Nilotinib is a tyrosine (protein) kinase inhibitor.

It is available as- 200mg hard capsule.

Ind: i. Treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase (CP); ii. Treatment of adult patients with chronic or accelerated phase (AP) Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) resistant to or intolerant of at least one prior therapy including imatinib.

C/I: Hypersensitivity to nilotinib or to any of the excipients.

S/E; Precautions & warnings: Please see manufacturer’s literature.

Pregnancy & lactation: Women of child-bearing potential must use highly effective method of contraception while receiving nilotinib and for up to 2 weeks after ending treatment.

Should not be used during pregnancy unless clearly necessary.

Breast-feeding in not recommended.

Dosage & admin: Patients with newly diagnosed Ph+ CML-CP: 300mg twice daily; Patients with CP and AP Ph+ CML resistant to or intolerant to at least one prior therapy including imatinib: 400mg twice daily.

Increases in blood glucose and serum cholesterol levels have been reported with nilotinib therapy. Blood glucose levels and lipid profiles should be assessed prior to initiating nilotinib therapy and as clinically indicated during treatment.

Nilotinib capsules should be taken twice daily at an interval of approximately 12 hours apart and must not be taken with food.

No food should be consumed for 2 hours before the dose and for at least one hour after the dose.

For patients who are unable to swallow capsules, the content of each capsule may be dispersed in one teaspoon of applesauce (pureed apple) and should be taken immediately. Not more than one teaspoon of applesauce and not food other than applesauce must be used. Avoid grapefruit juice & other foods that are known to inhibit CYP3A4.

Drug inter: Please see manufacturer’s literature. Note: For full information, please consult manufacturer’s literature.

Price: 200mg cap x 28’s pack: 78204.00 MRP