Prescription medicine
Basiliximab Brand names: Simulect
Basiliximab (Simulect) is a prescription medicine with an FDA approval on record since 1998. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the basiliximab FDA label on DailyMed (effective December 12, 2025, Novartis Pharmaceuticals Corporation); the BLA 103764 record on Drugs@FDA; every basiliximab label on DailyMed.
Highlights of the record
FDA label of December 12, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
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.
Used for
From the label: indications and usageSimulect ® (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.
Forms and strengths
- 10 mg/2.5ml
- 20 mg/5ml
Injection (powder) for solution.
On the market
- Earliest approval on file
- May 12, 1998 Simulect, Novartis; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 11,693 through July 30, 2026
What is basiliximab used for?
From the label: indications and usageSimulect ® (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.
Conditions named in the indications of basiliximab's FDA labels, with every medicine labeled for each:
From other basiliximab labelsOrgan transplant rejection: INDICATIONS AND USAGE 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 …
FDA pharmacologic class: Interleukin-2 Receptor Blocking Antibody.
Source: FDA drug label (Simulect), Novartis Pharmaceuticals Corporation, effective December 12, 2025 (SPL set 1af01887-b69d-444b-91ed-ebfe12784440), via openFDA; the full label on DailyMed
Is there a generic for basiliximab (Simulect)?
No generic basiliximab is approved (Drugs@FDA, October 8, 2026).
- 1998 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the basiliximab label say about other medicines?
The basiliximab label names 3 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name basiliximab. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Azathioprine | drug interactions | Drug Interactions No dose adjustment is necessary when Simulect is added to triple-immunosuppression regimens, including cyclosporine, corticosteroids, and either azathioprine or mycophenolate mofetil. |
| Cyclosporine | drug interactions | Drug Interactions No dose adjustment is necessary when Simulect is added to triple-immunosuppression regimens, including cyclosporine, corticosteroids, and either azathioprine or mycophenolate mofetil. |
| Mycophenolate mofetil | drug interactions | Drug Interactions No dose adjustment is necessary when Simulect is added to triple-immunosuppression regimens, including cyclosporine, corticosteroids, and either azathioprine or mycophenolate mofetil. |
Other labels that name basiliximab
Source: FDA drug label (Simulect), Novartis Pharmaceuticals Corporation, effective December 12, 2025 (SPL set 1af01887-b69d-444b-91ed-ebfe12784440), via openFDA; the full label on DailyMed
What do FAERS reports show for basiliximab?
The FDA Adverse Event Reporting System holds 11,693 reports that list basiliximab among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 2,503 are coded as a death and 4,896 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as basiliximab?
7 other medicines are given the same way (intravenous) and in the same FDA class as basiliximab or labeled mainly for the same use (organ transplant rejection), the same class first. Organ transplant rejection lists all 13 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Mycophenolate mofetil | Organ transplant rejection | 6 labelers | n/a | No current entry |
| Tacrolimus | Organ transplant rejection | 1 labeler | n/a | No current entry |
| Azathioprine | Organ transplant rejection | 1 labeler | n/a | No current entry |
| Belatacept | Organ transplant rejection | none listed | n/a | No current entry |
| Cyclosporine | Organ transplant rejection | none listed | n/a | No current entry |
| Lapine t-lymphocyte immune globulin | Organ transplant rejection | none listed | n/a | No current entry |
| Sirolimus | Organ transplant rejection | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as basiliximab
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to basiliximab
- 7 medicines for the same use
- Basiliximab side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other