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Torisel

Last reviewed on RxList: 4/5/2018
Torisel Side Effects Center

Last reviewed on RxList 4/5/2018

Torisel Kit (temsirolimus) is a cancer (antineoplastic) medication used to treat cancer of the kidneys, also called renal cell carcinoma. Common side effects of Torisel Kit include:

  • pain/sores in the mouth or throat,
  • nausea,
  • vomiting,
  • diarrhea,
  • constipation,
  • headache,
  • changes in taste,
  • weakness,
  • loss of appetite,
  • acne,
  • dry skin,
  • mild itching or rash,
  • hair loss,
  • dizziness,
  • problems with coordination,
  • muscle or joint pain,
  • back pain,
  • injection site reactions (pain, warmth, swelling, redness, itching, or irritation),
  • runny or stuffy nose,
  • sinus pain,
  • depression,
  • memory problems,
  • sleep problems (insomnia), and
  • tiredness

The recommended dose of Torisel for advanced renal cell carcinoma is 25 mg infused over a 30-60 minute period once a week. Torisel may interact with dexamethasone, rifabutin, rifampin, St. John's wort, sunitinib, blood thinners, insulin or oral diabetes medications, antibiotics, antifungals, HIV/AIDS medicines, or seizure medications. Tell your doctor all medications and supplements you use. Torisel is not recommended for use during pregnancy. It may harm a fetus. Men and women receiving this medication should use at least 2 forms of birth control (e.g., condoms, birth control pills) during treatment and for at least 3 months afterwards. If you become pregnant or think you may be pregnant, or if your partner becomes pregnant, tell your doctor. It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breastfeeding while using this drug is not recommended.

Our Torisel Kit (temsirolimus) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Torisel Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Some side effects may occur during the injection. Tell your caregiver right away if you feel dizzy, warm, tingly, light-headed, or short of breath.

Call your doctor at once if you have:

  • cough, chest pain, wheezing, trouble breathing;
  • stomach pain, bloody or tarry stools;
  • pain or burning when you urinate, blood in your urine;
  • a surgical incision that will not heal;
  • low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;
  • high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor;
  • kidney problems--little or no urination, puffy eyes, swelling in your feet or ankles, weight gain, urine that looks foamy; or
  • low potassium level--leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling.

Side effects such as diarrhea, swelling, and breathing problems may be more likely in older adults.

Common side effects may include:

  • low blood cell counts;
  • feeling weak or tired;
  • mouth sores or ulcers;
  • nausea, vomiting, stomach pain, loss of appetite;
  • swelling;
  • headache, joint pain;
  • rash; or
  • abnormal blood tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Torisel (Temsirolimus Injection)

Torisel Professional Information

SIDE EFFECTS

The following serious adverse reactions have been associated with TORISEL in clinical trials and are discussed in greater detail in other sections of the label [see WARNINGS AND PRECAUTIONS].

The most common (≥30%) adverse reactions observed with TORISEL are rash, asthenia, mucositis, nausea, edema, and anorexia. The most common (≥30%) laboratory abnormalities observed with TORISEL are anemia, hyperglycemia, hyperlipidemia, hypertriglyceridemia, lymphopenia, elevated alkaline phosphatase, elevated serum creatinine, hypophosphatemia, thrombocytopenia, elevated AST, and leukopenia.

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other trials and may not reflect the rates observed in clinical practice.

In the phase 3 randomized, open-label study of interferon alfa (IFN-α) alone, TORISEL alone, and TORISEL and IFN-α, a total of 616 patients were treated. Two hundred patients received IFN-α weekly, 208 received TORISEL 25 mg weekly, and 208 patients received a combination of TORISEL and IFN-α weekly [see Clinical Studies].

Treatment with the combination of TORISEL 15 mg and IFN-α was associated with an increased incidence of multiple adverse reactions and did not result in a significant increase in overall survival when compared with IFN-α alone.

Table 1 shows the percentage of patients experiencing treatment emergent adverse reactions. Reactions reported in at least 10% of patients who received TORISEL 25 mg alone or IFN-α alone are listed. Table 2 shows the percentage of patients experiencing selected laboratory abnormalities. Data for the same adverse reactions and laboratory abnormalities in the IFN-α alone arm are shown for comparison:

Table 1 : Adverse Reactions Reported in at Least 10% of Patients Who Received 25 mg IV TORISEL or IFN-α in the Randomized Trial

Adverse Reaction TORISEL 25 mg
n = 208
IFN-α
n = 200
All Grades*
n (%)
Grades 3&4*
n (%)
All Grades*
n (%)
Grades 3&4*
n (%)
General disorders
Asthenia 106 (51) 23 (11) 127 (64) 52(26)
Edema† 73(35) 7 (3) 21 (11) 1 (1)
Pain 59 (28) 10 (5) 31 (16) 4 (2)
Pyrexia 50 (24) 1 (1) 99 (50) 7 (4)
Weight Loss 39 (19) 3 (1) 50 (25) 4 (2)
Headache 31(15) 1 (1) 30 (15) 0 (0)
Chest Pain 34 (16) 2 (1) 18 (9) 2 (1)
Chills 17 (8) 1 (1) 59 (30) 3 (2)
Gastrointestinal disorders
Mucositis‡ 86 (41) 6 (3) 19 (10) 0 (0)
Anorexia 66 (32) 6 (3) 87 (44) 8 (4)
Nausea 77(37) 5 (2) 82 (41) 9 (5)
Diarrhea 56 (27) 3 (1) 40 (20) 4 (2)
Abdominal Pain 44 (21) 9 (4) 34 (17) 3 (2)
Constipation 42 (20) 0 (0) 36 (18) 1 (1)
Vomiting 40 (19) 4 (2) 57(29) 5 (3)
Infections
Infections§ 42 (20) 6 (3) 19 (10) 4 (2)
Urinary tract infection¶ 31(15) 3 (1) 24 (12) 3 (2)
Pharyngitis 25 (12) 0 (0) 3 (2) 0 (0)
Rhinitis 20 (10) 0 (0) 4 (2) 0 (0)
Musculoskeletal and connective tissue disorders
Back Pain 41 (20) 6 (3) 28    (14) 7 (4)
Arthralgia 37 (18) 2 (1) 29    (15) 2 (1)
Myalgia 16 (8) 1 (1) 29 (15) 2 (1)
Respiratory, thoracic and mediastinal disorders
Dyspnea 58 (28) 18 (9) 48 (24) 11 (6)
Cough 53 (26) 2 (1) 29 (15) 0 (0)
Epistaxis 25 (12) 0 (0) 7 (4) 0 (0)
Skin and subcutaneous tissue disorders
Rash# 97 (47) 10 (5) 14 (7) 0 (0)
Pruritus 40 (19) 1 (1) 16 (8) 0 (0)
Nail Disorder 28 (14) 0 (0) 1 (1) 0 (0)
Dry Skin 22 (11) 1 (1) 14 (7) 0 (0)
Acne 21 (10) 0 (0) 2 (1) 0 (0)
Nervous system disorders
DysgeusiaÞ 41 (20) 0 (0) 17 (9) 0 (0)
Insomnia 24 (12) 1 (1) 30 (15) 0 (0)
Depression 9 (4) 0 (0) 27(14) 4 (2)
*Common Toxicity Criteria for Adverse Events (CTCAE), Version 3.0.
†Includes edema, facial edema, and peripheral edema
‡Includes aphthous stomatitis, glossitis, mouth ulceration, mucositis, and stomatitis
§Includes infections not otherwise specified (NOS) and the following infections that occurred infrequently as distinct entities: abscess, bronchitis, cellulitis, herpes simplex, and herpes zoster
¶Includes cystitis, dysuria, hematuria, urinary frequency, and urinary tract infection
#Includes eczema, exfoliative dermatitis, maculopapular rash, pruritic rash, pustular rash, rash (NOS), and vesiculobullous rash
ÞIncludes taste loss and taste perversion

The following selected adverse reactions were reported less frequently (<10%).

Gastrointestinal Disorders - Gastrointestinal hemorrhage (1%), rectal hemorrhage (1%).

Eye Disorders - Conjunctivitis (including lacrimation disorder) (8%).

Immune System - Angioneurotic edema-type reactions (including delayed reactions occurring two months following initiation of therapy) have been observed in some patients who received TORISEL and ACE inhibitors concomitantly.

Infections - Pneumonia (8%), upper respiratory tract infection (7%), wound infection/post-operative wound infection (1%), sepsis (1%).

General Disorders and Administration Site Conditions - Diabetes mellitus (5%).

Respiratory, Thoracic and Mediastinal Disorders - Pleural effusion (4%).

Vascular - Hypertension (7%), venous thromboembolism (including deep vein thrombosis and pulmonary embolus [including fatal outcomes]) (2%), thrombophlebitis (1%), pericardial effusion (1%).

Nervous System Disorders - Convulsion (1%).

Table 2 : Incidence of Selected Laboratory Abnormalities in Patients Who Received 25 mg IV TORISEL or IFN-α in the Randomized Trial

Laboratory Abnormality TORISEL 25 mg
n = 208
IFN-α
n = 200
All Grades*
n (%)
Grades 3&4*
n (%)
All Grades*
n (%)
Grades 3&4*
n (%)
Any 208 (100) 162 (78) 195 (98) 144 (72)
Hematology
Hemoglobin Decreased 195 (94) 41 (20) 180 (90) 43 (22)
Lymphocytes Decreased† 110 (53) 33(16) 106 (53) 48 (24)
Neutrophils Decreased† 39 (19) 10 (5) 58 (29) 19 (10)
Platelets Decreased 84 (40) 3 (1) 51 (26) 0 (0)
Leukocytes Decreased 67 (32) 1 (1) 93 (47) 11 (6)
Chemistry
Alkaline Phosphatase Increased 141 (68) 7 (3) 111 (56) 13 (7)
AST Increased 79 (38) 5 (2) 103 (52) 14 (7)
Creatinine Increased 119 (57) 7 (3) 97 (49) 2 (1)
Glucose Increased 186 (89) 33(16) 128 (64) 6 (3)
Phosphorus Decreased 102 (49) 38 (18) 61 (31) 17 (9)
T otal Bilirubin Increased 16 (8) 2 (1) 25(13) 4 (2)
Total Cholesterol Increased 181 (87) 5 (2) 95 (48) 2 (1)
Triglycerides Increased 173 (83) 92 (44) 144 (72) 69 (35)
Potassium Decreased 43 (21) 11 (5) 15 (8) 0 (0)
*NCI CTC version 3.0
†Grade 1 toxicity may be under-reported for lymphocytes and neutrophils

Post-Marketing And Other Clinical Experience

The following adverse reactions have been identified during post approval use of TORISEL. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to readily estimate their frequency or establish a causal relationship to drug exposure.

The following adverse reactions have been observed in patients receiving temsirolimus: angioedema, rhabdomyolysis, Stevens-Johnson Syndrome, complex regional pain syndrome (reflex sympathetic dystrophy), pancreatitis, cholecystitis, and cholelithiasis.

There are also post-marketing reports of temsirolimus extravasations resulting in swelling, pain, warmth, and erythema.

Read the entire FDA prescribing information for Torisel (Temsirolimus Injection)

Related Resources for Torisel

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Read the Torisel User Reviews »

© Torisel Patient Information is supplied by Cerner Multum, Inc. and Torisel Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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