EVEROLIMUS 10MG

Afinitor 10mg containing an active ingredient known as Everolimus which is intercedes with cancer cell growth and slows down its process. Afinitor 10mg tablets are not used as curable medicine, which is used to slow their spreading in to the body.

Everolimus

10mg

10 tablets in a strip




Afinitor 10mg PRESCRIBING INFORMATION

Afinitor 10mg tablets are mainly indicated in:

Renal carcinoma Breast carcinoma Brain carcinoma Everolimus is also used in various advanced stage cancer in stomach, intestines or pancreas.

Afinitor 10mg MECHANISM

Everolimus is an mTOR prohibitor, binds at high compatibility to FK506 binding protein 12, through producing drug complex that prohibits the effective of mTOR.

This prohibition decrease the activity of effectors downstream, which may causes blockage of cell progression from G1 into S phase, subsequently causes cell growth arrest and apoptosis



Pharmacokinetic

The peak plasma concentration time of Everolimus reaches within 1 to 2 hours. The effect of food with Afinitor 10mg is given below; With heavy meal: Reduction of systemic exposure to Afinitor 10mg 10mg, and the peak blood plasma concentration by 54%.

The blood plasma ratio of Afinitor 10mg with the range of 5 to 5000mg/ml is 17% to 73%.Afinitor 10mg human plasma protein bound with the range of 74%.

The metabolism of Everolimus is occurred in liver, which is a substrate of CYP3A4. The metabolites of Everolimus; Three monohydroxylated metabolite, Two hydrolytic rings opened products, & Phosphatidylcholine conjugate of Everolimus.

The terminal half-life period of Everolimus is relatively 30 hours The major route of elimination; 5% in urine; the parent compound has been detected in urine or feces.




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everolimus-10-mg

Ingredients Everolimus
Strength 10mg
Pack 10 tablets in a strip
Rating

DOSAGE REGIMEN AND ADMINISTRATION OF AFINITOR

In breast cancer, renal cell cancer, pancreatic cancer, Neuro endocrine cancer: The recommended dosage is 10mg should be taken as a single dose.

In Brain or intracranial cancer:
The recommended dosage of Afinitor is 4.5mg/m2 orally as a single dose.

In pediatric:
The usual pediatric dosage of Afinitor in brain or intracranial tumor is 4.5mg/m2 should be taken orally as a single dose. Afinitor tablets should be administered with or without food.

Afinitor 10mg CAUSED 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

SAFETY MEASURES

Lymphomas:
Increased exposure of skin cancers, patient may protect from UV light

Serious infections:
Patients receiving Afinitor 10mg have high risk of acquiring various infections related to bacteria, virus, and fungi. Anti-microbial agents are preferred for the suspected patients.

Hepatic artery thrombosis:
In liver transplant patients, Afinitor 10mg therapy should not be recommended.

Nephrotoxicity:
Renal function should be monitored frequently; caution should be taken while using Afinitor 10mg in renal impaired patients.

Angioedema:
This may have occurred in the patients receiving concomitantly Afinitor 10mg with Angiotensin converting enzyme agents

Hyperlipidaemia:
Patient getting Afinitor 10mg with lipid lowering drugs causes increasing in plasma concentration of these drugs causes hyperlipidaemia

Interstitial lung disease:
Occurred in Afinitor 10mg therapy

Thrombocytopenia:
Using Afinitor 10mg with cyclosporine causes thrombocytopenia

Outbreak of diabetes:
Blood glucose level should be monitored

Embryo fetal toxicity:
Causes fetal damage using Afinitor 10mg in pregnancy condition

Immunization:
Using live vaccines in Afinitor 10mg therapy

Hereditary disorders:
In the conditions like galactose intolerance, glucose-galactose malabsorption, Afinitor 10mg should not be used may results in diarrhea & malabsorption.

Interact with grape juice:
Causes increasing blood levels of Everolimus; avoid these concomitants.

DRUG – DRUG INTERACTION

  • Afinitor 10mg is metabolized hepatically, a substrate of CYP3A4.
  • Afinitor 10mg combined with strong inhibitor of CYP3A4, or P-gp, leads to cause decreasing the efflux of Everolimus and increase the plasma concentration of Everolimus.
  • Afinitor 10mg with strong CYP3A4 inducers, causes increasing the exposure of Everolimus.
  • Co administration of Afinitor 10mg with cyclosporine causes increasing the AUC level of Everolimus frequently.
  • Afinitor 10mg tablet is combined with ketaconazole or other CYP3A4 inhibitors causes increasing the plasma concentration and AUC of Everolimus.
  • Concomitant of Afinitor 10mg with erythromycin causes increasing in AUC of Everolimus.
  • Co administration of Afinitor 10mg with verapamil leads to increasing the plasma concentration of Everolimus.
  • Co administration of Afinitor 10mg with Atorvastatin or pravastatin causes rhabdomyolysis, due to increasing concentration of lipid lowering agents.

Contraindications


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



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

Afinitor 10mg tablet should be kept at 25°C Keep the tablet away from moisture, heat and light

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

The over dosage of Everolimus is rarely occur, in case of over dosage patient must be provide with supportive measures. The acute toxicity of Everolimus over dosage should be monitored.

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