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Tykerb (Lapatinib) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Clinical Trials Experience

The safety of TYKERB has been evaluated in more than 3,500 patients in clinical trials. The efficacy and safety of TYKERB in combination with capecitabine in breast cancer was evaluated in 198 patients in a randomized, Phase 3 trial. [See Clinical Studies .] Adverse reactions which occurred in at least 10% of patients in either treatment arm and were higher in the combination arm are shown in Table 1.

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

The most common adverse reactions (>20%) during therapy with TYKERB plus capecitabine were gastrointestinal (diarrhea, nausea, and vomiting), dermatologic (palmar-plantar erythrodysesthesia and rash), and fatigue. Diarrhea was the most common adverse reaction resulting in discontinuation of study medication.

The most common Grade 3 and 4 adverse reactions (NCI CTC v3) were diarrhea and palmar-plantar erythrodysesthesia. Selected laboratory abnormalities are shown in Table 2.

Table 1. Adverse Reactions Occurring in ≥10% of Patients

TYKERB 1,250 mg/day + Capecitabine 2,000 mg/m2/day

Capecitabine 2,500 mg/m2/day

(N  = 198)

(N  = 191)

All Grades*

%

Grade 3

%

Grade 4

%

All Grades*

%

Grade 3

%

Grade 4

%

Reactions

Gastrointestinal disorders

Diarrhea

65

13

1

40

10

0

Nausea

44

2

0

43

2

0

Vomiting

26

2

0

21

2

0

Stomatitis

14

0

0

11

<1

0

Dyspepsia

11

<1

0

3

0

0

Skin and subcutaneous tissue disorders

Palmar-plantar erythrodysesthesia

53

12

0

51

14

0

Rash

28

2

0

14

1

0

Dry skin

10

0

0

6

0

0

General disorders and administrative site conditions

Mucosal inflammation

15

0

0

12

2

0

Musculoskeletal and connective tissue disorders

Pain in extremity

12

1

0

7

<1

0

Back pain

11

1

0

6

<1

0

Respiratory, thoracic, and mediastinal disorders

Dyspnea

12

3

0

8

2

0

Psychiatric disorders

Insomnia

10

<1

0

6

0

0

* National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.

Grade 3 dermatitis acneiform was reported in <1% of patients in TYKERB plus capecitabine group.

Table 2. Selected Laboratory Abnormalities

TYKERB 1,250 mg /day + Capecitabine 2,000 mg/m2/day

Capecitabine 2,500 mg/m 2/day

All Grades*

%

Grade 3

%

Grade 4

%

All Grades *

%

Grade 3

%

Grade 4

%

Parameters

Hematologic

Hemoglobin

56

<1

0

53

1

0

Platelets

18

<1

0

17

<1

<1

Neutrophils

22

3

<1

31

2

1

Hepatic

Total Bilirubin

45

4

0

30

3

0

AST

49

2

<1

43

2

0

ALT

37

2

0

33

1

0

* National Cancer Institute Common Terminology Criteria for Adverse Events, version 3.

Decreases in Left Ventricular Ejection Fraction

Due to potential cardiac toxicity with HER2 (ErbB2) inhibitors, LVEF was monitored in clinical trials at approximately 8-week intervals. LVEF decreases were defined as signs or symptoms of deterioration in left ventricular cardiac function that are ≥Grade 3 (NCI CTCAE), or a ≥20% decrease in left ventricular cardiac ejection fraction relative to baseline which is below the institution's lower limit of normal. Among 198 patients who received lapatinib/capecitabine combination treatment, 3 experienced Grade 2 and one had Grade 3 LVEF adverse reactions (NCI CTC 3.0). [See Warnings and Precautions .]

Interstitial Lung Disease/Pneumonitis

Lapatinib has been associated with interstitial lung disease and pneumonitis in monotherapy or in combination with other chemotherapies [see Warnings and Precautions].



REPORTS OF SUSPECTED TYKERB SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Tykerb. The information is not vetted and should not be considered as verified clinical evidence.

Possible Tykerb side effects / adverse reactions in 59 year old female

Reported by a consumer/non-health professional from United States on 2011-10-04

Patient: 59 year old female weighing 104.5 kg (229.9 pounds)

Reactions: Diarrhoea, Palmar-Plantar Erythrodysaesthesia Syndrome, Depression

Suspect drug(s):
Tykerb

Other drugs received by patient: Levothyroxine Sodium; Coumadin; Cymbalta; Metoprolol Tartrate; Ativan; Xeloda



Possible Tykerb side effects / adverse reactions in 35 year old female

Reported by a consumer/non-health professional from United States on 2011-10-04

Patient: 35 year old female

Reactions: Cardiopulmonary Failure

Adverse event resulted in: death

Suspect drug(s):
Tykerb



Possible Tykerb side effects / adverse reactions in 72 year old female

Reported by a consumer/non-health professional from United States on 2011-10-04

Patient: 72 year old female

Reactions: Death

Adverse event resulted in: death

Suspect drug(s):
Tykerb



See index of all Tykerb side effect reports >>

Drug label data at the top of this Page last updated: 2007-10-25

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