Niloren 200 mg (Capsule)

Unit Price: ৳ 800.00 (2 x 6: ৳ 9,600.00)
Strip Price: ৳ 4,800.00

Medicine Details

Category Details
Generic Nilotinib
Company Renata limited

Indications

  • Treatment of newly diagnosed adult patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase
  • Treatment of chronic phase (CP) and accelerated phase (AP) Ph+ CML in adult patients resistant to or intolerant to prior therapy

Pharmacology

  • Inhibition of the tyrosine kinase activity of the BCR-ABL protein
  • Inhibits TEL-platelet-derived growth factor receptor-beta (TEL-PDGFRbeta) and FIP1-like-1-PDGFRalpha
  • Inhibition of the c-Kit receptor kinase

Dosage & Administration

  • Recommended Dose: Newly diagnosed Ph+ CML-CP: 300 mg orally twice daily
  • Resistant or intolerant Ph+ CML-CP and CML-AP: 400 mg orally twice daily
  • Administer Nilotinib approximately 12 hours apart and must not take with food

Interaction

  • Drugs that inhibit gastric acid secretion may reduce solubility and bioavailability of Niloren

Contraindications

  • Hypokalaemia, hypomagnesaemia, long QT syndrome
  • Concomitant use with potent CYP3A4 inhibitors or antiarrhythmics and other QT prolonging drugs
  • Concomitant use with potent CYP3A4 inducers

Side Effects

  • Rash, pruritus, hepatotoxicity
  • Headache, fever, GI disturbances
  • Alopecia, asthenia, muscle spasms
  • Myelosuppression, thrombotic disorders or haemorrhage
  • Arrhythmias, heart failure, pericarditis

Pregnancy & Lactation

  • Pregnancy Category D
  • Sexually active female patients should use effective contraception during treatment
  • Should not breast-feed
  • No data to support use in pediatrics

Precautions & Warnings

  • History of pancreatitis, total gastrectomy
  • Hepatic impairment
  • Maintain adequate hydration and correct electrolyte imbalances prior to therapy

Overdose Effects

  • Symptoms: Neutropenia, vomiting and drowsiness
  • Management: Monitor patient and give supportive treatment

Therapeutic Class

  • Targeted Cancer Therapy

Storage Conditions

  • Store in a cool (not above 30°C) and dry place, away from light
  • Keep out of the reach of children

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