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Azel (Enzalutamide 40mg)

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AZEL 40MG

Description

Azel 40mg tablets are majorly indicated for prostate carcinoma, which contains Enzalutamide, as an active component considered as non-steroidal anti-androgen medication.

Azel 40mg is a prescription medicine, which can be used under the guidance of medical practitioners.

Azel 40mg tablet indication

The primary usage of Azel 40mg tablet is contained in the specific treatment of metastatic castration-resistant prostate cancer (mCRPC), taken orally.

The anti-androgen effect exhibits by obstruct the testosterone production by interfering with androgen synthesis, the hormone which is responsible for tumor cell growth.

Azel 40mg is majorly used to treat prostate cancer in men.

Dosing conditions of Azel 40mg

The usual prescribed dosage of Azel is 160mg as a single dose by taking with or without food.

Azel is available in the strength of 40mg; four tablets of Azel should be administered at the same time.

Azel tablet should not crush, not chew taken with a glass of water.

Dose adjustment

In patients with ≥ grade III toxicity:  Azel 40mg therapy should be refused for one week or the symptoms should be reduced to grade II, then restart with the same dose or decreased to 80mg or 120mg

Strong CYP2C8 inhibitors: While combining with Azel tablet, the dosage should be modified by reducing to 80mg as a single dose or avoid this combination.

Strong CYP3A4 inducers: Co-administration of Azel with Strong CYP3A4 inducers, the dosage of Azel tablet increased up to 240mg or stop this combination.

Azel 40mg overdosage

In the case of over dosage of Azel tablets, causes severe seizures.

If over dosage is occurring, immediately stop the therapy and maintain the safety measures.

In dose acceleration study, a seizure does not occur at ≤ 240mg daily.

Seizures may report in the dose of 360mg, 480mg & 600mg at high risk

Azel 40mg works as

Prostate carcinoma is developed by using male hormone known as androgen.

Testosterone is one of the major hormones secreted by testes and adrenal glands

Azel containing Enzalutamide will interfere with testosterone production, causes tumor cell growth depletion.

Azel interfere with androgen receptor signaling transduction and leads to cancer cell lysis

Azel 40mg ADME properties

Absorption

After receiving 160mg of Azel for mCRPC, from median time to attain peak plasma concentration time at 1 hour (variation with 0.5 to 3 hours).

Food does not cause any alteration in the absorption of Azel tablets.

Distribution

Maximum plasma protein bounding capacity of Azel tablets is occurring as 97% to 98%

Metabolism

Two most prominent cytochrome isoenzymes are involved in the metabolism of Azel tablets;

The isoenzymes like CYP2C8 & CYP3A4; whereas CYP2C8 is essential for the production of N-desmethyl Enzalutamide which is an active metabolite of Enzalutamide.

Excretion

Azel tablets go through elimination by hepatic metabolism

Major route of elimination;

71% in urine; 14% in feces

The terminal half-life period of Azel tablets 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.

Azel 40mg causes some side effects

Some side effects during the therapy using with Azel,

Hypertension & hot flush, Dizziness, headache, Asthenia conditions, Peripheral edema, Spinal cord compression, paresthesia, Mental impairment, Hypesthesia, Respiratory tract infections, Hematuria, Pollakiuria, Dry skin, Back pain, Arthralgia, Muscular weakness, pain, Diarrhea, Pruritus, Neutropenia, Thrombocytopenia, Increasing bilirubin level, Epistaxis, Infections like sepsis, Fall associated injuries like fractures, joint injury, and hematomas, Hallucinations.

Azel 40mg contraindication occurs as

Azel tablets 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 Azel tablets.

Azel 40mg storage conditions

Azel tablet container should be stored at the temperature of 20oC to 25oC (68oF to 77oF).

Keep the container in cool and dry place

Protect from light.

Azel 40mg warning and precautions

During the treatment with Azel tablets, patient may suffer with some adverse effects like;

Posterior reversible encephalopathy syndrome

Seizures

In PRES, some neurological disorders occur in patients. It may overcome by providing safety measures or discontinue the therapy as soon as possible.

PRES is recognized by using MRI

In seizures, patient must counsel about this adverse reaction before starting the therapy. Stop the therapy if possible.

Spermatogenesis occurs which may interfere with male fertility leads to hypo spermatogenesis.

In androgen depletion therapy, may have increase exposure of cardiovascular disease like worsening hypertension.

Azel 40mg interact with some drugs like

Azel 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 Azel should be reduced to 80mg.

Azel with CYP2C8 strong inducers causes variation in plasma exposure of Azel, to minimize this problem to avoid this concomitant.

Co administration of Azel tablets 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 Azel tablets causes depletes the plasma exposure of Azel.

Moderate CYP3A4 inducers like Bosentan, efavirenz, modafinil, st Johns wort causes decreasing the plasma concentration of Azel tablet.

Azel tablets are strong CYP3A4 inducers and moderate CYP2C8 & CYP2C19.

CYP3A4 strong inducers like Midazolam, CYP2C8 inducers like warfarin, & CYP2C19 inducers like Omeprazole with Azel causes reducing the plasma risk of Midazolam, warfarin & Omeprazole.

Azel 40mg specifically used in

Pregnancy

Pregnancy category of Azel tablet is D

Azel is contraindicated to pregnancy; it may cause fetal harm even to death.

Lactation

Breast feeding is not suggested, Azel is contraindicated in lactation

Azel 40mg missed dose

Azel 40mg is a chem. Drug, used in prostate cancer. Azel tablet should not be self-medicated, used by the patients only after getting advice from the medical oncologist.

If patient missed a dose, 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 the missed dose should be avoid and follow the regular schedule.

  • Trade name Azel
  • Substance Enzalutamide 40mg
  • Manufacturer Dr. Reddy's Laboratories
  • Packaging 28 tablets
  • Country of origin India
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