Restrict therapy with aldesleukin to patients with normal cardiac and pulmonary functions as defined by thallium stress testing and formal pulmonary function testing. Use extreme caution in patients with a normal thallium stress test and a normal pulmonary function test who have a history of cardiac or pulmonary disease.
Administer aldesleukin in a hospital setting under the supervision of a qualified physician experienced in the use of anticancer agents. An intensive care facility and specialists skilled in cardiopulmonary or intensive care medicine must be available.
Withhold aldesleukin administration in patients developing moderate to severe lethargy or somnolence; continued administration may result in coma.
Aldesleukin administration has been associated with capillary leak syndrome (CLS) which is characterized by a loss of vascular tone and extravasation of plasma proteins and fluid into the extravascular space. CLS results in hypotension and reduced organ perfusion which may be severe and can result in death. CLS may be associated with cardiac arrhythmias (supraventricular and ventricular), angina, myocardial infarction, respiratory insufficiency requiring intubation, gastrointestinal bleeding or infarction, renal insufficiency, edema, and mental status changes.
Aldesleukin treatment 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 initiation of aldesleukin therapy. 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.
Consider premedication with an antipyretic to reduce fever, an H2 antagonist for prophylaxis of GI irritation/bleeding, antiemetics, and antidiarrheals; continue premedications for 12 hours after the last aldesleukin dose. Antibiotic prophylaxis is recommended to reduce the incidence of infection. Aldesleukin doses >12 to 15 million units/m2 are associated with a moderate emetic potential; antiemetics are recommended to prevent nausea and vomiting.
Melanoma, metastatic: IV: 600,000 units/kg every 8 hours for a maximum of 14 doses; repeat after 9 days for a total of 28 doses per course (Atkins 1999); re-treat if tumor shrinkage observed (and if no contraindications) at least 7 weeks after hospital discharge date.
Off-label dosing: 720,000 units/kg every 8 hours for 14 doses; repeat cycle after a 6- to 9-day rest period. Additional courses of treatment were administered if tumor regression occurred or for stable disease (up to maximum of 5 treatment courses); each course of therapy was typically separated by a 6- to 12-week interval (Atkins 1999) or 720,000 units/kg every 8 hours for 12 to 15 doses; repeat with a second cycle ~14 days after the first dose of the initial cycle (Smith 2008).
Renal cell carcinoma, metastatic: Note: May be an option in patients with progression following treatment with PD-1/PD-L1 inhibitors (Buchbinder 2019).
IV: 600,000 units/kg every 8 hours for a maximum of 14 doses; then after 9 days have elapsed, repeat with a second cycle for a total of 28 doses per course (McDermott 2005); re-treat if tumor shrinkage observed (and if no contraindications) at least 7 weeks after hospital discharge date.
Off-label dosing: IV: 720,000 units/kg every 8 hours for up to 12 doses; then after 10 to 15 days have elapsed, repeat with a second cycle for a total of 24 doses per course; may repeat course if tumor regression observed or stable disease (and if no contraindications) at least 2 months after hospital discharge date (Klapper 2008).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Renal impairment prior to treatment initiation:
Serum creatinine ≤1.5 mg/dL: There are no dosage adjustments provided in the manufacturer's labeling.
Serum creatinine >1.5 mg/dL: Do not initiate treatment.
Renal toxicity during treatment:
Serum creatinine >4.5 mg/dL (or ≥4 mg/dL with severe volume overload, acidosis, or hyperkalemia): Withhold dose; may resume when <4 mg/dL and fluid/electrolyte status is stable.
Persistent oliguria or urine output <10 mL/hour for 16 to 24 hours with rising serum creatinine: Withhold dose; may resume when urine output is >10 mL/hour with serum creatinine decrease of >1.5 mg/dL or normalization.
Hemodialysis: Re-treatment is contraindicated in patients with renal failure requiring dialysis for >72 hours.
Hepatic impairment prior to treatment initiation: There are no dosage adjustments provided in the manufacturer's labeling.
Hepatotoxicity during treatment: Signs of hepatic failure (encephalopathy, increasing ascites, liver pain, hypoglycemia): Withhold dose and discontinue treatment for balance of cycle; may initiate a new course if indicated only after at least 7 weeks past resolution of all signs of hepatic failure (including hospital discharge).
(For additional information see "Aldesleukin: Pediatric drug information")
Note: Dosing and frequency may vary by indication, protocol, and/or treatment phase and hematologic response; refer to specific protocols. Consider premedication with an antipyretic to reduce fever, an H2 antagonist for prophylaxis of gastrointestinal irritation/bleeding, antiemetics, and antidiarrheals; continue for 12 hours after the last aldesleukin dose. Antibiotic prophylaxis is recommended to reduce the incidence of infection. Aldesleukin doses >12 to 15 million units/m2 are associated with a moderate emetic potential; antiemetics are recommended to prevent nausea and vomiting (Dupuis 2011):
Neuroblastoma: Limited data available: Children and Adolescents: IV: 3 million units/m2/day continuous infusion over 24 hours for 4 consecutive days during week 1 and 4.5 million units/m2/day continuous infusion over 24 hours for 4 consecutive days during week 2 of cycles 2 and 4 (regimen also includes isotretinoin, dinutuximab [an anti-GD2 antibody], and sargramostim) (Yu 2010)
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Dosing adjustment for toxicity: There are no pediatric-specific recommendations; the presented dosing adjustments are based on experience in adult patients. Refer to specific protocol for management in pediatric patients if available.
Adult:
Withhold or interrupt a dose for toxicity; do not reduce the dose.
Cardiovascular toxicity:
Atrial fibrillation, supraventricular tachycardia, or bradycardia that is persistent, recurrent, or requires treatment: Withhold dose; may resume when asymptomatic with full recovery to normal sinus rhythm.
Systolic BP <90 mm Hg (with increasing pressor requirements): Withhold dose; may resume treatment when systolic BP ≥90 mm Hg and stable or pressor requirements improve.
Any ECG change consistent with MI, ischemia or myocarditis (with or without chest pain), or suspected cardiac ischemia: Withhold dose; may resume when asymptomatic, MI/myocarditis have been ruled out, suspicion of angina is low, or there is no evidence of ventricular hypokinesia.
CNS toxicity: Mental status change, including moderate confusion or agitation. Withhold dose; may resume when resolved completely.
Dermatologic toxicity: Bullous dermatitis or marked worsening of preexisting skin condition: Withhold dose; may treat with antihistamines or topical products (do not use topical steroids); may resume with resolution of all signs of bullous dermatitis.
Gastrointestinal: Stool guaiac repeatedly >3 to 4+: Withhold dose; may resume with negative stool guaiac.
Infection: Sepsis syndrome, clinically unstable: Withhold dose; may resume when sepsis syndrome has resolved, patient is clinically stable, and infection is under treatment.
Respiratory toxicity: Oxygen saturation <90%: Withhold dose; may resume when >90%.
Retreatment with aldesleukin is contraindicated with the following toxicities: Sustained ventricular tachycardia (≥5 beats), uncontrolled or unresponsive cardiac arrhythmias, chest pain with ECG changes consistent with angina or MI, cardiac tamponade, intubation >72 hours, renal failure requiring dialysis for >72 hours, coma or toxic psychosis lasting >48 hours, repetitive or refractory seizures, bowel ischemia/perforation, or GI bleeding requiring surgery
Refer to adult dosing.
American Society of Clinical Oncology guidelines for appropriate systemic therapy dosing in adults with cancer with a BMI ≥30 kg/m2: The dosing in the FDA-approved prescribing information should be followed in all patients, regardless of obesity status. If a patient with a BMI ≥30 kg/m2 experiences high-grade toxicity from systemic anticancer therapy, the same dosage modification recommendations should be followed for all patients, regardless of obesity status. If dose reduction for toxicity is recommended in the prescribing information, the dose should be increased back to the initial or previously tolerated dose only if dose escalations are allowed in the prescribing information, if contributing underlying factors (eg, hepatic or kidney impairment) are sufficiently resolved, AND if performance status has markedly improved or is considered adequate (ASCO [Griggs 2021]).
Withhold or interrupt a dose for toxicity; do not reduce the dose.
Cardiovascular toxicity:
Atrial fibrillation, supraventricular tachycardia, or bradycardia that is persistent, recurrent, or requires treatment: Withhold dose; may resume when asymptomatic with full recovery to normal sinus rhythm.
Systolic BP <90 mm Hg (with increasing pressor requirements): Withhold dose; may resume treatment when systolic BP ≥90 mm Hg and stable or pressor requirements improve.
Any ECG change consistent with MI, ischemia or myocarditis (with or without chest pain), or suspected cardiac ischemia: Withhold dose; may resume when asymptomatic, MI/myocarditis have been ruled out, suspicion of angina is low, or there is no evidence of ventricular hypokinesia.
CNS toxicity: Mental status change, including moderate confusion or agitation: Withhold dose; may resume when resolved completely.
Dermatologic toxicity: Bullous dermatitis or marked worsening of preexisting skin condition: Withhold dose; may treat with antihistamines or topical products (do not use topical steroids); may resume with resolution of all signs of bullous dermatitis.
Gastrointestinal: Stool guaiac repeatedly >3-4+: Withhold dose; may resume with negative stool guaiac.
Infection: Sepsis syndrome, clinically unstable: Withhold dose; may resume when sepsis syndrome has resolved, patient is clinically stable, and infection is under treatment.
Respiratory toxicity: Oxygen saturation <90%: Withhold dose; may resume when ≥90%.
Re-treatment with aldesleukin is contraindicated with the following toxicities: Sustained ventricular tachycardia (≥5 beats), uncontrolled or unresponsive cardiac arrhythmias, chest pain with ECG changes consistent with angina or MI, cardiac tamponade, intubation >72 hours, renal failure requiring dialysis for >72 hours, coma or toxic psychosis lasting >48 hours, repetitive or refractory seizures, bowel ischemia/perforation, or GI bleeding requiring surgery.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Intravenous [preservative free]:
Proleukin: 22,000,000 units (1 ea)
No
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Intravenous:
Proleukin: 22,000,000 units (1 ea)
IV: Aldesleukin doses >12 to 15 million units/m2 are associated with a moderate emetic potential; antiemetics are recommended to prevent nausea and vomiting.
Administer as IV infusion over 15 minutes (do not administer with an inline filter). Allow solution to reach room temperature prior to administration. Flush before and after with D5W, particularly if maintenance IV line contains sodium chloride.
Parenteral: Aldesleukin doses >12 to 15 million units/m2 are associated with a moderate emetic potential; antiemetics are recommended to prevent nausea and vomiting (Dupuis 2011)
IV: Allow solution to reach room temperature prior to administration; infuse over 15 minutes; flush line before and after with D5W, particularly if maintenance IV line contains sodium chloride. Some protocols infuse as a continuous infusion (Legha 1998; Yu 2010).
Melanoma, metastatic: Treatment of metastatic melanoma in adults.
Renal cell cancer, metastatic: Treatment of metastatic renal cell cancer in adults.
Limitations of use: Careful patient selection is necessary. Assess performance status (PS); patients with a more favorable PS (Eastern Cooperative Oncology Group [ECOG] PS 0) at treatment initiation respond better to aldesleukin (higher response rate and lower toxicity). Experience in patients with ECOG PS >1 is limited.
Aldesleukin may be confused with oprelvekin
Proleukin may be confused with oprelvekin
This medication is in a class the Institute for Safe Medication Practices (ISMP) includes among its list of drug classes which have a heightened risk of causing significant patient harm when used in error.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%:
Cardiovascular: Hypotension (71%, grade 4: 3%), peripheral edema (28%), tachycardia (23%), edema (15%), vasodilation (13%), supraventricular tachycardia (12%, grade 4: 1%), cardiac disease (11%; includes blood pressure changes, HF and ECG changes)
Central nervous system: Chills (52%), confusion (34%, grade 4: 1%), malaise (27%), drowsiness (22%), anxiety (12%), pain (12%), dizziness (11%)
Dermatologic: Skin rash (42%), pruritus (24%), exfoliative dermatitis (18%)
Endocrine & metabolic: Weight gain (16%), acidosis (12%, grade 4: 1%), hypomagnesemia (12%), hypocalcemia (11%)
Gastrointestinal: Diarrhea (67%, grade 4: 2%), vomiting (19% to 50%, grade 4: 1%), nausea (19% to 35%), stomatitis (22%), anorexia (20%), abdominal pain (11%)
Genitourinary: Oliguria (63%, grade 4: 6%)
Hematologic & oncologic: Thrombocytopenia (37%, grade 4: 1%), anemia (29%), leukopenia (16%)
Hepatic: Hyperbilirubinemia (40%, grade 4: 2%), increased serum AST (23%, grade 4: 1%)
Immunologic: Antibody development (66% to 74%)
Infection: Infection (13%, grade 4: 1%)
Neuromuscular & skeletal: Weakness (23%)
Renal: Increased serum creatinine (33%, grade 4: 1%)
Respiratory: Dyspnea (43%, grade 4: 1%), pulmonary disease (24%; includes pulmonary congestion, rales, rhonchi), cough (11%), respiratory tract disease (11%; includes acute respiratory distress syndrome, pulmonary infiltrates, and pulmonary changes)
Miscellaneous: Fever (29%, grade 4: 1%)
1% to 10%:
Cardiovascular: Cardiac arrhythmia (10%), cardiac arrest (grade 4: 1%), myocardial infarction (grade 4: 1%), ventricular tachycardia (grade 4: 1%)
Central nervous system: Coma (grade 4: 2%), psychosis (grade 4: 1%), stupor (grade 4: 1%)
Gastrointestinal: Enlargement of abdomen (10%)
Genitourinary: Anuria (grade 4: 5%)
Hematologic & oncologic: Blood coagulation disorder (grade 4: 1%; includes intravascular coagulopathy)
Hepatic: Increased serum alkaline phosphatase (10%)
Infection: Sepsis (grade 4: 1%)
Renal: Acute renal failure (grade 4: 1%)
Respiratory: Rhinitis (10%), apnea (grade 4: 1%)
<1%, postmarketing, and/or case reports: Agitation, allergic interstitial nephritis, anaphylaxis, angioedema, asthma, atrial arrhythmia, atrioventricular block, blindness (transient or permanent), bowel infarction, bradycardia, brain disease, bullous pemphigoid, capillary leak syndrome, cardiomyopathy, cellulitis, cerebral edema, cerebral lesion, cerebral vasculitis, cerebrovascular accident, cholecystitis, colitis, delirium, depression (severe; leading to suicide), diabetes mellitus, duodenal ulcer, endocarditis, eosinophilia, exacerbation of Crohn's disease, extrapyramidal reaction, gastritis, hematemesis, hemoptysis, hemorrhage (including cerebral, gastrointestinal, retroperitoneal, subarachnoid, subdural), hepatic failure, hepatitis, hepatosplenomegaly, hypertension, hyperthyroidism, hyperuricemia, hyperventilation, hypothermia, hypoventilation, hypoxia, IgA glomerulonephritis (crescentic), increased blood urea nitrogen, increased nonprotein nitrogen, inflammatory arthritis, insomnia, intestinal necrosis, intestinal obstruction, intestinal perforation, ischemic heart disease, leukocytosis, lymphocytopenia, malignant hyperthermia, meningitis, myasthenia gravis (oculo-bulbar), mydriasis, myocarditis, myopathy, myositis, neuralgia, neuritis, neuropathy, neutropenia, optic neuritis, pancreatitis, paranoia, pericardial effusion, pericarditis, peripheral gangrene, phlebitis, pneumonia, pneumothorax, pulmonary edema, pulmonary embolism, renal tubular necrosis, respiratory acidosis, respiratory arrest, respiratory failure, restricted systemic blood flow, rhabdomyolysis, scleroderma, seizure, shock, Stevens-Johnson syndrome, syncope, thrombosis, thyroiditis, tissue necrosis at injection site, tracheoesophageal fistula, transient ischemic attacks, urticaria, ventricular premature contractions
Known history of hypersensitivity to aldesleukin or any component of the formulation; patients with abnormal thallium stress or abnormal pulmonary function tests; patients with organ allografts. Re-treatment is contraindicated in patients who have experienced sustained ventricular tachycardia (≥5 beats), uncontrolled or unresponsive cardiac arrhythmias, chest pain with ECG changes consistent with angina or myocardial infarction, cardiac tamponade, intubation >72 hours, renal failure requiring dialysis for >72 hours, coma or toxic psychosis lasting >48 hours, repetitive or refractory seizures, bowel ischemia/perforation, or GI bleeding requiring surgery.
Concerns related to adverse effects:
• Capillary leak syndrome: [US Boxed Warning]: Aldesleukin therapy is associated with capillary leak syndrome (CLS), characterized by vascular tone loss and extravasation of plasma proteins and fluid into extravascular space. CLS results in hypotension and reduced organ perfusion, which may be severe and can result in death. Cardiac arrhythmia (supraventricular and ventricular), angina, myocardial infarction, respiratory insufficiency (requiring intubation), GI bleeding or infarction, renal insufficiency, edema, and mental status changes may also be associated with CLS. CLS onset is immediately after treatment initiation with a concomitant decrease in mean arterial pressure in most patients within 2 to 12 hours after aldesleukin initiation. Monitor BP and heart rate frequently. Monitor fluid status and organ perfusion status carefully; consider fluids and/or pressor agents to maintain organ perfusion. Withhold treatment for signs of organ hypoperfusion, including altered mental status, reduced urine output, systolic BP <90 mm Hg, or cardiac arrhythmia. Once BP is normalized, may consider diuretics for excessive weight gain/edema (particularly if associated with dyspnea due to pulmonary congestion). Recovery from CLS generally begins soon after treatment cessation.
• CNS toxicity: [US Boxed Warning]: Withhold aldesleukin for patients developing moderate to severe lethargy or somnolence; continued treatment may result in coma. Mental status changes (irritability, confusion, depression) can occur and may indicate bacteremia, sepsis, hypoperfusion, CNS malignancy, and/or CNS toxicity. Aldesleukin may cause seizure; use with extreme caution in patients with seizure disorder. Patients should be evaluated and treated for CNS metastases and have a negative scan prior to treatment. New neurologic symptoms and lesions have been reported in patients without preexisting evidence of CNS metastases; clinical manifestations may include altered mental status, speech difficulties, cortical blindness, limb or gait ataxia, hallucinations, agitation, obtundation, and coma. Radiological findings may include multiple and occasionally single cortical lesions on MRI (with evidence of demyelination). Symptoms generally improve upon discontinuation; however, cases with permanent damage have been reported.
• GI toxicity: Aldesleukin doses >12 to 15 million units/m2 are associated with a moderate emetic potential; antiemetics are recommended to prevent nausea and vomiting (Dupuis 2011).
• Hyperglycemia: Symptomatic hyperglycemia and/or diabetes mellitus have been reported with aldesleukin.
• Infections: [US Boxed Warning]: Aldesleukin treatment is associated with impaired neutrophil function (reduced chemotaxis) and an increased risk of disseminated infection, including sepsis and bacterial endocarditis. Consequently, preexisting bacterial infections should be adequately treated prior to aldesleukin initiation. Patients with indwelling central lines are particularly at risk for infection with gram-positive microorganisms. Antibiotic prophylaxis has been associated with a reduced incidence of staphylococcal infections. Monitor for signs of infection or sepsis during treatment.
• Thyroid disorders: Thyroid disease (hypothyroidism, biphasic thyroiditis, and thyrotoxicosis) may occur; the onset of hypothyroidism is usually 4 to 17 weeks after treatment initiation; may be reversible upon treatment discontinuation (Hamnvik 2011). Hypothyroidism may sometimes be preceded by hyperthyroidism. Some cases of hypothyroidism required thyroid replacement therapy.
Disease-related concerns:
• Autoimmune/inflammatory disorders: Aldesleukin has been associated with exacerbation or new onset of autoimmune disease or inflammatory disorders. Exacerbation of Crohn disease, scleroderma, thyroiditis, inflammatory arthritis, diabetes mellitus, oculo-bulbar myasthenia gravis, crescentic IgA glomerulonephritis, cholecystitis, cerebral vasculitis, Stevens-Johnson syndrome, and bullous pemphigoid have been reported following aldesleukin monotherapy or combination therapy with interferon.
• Cardiopulmonary disease: [US Boxed Warning]: Treatment with aldesleukin should be restricted to patients with normal cardiac and pulmonary functions as defined by thallium stress and formal pulmonary function testing. Extreme caution should be used in patients with a history of prior cardiac or pulmonary disease and in patients who are fluid-restricted or where edema may be poorly tolerated. Eosinophilic infiltration of cardiac and pulmonary tissue may occur with aldesleukin. In a scientific statement from the American Heart Association, interleukin-2 has been determined to be an agent that may either cause direct myocardial toxicity (rare) or exacerbate underlying myocardial dysfunction (magnitude: major) (AHA [Page 2016]).
• Hepatic function: Aldesleukin may impair hepatic function; concomitant hepatotoxic agents may increase the risk of hepatotoxicity.
• Renal function: Patients must have a serum creatinine ≤1.5 mg/dL prior to treatment. Aldesleukin may impair renal function; concomitant nephrotoxic agents may increase the risk of renal toxicity.
Special populations:
• Older adult: The incidence of dyspnea and severe urogenital toxicities may be increased in elderly patients.
• Transplant recipients: Enhancement of cellular immune function due to aldesleukin may increase the risk of allograft rejection.
Other warnings/precautions:
• Contrast media: An acute array of symptoms resembling aldesleukin adverse reactions (fever, chills, nausea, rash, pruritus, diarrhea, hypotension, edema, and oliguria) were observed within 1 to 4 hours after iodinated contrast media administration, usually when given within 4 weeks after aldesleukin treatment, although symptoms have been reported several months after aldesleukin treatment.
• Experienced physician: [US Boxed Warning]: Aldesleukin should be administered under the supervision of an experienced cancer chemotherapy physician in a facility with cardiopulmonary or intensive specialists and intensive care facilities available.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
5-Aminosalicylic Acid Derivatives: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy
Alfuzosin: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Amifostine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Amifostine. Management: When used at chemotherapy doses, hold blood pressure lowering medications for 24 hours before amifostine administration. If blood pressure lowering therapy cannot be held, do not administer amifostine. Use caution with radiotherapy doses of amifostine. Risk D: Consider therapy modification
Amisulpride (Oral): May enhance the hypotensive effect of Hypotension-Associated Agents. Risk C: Monitor therapy
Antipsychotic Agents (Second Generation [Atypical]): Blood Pressure Lowering Agents may enhance the hypotensive effect of Antipsychotic Agents (Second Generation [Atypical]). Risk C: Monitor therapy
Barbiturates: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
BCG (Intravesical): Myelosuppressive Agents may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination
Benperidol: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Blood Pressure Lowering Agents: May enhance the hypotensive effect of Hypotension-Associated Agents. Risk C: Monitor therapy
Brimonidine (Topical): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Bromperidol: May diminish the hypotensive effect of Blood Pressure Lowering Agents. Blood Pressure Lowering Agents may enhance the hypotensive effect of Bromperidol. Risk X: Avoid combination
Chloramphenicol (Ophthalmic): May enhance the adverse/toxic effect of Myelosuppressive Agents. Risk C: Monitor therapy
Cladribine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk X: Avoid combination
CloZAPine: Myelosuppressive Agents may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor therapy
Corticosteroids: May diminish the antineoplastic effect of Aldesleukin. Risk X: Avoid combination
Deferiprone: Myelosuppressive Agents may enhance the neutropenic effect of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Risk D: Consider therapy modification
Diazoxide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Dipyrone: May enhance the adverse/toxic effect of Myelosuppressive Agents. Specifically, the risk for agranulocytosis and pancytopenia may be increased Risk X: Avoid combination
DULoxetine: Blood Pressure Lowering Agents may enhance the hypotensive effect of DULoxetine. Risk C: Monitor therapy
Fexinidazole: Myelosuppressive Agents may enhance the myelosuppressive effect of Fexinidazole. Risk X: Avoid combination
Herbal Products with Blood Pressure Lowering Effects: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Interferons (Alfa): May enhance the adverse/toxic effect of Aldesleukin. In particular, risks of myocardial and renal toxicity may be increased by this combination. Management: Consider using lower doses to minimize toxicity of this combination. Only coadminister aldesleukin and interferons (alfa) in patients in whom potential benefits outweigh the risk of severe toxicity. Monitor renal and cardiac function closely if combined. Risk D: Consider therapy modification
Iodinated Contrast Agents: Aldesleukin may enhance the potential for allergic or hypersensitivity reactions to Iodinated Contrast Agents. Risk C: Monitor therapy
Levodopa-Containing Products: Blood Pressure Lowering Agents may enhance the hypotensive effect of Levodopa-Containing Products. Risk C: Monitor therapy
Lormetazepam: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Molsidomine: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Naftopidil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Nicergoline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Nicorandil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Nitroprusside: Blood Pressure Lowering Agents may enhance the hypotensive effect of Nitroprusside. Risk C: Monitor therapy
Obinutuzumab: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Management: Consider temporarily withholding blood pressure lowering medications beginning 12 hours prior to obinutuzumab infusion and continuing until 1 hour after the end of the infusion. Risk D: Consider therapy modification
Olaparib: Myelosuppressive Agents may enhance the myelosuppressive effect of Olaparib. Risk C: Monitor therapy
Pentoxifylline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Pholcodine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Pholcodine. Risk C: Monitor therapy
Phosphodiesterase 5 Inhibitors: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Promazine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy
Prostacyclin Analogues: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Quinagolide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Risk C: Monitor therapy
Ropeginterferon Alfa-2b: Myelosuppressive Agents may enhance the myelosuppressive effect of Ropeginterferon Alfa-2b. Management: Avoid coadministration of ropeginterferon alfa-2b and other myelosuppressive agents. If this combination cannot be avoided, monitor patients for excessive myelosuppressive effects. Risk D: Consider therapy modification
Effective contraception is recommended for males and/or females of reproductive potential using this medication.
Adverse events were observed in animal reproduction studies.
It is not known if aldesleukin is present in breast milk. Due to the potential for serious adverse reactions in the breastfed infant, a decision should be made to discontinue breastfeeding or to discontinue the drug, taking into account the importance of treatment to the mother.
Baseline and periodic: CBC with differential and platelets (daily during treatment); blood chemistries, including electrolytes (daily during treatment), renal and hepatic function tests, and chest x-ray (daily during treatment); pulmonary function tests and arterial blood gases (baseline), thallium stress test (prior to treatment). Monitor thyroid function tests (thyroid-stimulating hormone at baseline then every 2 to 3 months during aldesleukin treatment [Hamnvik 2011]).
Monitoring during therapy should include daily (hourly if hypotensive) vital signs (temperature, pulse, BP, and respiration rate), weight, and fluid intake and output; in a patient with a decreased BP, especially systolic BP <90 mm Hg, cardiac monitoring for rhythm should be conducted. If an abnormal complex or rhythm is seen, an ECG should be performed; vital signs in these hypotensive patients should be taken hourly and central venous pressure checked; monitor for change in mental status, and for signs of infection.
The American Society of Clinical Oncology hepatitis B virus (HBV) screening and management provisional clinical opinion (ASCO [Hwang 2020]) recommends HBV screening with hepatitis B surface antigen, hepatitis B core antibody, total Ig or IgG, and antibody to hepatitis B surface antigen prior to beginning (or at the beginning of) systemic anticancer therapy; do not delay treatment for screening/results. Detection of chronic or past HBV infection requires a risk assessment to determine antiviral prophylaxis requirements, monitoring, and follow-up.
Aldesleukin is a human recombinant interleukin-2 product which promotes proliferation, differentiation, and recruitment of T and B cells, natural killer (NK) cells, and thymocytes; causes cytolytic activity in a subset of lymphocytes and subsequent interactions between the immune system and malignant cells; can stimulate lymphokine-activated killer (LAK) cells and tumor-infiltrating lymphocytes (TIL) cells.
Distribution: Primarily into plasma, lymphocytes, lungs, liver, kidney, and spleen; Vd: 6.3 to 7.9 L (Whittington 1993)
Metabolism: Renal (metabolized to amino acids in the cells lining the proximal convoluted tubules of the kidney)
Half-life elimination: IV:
Children: Distribution: 14 ± 6 minutes; Elimination: 51 ± 11 minutes
Adults: Distribution: 13 minutes; Terminal: 85 minutes
Excretion: Urine (primarily as metabolites); Clearance: 268 mL/minute
Solution (reconstituted) (Proleukin Intravenous)
22000000 unit (per each): $6,661.76
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