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glenza-40mg

PRODUCT DETAILS

Brand name : Glenza
Active ingredient : Enzalutamide
Strength :40MG
COMPANY NAME : Glenmark
TAB COUNT : 28 tablets

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Glenza is a hormonal therapy, for men who are all affected with prostate carcinoma in metastaic stage. Glenza 40mg Capsuless are majorly indicated for prostate carcinoma, which contains Enzalutamide, as an active component considered as non steroidal anti-androgen medication. Glenza 40mg is involved in association with castration in the therapy of metastatic or long lasting castration resistant prostate cancer. Glenza 40mg is a prescription medicine, the main ingredient which is used as enzalutamide, only prescribed by medical oncologist.

CAPSULES INDICATIONS

The primary usage of Glenza 40mg Capsules is involved in the effective treatment of mCRPC (metastatic castration resistant prostate cancer), taken orally. The effect of anti-androgen viewing by obstruct the testosterone production by inhibiting androgen synthesis, the hormone which is require for cancer cell growth. Glenza 40mg is majorly used to treat prostate cancer in men.

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. Glenza containing Enzalutamide will interfere with testosterone production, causes tumor cell growth depletion. Glenza interfere with androgen receptor signaling transduction and leads to cancer cell lysis

PHARMACOKINETICS

Absorption:
After receiving 160mg of Glenza 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 Glenza is accomplished by day 28 Food does not cause any alteration in absorption of Glenza Capsuless.
Distribution:
Volume of distribution 110L High plasma protein bounding capacity of Glenza Capsuless is occurs as 97% to 98%
Metabolism:
Two most prominent cytochrome isoenzymes are involved in metabolism of Glenza Capsuless; 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:
Glenza Capsuless undergoes excretion by hepatic metabolism Major route of elimination; 71% in urine; 14% in feces The terminal half life period of Glenza Capsuless 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.

DOSAGE

DOSING CONDITIONS AND ADMINISTRATION
The usual prescribed dosage of Glenza is 160mg as a single dose by taking with or without food. Glenza is available in the strength of 40mg; four Capsuless of Glenza should be administered at a same time. Glenza Capsules should not crush, not chew taken with glass of water. Dose adjustment: In patients with ≥ grade III toxicity: Glenza 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 Glenza Capsules, the dosage should be modified by reducing to 80mg as a single dose or avoid this combination. Strong CYP3A4 inducers: Co administration of Glenza with Strong CYP3A4 inducers, the dosage of Glenza Capsules increased up to 240mg or stop this combination.

WARNING AND PRECAUTIONS

During the treatment with Glenza Capsuless, 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.

DRUG INTEACTION

Glenza combined with CYP2C8 strong inhibitors, causes elevation of plasma concentration time curve of Enzalutamide and its active metabolite. So avoid this combination, otherwise dosage of Glenza should be reduced to 80mg. Glenza with CYP2C8 strong inducers causes variation in plasma exposure of Glenza, to minimize this problem to avoid this concomitant. Co administration of Glenza Capsuless with strong inhibitors or CYP3A4, leads to elevate the AUC of Enzalutamide and its metabolite. CYP3A4 strong inducers example like; phenytoin, Phenobarbital, carbamazepine etc combines with Glenza Capsuless causes depletes the plasma exposure of Glenza. Moderate CYP3A4 inducers like Bosentan, efavirenz, modafinil, st Johns wort causes decreasing the plasma concentration of Glenza Capsules. Glenza Capsuless are strong CYP3A4 inducers and moderate CYP2C8 & CYP2C19. CYP3A4 strong inducers like Midazolam, CYP2C8 inducers like warfarin, & CYP2C19 inducers like Omeprazole with Glenza causes reducing the plasma risk of Midazolam, warfarin & Omeprazole.

MISSED DOSE

Glenza 40mg is a chem. Drug, used in prostate cancer. Glenza Capsules 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.

CONTRAINDICATION

Glenza Capsuless are contraindicated to pregnancy condition, which may cause fetal harm leads to death. An Anaphylactic reaction happens, if patients are contraindicated to the ingredient present in Glenza Capsuless.

SIDE EFFECTS

Some side effects during the therapy using with Glenza; Back pain, Arthralgia, Muscular weakness, pain, Diarrhea, Hypertension & hot flush, Dizziness, headache, Asthenia conditions, Peripheral edema, Spinal cord compression, paresthesia, Mental impairment, Hypesthesia, Respiratory tract infections, Hematuria, Pollakiuria, Dry skin, Pruritus, Neutropenia, Thrombocytopenia, Increasing bilirubin level, Epistaxis, Infections like sepsis, Fractures, joint injury, and hematomas (Fall associated injuries). Hallucinations .

Lactation

Breast feeding is not suggested, Glenza is contraindicated in lactation

STORAGE

Glenza Capsules container should be stored at the temperature of 20℃ to 25℃ (68℉ to 77℉). Keep the container in cool and dry place Protect from light.

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