Everolimus 10mg tablet

Product Description

1. Technical Specifications

2. Product Description

Afinitor 10mg Tablet contains Everolimus, a selective mTOR (mammalian target of rapamycin) inhibitor.
It reduces cell proliferation, angiogenesis, and cancer cell survival by inhibiting the mTOR signaling pathway.

Also acts as an immunosuppressant in transplant medicine and as targeted therapy in certain cancers.

3. Product Highlights

4. Therapeutic Uses

• Advanced Breast Cancer (HR+, HER2-, postmenopausal women): In combination with exemestane

• Advanced Renal Cell Carcinoma: After failure of VEGF-targeted therapy

• Neuroendocrine Tumors (pancreatic NET, GI, lung): Unresectable, locally advanced or metastatic disease

• Subependymal Giant Cell Astrocytoma (SEGA): Associated with tuberous sclerosis (when surgery is not feasible)

• Renal Angiomyolipoma: In patients with tuberous sclerosis

5. Side Effects

Common:

• Stomatitis (mouth ulcers)

• Rash, pruritus, acne

• Fatigue, weakness

• Decreased appetite, weight loss

• Diarrhea, nausea

• Infections (respiratory, urinary tract)

• Cough, dyspnea

Serious / Severe:

• Non-infectious pneumonitis (serious lung toxicity)

• Severe infections due to immunosuppression

• Stomatitis with ulceration

• Hepatotoxicity (elevated liver enzymes)

• Renal failure (rare but serious)

• Hyperglycemia, hyperlipidemia

• Myelosuppression (low WBC, platelets, anemia)

6. Precautions

• Blood Monitoring: CBC, liver & kidney function, fasting glucose & lipid profile regularly.

• Infection Risk: Avoid exposure to sick contacts; report fever, cough, or breathing difficulty immediately.

• Oral Care: Maintain good oral hygiene; early treatment of mouth ulcers recommended.

• Pregnancy & Breastfeeding: Contraindicated; Everolimus is teratogenic.

• Drug Interactions:

  • Metabolized by CYP3A4 avoid strong inhibitors (ketoconazole, clarithromycin) & inducers (rifampicin, phenytoin).

  • Avoid live vaccines.

• Pulmonary Monitoring: Discontinue if severe non-infectious pneumonitis develops.