(denileukin diftitox) Injection
Important Safety Information
Infusion reactions, defined as symptoms occurring within 24 hours of infusion and resolving within 48 hours of the last infusion in that course, were reported in 70.5% of 234 ONTAK-treated patients across 3 clinical studies. Serious infusion reactions were reported in 8.1% of patients. There have been post-marketing reports of infusion reactions resulting in death. For patients completing at least 4 courses of ONTAK treatment in a placebo-controlled trial, the incidence of infusion reactions was lower in the third and fourth cycles as compared to the first and second cycles of ONTAK.
Capillary Leak Syndrome
Capillary leak syndrome was defined as the occurrence of at least 2 of the following 3 symptoms (hypotension, edema, serum albumin < 3.0 g/dL) at any time during ONTAK therapy. These symptoms were not required to occur simultaneously to be characterized as capillary leak syndrome. As defined, capillary leak syndrome was reported in 32.5% (76/234) of ONTAK-treated patients in clinical studies; one-third required hospitalization or medical intervention to prevent hospitalization. There are post-marketing reports of capillary leak syndrome resulting in death. The onset of symptoms in patients with capillary leak syndrome may be delayed, occurring up to 2 weeks following infusion. Symptoms may persist or worsen after the cessation of ONTAK.
Regularly assess patients for weight gain, new onset or worsening edema and hypotension (including orthostatic changes). Monitor serum albumin levels prior to each course of therapy and more often as clinically indicated. Withhold ONTAK for serum albumin levels less than 3 g/dL.
Loss of visual acuity, usually with loss of color vision, with or without retinal pigment mottling has been reported following administration of ONTAK. Recovery was reported in some of the affected patients; however, most patients reported persistent visual impairment.
Increase in ALT/AST from baseline occurred in 84% of ONTAK-treated patients. The majority of these elevations occurred during either the first or second cycle, resolved without medical intervention, and did not require discontinuation of ONTAK.
Pregnancy and Lactation
ONTAK should be given to a pregnant woman only if clearly needed and should not be used in women who are nursing.
Most Common Adverse Reactions
In clinical studies (n=234), the most common adverse reactions in ONTAK-treated patients (≥20%) were pyrexia, nausea, fatigue, rigors, vomiting, diarrhea, headache, peripheral edema, cough, dyspnea and pruritus. The most common serious adverse reactions were capillary leak syndrome (11.1%), infusion reactions (8.1%), and visual changes including loss of visual acuity (4%). ONTAK was discontinued in 28.2% of patients due to adverse reactions.
Please see the ONTAK Full Prescribing Information and patients' instructions for use including Boxed WARNINGS and additional important safety information or call Eisai Medical Information at 888-274-2378. To report suspected adverse reactions, call 877-873-4724.
ONTAK® is a registered trademark of Eisai Inc.
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