TABRECTA
Generic: CAPMATINIB
Basic Information
Manufacturer
Novartis Pharmaceuticals Corporation
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
455892c3-d144-4ba8-9ab4-79cabff9876d
Indications & Usage
1 INDICATIONS AND USAGE TABRECTA is indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test.
TABRECTA is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test.
TABRECTA is a kinase inhibitor indicated for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test.
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: ILD/Pneumonitis [see Warnings and Precautions (5.1)] Hepatotoxicity [see Warnings and Precautions (5.2)] Pancreatic Toxicity [see Warnings and Precautions (5.3)] Hypersensitivity reactions [see Warnings and Precautions (5.4)] The most common adverse reactions (≥ 20%) are edema, nausea, musculoskeletal pain, fatigue, vomiting, dyspnea, cough, and decreased appetite.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience 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.
Metastatic Non-Small Cell Lung Cancer The safety of TABRECTA was evaluated in GEOMETRY mono-1 [see Clinical Studies (14)] .
Patients received TABRECTA 400 mg orally twice daily until disease progression or unacceptable toxicity (N = 373).
Among patients who received TABRECTA, 37% were exposed for at least 6 months and 22% were exposed for at least one year.
Serious adverse reactions occurred in 53% of patients who received TABRECTA.
Serious adverse reactions in ≥ 2% of patients included dyspnea (7%), pneumonia (7%), pleural effusion (4.3%), musculoskeletal pain (3.8%), general physical health deterioration (2.9%), ILD/pneumonitis (2.7%), edema (2.4%), and vomiting (2.4%).
Fatal adverse reactions occurred in 0.5% of patients who received TABRECTA, including pneumonitis (0.3%) and death, not otherwise specified (0.3%).
Permanent discontinuation of TABRECTA due to an adverse reaction occurred in 17% of patients.
The most frequent adverse reactions (≥ 1%) leading to permanent discontinuation of TABRECTA were ILD/pneumonitis (2.4%), edema (2.4%), fatigue (1.3%), and pneumonia (1.1%).
Dose interruptions due to an adverse reaction occurred in 57% of patients who received TABRECTA.
Adverse reactions requiring dosage interruption in > 2% of patients who received TABRECTA included edema, increased blood creatinine, nausea, increased lipase, vomiting, increased ALT, dyspnea, pneumonia, fatigue, increased amylase, increased AST, musculoskeletal pain, abdominal pain, and increased blood bilirubin.
Dose reductions due to an adverse reaction occurred in 26% of patients who received TABRECTA.
Adverse reactions requiring dosage reductions in > 2% of patients who received TABRECTA included edema, increased ALT and increased blood creatinine.
The most common adverse reactions (≥ 20%) in patients who received TABRECTA were edema, nausea, musculoskeletal pain, fatigue, vomiting, dyspnea, cough, and decreased appetite.
Table 3 summarizes the adverse reactions in GEOMETRY mono-1.
Table 3: Adverse Reactions (≥ 10%) in Patients Who Received TABRECTA in GEOMETRY mono-1 a Edema includes edema peripheral, generalized edema, face edema, edema, localized edema, edema genital, eyelid edema, peripheral swelling, scrotal edema, and penile edema.
b Musculoskeletal pain includes arthralgia, back pain, bone pain, musculoskeletal chest pain, musculoskeletal pain, myalgia, neck pain, non-cardiac chest pain, pain in extremity, pain in jaw, spinal pain.
c Fatigue includes fatigue and asthenia.
d Pyrexia includes pyrexia and body temperature increased.
e Cough includes cough, upper airway cough syndrome, and productive cough.
f Pneumonia includes pneumonia aspiration, pneumonia, pneumonia influenzal, pneumonia bacterial, lower respiratory tract infection, and lung abscess.
g Rash includes rash, dermatitis acneiform, rash maculo-papular, eczema, erythema multiforme, rash macular, dermatitis, rash erythematous, rash pustular, dermatitis bullous, and rash vesicular.
h Dizziness includes dizziness, vertigo, and vertigo positional.
Adverse reactions TABRECTA (N = 373) Grades 1 to 4 (%) Grades 3 to 4 (%) General disorders and administration-site conditions Edema a 59 13 Musculoskeletal pain b 40 4.3 Fatigue c 34 8 Pyrexia d 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 Cough e 21 0.5 Pneumonia f 13 6 Metabolism and nutrition disorders Decreased appetite 21 1.1 Skin and subcutaneous tissue disorders Rash g 13 0.5 Nervous system disorders Dizziness h 13 0.5 Clinically relevant adverse reactions occurring in < 10% of patients treated with TABRECTA included pruritus (including allergic pruritus), ILD/pneumonitis, cellulitis, acute kidney injury (including renal failure), urticaria, and acute pancreatitis.
Table 4 summarizes the laboratory abnormalities in GEOMETRY mono-1.
Table 4: Select Laboratory Abnormalities (≥ 20%) Worsening From Baseline in Patients Who Received TABRECTA in GEOMETRY mono-1 a The denominator used to calculate the rate varied from 359 to 364 based on the number of patients with a baseline value and at least one post-treatment value.
Laboratory abnormalities TABRECTA a 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 Other Clinical Trials Experience The following adverse reactions have been reported following administration of TABRECTA: hypersensitivity and thrombocytopenia.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Novartis Pharmaceuticals Corporation at 1-888-669-6682 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience 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.
Metastatic Non-Small Cell Lung Cancer The safety of TABRECTA was evaluated in GEOMETRY mono-1 [see Clinical Studies (14)] .
Patients received TABRECTA 400 mg orally twice daily until disease progression or unacceptable toxicity (N = 373).
Among patients who received TABRECTA, 37% were exposed for at least 6 months and 22% were exposed for at least one year.
Serious adverse reactions occurred in 53% of patients who received TABRECTA.
Serious adverse reactions in ≥ 2% of patients included dyspnea (7%), pneumonia (7%), pleural effusion (4.3%), musculoskeletal pain (3.8%), general physical health deterioration (2.9%), ILD/pneumonitis (2.7%), edema (2.4%), and vomiting (2.4%).
Fatal adverse reactions occurred in 0.5% of patients who received TABRECTA, including pneumonitis (0.3%) and death, not otherwise specified (0.3%).
Permanent discontinuation of TABRECTA due to an adverse reaction occurred in 17% of patients.
The most frequent adverse reactions (≥ 1%) leading to permanent discontinuation of TABRECTA were ILD/pneumonitis (2.4%), edema (2.4%), fatigue (1.3%), and pneumonia (1.1%).
Dose interruptions due to an adverse reaction occurred in 57% of patients who received TABRECTA.
Adverse reactions requiring dosage interruption in > 2% of patients who received TABRECTA included edema, increased blood creatinine, nausea, increased lipase, vomiting, increased ALT, dyspnea, pneumonia, fatigue, increased amylase, increased AST, musculoskeletal pain, abdominal pain, and increased blood bilirubin.
Dose reductions due to an adverse reaction occurred in 26% of patients who received TABRECTA.
Adverse reactions requiring dosage reductions in > 2% of patients who received TABRECTA included edema, increased ALT and increased blood creatinine.
The most common adverse reactions (≥ 20%) in patients who received TABRECTA were edema, nausea, musculoskeletal pain, fatigue, vomiting, dyspnea, cough, and decreased appetite.
Table 3 summarizes the adverse reactions in GEOMETRY mono-1.
Table 3: Adverse Reactions (≥ 10%) in Patients Who Received TABRECTA in GEOMETRY mono-1 a Edema includes edema peripheral, generalized edema, face edema, edema, localized edema, edema genital, eyelid edema, peripheral swelling, scrotal edema, and penile edema.
b Musculoskeletal pain includes arthralgia, back pain, bone pain, musculoskeletal chest pain, musculoskeletal pain, myalgia, neck pain, non-cardiac chest pain, pain in extremity, pain in jaw, spinal pain.
c Fatigue includes fatigue and asthenia.
d Pyrexia includes pyrexia and body temperature increased.
e Cough includes cough, upper airway cough syndrome, and productive cough.
f Pneumonia includes pneumonia aspiration, pneumonia, pneumonia influenzal, pneumonia bacterial, lower respiratory tract infection, and lung abscess.
g Rash includes rash, dermatitis acneiform, rash maculo-papular, eczema, erythema multiforme, rash macular, dermatitis, rash erythematous, rash pustular, dermatitis bullous, and rash vesicular.
h Dizziness includes dizziness, vertigo, and vertigo positional.
Adverse reactions TABRECTA (N = 373) Grades 1 to 4 (%) Grades 3 to 4 (%) General disorders and administration-site conditions Edema a 59 13 Musculoskeletal pain b 40 4.3 Fatigue c 34 8 Pyrexia d 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 Cough e 21 0.5 Pneumonia f 13 6 Metabolism and nutrition disorders Decreased appetite 21 1.1 Skin and subcutaneous tissue disorders Rash g 13 0.5 Nervous system disorders Dizziness h 13 0.5 Clinically relevant adverse reactions occurring in < 10% of patients treated with TABRECTA included pruritus (including allergic pruritus), ILD/pneumonitis, cellulitis, acute kidney injury (including renal failure), urticaria, and acute pancreatitis.
Table 4 summarizes the laboratory abnormalities in GEOMETRY mono-1.
Table 4: Select Laboratory Abnormalities (≥ 20%) Worsening From Baseline in Patients Who Received TABRECTA in GEOMETRY mono-1 a The denominator used to calculate the rate varied from 359 to 364 based on the number of patients with a baseline value and at least one post-treatment value.
Laboratory abnormalities TABRECTA a 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 Other Clinical Trials Experience The following adverse reactions have been reported following administration of TABRECTA: hypersensitivity and thrombocytopenia.