Cutaneous T-cell lymphoma

Most common adverse reactions-

CNS -   asthenia  4%      dizziness 10%   fatigue  30%   headache  16%

Dermatologic -   pruritus  8%    rash  3%

GI - anorexia   4%  diarrhea   8%   nausea   20%    vomiting  5%

Musculoskeletal -  arthalgia   10%   myalgia  4%    rigors   18%

Respiratory -  cough  5%    dyspnea  3%    upper respiratory tract infection   10%

Miscellaneous -  edema  20%    pain 5%   pyrexia  14%

Special precautions/Warnings-

Infusion reactions-
Serious infusion reactions were reported in denileukin diftitox treated patients . Some
post marketing reports of infusion reactions including deaths have been reported

Resuscitative equipment - should be available during Denileukin Diftitox  administration.
Immediately stop and permanently discontinue denileukin diftitox for serious infusion
reactions

Weight gain - regularly assess patients for weight gain ,new onset or worsening edema
and hypotension including orthostatic changes and monitor serum albumin levels  prior
to initiation of each course.
Withhold denileukin diftitox for serum albumin levels less than 3g/dL

Visual loss - loss of visual acuity usually with loss of color vision with or without  retinal
pigment mottling has been reported following denileukin diftitox administration

Pregnancy-  Give denileukin diftitox to a  pregant woman only if clearly needed.

Lactation- Due to the potential for serious adverse reactions in breast feeding infants from
the drug, decide whether to stop nursing or the drug depending on the importance of the drug to the mother.

Children- safety and efficacy in children have not been established

Monitoring- carefully monitor weight , edema, and blood pressure prior to during treatment

Indication-

Cutaneous T-cell lymphoma

Dosage

Adults -
Premedication- premedicate with an anihistamine and acetoaminophen prior
to each denilukin difitox infusion

Usual dosage-  9 to 18mcg/kg/day by intravenous IV infusion over 30 to 60 minutes for
5 consecutive days every 21 days for 8 cycles.

Storage- store frozen  at or below -10C ( 14F ). Thaw vials in the refrigerator at 2 to 8C 
( 36 to 46F ) for not more than 24 hours or at room temp for 1 to 2 hours.
Do not freeze denileukin  difitox after thawing. Discard unused portion of  denileukin difitox 
immediately.

1. Advice patients to report -  fever, chills, breathing problems, chest pain, tachycardia,
    and urticaria following infusion

2. Report - rapid weight gain, edema, and or orthostatic hypotension following infusion

3. Instruct patients to weigh themselves daily

4. Report and visual loss, including loss of color vision to  your Doctor.

Pregnancy- 
Give denileukin diftitox to a  pregant woman if clearly needed.

Lactation-
Due to the potential for serious adverse reactions in breast feeding infants from
the drug, decide whether to stop nursing or the drug depending on the importance of the drug
to the mother.

Children-
Safety and efficacy in children have not been established

Monitoring-
Carefully monitor weight , edema, and blood pressure prior to during treatment