IMKELDI (imatinib mesylate)

There are 1 contraindications. Absolute contraindication.

Contraindication List
Lactation

There are 5 severe contraindications. Adequate patient monitoring is recommended for safer drug use.

Severe List
Anemia
Neutropenic disorder
Pregnancy
Severe hepatic disease
Thrombocytopenic disorder

There are 12 moderate contraindications. Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.

Moderate List
Chronic heart failure
Congenital heart disease
Coronary artery disease
Diabetes mellitus
Disease of liver
Hypertension
Kidney disease with likely reduction in glomerular filtration rate (GFr)
Kidney disease with reduction in glomerular filtration rate (GFr)
Left ventricular failure
Myocarditis
Valvular heart disease
Viral hepatitis B

There are 96 severe adverse reactions.

More Frequent	Less Frequent
Anemia Body fluid retention Edema Gastrointestinal hemorrhage Hemorrhage Neutropenic disorder Pericardial effusion Thrombocytopenic disorder Upper respiratory infection	Aphthous stomatitis Chest pain Conjunctivitis Depression Dyspnea Hyperbilirubinemia Hypokalemia Hypotension Influenza Lymphopenia Pancytopenia Periorbital edema Pleural effusions Pneumonia Pulmonary edema Purpura Tumor lysis syndrome

Rare/Very Rare

Abnormal hepatic function tests Acute cognitive impairment Acute myocardial infarction Acute pancreatitis Acute renal failure Acute respiratory failure Anaphylaxis Angina Angioedema Ascites Atrial fibrillation Avascular necrosis of bone Bullous dermatitis Cardiac arrhythmia Cardiogenic shock Cerebral edema Chronic heart failure Colitis Cystoid macular edema Diverticulitis of gastrointestinal tract DRESS syndrome Dyschromia Eosinophilia Erythema multiforme Erythema nodosum Exfoliative dermatitis Gastric ulcer Gastritis Gastroenteritis Gastrointestinal obstruction Gastrointestinal perforation Glaucoma Hematoma Hemorrhagic cyst of ovary Hepatic failure Hepatitis Hypersensitivity drug reaction Hypertension Hyperthyroidism Hypothyroidism Ileus Interstitial lung disease Intracranial hypertension Kidney disease with reduction in glomerular filtration rate (GFr) Left ventricular failure Lichenoid dermatitis drug eruption Lymphadenopathy Myopathy Nail disorders Ovarian cyst Palmar-plantar erythrodysesthesia Panniculitis Papilledema Pericardial tamponade Pericarditis Psoriasis Reactivation of hepatitis B Retinal hemorrhage Rhabdomyolysis Seizure disorder Stevens-johnson syndrome Subdural intracranial hemorrhage Sweet's syndrome Tachycardia Thrombocytosis Thrombotic thrombocytopenic purpura Toxic epidermal necrolysis Tumor hemorrhage Vascular ectasia of gastric antrum Vitreous hemorrhage

There are 62 less severe adverse reactions.

More Frequent	Less Frequent
Acute abdominal pain Arthralgia Back pain Cramps Diarrhea Dizziness Eye tearing Fatigue Fever Musculoskeletal pain Myalgia Nausea Pain Skin rash Vomiting	Abdominal distension Alopecia Anorexia Bone pain Chills Conjunctival hemorrhage Constipation Cough Dry skin Dyspepsia Epistaxis Flatulence Flushing Gastroesophageal reflux disease General weakness Headache disorder Hyperhidrosis Hypoesthesia Insomnia Night sweats Paresthesia Peripheral neuropathy Pharyngitis Sinusitis Stomatitis Weight gain

Rare/Very Rare
Blurred vision Drowsy Dry eye Dysgeusia Erectile dysfunction Gynecomastia Joint stiffness Lichen planus Malaise Memory impairment Menorrhagia Migraine Palpitations Pruritus of skin Raynaud's phenomenon Skin photosensitivity Symptoms of anxiety Syncope Thromboembolic disorder Tinnitus Vertigo

Can cause fetal harm based on human postmarketing reports and animal studies.

Imatinib and its metabolites are distributed into human milk; discontinue breast-feeding during therapy and for 1 month after the last dose.

Contraindicated
Absolute contraindication. (Human data usually available to support recommendations.) This drug should not be given to breast feeding mothers.

Drug Name	Excretion Potential	Effect on Infant	Notes
Imatinib	Excreted.This drug is known to be excreted in human breast milk.	It is not known whether this drug has an adverse effect on the nursing infant. (No data or inconclusive human data)	Avoid breastfeeding during treatment and for 1 month after the last dose

In clinical trials in patients with CML, approximately 20% of patients were over 65 years of age. With the exception of a higher incidence of edema, no substantial differences in safety and efficacy relative to younger adults were observed. In the trial in patients with unresectable or metastatic GIST, 16% of patients were over 65 years of age.

No substantial differences in safety and efficacy relative to younger adults were observed, but data are limited. In the adjuvant GIST study, 31% were over 65 years of age. With the exception of a higher incidence of edema, no substantial differences in safety and efficacy relative to younger adults were observed.

Precaution Exists
Geriatric management or monitoring precaution exists.

Drug Name	Narrative	REN	HEP	CARDIO	NEURO	PULM	ENDO
Imatinib	Cardiovascular-Greater risk of edema. Monitor patients with underlying CHF, establish baseline left ventricular function. Renal-Adjust dose for mild to moderate renal impairment. Increased risk of renal toxicity with prolonged therapy.	Y	Y	Y	N	N	N