Sirolimus Protein-bound Side Effects

Medically reviewed by Drugs.com. Last updated on Jan 2, 2025.

Applies to sirolimus protein-bound: intravenous powder for suspension.

Precautions

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.

Serious side effects

Along with its needed effects, sirolimus protein-bound 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 while taking sirolimus protein-bound:

Other side effects

Some side effects of sirolimus protein-bound 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:

For healthcare professionals

Applies to sirolimus protein-bound: intravenous powder for injection.

General adverse events

The most common adverse reactions were stomatitis (79%), fatigue and rash (68% each), infection (59%), nausea and edema (50% each), and diarrhea, musculoskeletal pain, and decreased weight (47% each).^[Ref]

Cardiovascular

• Very common (10% or more): Hypertension (29%)^[Ref]

Dermatologic

• Very common (10% or more): Rash (68%), alopecia (24%), pruritus (18%)

Dry skin (12%), nail disorder (12%)^[Ref]

Gastrointestinal

• Very common (10% or more): Stomatitis (79%), nausea (50%), diarrhea (47%), vomiting (32%), abdominal pain (29%), constipation (24%), dry mouth (15%), hemorrhoids (12%)^[Ref]

Hematologic

• Very common (10% or more): Hemorrhage (24%)^[Ref]

Metabolic

• Very common (10% or more): Decreased appetite (444%), dehydration (15%)^[Ref]

Musculoskeletal

• Very common (10% or more): Musculoskeletal pain - including arthralgias, back pain, myalgias (47%)^[Ref]

Ocular

• Very common (10% or more): Blurred vision (12%)^[Ref]

Other

• Very common (10% or more): Infections - upper respiratory tract infection, urinary tract infection, sinusitis, skin infection, folliculitis, nasopharyngitis, pharyngitis, pharyngitis streptococcal, pneumonia, vaginal infection (59%)^[Ref]

Psychiatric

• Very common (10% or more): Insomnia (21%)^[Ref]

Respiratory

• Very common (10% or more): Cough (35%), pneumonitis (18%), dyspnea (12%)^[Ref]

See also:

Further information

Sirolimus protein-bound side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer