Composition: Biganib: Each
tablet contains Brigatinib INN 90mg.
Biganib-180: Each tablet contains Brigatinib INN 180mg.
is indicated for the treatment of patients with anaplastic lymphoma kinase
(ALK)-positive metastatic Non-small cell lung cancer
(NSCLC) who have progressed on or are intolerant to Crizotinib.
Dosage and Administration: The
recommended dosing regimen for Biganib is:
• 90 mg orally once daily for the first 7 days;
• If 90 mg is tolerated during the first 7 days, the dose should be increased to 180 mg orally once daily. Biganib should be administered until disease progression or unacceptable toxicity. If Biganib is interrupted for 14 days or longer for reasons other than adverse reactions, treatment should be resumed at 90 mg once daily for 7 days before increasing to the previously tolerated dose. Biganib may be taken with or without food. Patients should be instructed to swallow tablets whole. Tablets should not be crushed or chewed. If a dose of Biganib is missed or vomiting occurs after taking a dose, an additional dose should not be administered and take the next dose of Biganib should be taken at the scheduled time. Or, as directed by the registered physicians.
Use in Pregnancy and Lactation: There
are no clinical data on the use of Biganib in pregnant women. If this drug is
used during pregnancy, or if the
patient becomes pregnant while taking this drug, advise the patient of the potential risk to a fetus.
Packing: Biganib: Each
box contains 30 tablets in a blister pack.
Biganib-180: Each container contains 30 tablets in a box.