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• Tabrecta 200 Mg Tablets
• Novartis
• Generic Name : Capmatinib Tablets
• Packing : 56 Film Coated Tablets

What is the use of Tabrecta ?

Tabrecta medicine treat lung cancer (NSCLC) that spread of the body or cannot removed by surgery (metastatic). The tumors have abnormal mesenchymal epithelial progression (MET) genes.

What is Tabrecta?

Tabrecta is a medicine prescribed by  doctor used to treat adults with a type of lung cancer called non-small cell lung cancer (NSCLC):

• has spread to different parts of the body or can’t take out by a surgery (metastatic), and
• whose tumors have a abnormal mesenchymal epithelial transition (MET) gene

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Indications

The drug shown in FDA-cleared tests for treating elderly patients with metastatic non-small cell lung cancer (NSCLC) who have a tumor with a mutation that causes mesenchymal-epithelial metastasis (MET) different exon 14 cross.

This sign approved under accelerated approval dependent on overall response rate and length of reaction. Proceeded with approval for this sign might dependent upon verification and description of clinical advantage in confirmatory trial(s).

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Dosage

Patient Selection

Select patients for treatment dependent on the presence of a mutation that prompts MET exon 14 avoiding in tumor examples. Data on FDA-approved tests is accessible at Companion Diagnostics.

Suggested Dosage

The suggested dosage of TABRECTA is 400 mg orally twice every day with\ without food.

Swallow TABRECTA tablets. Try not to break, crush or chew the tablets.

If a patient misses or vomits a dose, instruct the patient not to make up the dose, but rather to take the following dose at its scheduled time.

Tabrecta Side Effects

Most common Tabrecta side effects :

• loss of appetite
• weakness and tiredness
• swelling of your hands or feet
• changes in certain blood tests
• vomiting

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Drug Interactions

Effect of Other Drugs on Tabrecta

Strong CYP3A Inhibitor

Co-administration of TABRECTA and a strong CYP3A inhibitor increases the exposure of capmatinib, which may increase the incidence and severity of TABRECTA adverse reactions [see Clinical Pharmacology]. Closely monitor patients for adverse reactions during the co-administration of TABRECTA with strong CYP3A inhibitors. Strong and moderate CYP3A inducers TABRECTA co-administration with strong CYP3A inducers reduced capmatinib exposure. Co-administration of TABRECTA and moderate CYP3A inducers may also reduce capmatinib exposure. Reducing the exposure to capmatinib may reduce the anti-tumor activity of TABRECTA [see Clinical Pharmacology]. Avoid co-administration of TABRECTA with strong and moderate CYP3A inducers.

Effect of Tabrecta on Other Drugs

Co-administration of the CYP1A2 substrate TABRECTA increases the exposure of CYP1A2 substrates, which may increase the adverse reactions of these substrates [see Clinical Pharmacology]. If co-administration between TABRECTA and CYP1A2 substrate is inevitable, and small changes in concentration can cause serious adverse reactions, reduce the dose of CYP1A2 substrate according to the approved prescribing information. TABRECTA increases the exposure of P-gp and BCRP substrates, which may increase the adverse reactions of these substrates [see Clinical Pharmacology].

More Detail

If co-administration between TABRECTA and P-gp or BCRP substrate is unavoidable, and small changes in concentration may cause serious adverse reactions, please reduce the dose of P-gp or BCRP substrate according to the approved prescribing information. Exposure of MATE1 and MATE2K substrates can increase the adverse reactions of these substrates [see Clinical Pharmacology]. If the co-administration of TABRECTA and MATE1 or MATE2K substrate is unavoidable, and small changes in concentration can cause serious adverse reactions, please reduce the dose of MATE1 or MATE2K substrate according to the approved prescribing information.

Warnings and Precautions

Precautions

Interstitial Lung Disease (IP)/Pneumonia Pneumonia/IP can  fatal and occurs in patients treated with TABRECTA [see Contraindications]. GEOMETRY mono-1 developed ILD/pneumonia in 4.5% of patients treated with this drug, 1.8% of patients developed grade 3 ILD/pneumonia and one patient died (0.3%).  The median time to onset of grade 3 or higher ILD/pneumonia was 1.4 months (range: 0.2 months to 1.2 years).

Look for signs of new or worsening lung disease (such as shortness of breath, cough, fever) indicating ILD/pneumonia. Stop this drug immediately for patients with suspected ILD/pneumonia. Permanent exclusion unless other causes of PID/pneumonia have identified [see Medication Administration and Control].

Hepatotoxicity

Hepatotoxicity occurs in patients treated with TABRECTA [see Adverse Reactions].3 patients (0.9%) were discontinued from this treatment. The average height of grade 3 or higher ALT/AST was 1.4 months (maximum: 0.5 to 4.1 months). Monitor liver function (including ALT, AST and total bilirubin) before starting TABRECTA, every 2 weeks for the first 3 months of treatment, then monthly for patients with high dose transaminases or on treatment or frequent bilirubin. Discontinue, reduce dose, or discontinue TABRECTA permanently depending on severity of reaction [see Dosage and Administration].

Photosensitivity Hazards

According to the results of animal studies, TABRECTA has a potential risk of photosensitivity [see Non-clinical Toxicology]. In GEOMETRY mono-1, patients are advised to take preventive measures to prevent UV exposure, such as wearing sunscreen or protective clothing during TABRECTA treatment. It is recommended that patients limit direct UV exposure during TABRECTA treatment.

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Drug Interactions

Embryo-fetal toxicity

According to the results of animal studies and its mechanism of action, Capmatinib may cause fetal harm when administered to pregnant women. According to the area under the curve (AUC) clinical dose of 400 mg twice a day, oral administration of Capmatinib to pregnant rats and rabbits during the organ formation period caused malformations, and the exposure was lower than the human exposure. Inform pregnant women of the potential risks to the fetus.It is recommended that women of childbearing age take the correct vaccine at the same time and within one week of the last dose. Men whose partners are able to conceive are encouraged to take the appropriate vaccine while taking this medication and within a week of the last dose. Manufactured by Novartis Capmatinib tablet 200 mg Tabrecta price in india at JollyRX .

Clinical trials on Tabrecta

The FDA approval of Capmatinib is based on the GEOMETRY mono-1 Phase II multicenter, open-label, non-randomized, multi-cohort study.

The study evaluated a total of 97 adult patients, including 69 previously treated patients and 28 treatment-naïve patients after central confirmation of the METex14 skipping. Enrolled patients were referred to group 4 or 5b and received 400 mg  twice daily until infectious or non-infectious.

The study overall response rate (ORR) and duration of response (DOR) as efficacy outcomes.

The confirmed ORR was 41% and 68% among previously treated and treatment-naïve patients, respectively.

Median DOR was found 9.7 months in previously treated patients (28 responders) and 12.6 months in treatment naïve patients (19 responders). The most common side effects observed in patients during the trial were nausea, vomiting, fatigue, shortness of breath, decreased appetite, and peripheral edema.

Tabrecta Approvals

• Novartis submitted the New Drug Application (NDA) for the use of  Capmatinib to the FDA in December 2019. The MET inhibitor received priority review from the FDA in February 2020.
• The FDA approved the therapy under the provisions of the accelerated approval regulations based on overall response rate and duration of response, in May 2020.
• It also approved Foundation One  CDx for use as an companion diagnosis to Tabrecta aid in the Identification of mutations that contribute to METex14 skipping in tumor tissue.
• The regulator previously granted innovative therapy and orphan drug designations to Novartis for Capmatinib.
• In June 2020, Tabrecta Price received approval from the Ministry of Health, Labor and Welfare of Japan (MHLW) for use in the treatment of advanced or recurrent unrespectable NSCLC with a positive METex14 mutation.
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