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Who is ONTAK for?

ONTAK is for patients with cutaneous T-cell lymphoma whose previous therapies have not worked, or no longer work, and whose lymphoma cells are distinguished by a certain characteristic known as "CD25". ONTAK is available by prescription only.

What important safety information should I know about ONTAK?

•Serious and fatal infusion reactions have been reported. ONTAK should be given in a facility equipped and staffed to handle medical emergencies. ONTAK must be immediately and permanently stopped for serious infusion reactions.
•Capillary leak syndrome resulting in death has been reported. Your weight, any swelling of body tissues (called edema), blood pressure and levels of a substance in the blood called albumin, will be monitored before and during ONTAK treatment.
•Loss of visual acuity, usually with loss of color vision, has been reported after receiving ONTAK.

Serious infusion reactions

  • Infusion reactions are symptoms that occur within 24 hours of receiving ONTAK and disappear within 48 hours of receiving the last infusion in that cycle of treatment. In medical studies, infusion reactions were reported in 70.5% (165/234) ONTAK-treated patients.
  • Serious infusion reactions were reported in 8% of patients.
  • Patients who completed at least 4 cycles of ONTAK in a large medical study, experienced less infusion reactions in the 3rd and 4th cycles when compared to the 1st and 2nd cycles.

Capillary leak syndrome

  • Capillary leak syndrome is the occurrence of at least 2 of the following 3 symptoms (low blood pressure, edema, low blood albumin) at any time during ONTAK therapy. These symptoms do not have to occur at the same time.
  • In medical studies, capillary leak syndrome was reported in 32.5% (76/234) of ONTAK-treated patients; one-third of those 76 patients required hospitalization or needed medical treatment to prevent hospitalization.
  • The start of symptoms in patients with capillary leak syndrome may be delayed, and can occur up to 2 weeks after receiving an infusion. Symptoms may stay the same or get worse after stopping ONTAK.
  • You will be regularly checked for weight gain, new or worsening edema and low blood pressure (including any dizziness when you stand up or sit up in bed).
  • Your blood albumin levels will be monitored before you receive each course of ONTAK and more often if needed. You will not receive ONTAK if you have low blood albumin.

Visual loss

  • Loss of visual acuity, usually with loss of color vision has been reported after receiving ONTAK.
  • Recovery was reported in some of the affected patients, but most patients reported that their visual impairment stayed the same.

Liver disorders

  • In medical studies, 84% (197/234) of ONTAK-treated patients experienced an increase in their liver enzyme levels.
  • Most of these increases occurred during either the 1st or 2nd cycle of treatment and returned to normal levels without medical treatment or stopping ONTAK.

Pregnancy and Nursing

  • ONTAK should be given to a pregnant woman only if clearly needed and should not be used in women who are nursing

Most common side effects

  • In medical studies, more than 20% of the 234 ONTAK-treated patients experienced fever, nausea, tiredness, chills, vomiting, diarrhea, headache, swelling of the ankles or fingers, cough, shortness of breath and itching.
  • The most common serious side effects were capillary leak syndrome (11%), infusion reactions (8%), and visual changes including loss of visual acuity (4%).
  • ONTAK was stopped in 28.2% of patients due to side effects.

Please see the ONTAK package insert including Boxed WARNINGS and additional important safety information.

References

  1. ONTAK [prescribing information]. Woodcliff Lake, NJ: Eisai Inc; October 2008.
  2. Data on file, Eisai Inc. Woodcliff Lake, NJ.
  3. Olsen E, Duvic M, Frankel A, et al. Pivotal phase III trial of two dose levels of denileukin diftitox for the treatment of cutaneousT-cell lymphoma. J Clin Oncol. 2001;19(2)376-388.