Inpoza 150 mg (Tablet)

Unit Price: ৳ 1,000.00 (6 x 10: ৳ 60,000.00)
Strip Price: ৳ 10,000.00

Medicine Details

Category Details
Generic Olaparib
Company Genvio pharma ltd

Title and Categories

  • Inpoza 400mg Capsule
  • Targeted Cancer Therapy

Dosage and Administration

  • Recommended dose: 400 mg taken orally twice daily
  • Swallow capsule whole, do not chew or open
  • Dosage modifications for adverse reactions

Indications

  • Treatment of adult patients with BRCA-mutated metastatic breast cancer
  • Indicated for platinum-sensitive relapsed high-grade ovarian, fallopian tube, or primary peritoneal cancer

Pharmacology

  • Inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes
  • Involved in DNA transcription, cell cycle regulation, and DNA repair
  • Rapid absorption with peak plasma concentrations achieved between 1 to 3 hours after dosing
  • Metabolism primarily by CYP3A4/5 enzymes
  • Terminal plasma half-life of 11.9 hours

Interaction

  • Potentiation and prolongation of myelosuppressive toxicity with anticancer agents
  • Drugs that may increase or decrease Inpoza plasma concentrations
  • Avoid concomitant use of strong and moderate CYP3A inhibitors or inducers

Contraindications

  • Hypersensitivity to the drug or any ingredient in the formulation

Side Effects

  • Common serious adverse reaction: anemia
  • Proportion of patients who permanently discontinued Inpoza due to adverse events

Pregnancy & Lactation

  • Can cause fetal harm when administered to a pregnant woman
  • Potential risk for loss of the pregnancy
  • Not known whether excreted in human milk

Precautions & Warnings

  • Incidence of Myelodysplastic Syndrome/Acute Myeloid Leukemia (1.5%)
  • Pneumonitis occurred in less than 1% of patients treated with Inpoza

Overdose Effects

  • No specific treatment in the event of Inpoza overdose
  • Physicians should follow general supportive measures and treat symptomatically

Pharmacokinetics

  • Rapid absorption with peak plasma concentrations achieved between 1 to 3 hours after dosing
  • Limited data suggest that the systemic exposure of Olaparib increases less than proportionally with dose over 100 to 400 mg

Metabolism

  • Primarily metabolized by CYP3A4/5 enzymes
  • Extent of metabolism with glucuronide or sulfate conjugation

Excretion

  • 86% of the dosed radioactivity was recovered within a 7-day collection period
  • Majority excreted via urine and feces

Dosage Modifications

  • For adverse reactions
  • For use with CYP3A inhibitors
  • For patients with renal impairment

Drug Classes

  • Targeted Cancer Therapy

Storage Conditions

  • Store in a dry place below 30°C
  • Protect from light
  • Keep out of the reach of children

Mode of Action

  • Inhibitor of PARP enzymes

Warnings

  • Pneumonitis occurred in less than 1% of patients treated with Inpoza

Precautions

  • Monitor complete blood count for cytopenia at baseline and monthly thereafter for clinically significant changes during treatment
  • Interrupt Inpoza and monitor blood counts weekly for prolonged hematological toxicities

Absorption

  • Rapid with peak plasma concentrations typically achieved between 1 to 3 hours after dosing

Distribution

  • Mean apparent volume of distribution at steady state of 167 ± 196 L after a single 400 mg dose

Metabolism & Excretion

  • Excreted primarily via urine and feces
  • Metabolized by CYP3A4/5 enzymes

Dosage Modifications for Adverse Reactions

  • Interrupt treatment or dose reduction

Dose Modifications for Use with CYP3A Inhibitors

  • Avoid concomitant use of strong and moderate CYP3A inhibitors
  • Reduce the Olaparib dose if co-administered with CYP3A inhibitors

Dose Modifications for Patients with Renal Impairment

  • Dose reduction for moderate renal impairment
  • Safety and efficacy not established in patients with severe renal impairment or end-stage renal disease

Pediatric Use

  • Safety and efficacy not established in pediatric patients

Drugs That May Increase Inpoza Plasma Concentrations

  • Co-administration of CYP3A inhibitors increased AUC of Inpoza
  • Avoid concomitant use of strong and moderate CYP3A inhibitors

Drugs That May Decrease Inpoza Plasma Concentrations

  • Co-administration of CYP3A inducers decreased AUC of Inpoza
  • Avoid concomitant use of strong and moderate CYP3A4 inducers

Anticancer Agents Interaction

  • Potentiation and prolongation of myelosuppressive toxicity

Storage

  • Store in a dry place below 30°C
  • Protect from light

Absorption with Food

  • Co-administration with a high fat meal slowed the rate of absorption

Precautions for Myelodysplastic Syndrome/Acute Myeloid Leukemia

  • Monitor complete blood count for cytopenia at baseline and monthly thereafter
  • Refer to a hematologist for further investigations if levels have not recovered after 4 weeks

Warnings for Pneumonitis

  • If patients present with new or worsening respiratory symptoms, interrupt Inpoza treatment

Pregnancy Warning

  • Potential hazard to the fetus and the risk for loss of pregnancy

Nursing Mothers

  • Not known whether excreted in human milk
  • Consider discontinuation of nursing or the drug, taking into account the importance of the drug to the mother

Overdose

  • No specific treatment established
  • Follow general supportive measures and treat symptomatically

Drug Storage

  • Store in a dry place below 30°C
  • Protect from light
  • Keep out of the reach of children

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