Temsirolimus Side Effects

Some side effects of temsirolimus may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to temsirolimus: intravenous solution

Some people receiving a temsirolimus injection have had a reaction to the infusion (when the medicine is injected into the vein). Tell your caregiver right away if you feel dizzy, warm, tingly, light-headed, short of breath, or have chest pain or trouble breathing during the injection.

Get emergency medical help if you have any of these signs of an allergic reaction while taking temsirolimus: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• fever, chills, body aches, flu symptoms, sores in your mouth and throat;

• chest pain, dry cough, wheezing, feeling short of breath;

• severe stomach pain, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• drowsiness, confusion, mood changes, swelling, rapid weight gain;

• loss of movement on one side of your body;

• urinating less than usual or not at all;

• pain or burning when you urinate;

• pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• any wound that will not heal; or

• high blood sugar (increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss).

Less serious side effects include mild skin rash

• acne, dry skin, mild itching or rash;

• nausea, vomiting, loss of appetite;

• diarrhea, constipation;

• hair loss;

• muscle or joint pain, back pain;

• headache, dizziness, problems with coordination;

• pain, warmth, swelling, redness, itching, or irritation around the IV needle.

• runny or stuffy nose, sinus pain;

• depression, memory problems, sleep problems (insomnia), feeling weak or tired;

• decreased sense of taste; or

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to temsirolimus: intravenous solution

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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