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Proleukin Dosage

Generic name: aldesleukin 1.1mg in 1mL
Dosage form: injection, powder, lyophilized, for solution
Drug classes: Interleukins, Miscellaneous antineoplastics

Medically reviewed by Drugs.com. Last updated on Feb 7, 2024.

Recommended Evaluation and Testing Before Initiating Proleukin

Conduct baseline hematologic, chemistry, renal and hepatic function tests. Additionally, evaluate cardiac ejection fraction, coronary artery disease as appropriate, pulmonary function with PFTs, and evaluate for renal, hepatic, and CNS impairment prior to initiating treatment with Proleukin [see Contraindications (4), Warnings and Precautions (5.1, 5.2)].

Verify pregnancy status of females of reproductive potential prior to initiating Proleukin [see Warnings and Precautions (5.6), Use in Specific Populations (8.1, 8.3)].

Recommended Dosage

Administer Proleukin in an inpatient hospital setting. An intensive care facility with specialists skilled in cardiopulmonary or intensive care medicine must be available [see Warnings and Precautions (5.1)].

The recommended dosage of Proleukin for metastatic renal cell carcinoma and metastatic melanoma is described in Table 1.

Administer Proleukin as an intravenous infusion after dilution [see Dosage and Administration (2.5)].

Administer pre-infusion medications and supportive treatment, as appropriate, prior to and during each infusion [see Dosage and Administration (2.3)]. Discontinue Proleukin for unacceptable toxicity [see Dosage and Administration (2.4)].

Table 1: Recommended Dosage of Proleukin
*
A maximum of 28 doses (2 cycles) per treatment course
Each course of therapy consists of the following:
Cycle 1 Days 1-5 600,000 IU/kg (0.037 mg/kg) every 8 hours; maximum of 14 doses*
Rest period Days 6-14
Cycle 2 Days 15-19 600,000 IU/kg (0.037 mg/kg) every 8 hours; maximum of 14 doses*

Evaluate patients for response approximately 4 weeks after completion of a course of therapy and again immediately prior to the scheduled start of the next treatment course.

Additional courses of treatment may be administered to patients if there is a treatment response following the last course, and the patient did not experience any adverse reactions in previous course(s) that led to permanent discontinuation [see Dosage and Administration (2.4)].

Separate each treatment course by a rest period of at least 7 weeks from the date of hospital discharge.

Premedication and Supportive Medications

Premedicate patients with an antipyretic immediately prior to beginning Proleukin. Continue antipyretics during treatment as needed for fever [see Warnings and Precautions (5.1, 5.10)].

Administer prophylactic antibiotics per institutional guidelines prior to beginning Proleukin and throughout the treatment course for patients with indwelling central catheters [see Warnings and Precautions (5.3)].

Administer prophylactic medication for gastrointestinal irritation and bleeding during each Proleukin treatment course [see Adverse Reactions (6.1)].

Additional medications may be needed if patients experience hypotension, dyspnea, rigors, nausea, diarrhea, pruritis, or dermatitis [see Warnings and Precautions (5.1, 5.8, 5.9)].

Dosage Modifications for Adverse Reactions

No dose reduction for Proleukin is recommended for adverse reactions. In general, withhold or interrupt a dose or permanently discontinue Proleukin based on the severity of the adverse reaction as described in Table 2.

Table 2: Recommended Dosage Modifications for Adverse Reactions
Adverse Reaction Severity Dosage Modification
Cardiovascular [see Warnings and Precautions (5.1)]
  • Atrial fibrillation,
  • Supraventricular tachycardia, or
  • Bradycardia that requires treatment or is recurrent or persistent
  • Decrease in systolic blood pressure to <90 mmHg
 Withhold until patient is asymptomatic with full recovery to normal sinus rhythm
  • Sustained ventricular tachycardia (≥5 beats)
  • Cardiac rhythm disturbances not controlled or unresponsive to management
  • ECG changes consistent with ischemia or myocardial infarction or angina/chest pain
  • Cardiac tamponade
 Permanently discontinue
Respiratory [see Warnings and Precautions (5.1)]
  • O2 saturation <90%
 Withhold until O2 saturation is >90%
  • Intubation for >72 hours
 Permanently discontinue
Neurologic [see Warnings and Precautions (5.2)]
  • Mental status changes, including moderate confusion or agitation
 Withhold until completely resolved
  • Coma or toxic psychosis lasting >48 hours
  • Repetitive or difficult to control seizures
 Permanently discontinue
Gastrointestinal [see Warnings and Precautions (5.1)] Fecal immunochemical test (FIT) or fecal occult blood test (FOBT) positive Withhold until FIT or FOBT negative
Bowel ischemia/perforation or GI bleeding requiring surgery Permanently discontinue
Hepatic [see Warnings and Precautions (5.1)] Signs of hepatic toxicity including liver pain or ≥ Grade 3 AST or ALT elevation Withhold all further treatment for that course. Initiate a new course of treatment no sooner than 7 weeks after signs of hepatic toxicity have resolved and hospital discharge
Hepatic failure Permanently discontinue
Dermatologic [see Warnings and Precautions (5.5, 5.7)] Bullous dermatitis or marked worsening of pre-existing skin condition Withhold until all signs of bullous dermatitis have resolved
Infectious [see Warnings and Precautions (5.3)] Sepsis syndrome, patient is clinically unstable Withhold until sepsis syndrome has resolved, patient is clinically stable, infection is under treatment
Renal [see Warnings and Precautions (5.1, 5.4)] Serum creatinine >4.5 mg/dL or a serum creatinine of ≥4 mg/dL in the presence of severe volume overload, acidosis, or hyperkalemia Withhold until serum creatinine levels return to normal (<1.5 mg/dL) or baseline and fluid and electrolyte status are stable
Persistent oliguria, urine output of <10 mL/hr for 16-24 hours with rising SCr Withhold until urine output >10 mL/hour with a decrease of serum creatinine >1.5 mg/dL or normalization of serum creatinine
Renal failure requiring dialysis >72 hours Permanently discontinue

Preparation and Administration

Preparation

Reconstitute Proleukin using Sterile Water for Injection, USP. Do not reconstitute or dilute Proleukin with Bacteriostatic Water for Injection, or 0.9% Sodium Chloride Injection.

  • Add 1.2 mL of Sterile Water for Injection, USP, by injecting the water along the walls of the vial and not directly on the lyophilized powder. The resulting concentration is 18 million IU (1.1 mg)/mL of Proleukin.
  • The prepared solution is a clear, colorless to slightly yellow liquid.
  • Slowly swirl the vial; do not shake.
  • Withdraw the required dose of Proleukin and discard the vial with any unused portion.
  • Use polyvinyl chloride bags for dilution of Proleukin and dilute using 5% Dextrose Injection to a concentration between 0.03 mg/mL and 0.07 mg/mL based on the required dose as follows:
Table 3: Recommended Proleukin Dilution
Dose 5% Dextrose Volume
≤25.4 million IU (≤1.5 mg) 25 mL
>25.4 million IU-60 million IU (>1.5 mg-3.5 mg) 50 mL
>60 million IU (>3.5 mg) 100 mL

Storage of Diluted Proleukin Infusion Solution

  • Store under refrigeration at 2° to 8°C (36° to 46°F) for no more than 48 hours from the time of preparation to the end of the infusion.
  • Protect from light.
  • Do not freeze.
  • Allow the diluted solution to come to room temperature prior to administration.

Administration

  • Do not use in-line filters when administering Proleukin.
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
  • Do not co-administer Proleukin with other drugs through the same intravenous line.
  • Administer by intravenous infusion over 15 minutes.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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