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Tasigna

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Tasigna Capsules

Indications
Dosage
How Supplied

INDICATIONS

Newly Diagnosed Ph+ CML-CP

Tasigna (nilotinib) is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. The effectiveness of Tasigna is based on major molecular response and cytogenetic response rates [see Clinical Studies]. The study is ongoing and further data will be required to determine long-term outcome.

Resistant Or Intolerant Ph+ CML-CP And CML-AP

Tasigna is indicated for the treatment of chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (Ph+ CML) in adult patients resistant or intolerant to prior therapy that included imatinib. The effectiveness of Tasigna is based on hematologic and cytogenetic response rates [see Clinical Studies].

DOSAGE AND ADMINISTRATION

Recommended Dosing

Tasigna should be taken twice daily at approximately 12-hour intervals and must be taken on an empty stomach. No food should be consumed for at least 2 hours before the dose is taken and for at least 1 hour after the dose is taken. Advise patients to swallow the capsules whole with water [see BOXED WARNING, WARNINGS AND PRECAUTIONS, CLINICAL PHARMACOLOGY].

For patients who are unable to swallow capsules, the contents of each capsule may be dispersed in 1 teaspoon of applesauce (puréed apple). The mixture should be taken immediately (within 15 minutes) and should not be stored for future use [see CLINICAL PHARMACOLOGY].

Tasigna may be given in combination with hematopoietic growth factors such as erythropoietin or G-CSF if clinically indicated. Tasigna may be given with hydroxyurea or anagrelide if clinically indicated.

Newly Diagnosed Ph+ CML-CP

The recommended dose of Tasigna is 300 mg orally twice daily [see CLINICAL PHARMACOLOGY].

Resistant or Intolerant Ph+ CML-CP and CML-AP

The recommended dose of Tasigna (nilotinib) is 400 mg orally twice daily [see CLINICAL PHARMACOLOGY].

Dose Adjustments Or Modifications

QT Interval Prolongation:

Table 1: Dose Adjustments for QT Prolongation

ECGs with a QTc > 480 msec
  1. Withhold Tasigna, and perform an analysis of serum potassium and magnesium, and if below lower limit of normal, correct with supplements to within normal limits. Concomitant medication usage must be reviewed.
  2. Resume within 2 weeks at prior dose if QTcF returns to < 450 msec and to within 20 msec of baseline.
  3. If QTcF is between 450 msec and 480 msec after 2 weeks, reduce the dose to 400 mg once daily.
  4. If, following dose-reduction to 400 mg once daily, QTcF returns to > 480 msec, Tasigna should be discontinued.
  5. An ECG should be repeated approximately 7 days after any dose adjustment.

Myelosuppression

Withhold or dose reduce Tasigna for hematological toxicities (neutropenia, thrombocytopenia) that are not related to underlying leukemia (Table 2).

Table 2: Dose Adjustments for Neutropenia and Thrombocytopenia

Newly diagnosed Ph+ CML in chronic phase at 300 mg twice daily ANC* < .0 x 109/L and/or platelet counts < 50 x 109/L
  1. Stop Tasigna, and monitor blood counts
  2. Resume within 2 weeks at prior dose if ANC > 1.0 x 109/L and platelets > 50 x 109/L
  3. If blood counts remain low for >2 weeks, reduce the dose to 400 mg once daily
Resistant or intolerant Ph+ CML in chronic phase or accelerated phase at 400 mg twice daily
*ANC=absolute neutrophil count

See Table 3 for dose adjustments for elevations of lipase, amylase, bilirubin, and/or hepatic transaminases [see ADVERSE REACTIONS].

Table 3: Dose Adjustments for Selected Non-hematologic Laboratory Abnormalities

Elevated serum lipase or amylase ≥ Grade 3
  1. Withhold Tasigna, and monitor serum lipase or amylase
  2. Resume treatment at 400 mg once daily if serum lipase or amylase returns to ≤ Grade 1
Elevated bilirubin ≥ Grade 3
  1. Withhold Tasigna, and monitor bilirubin
  2. Resume treatment at 400 mg once daily if bilirubin returns to ≤ Grade 1
Elevated hepatic transaminases ≥ Grade 3
  1. Withhold Tasigna, and monitor hepatic transaminases
  2. Resume treatment at 400 mg once daily if hepatic transaminases returns to ≤ Grade 1

Other Non-hematologic Toxicities

If other clinically significant moderate or severe non-hematologic toxicity develops, withhold dosing, and resume at 400 mg once daily when the toxicity has resolved. If clinically appropriate, escalation of the dose back to 300 mg (newly diagnosed Ph+ CML-CP) or 400 mg (resistant or intolerant Ph+ CML-CP and CMLAP) twice daily should be considered. For Grade 3 to 4 lipase elevations, dosing should be withheld, and may be resumed at 400 mg once daily. Test serum lipase levels monthly or as clinically indicated. For Grade 3 to 4 bilirubin or hepatic transaminase elevations, dosing should be withheld, and may be resumed at 400 mg once daily. Test bilirubin and hepatic transaminases levels monthly or as clinically indicated [see WARNINGS AND PRECAUTIONS, Use In Specific Populations].

Hepatic Impairment

If possible, consider alternative therapies. If Tasigna must be administered to patients with hepatic impairment, consider the following dose reduction:

Table 4: Dose Adjustments for Hepatic Impairment (At Baseline)

Newly diagnosed Ph+ CML in chronic phase at 300 mg twice daily Mild, Moderate, or Severe* An initial dosing regimen of 200 mg twice daily followed by dose escalation to 300 mg twice daily based on tolerability
Resistant or intolerant Ph+ CML in chronic phase or accelerated phase at 400 mg twice daily Mild or Moderate* An initial dosing regimen of 300 mg twice daily followed by dose escalation to 400 mg twice daily based on tolerability
Severe* A starting dose of 200 mg twice daily followed by a sequential dose escalation to 300 mg twice daily and then to 400 mg twice daily based on tolerability
*Mild=mild hepatic impairment (Child-Pugh Class A); Moderate=moderate hepatic impairment (Child-Pugh Class B); Severe=severe hepatic impairment (Child-Pugh Class C) [see WARNINGS AND PRECAUTIONS, Use In Specific Populations].

Concomitant Strong CYP3A4 Inhibitors

Avoid the concomitant use of strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, atazanavir, indinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole). Avoid grapefruit products since they may also increase serum concentrations of nilotinib. Should treatment with any of these agents be required, therapy with Tasigna should be interrupted. If patients must be coadministered a strong CYP3A4 inhibitor, based on pharmacokinetic studies, consider a dose reduction to 300 mg once daily in patients with resistant or intolerant Ph+ CML or to 200 mg once daily in patients with newly diagnosed Ph+ CML-CP. However, there are no clinical data with this dose adjustment in patients receiving strong CYP3A4 inhibitors. If the strong inhibitor is discontinued, a washout period should be allowed before the Tasigna dose is adjusted upward to the indicated dose. For patients who cannot avoid use of strong CYP3A4 inhibitors, monitor closely for prolongation of the QT interval [see BOXED WARNING, WARNINGS AND PRECAUTIONS, DRUG INTERACTIONS].

Concomitant Strong CYP3A4 Inducers

Avoid the concomitant use of strong CYP3A4 inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital). Also inform patients not to take St. John's Wort since these agents may reduce the concentration of Tasigna. Based on the nonlinear pharmacokinetic profile of nilotinib, increasing the dose of Tasigna when coadministered with such agents is unlikely to compensate for the loss of exposure [see DRUG INTERACTIONS].

HOW SUPPLIED

Dosage Forms And Strengths

150 mg red opaque hard gelatin capsules with black axial imprint “NVR/BCR”.

200 mg light yellow opaque hard gelatin capsules with a red axial imprint “NVR/TKI”.

Storage And Handling

Tasigna (nilotinib) 150 mg capsules are red opaque hard gelatin capsules, size 1 with black axial imprint “NVR/BCR”. Tasigna (nilotinib) 200 mg capsules are light yellow opaque hard gelatin capsules, size 0 with the red axial imprint “NVR/TKI.” Tasigna capsules are supplied in blister packs.

150 mg

Carton of 4 blister packs of (4x28) .........................NDC 0078-0592-87
Blisters of 28 capsules ............................................NDC 0078-0592-51

200 mg

Carton of 4 blister packs of (4x28) .........................NDC 0078-0526-87
Blisters of 28 capsules ............................................NDC 0078-0526-51

Tasigna (nilotinib) capsules should be stored at 25°C (77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].

Manufactured by: Novartis Pharma Stein AG Stein, Switzerland Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936. Revised: January 2014

Last reviewed on RxList: 2/3/2014
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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