Keep your skin meticulously clean and check frequently for any cracks, fungal infections or rashes Moisturize your skin daily, especially after taking a shower or bath. Use appropriate ointments or lotions Dry your skin thoroughly with a soft towel after taking a shower or bath; do not scrub If you undergo radiation therapy apply the ointments recommended by your physician to any radiation redness on your skin and avoid direct exposure to sunlight Avoid cosmetics that irritate the skin Clothing — Jewelry — Compression Stocking Avoid clothing that is too tight, such as underwear, socks or stockings that restrict Do not wear tight jewelry and avoid elastic bands around your ankle Wear your compression stocking or pantyhose all day, and if necessary apply your bandages at night. Use rubber gloves when you put on your compression garment.
Discontinuation of nilotinib therapy should be initiated by a physician experienced in the treatment of patients with CML see sections 4. Eligible patients who discontinue nilotinib therapy must have their BCR-ABL transcript levels and complete blood count with differential monitored monthly for one year, then every 6 weeks for the second year, and every 12 weeks thereafter.
Patients who lose MMR must re-initiate treatment within 4 weeks of when loss of remission is known to have occurred. Nilotinib therapy should be re-initiated at mg twice daily or at a reduced dose level of mg once daily if the patient had a dose reduction prior to discontinuation of therapy.
Patients who re-initiate nilotinib therapy should have their BCR-ABL transcript levels monitored monthly until MMR is re-established and every 12 weeks thereafter see section 4. Adult Philadelphia chromosome positive CML patients in chronic phase who have achieved a sustained deep molecular response MR 4.
Nilotinib therapy should be re-initiated at either mg or mg twice daily. Patients who re-initiate nilotinib therapy should have their BCR-ABL transcript levels monitored monthly until previous major molecular response or MR4 level is re-established and every 12 weeks thereafter see section 4.
Treatment with nilotinib must be interrupted and blood count monitored. If blood counts remain low, a dose reduction to mg once daily may be required.
If event occurs after dose reduction, consider discontinuing treatment. For Grade serum lipase elevations, doses in adult patients should be reduced to mg once daily or interrupted. Serum lipase levels should be tested monthly or as clinically indicated see section 4.
Elevated bilirubin and hepatic transaminases: For Grade bilirubin and hepatic transaminase elevations in adult patients, doses should be reduced to mg once daily or interrupted. Bilirubin and hepatic transaminases levels should be tested monthly or as clinically indicated. Renal impairment Clinical studies have not been performed in patients with impaired renal function.
Since nilotinib and its metabolites are not renally excreted, a decrease in total body clearance is not anticipated in patients with renal impairment. Hepatic impairment Hepatic impairment has a modest effect on the pharmacokinetics of nilotinib.
Dose adjustment is not considered necessary in patients with hepatic impairment. However, patients with hepatic impairment should be treated with caution see section 4.
Cardiac disorders In clinical studies, patients with uncontrolled or significant cardiac disease e. Caution should be exercised in patients with relevant cardiac disorders see section 4. Increases in total serum cholesterol levels have been reported with nilotinib therapy see section 4.
Lipid profiles should be determined prior to initiating nilotinib therapy, assessed at month 3 and 6 after initiating therapy and at least yearly during chronic therapy. Increases in blood glucose levels have been reported with nilotinib therapy see section 4.
Blood glucose levels should be assessed prior to initiating nilotinib therapy and monitored during treatment. Paediatric population The safety and efficacy of Tasigna in paediatric patients with Philadelphia chromosome positive CML in chronic phase from 2 to less than 18 years of age have been established see sections 4.Low-grade non-Hodgkin’s lymphoma (NHL) is an indolent form of the disease with a generally slow course of progression.
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