Tasigna 200mg (Nilotinib)

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Tasigna 200mg , also known as AMN107, is a tyrosine kinase inhibitor under investigation as a probably therapy for chronic myelogenous leukemia (CML) Tasigna 200mg is cancer drugs, which interfere... Read more
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  • Novartis India Ltd
  • Trade name Tasigna 200mg
  • Substance Nilotinib
  • Manufacturer Novartis India Ltd
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Tasigna 200mg

Description

Tasigna 200mg, also known as AMN107, is a tyrosine kinase inhibitor under investigation as a probably therapy for chronic myelogenous leukemia (CML)

Tasigna 200mg is cancer drugs, which interfere with growth of the cancer cells.

Tasigna 200mg is a prescription medicine, which is used under the knowledge of medical oncologist.

Tasigna 200mg indication

Tasigna 200mg 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

Tasigna 200mg pharmacology

Mechanism of action

Specifically connect with maximum affinity to ATP-binding site of BCR-ABL kinase prohibiting cell replication in cell lines and in primary Ph+ CML leukaemia cells

Effective against imatinib-resistant mutant forms of Bcr-Abl

Prevents PDGFR and c-Kit kinase

Pharmacokinetic

Absorption

The high plasma concentration of Tasigna 200mg tablet is occurred within 3 hours after administration and bioavailability are 50%

Distribution

The human plasma protein binding of the Tasigna 200mg is approximately 98%

The blood to serum ratio of nilotinib is 0.68

Metabolism

Tasigna 200mg 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 200mg is approximately 17 hours

The mean apparent clearance value is 29L/hr

Tasigna 200mg 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 take 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

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

In pediatrics

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

The maximum dose of Tablet Tasigna is 400mg.

Tasigna 200mg 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

Tasigna 200mg drug interaction

While Tasigna 200mg interaction with strong CYP3A inhibitors leads to increase nilotinib concentrations compared to while using Tasigna 200mg alone

Tasigna 200mg interaction with strong CYP3A inducer leads to reduce nilotinib concentration

Tasigna 200mg with proton pump inhibitors: reduce Tasigna 200mg efficacy

Avoid interaction of Tasigna 200mg with drugs that may prolong the QT interval like anti-arrhythmic drugs

Tasigna 200mg contraindication

Tasigna 200mg do not used in the patients who are having;

Hypokalemia

Hypomagnesemia

Long QT syndrome

Precautions and warning

Tasigna 200mg may cause thrombocytopenia, neutropenia and anemia, so check blood counts periodically to reduce these complications

Care should be taking while using Tasigna 200mg in patient who are suffered with

Hypokalemia

Hypomagnesemia

Long QT syndrome

Pancreatitis and elevated lipase

Hepatotoxicity

Electrolyte abnormalities

Tumor lysis syndrome

Pregnancy and lactation

Pregnancy category: D

Tasigna 200mg should not be used in pregnancy condition and women who become pregnant

Tasigna 200mg not recommended in breastfeeding mothers

Storage

Tasigna 200mg tablets should be stored at room temperature between 68oF to 77oF (20oC to 25oC)

Tasigna 200mg container should be keep away from heat, moisture and light

Missed dose

If patients missed to administer the dose of Tasigna 200mg should be taken within the time, otherwise the missed dose should be skipped and follow the next dosing schedule.

  • Trade name Tasigna 200mg
  • Substance Nilotinib
  • Manufacturer Novartis India Ltd
  • Packaging 4 tablets
  • Country of origin India
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