pharmacopeia
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Boxed warning

Only physicians experienced in immunosuppression therapy and management of organ transplantation patients should prescribe Simulect ® (basiliximab). The physician responsible for Simulect administration should have complete information requisite for the follow-up of the patient. Patients receiving the drug should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources.

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Interleukin 2 Receptor Antagonists; Interleukin 2 Receptor-directed Antibody Interactions.

Interleukin 2 Receptor

Indications

Sourced from openFDA
  • Simulect ® (basiliximab) is indicated for the prophylaxis of acute organ rejection in patients receiving renal transplantation when used as part of an immunosuppressive regimen that includes cyclosporine, USP (MODIFIED), and corticosteroids. The efficacy of Simulect for the prophylaxis of acute rejection in recipients of other solid organ allografts has not been demonstrated.

Contraindications

Sourced from openFDA
  • Simulect ® (basiliximab) is contraindicated in patients with known hypersensitivity to basiliximab or any other component of the formulation. See composition of Simulect under DESCRIPTION.contraindicated

Dosage & administration

Sourced from openFDA

Simulect ® (basiliximab) is used as part of an immunosuppressive regimen that includes cyclosporine, USP (MODIFIED) and corticosteroids. Simulect is for central or peripheral intravenous administration only. Reconstituted Simulect should be given either as a bolus injection or diluted to a volume of 25 mL (10-mg vial) or 50 mL (20-mg vial) with 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP and administered as an intravenous infusion over 20 to 30 minutes. Bolus administration may be associated with nausea, vomiting and local reactions, including pain. Simulect should only be administered once it has been determined that the patient will receive the graft and concomitant immunosuppression. Patients previously administered Simulect should only be re-exposed to a subsequent course of therapy with extreme caution due to the potential risk of hypersensitivity (see WARNINGS). Parenteral drug products should be inspected visually for particulate matter and discoloration before administration. After reconstitution, Simulect should be a clear-to-opalescent, colorless solution. If particulate matter is present or the solution is colored, do not use. Care must be taken to assure sterility of the prepared solution because the drug product does not contain any antimicrobial preservatives or bacteriostatic agents. It is recommended that after reconstitution, the solution should be used immediately. If not used immediately, it can be stored at 2ºC to 8ºC (36ºF to 46ºF) for 24 hours or at room temperature for 4 hours.

Warnings & precautions

Sourced from openFDA

WARNINGS. See Boxed WARNING.

Adverse reactions

Sourced from openFDA

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The adverse reaction information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates. The incidence of adverse events for Simulect ® (basiliximab) was determined in four randomized, double-blind, placebo-controlled clinical trials for the prevention of renal allograft rejection. Two of the studies (Study 1 and Study 2), used a dual maintenance immunosuppressive regimen comprised of cyclosporine, USP (MODIFIED) and corticosteroids, whereas the other two studies (Study 3 and Study 4) used a triple-immunosuppressive regimen comprised of cyclosporine, USP (MODIFIED), corticosteroids, and either azathioprine or mycophenolate mofetil. Simulect did not appear to add to the background of adverse events seen in organ transplantation patients as a consequence of their underlying disease and the concurrent administration of immunosuppressants and other medications. Adverse events were reported by 96% of the patients in the placebo-treated group and 96% of the patients in the Simulect-treated group. In the four placebo-controlled studies, the pattern of adverse events in 590 patients treated with the recommended dose of Simulect was similar to that in 594 patients treated with placebo.

Pharmacokinetics

Sourced from openFDA
Metabolism
Adults : Single-dose and multiple-dose pharmacokinetic studies have been conducted in patients undergoing first kidney transplantation. Cumulative doses ranged from 15 mg up to 150 mg.

Overdosage

Sourced from openFDA

A maximum tolerated dose of Simulect ® (basiliximab) has not been determined in patients. During the course of clinical studies, Simulect has been administered to adult renal transplantation patients in single doses of up to 60 mg, or in divided doses over 3-5 days of up to 120 mg, without any associated serious adverse events. There has been one spontaneous report of a pediatric renal transplantation patient who received a single 20-mg dose (2.3 mg/kg) without adverse events.

Approval history

Sourced from openFDA
  • May 12, 1998BLABLA103764Novartis

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
11,494 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Off Label Use9658.4%
  2. 2Cytomegalovirus Infection9047.9%
  3. 3Drug Ineffective8897.7%
  4. 4Transplant Rejection8517.4%
  5. 5Kidney Transplant Rejection7686.7%
  6. 6Pyrexia6125.3%
  7. 7Product Use In Unapproved Indication5364.7%
  8. 8Blood Creatinine Increased5114.4%
  9. 9Diarrhoea5014.4%
  10. 10Renal Impairment4604.0%
  11. 11Anaemia4363.8%
  12. 12Acute Kidney Injury4213.7%
  13. 13Sepsis4193.6%
  14. 14Multiple Organ Dysfunction Syndrome4103.6%
  15. 15Thrombotic Microangiopathy3963.4%

Literature

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Recent PubMed references pinned to Basiliximab as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 169 ClinicalTrials.gov registrations naming Basiliximab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Basiliximab work?
Mechanism-of-action classes: Interleukin 2 Receptor Antagonists; Interleukin 2 Receptor-directed Antibody Interactions.
What is Basiliximab used for?
According to FDA labeling, Basiliximab carries indications including: Simulect ® (basiliximab) is indicated for the prophylaxis of acute organ rejection in patients receiving renal transplantation when used as part of an immunosuppressive regimen that includes cyclosporine, USP (MODIFIED), and corticosteroids. The efficacy of Simulect for the prophylaxis of acute rejection in recipients of other solid organ allografts has not been demonstrated.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Basiliximab?
Basiliximab is classified as Interleukin inhibitors, Interleukin-2 Receptor Blocking Antibody, Interleukin 2 Receptor Antagonists, Interleukin 2 Receptor-directed Antibody Interactions, Decreased Cytokine Activity, Decreased Lymphocyte Cell Production.
What are the brand names for Basiliximab?
Basiliximab is marketed under brand names including Simulect.
What are the contraindications for Basiliximab?
Basiliximab labeling lists contraindications including: Simulect ® (basiliximab) is contraindicated in patients with known hypersensitivity to basiliximab or any other component of the formulation. See composition of Simulect under DESCRIPTION.. Always consult the full prescribing information and a clinician.
Note. Data for basiliximab is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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