TASIGNA. 200 mg. 28. capsules

INDICATION :
Tasigna is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia in chronic phase.

Dosage and administration :
Treatment should be initiated by a physician experienced in the diagnosis and treatment of patients with CML

dosage:
The recommended dose of Tasigna is 300 mg twice daily. Treatment should continue until the patient benefit from it.
For a dose of 400 mg once daily has available capsules of 200 mg .

Correction or modification of the dose:
You may need treatment with Tasigna temporarily withheld and / or dose reduced for haematological toxicity that is not related to underlying leukemia.

If clinically significant moderate or severe non-haematological toxicity , administration should be discontinued and may be resumed at 400 mg once daily once the toxicity has resolved . If clinically appropriate perspective, you should consider re-escalation of the dose to 30 mg twice daily.

Elevations in serum lipase :
Displaying serum lipase level 3-4 doses should be reduced to 400 mg once daily or discontinued. Serum lipase levels should be tested monthly or as clinically indicated .

Elevated bilirubin and hepatic transaminases :
When elevated bilirubin and hepatic transaminases Grade 3-4 doses should be reduced to 400 mg once daily or discontinued. Bilirubin and hepatic transaminases levels should be tested monthly or as clinically indicated .

Paediatric population:
Safety and efficacy of the incisura in patients under 18 years have not been established. Therefore use in pediatric patients is not recommended due to the lack of data on safety and efficacy.

Elderly :
Approximately 12% of subjects in the clinical study were / are over 65 years old. No significant differences in terms of safety and efficacy in patients aged more than 65 years compared with patients aged 18 to 65 years.
 
Patients with renal impairment:
No clinical studies in patients with impaired renal function. Since nilotinib and its metabolites are excreted by the kidneys , patients with renal impairment is not expected to decrease in total body clearance.

Patients with hepatic impairment:
Liver damage moderate influence the pharmacokinetics of nilotinib. There is no need for dosage adjustment in patsienit with hepatic impairment. However , patients with hepatic impairment should be treated with caution .
 
Cardiac disorders:
In clinical studies , patients with uncontrolled or significant cardiac disease . Caution should be exercised in patients with relevant cardiac disorders .

 
Method of administration :
It should be taken twice daily at an interval of approximately 12 hours and should not be taken with food. The capsules should be swallowed whole with water. Should not eat within two hours before the dose and at least an hour afterwards.
In the event that a dose is missed the patient should not take an additional dose , but take the usual next dose as prescribed.
In patients who can not swallow capsules, the contents of the capsule may be dissolved in a teaspoon of applesauce and taken immediately. You should not use more than a teaspoon of applesauce or other food except applesauce .
When clinically indicated Tasigna may be given in combination with hematopoietic growth factors such as erythropoietin and granulocyte colony-stimulating factor. In the presence of clinical indications can be given with hydroxyurea or anagrelide.


Fertility , pregnancy and lactation
Women of childbearing potential:
Women of childbearing potential should be advised to use effective contraception during treatment with Tasigna .

pregnancy:
There are no adequate data from the use of nilotinib in pregnant women. Studies in animals have shown reproductive toxicity. Tasigna should not be used during pregnancy unless the clinical condition of the woman requires treatment with nilotinib.

lactation
It is not known whether nilotinib is excreted in breast milk. Available toxicological data in animals have shown excretion of nilotinib in milk. Can not exclude a risk for newborns / infants .
Fertility :
Studies in animals have shown no effect on fertility in male and female rats .
 
SIDE EFFECTS :
The most frequent non-hematologic drug-related adverse events were rash , pruritus, headache, nausea, fatigue and myalgia. The majority of these adverse events were mild to moderate in severity. More rarely been observed pain in the upper abdomen, alopecia , constipation , diarrhea, asthenia , dry skin , muscle spasms , arthralgia, vomiting , abdominal pain and peripheral edema, which were mild to moderate in severity. Discontinuations due to adverse events regardless of causality was observed in 6.8% of patients.