Bexdeco

Ivacaftor ·Beximco Pharmaceuticals Ltd.·Tablet

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Packages & prices

Pack	Price	Details
Unit Price	৳ 23250.00	Unit Price: ৳ 775.00 (1 x 30: ৳ 23,250.00)

Administration

6 years and older: One 150 mg tablet every 12 hours. Taken orally with fat containing food.

Ivacaftor is not recommended in patients less than 6 years of age with any level of hepatic impairment. No dose adjustment is necessary for patients aged 6 months and older with hepatic impairment. Administer Ivacaftor tablets with fat-containing food. Examples include eggs, butter, peanut butter, cheese pizza, whole-milk dairy products (such as whole milk, cheese, yogurt, breast milk, or infant formula), etc.

Effects

Elevated transaminases have been reported in patients with CF receiving Bexdeco.
Cataracts in pediatric patients have been reported.

Indications

Bexdeco is a cystic fibrosis transmembrane conductance regulator (CFTR) potentiator indicated for the treatment of cystic fibrosis (CF) in patients age 6 years and older who have at least one mutation in the CFTR gene that is responsive to Bexdeco based on clinical and/or in vitro assay data.

Pharmacology

Ivacaftor is a first-in-class CFTR potentiator, it works by prolonging the time that activated CFTR channels remain open, thereby enhancing the regulation of chloride and water transport across cell membranes. This results in improved functioning of multiple organs, most notably lungs.

Precautions

Transaminase (ALT or AST) Elevations: Elevated transaminases have been reported in patients with CF receiving Bexdeco. ALT and AST should be assessed prior to initiating Bexdeco, every 3 months during the first year of treatment, and annually thereafter. For patients with a history of transaminase elevations, consider more frequent monitoring of liver function tests. Patients who develop increased transaminase levels should be closely monitored until the abnormalities are resolved. Dosing should be interrupted in patients with ALT or AST of greater than 5 times the upper limit of normal (ULN). Following resolution of transaminase elevations, consider the benefits and risks of resuming Bexdeco.

Concomitant Use with CYP3A Inducers: Use of Bexdeco with strong CYP3A inducers, such as rifampin, substantially decreases the exposure of Bexdeco, which may reduce the therapeutic effectiveness of Bexdeco. Therefore, co-administration of Bexdeco with strong CYP3A inducers is not.

Cataracts: Cases of non-congenital lens opacities/cataracts have been reported in pediatric patients treated with Bexdeco. Although other risk factors were present in some cases (such as corticosteroid use and/or exposure to radiation), a possible risk attributable to Bexdeco cannot be excluded. Baseline and follow-up ophthalmological examinations are recommended in pediatric patients initiating Bexdeco treatment.