Niranib 140 mg (Niraparib)

Product Name : Niranib
Generic Name : Niraparib
Formulation : Capsule
Available Pack Size : 120’s
Available Strengths : 140 mg
Registrations : Bangladesh
Category:

Product Description

What is Niranib 140mg?

Niranib 100mg is a drug that is researched and prepared By Everast Pharma Bangladesh. Niranib 100mg is used for ovarian, fallopian tube or peritoneal cancer.

Basic information of the drug Niranib 140mg

  • Active ingredient: Niraparib.
  • Classification of active ingredients: Anti-cancer drugs.
  • Trade name: Niranib.
  • Dosage form: Capsules.
  • Product packaging: 1 box of 30 tablets.
  • Origin: Everest.

Ingredients

Each Niranib film-coated tablet contains:

  • Active ingredient: Niraparib 140 mg.

Pharmacodynamic properties

  • Niraparib is an inhibitor of the poly(ADP-ribose) polymerase (PARP), PARP-1 and PARP-2 enzymes, which play a role in DNA repair. In vitro studies have shown that niraparib-induced cytotoxicity may be related to inhibition of PARP enzyme activity and increased formation of PARP-DNA complexes leading to DNA damage, apoptosis, and cell death. cell.

Pharmacokinetic properties

  • Absorption: Following a single dose of 300 mg niraparib under fasting conditions, niraparib can be measured in plasma within 30 minutes and mean peak plasma concentration (C max) of niraparib is reached after approximately 3 hour [804 ng/mL (% CV: 50.2%)].

 

  • Distribution: Niraparib is moderately protein bound in human plasma (83.0%), mainly to serum albumin. In a population pharmacokinetic analysis of niraparib, the apparent volume of distribution (V d/F) was 1,311 L (based on a 70 kg patient) in cancer patients (CV 116%), giving extensive distribution of niraparib in tissues was observed.

 

  • Metabolism: Niraparib is metabolized primarily by carboxylesterases (CEs) to form the major inactive metabolite, M1. In a mass balance study, M1 and M10 (subsequently formed M1 glucuronides) were the major cyclic metabolites.

 

  • Elimination: Niraparib is eliminated primarily by the hepatobiliary and renal routes. Following a single oral dose of 300 mg [14 C]-niraparib, a mean of 86.2% (range 71% to 91%) of the administered dose was recovered in urine and feces over 21 days. The recovery of radioactivity in urine accounted for 47.5% (range 33.4% to 60.2%) and in feces for 38.8% (range 28.3% to 47.0%) of the dose. In pooled samples collected over 6 days, 40.0% of the administered dose was recovered in the urine mainly as metabolites and 31.6% of the dose was recovered in the feces mainly as unchanged niraparib.
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