Product ID: 535122
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Capmatinib is sold under the brand Tabrecta, is marketed under the brand name Tabrecta is a drug to treat adults who have metastatic non-small-cell lung cancer, whose tumors carry an abnormality that causes the skipping of exon 14 of the MET gene that encodes to the receptor membrane HGFR which is
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Capmatinib is a kinase inhibitor that targets c-Met. This receptor tyrosine kinase activates signaling pathways involved in organ regeneration and tissue repair in healthy humans. Multiple downstream signaling pathways, including STAT3, PI3K/ATK, and RAS/MAPK, are overactivated due to aberrant c-Met activation, which can be caused by mutations, amplification, or overexpression. Mutations in the MET gene have been found in non-small cell lung cancer (NSCLC), with a prevalence of MET amplification ranging from 1.4 percent to 21% in EGFR-TKI-naive patients with NSCLC. Because of this, c-Met has become a desirable target in the therapy of NSCLC.
Tabrecta is a medicine used to treat adults with a kind of lung cancer called non-small cell lung cancer. It is treated when the cancer is advanced, and there has been a change in the so-called 'metex14 skipping' gene associated with the mesenchymal-epithelial transition factor gene. Based on the overall response rate and length of the response, this indication has been given accelerated approval. Verification and description of clinical benefits in confirmatory trials may be required for continued approval for this indication.
Only with prescription is Tabrecta available, and only a medical professional with experience in using cancer medications should initiate and oversee treatment. The patients should undergo tests to determine whether the METex14 skipping mutations in their cancer exist before beginning treatment. Then the oral tablet form of Tabrecta is offered.
The suggested dosage is 400 mg twice daily. It can be continued if the patient continues to benefit from the Tabrecta treatment. The doctor may decide to lower the dose or stop or interrupt Tabrecta treatment if specific side effects manifest. Consult the product information leaflet or contact your doctor or pharmacist for more details on using Tabrecta.
TABRECTA should be taken orally twice daily, with or without food, in 400 mg each.
Inhale whole TABRECTA tablets. Avoid chewing, crushing, or breaking the tablets.
If a patient misses or throws up after taking a dose, tell them to take the following amount at the scheduled time instead of making up for the missed one.
The MET protein is a member of the receptor tyrosine kinase family of enzymes essential for cell growth. An abnormal form of the MET protein is produced in NSCLC patients with "METex14 skipping," which leads to uncontrolled division and growth of cancer cells.
A receptor tyrosine kinase inhibitor called lapatinib, the active ingredient in Tabrecta, binds to this aberrant MET protein inside cancer cells. This halts the effects of MET and aids in slowing the development and spread of cancer.
150mg: Light-orange, oval, film-coated dome with chamfered, non-dividing edges, engraved "DU" on one side and "NVR" on the other.
200mg: yellow, oval, curved film-coated with beveled, indivisible edges, engraved "LO" on one side and "NVR" on the other.
Use the desiccant cartridge and distribute it in the original container. Defend against moisture. After six weeks from the time the bottle is first opened, throw away any TABRECTA that hasn't been used.
There is additional information about the following clinically significant adverse reactions in the labeling:
A drug's adverse reaction rates in clinical trials cannot be directly compared to rates in clinical trials of other medications. They may not accurately reflect rates seen in actual use because clinical trials are carried out under a wide range of conditions.
In GEOMETRY mono-1, the safety of TABRECTA was assessed [see Clinical Studies]. Patients (N=334) received TABRECTA 400 mg twice daily until their disease progressed or the side effects became intolerable. Thirty-one percent of TABRECTA-treated patients were exposed for at least six months, and sixteen percent were exposed for at least a year.
Of the patients who received TABRECTA, 51% experienced severe adverse reactions. Dyspnea (7%), pneumonia (4.8%), pleural effusion (3.6%), general physical health deterioration (3%), vomiting (2.4%), and nausea (2.1%) were severe adverse reactions that occurred in less than 2% of patients. One patient (0.3%) experienced a fatal adverse reaction due to pneumonitis.
In 16% of patients, TABRECTA was permanently stopped due to an adverse reaction. Peripheral edema (1.8%), pneumonitis (1.8%), and fatigue (1.5%) were the most frequent adverse reactions ( 1%) that resulted in the permanent discontinuation of TABRECTA.
In 54% of patients who received TABRECTA, dose interruptions occurred because of an adverse reaction. Peripheral edema, increased blood creatinine, nausea, vomiting, increased lipase, increased ALT, dyspnea, amylase, increased AST, increased blood bilirubin, fatigue, and pneumonia were among the adverse reactions that required dosage interruption in more than 2% of patients who received TABRECTA.
In 23% of patients who received TABRECTA, dose reductions resulted from an adverse reaction. Peripheral edema, elevated ALT, elevated blood creatinine, and nausea were adverse reactions that required dosage reductions in > 2% of patients receiving TABRECTA.
Peripheral edema, fatigue, nausea, vomiting, dyspnea, and decreased appetite were the side effects that affected patients receiving TABRECTA the most frequently ( 20%).
Capmatinib exposure was increased by coadministering TABRECTA with a potent CYP3A inhibitor, which may impact the frequency and intensity of TABRECTA side effects. Patients should be closely watched for adverse reactions when taking TABRECTA and potent CYP3A inhibitors.
Capmatinib exposure was reduced when TABRECTA was administered along with a potent CYP3A inducer. Additionally, the exposure to lapatinib may be decreased by coadministering TABRECTA with a mild CYP3A inducer. TABRECTA's anti-tumor activity may decrease as lapatinib exposure declines. TABRECTA should be taken separately as both strong and moderate CYP3A inducers.
TABRECTA coadministration increased a CYP1A2 substrate's exposure, which could worsen the substrate's adverse effects. Reduce the dosage of the CYP1A2 substrate per the approved prescribing information if coadministration of TABRECTA and CYP1A2 substrates is required in cases where even small concentration changes could result in severe adverse reactions.
The potentially fatal ILD/pneumonitis occurred in patients receiving TABRECTA. 4.5% of patients receiving TABRECTA in GEOMETRY mono-1 developed ILD/pneumonitis, 1.8% of patients developed Grade 3 ILD/pneumonitis, and 0.3% died. ILD/pneumonitis led to the discontinuation of TABRECTA in eight patients (2.4%). The median time-to-onset of ILD/pneumonitis in Grade 3 or higher was 1.4 months (range: 0.2 months to 1.2 years).
Keep an eye out for any new or developing pulmonary symptoms of ILD or pneumonia (e.g., dyspnea, cough, fever). Patients with suspected ILD/pneumonitis should have TABRECTA immediately withheld, and if no additional causes of ILD/pneumonitis are found, TABRECTA should be permanently discontinued.
The most frequent side effects of Tabrecta (which may affect more than 1 in 5) include peripheral edema (swelling, especially of the hands, ankles, or feet), nausea (feeling sick), fatigue, an increase in blood creatinine levels (a sign of kidney problems), vomiting, difficulty breathing, decreased appetite, and back pain.
Breathing problems, interstitial lung disease (a condition that causes scarring in the lungs), pneumonitis (lung inflammation), cellulitis (inflammation of the deep skin tissue), peripheral edema, and elevated levels of the liver enzyme alanine aminotransferase (ALT), as well as amylase and lipase, in the blood, are the most frequent serious side effects of Tabrecta (a sign of pancreatic problems).
According to results from animal studies, TABRECTA may increase the risk of photosensitivity reactions [see Nonclinical Toxicology]. During treatment with TABRECTA, GEOMETRY mono-1 advised patients to take precautions against UV exposure, such as wearing sunscreen or protective clothing. Encourage patients to avoid prolonged exposure to sunlight while taking TABRECTA.
TABRECTA can cause serious side effects, including:
Breathing or lung issues TABRECTA may result in lung inflammation that can be fatal. If you experience any new or escalating symptoms, such as:
? trouble breathing or shortness of breath
If you experience lung or breathing issues while taking TABRECTA, your doctor may decide to halt or permanently stop your treatment temporarily.
Liver issues: TABRECTA may result in abnormal blood tests for the liver. Before and during your TABRECTA treatment, your doctor will perform blood tests to assess the health of your liver. Immediately notify your healthcare provider if you experience any signs or symptoms of liver issues, such as:
? the color of your skin or the whites of your eyes become yellow (jaundice)
? appetite loss that lasts several days or longer
? dark or &lduqo;tea-colored&rduqo; urine
? nausea and vomiting
? light-colored stools (bowel movements)
? You feel discomfort, aching, or tenderness on the right side of your abdomen (abdomen)
? swelling in your stomach-area