ENZALUTAMIDE 40MG


Defines


Xtandi 40mg is a non steroidal anti-androgen drug; by inhibiting the androgen synthesis and expels anti-neoplastic activity against prostate tumor. Xtandi 40mg is an oral tablet form, which is endorsed by FDA. Enzalutamide is related with a reducing rate of serum enzyme increased during treatment, be that as it may, have not been connected to instances of clinically clear liver damage with jaundice.

Xtandi 40mg tablets are containing an active substance known as Enzalutamide, which has anti-tumor activity by exhibiting androgen receptor inhibitory activity.


Xtandi 40mg


The major clinical indication of Xtandi 40mg is involved in the treatment of long lasting or metastatic castration resistant prostate cancer patients who are not responding with docetaxel therapy.


Dosage management


Generally Xtandi is available in the strength of 40mg; the usual dose of Enzalutamide is 160mg taken as once a day. Four Xtandi 40mg tablets should be taken as such at whole. Xtandi 40mg tablets should be administered with or without food Do not chew, open or crush the capsules.




Xtandi 40mg pharmacokinetic properties


Absorption:
The maximum plasma concentration time of Enzalutamide is reaches within 1 hour The Cmax value of Enzalutamide and its metabolite are 16.6ng/ml & 12.7ng/ml respectively The steady state value is achieved in day 28 of Xtandi therapy.
Distribution:
The maximum plasma concentration time of Enzalutamide is reaches within 1 hour The Cmax value of Enzalutamide and its metabolite are 16.6ng/ml & 12.7ng/ml respectively The steady state value is achieved in day 28 of Xtandi therapy.
Metabolism:
Enzalutamide undergone hepatic metabolism, The two most important cytochrome isoenzymes like CYP2C8 & CYP3A4 are responsible for metabolism of Enzalutamide; whereas CYP2C8 is involved in the formation of active metabolite of Enzalutamide.
Elimination
The elimination of Enzalutamide is occurs by liver metabolism, whereas 71% excreted through urine; 14% in feces. The clearance value of Enzalutamide after a single dose intake is 0.56L/hr. The mean half life period of Enzalutamide is 5.8 days with approximately 2.8 to 10.2 days.

Dose alteration


If patient accomplished with toxicities with the grade of III, postpone the therapy using with Xtandi 40mg capsules until changed to grade II. Then continue with the same dose or dose will be reduced to 120mg or 80mg depending upon the condition of the patients.

In combination with strong CYP2C8 inhibitors, dosage altered as


Xtandi 40mg capsules, CYP2C8 inhibitors combination should be avoided if possible. Co administration of Xtandi 40mg capsules with strong CYP2C8 inhibitors, the dose of Xtandi should be decreased to 80mg as a single dose. After discontinuation of strong CYP2C8 inhibitors, the dose of Xtandi 40mg capsules should be used as such before the co administration starts.

Mechanism of action


Androgen is a male hormone; testosterone is a one of the hormone secreted from androgen which is responsible for growth of the tumor cells present in the prostate glands. Xtandi 40 mg tablets are comprises of Enzalutamide which acts by inhibiting the binding of androgen into androgen receptor site. This inhibition leads to interfere with signal transduction of receptors and causes growth retardation. The active metabolite of Enzalutamide is N-desmethyl Enzalutamide which is similar to parent form. Xtandi exhibits anti-neoplastic effect by reducing the cell proliferation leads to cell death and reduce the tumor cell volume.

Drug interaction occurs during therapy with Xtandi 40mg


A Xtandi 40mg capsule combines with strong CYP2C8 inducers or inhibitors; Co administration of Xtandi with strong CYP2C8 inhibitors causes elevation of Cmax and AUC (plasma concentration) of Enzalutamide, to avoid this problem during this concomitant reduce the dose of Xtandi to 80mg as a single dose. Co administration of Xtandi with CYP2C8 inducers causes variation in plasma exposure of Xtandi. Avoid this combination if required. Concurrent use of Xtandi tablet with CYP3A4 inhibitors, causes elevating the AUC of Enzalutamide. Concurrent use of Xtandi with strong CYP3A4 inducers causes decreasing the plasmaexposure of Xtandi. Avoid concurrent use of Xtandi with anti-convulsants, anti-mycobacterials, anti-virals, herbal product like st. Johns wort. Enzalutamide is considered as strong CYP3A4 inducer & moderate CYP2C9 & CYP2C19 inducers. Xtandi diminish the plasma exposure to Midazolam, Omeprazole, and warfarin. Concurrent use of Xtandi with drugs metabolized by CYP3A4 like cyclosporine, ergotamine, fentanyl, quinidine, sirolimus or Tacrolimus may leads to reduce their exposure. Avoid concomitant use of warfarin with Xtandi capsules.

Xtandi 40mg safety measures


The major adverse caused during the Xtandi capsules therapy is seizures. Due to avoid the severe problem , the Patient must be counsel with the risk of participating in any action where sudden loss of awareness could make genuine damage themselves or others

Storage


Xtandi capsules should be stored at 200C to 250 F Kept the drug in dry and cool place. Protect from light.

Pregnancy


The pregnancy category of Enzalutamide X, which means it, may cause fetal harm even to death. Xtandi 40mg should not be recommended in pregnancy conditions.

Pediatric


The potency and effectiveness of Xtandi 40mg capsules should not be evaluated in pediatric patients. In renal & hepatic damaged patients, the dosage adjustment of Xtandi capsules should not be suggested.

Lactation


Breast feeding should not be suggested.

Enzalutamide Side Effects


Peripheral edema, Back pain, Arthralgia, Musculoskeletal pain, Musculoskeletal stiffness, weakness, Diarrhea, Hot flush, Hypertension, Head ache, Dizziness, Mental impairment, Hypoesthesia, Respiratory tract infection, Insomnia, Anxiety, Hematuria, Pollakiuria, Fall associated injuries, Non pathogenic fractures, Pruritus, Dry skin, Epistaxis, Elevation of AST & ALT, Elevation of bilirubin, Sepsis, Hallucination.



Over dosage


In over dosage condition, seizure may expose largely in the patients who are suspected with over dose of Xtandi.


Contraindication


Xtandi is contraindicated in pregnancy condition, it may cause fetal damge.


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