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Aldesleukin Dosage

Applies to the following strength(s): 22000000 intl units

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Renal Cell Carcinoma

0.037 mg/kg (600,000 IU/kg) every 8 hours via a 15-minute IV infusion for a maximum of 14 doses; the schedule is repeated for another 14 doses after 9 days of rest.

Maximum Dose: 28 doses per course, as tolerated

Therapy Duration: During the first therapy course, metastatic RCC patients received a median of 20 doses and metastatic melanoma patients received a median of 18 doses.

Comments:
-Each treatment course consists of two 5-day treatment cycles separated by a rest period.
-Patient selection should include assessment of ECOG PS (Eastern Cooperative Oncology Group performance status).

Use: Treatment of metastatic renal cell carcinoma (RCC) and metastatic melanoma.

Usual Adult Dose for Melanoma - Metastatic

0.037 mg/kg (600,000 IU/kg) every 8 hours via a 15-minute IV infusion for a maximum of 14 doses; the schedule is repeated for another 14 doses after 9 days of rest.

Maximum Dose: 28 doses per course, as tolerated

Therapy Duration: During the first therapy course, metastatic RCC patients received a median of 20 doses and metastatic melanoma patients received a median of 18 doses.

Comments:
-Each treatment course consists of two 5-day treatment cycles separated by a rest period.
-Patient selection should include assessment of ECOG PS (Eastern Cooperative Oncology Group performance status).

Use: Treatment of metastatic renal cell carcinoma (RCC) and metastatic melanoma.

Renal Dose Adjustments

No adjustment recommended; however, use caution as the risk of toxic reactions to this drug may be greater in patients with impaired renal function.

For Renal Toxicity:
-Decisions to stop, hold, or restart treatment should be made after performing a global patient assessment; dose reductions are not recommended.
-Life-threatening toxicities may be ameliorated with IV dexamethasone, which may also cause aldesleukin to lose its therapeutic effects.
-Retreatment is contraindicated in patients who have experienced these toxicities.

-HOLD DOSE: Serum creatinine greater than 4.5 mg/dL or 4 mg/dL or greater in the presence of severe volume overload, acidosis, or hyperkalemia; persistent oliguria, urine output of less than 10 mL/hr for 16 to 24 hours with rising SCr.
-RESTART DOSE: SCr less than 4 mg/dL and stable fluid and electrolyte status; urine output greater than 10 mL/hr with a decrease of SCr greater than 1.5 mg/dL or normalization of SCr.

Liver Dose Adjustments

Data not available.

For Hepatic Toxicity:
-Decisions to stop, hold, or restart treatment should be made after performing a global patient assessment; dose reductions are not recommended.
-Life-threatening toxicities may be ameliorated with IV dexamethasone, which may also cause aldesleukin to lose its therapeutic effects.
-Retreatment is contraindicated in patients who have experienced these toxicities.

-HOLD DOSE: Signs of hepatic failure including encephalopathy, increasing ascites, liver pain, hypoglycemia.
-RESTART DOSE: All signs of hepatic failure have resolved; discontinue all further treatment for that course; a new treatment course (if warranted) should be initiated no sooner than 7 weeks after cessation of adverse event and hospital discharge.

Dose Adjustments

For Toxicity:
-Decisions to stop, hold, or restart treatment should be made after performing a global patient assessment; dose reductions are not recommended.
-Life-threatening toxicities may be ameliorated with IV dexamethasone, which may also cause aldesleukin to lose its therapeutic effects.
-Retreatment is contraindicated in patients who have experienced these toxicities:

CARDIOVASCULAR:
-HOLD DOSE: Atrial fibrillation, supraventricular tachycardia, or bradycardia that requires treatment or is recurrent or persistent; systolic blood pressure (BP) less than 90 mm Hg with increasing requirements for pressors; any ECG changes consistent with myocardial infarction (MI), ischemia, or myocarditis with or without chest pain; suspicion of cardiac ischemia.
-RESTART DOSE: Patient is asymptomatic with full recovery to normal sinus rhythm; systolic BP 90 mm Hg or greater and stable or improving requirements for pressors; patient is asymptomatic, MI and myocarditis have been ruled out, and clinical suspicion of angina is low; there is no evidence of ventricular hypokinesia.

DERMATOLOGICAL:
-HOLD DOSE: Bullous dermatitis or marked worsening of pre-existing skin condition; topical steroid therapy should be avoided.
-RESTART DOSE: Resolution of all signs of bullous dermatitis.

GASTROINTESTINAL:
-HOLD DOSE: Stool guaiac repeatedly greater than 3 to 4+.
-RESTART DOSE: Negative stool guaiac.

GENERAL:
-HOLD DOSE: Sepsis syndrome; patient clinically unstable.
-RESTART DOSE: Sepsis syndrome resolved, patient clinically stable, infection is under treatment.

NERVOUS SYSTEM:
-HOLD DOSE: Mental status changes, including moderate confusion or agitation.
-RESTART DOSE: Mental status changes completely resolved.

RESPIRATORY:
-HOLD DOSE: O2 saturation less than 90%.
-RESTART DOSE: O2 sat greater than 90%

Precautions

US BOXED WARNINGS:
-CARDIOPULMONARY DISEASE: This drug should be restricted to patients with normal cardiac and pulmonary functions as defined by thallium stress testing and formal pulmonary function testing; extreme caution should be used in patients with normal test results who have a history of cardiac or pulmonary disease.
-EXPERIENCED PHYSICIAN: This drug should be administered in a hospital setting under the supervision of a physician experienced in the use of anticancer agents; an intensive care facility and cardiopulmonary or intensive care specialists also must be available.
-CAPILLARY LEAK SYNDROME (CLS): Administration of this drug has been associated with CLS. CLS results in hypotension and reduced organ perfusion, which may be severe and result in death.
-INFECTIONS: This drug is associated with impaired neutrophil function (reduced chemotaxis) and with an increased risk of disseminated infection, including sepsis and bacterial endocarditis. Consequently, preexisting bacterial infections should be adequately treated prior to use of this drug. Patients with indwelling central lines are particularly at risk for infection with gram positive microorganisms. Antibiotic prophylaxis with oxacillin, nafcillin, ciprofloxacin, or vancomycin has been associated with a reduced incidence of staphylococcal infections.
-CNS TOXICITY: This drug should be withheld in patients developing moderate to severe lethargy or somnolence; continued administration may result in coma.

Safety and efficacy have not been established in patients younger than 18 years.

Dialysis

Data not available.

Other Comments

Administration Advice:
-Patients should be evaluated for response approximately 4 weeks after therapy course completion and again immediately prior to the next treatment course.
-Each treatment course should be separated by a rest period of at least 7 weeks from the date of hospital discharge.
-Additional treatment courses should be given only if there is some tumor shrinkage following the last course and retreatment is not contraindicated.
-Patients should have normal cardiac, pulmonary, hepatic, and CNS function at the start of therapy.
-In-line filters should not be used.
-This drug should be administered within 48 hours of reconstitution.
-This drug should not be co-administered with other drugs in the same container.
-This drug should be brought to room temperature before administration.

Storage Requirements:
-This drug should be kept in its original package; protected from light; and refrigerated at 2 to 8 degrees Celsius (36 to 46 Fahrenheit) before and after reconstitution and dilution.
-Unused drug should be discarded.

Reconstitution and Dilution Directions:
-The manufacturer product information should be consulted.

General:
-Clinical studies show patients with ECOG PS 0 at treatment initiation have a higher response rate and experience lower toxicity; data in patients with ECOG PS greater than 1 is extremely limited.
-The impact of anti-aldesleukin antibody formation on clinical efficacy and safety is unknown.
-The relationship between potency and protein mass: 18 million IUs aldesleukin equals 1.1 mg protein.
-Each vial contains 22 million IUs (1.3 mg) of drug and no preservatives.
-The solubilizing agent sodium dodecyl sulfate may have an effect on the kinetic properties of this drug.
-This drug is produced by recombinant DNA technology using a genetically engineered E. coli strain containing an analog of the human IL-2 gene.
-The potential for mutagenicity or carcinogenicity is considered low given the similarities between this drug and endogenous IL-2.
-The manufacturer product information should be consulted for concomitant medications shown to be useful in managing adverse effects experienced by patients.

Monitoring:
-Cardiovascular: Vital signs, clinical exams, organ function monitoring (daily); hypovolemia (via catheterization and central pressure monitoring)
-Endocrine: Thyroid abnormalities and other potential autoimmune phenomena, blood glucose
-Hematological: CBC with differential, platelet counts, and other standard tests (daily); blood chemistries [e.g., fluid and electrolyte balance, renal, and hepatic function tests] (daily)
-Respiratory: Pulmonary function (via clinical exams, vital signs, pulse oximetry)

Patient Advice:
-This drug may cause side effects such as confusion and drowsiness that can affect your ability to perform certain activities; avoid driving and activities such as operating machinery until you know how this drug affects you.

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