Rapamune Side Effects

Generic Name: sirolimus

Please note - some side effects for Rapamune may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Rapamune - for the Consumer

Rapamune

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Rapamune:

Acne; back pain; constipation; diarrhea; headache; joint pain; nausea; trouble sleeping; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); calf pain or swelling; chest pain; dark urine; decreased urination; fast or irregular heartbeat; infection (fever, chills, sore throat, unusual vaginal discharge or odor, frequent or painful urination); mental or mood changes; muscle pain or tenderness; night sweats; red, swollen, blistered, or peeling skin; severe headache; shortness of breath; skin growths or discoloration; swelling of the hands, ankles, or feet; swollen glands or veins; tremor; unusual bleeding or bruising; unusual lumps; unusual tiredness or weakness; unusual weight gain or loss; vision changes; wound healing problems; yellowing of the skin or eyes.

Rapamune Solution

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Rapamune Solution:

Acne; back pain; constipation; diarrhea; headache; joint pain; nausea; trouble sleeping; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); calf pain or swelling; chest pain; dark urine; decreased urination; fast or irregular heartbeat; infection (fever, chills, sore throat, unusual vaginal discharge or odor, frequent or painful urination); mental or mood changes; muscle pain or tenderness; night sweats; red, swollen, blistered, or peeling skin; severe headache; shortness of breath; skin growths or discoloration; swelling of the hands, ankles, or feet; swollen glands or veins; tremor; unusual bleeding or bruising; unusual lumps; unusual tiredness or weakness; unusual weight gain or loss; vision changes; wound healing problems; yellowing of the skin or eyes.

Rapamune Side Effects - for the Professional

Rapamune

The most common (> 30%) adverse reactions are: peripheral edema, hypertriglyceridemia, hypertension, hypercholesterolemia, creatinine increased, abdominal pain, diarrhea, headache, fever, urinary tract infection, anemia, nausea, arthralgia, pain, and thrombocytopenia (6).

To report SUSPECTED ADVERSE REACTIONS, contact Wyeth Pharmaceuticals Inc. at 1-800-934-5556 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Side Effects by Body System

Respiratory

Respiratory side effects including dyspnea (22% to 30%), upper respiratory infection (20% to 26%), pharyngitis (16% to 21%), pleural effusion, and alveolar proteinosis have been reported. Cases of interstitial lung disease (including pneumonitis, and infrequently bronchiolitis obliterans organizing pneumonia and pulmonary fibrosis) with no identified infectious etiology and sometimes ending up being fatal, have been reported. Bronchial anastomotic dehiscence has also been reported, including fatal cases in lung transplant patients treated with a combination of sirolimus, tacrolimus, and corticosteroids. Three cases of diffuse alveolar hemorrhage have been reported.

It has been recommended that pulmonary toxicity due to sirolimus be included as a part of the differential diagnosis of kidney transplant patients who display signs of interstitial pneumonia.

Metabolic

Metabolic side effects including peripheral edema (54% to 64%), hyperlipidemia (38% to 57%), hypercholesterolemia (35% to 46%), increased creatinine (35% to 40%), edema (16% to 24%), hypophosphatemia (15% to 23%), hypokalemia (11% to 21%), weight gain (8% to 21%), and hyperkalemia (12% to 17%) have been reported. High triglycerides have also been reported.

Cardiovascular

Cardiovascular side effects including hypertension (39% to 49%) and chest pain (16% to 24%) have been reported. There have been reports of pericardial effusion (including hemodynamically significant effusions and tamponade requiring intervention in children and adults). A case of life-threatening coronary artery spasm following sirolimus-eluting stent deployment has also been reported.

Gastrointestinal

Gastrointestinal side effects including diarrhea (25% to 42%), constipation (28% to 38%), abdominal pain (28% to 36%), nausea (25% to 36%), vomiting (19% to 25%), and dyspepsia (17% to 25%) have been reported. A case of sirolimus-induced intractable chronic diarrhea and a case of delayed gastric ulcer healing have also been reported.

General

General side effects including asthenia (22% to 38%), fever (23% to 34%), headache (23% to 34%), and pain (24% to 33%) have been reported.

Hematologic

Hematologic side effects including anemia (23% to 37%), thrombocytopenia (13% to 20%), leukopenia (9% to 15%), capillary leak syndrome, and lymphedema have been reported.

Genitourinary

Genitourinary side effects including urinary tract infection (20% to 26%), proteinuria, and focal segmental glomerulosclerosis have been reported. Azoospermia has also been reported and has been reversible upon discontinuation of in most cases.

Musculoskeletal

Musculoskeletal side effects including arthralgia (25% to 31%) have been reported. A case of premature osteonecrosis and a case of myopathy have also been reported.

Nervous system

Nervous system side effects including tremor (21% to 31%) and insomnia (13% to 22%) have been reported. A case of posterior reversible encephalopathy syndrome has also been reported.

Dermatologic

Dermatologic side effects including acne (20% to 31%), rash (10% to 20%), and exfoliative dermatitis have been reported. A case of chronic pyogenic periungual infection and a case of chylous ascites have also been reported.

Renal

Patients treated with cyclosporine and sirolimus were reported to have higher serum creatinine levels and lower glomerular filtration rates when compared to patients treated with cyclosporine and placebo or azathioprine controls. The rate of decline in renal function in these studies was greater in patients receiving sirolimus and cyclosporine compared with control therapies.

In patients with delayed graft function, sirolimus may delay recovery of renal function.

Renal side effects have included nephrotic syndrome, higher serum creatinine levels, and lower glomerular filtration rates.

Ocular

The underlying mechanism for severe eyelid edema is unknown.

Ocular side effects including severe eyelid edema have been reported.

Hepatic

Hepatic side effects including hepatotoxicity and hepatic artery thrombosis have been reported. Abnormal liver function tests including increased AST/SGOT, increased ALT/SGPT, hypophosphatemia, hyperglycemia have also been reported.

Hypersensitivity

Hypersensitivity side effects including anaphylactic and anaphylactoid reactions, angioedema, and hypersensitivity vasculitis, have been reported.

Other

Other side effects including lymphedema, tuberculosis, and incisional hernia have been reported. A case of unilateral upper extremity edema has also been reported.

Oncologic

Oncologic side effects have been reported in animal studies including lymphoma, hepatocellular adenoma and carcinoma, and testicular adenoma.

Endocrine

Endocrine side effects have included increased basal and stimulated insulin levels in vitro and insulin content in vitro regardless of culture duration.

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