Tasigna - 150mg


Tasigna - 150mg Description


Nilotinib is a targeted cancer medicine (biological therapy) and also called Tasigna , the trade name of nilotinib Tasigna is cancer drugs, which interfere with growth of the cancer cells. Tasigna is a prescription medicine, which is used under the knowledge of medical oncologist. The safety and efficacy of the medicine Tasigna in children younger than 1 year has not been established Tasigna is comes under the group of kinase inhibitors.


Indication


Tasigna tablets are primarily indicated in the conditions like; Adults with chronic and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (Ph+ CML) resistant or intolerant to prior therapy that included Imatinib

Dosage and administration


Generally the recommended dose of Tablet Tasigna should be taken as twice daily at time intervals of 12 hours. Tasigna must be taken on an empty stomach Food should not be taken for at least 1 hour after the dose is taken or 2 hours before the dose is taken The patients, who are unable to taken the Tasigna capsules, should be dispersed in one teaspoon of applesauce. This mixture should be taken immediately within 15 minutes Tasigna should be concomitant with hematopoietic growth factors such as erythropoietin or G-CSF Also with hydroxyurea or anagrelide





Pharmacokinetics


Absorption :
The bioavailability of Tasigna tablets are about 50% The peak plasma concentration of Tasigna tablet is occurred within 3 hours after administration.
Effect of food:
While compared to fasted patient, the effect of drug is increased to 82% when the dose was given 30 minutes after a high fat meal
Distribution:
The serum protein binding of the Tasigna is approximately 98% The blood to serum ratio of Nilotinib is 0.68
Metabolism:
Tasigna is metabolized through CYP3A4 mediated oxidation Nilotinib is the prime circulating component in the blood stream
Elimination:
The terminal half life period of Tablet Tasigna is approximately 17 hours The mean apparent clearance value is 29L/hr

Dosage in adult patients with Philadelphia positive CML-CP


The prescribed dose of the Tasigna tablet in this condition is 300mg should be given orally as twice daily.

With resistant or intolerant Philadelphia positive CML-CP and CML-AP


The prescribed dose is 400mg should be administered as orally twice daily


Mechanism of action


CML
chronic myelogenous leukemia is caused by BCR-ABL oncogene Tasigna (nilotinib) is a kinase inhibitor, which prohibits BCR-ABL kinase activity
Tasigna bind to the ATP-binding site of BCR-ABL protein Tasigna prohibits multiplication of murine leukemic cell lines and human cell lines derived from patients with Philadelphia positive CML

In pediatrics


The recommended dose 230mg/m2 should be given orally twice daily

BSA (body surface area) Single dose Total daily dose
Up to 0.32 m2 50 mg 100mg
0.33 to 0.54 m2 100mg 200mg
0.55 to 0.76 m2 150mg 300mg
0.55 to 0.76 m2 150mg 300mg
0.77 to 0.97 m2 200mg 400mg
0.98 to 1.19 m2 250mg 500mg
1.20 to 1.41 m2 300mg 600mg
1.42 to 1.63 m2 350mg 700mg
≥1.64 m2 400mg 800mg

Tasigna side effects


Tasigna (nilotinib) side effects are given below,

Skin:
Rash, Pruritus, alopecia, dry skin
GIT:
Nausea, constipation, diarrhea, vomiting, upper abdominal pain, dyspepsia
Nerve system:
Headache, dizziness
General:
Fatigue, pyrexia, asthenia, peripheral edema, face edema
Muscle:
Myalgia, arthralgia, muscle spasm, pain in extremity, back pain
Pulmonary:
Cough, oropharyngeal pain, dyspnea
Infections & infestations:
Nasopharyngitis, upper respiratory tract infection, influenza, gastroenteritis
Eye:Eyelid edema, periorbital edema
Psychiatric: Insomnia
Vascular:Hypertension

Drug interaction


Tasigna While concomitant with strong CYP3A inhibitors leads to increase Nilotinib concentrations compared to while using Tasigna alone Tasigna Concomitant with strong CYP3A inducer leads to reduce Nilotinib concentration Tasigna With proton pump inhibitors: reduce Tasigna efficacy Avoid concomitant of Tasigna with drugs that may prolong the QT interval like anti-arrhythmic drugs

Precautions and warning


Tasigna may cause thrombocytopenia, neutropenia and anemia, so check blood counts periodically to reduce these complications Care should be take while using Tasigna in patient who are suffered with Hypokalemia, Hypomagnesemia, Long QT syndrome, Pancreatitis and elevated lipase, Hepatotoxicity, Electrolyte abnormalities, Tumor lysis syndrome.

Missed dose


If patients fails to administer the dose of Tasigna should be take within the time, otherwise the missed dose should be skipped and follow the next dosing schedule.



Pregnancy


Pregnancy category: D Tasigna should not be used in pregnancy condition and women who become pregnant Tasigna not recommended in breastfeeding mothers


Storage


Tasigna tablets should be stored at room temperature between 68oF to 77oF (20oC to 25oC) Tasigna container should be keep away from heat, moisture and light


Contraindication


Tasigna do not used in the patients who are having; Hypokalemia Hypomagnesemia Long QT syndrome


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