urine, dry mouth, irregular heartbeat, increased thirst, loss of appetite, mood changes, muscle pain or cramps, nausea or vomiting, numbness or tingling in the hands, feet, or lips, trouble breathing, or unusual tiredness or weakness. These may be symptoms of hypokalemia (low potassium in the blood).

This medicine may increase your blood sugar levels. Check with your doctor right away if you have blurred vision, dry mouth, fatigue, flushed, dry skin. fruit-like breath odor, increased hunger, increased thirst, increased urination, nausea, sweating, trouble breathing, unexplained weight loss, or vomiting. If you notice a change in the results of your urine or blood sugar tests, or if you have any questions, check with your doctor.

Check with your doctor right away if you have chest pain, cough, difficult breathing, fever, general feeling of discomfort or illness, or thickening of bronchial secretions. These may be symptoms of serious lung or breathing problems, including interstitial lung disease or pneumonitis.

This medicine may cause serious bleeding problems. Check with your doctor right away if you have bleeding gums, coughing up blood, difficulty in breathing or swallowing, dizziness, headache, increased menstrual flow or vaginal bleeding, nosebleeds, paralysis, prolonged bleeding from cuts, red or dark brown urine, red or black, tarry stools, or trouble breathing.

This medicine may cause serious types of allergic reactions, including anaphylaxis and angioedema, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs, red, swollen skin, trouble breathing, trouble swallowing, or chest tightness while you are using this medicine.

This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.

While you are being treated with sirolimus protein-bound injection, do not have any immunizations (live vaccines) without your doctor's approval.

This medicine is made from donated human blood. Some human blood products have transmitted certain viruses (eg, Creutzfeldt-Jakob disease) to people who have received them, although the risk is low. Human donors and donated blood are both tested for viruses to keep the transmission risk low. Talk with your doctor if you have concerns about this risk.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Bleeding gums

blood in the urine or stools

blurred vision

chest pain

chills

confusion

cough

coughing up blood

cracked lips

decreased urine

diarrhea

difficulty in swallowing

dizziness

dry mouth

fever

flushed, dry skin

fruit-like breath odor

general feeling of discomfort or illness

headache

increased hunger

increased menstrual flow or vaginal bleeding

increased thirst

increased urination

irritation or soreness of the mouth

lightheadedness

loss of appetite

mood changes

muscle pain or cramps

nausea or vomiting

nervousness

nosebleeds

numbness or tingling in hands, feet, or lips

painful or difficult urination

pale skin

paralysis

pinpoint red spots on the skin

pounding in the ears

prolonged bleeding from cuts

red or dark brown urine

red or black, tarry stools

slow, fast, or irregular heartbeat

sore throat

sores, ulcers, or white spots on the lips, tongue, or inside the mouth

stomach pain

sunken eyes

sweating

swelling of the hands, ankles, feet, or lower legs

thickening of bronchial secretions

trouble breathing

unexplained weight loss

unusual bleeding or bruising

unusual tiredness or weakness

wrinkled skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Bleeding after defecation

burning, numbness, tingling, or painful sensations

constipation

discoloration of the fingernails or toenails

dry skin

loss or thinning of the hair

muscle or bone pain

trouble sleeping

uncomfortable swelling around the anus

unsteadiness or awkwardness

weakness in arms, hands, legs, or feet

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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