Tasigna 150mg (Nilotinib)

DESCRIPTION

Nilotinib sold under the brand name Tasigna and its belongs to targeted cancer cells Tasigna is anticancer drugs, which prohibits development of the cancer cells.

Tasigna is a prescription medicine, which sold under the supervision of medical oncologist. Tasigna is also belongs to the class of kinase inhibitors.

INDICATION

Tasigna tablets is mainly indicated in the conditions like; Chronic and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (Ph+ CML) resistant or intolerant to prior therapy that included Imatinib in adult patients               

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 link to the ATP-bounding site of BCR-ABL protein Tasigna inhibits proliferation of murine leukemic cell lines and human cell lines derived from patients with Philadelphia positive CML

PHARMACOKINETICS

ABSORPTION

The bioavailability of Tasigna tablets are about 50% The time to high plasma concentration of Tasigna tablet is occurred within 3 hours after administration.

EFFECT OF FOOD

The effect of drug is increased to 82% when the dose was given 30 minutes after a high fat meal when compared to fasted patient.

DISTRIBUTION

The binding of serum protein of the Tasigna is approximately 98% The drug nilotinib blood plasma ratio is 0.68

METABOLISM

Tasigna is metabolized through CYP3A4 mediated oxidation Tasigna is the prime flowing component in the blood stream

ELIMINATION

The Tasigna half life period is approximately 17 hours

DOSAGE MANAGEMENT

DOSAGE MANAGEMENT

The usual dose of Tasigna Tablet should be taken as two times in a day at time intervals of 12 hours. The tablet Tasigna administrated 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

Tasigna capsules, should be dispersed in one teaspoon of applesauce for the patients, who are unable to taken through mouth Immediately within 15 minutes this mixture should be taken . concomitant use with hematopoietic growth factors such as erythropoietin or G-CSF is mandatory Also with hydroxyurea or anagrelide

DOSAGE IN ADULT PATIENTS WITH PHILADELPHIA POSITIVE CML-CP

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

IN PEDIATRICS

The usual dose for child 230mg/m2 should be administred orally twice daily The maximum dose of Tablet Tasigna is 400mg.

PRECAUTIONS

Check blood counts periodically to reduce some complications because Tasigna may cause thrombocytopenia, neutropenia and anemia, While using Tasigna in patient who are suffered these disease Care should be take Hypokalemia Hypomagnesemia Long QT syndrome Pancreatitis and elevated lipase Hepatotoxicity Electrolyte abnormalities Tumor lysis syndrome

SIDE EFFECTS

TASIGNA SIDE EFFECTS

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

While concomitant with strong CYP3A inhibitors leads to rises nilotinib concentrations compared to while using Tasigna alone Tasigna interaction with strong CYP3A inducer leads to decrease nilotinib concentration Interaction of tasgina with proton pump inhibitors: decrease Tasigna efficacy Tasigna concomitant with drugs that may prolong the QT interval like anti-arrhythmic drugs

CONTRAINDICATIONS

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

PREGNANCY & LACTATION

Pregnancy category: D Tasigna tablet avoid during pregnancy condition and women who become pregnant Tasigna not recommended in breastfeeding mothers

STORAGE 

Stored at 68°F to 77°F (20°C to 25°C) keep the cartoon away from heat, moisture and light

MISSED DOSE

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