Denileukin diftitox Side Effects

Some side effects of 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.

For the Consumer

Applies to denileukin diftitox: intravenous solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking denileukin diftitox: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

You may have a reaction from a denileukin diftitox injection within hours or days after receiving the injection. Call your doctor promptly if you have one or more of these symptoms: fever, chills, weakness, muscle or joint pain, nausea, vomiting, or stomach upset.

Call your doctor at once if you have:

• blurred vision, changes in color vision;

• swelling in your hands, ankles, or feet;

• fever, chills, body aches, flu symptoms, sores in your mouth and throat;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum);

• fast heart rate;

• back pain, trouble breathing or swallowing, chest pain or tightness, tight feeling in your throat;

• a light-headed feeling, like you might pass out; or

• warmth or redness in your face, neck, or chest.

Common side effects may include:

• headache, dizziness, or nervousness;

• numbness or tingling, skin itching or rash;

• runny or stuffy nose;

• weight gain or loss;

• mild diarrhea or constipation; or

• nausea, vomiting, loss of appetite.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to denileukin diftitox: intravenous solution

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.

Hepatic

In the majority of subjects, these enzyme elevations occurred during either the first or the second cycle. Enzyme elevation resolved without medical intervention and did not require discontinuation of denileukin diftitox.

Hepatic side effects including an increase in serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) from baseline has been reported in 84% of subjects treated with denileukin diftitox.

Local

Local side effects including injection site reaction (8%) have been reported.

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