Alunib Tablet

Introduction

Alunib Tablet 90 mg is an oral tyrosine kinase inhibitor used in the treatment of non-small cell lung cancer (NSCLC) with anaplastic lymphoma kinase (ALK) gene rearrangements. It is designed to target and inhibit the activity of ALK, which is involved in the growth and proliferation of cancer cells.

Uses

Alunib Tablet 90 mg is primarily used for:

Treating adults with locally advanced or metastatic NSCLC who have ALK-positive disease and have progressed on or are intolerant to crizotinib.
It may be used as a first-line therapy in some cases, based on the clinical scenario and physician's judgment.

Brand Name	Alunib
Type	Tablet
Weight	90 mg
Generic	Brigatinib
Manufacturer	Jenphar Bangladesh Ltd.
Available in	English বাংলা

Mechanism of Action

Alunib Tablet 90 mg works by selectively inhibiting the ALK tyrosine kinase. By binding to the ALK enzyme, Alunib Tablet 90 mg prevents the activation of signaling pathways that promote cell growth and survival. This inhibition disrupts the proliferation of ALK-positive cancer cells and contributes to tumor regression.

How Long Does It Take to Work?

The onset of action for Alunib Tablet 90 mg can vary among patients. Initial signs of clinical benefit may be observed within a few weeks of starting therapy. However, a complete assessment of its effectiveness typically requires several months of treatment and regular imaging studies.

Absorption

Alunib Tablet 90 mg is well absorbed following oral administration, with peak plasma concentrations usually reached within 4 to 6 hours. Food intake does not significantly affect its absorption, allowing for flexibility in dosing relative to meals.

Route of Elimination

Alunib Tablet 90 mg is primarily metabolized in the liver via cytochrome P450 enzymes, particularly CYP3A4. The drug and its metabolites are then excreted in both urine and feces.

Dosage

The recommended dosing regimen for Brigatinib 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.

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, treatment should be resumed 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. 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 take the next dose of Brigatinib should be taken at the scheduled time.

Pediatric Use: The safety and efficacy of Brigatinib in pediatric patients have not been established.

The recommended starting dose of Alunib Tablet 90 mg is 90 mg orally once daily for the first 7 days, followed by a dose increase to 180 mg once daily. The dose may be adjusted based on individual tolerance and side effects.

Administration

Alunib Tablet 90 mg should be taken orally with or without food. It is important to take the medication consistently at the same time each day to maintain even drug levels. If a dose is missed, it should be taken as soon as remembered, but not within 12 hours of the next dose.

Side Effects

Common side effects of Alunib Tablet 90 mg include:

Nausea and vomiting
Diarrhea
Fatigue
Headache
Elevated liver enzymes

Serious side effects can include interstitial lung disease, pancreatitis, and severe infections. Patients should report any unusual symptoms or severe reactions to their healthcare provider.

Toxicity

Overdose of Alunib Tablet 90 mg can lead to severe side effects, such as significant gastrointestinal distress, liver enzyme abnormalities, and pulmonary symptoms. In case of overdose, supportive care should be provided, and immediate medical attention is necessary.

Precautions

Precautions for Alunib Tablet 90 mg include:

Monitoring for signs of interstitial lung disease (ILD) or pneumonitis, which can be serious or fatal.
Regular monitoring of liver function due to potential hepatotoxicity.
Periodic assessment of blood glucose levels, as Alunib Tablet 90 mg may affect glucose metabolism.

Interaction

Alunib Tablet 90 mg may interact with other medications metabolized by CYP3A4. Caution should be used when combining Alunib Tablet 90 mg with strong CYP3A4 inhibitors or inducers, as these interactions can affect Alunib Tablet 90 mg levels and efficacy.

Disease Interaction

Alunib Tablet 90 mg should be used with caution in patients with pre-existing lung disease or liver impairment. The drug may exacerbate these conditions or affect the metabolism of other medications.

Drug Interaction

Drug interactions with Alunib Tablet 90 mg can occur with other drugs that are substrates, inducers, or inhibitors of CYP3A4. These interactions can affect the efficacy and safety profile of Alunib Tablet 90 mg. A thorough review of all concomitant medications is essential before starting Alunib Tablet 90 mg therapy.

Food Interactions

Food intake does not significantly affect the absorption of Alunib Tablet 90 mg. The drug can be taken with or without food, allowing for flexibility in administration.

Pregnancy Use

The safety of Alunib Tablet 90 mg during pregnancy has not been established. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Women of childbearing potential should use effective contraception during treatment.

Lactation Use

It is unknown whether Alunib Tablet 90 mg is excreted in breast milk. Due to potential risks, breastfeeding is generally not recommended during Alunib Tablet 90 mg therapy. Women should discuss with their healthcare provider the risks and benefits of breastfeeding while on Alunib Tablet 90 mg.

Acute Overdose

In case of acute overdose, symptomatic and supportive treatment should be provided. There is no specific antidote for Alunib Tablet 90 mg, and treatment should focus on managing the symptoms and monitoring for adverse effects.

Contraindication

Alunib Tablet 90 mg is contraindicated in patients with a known hypersensitivity to Alunib Tablet 90 mg or any of its components. It should not be used in patients with severe liver impairment or those who are pregnant unless absolutely necessary.

Use Direction

Patients should adhere to the prescribed dosing regimen and take Alunib Tablet 90 mg consistently at the same time each day. Regular follow-up with healthcare providers is important to monitor the effectiveness and manage any side effects.

Storage Conditions

Alunib Tablet 90 mg should be stored at room temperature, 20°C to 25°C (68°F to 77°F), in a tightly closed container. It should be kept away from moisture and heat, and out of reach of children.

Volume of Distribution

The volume of distribution of Alunib Tablet 90 mg is approximately 2.6 L/kg, indicating that the drug is widely distributed throughout the body.

Half Life

The terminal half-life of Alunib Tablet 90 mg is approximately 24 to 30 hours, allowing for once-daily dosing. This extended half-life contributes to its effectiveness in maintaining therapeutic drug levels with regular dosing.

Clearance

Alunib Tablet 90 mg is primarily cleared through metabolic pathways involving the liver. The drug's clearance is influenced by liver function and can be affected by concomitant medications that alter liver enzyme activity.

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