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Aldesleukin

Pronunciation

(al des LOO kin)

Index Terms

  • IL-2
  • Interleukin 2
  • Interleukin-2
  • Lymphocyte Mitogenic Factor
  • Recombinant Human Interleukin-2
  • T-Cell Growth Factor
  • TCGF
  • Thymocyte Stimulating Factor

Dosage Forms

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)

Brand Names: U.S.

  • Proleukin

Pharmacologic Category

  • Antineoplastic Agent, Biological Response Modulator
  • Antineoplastic Agent, Miscellaneous

Pharmacology

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.

Absorption

Oral: Not absorbed

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)

Excretion

Urine (primarily as metabolites)

Half-Life Elimination

IV:

Children: Distribution: 14 ± 6 minutes; Elimination: 51 ± 11 minutes

Adults: Distribution: 13 minutes; Terminal: 85 minutes

Use: Labeled Indications

Melanoma, metastatic: Treatment of metastatic melanoma

Renal cell cancer, metastatic: Treatment of metastatic renal cell cancer

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.

Contraindications

Hypersensitivity to aldesleukin or any component of the formulation; patients with abnormal thallium stress or pulmonary function tests; patients who have had an organ allograft. 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 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.

Dosing: Adult

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.

Renal cell carcinoma, 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; re-treat if tumor shrinkage observed (and if no contraindications) at least 7 weeks after hospital discharge date

or

Off-label dosing: 720,000 units/kg every 8 hours for up to 12 doses; repeat with a second cycle 10 to 15 days later (Klapper, 2008)

Melanoma, metastatic: IV:

Single-agent use: 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; re-treat if tumor shrinkage observed (and if no contraindications) at least 7 weeks after hospital discharge date

or

Off-label dosing: 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)

Combination biochemotherapy (off-label use): 9 million units/m2/day continuous infusion over 24 hours for 4 days every 3 weeks for up to 4 cycles (Atkins, 2008) or 9 million units/m2/day continuous infusion over 24 hours days 5 to 8, 17 to 20, and 26 to 29 every 42 days for up to 5 cycles (Eton, 2002) or 9 million units/m2/day continuous infusion over 24 hours for 4 days every 3 weeks for 6 cycles (Legha, 1998)

Dosing: Geriatric

Refer to adult dosing.

Dosing: Pediatric

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 (off-label use): IV: 3 million units/m2/day continuous infusion over 24 hours daily for 4 days during week 1 and 4.5 million units/m2/day continuous infusion over 24 hours daily for 4 days during week 2 of cycles 2 and 4 (regimen also includes isotretinoin, dinutuximab, and sargramostim) (Yu, 2010).

Dosing: Renal Impairment

Adults:

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 >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.

Dosing: Hepatic Impairment

Adults:

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).

Dosing: Adjustment for Toxicity

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

Reconstitution

Reconstitute vials with 1.2 mL SWFI (preservative free) to a concentration of 18 million units (1.1 mg)/1 mL (sterile water should be injected towards the side of the vial). Gently swirl; do not shake. Further dilute with 50 mL of D5W. Smaller volumes of D5W should be used for doses ≤1.5 mg; avoid concentrations <30 mcg/mL and >70 mcg/mL (an increased variability in drug delivery has been seen). Plastic (polyvinyl chloride) bags result in more consistent drug delivery and are recommended. Filtration may result in loss of bioactivity. Addition of 0.1% albumin has been used to increase stability and decrease the extent of sorption if low final concentrations cannot be avoided.

Avoid bacteriostatic water for injection and NS for reconstitution or dilution; increased aggregation may occur.

Administration

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).

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. Some off-label uses/doses are infused as a continuous infusion (Legha, 1998; Yu, 2010). Has also been administered by SubQ injection (off-label route).

Compatibility

Stable in D5W.

Y-site administration: Incompatible with fluorouracil, ganciclovir, lorazepam, pentamidine, prochlorperazine edisylate, promethazine, sodium chloride.

Storage

Store intact vials under refrigeration at 2°C to 8°C (36°F to 46°F). Protect from light. Plastic (polyvinyl chloride) bags result in more consistent drug delivery and are recommended. According to the manufacturer, reconstituted vials and solutions diluted for infusion are stable for 48 hours at room temperature or refrigerated although refrigeration is preferred because they do not contain preservatives. Do not freeze.

Drug Interactions

Alfuzosin: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Amifostine: Blood Pressure Lowering Agents may enhance the hypotensive effect of Amifostine. Management: When amifostine is used at chemotherapy doses, blood pressure lowering medications should be withheld for 24 hours prior to amifostine administration. If blood pressure lowering therapy cannot be withheld, amifostine should not be administered. Consider therapy modification

Antipsychotic Agents (Second Generation [Atypical]): Blood Pressure Lowering Agents may enhance the hypotensive effect of Antipsychotic Agents (Second Generation [Atypical]). Monitor therapy

Barbiturates: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

BCG (Intravesical): Myelosuppressive Agents may diminish the therapeutic effect of BCG (Intravesical). Avoid combination

Blood Pressure Lowering Agents: May enhance the hypotensive effect of Hypotension-Associated Agents. Monitor therapy

Brimonidine (Topical): May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

CloZAPine: Myelosuppressive Agents may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk for neutropenia may be increased. Monitor therapy

Corticosteroids: May diminish the antineoplastic effect of Aldesleukin. Exceptions: Beclomethasone (Nasal); Budesonide (Nasal); Ciclesonide (Nasal); Desonide; Dexamethasone (Ophthalmic); Difluprednate; Flunisolide (Nasal); Fluocinolone (Ophthalmic); Fluticasone (Nasal); Hydrocortisone (Ophthalmic); Loteprednol; Mometasone (Nasal); PrednisoLONE (Ophthalmic); Triamcinolone (Nasal); Triamcinolone (Ophthalmic). Avoid combination

Deferiprone: Myelosuppressive Agents may enhance the neutropenic effect of Deferiprone. Avoid combination

Diazoxide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Dipyrone: May enhance the adverse/toxic effect of Myelosuppressive Agents. Specifically, the risk for agranulocytosis and pancytopenia may be increased Avoid combination

DULoxetine: Blood Pressure Lowering Agents may enhance the hypotensive effect of DULoxetine. Monitor therapy

Herbs (Hypotensive Properties): May enhance the hypotensive effect of Blood Pressure Lowering Agents. 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. Consider therapy modification

Iodinated Contrast Agents: Aldesleukin may enhance the potential for allergic or hypersensitivity reactions to Iodinated Contrast Agents. Monitor therapy

Levodopa: Blood Pressure Lowering Agents may enhance the hypotensive effect of Levodopa. Monitor therapy

Molsidomine: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Naftopidil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Nicergoline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Nicorandil: May enhance the hypotensive effect of Blood Pressure Lowering Agents. 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. Consider therapy modification

Pentoxifylline: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Phosphodiesterase 5 Inhibitors: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Prostacyclin Analogues: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Quinagolide: May enhance the hypotensive effect of Blood Pressure Lowering Agents. Monitor therapy

Adverse Reactions

>10%:

Cardiovascular: Hypotension (71%, grade 4: 3%), peripheral edema (28%), tachycardia (23%), edema (15%), vasodilatation (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%)

Miscellaneous: Fever (29%, 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)

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% (Limited to important or life-threatening): 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

ALERT: U.S. Boxed Warning

Cardiopulmonary disease:

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.

Experienced physician:

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.

CNS toxicity:

Withhold aldesleukin administration in patients developing moderate to severe lethargy or somnolence; continued administration may result in coma.

Capillary leak syndrome:

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.

Infections:

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.

Warnings/Precautions

Concerns related to adverse effects:

• Adverse effects: Are frequent and sometimes fatal.

• Capillary leak syndrome: [U.S. 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, angina, myocardial infarction, respiratory insufficiency (requiring intubation), gastrointestinal bleeding or infarction, renal insufficiency, edema and mental status changes are also associated with CLS. CLS onset is immediately after treatment initiation. 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 blood pressure is normalized, may consider diuretics for excessive weight gain/edema. Recovery from CLS generally begins soon after treatment cessation.

• CNS toxicity: [U.S. Boxed Warning]: Withhold treatment 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, or CNS toxicity. May cause seizure; use with caution in patients with seizure disorder. Ethanol use may increase CNS adverse effects.

• Gastrointestinal 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).

• Infections: [U.S. Boxed Warning]: Impaired neutrophil function is associated with treatment; patients are at risk for disseminated infection (including sepsis and bacterial endocarditis), and central line-related gram-positive infections. Treat preexisting bacterial infection appropriately prior to treatment initiation. Antibiotic prophylaxis that has been associated with a reduced incidence of staphylococcal infections in aldesleukin studies includes the use of oxacillin, nafcillin, ciprofloxacin, or vancomycin. 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).

Disease-related concerns:

• Autoimmune/inflammatory disorders: Use with caution in patients with autoimmune disease or inflammatory disorders; exacerbation and/or new onset have been reported with aldesleukin and interferon alfa combination therapy.

• Cardiopulmonary disease: [U.S. 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.

• CNS metastases: 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; symptoms generally improve upon discontinuation, however, cases with permanent damage have been reported.

• Hepatic function: 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. May impair renal function; concomitant nephrotoxic agents may increase the risk of renal toxicity.

Concurrent drug therapy issues:

• Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

• Supportive care for high-dose treatment: Standard prophylactic supportive care during high-dose aldesleukin treatment includes acetaminophen to relieve constitutional symptoms and an H2 antagonist to reduce the risk of GI ulceration and/or bleeding.

Special populations:

• Elderly: The incidence of dyspnea and severe urogenital toxicities is potentially increased in elderly patients.

• Transplant patients: Enhancement of cellular immune function may increase the risk of allograft rejection.

Other warnings/precautions:

• Appropriate patient selection: Perform a thorough clinical evaluation prior to treatment initiation. Exclude patients with significant cardiac, pulmonary, renal, hepatic, or central nervous system impairment from treatment. Patients with a more favorable performance status prior to treatment initiation are more likely to respond to aldesleukin treatment, with a higher response rate and generally lower toxicity.

• Contrast media: An acute array of symptoms resembling aldesleukin adverse reactions (fever, chills, nausea, rash, pruritus, diarrhea, hypotension, edema, and oliguria) were observed within 1-4 hours after iodinated contrast media administration, usually when given within 4 weeks after aldesleukin treatment, although has been reported several months after aldesleukin treatment.

• Experienced physician: [U.S. Boxed Warning]: 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.

Monitoring Parameters

Baseline and periodic: CBC with differential and platelets, blood chemistries including electrolytes, renal and hepatic function tests, and chest x-ray; pulmonary function tests and arterial blood gases (baseline), thallium stress test (prior to treatment). Monitor thyroid function tests (TSH at baseline then every 2-3 months during aldesleukin treatment [Hamnvik, 2011]).

Monitoring during therapy should include daily (hourly if hypotensive) vital signs (temperature, pulse, blood pressure, and respiration rate), weight and fluid intake and output; in a patient with a decreased blood pressure, 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 hypotension patients should be taken hourly and central venous pressure (CVP) checked; monitor for change in mental status, and for signs of infection.

Pregnancy Risk Factor

C

Pregnancy Considerations

Adverse events were observed in animal reproduction studies. Use during pregnancy only if benefits to the mother outweigh potential risk to the fetus. Effective contraception is recommended for fertile males and/or females using this medication.

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience nausea, vomiting, anxiety, lack of appetite, diarrhea, or rhinorrhea. Have patient report immediately to prescriber signs of capillary leak syndrome (abnormal heartbeat; angina; shortness of breath; weight gain; vomiting blood or vomit that looks like coffee grounds; black, tarry, or bloody stools; unable to pass urine or change in amount of urine passed; blood in the urine), signs of infection, feeling sluggish or severe fatigue, signs of liver problems (dark urine, feeling tired, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin or eyes), signs of depression (suicidal ideation, anxiety, emotional instability, illogical thinking), signs of high blood sugar (confusion, feeling sleepy, more thirst, hunger, passing urine more often, flushing, fast breathing, or breath that smells like fruit), severe dizziness, passing out, mouth sores, hallucinations, difficulty speaking, abnormal gait, change in balance, blindness, bruising, bleeding, or signs of Stevens-Johnson syndrome/toxic epidermal necrolysis (red, swollen, blistered, or peeling skin [with or without fever]; red or irritated eyes; or sores in your mouth, throat, nose, or eyes) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

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