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XTANDI 40MG TABLETS MECHANISM


Xtandi 40mg containing anti-androgen agent like Enzalutamide, it expels an anti-tumor activity in different steps. Xtandi tablets are interfere in androgen receptor signaling pathway, which prohibiting androgen binding to androgen receptors leads to androgen receptor nuclear translocation inhibition and interact with DNA. The major metabolite of Xtandi is N-desmethyl Enzalutamide which is similar to Enzalutamide activity. The anti-tumor activity of Xtandi is exposed by depleting the multiplication and persuades cell lysis in prostate cancer cells.


DOSAGE AND ADMINISTRATION

The usual recommended dosage of Xtandi is 160mg, but available strength of Xtandi is 40mg. Four tablets of Xtandi 40mg should be taken at a time as a single dose. Xtandi tablet should be administered with or without food.

Dosing alteration: In ≥ grade 3 toxicity or extreme side effects: Postpone the dose of Xtandi for 1 week or as far as symptoms progress to ≤ grade 2, continue at the same or reduced to 120mg or 80mg. Concurrent use with strong CYP2C8 inhibitors:

In case of combination with strong CYP2C8 inhibitors, diminish the dose of Xtandi to 80mg as a single dose. Concurrent use with strong CYP3A4 inducers: In case of combination with strong CYP3A4 inducers, increasing the dose of Xtandi 160mg to 240mg as a single dose.



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Brand : Xtandi
Ingredients : Enzalutamide
Strength : 40mg
Manufactured : Astellas Pharma Inc
Package : 28 Tablets

ADME PROPERTIES

After an oral administration of Xtandi 40mg tablets (160mg of dose), undergoes ADME process and exhibits activity. The peak plasma concentration time of Xtandi occurs at 1 hour with the range of 0.5 to 3 hours). The steady state of Xtandi occurs in day 28. The volume of distribution occur after single dose of Xtandi is 110L Xtandi has highly bounds to the human plasma protein with the range of 97 to 98%.

The major metabolite of Enzalutamide is N-desmethyl Enzalutamide has 95% bound to human plasma protein. The most important isoenzymes responsible for the metabolism of Enzalutamide are CYP2C8 & CYP3A4. CYP2C8 is involved in the formation of an active metabolite N-desmethyl Enzalutamide. Xtandi is majorly excreted through liver metabolism, 71% of metabolite present in urine and 14% in feces. The terminal half life period of Xtandi 40mg tablet is occurs after a single dose at 5.8days and N-desmethyl Enzalutamide is taken 7.8 to 8.6 days.

XTANDI 40MG TABLETS CAUSING SIDE EFFECTS

Asthenia Peripheral edema Back pain, arthralgia Musculoskeletal pain Muscular weakness Musculoskeletal stiffness Diarrhea Hot flush Hypertension Headache Dizziness Spinal cord compression Caude equine syndrome Paresthesia Mental disorders Hypoesthesia Respiratory tract infections Insomnia Anxiety Hematuria Pollakiuria Non pathologic fractures Pruritus Dry skin Epistaxis

XTANDI 40MG TABLETS SAFETY PRECAUTIONS

The major adverse effect during the therapy of Xtandi tablets are;

Seizure
Seizure may produce during the treatment with Xtandi tablets, if seizure occurs the treatment should be discontinued until seizure resolved. To avoid this condition, patient should be counsel about the problems occurred during the therapy before starting the treatment. Seizure may leads to loss of consciousness.

Posterior reversible encephalopathy syndrome PRES
Patient who are all taking Xtandi tablets acquired PRES, is a neurological problem produce symptoms like headache, lethargy, confusion, loss of vision, other neurological problems related with hypertension. PRES diagnosed by MRI. If patient acquired with PRES, discontinue the Xtandi therapy



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XTANDI 40MG TABLETS INTERACT WITH SOME OTHER DRUGS

Xtandi tablets concomitant with strong CYP2C8 inhibitors like gemfibrozil which may increase the plasma concentration time curve of Enzalutamide, so avoid this concomitant if possible. If required condition, the dose of Xtandi is reduced to 80mg. Xtandi tablet combined with CYP3A4 inducers, causes depletion of AUC of Enzalutamide and its active metabolite. CYP3A4 inducers like rifampicin, anti-convulsants, st. Johns wort. This combination should be avoided, in unavoidable condition the dose of Xtandi is increased up to 240mg. Xtandi with st. Johns wort causes depletion of Enzalutamide exposure.

Xtandi with CYP3A4 strong inducer, CYP2C9 & CYP2C19 moderate inducers; CYP3A4 strong inducer: Midazolam CYP2C9: warfarin CYP2C19: Omeprazole The concurrent use of Xtandi with these drugs may cause depletion of plasma exposure of these drugs. Drugs metabolized by CYP3A4 such as cyclosporine, dihydroergotamine, fentanyl, pimozide, quinidine, sirolimus etc combined with Xtandi causes decreasing the exposure of these drugs.






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