In this article, we will discuss Nilotinib (Side Effects). So, let’s get started.
The following clinically significant adverse reactions can occur with Nilotinib (Tasigna®) and are discussed below:
• QT Prolongation
• Sudden Deaths
• Cardiac and Arterial Vascular Occlusive Events
• Pancreatitis and Elevated Serum Lipase
• Electrolyte Abnormalities
• Fluid Retention
Warnings and Precautions
• Myelosuppression: Monitor complete blood count (CBC) during therapy and manage by treatment interruption or dose reduction.
• Cardiac and Arterial Vascular Occlusive Events: Evaluate cardiovascular status, monitor and manage cardiovascular risk factors during Nilotinib (Tasigna®) therapy.
• Pancreatitis and Elevated Serum Lipase: Monitor serum lipase, if elevations are accompanied by abdominal symptoms, interrupt doses and consider appropriate diagnostics to exclude pancreatitis.
• Hepatotoxicity: Monitor hepatic function tests monthly or as clinically indicated.
• Electrolyte Abnormalities: Nilotinib (Tasigna®) can cause hypophosphatemia, hypokalemia, hyperkalemia, hypocalcemia, and hyponatremia. Correct electrolyte abnormalities prior to initiating Nilotinib (Tasigna®) and monitor periodically during therapy.
• Tumor Lysis Syndrome: Maintain adequate hydration and correct uric acid levels prior to initiating therapy with Nilotinib (Tasigna®).
• Hemorrhage: Hemorrhage from any site may occur. Advise patients to report signs and symptoms of bleeding and medically manage as needed.
• Fluid Retention: Monitor patients for unexpected rapid weight gain, swelling, and shortness of breath. Manage medically.
• Effects on Growth and Development in Pediatric Patients: Growth retardation has been reported in pediatric patients treated with Nilotinib (Tasigna®). Monitor growth and development in pediatric patients.
• Embryo-Fetal Toxicity: Advise patients of potential risk to a fetus and to use effective contraception.
• Treatment Discontinuation: Patients must have typical BCR-ABL transcripts. An FDA-authorized test with a detecuon limit below MR4.5 must be used to determine eligibility for discontinuation. Patients must be frequently monitored by the FDA authorized test to detect possible loss of remission.