Evertor - 10mg



Indication of Evertor


Primarily Evertor 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.


Dosage regimen of Evertor


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.


Dosage and administration


Evertor tablets should be given with or without food.



Evertor drug profile


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

Pharmacokinetics


Absorption :
The maximium 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 process; • 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.

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 reduce 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

Safety measures


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


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

Food drug interaction


Grape fruit juice may increase the levels of blood and effect of Everolimus. Interaction of Orange fruit is not correctly

Pregnancy and lactation


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

Storage and handling


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

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 .



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


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.


Contraindication


If patients are contraindicated to the components present in the Evertor tablets. Some anaphylactic reaction occurs.


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