Bdenza

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

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Drug profile of Bdenza

Bdenza capsules are containing dynamic substance known as Enzalutamide which is against neoplastic operator, which is most typically used thing confirmed by FDA.

Enzalutamide is a hormonal treatment which for the most part used in men, which may targets androgen making testosterone responsible for advancement.

Bdenza compartments are exceptionally used as a piece of conjunction with injuring in the treatment of bleeding edge prostate development

Bdenza are not self pharmaceutical, it is solution use simply under the supervision of remedial oncologist.

Bdenza including Enzalutamide is arranged as second generation of non steroidal anti androgenic administrator.

Bdenza is pharmacologically classified as;

Anti-neoplastic agent

Anti-androgenic agent

Prescribing information of Bdenza

The most common indication of Bdenza in adults is;

 Advanced or metastatic castration resistance prostate cancer.

Mechanism of Bdenza

Bdenza is Enzalutamide item which is named androgen receptor inhibitor lines up on different advances related with androgen receptors hail transduction.

Enzalutamide intrude with the authority of androgen into androgen receptors by forbidding the hailing transduction of androgen receptors.

This may debilitate the androgen receptor nuclear translocation and comparing action with DNA.

This hailing pathway is fundamental for cell division, Bdenza has connected with;

Diminishing prostate illness cell extension

Activate the cell going of prostate development cells

Loss of tumor volume

Absorption

The maximum plasma concentration of Bdenza 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 Bdenza 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 Bdenza, 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 Bdenza is relatively occurred in 7.8 to 8.6 days.

When to take the Bdenza

There is no effect of food occur in Bdenza therapy.

Bdenza 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 Bdenza

The dosing information of Bdenza is given below as follows;

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

Dose variation occurs in Bdenza treatment:

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

In co administration of Bdenza with strong CYP3A4 inducers:

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

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

In co administration of strong CYP2C8 inhibitors:

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

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

Bdenza caused side effects

The most undesirable adverse effects like;

Seizures

Posterior reversibly encephalopathy syndrome

The common side effects;

Non pathological fractures

Pruritus

Dry skin

Epistaxis

Back pain

Arthralgia

Musculoskeletal pain

Muscle weakness

Muscle stiffness

Diarrhea

Headache

Dizziness

Hypersensitivity reactions

Vomiting

Rash

Asthenia

Peripheral edema

Spinal cord compression

Paresthesia

Mental impairment disorders

Hypoesthesia

Respiratory tract infection

 Insomnia

Anxiety

Hematuria

Pollakiuria

Fall

Drug- drug interaction

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

 

Bdenza 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 Bdenza to 80mg as a single dose.

 

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

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

Concurrent use of Bdenza 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 Bdenza 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.

Bdenza capsules should be administered with or without food.

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

Possible contraindications

Bdenza is contraindicated to pregnancy & lactating women

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

Safety measures

Seizures:

The most worsening condition that occurs during the Bdenza 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 Bdenza 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 Bdenza, symptoms like seizure, headache, lethargy, confusion, blindness, neurological & ocular disturbances may occur.

PRES is diagnosed by using brain imaging, especially MRI.

Discontinue the Bdenza treatment while getting PRES in patients.

Pregnancy and lactation

Pregnancy category: X

Bdenza should not be used in pregnancy condition

Bdenza 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 Bdenza 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

Bdenza 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 Bdenza 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, Bdenza 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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