Afinitor (Everolimus) Tablets – Complete Product Description | EZ Chemist Online Pharmacy
Afinitor Everolimus Tablets – Targeted Therapy for Cancer, Tumors & Tuberous Sclerosis | Buy Online at EZ Chemist

What is Afinitor used for?
Afinitor is a prescription medication containing everolimus, an mTOR inhibitor used to treat various cancers such as advanced kidney cancer, breast cancer, pancreatic tumors, and conditions like tuberous sclerosis complex (TSC). It works by blocking cell growth and angiogenesis, slowing disease progression.
Brand Name: Afinitor

Generic Name: Everolimus
Formulation: Oral tablets
Available Strengths: 2.5 mg, 5 mg, 7.5 mg, 10 mg
Drug Class: mTOR (mammalian target of rapamycin) inhibitor

Prescription Status: Prescription-only medication (Rx)
Manufacturer: Novartis
Availability in India: Buy Afinitor Online – EZ Chemist
Everolimus
A derivative of sirolimus (rapamycin), everolimus acts as an inhibitor of mTOR, a protein kinase involved in regulating cell growth, metabolism, angiogenesis, and survival.

Other Popular or Generic Names:
Generic: Everolimus

Related Brands: Certican (used for transplant), Zortress (US brand for transplant indications), Votubia (EU brand for tuberous sclerosis)

Related Drug Class: Rapalogs (Rapamycin analogs)

Mode of Action:
Everolimus binds to FKBP-12, forming a complex that inhibits the mTORC1 pathway, a key regulator of cell cycle progression and angiogenesis. This results in:

Reduced tumor cell proliferation

Inhibited blood vessel formation (angiogenesis)

Suppressed immune activation (transplant and autoimmune indications)

NEJM (2008) and The Lancet Oncology (2012) report that everolimus significantly slows disease progression in advanced cancers and improves outcomes in patients with TSC-associated tumors.
Afinitor is approved for the treatment of:

Advanced Renal Cell Carcinoma (RCC) after failure of VEGF-targeted therapy

Hormone Receptor-Positive, HER2-Negative Breast Cancer (postmenopausal women, in combination with exemestane)

Neuroendocrine Tumors (NETs) of pancreatic, gastrointestinal, or lung origin

Tuberous Sclerosis Complex (TSC) associated with:

Renal Angiomyolipoma

Subependymal Giant Cell Astrocytoma (SEGA)

Advanced or progressive meningioma (off-label or trial)

Indication Typical Dose Notes
RCC, Breast Cancer, NETs 10 mg once daily With or without food
TSC (SEGA, Angiomyolipoma) Dose based on body surface area (BSA) Adjusted via blood levels
Transplant (non-Afinitor brand) Lower dose (0.75–1 mg BID) Immunosuppressive role

Administration: Swallow tablets whole with water. Do not crush or chew.

Monitoring: Blood everolimus levels (esp. in TSC), renal and hepatic function, lipid profile
Route of Administration: Oral

Pregnancy Category: Category D – Not recommended; may cause fetal harm

Pediatric Use: Approved for TSC-related indications

Geriatric Use: No specific dose adjustment required, but monitor organ function

Mouth ulcers (stomatitis)
Fatigue
Rash
Diarrhea
Cough
Edema

Infections (respiratory, urinary)
Non-infectious pneumonitis

Renal impairment

Hyperglycemia, hyperlipidemia

Myelosuppression (anemia, leukopenia)

Impaired wound healing

Monitoring Required:

CBC (complete blood count)

Fasting glucose, lipids

Renal and liver function

Pulmonary symptoms
Infections: Increased risk of opportunistic infections; monitor closely

Wound healing complications: Avoid use around surgical periods

Lung toxicity: Non-infectious pneumonitis requires dose reduction or discontinuation

Avoid live vaccines during treatment

Hepatic impairment: Dose reduction recommended

Drug levels monitoring required in TSC
CYP3A4 and P-gp Substrate – Use Caution With:

Inhibitors (↑ Afinitor levels):

Ketoconazole, Clarithromycin, Ritonavir, Verapamil

Inducers (↓ Afinitor levels):

Rifampicin, Carbamazepine, Phenytoin, St John's Wort

Other Interactions:

Live vaccines: Avoid due to immunosuppression

ACE inhibitors: Increased risk of angioedema

NSAIDs and nephrotoxic drugs: Use with caution
A study published in Cancer Chemotherapy and Pharmacology (2010) demonstrated that CYP3A4 inhibitors significantly increase everolimus levels, warranting dose adjustments or substitution.

Store at 20–25°C (68–77°F)

Keep in original packaging to protect from moisture and light

Keep out of reach of children

Frequently Asked Questions (FAQs):
Q1: What is Afinitor used for?
Afinitor is used to treat advanced cancers (kidney, breast, neuroendocrine tumors) and non-cancer conditions like tuberous sclerosis complex (TSC).

Q2: Is Afinitor chemotherapy?
No. It is a targeted therapy that inhibits the mTOR pathway but is not classified as traditional chemotherapy.

Q3: Can Afinitor be used in children?
Yes, for TSC-associated SEGA and angiomyolipoma in children over 1 year (dose is weight/BSA-based).

Q4: Can Afinitor cause lung problems?
Yes. It can cause non-infectious pneumonitis, presenting as cough or shortness of breath. Inform your doctor immediately if these occur.

Q5: How long can I take Afinitor?
Duration depends on your condition and response. In cancer, it is continued until disease progression or unacceptable toxicity.

Q6: Can Afinitor affect fertility?
Yes. It may impair female and male fertility. Discuss fertility preservation if applicable before starting therapy.

Clinical References:
Motzer RJ et al. – Everolimus for advanced RCC (NEJM, 2008)

Baselga J et al. – Everolimus plus exemestane in advanced breast cancer (NEJM, 2012)

Franz DN et al. – Everolimus in SEGA associated with TSC (Lancet, 2013)

FDA Prescribing Information – Afinitor

ClinicalTrials.gov – Everolimus trials and real-world data

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