Nilotinib Brand Name– Tasigna
What is Nilotinib
Nilotinib is a BCR-ABL tyrosine kinase inhibitor.
It is indicated in adult and pediatric patients for the treatment of newly diagnosed, chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML), for the treatment of CP Ph+ CML in adult and pediatric patients resistant or intolerant to prior therapy, and the treatment of accelerated phase Ph+ CML in adult patients resistant to or intolerant to prior therapy including imatinib.
Eligible adult patients with chronic phase Ph+ CML who have received nilotinib for a minimum of 3 years and have achieved a sustained molecular response (MR4.5) may be considered for treatment discontinuation.
Treatment with nilotinib may cause QT prolongation; sudden death has been reported.
Indications
- chronic myelogenous leukemia (CML)
For the treatment of Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia (CML)
NOTE: Nilotinib has been designated an orphan drug by the FDA for the treatment of CML.
Side Effects
- abdominal pain
- abdominal pain
- acne vulgaris
- alopecia
- alopecia
- amnesia
- anemia
- anemia
- angina
- angioedema
- anorexia
- anorexia
- anxiety
- appetite stimulation
- arthralgia
- arthralgia
- ascites
- ascites
- asthenia
- asthenia
- atrial fibrillation
- atrial flutter
- AV block
- back pain
- back pain
- bleeding
- blepharedema
- blepharitis
- blurred vision
- bone pain
- bone pain
- bradycardia
- candidiasis
- cerebral edema
- chest pain (unspecified)
- chills
- cholestasis
- confusion
- conjunctival hyperemia
- conjunctivitis
- constipation
- constipation
- cough
- cough
- cyanosis
- dehydration
- depression
- diabetes mellitus
- diarrhea
- diarrhea
- diplopia
- dizziness
- dizziness
- dysesthesia
- dysgeusia
- dyspepsia
- dyspepsia
- dysphonia
- dysphoria
- dyspnea
- dyspnea
- dysuria
- ecchymosis
- eczema vaccinatum
- edema
- elevated hepatic enzymes
- elevated hepatic enzymes
- enterocolitis
- eosinophilia
- epistaxis
- erythema
- erythema multiforme
- erythema nodosum
- esophagitis
- exfoliative dermatitis
- fatigue
- fatigue
- fever
- fever
- flank pain
- flatulence
- fluid retention
- flushing
- folliculitis
- gastritis
- gastroesophageal reflux
- GI bleeding
- GI perforation
- gingivitis
- gout
- growth inhibition
- gynecomastia
- headache
- headache
- hearing loss
- heart failure
- hematemesis
- hematoma
- hematuria
- hemorrhoids
- hepatitis
- hepatomegaly
- hyperamylasemia
- hyperbilirubinemia
- hyperbilirubinemia
- hypercalcemia
- hypercholesterolemia
- hyperemia
- hyperesthesia
- hyperglycemia
- hyperglycemia
- hyperhidrosis
- hyperkalemia
- hyperkeratosis
- hyperlipidemia
- hyperphosphatemia
- hypertension
- hypertension
- hypertensive crisis
- hyperthyroidism
- hypertriglyceridemia
- hyperuricemia
- hypoalbuminemia
- hypocalcemia
- hypocalcemia
- hypoesthesia
- hypoglycemia
- hypokalemia
- hypokalemia
- hypomagnesemia
- hyponatremia
- hyponatremia
- hypophosphatemia
- hypophosphatemia
- hypotension
- hypothyroidism
- impotence (erectile dysfunction)
- increased urinary frequency
- infection
- infection
- influenza
- insomnia
- insomnia
- intracranial bleeding
- jaundice
- lethargy
- leukocytosis
- leukopenia
- lymphopenia
- malaise
- mastalgia
- melena
- menorrhagia
- migraine
- musculoskeletal pain
- musculoskeletal pain
- myalgia
- myalgia
- myocardial infarction
- nausea
- nausea
- neutropenia
- neutropenia
- night sweats
- night sweats
- nocturia
- ocular hemorrhage
- ocular irritation
- ocular pain
- ocular pruritus
- optic neuritis
- oral ulceration
- otalgia
- palmar-plantar erythrodysesthesia (hand and foot syndrome)
- palpitations
- pancreatitis
- pancytopenia
- papilledema
- paresthesias
- peptic ulcer
- pericardial effusion
- pericarditis
- peripheral edema
- peripheral edema
- peripheral neuropathy
- petechiae
- pharyngitis
- pharyngitis
- photophobia
- photopsia
- photosensitivity
- pleural effusion
- pruritus
- pruritus
- psoriasis
- pulmonary edema
- pulmonary hypertension
- QT prolongation
- rash
- rash
- renal failure (unspecified)
- restless legs syndrome (RLS)
- retroperitoneal bleeding
- sinus tachycardia
- skin atrophy
- skin discoloration
- skin hyperpigmentation
- skin ulcer
- stomatitis
- stroke
- syncope
- throat irritation
- thrombocytopenia
- thrombocytopenia
- thrombocytosis
- thrombosis
- thrombotic microangiopathy
- tinnitus
- tremor
- tumor lysis syndrome (TLS)
- urinary incontinence
- urinary urgency
- urticaria
- vertigo
- visual impairment
- vomiting
- vomiting
- weakness
- weight gain
- weight loss
- wheezing
- xerophthalmia
- xerosis
- xerostomia
Monitoring Parameters
- blood glucose
- CBC with differential
- ECG
- growth rate
- LFTs
- pregnancy testing
- serum creatinine/BUN
- serum electrolytes
- serum lipase
- serum lipid profile
- serum uric acid
- weight
Contraindications
- anemia
- angina
- apheresis
- ascites
- AV block
- bleeding
- bradycardia
- breast-feeding
- cardiac disease
- cardiomyopathy
- celiac disease
- cerebrovascular disease
- children
- contraception requirements
- dehydration
- edema
- females
- fever
- galactose-free diet
- gelatin hypersensitivity
- geriatric
- growth inhibition
- heart failure
- hepatic disease
- human immunodeficiency virus (HIV) infection
- hypercholesterolemia
- hyperglycemia
- hyperlipidemia
- hyperparathyroidism
- hypertriglyceridemia
- hypocalcemia
- hypoglycemia
- hypokalemia
- hypomagnesemia
- hypothermia
- hypothyroidism
- infants
- lactase deficiency
- leukocytosis
- long QT syndrome
- mortality
- myocardial infarction
- neonates
- neutropenia
- occlusive vascular disease
- pancreatitis
- pericardial effusion
- pheochromocytoma
- pleural effusion
- pregnancy
- pregnancy testing
- pulmonary edema
- QT prolongation
- reproductive risk
- rheumatoid arthritis
- sickle cell disease
- sleep deprivation
- stroke
- systemic lupus erythematosus (SLE)
- thrombocytopenia
- total gastrectomy
- tumor lysis syndrome (TLS)
Interactions
- Abemaciclib
- Acalabrutinib
- Acetaminophen; Butalbital; Caffeine; Codeine
- Acetaminophen; Caffeine; Dihydrocodeine
- Acetaminophen; Codeine
- Acetaminophen; Hydrocodone
- Acetaminophen; Oxycodone
- Acetaminophen; Tramadol
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- Aliskiren; Amlodipine
- Aliskiren; Amlodipine; Hydrochlorothiazide, HCTZ
- Alprazolam
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- Aluminum Hydroxide; Magnesium Carbonate
- Aluminum Hydroxide; Magnesium Hydroxide
- Aluminum Hydroxide; Magnesium Hydroxide; Simethicone
- Aluminum Hydroxide; Magnesium Trisilicate
- Amiodarone
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- Amlodipine; Celecoxib
- Amlodipine; Hydrochlorothiazide, HCTZ; Olmesartan
- Amlodipine; Hydrochlorothiazide, HCTZ; Valsartan
- Amlodipine; Olmesartan
- Amlodipine; Telmisartan
- Amlodipine; Valsartan
- Amoxicillin; Clarithromycin; Lansoprazole
- Amoxicillin; Clarithromycin; Omeprazole
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