AFINITOR (EVEROLIMUS)

Afinitor is a brand name for a generic drug called Everolimus. It is a prescription antineoplastic medication that got FDA approval for the treatment of patients suffering from advanced breast or kidney cancer or certain types of brain tumors. Doctors even recommend this medication to treat certain types of progressive or advanced tumors of the intestine, pancreas, or stomach; seizures, or benign tumors of the brain or kidney in patients having a genetic condition called tuberous sclerosis complex.

Afinitor tablets contain Everolimus as the active ingredient and the following inactive ingredients: butylated hydroxytoluene, anhydrous lactose, lactose monohydrate, crospovidone, magnesium stearate, and Hypromellose. Everolimus is chemically designated as (1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26E,28E,30S,32S,35R)-1,18- dihydroxy-12-{(1R)-2-[(1S,3R,4R)-4-(2-hydroxyethoxy)-3-methoxycyclohexyl]-1-methylethyl}-19,30-dimethoxy15,17,21,23,29,35-hexamethyl-11,36-dioxa-4-aza-tricyclo[30.3.1.04,9]hexatriaconta-16,24,26,28-tetraene-2,3,10,14,20pentaone.

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Afinitor belongs to the pharmacological class: Antineoplastic mTOR Kinase Inhibitors. Antineoplastic mTOR (Mammalian target of rapamycin) kinase inhibitors are the class of medications that can treat advanced renal cell carcinoma, breast cancer, subependymal giant cell astrocytoma (a type of brain tumor), and seizures. This drug class can even prevent transplant rejection in patients who have had liver or kidney transplants.

mTOR kinase inhibitors bind to FKBP 12, an intercellular protein, and the resulting protein-drug complex causes inhibition of mTOR activity. mTOR activity is to regulate growth factors that stimulate cell growth and control cell division as well as angiogenesis. As a result, there is G1 growth arrest in tumor cells, thus blocking the mTOR pathway, which is very active in certain cancerous cells.

Afinitor is an mTOR kinase inhibitor that can work to reduce the blood supply to the cancer cells and prevent their growth and reproduction. However, it cannot prevent the rejection of organ transplants by acting as an immunosuppressant, which only other brands can do.

Afinitor tablets come in 4 strengths: 2.5mg, 5mg, 7.5mg, and 10mg. These tablets are white to slightly yellow, elongated, and have beveled edges.

• 2.5mg: This strength tablet has “LCL” engraved on one side and “NVR” on the other side.
• 5mg: This strength tablet has “5” engraved on one side and “NVR” on the other side.
• 7.5mg: This strength tablet has “7P5” engraved on one side and “NVR” on the other side.
• 10mg: This strength tablet has “UHE” engraved on one side and “NVR” on the other side.

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Afinitor is given by doctors to treat the following medical conditions:

• Advanced hormone receptor-positive, HER 2-negative breast cancer: Afinitor in combination with exemestane can help treat postmenopausal women having this medical condition. Exemestane is taken when letrozole or anastrozole fails to treat the condition.
• Neuroendocrine tumors (NET): Afinitor can help treat adult patients with progressive neuroendocrine tumors of pancreatic origin (PNET) or progressive, well-differentiated, non-functional NET of gastrointestinal (GI) or lung origin that are unresectable, locally advanced, or metastatic disease.
• Advanced renal cell carcinoma: Afinitor can treat adults having advanced renal cell carcinoma when sorafenib and sunitinib medications fail.
• Tuberous Sclerosis Complex (TSC)- Associated Renal Angiomyolipoma: Afinitor can help treat adults with such conditions when they do not need immediate surgery.
• Tuberous Sclerosis Complex (TSC)- Associated Subependymal Giant Cell Astrocytoma (SEGA): Afinitor is taken by adults and pediatric patients aged a year and older with TSC for the treatment of subependymal giant cell astrocytoma that cannot be curatively resected instead needs a therapeutic intervention.

• The usual suggested dosage for an Afinitor regular tablet is 10 mg, at the same time once daily.
• For treatment of TSC-SEGA, the suggested starting dose is 4.5 mg once daily.
• The recommended dosage can be taken until the progression of the indicated medical condition or unacceptable toxicity.

Afinitor is available in the form of regular tablets meant for oral administration. These tablets can be taken with or without food. The medicine is absorbed in the blood so that it can target the affected area.

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Commonly reported side effects of taking Afinitor are:

• Mouth sores
• Nausea or Loss of appetite.
• Diarrhea or Constipation.
• Weight loss
• Cough, fever, infections, tiredness or weakness.
• Skin rash
• Swelling anywhere in the body.
• Headache
• Missed menses
• Hyperglycemia- signs include dry mouth, increased thirst and urination, and fruity odor of breath.

The serious or rarely reported side effects include:

• Ulcers or blisters in the mouth, swollen/red gums, and difficulty swallowing.
• Kidney problems
• Lung problems
• Signs of infection.
• Liver problems
• Low blood cell counts.
• Non-healing wounds.
• Signs of an allergic reaction.

This is not an exhaustive list of side effects. Talk to your doctor for medical advice if experiencing any unwanted effects of taking Afinitor.

Some of the drugs known to interact with Afinitor include:

• Antibiotics
• Antifungals
• Anti-seizure medications
• Medications to treat narcolepsy.
• Medication to treat tuberculosis.
• Heart or blood pressure medication.
• Medication to treat hepatitis C or HIV/AIDS.
• Drugs that weaken the immune system such as medications to prevent organ transplant rejection, steroids, and other antineoplastic agents.
• St John’s wort
• Aminoglutethimide
• Aprepitant
• Bosentan
• Conivaptan
• Dexamethasone
• Diclofenac
• Enoxacin
• Imatinib
• Isoniazid
• Phenylbutazone
• Antidepressants
• Barbiturates

Other drugs can interact with Afinitor and are not mentioned here. Therefore, you should inform your doctor about your current intake of drugs to ensure that Afinitor does not cause you harm with other drugs.

Afinitor is not safe for use by:

• Women who are pregnant or intend to get pregnant.
• Breastfeeding women
• Children under the age of 18 years.
• Anyone having known hypersensitivity to any of the ingredients of Afinitor tablet or other rapamycin derivatives.
• Patients who have or ever had kidney disease, liver disease (especially Hepatitis B), active or chronic infection, diabetes, hypertension, or hypercholesterolemia.
• Patients who are scheduled for a vaccine.

When taking Afinitor, it is important to watch for the following:

• Avoid scheduling for any live vaccine or coming in contact with anyone who has recently got a live vaccine.
• Avoid intake of grapefruit or its products.
• Do not use mouthwashes or apply medications containing iodine, alcohol, peroxide, or thyme, if having mouth sores because of taking Afinitor.
• Before starting the course of Afinitor, inform the doctor of any existing allergies or medical conditions, current intake of medications/supplements, whether pregnant or breastfeeding and other significant health-related facts.
• Do not make up for missed doses by doubling the dose.
• Do not take Afinitor if it is out of date, the tablets show signs of deterioration, or the package is torn.

• Store Afinitor tablets in their blistered pack at room temperature, preferably 15-30°C.
• Keep it away from light, moisture, heat, and small children.

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