Drug Profile

Afinitor 10mg consist of an active ingredient known as Everolimus which is intrude with growth of cancer cell and process is slows down. Afinitor 10mg tablets is not a curable medication, which is helps to slow their spreading in to the body.


Primarily Afinitor 10mg tablets indicated for the treatment
* kidney carcinoma
* Breast carcinoma
* Brain carcinoma
Everolimus is also indicated in various advanced stage cancer in stomach, intestines or pancreas.


Everolimus is an inhibitor of mTOR, joins at high compatibility to FK506 binding protein 12, via producing drug complex that inhibits the productive of mTOR.
This inhibition reduces the activity of effectors downstream, which may lead to stoppage of cell progression from G1 into S phase, finally causes cell growth arrest and apoptosis


Absorption :
The maximum plasma concentration time of Everolimus reaches within 1 to 2 hours.
Distribution :
Albumin human plasma protein bound of 74%.
Metabolism :
In hepatic Everolimus metabolism is occurred, which is a substrate of CYP3A4.
The metabolites of Everolimus in 3 processes;
• Three monohydroxylated metabolite,
• Two hydrolytic rings opened products,
• Phosphatidylcholine conjugate of Everolimus.
Half-life period of Everolimus is 30 hours
The elimination primarily via 5% in urine; the parent compound has been detected in urine or feces.

Dosage and administration

Afinitor 10mg tablets should be given with or without food.
Dosage regimen of Afinitor 10mg;
In breast cancer, renal cell cancer, pancreatic cancer, Neuro endocrine cancer:
The prescribed dosage is 10mg should be taken as a single dose.
In Brain or intracranial cancer:
The prescribed dosage of Afinitor as a single dose. is 4.5mg/m2 given orally
In pediatric:
The pediatric dosage of Afinitor as a single dose in brain or intracranial tumor is 4.5mg/m2 should be given orally.


Developed hazard of skin cancers, patient may protect from UV light
Serious infections:
Patients getting Afinitor 10mg have severe risk of achieve various infections related to bacteria, virus, and fungi.
Hepatic artery thrombosis :
Afinitor 10mg therapy should not be recommended in in liver transplant patients
Nephrotoxicity :
While using Afinitor 10mg in renal impaired patients Renal function should be monitored frequently; drug use with caution
Angioedema :
While patients receiving concomitantly Afinitor 10mg with Angiotensin converting enzyme agents will cause angioedema
Interstitial lung disease:
In Afinitor 10mg therapy interstitial lung disease occur
Blood glucose level should be monitored
Embryo fetal toxicity:
Using Afinitor 10mg in pregnancy condition Causes fetal damage
Hereditary disorders:
While using Afinitor the conditions occurs like galactose intolerance, glucose-galactose malabsorption, Afinitor 10mg should not be used may results in diarrhea & malabsorption.
Grape juice interaction:
Avoid these concomitant use with grape juice Causes increasing blood levels of Everolimus.

Drug interaction

Afinitor 10mg interaction with strong inhibitor of CYP3A4, or P-g p, cause reducing the efflux of Everolimus and high plasma concentration of Everolimus.
Interaction of Afinitor 10mg with strong CYP3A4 inducers, will increasing the disclosure of Everolimus.
Combination of Afinitor 10mg with cyclosporine will increasing the AUC level of Everolimus frequently.
Combination ketoconazole with Afinitor 10mg tablet or other CYP3A4 inhibitors will increasing the plasma concentration and AUC of Everolimus.
Concomitant use of Afinitor 10mg with verapamil leads to increasing the plasma concentration of Everolimus.
Concomitant use of Afinitor 10mg with Atorvastatin or pravastatin leads to rhabdomyolysis, due to increasing concentration of lipid lowering agents.
Afinitor 10mg interaction with rifampicin will decreasing the AUC of Everolimus


Afinitor 10mg tablet store at 25oC
Store the medicine away from moisture, heat and light

Missed Dose

In case of missed dose, patients must consult with medical practitioner and follow the instructions given by them.
Thereby missed dose should be avoid and follow the regular dosing schedule.

side effects

Hypersensitivity reactions, Lymphomas & other malignancy, Serious infections, Kidney graft thrombosis, Hepatic artery thrombosis, Nephrotoxicity, Hyperlipemia, Angioedema, Interstitial lung disease, Thrombocytopenia, Male infertility, Proteinuria, New commencement of diabetes .

Pregnancy and lactation

Pregnancy category of Everolimus C
In patients Afinitor 10mg is used only after knowing the benefits to the mother exceed the risk to fetus.
Breast feeding should not be suggested

Over Dosage

The over dosage of Everolimus is limited, If over dosage occurs patient must be provide with supportive measures. And monitor evidence of toxicity in Everolimus over dosage

Possible Contraindication

If patients are contraindicated to the components present in the Afinitor 10mg tablets. Some anaphylactic reaction occurs.

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