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Tasigna

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Overview

What is Tasigna?

Tasigna contains nilotinib, which belongs to a pharmacologic class of drugs known as kinase inhibitors.

Nilotinib drug substance, in the form of monohydrochloride monohydrate, is a white to slightly yellowish to slightly greenish yellow powder with the molecular formula and weight, respectively, of CHFNO•HCl • HO and 584 (corresponding molecular formula and weight of nilotinib base, anhydrous are CHFNO and 529 respectively). The solubility of nilotinib in aqueous solutions decreases with increasing pH. Nilotinib is not optically active. The pK1 was determined to be 2.1; pK2 was estimated to be 5.4.

The chemical name of nilotinib monohydrochloride monohydrate is 4-methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-benzamide, monohydrochloride, monohydrate. Its structure is shown below:

Tasigna (nilotinib) capsules, for oral use, contain 50 mg, 150 mg, or 200 mg nilotinib base, anhydrous (equivalent to 55 mg, 166 mg, and 221 mg nilotinib monohydrochloride monohydrate respectively) with the following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate and poloxamer 188. The capsules contain gelatin, iron oxide (red), iron oxide (yellow), iron oxide (black), and titanium dioxide.



What does Tasigna look like?



What are the available doses of Tasigna?

Capsules: 50 mg, 150 mg and 200 mg ()

What should I talk to my health care provider before I take Tasigna?

     

How should I use Tasigna?

Tasigna (nilotinib) is indicated for the treatment of adult and pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase.

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

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 .

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.

Dosage in Adult Patients with Newly Diagnosed Ph+ CML-CP

The recommended dose of Tasigna is 300 mg orally twice daily.

Dosage in Adult Patients with Resistant or Intolerant Ph+ CML-CP and CML-AP

The recommended dose of Tasigna is 400 mg orally twice daily.

Dosage in Pediatric Patients with Newly Diagnosed Ph+ CML-CP or Resistant or Intolerant Ph+ CML-CP

The recommended dose of Tasigna for pediatric patients is 230 mg/m orally twice daily, rounded to the nearest 50 mg dose (to a maximum single dose of 400 mg) (see Table 1). If needed, attain the desired dose by combining different strengths of Tasigna capsules. Continue treatment as long as clinical benefit is observed or until unacceptable toxicity occurs.


What interacts with Tasigna?

Sorry No Records found


What are the warnings of Tasigna?

Sorry No Records found


What are the precautions of Tasigna?

Sorry No Records found


What are the side effects of Tasigna?

Sorry No records found


What should I look out for while using Tasigna?

Tasigna is contraindicated in patients with hypokalemia, hypomagnesemia, or long QT syndrome


What might happen if I take too much Tasigna?

Overdose with nilotinib has been reported, where an unspecified number of Tasigna capsules were ingested in combination with alcohol and other drugsEvents included neutropenia, vomiting, and drowsinessIn the event of overdose, the patient should be observed and appropriate supportive treatment given.


How should I store and handle Tasigna?

Unopened vials of Gemcitabine for Injection, USP are stable until the expiration date indicated on the package when stored at controlled room temperature 20° to 25°C (68° to 77°F) and that allows for excursions between 15° and 30°C (59° and 86°F) [See USP Controlled Room Temperature] . Tasigna (nilotinib) 50 mg capsules are red opaque cap and light yellow opaque body hard gelatin capsules, size 4 with black radial imprint “NVR/ABL.” 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 50 mg capsules are supplied in bottles and Tasigna 150 mg and 200 mg capsules are supplied in blister packs.50 mgBottle of 120 capsules………………………………………………………………NDC 0078-0951-66150 mgCarton of 4 blister packs of (4x28)…………………………………………………NDC 0078-0592-87Blisters of 28 capsules………………………………………………………………NDC 0078-0592-51200 mgCarton of 4 blister packs of (4x28)…………………………………………………NDC 0078-0526-87Blisters of 28 capsules………………………………………………………………NDC 0078-0526-51Tasigna (nilotinib) capsules should be stored at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].Tasigna (nilotinib) 50 mg capsules are red opaque cap and light yellow opaque body hard gelatin capsules, size 4 with black radial imprint “NVR/ABL.” 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 50 mg capsules are supplied in bottles and Tasigna 150 mg and 200 mg capsules are supplied in blister packs.50 mgBottle of 120 capsules………………………………………………………………NDC 0078-0951-66150 mgCarton of 4 blister packs of (4x28)…………………………………………………NDC 0078-0592-87Blisters of 28 capsules………………………………………………………………NDC 0078-0592-51200 mgCarton of 4 blister packs of (4x28)…………………………………………………NDC 0078-0526-87Blisters of 28 capsules………………………………………………………………NDC 0078-0526-51Tasigna (nilotinib) capsules should be stored at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].Tasigna (nilotinib) 50 mg capsules are red opaque cap and light yellow opaque body hard gelatin capsules, size 4 with black radial imprint “NVR/ABL.” 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 50 mg capsules are supplied in bottles and Tasigna 150 mg and 200 mg capsules are supplied in blister packs.50 mgBottle of 120 capsules………………………………………………………………NDC 0078-0951-66150 mgCarton of 4 blister packs of (4x28)…………………………………………………NDC 0078-0592-87Blisters of 28 capsules………………………………………………………………NDC 0078-0592-51200 mgCarton of 4 blister packs of (4x28)…………………………………………………NDC 0078-0526-87Blisters of 28 capsules………………………………………………………………NDC 0078-0526-51Tasigna (nilotinib) capsules should be stored at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].Tasigna (nilotinib) 50 mg capsules are red opaque cap and light yellow opaque body hard gelatin capsules, size 4 with black radial imprint “NVR/ABL.” 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 50 mg capsules are supplied in bottles and Tasigna 150 mg and 200 mg capsules are supplied in blister packs.50 mgBottle of 120 capsules………………………………………………………………NDC 0078-0951-66150 mgCarton of 4 blister packs of (4x28)…………………………………………………NDC 0078-0592-87Blisters of 28 capsules………………………………………………………………NDC 0078-0592-51200 mgCarton of 4 blister packs of (4x28)…………………………………………………NDC 0078-0526-87Blisters of 28 capsules………………………………………………………………NDC 0078-0526-51Tasigna (nilotinib) capsules should be stored at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].Tasigna (nilotinib) 50 mg capsules are red opaque cap and light yellow opaque body hard gelatin capsules, size 4 with black radial imprint “NVR/ABL.” 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 50 mg capsules are supplied in bottles and Tasigna 150 mg and 200 mg capsules are supplied in blister packs.50 mgBottle of 120 capsules………………………………………………………………NDC 0078-0951-66150 mgCarton of 4 blister packs of (4x28)…………………………………………………NDC 0078-0592-87Blisters of 28 capsules………………………………………………………………NDC 0078-0592-51200 mgCarton of 4 blister packs of (4x28)…………………………………………………NDC 0078-0526-87Blisters of 28 capsules………………………………………………………………NDC 0078-0526-51Tasigna (nilotinib) capsules should be stored at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].Tasigna (nilotinib) 50 mg capsules are red opaque cap and light yellow opaque body hard gelatin capsules, size 4 with black radial imprint “NVR/ABL.” 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 50 mg capsules are supplied in bottles and Tasigna 150 mg and 200 mg capsules are supplied in blister packs.50 mgBottle of 120 capsules………………………………………………………………NDC 0078-0951-66150 mgCarton of 4 blister packs of (4x28)…………………………………………………NDC 0078-0592-87Blisters of 28 capsules………………………………………………………………NDC 0078-0592-51200 mgCarton of 4 blister packs of (4x28)…………………………………………………NDC 0078-0526-87Blisters of 28 capsules………………………………………………………………NDC 0078-0526-51Tasigna (nilotinib) capsules should be stored at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].Tasigna (nilotinib) 50 mg capsules are red opaque cap and light yellow opaque body hard gelatin capsules, size 4 with black radial imprint “NVR/ABL.” 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 50 mg capsules are supplied in bottles and Tasigna 150 mg and 200 mg capsules are supplied in blister packs.50 mgBottle of 120 capsules………………………………………………………………NDC 0078-0951-66150 mgCarton of 4 blister packs of (4x28)…………………………………………………NDC 0078-0592-87Blisters of 28 capsules………………………………………………………………NDC 0078-0592-51200 mgCarton of 4 blister packs of (4x28)…………………………………………………NDC 0078-0526-87Blisters of 28 capsules………………………………………………………………NDC 0078-0526-51Tasigna (nilotinib) capsules should be stored at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].Tasigna (nilotinib) 50 mg capsules are red opaque cap and light yellow opaque body hard gelatin capsules, size 4 with black radial imprint “NVR/ABL.” 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 50 mg capsules are supplied in bottles and Tasigna 150 mg and 200 mg capsules are supplied in blister packs.50 mgBottle of 120 capsules………………………………………………………………NDC 0078-0951-66150 mgCarton of 4 blister packs of (4x28)…………………………………………………NDC 0078-0592-87Blisters of 28 capsules………………………………………………………………NDC 0078-0592-51200 mgCarton of 4 blister packs of (4x28)…………………………………………………NDC 0078-0526-87Blisters of 28 capsules………………………………………………………………NDC 0078-0526-51Tasigna (nilotinib) capsules should be stored at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].Tasigna (nilotinib) 50 mg capsules are red opaque cap and light yellow opaque body hard gelatin capsules, size 4 with black radial imprint “NVR/ABL.” 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 50 mg capsules are supplied in bottles and Tasigna 150 mg and 200 mg capsules are supplied in blister packs.50 mgBottle of 120 capsules………………………………………………………………NDC 0078-0951-66150 mgCarton of 4 blister packs of (4x28)…………………………………………………NDC 0078-0592-87Blisters of 28 capsules………………………………………………………………NDC 0078-0592-51200 mgCarton of 4 blister packs of (4x28)…………………………………………………NDC 0078-0526-87Blisters of 28 capsules………………………………………………………………NDC 0078-0526-51Tasigna (nilotinib) capsules should be stored at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].Tasigna (nilotinib) 50 mg capsules are red opaque cap and light yellow opaque body hard gelatin capsules, size 4 with black radial imprint “NVR/ABL.” 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 50 mg capsules are supplied in bottles and Tasigna 150 mg and 200 mg capsules are supplied in blister packs.50 mgBottle of 120 capsules………………………………………………………………NDC 0078-0951-66150 mgCarton of 4 blister packs of (4x28)…………………………………………………NDC 0078-0592-87Blisters of 28 capsules………………………………………………………………NDC 0078-0592-51200 mgCarton of 4 blister packs of (4x28)…………………………………………………NDC 0078-0526-87Blisters of 28 capsules………………………………………………………………NDC 0078-0526-51Tasigna (nilotinib) capsules should be stored at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Nilotinib is an inhibitor of the BCR-ABL kinase. Nilotinib binds to and stabilizes the inactive conformation of the kinase domain of ABL protein. In vitro, nilotinib inhibited BCR-ABL mediated proliferation of murine leukemic cell lines and human cell lines derived from patients with Ph+ CML. Under the conditions of the assays, nilotinib was able to overcome imatinib resistance resulting from BCR-ABL kinase mutations, in 32 out of 33 mutations tested. Nilotinib inhibited the autophosphorylation of the following kinases at IC50 values as indicated: BCR-ABL (20 to 60 nM), PDGFR (69 nM), c-KIT (210 nM), CSF-1R (125 to 250 nM), and DDR1 (3.7 nM).

Non-Clinical Toxicology
Tasigna is contraindicated in patients with hypokalemia, hypomagnesemia, or long QT syndrome

Tumor lysis syndrome cases have been reported in Tasigna treated patients with resistant or intolerant CML. Malignant disease progression, high WBC counts and/or dehydration were present in the majority of these cases. Due to potential for tumor lysis syndrome, maintain adequate hydration and correct uric acid levels prior to initiating therapy with Tasigna.

Treatment with Tasigna can cause Grade 3/4 thrombocytopenia, neutropenia and anemiaPerform complete blood counts every 2 weeks for the first 2 months and then monthly thereafter, or as clinically indicated. Myelosuppression was generally reversible and usually managed by withholding Tasigna temporarily or dose reduction

The following serious adverse reactions can occur with Tasigna and are discussed in greater detail in other sections of labeling:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

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Interactions

Interactions

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