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.

QUESTION

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

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)

Learn More »

SLIDESHOW

Lung Cancer: Early Signs, Symptoms, Stages See Slideshow

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 Reactions	TABRECTA (N = 334)
Adverse Reactions	Grades 1 to 4 (%)	Grades 3 to 4^a (%)
General disorders and administration-site conditions
Peripheral edema^b	52	9
Fatigue^c	32	8
Non-cardiac chest pain^d	15	2.1
Back pain	14	0.9
Pyrexia^e	14	0.6
Weight decreased	10	0.6
Gastrointestinal disorders
Nausea	44	2.7
Vomiting	28	2.4
Constipation	18	0.9
Diarrhea	18	0.3
Respiratory, thoracic, and mediastinal disorders
Dyspnea	24	7a
Cough	16	0.6
Metabolism and nutrition disorders
Decreased appetite	21	0.9
^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 Abnormalities	TABRECTA^a (N = 334)
Laboratory Abnormalities	Grades 1 to 4 (%)	Grades 3 to 4 (%)
Chemistry
Decreased albumin	68	1.8
Increased creatinine	62	0.3
Increased alanine aminotransferase	37	8
Increased alkaline phosphatase	32	0.3
Increased amylase	31	4.4
Increased gamma-glutamyltransferase	29	7
Increased lipase	26	7
Increased aspartate aminotransferase	25	4.9
Decreased sodium	23	6
Decreased phosphate	23	4.6
Increased potassium	23	3.1
Decreased glucose	21	0.3
Hematology
Decreased lymphocytes	44	14
Decreased hemoglobin	24	2.8
Decreased leukocytes	23	0.9
^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)

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