Evertor - 5mg



Drug Profile


Evertor 5mg consist of an active ingredient known as Everolimus which is intrude with growth of cancer cell and process is slows down.
Evertor 5mg tablets is not a curable medication, which is helps to slow their spreading in to the body.


Indication


Primarily Evertor 5mg 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.

Mechanism


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 leads to stoppage of cell progression from G1 into S phase, Finally causes cell growth arrest and apoptosis



Pharmacokinetics


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.
Excretion:
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


Evertor 5mg tablets should be given with or without food.
Dosage regimen of Evertor 5mg;
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 Evertor as a single dose. is 4.5mg/m2 given orally
In pediatric:
The pediatric dosage of Evertor as a single dose in brain or intracranial tumor is 4.5mg/m2 should be given orally.

Precaution


Lymphomas :
Developed hazard of skin cancers, patient may protect from UV light
Serious infections :
Patients getting Evertor 5mg have severe risk of achieve various infections related to bacteria, virus, and fungi.
Hepatic artery thrombosis :
Evertor 5mg therapy should not be recommended in in liver transplant patients,
Nephrotoxicity :
While using Evertor 5mg in renal impaired patients Renal function should be monitored frequently; drug use with caution Angioedema
While patients receiving concomitantly Evertor 5mg with Angiotensin converting enzyme agents will cause angioedema
Interstitial lung disease:
In Evertor 5mg therapy interstitial lung disease occur
Blood glucose level should be monitored
Embryo fetal toxicity:
Using Evertor 5mg in pregnancy condition Causes fetal damage
Hereditary disorders:
While using Evertor the conditions occurs like galactose intolerance, glucose-galactose malabsorption, Evertor 5mg 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


Evertor 5mg interaction with strong inhibitor of CYP3A4, or P-g p, cause reducing the efflux of Everolimus and high plasma concentration of Everolimus.
Interaction of Evertor 5mg with strong CYP3A4 inducers, will increasing the disclosure of Everolimus.
Combination of Evertor 5mg with cyclosporine will increasing the AUC level of Everolimus frequently.
Combination ketoconazole with Evertor 5mg tablet or other CYP3A4 inhibitors will increasing the plasma concentration and AUC of Everolimus. Concomitant use of Evertor 5mg with verapamil leads to increasing the plasma concentration of Everolimus.
Concomitant use of Evertor 5mg with Atorvastatin or pravastatin leads to rhabdomyolysis, due to increasing concentration of lipid lowering agents.
Evertor 5mg interaction with rifampicin will decreasing the AUC of Everolimus

Storage


Evertor 5mg tablet store at 25oC
Store the medicine away from moisture, heat and light

Missed Dose


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

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 Evertor 5mg 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 Evertor 5mg tablets. Some anaphylactic reaction occurs.


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