Glenza

Brand name: Glenza Active substance: Enzalutamide Strength: 40Mg Mfg: Glenmark Pack: 28 capsules in blister X 4 blisters Categorized: Anti-neoplastic agent read more

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Drug profile of Glenza

Glenza capsules are containing active substance known as Enzalutamide which is against neoplastic agent, which is most usually utilized item affirmed by FDA.

Enzalutamide is a hormonal treatment which generally utilized as a part of men, which may targets androgen creating testosterone in charge of development.

Glenza containers are extraordinarily utilized as a part of conjunction with maiming in the treatment of cutting edge prostate growth

Glenza are not self pharmaceutical, it is medicine utilize just under the supervision of therapeutic oncologist.

Glenza comprising Enzalutamide is sorted as second generation of non steroidal hostile to androgenic operator.

Glenza is pharmacologically classified as;

Anti-neoplastic agent

Anti-androgenic agent

Prescribing information of Glenza

The most common indication of Glenza in adults is;

 Advanced or metastatic castration resistance prostate cancer.

Mechanism of Glenza

Glenza an Enzalutamide product which is named androgen receptor inhibitor follows up on various advances associated with androgen receptors flag transduction.

Enzalutamide meddle with the official of androgen into androgen receptors by disallowing the flagging transduction of androgen receptors.

This may discourage the androgen receptor atomic translocation and corresponding activity with DNA.

This flagging pathway is basic for cell division, Glenza has engaged with;

Decreasing prostate disease cell expansion

Actuate the cell passing of prostate growth cells

Loss of tumor volume

Absorption

The maximum plasma concentration of Glenza after administration occurs within 1 hour with the range of 0.5 to 3 hours.

The Cmax value of Enzalutamide and its metabolite like N-desmethyl Enzalutamide is 16.6ng/ml & 12.7ng/ml respectively.

The steady state reached by day 28.

Distribution

The apparent volume of distribution of Glenza is 110L.

Enzalutamide is largely bounds to human plasma protein with the range of 97% to 98%.

The active metabolite has large protein binding capacity like nearly 95%.

Metabolism

On oral administration of 160mg of Glenza, undergoes metabolism with the help of CYP2C8 & CYP3A4; whereas CYP2C8 is essential in production of N-desmethyl Enzalutamide.

Excretion

Enzalutamide is excreted by liver metabolism, nearly 71% of metabolite recovered in urine, 14% in feces.

The mean apparent creatinine clearance value 0.56L/hr with the range of 0.33 to 1.02L/hr.

The mean terminal half life of Glenza is relatively occurred in 7.8 to 8.6 days.

When to take the Glenza

There is no effect of food occur in Glenza therapy.

Glenza capsules should be administered with or without food.

Swallow the capsules whole with water, do not open the capsules or chew, crush.

Dosage regimens of Glenza

The dosing information of Glenza is given below as follows;

The prescribed dose of Glenza is 160mg (four capsules) should be administered orally as a single dose.

Dose variation occurs in Glenza treatment:

If patients suffered with toxicity with grade III, interrupt the Glenza capsules for one week or symptoms should be bettered to grade II, and then continue the Glenza capsules as same dose or in some condition the dose should be reduced to 80mg or 120mg if required.

In co administration of strong CYP2C8 inhibitors:

Glenza combined with potent CYP2C8 inhibitors, to avoid the complications the dose of Glenza should be decreased to 80mg as a single dose.

In case of stopping Coadminstration of Glenza with strong CYP2C8 inhibitors, thecontinue the Glenza dose used prior to commencement of strong CYP2C8 inhibitors.

In co administration of Glenza with strong CYP3A4 inducers:

If patients co administered Glenza with strong CYP3A4 inducers, then the dose of Glenza may increased to 160mg to 240mg as a once daily if tolerated.

In case of stopping Coadminstration of Glenza with strong CYP3A4 inducers, thecontinue the Glenza dose used prior to commencement of strong CYP3A4 inducers

Glenza caused side effects

The most undesirable adverse effects like;

Seizures

Posterior reversibly encephalopathy syndrome

The common side effects;

Asthenia

Peripheral edema

Spinal cord compression

Paresthesia

Mental impairment disorders

Hypoesthesia

Respiratory tract infection

 Insomnia

Anxiety

Hematuria

Pollakiuria

Fall

Non pathological fractures

Pruritus

Dry skin

Epistaxis

Back pain

Arthralgia

Musculoskeletal pain

Muscle weakness

Muscle stiffness

Diarrhea

Headache

Dizziness

Hypersensitivity reactions

Vomiting

Rash

Drug- drug interaction

Glenza combined with CYP2C8 inhibitor drugs, leads to increase the systemic exposure of Enzalutamide which may causes adverse effects.

To overcome this complication, reduce the dose of Glenza to 80mg as a single dose.

 

Glenza capsules are combined with CYP3A4 inducers, like rifampin leads to decrease the systemic exposure of Enzalutamide and causes loss of therapeutic effect of Glenza. To avoid this problem the dose of Glenza should be increased to 240mg as a single dose.

 

Drug which is metabolized by CYP3A4, CYP2C9 & CYP2C19 substrates, while combining these with Glenza;

Glenza with Midazolam (CYP3A4 substrate), Omeprazole (CYP2C19), or warfarin (CYP2C9) may leads to decrease the systemic exposure of these drugs.

Concurrent use of Glenza with drugs metabolized by CYP3A4 like alfentanil, cyclosporine, fentanyl, dihydroergotamine, sirolimus or Tacrolimus, CYP2C9 like phenytoin, warfarin or CYP2C19 like mephenytoin causes reduction of AUC of these drugs.

 

While combining Glenza with warfarin, should monitor the INR values frequently.

Food drug interaction

 There is no specific food drug interaction may occur, food does not causes any changes in absorption of Enzalutamide.

Glenza capsules should be administered with or without food.

Diet should be followed only after getting advice from medical oncologist.

Possible contraindications

Glenza is contraindicated to pregnancy & lactating women

Hypersensitivity reactions may occur due to patients may contraindicate to the component present in the Glenza capsules.

Safety measures

Seizures:

The most worsening condition that occurs during the Glenza therapy is seizures.

In this condition, treatment should be permanently stopped and patients should be provided with safety measures.

Advice the patients who are receiving the Glenza capsule about this adverse condition and counsel them.

The sudden loss of consciousness leads to severe condition.

In posterior reversibly encephalopathy syndrome:

PRES is occurred during the treatment with Glenza, symptoms like seizure, headache, lethargy, confusion, blindness, neurological & ocular disturbances may occur.

PRES is diagnosed by using brain imaging, especially MRI.

Discontinue the Glenza treatment while getting PRES in patients.

Pregnancy and lactation

Pregnancy category: X

Glenza should not be used in pregnancy condition

Glenza should not recommend for lactating women.

The potency of Enzalutamide should not be evaluated in pediatric patients.

In renal & hepatic impaired patients,

No dosage adjustment of Glenza should be suggested in mild & moderate renal damage patients, in severe condition CrCl <30ml/min or end stage has not been evaluated.

No dosage adjustment in mild, moderate or severe hepatic impairment patients.

Storage and handling

Glenza capsules container should be kept at 20oC to 25oC.

Keep the container in dry & cool place

Protect from light

Keep the container tightly closed

Missed dose

Missed dose of Glenza should be avoid

In case of missed dose, patient must get advice from medical practitioner

To overcome the problems related to missed dose, follow the regular dosing schedule

Over dosage

In case of over dosage, Glenza treatment should be stopped permanently and provide with supportive measures.

In dose escalation study, no seizures produce at ≤ 240mg, whereas seizure may occurs in the dose of 360mg, 480mg, & 600mg as a single dose.

Patients may occur with seizures for following doses.


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