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Torisel

Torisel

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].

Hypersensitivity/Infusion Reactions [see WARNINGS AND PRECAUTIONS]
Hyperglycemia/Glucose Intolerance [see WARNINGS AND PRECAUTIONS]
Interstitial Lung Disease [see WARNINGS AND PRECAUTIONS]
Hyperlipemia [see WARNINGS AND PRECAUTIONS]
Bowel Perforation [see WARNINGS AND PRECAUTIONS]
Renal Failure [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, 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-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)
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.
aIncludes edema, facial edema, and peripheral edema
bIncludes aphthous stomatitis, glossitis, mouth ulceration, mucositis, and stomatitis
cIncludes infections not otherwise specified (NOS) and the following infections that occurred infrequently as distinct entities: abscess, bronchitis, cellulitis, herpes simplex, and herpes zoster
dIncludes cystitis, dysuria, hematuria, urinary frequency, and urinary tract infection
eIncludes eczema, exfoliative dermatitis, maculopapular rash, pruritic rash, pustular rash, rash (NOS), and vesiculobullous rash
fIncludes taste loss and taste perversion

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

Gastrointestinal Disorders – Fatal bowel perforation (1%), gastrointestinal hemorrhage (1%), rectal hemorrhage (1%)

Eye Disorders – Conjunctivitis (including lacrimation disorder) (8%)

Immune System – Allergic/Hypersensitivity reactions (9%).

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%), impaired wound healing (1%)

Respiratory, Thoracic and Mediastinal Disorders – Pleural effusion (4%), interstitial lung disease/pneumonitis (2%) including fatalities

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)
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 Torisel (temsirolimus injection) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Agents Inducing CYP3A Metabolism

Co-administration of TORISEL with rifampin, a potent CYP3A4/5 inducer, had no significant effect on temsirolimus Cmax (maximum concentration) and AUC (area under the concentration versus the time curve) after intravenous administration, but decreased sirolimus Cmax by 65% and AUC by 56% compared to TORISEL treatment alone. If alternative treatment cannot be administered, a dose adjustment should be considered [see DOSAGE AND ADMINISTRATION].

Agents Inhibiting CYP3A Metabolism

Co-administration of TORISEL with ketoconazole, a potent CYP3A4 inhibitor, had no significant effect on temsirolimus Cma x or AUC; however, sirolimus AUC increased 3.1-fold, and Cma x increased 2.2-fold compared to TORISEL alone. If alternative treatment cannot be administered, a dose adjustment should be considered [see DOSAGE AND ADMINISTRATION].

Interactions With Drugs Metabolized By CYP2D6

The concentration of desipramine, a CYP2D6 substrate, was unaffected when 25 mg of TORISEL was co-administered. No clinically significant effect is anticipated when temsirolimus is co-administered with agents that are metabolized by CYP2D6 or CYP3A4.

Read the Torisel Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 4/18/2014
This monograph has been modified to include the generic and brand name in many instances.

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