Details About Generic Salt ::  Aldesleu

Main Medicine Class::    

(al-dess-LOO-kin)

Proleukin

Preservative-free powder for reconstitution

22 million international units (1.3 mg) vials

Class: Biologic response modifier

 Indications Metastatic Renal Cell Carcinoma, Metastatic Melanoma.

Colorectal cancer, non-Hodgkin’s lymphoma, after autologous bone marrow transplantation (ABMT).

 Contraindications Hypersensitivity to interleukin-2 or any component of the formaultion; abnormal thallium stress test or pulmonary function tests; organ allografts; retreatment in patients experiencing Capillary Leak Syndrome (CLS) toxicities during initial therapy.

 Route/Dosage

Metastatic renal cell carcinoma, metastatic melanoma

ADULTS: IV 600,000 IU/kg q 8 hr for 14 doses. Repeat regimen after 9 days recovery for a total of 28 doses/course. Evaluate tumor response 4 wk after therapy. If tumor shrinkage is evident and further treatment is not contraindicated, another course of aldesleukin may be given using the same regimen. Allow ³ 7 wk between treatment courses (from date of hospital discharge). If toxicity occurs, hold or interrupt doses rather than decrease them. If hepatic failure occurs, discontinue further treatment for that course. Further courses may be given ³ 7 wk after resolution of hepatic failure or hospital discharge, whichever is most recent.

Breast Cancer, After ABMT

ADULTS: SC injection or continuous IV infusion Doses ranging from 600,000 to 1,800,000 IU/m²/day for 7 to 28 days.

Acute myelogenous leukemia, after ABMT

ADULTS: Continuous IV infusion Induction: 3,000,000 to 9,000,000 IU/m²/day for 4– to 5– days. After a 4– to 7-day rest period, begin maintenance therapy with aldesleukin 300,000 to 1,600,000 IU/m²/day for 10 days.

Required Dosage Modification Due To Adverse Effects

CV: Permanently discontinue therapy if sustained ventricular tachycardia (³ 5 beats), uncontrolled or unresponsive arrhythymias, recurrent chest pain with ECG changes, documented angina, MI, pericardial tamponade. Delay subsequent doses if artrial fibrillation, supraventricular tachycardia, or bradycardia, which requires therapy, recurs or persists. If systolic blood pressure < 90 mmHg with increasing pressor requirements occur. IF ECG changes consistent with MI, myocarditis, or ischemia with or without chest pain, or suspected cardiac ischemia occurs. Continue with subsequent doses if asymptomatic with full recovery to normal sinus rhythm, or if MI is ruled out, angina not suspected, and patient asymptomatic, or if no ventricular hypokinesia is present.

CNS: Permanently discontinue therapy if coma or toxic psychoses lasting > 48 hr or if repetitive or refractory seizures occur. Delay subsequent doses if mental status changes occur (eg, moderate confusion, agitation). Continue with subsequent doses if complete resolution of mental status changes occur.

DERMATOLOGIC: Delay subsequent doses if bullous dermatitis or if marked worsening of pre-existing skin condition occurs. Continue with subsequent doses if complete resolution of bullous dermatitis occurs.

GI: Permanently discontinue therapy if bowel ischemia, perforation, or bleeding requiring surgery occur. Delay subsequent doses if stool guaiac > 3 to 4+, repeatedly. Continue with subsequent doses if negative stool guaiac occur.

HEMATOLOGIC: Delay subsequent doses if signs of hepatic failure (eg, encephalopathy, increased ascites, liver pain, hypglycemia) occur. Continue with subsequent doses if resolution of hepatic failure occurs.

RESPIRATORY: Permanently discontinue therapy if intubation is required for > 72 hr. Delay subsequent doses if oxygen saturation < 94% on room air or < 90% on 2 L oxygen by nasal cannula. Continue with subsequent doses if oxygen saturation > 94% on room air or > 90% on 2 L oxygen by nasal cannula.

RENAL: Permanently discontinue therapy if dysfunction requiring dialysis for > 72 hr occur. Delay subsequent doses if serum creatinine > 4.5 mg/dL or serum creatinine of > 4 mg/dL with severe volume overload, acidosis, or hyperkalemia. Persistent oliguria or urine output < 10 mL/hr for 16 to 24 hr with increasing serum creatinine. Continue with subsequent doses if serum creatinine > 4 mg/dL with stable fluid and electrolytes, or if urine output > 10 mL/hr with normalization or decrease (> 1.5 mg/dL) in creatinine.

SYST: Delay subsequent doses if sepsis syndrome occurs. Continue with subsequent doses if resolution of sepsis syndrome, patient is clinically stable, or if infection is under treatment.

Interactions

Beta-blockers and other antihypertensives

May exacerbate aldesleukin-induced hypotension.

Cardiotoxic drugs (eg, doxorubicin)

May exacerbate aldesleukin cardiotoxicity.

CNS depressants (eg, narcotics, analgesics, alcohol, antiemetics, benzodiazepines, sedatives, tranquilizers)

May exacerbate aldesleukin CNS adverse effects.

Corticosteroids

May reduce the antineoplastic effect of aldesleukin.

Hepatotoxic drugs (eg, methotrexate, asparaginase)

May exacerbate aldesleukin hepatotoxicity.

Myelotoxic drugs (eg, cytotoxic chemotherapy)

May exacerbate aldesleukin myelotoxicity.

Nephrotoxic drugs (eg, aminoglycosides or NSAIDs)

May exacerbate aldesleukin nephrotoxicity.

Lab Test Interferences None well documented.

 Adverse Reactions

CARDIOVASCULAR: Capillary leak syndrome with resultant hypotension; myocardial ischemia or infarction; myocarditis; sinus tachycardia; edema; chest pain; arrhythmias; bradycardia; PVCs; premature atrial contractions; cardiac arrest. Hypotension is a dose-limiting toxicity after autologous bone marrow transplantation. CNS: Confusion; agitation; lethargy; somnolence; weakness; insomnia; seizures; coma; malaise; mental status changes; dizziness; sensory dysfunction; disorders of vision, speech, taste; syncope; motor dysfunction. DERMATOLOGIC: Pruritus; erythema; rash; localized irritation at the site of injection; dry skin; exfoliative dermatitis; purpura/petechiae; urticaria. ENDOCRINE: Hypothyroidism. GI: High potential for nausea and vomiting; anorexia; diarrhea; elevated LFTs; GI bleeding; bowel perforation or infarction; ileus’ stomatitis; dyspepsia; constipation. HEMATOLOGIC: Impaired neutrophil function; anemia; thrombocytopenia. Platelet requirements may be greater with continuous infusion regimens; leukopenia; coagulation disorders; leukocytosis; eosinophilia. HEPATIC: Jaundice; ascites. MUSCULOSKELETAL: Arthralgia; myalgia. RENAL: Oliguria; anuria; increased BUN and creatinine; proteinuria; hematuria; dysuria. RESPIRATORY: Dyspnea; pulmonary edema; respiratory failure; pulmonary congestion; tachypnea; pleural effusion; wheezing. OTHER: Flu-like symptoms including fever, chills, fatigue, myalgias, headache, and arthralgias. Almost all patients develop some symptoms, especially with initial therapy. Abdominal pain; back pain; infection; weight gain (³ 10%); weight loss (³ 10%); conjunctivitis.

 Precautions

Pregnancy: Category C. Lactation: Undetermined. Because of the potential for serious adverse reactions in nursing infants, decide whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Children: Safety and efficacy in children < 18 yr not established. CLS: Aldesleukin has been associated with CLS. Begins immediately after initiation of treament and results from extravasation of plasma proteins and fluid into the extravascular space and loss of vascular tone. Watch for a drop in mean arterial blood pressure within 2 to 12 hr after the start of treatment and reduced organ perfusion, which may be severe and result in death. CLS may be associated with cardiac arrhythmias, angina, MI, respiratory insufficiency, GI bleeding or infarction, renal insufficiency, and mental status change. Cardiopulmonary disease: Restrict therapy 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 normal thallium stress tests and pulmonary function tests who have a history of prior cardiac or pulmonary disease. Iodinated contrast media: Acute, atypical adverse reactions (eg, fever, chills, nausea, vomiting, pruritis, rash, diarrhea, hypotension, edema) have been reported in patients administered iodine contrast media subsequent to IL-2 treatment. Lethargy: Hold aldesleukin administration in patients developing moderate to severe lethargy or somnolence; continued administration may result in coma. Autoimmune diseases: Aldesleukin may exacerbate autoimmune disease. CNS metastases: May exacerbate disease symptoms in patients with clinically unrecognized or untreated CNS metastases. Mental status changes: Mental status changes including irritability, confusion, or depression may occur and may be indicators of bacteremia or early bacterial sepsis. Retreatment: Contraindicated in patients who experienced the following toxicities while receiving an earlier course of therapy: sustained ventricular tachycardia (³ 5 beats); cardiac rhythm disturbances uncontrolled or unresponsive; recurrent chest pain with ECG changes, consistent with angina or MI; intubation required > 72 hr; pericadial tamponade, renal dysfunction requiring dialysis > 72 hr; coma or toxic psychosis lasting > 48 hr; repetitive or difficult to control seizures; bowel ischemia/perforation; GI bleeding requiring surgery. Bacterial infections: Intensive treatment is associated with impaired neutrophil function (reduced chemotaxis) and with an increased risk of disseminated infection, including sepsis and bacterial endocarditis. Treat pre-existing bacterial infections prior to initiation of therapy. Renal/Hepatic function toxicity: Impairment of renal and hepatic function occurs during treatment. Fertility impairment: It is recommended that this drug not be administered to fertile persons of either sex not practicing effective contraception. Thyroid function impairment: Impairment has occurred following treatment. Allograft rejection: Enhancement of cellular immune function may increase the risk of allograft rejection in transplant patients.

PATIENT CARE CONSIDERATIONS

 Administration/Storage

• Refrigerate sterile powder. Do not freeze.
• Reconstitute vial with 1.2 mL of sterile water for injection. Direct sterile water at side of vial, gently swirling contents to avoid excessive foaming. Do not shake vial.
• Do not reconstitute or dilute with bacteriostatic diluents or 0.9% Sodium Chloride because increased aggregation may occur.
• Dilute the desired dose of aldesleukin in 50 mL of 5% Dextrose to achieve a final aldesleukin concentration of 30 to 70 mcg/mL. Alternately, the dose may be prepared with human serum albumin 0.1% to 2% for aldesleukin concentrations < 30 mcg/mL.
• Pharmacia Deltec CADD infusion cassette: Dilute the desired dose of aldesleukin with 5% Dextrose to achieve a final aldesleukin concentration of 100 to 500 mcg/mL. For aldesleukin concentrations between 5 to 60 mcg/mL, add human serum albumin to achieve a final albumin concentration of 0.1%. Diluted solutions containing 5% Dextrose and 100 to 500 mcg/mL aldesleukin are stable for up to 6 days at room temperature. Diluted solutions containing 5% Dextrose, 5 to 60 mcg/mL aldesleukin, and 0.1% human serum albumin are also stable for up to 6 days at room temperature.
• Aldesleukin is chemically stable for up to 48 hr under refrigeration. The manufacturer recommends use within 48 hr of reconstitution. However, aldesleukin contains no preservative and should be used within 24 hr of reconstitution.
• Diluted solutions containing 5% Dextrose and 2% human serum albumin are stable for 48 hr at room temperature. Because these preparations contain no preservatives, use within 24 hr of preparation.
• Bring solution to room temperature prior to infusion.
• Administer by IV infusion, continuous IV infusion, SC injection.
• Pretreatment with a nonsteroidal anti-inflammatory drug or acetaminophen may minimize the risk of developing fever or reduce its severity. Initiate premedication immediately before giving aldesleukin and continue for 12 hr after the final aldesleukin dose.
• IV: Infuse diluted solution over 15 min. Do not filter.
• Continuous infusion: Infuse solution with Pharmacia Deltec CADD infusion pump device. Contents of each cassette infuse over up to 6 days.

 Assessment/Interventions

• Treat preexisting bacterial infections prior to therapy. If infection is suspected during aldesleukin therapy and the patient has an indwelling central venous catheter, start antibiotics effective against S. aureus.
• Monitor standard hematologic tests, including CBC, differential, platelet count, blood chemistries, electrolytes, renal and hepatic function tests at baseline and daily during aldesleukin therapy. More than 80% of an administered dose of aldesleukin is eliminated by the kidneys.
• Obtain a chest x-ray at baseline and periodically during aldesleukin therapy.
• Monitor vital signs and weight frequently throughout the day. In a patient with a decreased blood pressure, especially < 90 mmHg, conduct constant cardiac monitoring for rhythm. If an abnormal complex or rhythm is seen, perform an ECG. Take vital signs in these hypotensive patients hourly and check central venous pressure.
• Prior to beginning therapy, obtain pulmonary function tests with arterial blood gases; document FEV₁ > 2 L or ³ 75% of predicted value for height and age. Obtain a stress thallium study; document normal ejection fraction and unimpaired wall motion. If minor wall motion abnormalities are noted, consider stress ECG to rule out significant coronary artery disease.
• During treatment monitor pulmonary function on a regular basis by clinical examination, assessment of vital signs, and pulse oximetry. Further assess patients with dyspnea or clinical signs of respiratory impairment (tachypnea or rales) with arterial blood gas determination. Repeat these tests as often as clinically indicated.
• Because of the severe adverse events that generally accompany therapy at the recommended dosages, perform thorough clinical evaluation to exclude patients with significant cardiac, pulmonary, renal, hepatic, or CNS impairment. Patients who have had a nephrectomy are still eligible for treatment if they have serum creatinine levels £ 1.5 mg/dL.
• CLS commonly occurs 2 to 12 hr after starting therapy. May occur less frequently with continuous infusion regimens. Monitor fluid and organ perfusion status frequently, measuring blood pressure, pulse, mental status, and urine output. Volume status may be determined by central venous pressure monitoring. Give IV fluids if central venous pressure is below 3 to 4 mm water. Although large volumes may be required, use caution becasue excessive fluid accumulation can cause pulmonary edema. Administration of dopamine 1 to 5 mcg/kg/min, before hypotension develps may help maintain organ perfusion and urine output. Dopamine may be increased to 6 to 10 mcg/kg/min or phenylephrine 1 to 5 mcg/km/min may be added if response is inadequate. Prolonged therapy with pressors is not recommended caused by the risk of cardiac arrhythmias. Recovery from CLS occurs rapidly after discontinuing aldesleukin therapy, usually within a few hr. In patients with excessive weight gain or edema, diuretics can be used after blood pressure has normalized.

OVERDOSAGE: SIGNS & SYMPTOMS   Dose related side effects.

Medicscientist Drug Facts

Drugs Class ::

Indications for Drugs ::

 Indications Metastatic Renal Cell Carcinoma, Metastatic Melanoma.

Colorectal cancer, non-Hodgkin’s lymphoma, after autologous bone marrow transplantation (ABMT).

Drug Dose ::

 Route/Dosage

Metastatic renal cell carcinoma, metastatic melanoma

ADULTS: IV 600,000 IU/kg q 8 hr for 14 doses. Repeat regimen after 9 days recovery for a total of 28 doses/course. Evaluate tumor response 4 wk after therapy. If tumor shrinkage is evident and further treatment is not contraindicated, another course of aldesleukin may be given using the same regimen. Allow ³ 7 wk between treatment courses (from date of hospital discharge). If toxicity occurs, hold or interrupt doses rather than decrease them. If hepatic failure occurs, discontinue further treatment for that course. Further courses may be given ³ 7 wk after resolution of hepatic failure or hospital discharge, whichever is most recent.

Breast Cancer, After ABMT

ADULTS: SC injection or continuous IV infusion Doses ranging from 600,000 to 1,800,000 IU/m²/day for 7 to 28 days.

Acute myelogenous leukemia, after ABMT

ADULTS: Continuous IV infusion Induction: 3,000,000 to 9,000,000 IU/m²/day for 4– to 5– days. After a 4– to 7-day rest period, begin maintenance therapy with aldesleukin 300,000 to 1,600,000 IU/m²/day for 10 days.

Required Dosage Modification Due To Adverse Effects

CV: Permanently discontinue therapy if sustained ventricular tachycardia (³ 5 beats), uncontrolled or unresponsive arrhythymias, recurrent chest pain with ECG changes, documented angina, MI, pericardial tamponade. Delay subsequent doses if artrial fibrillation, supraventricular tachycardia, or bradycardia, which requires therapy, recurs or persists. If systolic blood pressure < 90 mmHg with increasing pressor requirements occur. IF ECG changes consistent with MI, myocarditis, or ischemia with or without chest pain, or suspected cardiac ischemia occurs. Continue with subsequent doses if asymptomatic with full recovery to normal sinus rhythm, or if MI is ruled out, angina not suspected, and patient asymptomatic, or if no ventricular hypokinesia is present.

CNS: Permanently discontinue therapy if coma or toxic psychoses lasting > 48 hr or if repetitive or refractory seizures occur. Delay subsequent doses if mental status changes occur (eg, moderate confusion, agitation). Continue with subsequent doses if complete resolution of mental status changes occur.

DERMATOLOGIC: Delay subsequent doses if bullous dermatitis or if marked worsening of pre-existing skin condition occurs. Continue with subsequent doses if complete resolution of bullous dermatitis occurs.

GI: Permanently discontinue therapy if bowel ischemia, perforation, or bleeding requiring surgery occur. Delay subsequent doses if stool guaiac > 3 to 4+, repeatedly. Continue with subsequent doses if negative stool guaiac occur.

HEMATOLOGIC: Delay subsequent doses if signs of hepatic failure (eg, encephalopathy, increased ascites, liver pain, hypglycemia) occur. Continue with subsequent doses if resolution of hepatic failure occurs.

RESPIRATORY: Permanently discontinue therapy if intubation is required for > 72 hr. Delay subsequent doses if oxygen saturation < 94% on room air or < 90% on 2 L oxygen by nasal cannula. Continue with subsequent doses if oxygen saturation > 94% on room air or > 90% on 2 L oxygen by nasal cannula.

RENAL: Permanently discontinue therapy if dysfunction requiring dialysis for > 72 hr occur. Delay subsequent doses if serum creatinine > 4.5 mg/dL or serum creatinine of > 4 mg/dL with severe volume overload, acidosis, or hyperkalemia. Persistent oliguria or urine output < 10 mL/hr for 16 to 24 hr with increasing serum creatinine. Continue with subsequent doses if serum creatinine > 4 mg/dL with stable fluid and electrolytes, or if urine output > 10 mL/hr with normalization or decrease (> 1.5 mg/dL) in creatinine.

SYST: Delay subsequent doses if sepsis syndrome occurs. Continue with subsequent doses if resolution of sepsis syndrome, patient is clinically stable, or if infection is under treatment.

Contraindication ::

 Contraindications Hypersensitivity to interleukin-2 or any component of the formaultion; abnormal thallium stress test or pulmonary function tests; organ allografts; retreatment in patients experiencing Capillary Leak Syndrome (CLS) toxicities during initial therapy.

Drug Precautions ::

 Precautions

Pregnancy: Category C. Lactation: Undetermined. Because of the potential for serious adverse reactions in nursing infants, decide whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Children: Safety and efficacy in children < 18 yr not established. CLS: Aldesleukin has been associated with CLS. Begins immediately after initiation of treament and results from extravasation of plasma proteins and fluid into the extravascular space and loss of vascular tone. Watch for a drop in mean arterial blood pressure within 2 to 12 hr after the start of treatment and reduced organ perfusion, which may be severe and result in death. CLS may be associated with cardiac arrhythmias, angina, MI, respiratory insufficiency, GI bleeding or infarction, renal insufficiency, and mental status change. Cardiopulmonary disease: Restrict therapy 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 normal thallium stress tests and pulmonary function tests who have a history of prior cardiac or pulmonary disease. Iodinated contrast media: Acute, atypical adverse reactions (eg, fever, chills, nausea, vomiting, pruritis, rash, diarrhea, hypotension, edema) have been reported in patients administered iodine contrast media subsequent to IL-2 treatment. Lethargy: Hold aldesleukin administration in patients developing moderate to severe lethargy or somnolence; continued administration may result in coma. Autoimmune diseases: Aldesleukin may exacerbate autoimmune disease. CNS metastases: May exacerbate disease symptoms in patients with clinically unrecognized or untreated CNS metastases. Mental status changes: Mental status changes including irritability, confusion, or depression may occur and may be indicators of bacteremia or early bacterial sepsis. Retreatment: Contraindicated in patients who experienced the following toxicities while receiving an earlier course of therapy: sustained ventricular tachycardia (³ 5 beats); cardiac rhythm disturbances uncontrolled or unresponsive; recurrent chest pain with ECG changes, consistent with angina or MI; intubation required > 72 hr; pericadial tamponade, renal dysfunction requiring dialysis > 72 hr; coma or toxic psychosis lasting > 48 hr; repetitive or difficult to control seizures; bowel ischemia/perforation; GI bleeding requiring surgery. Bacterial infections: Intensive treatment is associated with impaired neutrophil function (reduced chemotaxis) and with an increased risk of disseminated infection, including sepsis and bacterial endocarditis. Treat pre-existing bacterial infections prior to initiation of therapy. Renal/Hepatic function toxicity: Impairment of renal and hepatic function occurs during treatment. Fertility impairment: It is recommended that this drug not be administered to fertile persons of either sex not practicing effective contraception. Thyroid function impairment: Impairment has occurred following treatment. Allograft rejection: Enhancement of cellular immune function may increase the risk of allograft rejection in transplant patients.

Drug Side Effects ::

 Adverse Reactions

CARDIOVASCULAR: Capillary leak syndrome with resultant hypotension; myocardial ischemia or infarction; myocarditis; sinus tachycardia; edema; chest pain; arrhythmias; bradycardia; PVCs; premature atrial contractions; cardiac arrest. Hypotension is a dose-limiting toxicity after autologous bone marrow transplantation. CNS: Confusion; agitation; lethargy; somnolence; weakness; insomnia; seizures; coma; malaise; mental status changes; dizziness; sensory dysfunction; disorders of vision, speech, taste; syncope; motor dysfunction. DERMATOLOGIC: Pruritus; erythema; rash; localized irritation at the site of injection; dry skin; exfoliative dermatitis; purpura/petechiae; urticaria. ENDOCRINE: Hypothyroidism. GI: High potential for nausea and vomiting; anorexia; diarrhea; elevated LFTs; GI bleeding; bowel perforation or infarction; ileus’ stomatitis; dyspepsia; constipation. HEMATOLOGIC: Impaired neutrophil function; anemia; thrombocytopenia. Platelet requirements may be greater with continuous infusion regimens; leukopenia; coagulation disorders; leukocytosis; eosinophilia. HEPATIC: Jaundice; ascites. MUSCULOSKELETAL: Arthralgia; myalgia. RENAL: Oliguria; anuria; increased BUN and creatinine; proteinuria; hematuria; dysuria. RESPIRATORY: Dyspnea; pulmonary edema; respiratory failure; pulmonary congestion; tachypnea; pleural effusion; wheezing. OTHER: Flu-like symptoms including fever, chills, fatigue, myalgias, headache, and arthralgias. Almost all patients develop some symptoms, especially with initial therapy. Abdominal pain; back pain; infection; weight gain (³ 10%); weight loss (³ 10%); conjunctivitis.

Drug Mode of Action ::  

Drug Interactions ::

Interactions

Beta-blockers and other antihypertensives

May exacerbate aldesleukin-induced hypotension.

Cardiotoxic drugs (eg, doxorubicin)

May exacerbate aldesleukin cardiotoxicity.

CNS depressants (eg, narcotics, analgesics, alcohol, antiemetics, benzodiazepines, sedatives, tranquilizers)

May exacerbate aldesleukin CNS adverse effects.

Corticosteroids

May reduce the antineoplastic effect of aldesleukin.

Hepatotoxic drugs (eg, methotrexate, asparaginase)

May exacerbate aldesleukin hepatotoxicity.

Myelotoxic drugs (eg, cytotoxic chemotherapy)

May exacerbate aldesleukin myelotoxicity.

Nephrotoxic drugs (eg, aminoglycosides or NSAIDs)

May exacerbate aldesleukin nephrotoxicity.

Drug Assesment ::

 Assessment/Interventions

• Treat preexisting bacterial infections prior to therapy. If infection is suspected during aldesleukin therapy and the patient has an indwelling central venous catheter, start antibiotics effective against S. aureus.
• Monitor standard hematologic tests, including CBC, differential, platelet count, blood chemistries, electrolytes, renal and hepatic function tests at baseline and daily during aldesleukin therapy. More than 80% of an administered dose of aldesleukin is eliminated by the kidneys.
• Obtain a chest x-ray at baseline and periodically during aldesleukin therapy.
• Monitor vital signs and weight frequently throughout the day. In a patient with a decreased blood pressure, especially < 90 mmHg, conduct constant cardiac monitoring for rhythm. If an abnormal complex or rhythm is seen, perform an ECG. Take vital signs in these hypotensive patients hourly and check central venous pressure.
• Prior to beginning therapy, obtain pulmonary function tests with arterial blood gases; document FEV₁ > 2 L or ³ 75% of predicted value for height and age. Obtain a stress thallium study; document normal ejection fraction and unimpaired wall motion. If minor wall motion abnormalities are noted, consider stress ECG to rule out significant coronary artery disease.
• During treatment monitor pulmonary function on a regular basis by clinical examination, assessment of vital signs, and pulse oximetry. Further assess patients with dyspnea or clinical signs of respiratory impairment (tachypnea or rales) with arterial blood gas determination. Repeat these tests as often as clinically indicated.
• Because of the severe adverse events that generally accompany therapy at the recommended dosages, perform thorough clinical evaluation to exclude patients with significant cardiac, pulmonary, renal, hepatic, or CNS impairment. Patients who have had a nephrectomy are still eligible for treatment if they have serum creatinine levels £ 1.5 mg/dL.
• CLS commonly occurs 2 to 12 hr after starting therapy. May occur less frequently with continuous infusion regimens. Monitor fluid and organ perfusion status frequently, measuring blood pressure, pulse, mental status, and urine output. Volume status may be determined by central venous pressure monitoring. Give IV fluids if central venous pressure is below 3 to 4 mm water. Although large volumes may be required, use caution becasue excessive fluid accumulation can cause pulmonary edema. Administration of dopamine 1 to 5 mcg/kg/min, before hypotension develps may help maintain organ perfusion and urine output. Dopamine may be increased to 6 to 10 mcg/kg/min or phenylephrine 1 to 5 mcg/km/min may be added if response is inadequate. Prolonged therapy with pressors is not recommended caused by the risk of cardiac arrhythmias. Recovery from CLS occurs rapidly after discontinuing aldesleukin therapy, usually within a few hr. In patients with excessive weight gain or edema, diuretics can be used after blood pressure has normalized.

Medicscientist Drug Facts

Drug Storage/Management ::

 Administration/Storage

• Refrigerate sterile powder. Do not freeze.
• Reconstitute vial with 1.2 mL of sterile water for injection. Direct sterile water at side of vial, gently swirling contents to avoid excessive foaming. Do not shake vial.
• Do not reconstitute or dilute with bacteriostatic diluents or 0.9% Sodium Chloride because increased aggregation may occur.
• Dilute the desired dose of aldesleukin in 50 mL of 5% Dextrose to achieve a final aldesleukin concentration of 30 to 70 mcg/mL. Alternately, the dose may be prepared with human serum albumin 0.1% to 2% for aldesleukin concentrations < 30 mcg/mL.
• Pharmacia Deltec CADD infusion cassette: Dilute the desired dose of aldesleukin with 5% Dextrose to achieve a final aldesleukin concentration of 100 to 500 mcg/mL. For aldesleukin concentrations between 5 to 60 mcg/mL, add human serum albumin to achieve a final albumin concentration of 0.1%. Diluted solutions containing 5% Dextrose and 100 to 500 mcg/mL aldesleukin are stable for up to 6 days at room temperature. Diluted solutions containing 5% Dextrose, 5 to 60 mcg/mL aldesleukin, and 0.1% human serum albumin are also stable for up to 6 days at room temperature.
• Aldesleukin is chemically stable for up to 48 hr under refrigeration. The manufacturer recommends use within 48 hr of reconstitution. However, aldesleukin contains no preservative and should be used within 24 hr of reconstitution.
• Diluted solutions containing 5% Dextrose and 2% human serum albumin are stable for 48 hr at room temperature. Because these preparations contain no preservatives, use within 24 hr of preparation.
• Bring solution to room temperature prior to infusion.
• Administer by IV infusion, continuous IV infusion, SC injection.
• Pretreatment with a nonsteroidal anti-inflammatory drug or acetaminophen may minimize the risk of developing fever or reduce its severity. Initiate premedication immediately before giving aldesleukin and continue for 12 hr after the final aldesleukin dose.
• IV: Infuse diluted solution over 15 min. Do not filter.
• Continuous infusion: Infuse solution with Pharmacia Deltec CADD infusion pump device. Contents of each cassette infuse over up to 6 days.

Drug Notes ::

 Assessment/Interventions

• Treat preexisting bacterial infections prior to therapy. If infection is suspected during aldesleukin therapy and the patient has an indwelling central venous catheter, start antibiotics effective against S. aureus.
• Monitor standard hematologic tests, including CBC, differential, platelet count, blood chemistries, electrolytes, renal and hepatic function tests at baseline and daily during aldesleukin therapy. More than 80% of an administered dose of aldesleukin is eliminated by the kidneys.
• Obtain a chest x-ray at baseline and periodically during aldesleukin therapy.
• Monitor vital signs and weight frequently throughout the day. In a patient with a decreased blood pressure, especially < 90 mmHg, conduct constant cardiac monitoring for rhythm. If an abnormal complex or rhythm is seen, perform an ECG. Take vital signs in these hypotensive patients hourly and check central venous pressure.
• Prior to beginning therapy, obtain pulmonary function tests with arterial blood gases; document FEV₁ > 2 L or ³ 75% of predicted value for height and age. Obtain a stress thallium study; document normal ejection fraction and unimpaired wall motion. If minor wall motion abnormalities are noted, consider stress ECG to rule out significant coronary artery disease.
• During treatment monitor pulmonary function on a regular basis by clinical examination, assessment of vital signs, and pulse oximetry. Further assess patients with dyspnea or clinical signs of respiratory impairment (tachypnea or rales) with arterial blood gas determination. Repeat these tests as often as clinically indicated.
• Because of the severe adverse events that generally accompany therapy at the recommended dosages, perform thorough clinical evaluation to exclude patients with significant cardiac, pulmonary, renal, hepatic, or CNS impairment. Patients who have had a nephrectomy are still eligible for treatment if they have serum creatinine levels £ 1.5 mg/dL.
• CLS commonly occurs 2 to 12 hr after starting therapy. May occur less frequently with continuous infusion regimens. Monitor fluid and organ perfusion status frequently, measuring blood pressure, pulse, mental status, and urine output. Volume status may be determined by central venous pressure monitoring. Give IV fluids if central venous pressure is below 3 to 4 mm water. Although large volumes may be required, use caution becasue excessive fluid accumulation can cause pulmonary edema. Administration of dopamine 1 to 5 mcg/kg/min, before hypotension develps may help maintain organ perfusion and urine output. Dopamine may be increased to 6 to 10 mcg/kg/min or phenylephrine 1 to 5 mcg/km/min may be added if response is inadequate. Prolonged therapy with pressors is not recommended caused by the risk of cardiac arrhythmias. Recovery from CLS occurs rapidly after discontinuing aldesleukin therapy, usually within a few hr. In patients with excessive weight gain or edema, diuretics can be used after blood pressure has normalized.

Medicscientist Drug Facts

Disclaimer ::

The Information available on this site is for only Informational Purpose , before any use of this information please consult your Doctor .Price of the drugs indicated above may not match to real price due to many possible reasons may , including local taxes etc.. These are only approximate indicative prices of the drug.