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PROLEUKIN is a brand name for Aldesleukin, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: PROLEUKIN (aldesleukin) is indicated for: • the treatment of adults (≥18 years of age) with metastatic renal cell carcinoma (metastatic RCC). • the treatment of adults (≥18 years of age) with metastatic malignant melanoma (metastatic MM). Careful patient selection is mandatory prior to the administration of PROLEUKIN.…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations The recommended PROLEUKIN (aldesleukin) treatment regimen is administered by 15-minute IV infusion every 8 hours. Before initiating treatment, carefully review the 1 INDICATIONS, 2 CONTRAINDICATIONS, 7 WARNINGS AND PRECAUTIONS, and 8 ADVERSE REACTIONS sections, particularly regarding patient selection, possible serious adverse events, patient monitoring and withholding dosage.
Evaluation of clinical studies to date reveals that patients with more favorable Eastern Cooperative Oncology Group performance status (ECOG PS 0) at treatment initiation respond better to PROLEUKIN, with a higher response rate and lower toxicity (See 8 ADVERSE REACTIONS).
Therefore, selection of patients for treatment should include assessment of performance status. Experience in patients with ECOG PS >1 is limited. 2 Recommended Dose and Dosage Adjustment The following schedule has been used to treat adult patients with metastatic RCC or metastatic MM.
Each course of treatment consists of two 5-day treatment cycles separated by a rest period. 037 mg/kg) dose administered every 8 hours by a 15-minute IV infusion for a maximum of 14 doses. Following 9 days of rest, the schedule is repeated for another 14 doses, for a maximum of 28 doses per course, as tolerated.
2 Recommended Dose and Dosage Adjustment). Metastatic RCC patients treated with this schedule received a median of 20 of the 28 doses during the first course of therapy. Metastatic MM patients received a median of 18 doses during the first course of therapy.
Retreatment Patients should be evaluated 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. PrPROLEUKIN® aldesleukin Page 6 of 39 Additional courses of treatment should be given to patients only if there is some tumor shrinkage following the last course and retreatment is not contraindicated (see 2 CONTRAINDICATIONS).
Each treatment course should be separated by a rest period of at least 7 weeks from the date of hospital discharge. Dose Modifications Dose modification for toxicity should be accomplished by withholding or interrupting a dose rather than reducing the dose to be given.
Decisions to stop, hold, or restart PROLEUKIN therapy must be made after a global assessment of the patient. 5 mg/dL or normalization of serum creatinine Digestive Signs of hepatic failure including encephalopathy, increasing ascites, liver pain, hypoglycemia All signs of hepatic failure have resolved Stool guaiac repeatedly >3-4+ Stool guaiac negative Skin Bullous dermatitis or marked worsening of pre-existing skin condition, avoid topical steroid therapy Resolution of all signs of bullous dermatitis Discontinue all further treatment for that course.
sections, particularly regarding patient selection, possible serious adverse events, patient monitoring and withholding dosage. Evaluation of clinical studies to date reveals that patients with more favorable Eastern Cooperative Oncology Group performance status (ECOG PS 0) at treatment initiation respond better to PROLEUKIN, with a higher response rate and lower toxicity (See 8 ADVERSE REACTIONS).
Therefore, selection of patients for treatment should include assessment of performance status. Experience in patients with ECOG PS >1 is limited. 2 Recommended Dose and Dosage Adjustment The following schedule has been used to treat adult patients with metastatic RCC or metastatic MM.
Each course of treatment consists of two 5-day treatment cycles separated by a rest period. 037 mg/kg) dose administered every 8 hours by a 15-minute IV infusion for a maximum of 14 doses. Following 9 days of rest, the schedule is repeated for another 14 doses, for a maximum of 28 doses per course, as tolerated.
2 Recommended Dose and Dosage Adjustment). Metastatic RCC patients treated with this schedule received a median of 20 of the 28 doses during the first course of therapy. Metastatic MM patients received a median of 18 doses during the first course of therapy.
Retreatment Patients should be evaluated 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. PrPROLEUKIN® aldesleukin Page 6 of 39 Additional courses of treatment should be given to patients only if there is some tumor shrinkage following the last course and retreatment is not contraindicated (see 2 CONTRAINDICATIONS).
Each treatment course should be separated by a rest period of at least 7 weeks from the date of hospital discharge. Dose Modifications Dose modification for toxicity should be accomplished by withholding or interrupting a dose rather than reducing the dose to be given.
sections regarding patient screening, including recommended cardiac and pulmonary function tests and laboratory tests. 1 Pediatrics (< 18 years of age) No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.
2 Geriatrics No formal clinical trials were conducted to compare the efficacy or safety of PROLEUKIN in geriatric patients to those in younger patients. It is recommended that clinicians exercise caution in prescribing PROLEUKIN to geriatric patients since decline in renal and hepatic function may occur with increasing age.
2 CONTRAINDICATIONS PROLEUKIN (aldesleukin) is contraindicated in patients with a known history of hypersensitivity to interleukin-2 or any component of the PROLEUKIN formulation. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
PROLEUKIN is contraindicated in patients with an abnormal thallium stress test or abnormal pulmonary function tests and those with organ allografts. 1 Dosing Considerations The recommended PROLEUKIN (aldesleukin) treatment regimen is administered by 15-minute IV infusion every 8 hours.
Before initiating treatment, carefully review the 1 INDICATIONS, 2 CONTRAINDICATIONS, 7 WARNINGS AND PRECAUTIONS, and
and 7 WARNINGS AND PRECAUTIONS sections regarding patient screening, including recommended cardiac and pulmonary function tests and laboratory tests. 1 Pediatrics (< 18 years of age) No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use.
2 Geriatrics No formal clinical trials were conducted to compare the efficacy or safety of PROLEUKIN in geriatric patients to those in younger patients. It is recommended that clinicians exercise caution in prescribing PROLEUKIN to geriatric patients since decline in renal and hepatic function may occur with increasing age.
2 CONTRAINDICATIONS PROLEUKIN (aldesleukin) is contraindicated in patients with a known history of hypersensitivity to interleukin-2 or any component of the PROLEUKIN formulation. For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
PROLEUKIN is contraindicated in patients with an abnormal thallium stress test or abnormal pulmonary function tests and those with organ allografts. Retreatment with PROLEUKIN is contraindicated in patients who experienced the following drug related toxicities while receiving an earlier course of therapy: • Sustained ventricular tachycardia (≥5 beats) • Cardiac arrhythmias not controlled or unresponsive to management • Chest pain with electrocardiogram (ECG) changes, consistent with angina or myocardial infarction • Cardiac tamponade • Intubation required >72 hours • Renal failure requiring dialysis >72 hours • Coma or toxic psychosis lasting >48 hours PrPROLEUKIN® aldesleukin Page 5 of 39 • Repetitive or difficult to control seizures • Bowel ischemia/perforation • GI bleeding requiring surgery
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A new course of treatment, if warranted, should be initiated no sooner than 7 weeks after cessation of adverse event and hospital discharge. 3 Reconstitution Parenteral Products: Reconstitution and dilution procedures other than those recommended may alter the delivery and/or pharmacology of PROLEUKIN and thus should be avoided.
1. PROLEUKIN is a sterile, white to off-white, preservative-free, lyophilized powder suitable for IV infusion upon reconstitution and dilution. 3 MG) OF PROLEUKIN AND SHOULD BE RECONSTITUTED ASEPTICALLY […]
Decisions to stop, hold, or restart PROLEUKIN therapy must be made after a global assessment of the patient. 5 mg/dL or normalization of serum creatinine Digestive Signs of hepatic failure including encephalopathy, increasing ascites, liver pain, hypoglycemia All signs of hepatic failure have resolved Stool guaiac repeatedly >3-4+ Stool guaiac negative Skin Bullous dermatitis or marked worsening of pre-existing skin condition, avoid topical steroid therapy Resolution of all signs of bullous dermatitis Discontinue all further treatment for that course.
A new course of treatment, if warranted, should be initiated no sooner than 7 weeks after cessation of adverse event and hospital discharge. 3 Reconstitution Parenteral Products: Reconstitution and dilution procedures other than those recommended may alter the delivery and/or pharmacology of PROLEUKIN and thus should be avoided.
1. PROLEUKIN is a sterile, white to off-white, preservative-free, lyophilized powder suitable for IV infusion upon reconstitution and dilution. 2 ML OF STERILE WATER FOR INJECTION, USP. 1 MG) OF PROLEUKIN. The resulting solution should be a clear, colorless to slightly yellow liquid.
The vial is for […]