Adult Dosing

Persistent or recurrent cutaneous T-cell lymphoma

• 9 or 18 mcg/kg intravenously over 30-60 minutes for 5 consecutive days every 21 days for 8 cycles
• Note: Premedicate with an antihistamine and acetaminophen prior to denileukin diftitox administration

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

• Primary cutaneous T-cell lymphoma, CD25-positive, persistent or recurrent disease

• Hypersensitivity to any of the ingredients of the product
• Hypersensitivity to diphtheria toxin
• Hypersensitivity to IL-2

• Therapy may cause serious and fatal infusion reactions. Therefore administer therapy in a facility equipped and staffed for cardiopulmonary resuscitation. Suspend therapy immediately if serious infusion reactions occur
• Prior to initiating therapy carefully monitor weight, edema, blood pressure and serum albumin levels as therapy may cause capillary leak syndrome resulting in death
• Following administration of drug, incidences of loss of visual acuity, usually with loss of color vision, with or without retinal pigment mottling has been reported

Renal Dose Adjustment

• Renal impairment: Dose adjustments not defined

Hepatic Dose Adjustment

• Hepatic impairment: Dose adjustments not defined

• Administer therapy in a facility equipped and staffed for cardiopulmonary resuscitation as it may cause serious and fatal infusion reactions. Suspend therapy immediately if serious infusion reactions occur [US Black Box Warning]
• Carefully monitor weight, edema, blood pressure and serum albumin levels prior to initiating therapy as it may cause capillary leak syndrome resulting in death [US Black Box Warning]
• Following administration of drug, incidences of loss of visual acuity, usually with loss of color vision, with or without retinal pigment mottling has been reported [US Black Box Warning]
• Prior to initiating therapy confirm that the patient’s malignant cells express CD25
• Monitor serum albumin levels prior to the initiation of each treatment course. Suspend therapy if serum albumin levels are less than 3.0 g/dL

Caution: Use cautiously in

• Geriatric patients

Pregnancy Category:C

Breastfeeding: Due to the potential for serious adverse reactions in nursing infants, manufacturer recommends discontinuation of nursing or discontinuation of drug, taking into account the importance of the drug to the mother.

• CNS: Asthenia, dizziness, headache, confusion, insomnia, nervousness, weakness, dysgeusia
• EENT: Loss of visual acuity, loss of color vision, rhinitis
• NEURO: Paresthesia
• RESP: URI, cough, dyspnea, pharyngitis
• CV: Chest pain, severe edema, hypotension, tachycardia, arrhythmia, hypotension, thrombotic events
• EENT: Decreased visual acuity
• DERM: Rash, pruritis, sweating
• GI: Anorexia, diarrhea, nausea, vomiting, constipation, dyspepsia, dysphagia, dehydration, increased transaminases
• GU: Albuminuria, hematuria
• HEMA: Anemia, leukopenia, thrombocytopenia
• LOCAL: Injection site reactions
• METABOLIC: Hypoalbuminemia, weight loss, hypocalcemia, hypokalemia
• MUSC: Myalgia, arthralgia, back pain
• MISC: Acute hypersensitivity reactions, severe or fatal infusion reactions, capillary leak syndrome, chills, fever, flu-like syndrome, infection, fatigue, death

• Cytotoxic protein; causes cell death (recombinant diphtheria toxin fusion protein) by binding to high affinity IL-2 receptors and by inhibiting protein synthesis
• Metabolized by proteolytic breakdown
• Excretion: Unknown
• Half-life: 70-80 mins

US Trade Name(s)

• Ontak

US Availability

Ontak

• INJ: 150 mcg/mL

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• N/A

UK Availability

• N/A

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

Hematology/Oncology

Antineoplastics

Cytotoxic Proteins