Biganib 180 (30pcs Pot)

Mechanism of Action:

• Brigatinib is a tyrosine kinase inhibitor with in vitro activity against multiple kinases, including ALK, ROS1, IGF-1R, FLT-3, EGFR deletion, and point mutations.

Inhibition:

It inhibits autophosphorylation of ALK and ALK-mediated phosphorylation of downstream signaling proteins such as STAT3, AKT, ERK1/2, and S6 in vitro and in vivo assays.

Proliferation Inhibition:

Demonstrated dose-dependent inhibition of EML4-ALK-positive NSCLC xenograft growth in mice.

Metabolism:

Primarily metabolized by CYP2C8 and CYP3A4 in vitro. The major metabolite, AP26123, has lower potency against ALK compared to Brigatinib.

Excretion:

 Excreted mainly through feces (65%) and urine (25%).

Dosage and Administration:

The recommended dosing regimen for Brigatinib is as follows:

• 90mg orally once daily for the first 7 days.
• If 90mg is tolerated during the initial 7 days, increase the dose to 180mg orally once daily.
• Continue administering Brigatinib 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.
• Instruct patients to swallow tablets whole; tablets should not be crushed or chewed.
• If a dose of Brigatinib is missed or vomiting occurs after taking a dose, an additional dose should not be administered, and the next dose of Brigatinib should be taken at the scheduled time.

Note: Patients should follow the dosage instructions as directed by the registered physician.

Interaction:

 Avoid strong CYP3A inhibitors; if unavoidable, reduce the Biganib dose by approximately 50%. Strong CYP3A inducers should be avoided as they may decrease Brigatinib efficacy.

Contraindications:

• Hypersensitivity: Contraindicated in patients with known hypersensitivity to Brigatinib or any other components.

Side Effects:

• Interstitial Lung Disease (ILD)/Pneumonitis
• Hypertension
• Bradycardia
• Visual Disturbance
• Creatine Phosphokinase (CPK) Elevation
• Pancreatic Enzyme Elevation
• Hyperglycemia

Use in Pregnancy and Lactation:

• Pregnancy: 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 is no data regarding the secretion of Brigatinib in human milk or its effects on the breastfed infant or milk production. Due to the potential for adverse reactions in breastfed infants, lactating women should not be advised to breastfeed during treatment with Brigatinib and for 1 week following the final dose.

Precautions & Warnings:

• ILD/Pneumonitis: Severe reactions observed; evaluate promptly for ILD/pneumonitis.
• Hypertension: Monitor blood pressure; withhold for Grade 3 hypertension.
• Bradycardia: Monitor heart rate; use caution with concomitant bradycardia-inducing agents.
• Visual Disturbance: Withhold for Grade 2 or greater severity; permanently discontinue for Grade 4.
• CPK Elevation: Monitor for muscle pain; withhold for Grade 3 or 4 CPK elevation.
• Pancreatic Enzyme Elevation: Monitor amylase and lipase; withhold for Grade 3 or 4 elevation.
• Hyperglycemia: Monitor glucose levels; adjust antihyperglycemic medications as needed.

Storage Conditions

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.