Ontak Indications, Dosage, Storage, Stability - Denileukin Diftitox

Ontak Indications, Dosage, Storage, Stability - Denileukin Diftitox

INDICATIONS

ONTAK is indicated for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma whose malignant cells express the CD25 component of the IL-2 receptor (See PRECAUTIONS , Laboratory Tests , for CD25 expression testing). The safety and efficacy of denileukin diftitox in patients with CTCL whose malignant cells do not express the CD25 component of the IL-2 receptor have not been examined.

ONTAK is for intravenous (IV) use only. The recommended treatment regimen (one treatment cycle) is 9 or 18 mcg/kg/day administered intravenously for five consecutive days every 21 days. ONTAK should be infused over at least 15 minutes. If infusional adverse reactions occur (see ADVERSE REACTIONS), the infusion should be discontinued or the rate should be reduced depending on the severity of the reaction. There is no clinical experience with prolonged infusion times (> 80 minutes).

The optimal duration of therapy has not been determined; however, only 2% (1/51) of patients who did not demonstrate at least a 25% decrease in tumor burden prior to the fourth course of treatment subsequently responded.

Special Handling:

• ONTAK must be brought to room temperature, up to 25° C (77°F), before preparing the dose. The vials may be thawed in the refrigerator at 2 to 8°C (36 to 46°F) for not more than 24 hours or at room temperature for 1 to 2 hours. ONTAK MUST NOT BE HEATED.
• The solution in the vial may be mixed by gentle swirling; DO NOT VIGOROUSLY SHAKE ONTAK SOLUTION.
• After thawing, a haze may be visible. This haze should clear when the solution is at room temperature.
• ONTAK solution must not be used unless the solution is clear, colorless and without visible particulate matter.
• ONTAK MUST NOT BE REFROZEN.

Preparation and Administration:

• USE APPROPRIATE ASEPTIC TECHNIQUE IN DILUTION AND ADMINISTRATION OF ONTAK.
• Prepare and hold diluted ONTAK in plastic syringes or soft plastic IV bags. DO NOT USE A GLASS CONTAINER because adsorption to glass may occur in the dilute state.
• The concentration of ONTAK must be at least 15 mcg/mL during all steps in the preparation of the solution for IV infusion. This is best accomplished by withdrawing the calculated dose from the vial(s) and injecting it into an empty IV infusion bag. FOR EACH 1 ML OF ONTAK FROM THE VIAL(S), NO MORE THAN 9 ML OF STERILE SALINE WITHOUT PRESERVATIVE SHOULD THEN BE ADDED TO THE IV BAG.
• The ONTAK dose should be infused over at least 15 minutes.
• ONTAK SHOULD NOT BE ADMINISTERED AS A BOLUS INJECTION.
• Do not physically mix ONTAK with other drugs.
• DO NOT ADMINISTER ONTAK THROUGH AN IN-LINE FILTER.
• Prepared solutions of ONTAK should be administered within 6 hours, using a syringe pump or IV infusion bag.
• Unused portions of ONTAK should be discarded immediately.

ONTAK is supplied as:

150 mcg/mL sterile, frozen solution (300 mcg in 2 mL) in a sterile, single-use vial

NDC 64365-503-01, 6 vials in a package.

Store frozen at or below -10°C.

REFERENCES

1. Nakase K, Kita K, Nasu K, Ueda T, Tanaka I, Shirakawa S and Tsudo M. Differential expression of interleukin-2 receptor ((alpha) and (beta) chain) in mature lymphoid neoplasms. Amer. J. Hematol. 1994; 46: 179-183.

Manufactured by:
Seragen, Incorporated
Hopkinton, MA 01748

Distributed by:
Ligand Pharmaceuticals Incorporated
San Diego, CA 92121