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TORISEL® (temsirolimus) Adverse Reactions

6 ADVERSE REACTIONS

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 (5)].

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.

6.1 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 (14)].

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 (%)
*
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
Þ
Includes taste loss and taste perversion
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)

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 (%)
*
NCI CTC version 3.0
Grade 1 toxicity may be under-reported for lymphocytes and neutrophils
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)

6.2 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.

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