Brigatinib INN
Composition:
Brigatinib: Each film coated tablet contains Brigatinib INN 90 mg.
Brigatinib-180: Each film coated tablet contains Brigatinib INN 180 mg.
Indications: Brigatinib is indicated for the treatment of adult patients with
anaplastic lymphoma kinase (ALK)- positive metastatic non-small cell lung
cancer (NSCLC).
Dosage and
Administration: The recommended dosing regimen for Brigatinib is 90mg
orally once daily for the first 7 days; if 90mg is tolerated during the first 7
days, the dose should be increased to 180mg orally once daily. Brigatinib
should be administered until disease progression or unacceptable toxicity. If Brigatinib
is interrupted for 14 days or longer for reasons other than adverse reactions,
resume treatment at 90 mg once daily for 7 days before increasing to the
previously tolerated dose. Brigatinib may be taken with or without food. Patients
should be instructed to swallow tablets whole. Tablet should not be crushed or
chewed. If a dose of Brigatinib is missed or vomiting occurs after taking a
dose, an additional dose should be administered and the next dose of Brigatinib
should be taken at the scheduled time. Or, as
directed by the registered physician.
Use in Pregnancy
and Lactation: Brigatinib can
cause fetal harm when administered to a pregnant woman. There are no clinical
data on the use of Brigatinib in pregnant women. Pregnant women should be
advised of the potential risk to a fetus. Lactation: There
are no data regarding the secretion of Brigatinib in human milk or its effects
on the breastfed infant or milk production. Because of the potential for
adverse reactions in breastfed infants, lactating women should not advise to
breastfeed during treatment with Brigatinib and for 1 week following the final
dose.
Packing:
Biganib: Each box contains 10 tablets in blister
pack.
Biganib-180: Each box contains 7 tablets in blister
pack.
