Torisel Side Effects

Generic Name: temsirolimus

Please note - some side effects for Torisel 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 Torisel - for the Consumer

Torisel

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 Torisel:

Acne; back pain; constipation; diarrhea; dry skin; fingernail or toenail changes; headache; joint or muscle pain; loss of appetite; mouth pain; nausea; nosebleed; runny nose; stomach pain or upset; taste changes; trouble sleeping; vomiting; weakness; weight loss.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black or bloody stools; calf pain or tenderness; chest pain; cough; coughing blood; decreased, difficult, or painful urination; depression; eye pain, redness, or swelling; fast or irregular heartbeat; fever, chills, or sore throat; new or worsening shortness of breath or other breathing problems; severe or persistent headache; severe or persistent stomach pain or diarrhea; severe tiredness or weakness; swelling of the hands, feet, or ankles; symptoms of high blood sugar (eg, increased hunger, thirst, or urination; confusion; unusual drowsiness); unusual bruising or bleeding; yellowing of the eyes or skin.

Side Effects by Body System

Respiratory

Some patients with interstitial lung disease were asymptomatic with infiltrates detected on computed tomography scan or chest radiograph. Others presented with symptoms such as dyspnea, cough, hypoxia, and fever. Some patients required discontinuation of temsirolimus and/or treatment with corticosteroids and/or antibiotics, while other patients continued treatment without additional intervention. Patients should be advised to report promptly any new or worsening respiratory symptoms.

Respiratory side effects including dyspnea (28%), cough (26%), epistaxis (12%), pharyngitis (12%), rhinitis (10%), pneumonia (8%), and upper respiratory tract infection (7%) have been reported.

Interstitial lung disease has been reported in five patients (2%), including rare fatalities.

Hypersensitivity

Hypersensitivity and allergic side effects (9%) have been reported.

Hypersensitivity reactions have included anaphylaxis, dyspnea, flushing, and chest pain. Temsirolimus should be used with caution in persons with known hypersensitivity to temsirolimus or its metabolites (including sirolimus), polysorbate 80, or to any other component (including the excipients) of temsirolimus.

An H1 antihistamine should be administered to patients before the start of the intravenous temsirolimus infusion. Temsirolimus should be used with caution in patients with known hypersensitivity to an antihistamine, or patients who cannot receive an antihistamine for other medical reasons.

If a patient develops a hypersensitivity reaction during the temsirolimus infusion, the infusion should be stopped and the patient should be observed for at least 30 to 60 minutes (depending on the severity of the reaction). At the discretion of the physician, treatment may be resumed with the administration of an H1-receptor antagonist (such as diphenhydramine), if not previously administered and/or an H2-receptor antagonist (such as intravenous famotidine 20 mg or intravenous ranitidine 50 mg) approximately 30 minutes before restarting the temsirolimus infusion. The infusion may then be resumed at a slower rate (up to 60 minutes).

Hematologic

Hematologic side effects including decreased hemoglobin (94%), decreased lymphocytes (53%), decreased platelets (40%), decreased leukocytes (32%), and decreased neutrophils (19%) have been reported.

Other

Other side effects including laboratory abnormalities have been reported in 100% of patients. Blood chemistry abnormalities have included increased glucose (89%), increased total cholesterol (87%), increased triglycerides (83%), increased alkaline phosphatase (68%), increased creatinine (57%), decreased phosphorus (49%), increased AST (38%), decreased potassium (21%), and increased total bilirubin (8%).

General

General side effects including asthenia (51%), edema (35%), pain (28%), pyrexia (24%), weight loss (19%), chest pain (16%), headache (15%), chills (8%), and impaired wound healing (1%) have been reported.

Because temsirolimus has been associated with abnormal wound healing, caution should be exercised with the use of temsirolimus in the perioperative period.

Gastrointestinal

Cases of fatal bowel perforation have been reported in patients who received temsirolimus. These patients presented with fever, abdominal pain, metabolic acidosis, bloody stools, diarrhea, and/or acute abdomen. Patients should be advised to report promptly any new or worsening abdominal pain or blood in their stools.

Gastrointestinal side effects including mucositis (41%), nausea (37%), anorexia (32%), diarrhea (27%), abdominal pain (21%), constipation (20%), and vomiting (19%) have been reported. Fatal bowel perforation has also been.

Genitourinary

Genitourinary side effects including urinary tract infection (15%) have been reported.

Renal

Some of these cases of rapidly progressive acute renal failure were not responsive to dialysis.

Renal side effects including cases of rapidly progressive and sometimes fatal acute renal failure not clearly related to disease progression have been reported.

Musculoskeletal

Musculoskeletal side effects including back pain (20%), arthralgia (18%), and myalgia (8%) have been reported.

Dermatologic

Dermatologic side effects including rash (47%) pruritus (19%), nail disorder (14%), dry skin (11%), and acne (10%) have been reported.

Nervous system

Nervous system side effects including dysgeusia (including taste loss and taste perversion) (20%), insomnia (12%), and depression (4%) have been reported.

Ocular

Ocular side effects such as conjunctivitis (including lacrimation disorder) (7%) have been reported.

Cardiovascular

Cardiovascular side effects including hypertension (7%), venous thromboembolism (including deep vein thrombosis and pulmonary embolus) (2%) and thrombophlebitis (1%) have been reported.

Oncologic

Oncologic side effects have not been reported with temsirolimus. However, animal studies have reported sirolimus (the major metabolite of temsirolimus in humans) to be carcinogenic. The following effects have been reported in animals in the carcinogenicity studies conducted with sirolimus: lymphoma, hepatocellular adenoma and carcinoma, and testicular adenoma.

Metabolic

Increases in serum glucose may result in the need for an increase in the dose of, or the initiation of, insulin and/or oral hypoglycemic agent therapy. Serum glucose should be tested before and during treatment with temsirolimus. Patients should be advised to report excessive thirst or any increase in the volume or frequency of urination.

Increases in serum triglycerides and cholesterol may require the initiation of, or increase in the dose of lipid-lowering agents. Serum cholesterol and triglycerides should be tested before and during treatment with temsirolimus.

Metabolic side effects including increases in serum glucose are likely. In a phase 3 trial, 89% of patients receiving temsirolimus had at least one elevated serum glucose while on treatment, and 26% of patients reported hyperglycemia as an adverse event.

The use of temsirolimus is also likely to result in increases in serum triglycerides and cholesterol. In a phase 3 trial, 87% of patients receiving temsirolimus had at least one elevated serum cholesterol value and 83% had at least one elevated serum triglyceride value.

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