Knilonat ( nilotinib 200 mg )

Knilonat (nilotinib 200 mg), a generic version of nilotinib, is a kinase inhibitor prescribed to treat various conditions. These conditions include newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase, in both adult and pediatric patients aged one year and older. Additionally, it is indicated for chronic phase (CP) and accelerated phase (AP) Ph+ CML in adult patients who have shown resistance to or intolerance to previous treatments, including imatinib. Pediatric patients aged one year and older with Ph+ CML-CP and CML-AP, who have demonstrated resistance to or intolerance to prior tyrosine-kinase inhibitor (TKI) therapies, can also benefit from this medication.

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nilotinib dosage

The dosing recommendations for Knilonat (nilotinib 200 mg) vary based on the patient's age and condition:

Recommended Adult Dose:

• For newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia in chronic phase (Ph+ CML-CP): The recommended dosage is 300 mg taken orally twice daily.
• For patients with Ph+ CML-CP and CML-AP who have shown resistance to or intolerance to prior tyrosine-kinase inhibitor therapy: The recommended dosage is 400 mg taken orally twice daily.

Recommended Pediatric Dose:

• For pediatric patients with newly diagnosed Ph+ CML-CP or Ph+ CML-CP and CML-AP who are resistant to or intolerant to prior TKI therapy: The recommended dosage is 230 mg/m2 taken orally twice daily, rounded to the nearest 50 mg dose (up to a maximum single dose of 400 mg).

For comprehensive information on dosing and administration, including instructions for reducing the dosage due to toxicity, please consult the Dosage and Administration section provided.

It is crucial to adjust the starting dose in patients who have pre-existing liver impairment.

Eligible adult patients who have been taking Nilotinib for a minimum of 3 years and have achieved a sustained molecular response (MR4.5) in newly diagnosed Ph+ CML-CP or in patients resistant or intolerant to imatinib may be considered for discontinuation of treatment.

nilotinib side effects

It is important to be aware of the potential side effects of Nilotinib, as it may cause low blood cell counts, including red blood cells, white blood cells, and platelets. While this is a common occurrence, it can also be severe. Your healthcare provider will regularly monitor your blood counts during your Nilotinib treatment. If you notice any signs or symptoms of low blood counts, such as fever, chills, signs of infection, unexplained bleeding or bruising, weakness, or shortness of breath, it is crucial to contact your healthcare provider immediately or seek medical assistance.

Individuals recently diagnosed with Ph+ CML who are taking Nilotinib may face a risk of decreased blood flow to the leg, heart, or brain. If you experience sudden symptoms such as chest pain, numbness or weakness, difficulty walking or speaking, leg pain, cold sensation in your leg, or a change in the color of your leg's skin, it is important to seek urgent medical help.

Another potential side effect of Nilotinib is pancreatitis, which is characterized by inflammation of the pancreas. If you experience sudden stomach pain in the abdominal area accompanied by nausea and vomiting, promptly inform your healthcare provider.

Nilotinib can also increase the risk of liver problems. If you notice symptoms such as abdominal pain, yellowing of the skin and eyes, or dark-colored urine, contact your healthcare provider immediately.

Tumor Lysis Syndrome (TLS) is a condition that can occur due to the rapid breakdown of cancer cells. Your healthcare provider may perform blood tests to monitor for TLS. Symptoms of TLS include kidney failure requiring dialysis treatment and abnormal heartbeats.

Serious bleeding problems, including those leading to death, have been reported during Nilotinib treatment. If you experience any signs or symptoms of bleeding, it is crucial to inform your healthcare provider immediately.

Fluid retention is another potential effect of Nilotinib, characterized by symptoms such as shortness of breath, rapid weight gain, and swelling.

In children with chronic phase Ph+ CML, abnormal growth and development have been observed during Nilotinib treatment. Some children and adolescents may experience slower growth compared to normal during treatment.

The most common side effects of Nilotinib in both adults and children include nausea, rash, headache, tiredness, itching, vomiting, diarrhea, cough, constipation, muscle and joint pain, runny or stuffy nose, sneezing, sore throat, fever, and night sweats.

If you and your healthcare provider decide to discontinue Nilotinib and attempt treatment-free remission (TFR), it is important to note that you may experience more musculoskeletal symptoms than before stopping the treatment. These symptoms may include muscle pain, arm and leg pain, and joint pain.