Bdenza is a hormonal therapy, for men who are all affected with prostate carcinoma in metastatic stage. Bdenza 40mg capsules are majorly indicated for prostate carcinoma, which contains Enzalutamide, as an active component considered as non steroidal anti-androgen medication. Bdenza 40mg is involved in association with castration in the therapy of metastatic or long lasting castration resistant prostate cancer. Bdenza 40mg is a prescription medicine, the main ingredient which is used as enzalutamide, only prescribed by medical oncologist.
DOSING CONDITIONS AND ADMINISTRATION
The usual prescribed dosage of Bdenza is 160mg as a single dose by taking with or without food. Bdenza is available in the strength of 40mg; four capsules of Bdenza should be administered at a same time. Bdenza capsule should not crush, not chew taken with glass of water. Dose adjustment: In patients with ≥ grade III toxicity: Bdenza 40mg therapy should be refuse for one week or the symptoms should be reduced to grade II, then restart with same dose or decreased to 80mg or 120mg Strong CYP2C8 inhibitors: While combining with Bdenza capsule, the dosage should be modified by reducing to 80mg as a single dose or avoid this combination. Strong CYP3A4 inducers: Co administration of Bdenza with Strong CYP3A4 inducers, the dosage of Bdenza capsule increased up to 240mg or stop this combination.
PHARMACOKINETICS
Absorption:
After receiving 160mg of Bdenza for mCRPC, from median time to attain peak plasma concentration time at 1 hour (variation with 0.5 to 3 hours). The steady state level of Bdenza is accomplished by day 28 Food does not cause any alteration in absorption of Bdenza capsules.
Distribution:
Volume of distribution 110L High plasma protein bounding capacity of Bdenza capsules is occurs as 97% to 98%
Metabolism:
Two most prominent cytochrome isoenzymes are involved in metabolism of Bdenza capsules; There are two isoenzymes i.e CYP2C8 & CYP3A4; in which CYP2C8 is vital for production of N-desmethyl Enzalutamide which is an active metabolite of Enzalutamide.
Excretion:
Bdenza capsules undergoes excretion by hepatic metabolism Major route of elimination; 71% in urine; 14% in feces The terminal half life period of Bdenza capsules is 5.8 days (range at 2.8 to 10.2 days); N-desmethyl Enzalutamide has half life period of relatively 7.8 to 8.6 days.
After receiving 160mg of Bdenza for mCRPC, from median time to attain peak plasma concentration time at 1 hour (variation with 0.5 to 3 hours). The steady state level of Bdenza is accomplished by day 28 Food does not cause any alteration in absorption of Bdenza capsules.
Distribution:
Volume of distribution 110L High plasma protein bounding capacity of Bdenza capsules is occurs as 97% to 98%
Metabolism:
Two most prominent cytochrome isoenzymes are involved in metabolism of Bdenza capsules; There are two isoenzymes i.e CYP2C8 & CYP3A4; in which CYP2C8 is vital for production of N-desmethyl Enzalutamide which is an active metabolite of Enzalutamide.
Excretion:
Bdenza capsules undergoes excretion by hepatic metabolism Major route of elimination; 71% in urine; 14% in feces The terminal half life period of Bdenza capsules is 5.8 days (range at 2.8 to 10.2 days); N-desmethyl Enzalutamide has half life period of relatively 7.8 to 8.6 days.
MECHANISM
An androgen which is a male hormone is used to develop prostate carcinoma. One of the major hormone secreted by testes and adrenal glands is known as testosterone. Bdenza containing Enzalutamide will interfere with testosterone production, causes tumor cell growth depletion. Bdenza interfere with androgen receptor signaling transduction and leads to cancer cell lysis
DISTINCTLY IN
Pregnancy :
Pregnancy category of Bdenza capsule is D Bdenza is contraindicated to pregnancy; it may cause fetal harm even to death.
Lactation :
Breast feeding is not suggested, Bdenza is contraindicated in lactation.
Pregnancy category of Bdenza capsule is D Bdenza is contraindicated to pregnancy; it may cause fetal harm even to death.
Lactation :
Breast feeding is not suggested, Bdenza is contraindicated in lactation.
WARNING AND PRECAUTIONS
During the treatment with Bdenza capsules, patient may suffer with some adverse effects like; Posterior reversible encephalopathy syndrome Seizures In PRES, some neurological disorders occur in patients. The condition can recovered by providing safety measures or discontinue the therapy as soon as possible. PRES is recognized by using MRI In seizures, Before starting the treatment patient must counsel about this adverse reaction and Stop the therapy if possible. Spermatogenesis occurs that may prohibit the male fertility leads to hypo spermatogenesis. In androgen decline the treatment, may have increase exposure of cardiovascular disease like worsening hypertension.
MISSED DOSE
Bdenza 40mg is a chem. Drug, used in prostate cancer. Bdenza capsule should not be self medicated, used by the patients only after getting advice from the medical oncologist. If a single dose missed by patient, then must consult with the physician and follow the instructions as per the guidance of medical adviser, the missed dose should be taken within a time or avoid the missed dose and follow the regular schedule.
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