Rulicent 10 mg (Tablet)

Unit Price: ৳ 300.00 (2 x 7: ৳ 4,200.00)
Strip Price: ৳ 2,100.00

Medicine Details

Category Details
Generic Ruxolitinib oral
Company Incepta pharmaceuticals ltd
Also available as

Indications

  • Treatment of myelofibrosis in adults
  • Treatment of polycythemia vera in adults
  • Treatment of acute graft-versus-host disease in adult and pediatric patients
  • Treatment of steroid-refractory acute graft-versus host disease in adult and pediatric patients

Pharmacology

  • Inhibition of Janus Associated Kinases (JAKs) JAK1 and JAK2
  • Modulation of gene expression
  • Prevention of splenomegaly
  • Reduction of JAK2V617F mutant cells in the spleen
  • Decreased circulating inflammatory cytokines

Absorption

  • Rapid absorption after oral administration
  • Maximal plasma concentration achieved within 1 to 2 hours post-dose
  • Estimated to be at least 95% orally absorbed

Distribution

  • Mean volume of distribution at steady-state is 72 L in myelofibrosis patients

Half-life

  • Mean half-life of approximately 5.8 hours
  • Elimination half-life of approximately 3 hours

Plasma protein binding

  • 97%, mostly to albumin

Metabolism

  • Metabolized by CYP3A4 and to a lesser extent by CYP2C9

Excretion

  • Elimination predominately through metabolism
  • 74% excreted in urine

Dosage

  • Starting dose based on platelet count
  • Dose titration based on safety and efficacy

Administration

  • Oral administration with or without food
  • Not to take additional dose if missed

Interaction

  • Contraindicated with fluconazole greater than 200 mg daily
  • Increased exposure with strong CYP3A4 inhibitors
  • No dose adjustment recommended with strong CYP3A4 inducers

Contraindications

  • Hypersensitivity to Ruxolitinib or its components

Side Effects

  • Thrombocytopenia, anemia, neutropenia
  • Risk of infection, bruising, dizziness, headache
  • Symptom exacerbation after discontinuation
  • Non-melanoma skin cancer

Pregnancy & Lactation

  • No adequate and well-controlled studies
  • Discontinuation of breastfeeding during treatment

Precautions & Warnings

  • Management of thrombocytopenia, anemia, neutropenia
  • Observation for signs and symptoms of infection
  • Evaluation for tuberculosis risk factors
  • Monitoring and treatment for lipid parameter elevations
  • Safe and effective use in pediatric patients not established

Use in Special Populations

  • Safety and effectiveness not established in pediatric patients

Overdose Effects

  • No known antidote
  • Increased myelosuppression with higher than recommended repeat doses
  • Appropriate supportive treatment required

Therapeutic Class

  • Pyrrolopyrimidines

Storage Conditions

  • Store below 30°C in a dry place, away from sunlight

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