Denileukin diftitox Side Effects

Brand Names: Ontak

Please note - some side effects for Denileukin diftitox may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Denileukin diftitox - for the Consumer

Denileukin Diftitox

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Denileukin Diftitox:

Abnormal skin sensations; confusion; constipation; cough; diarrhea; dizziness; headache; indigestion; injection site reaction; lightheadedness; loss of appetite; muscle or joint aches; nausea; nervousness; pain; runny nose; sleeplessness; sweating; vomiting; weakness; weight loss.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); back pain; chest pain; difficulty swallowing; fainting; fast or irregular heartbeat; flu-like symptoms (eg, fever, chills, sore throat); leg pain; severe diarrhea with nausea and vomiting; sudden unusual weight gain; swelling of the hands, legs, or ankles; vision changes (eg, loss of color vision).

Side Effects by Body System

Cardiovascular

Cardiovascular side effects including hypotension (36%), vasodilation (22%), tachycardia (12%), thrombotic events (7%), hypertension (6%), and arrhythmia (6%) have been reported.

Two patients with preexisting coronary artery disease experienced acute myocardial infarctions while receiving denileukin diftitox. In addition, ten patients (7%) experienced thrombotic events. Six other patients experienced less severe superficial thrombophlebitis.

Gastrointestinal

Gastrointestinal side effects including nausea/vomiting (64%), anorexia (up to 36%), diarrhea (up to 29%), constipation (9%), dyspepsia (7%), and dysphagia (6%) have been reported.

Onset of diarrhea may be delayed and the duration may be prolonged after taking denileukin diftitox. Dehydration, occurring with vomiting or anorexia, has been reported in 9% of patients.

Hematologic

Hematologic side effects including anemia (18%), thrombocytopenia (8%), and leukopenia (6%) have been the major hematologic adverse effects reported in patients receiving denileukin diftitox.

Musculoskeletal

Musculoskeletal side effects including myalgias (up to 20%) and arthralgias (up to 15.6%) have been reported.

Nervous system

Nervous system side effects have included dizziness (22%), paresthesia (13%), nervousness (11%), confusion (8%), and insomnia (9%).

Respiratory

Respiratory side effects have included dyspnea (up to 29%), increased cough (up to 26%), pharyngitis (17%), upper respiratory tract infection (13.3%), rhinitis (13%), and lung disorder (8%).

Dermatologic

Various rashes have been reported including maculopapular, petechial, vesicular bullous, urticaria with or without eczematous with both an acute and delayed onset. Treatment of the minor rashes includes antihistamines, and, for more severe rashes, topical and/or oral steroids may be required.

Dermatologic side effects including rash (up to 34%), pruritus (up to 20%), and sweating (10%) have been reported.

Genitourinary

Genitourinary side effects including hematuria (10%), albuminuria (10%), pyuria (10%), and increased creatinine (7%) have been reported.

General

General side effects have included chills/fever (81%), asthenia (up to 66%), pyrexia (63.6%), infection (48%), pain (up to 48%), rigors (47.3%), fatigue (46.7%), headache (up to 28.9%), peripheral edema (25.5%), chest pain (up to 24%), flu-like syndrome (8%).

The flu-like syndrome has been reported in 91% of patients several hours to days after infusion of denileukin diftitox. Symptoms consisted of the following, fever, and/or chills (81%), asthenia (66%), digestive (64%), myalgias (18%), and arthralgias (8%). These symptoms were mild to moderate in the majority of patients and responded to treatment with antipyretics and/or antiemetics.

Hypersensitivity

Symptoms associated with the hypersensitivity reaction include, hypotension in 50%, back pain in 30%, dyspnea in 28%, vasodilation in 28%, rash in 25%, chest pain/tightness in 24%, tachycardia in 12%, dysphagia in 5%, syncope in 3% and/or anaphylaxis in 1% of reported patients. Management of this condition consists of decrease or discontinuation of the denileukin diftitox infusion and administration of IV antihistamines, corticosteroids and/or epinephrine.

Hypersensitivity side effects including acute hypersensitivity reactions have been reported in 69% of patients during or within 24 hours of infusion with denileukin diftitox.

Metabolic

Hypoalbuminemia has been reported in 83% of patients receiving denileukin diftitox and has been considered moderate to severe in 17% of patients. In the majority of patients, the nadir was seen 1 to 2 weeks after drug administration. The manufacturer recommends monitoring albumin levels before each course of denileukin diftitox and delaying treatment until levels are at least 3 g/dL.

Metabolic side effects reported in patients receiving denileukin diftitox have included hypoalbuminemia (83%), increased transaminases (61%), edema (47%), hypocalcemia (17%), decreased weight (14%), dehydration (9%), and hypokalemia (6%).

Other

Other side effects have included vascular leak syndrome (27%) and dysgeusia (10.9%).

The vascular leak syndrome was delayed and occurred within the first two weeks of therapy. Symptoms included hypotension, edema and/or hypoalbuminemia. Careful monitoring of weight, edema, blood pressure and albumin levels is recommended with treatment dependent on whether edema or hypotension is the primary problem.

Immunologic

The lymphocyte count, generally, dropped during the dosing period and returned to normal by day 15. With subsequent courses, smaller changes with more rapid recoveries were seen.

Immunologic side effects have included various types of infections (48%) as well as decreased lymphocyte counts (34%).

Ocular

Recovery was reported in some of the affected patients. However, most patients reported persistent visual impairment.

Ocular side effects including loss of visual acuity usually with loss of color vision with or without retinal pigment mottling has been reported.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.