Recommended Topic Related To:

Torisel

"Investigators in The Cancer Genome Atlas (TCGA) Research Network have uncovered a connection between how tumor cells use energy from metabolic processes and the aggressiveness of the most common form of kidney cancer, clear cell renal cell carcin"...

Torisel

Torisel Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Torisel Kit (temsirolimus) is used to treat cancer of the kidneys, also called renal cell carcinoma. It is a cancer (antineoplastic) medication. Common side effects include pain/sores in the mouth or throat, nausea, vomiting, diarrhea, headache, changes in taste, weakness, and loss of appetite.

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Torisel in Detail - Patient Information: Side Effects

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: 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;
  • loss of movement on one side of your body;
  • drowsiness, confusion, mood changes, swelling, rapid weight gain;
  • 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;
  • headache, dizziness, problems with coordination;
  • muscle or joint pain, back pain;
  • 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. You may report side effects to FDA at 1-800-FDA-1088.

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

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Torisel Overview - Patient Information: Side Effects

SIDE EFFECTS: Pain/sores in the mouth or throat, nausea, vomiting, diarrhea, headache, changes in taste, weakness, and loss of appetite may occur. If these effects persist or worsen, tell your doctor or pharmacist promptly.

Many people using this medication have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including: flushing, slow wound healing, swelling ankles/feet, eye redness/itching, easy bruising/bleeding, unusual tiredness, muscle cramps, fast/pounding heartbeat, pain/redness/swelling of arms or legs, missed/heavy/painful periods.

This medication can lower the body's ability to fight an infection. Tell your doctor promptly if you develop any signs of an infection such as fever, chills, or persistent sore throat.

Temsirolimus may cause your cholesterol/triglycerides or blood sugar to increase. You may be required to have your cholesterol/triglycerides or blood sugar checked periodically. You may need medication to control your cholesterol/triglycerides or blood sugar. Tell your doctor or pharmacist if you experience symptoms of high blood sugar, including increased thirst/hunger, frequent urination.

This medication can infrequently cause serious (rarely fatal) lung, kidney, or intestinal problems. Tell your doctor immediately if you notice any symptoms of lung, kidney, or intestinal problems, including: shortness of breath, cough, change in the amount of urine, severe abdominal pain, black/bloody stool.

This drug increases the risk of a possibly fatal brain infection (PML - progressive multifocal leukoencephalopathy). Tell your doctor right away if you have any of these symptoms: clumsiness, sudden change in your thinking (such as confusion, difficulty concentrating), difficulty moving muscles, seizure, difficulty speaking.

Infrequently a very serious allergic reaction to this drug might occur, especially while your dose is being given (infusion reaction). Get medical help right away if you notice any of the following symptoms of a serious allergic reaction: rash/flushing, itching/swelling (especially of the face/tongue/throat), severe dizziness, chest pain, trouble breathing.

Temsirolimus can commonly cause a mild rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe allergic reaction. Therefore, get medical help right away if you develop any rash.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Torisel (Temsirolimus Injection)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Torisel FDA Prescribing Information: Side Effects
(Adverse Reactions)

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 PRECAUTION].

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, hyperlipemia, 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-&apha;) alone, TORISEL alone, and TORISEL and IFN-&apha;, a total of 616 patients were treated. Two hundred patients received IFN-&apha; weekly, 208 received TORISEL 25 mg weekly, and 208 patients received a combination of TORISEL and IFN-&apha; weekly [see Clinical Studies].

Treatment with the combination of TORISEL 15 mg and IFN-&apha; 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-&apha; 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-&apha; 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-&apha; 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-&apha; in the Randomized Trial

Adverse Reaction TORISEL25 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)
  Edemaa 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
  Mucositisb 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
  Infectionsc 42 (20) 6 (3) 19 (10) 4 (2)
  Urinary tract infectiond 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
  Rashe 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
  Dysgeusiaf 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.
a Includes edema, facial edema, and peripheral edema
b Includes aphthous stomatitis, glossitis, mouth ulceration, mucositis, and stomatitis
c Includes infections not otherwise specified (NOS) and the following infections that occurred infrequently as distinct entities: abscess, bronchitis, cellulitis, herpes simplex, and herpes zoster
d Includes cystitis, dysuria, hematuria, urinary frequency, and urinary tract infection
e Includes eczema, exfoliative dermatitis, maculopapular rash, pruritic rash, pustular rash, rash (NOS), and vesiculobullous rash
f Includes 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/postoperative 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-&apha; 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)
  Total 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: rhabdomyolysis, Stevens-Johnson Syndrome, and complex regional pain syndrome (reflex sympathetic dystrophy).

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) »

A A A

Torisel - User Reviews

Torisel User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Torisel sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


Women's Health

Find out what women really need.