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ALDESLEUKIN
DIR Classification
Classification:Moderate-DIR concern
Severity Score:3
Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF
- PRECAUTIONS
- Drug Interactions
- Proleukin may affect central nervous function. Therefore, interactions could occur following concomitant administration of psychotropic drugs (e.g., narcotics, analgesics, antiemetics, sedatives, tranquilizers).
- Concurrent administration of drugs possessing nephrotoxic (e.g., aminoglycosides, indomethacin), myelotoxic (e.g., cytotoxic chemotherapy), cardiotoxic (e.g., doxorubicin) or hepatotoxic (e.g., methotrexate, asparaginase) effects with Proleukin may increase toxicity in these organ systems. The safety and efficacy of Proleukin in combination with any antineoplastic agents have not been established.
- In addition, reduced kidney and liver function secondary to Proleukin treatment may delay elimination of concomitant medications and increase the risk of adverse events from those drugs.
- Hypersensitivity reactions have been reported in patients receiving combination regimens containing sequential high dose Proleukin and antineoplastic agents, specifically, dacarbazine, cis-platinum, tamoxifen and interferon-alfa. These reactions consisted of erythema, pruritus, and hypotension and occurred within hours of administration of chemotherapy. These events required medical intervention in some patients.
- Myocardial injury, including myocardial infarction, myocarditis, ventricular hypokinesia, and severe rhabdomyolysis appear to be increased in patients receiving Proleukin and interferon-alfa concurrently.
- Exacerbation or the initial presentation of a number of autoimmune and inflammatory disorders has been observed following concurrent use of interferon-alfa and Proleukin, including crescentic IgA glomerulonephritis, oculo-bulbar myasthenia gravis, inflammatory arthritis, thyroiditis, bullous pemphigoid, and Stevens-Johnson syndrome.
- Although glucocorticoids have been shown to reduce Proleukin-induced side effects including fever, renal insufficiency, hyperbilirubinemia, confusion, and dyspnea, concomitant administration of these agents with Proleukin may reduce the antitumor effectiveness of Proleukin and thus should be avoided.
- Beta-blockers and other antihypertensives may potentiate the hypotension seen with Proleukin.
- ADVERSE REACTIONS
- Post Marketing Experience
- The following adverse reactions have been identified during post-approval use of Proleukin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Blood and lymphatic system: neutropenia, febrile neutropenia, eosinophilia, lymphocytopenia
- Cardiac: cardiomyopathy, cardiac tamponade
- Endocrine: hyperthyroidism
- Gastrointestinal: gastritis, intestinal obstruction, colitis
- General and administration site conditions: injection site necrosis
- Hepatobiliary: hepatitis, hepatosplenomegaly, cholecystitis
- Immune system: anaphylaxis, angioedema, urticaria
- Infections and infestations: pneumonia (bacterial, fungal, viral), fatal endocarditis, cellulitis
- Musculoskeletal and connective tissue: myopathy, myositis, rhabdomyolysis
- Nervous system: cerebral lesions, encephalopathy, extrapyramidal syndrome, neuralgia, neuritis, demyelinating neuropathy
- Psychiatric: insomnia
- Vascular: hypertension, fatal subdural and subarachnoid hemorrhage, cerebral hemorrhage, retroperitoneal hemorrhage
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
Rhabdomyolysis
2
42910
Other ADRs
1299
14115980
Odds Ratio = 0.507
Drug Property Information
ATC Code(s):
- L03AC01 - aldesleukin
- L03AC - Interleukins
- L03A - IMMUNOSTIMULANTS
- L03 - IMMUNOSTIMULANTS
- L - ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
Active Ingredient:aldesleukin
Active Ingredient UNII:M89N0Q7EQR
Drugbank ID:DB00041
PubChem Compound:N/A
CAS Number:110942-02-4
Dosage Form(s):injection, powder, lyophilized, for solution
Route(s) Of Administrator:intravenous
Daily Dose:
- 0.2 mg/day L03AC01
Chemical Structure: 
SMILE Code:
-
-
Reference
COHORT STUDY:
N/AOTHER REFERENCE(S):
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