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Adverse Reactions
Laboratory Abnormalities
Managing ARs and Edema

Common adverse reactions (≥10%) across all cohorts in GEOMETRY mono-12,3
 

 

TABRECTA® (capmatinib) tablets (N=373)

COMMON ADVERSE REACTIONS

ALL GRADES (%)

GRADE 3 (%)

GRADE 4 (%)

General disorders and administration-site conditions

Edemaa 

59

13

-

Musculoskeletal painb

40

4.3

-

Fatiguec 

34

8

-

Pyrexiad

14

0.8

-

Weight decreased

11

0.5

-

Gastrointestinal disorders

Nausea

46

2.4

-

Vomiting

28

2.4

-

Constipation

19

0.8

-

Diarrhea

19

0.5

-

Respiratory, thoracic, and mediastinal disorders

Dyspnea

25

7*

0.5

Coughe

21

0.5

-

Pneumoniaf

13

6*

0.5

Metabolism and nutrition disorders

Decreased appetite

21

1.1

-

Skin and subcutaneous tissue disorders

Rashg

13

0.5

-

Nervous system disorders

Dizzinessh

13

0.5

-

aEdema includes edema peripheral, generalized edema, face edema, edema, localized edema, edema genital, eyelid edema, peripheral swelling, scrotal edema, and penile edema. 
bMusculoskeletal pain includes arthralgia, back pain, bone pain, musculoskeletal chest pain, musculoskeletal pain, myalgia, neck pain, noncardiac chest pain, pain in extremity, pain in jaw, spinal pain. 
cFatigue includes fatigue and asthenia. 
dPyrexia includes pyrexia and body temperature increased. 
eCough includes cough, upper airway cough syndrome, and productive cough. 
fPneumonia includes pneumonia aspiration, pneumonia, pneumonia influenzal, pneumonia bacterial, lower respiratory tract infection, and lung abscess. 
gRash includes rash, dermatitis acneiform, rash maculo-papular, eczema, erythema multiforme, rash macular, dermatitis, rash erythematous, rash pustular, dermatitis bullous, and rash vesicular. 
hDizziness includes dizziness, vertigo, and vertigo positional. 
*Includes both grade 3 and 4.

 

The majority of patients who reported adverse reactions (ARs) remained on TABRECTA® (capmatinib) tablets.2

  • Dose reductions due to ARs occurred in 26% of patients, and dose interruptions due to ARs occurred in 57% of patients2

  • Sixty-five patients (17%) treated with TABRECTA® (capmatinib) tablets discontinued therapy due to ARs2,3

    • The most frequent ARs (≥1%) leading to permanent discontinuation of TABRECTA were ILD/pneumonitis (2.4%), edema (2.4%), fatigue (1.3%), and pneumonia (1.1%)

Fatal ARs occurred in 0.5% of patients who received TABRECTA, including pneumonitis (0.3%) and death, not otherwise specified (0.3%).2

Clinically relevant ARs occurring in <10% of patients treated with TABRECTA® (capmatinib) tablets included pruritus (including allergic pruritus), ILD/pneumonitis, cellulitis, acute kidney injury (including renal failure), urticaria, and acute pancreatitis.2

Serious hypersensitivity reactions and thrombocytopenia occurred in patients treated with TABRECTA® (capmatinib) tablets in clinical trials other than GEOMETRY mono-1.2

Select laboratory abnormalities (≥20%) worsening from baseline in patients who received TABRECTA® (capmatinib) tablets in GEOMETRY mono-12 

 

TABRECTA® (capmatinib) tabletsa

LABORATORY ABNORMALITIES

Grades 1 to 4 (%)

Grades 3 to 4 (%)

Chemistry

Decreased albumin

72

1.9

Increased creatinine

65

0.5

Increased alanine aminotransferase

39

9

Increased amylase

34

4.7

Increased alkaline phosphatase

32

0.6

Increased gamma-glutamyltransferase

30

6

Increased lipase

29

9

Increased aspartate aminotransferase

28

6

Decreased phosphate

26

4.4

Increased potassium

25

4.1

Decreased sodium

24

6

Decreased glucose

23

0.3

Hematology

Decreased lymphocytes

45

14

Decreased leukocytes

25

1.7

Decreased hemoglobin

24

2.8

aThe denominator used to calculate the rate varied from 359 to 364 based on the number of patients with a baseline value and at least 1 post-treatment value.

Select ARs can be managed with dose modifications2 

ADVERSE REACTION

SEVERITY

DOSE MODIFICATION

ILD/pneumonitis

Any grade

Permanently discontinue TABRECTA

Increased ALT and/or AST without increased total bilirubin

Grade 3

Withhold TABRECTA until recovery to baseline ALT/AST

 

If recovered to baseline within 7 days, then resume TABRECTA at the same dose; otherwise, resume TABRECTA at a reduced dose

Grade 4

Permanently discontinue TABRECTA

Increased ALT and/or AST with increased total bilirubin in the absence of cholestasis or hemolysis

ALT and/or AST greater than 3 times ULN with total bilirubin greater than 2 times ULN

Permanently discontinue TABRECTA

Increased total bilirubin without concurrent increased ALT and/or AST

Grade 2

Withhold TABRECTA until recovery to baseline bilirubin

 

If recovered to baseline within 7 days, then resume TABRECTA at the same dose; otherwise, resume TABRECTA at a reduced dose

Grade 3

Withhold TABRECTA until recovery to baseline bilirubin

 

If recovered to baseline within 7 days, then resume TABRECTA at a reduced dose; otherwise, permanently discontinue TABRECTA

Grade 4

Permanently discontinue TABRECTA

Increased lipase or amylase

Grade 3

Withhold TABRECTA until ≤grade 2 or baseline

 

If recovered to baseline or ≤grade 2 within 14 days, resume TABRECTA at a reduced dose; otherwise, permanently discontinue TABRECTA

Grade 4

Permanently discontinue TABRECTA

Pancreatitis

Grade 3 or grade 4

Permanently discontinue TABRECTA

Hypersensitivity

All grades

If hypersensitivity is suspected based on clinical judgment, withhold TABRECTA until resolution of the event

 

Permanently discontinue TABRECTA in patients who develop serious hypersensitivity reactions

Other adverse reactions

Grade 2

Maintain dose level. If intolerable, consider withholding TABRECTA until resolved, then resume TABRECTA at a reduced dose

Grade 3

Withhold TABRECTA until resolved, then resume TABRECTA at a reduced dose

Grade 4

Permanently discontinue TABRECTA

ALT, alanine aminotransferase; AST, aspartate aminotransferase; ULN, upper limit of normal.
 

 

Although the exact mechanism is unknown, the MET inhibitor TABRECTA may cause edema2 
 

In the GEOMETRY mono-1 clinical trial, edema occurred in 59% of patients and was managed based on severity2,4:

  • Grade ≤2 peripheral edema: Consider measures such as leg elevation, compression stockings, or dietary salt modification 

Peripheral edema icons

  • Grade ≥3 peripheral edema: Initiate or intensify the above measures 

Edema was one of the most common ARs in GEOMETRY mono-1, leading to discontinuation in 2.4% of patients.2
 

Edema is a common AR and its management may help patients remain on treatment