Tabrecta

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 9/7/2021
Tabrecta Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Tabrecta?

Tabrecta (capmatinib) is a kinase inhibitor used to treat 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.

What Are Side Effects of Tabrecta?

Side effects of Tabrecta include:

  • swelling of extremities,
  • nausea,
  • fatigue,
  • vomiting,
  • shortness of breath,
  • decreased appetite,
  • non-cardiac chest pain,
  • back pain,
  • fever,
  • weight loss,
  • constipation,
  • diarrhea, and
  • cough

Dosage for Tabrecta

The recommended dosage of Tabrecta is 400 mg orally twice daily with or without food.

Tabrecta In Children

Safety and effectiveness of Tabrecta in pediatric patients have not been established.

What Drugs, Substances, or Supplements Interact with Tabrecta?

Tabrecta may interact with other medicines such as:

  • strong CYP3A inhibitors,
  • strong and moderate CYP3A inducers,
  • CYP1A2 substrates,
  • P-gp substrates,
  • BCRP substrates, and
  • MATE1 and MATE2K substrates

Tell your doctor all medications and supplements you use.

Tabrecta During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Tabrecta; it may harm a fetus. Females of reproductive potential and males with female partners of reproductive potential are advised to use effective contraception during treatment with Tabrecta and for 1 week after the last dose. It is unknown if Tabrecta passes into breast milk. Because of the potential for serious adverse reactions in breastfed children, women are advised not to breastfeed during treatment with Tabrecta and for 1 week after the last dose.

Additional Information

Our Tabrecta (capmatinib) Tablets, For Oral Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

Lung Cancer: Early Signs, Symptoms, Stages See Slideshow
Tabrecta Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • new or worsening cough, chest pain, trouble breathing;
  • fever, cough with mucus;
  • severe ongoing nausea and vomiting; or
  • liver problems--swelling around your midsection, right-sided upper stomach pain, vomiting, confusion, weakness, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

  • trouble breathing;
  • nausea, vomiting, decreased appetite;
  • feeling weak or tired;
  • abnormal liver function tests; or
  • swelling in your hands or feet.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Tabrecta (Capmatinib Tablets)

QUESTION

Lung cancer is a disease in which lung cells grow abnormally in an uncontrolled way. See Answer
Tabrecta Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • ILD/Pneumonitis [see WARNINGS AND PRECAUTIONS]
  • Hepatotoxicity [see WARNINGS AND PRECAUTIONS]

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]. Patients received TABRECTA 400 mg orally twice daily until disease progression or unacceptable toxicity (N=334). Among patients who received TABRECTA, 31% were exposed for at least 6 months and 16% were exposed for at least one year.

Serious adverse reactions occurred in 51% of patients who received TABRECTA. Serious adverse reactions in ≥ 2% of patients included dyspnea (7%), pneumonia (4.8%), pleural effusion (3.6%), general physical health deterioration (3%), vomiting (2.4%), and nausea (2.1%). A fatal adverse reaction occurred in one patient (0.3%) due to pneumonitis.

Permanent discontinuation of TABRECTA due to an adverse reaction occurred in 16% of patients. The most frequent adverse reactions (≥ 1%) leading to permanent discontinuation of TABRECTA were peripheral edema (1.8%), pneumonitis (1.8%), and fatigue (1.5%).

Dose interruptions due to an adverse reaction occurred in 54% of patients who received TABRECTA. Adverse reactions requiring dosage interruption in > 2% of patients who received TABRECTA included peripheral edema, increased blood creatinine, nausea, vomiting, increased lipase, increased ALT, dyspnea, increased amylase, increased AST, increased blood bilirubin, fatigue, and pneumonia.

Dose reductions due to an adverse reaction occurred in 23% of patients who received TABRECTA. Adverse reactions requiring dosage reductions in > 2% of patients who received TABRECTA included peripheral edema, increased ALT, increased blood creatinine, and nausea.

The most common adverse reactions (≥ 20%) in patients who received TABRECTA were peripheral edema, nausea, fatigue, vomiting, dyspnea, 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

Adverse ReactionsTABRECTA
(N = 334)
Grades 1 to 4 (%)Grades 3 to 4a (%)
General disorders and administration-site conditions
Peripheral edemab529
Fatiguec328
Non-cardiac chest paind152.1
Back pain140.9
Pyrexiae140.6
Weight decreased100.6
Gastrointestinal disorders
Nausea442.7
Vomiting282.4
Constipation180.9
Diarrhea180.3
Respiratory, thoracic, and mediastinal disorders
Dyspnea247a
Cough160.6
Metabolism and nutrition disorders
Decreased appetite210.9
a Only includes Grade 3 adverse reactions with exception of dyspnea. Grade 4 dyspnea was reported in 0.6% of patients.
b Peripheral edema includes peripheral swelling, peripheral edema, and fluid overload.
c Fatigue includes fatigue and asthenia.
d Non-cardiac chest pain includes chest discomfort, musculoskeletal chest pain, non-cardiac chest pain, and chest pain.
e Pyrexia includes pyrexia and body temperature increased.

Clinically relevant adverse reactions occurring in < 10% of patients treated with TABRECTA included pruritus (allergic and generalized), 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

Laboratory AbnormalitiesTABRECTAa
(N = 334)
Grades 1 to 4 (%)Grades 3 to 4 (%)
Chemistry
Decreased albumin681.8
Increased creatinine620.3
Increased alanine aminotransferase378
Increased alkaline phosphatase320.3
Increased amylase314.4
Increased gamma-glutamyltransferase297
Increased lipase267
Increased aspartate aminotransferase254.9
Decreased sodium236
Decreased phosphate234.6
Increased potassium233.1
Decreased glucose210.3
Hematology
Decreased lymphocytes4414
Decreased hemoglobin242.8
Decreased leukocytes230.9
a The denominator used to calculate the rate varied from 320 to 325 based on the number of patients with a baseline value and at least one post-treatment value.

Read the entire FDA prescribing information for Tabrecta (Capmatinib Tablets)

© Tabrecta Patient Information is supplied by Cerner Multum, Inc. and Tabrecta Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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