Afinitor Tablet

Introduction

Afinitor Tablet 5 mg is an orally administered mTOR inhibitor, which is a type of antineoplastic drug. It is used to treat advanced renal cell carcinoma (RCC) and subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC). It is believed to act by inhibiting mTOR, the target of rapamycin, a protein involved in the regulation of cell cycle progression, proliferation, angiogenesis, and metabolism.

Uses

Afinitor Tablet 5 mg is used to treat advanced renal cell carcinoma (RCC) and subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC).

Brand Name	Afinitor
Type	Tablet
Weight	5 mg
Generic	Everolimus
Manufacturer	Novartis (Bangladesh) Ltd.
Available in	English বাংলা

Mechanism of Action

Afinitor Tablet 5 mg works by inhibiting mTOR, the target of rapamycin, a protein involved in the regulation of cell cycle progression, proliferation, angiogenesis, and metabolism.

How Long Does It Take to Work?

Afinitor Tablet 5 mg usually begins to work within the first few weeks of treatment, with the effects becoming more noticeable over time. Patients treated with Afinitor Tablet 5 mg may experience improvement in symptoms within 8-12 weeks.

Absorption

Afinitor Tablet 5 mg is rapidly and almost completely absorbed following oral administration.

Route of Elimination

Afinitor Tablet 5 mg is primarily eliminated via the bile.

Dosage

Everolimus are two different dosage forms. Select the recommended dosage form based on the indication. Do not combine Everolimus to achieve the total dose. Modify the dosage for patients with hepatic impairment or for patients taking drugs that inhibit or induce P glycoprotein (P-gp) and CYP3A4.

Hormone Receptor-Positive, HER2-Negative Breast Cancer: The recommended dosage of Everolimus is 10 mg orally once daily until disease progression or unacceptable toxicity.

Neuroendocrine Tumors (NET): The recommended dosage of Everolimus is 10 mg orally once daily until disease progression or unacceptable toxicity.

Renal Cell Carcinoma (RCC): The recommended dosage of Everolimus is 10 mg orally once daily until disease progression or unacceptable toxicity.

Tuberous Sclerosis Complex (TSC): Associated Renal Angiomyolipoma: The recommended dosage of Everolimus is 10 mg orally once daily until disease progression or unacceptable toxicity.

Tuberous Sclerosis Complex (TSC)-Associated Subependymal Giant Cell Astrocytoma (SEGA): The recommended starting dosage of Everolimus is 4.5 mg/m2 orally once daily until disease progression or unacceptable toxicity.

Tuberous Sclerosis Complex (TSC)-Associated Partial-Onset Seizures: The recommended starting dosage of Everolimus is 5 mg/m2 orally once daily until disease progression or unacceptable toxicity.

For the treatment of advanced RCC, the recommended dosage of Afinitor Tablet 5 mg is 10 mg orally once daily.

Administration

Afinitor Tablet 5 mg should be taken orally, once daily, with or without food.

Side Effects

Common side effects of Afinitor Tablet 5 mg include fatigue, diarrhea, anemia, nausea, stomatitis, asthenia, constipation, decreased appetite, fever, infection, vomiting, cough, mucositis, abdominal pain, and rash.

Toxicity

Afinitor Tablet 5 mg is generally well-tolerated; the most severe toxicities associated with its use are infections and gastrointestinal inflammation. Other side effects that may occur include hypercholesterolemia, hypertension, hypertriglyceridemia, hypophosphatemia, hyperglycemia, and hypokalemia.

Precaution

Patients should be monitored closely for signs and symptoms of infection while taking Afinitor Tablet 5 mg and should be instructed to contact their healthcare provider for any symptoms. Patients may also be at risk of developing severe and potentially fatal complications associated with the use of Afinitor Tablet 5 mg, including interstitial lung disease, hepatotoxicity, and immune-mediated events.

Interactions

Afinitor Tablet 5 mg can interact with a variety of medications and other drugs, and patients should discuss any potential drug interactions with their healthcare provider. Patients should also be aware of potential food–drug interactions and should avoid eating grapefruit or drinking grapefruit juice while taking Afinitor Tablet 5 mg.

Disease Interaction

Afinitor Tablet 5 mg may interact with certain medical conditions, and should be taken with caution in patients with a history of diabetes mellitus, cholestasis, hepatic impairment, severe infections, or autoimmune diseases.

Drug Interactions

Afinitor Tablet 5 mg may interact with certain drugs, and should not be taken with ACE inhibitors, cyclosporine, hypotension-inducing agents, or specific antifungal agents.

Food Interactions

Grapefruit and grapefruit juice should be avoided while taking Afinitor Tablet 5 mg.

Pregnancy Use

Afinitor Tablet 5 mg is not recommended for use in pregnant women. Animal studies have not shown any evidence of fetal harm, but the potential risks to humans are not known.

Lactation Use

Afinitor Tablet 5 mg is not recommended for use in nursing mothers. It is not known whether Afinitor Tablet 5 mg is excreted in breast milk, and the potential risks to an infant are not known.

Acute Overdose

The most commonly reported symptoms following an Afinitor Tablet 5 mg overdose are fatigue, dizziness, and nausea. If an overdose is suspected, it is important to contact a healthcare provider immediately for appropriate medical care.

Contraindication

Afinitor Tablet 5 mg is contraindicated in patients with a history of hypersensitivity to Afinitor Tablet 5 mg or its excipients.

Use Direction

Take Afinitor Tablet 5 mg by mouth, once daily, with or without food. Swallow the capsule whole with water. Do not break, crush, or chew the capsule. Take your Afinitor Tablet 5 mg at the same time each day.