Basiliximab Injection
Basiliximab injection (Simulect) is an immunosuppressant used to help prevent acute rejection after kidney transplantation.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
⚠️ FDA Boxed Warning — the FDA’s strongest safety alert ▾
Simulect must only be prescribed and supervised by doctors who specialize in organ transplantation and immunosuppression therapy. This is a powerful medicine that affects your immune system in significant ways. It should only be given in medical facilities that have full laboratory support and the resources needed to manage transplant patients. Your doctor must have complete information about your condition and be available to follow your care throughout treatment.
📖 Basiliximab Injection: Patient Information Guide
A plain-language walkthrough of Basiliximab Injection — what it treats, how it works, how it’s taken, side effects, warnings and interactions. Tap any section to expand it.
🎯What it's used for▾
Basiliximab injection (Simulect) is used to help prevent the immune system from rejecting a transplanted kidney.
- Simulect (intravenous) is approved for the prevention of acute organ rejection in patients undergoing kidney (renal) transplantation, when used as part of an immunosuppressive regimen that includes cyclosporine and corticosteroids.
- Simulect has not been shown to be effective for preventing rejection in other types of solid organ transplants.
⚙️How it works▾
After a kidney transplant, the immune system recognizes the new organ as foreign and tries to attack it. Basiliximab blocks this process by targeting a protein called IL-2Rα (the alpha chain of the IL-2 receptor) found specifically on activated T-cells — the immune cells that lead the rejection response. By binding tightly to this receptor, basiliximab prevents a chemical signal called interleukin-2 (IL-2) from activating those T-cells, which helps the body tolerate the new kidney.
While Simulect is active in the bloodstream, it partially impairs the immune system's ability to respond to new challenges. Whether this effect fully reverses after the drug clears is not yet known.
💊How it's taken▾
Simulect is given only by intravenous (IV) injection or infusion in a medical setting — never taken by mouth. The standard course is just two doses, timed around the transplant procedure.
- The first dose is given within two hours before transplant surgery.
- The second dose is given four days after the transplant.
- If a serious allergic reaction occurs or the transplanted kidney is lost, the second dose is withheld.
- Your transplant team manages all dosing; there is no home administration.
🤒Side effects — in detail▾
Simulect's side effect profile in clinical trials was similar to that seen with placebo, since most effects reflect the transplant itself and the other immunosuppressive medicines used alongside it. Common effects reported in at least 10% of patients include:
- Digestive issues: constipation, nausea, abdominal pain, vomiting, diarrhea
- Swelling, fever, pain, or viral infections
- Abnormal blood levels: high potassium, low potassium, high blood sugar, high cholesterol
- Urinary tract infections
- Shortness of breath or upper respiratory infections
- High blood pressure
- Headache or tremor
- Trouble sleeping; anemia
Seek emergency help immediately if you experience sudden difficulty breathing, a rapid heartbeat, hives, or a drop in blood pressure — these may signal a life-threatening allergic reaction (anaphylaxis).
⚠️Warnings & precautions▾
Severe allergic reactions (anaphylaxis) are the most critical safety concern. These can occur within 24 hours of a dose, even on first exposure, and the risk is substantially higher if Simulect is given again after a gap of several months — especially in patients whose first transplant failed. Emergency treatment for anaphylaxis must be on hand wherever Simulect is administered. If a severe reaction occurs, Simulect must be stopped permanently.
- Serious infections: Immunosuppression increases the risk of bacterial, viral, and fungal infections. In patients on a three-drug regimen, serious cytomegalovirus (CMV) infections occurred more frequently with Simulect than with placebo.
- Lymphoproliferative disorders and malignancies: All patients on long-term immunosuppressants face a small but real increased risk of certain cancers; monitor for unusual symptoms.
- Impaired immune response: Simulect may reduce your body's ability to respond to vaccines or new infections; discuss vaccinations with your transplant team before and after treatment.
- Re-exposure caution: Patients who previously received Simulect and then lost the graft early are at particularly high risk for severe reactions if Simulect is given again.
🔀What it interacts with▾
Simulect is always given alongside other transplant medicines, and some of those combinations affect how long it stays in the body — though no dose changes are required.
- Azathioprine: Adding this to a cyclosporine/corticosteroid regimen reduces Simulect's clearance by about 22%, meaning it stays in the body a bit longer.
- Mycophenolate mofetil: Reduces Simulect's clearance by about 51% — it stays in the body notably longer — but the clinical effect is within the same range seen with standard two-drug therapy, so no dose adjustment is needed.
- Cyclosporine, corticosteroids, ATG/ALG, azathioprine, mycophenolate mofetil, muromonab-CD3: All used alongside Simulect in clinical trials without an increase in adverse reactions.
- Other IV medications: Do not add any other drugs to the same IV line as Simulect; compatibility with other IV substances has not been studied.
This is not a complete list of interactions. Always talk with your doctor or pharmacist before starting, stopping, or changing any medication.
📋Before taking it▾
- Allergy to basiliximab: Simulect is contraindicated if you have a known allergy to basiliximab or any ingredient in the formulation.
- Previous Simulect use: If you received Simulect before — especially if that transplant was abandoned or the organ was lost — your risk of a dangerous allergic reaction on re-exposure is significantly higher. Tell your transplant team.
- Pregnancy: There are no adequate studies in pregnant women. Because basiliximab is an antibody that can cross the placenta, and because the IL-2 receptor may be important in fetal immune development, Simulect should only be used in pregnancy when the benefit clearly outweighs the risk.
- Contraception: Women who can become pregnant should use effective birth control before, during, and for 4 months after Simulect therapy.
- Breastfeeding: It is not known whether basiliximab passes into breast milk. A decision to stop breastfeeding or stop the medication should be made weighing the importance of the drug to the mother.
- Children: Simulect has been used in pediatric kidney transplant patients; dosing is weight-based and managed by the transplant team. Younger children clear the drug more slowly than adults.
- Older adults (65+): No difference in adverse events compared to younger patients was seen in clinical data, and no dose adjustment is needed — but all immunosuppressants require extra caution in elderly patients.
- Vaccines: It is unknown whether immune responses to vaccines are impaired during or after Simulect therapy; consult your transplant team.
🚑If you take too much▾
A maximum safe dose of Simulect has not been formally established. In clinical studies, adult transplant patients received single doses up to 60 mg and multi-day courses up to 120 mg without serious adverse events being attributed to the higher amounts. One report described a pediatric patient who received a higher-than-standard single dose without adverse effects.
If an overdose is suspected, contact your transplant center or seek emergency medical care immediately.
📡Pharmacodynamics — effects in the body▾
Simulect blocks the IL-2Rα receptor on activated T-cells for as long as blood levels remain above a threshold of 0.2 mcg/mL. Once levels fall below that point, T-cells with unbound receptors return to pre-treatment levels within one to two weeks. When Simulect is combined with cyclosporine and corticosteroids, this receptor blockade lasts about 36 days on average; adding azathioprine or mycophenolate mofetil to the regimen extends that duration to roughly 50–59 days. Importantly, Simulect does not appear to meaningfully change the total number of lymphocytes circulating in the blood.
🔬Pharmacokinetics — how your body processes it▾
In adults, Simulect is given intravenously and reaches peak blood levels quickly after infusion. It has a half-life (the time for blood levels to fall by half) of about 7 days in adults, meaning it stays in the body for several weeks after the two-dose course. In younger children (ages 1–11), the drug clears about 50% more slowly and distributes into a smaller volume compared to adults, so the same effect is achieved with lower doses. In adolescents (ages 12–16), the drug behaves similarly to adults. Age, sex, and race do not meaningfully affect how the drug is processed in adults.
📦How to store it▾
Store lyophilized Simulect under refrigerated conditions at 2ºC to 8ºC (36ºF to 46ºF).
📄 Written from Basiliximab Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Every point is grounded in that labeling — nothing is invented. How we use AI →
Supplements & herbs that interact with Basiliximab Injection
70 supplements and herbal products have documented interactions with Basiliximab Injection in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 1
- Moderate · 59
- Minor · 10
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
🩺 Pharmacist Counseling Corner
Quick, plain-English answers to the questions patients ask most about Basiliximab Injection — the kind of thing our pharmacy team would talk through with you at the counter.
Why do I only get two doses of this medicine? That seems like very little. ▾
What should I watch for after getting Simulect? ▾
I had a kidney transplant before and received Simulect then. Is it safe to receive it again? ▾
Can I get vaccinated while I'm on this treatment? ▾
Is this medicine safe during pregnancy? ▾
Will I feel the injection? Are there side effects right when it's given? ▾
Is Basiliximab Injection available over the counter? ▾
When was Basiliximab Injection first available? ▾
Who makes Basiliximab Injection? ▾
💬 Answers drafted from Basiliximab Injection’s FDA-approved label information, summarized in plain language with AI, and reviewed by our pharmacy team before publication. Grounded in that labeling — nothing is made up. How we use AI →
🧰 Keep exploring
💊 How Basiliximab Injection comes
Basiliximab Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- Simulect is used intravenously to prevent acute rejection in adults and children receiving a kidney transplant
- Simulect is given as part of a regimen that also includes cyclosporine and corticosteroids, and sometimes azathioprine or mycophenolate mofetil
- Simulect is given by a healthcare professional as an IV bolus injection or infused into a vein over 20 to 30 minutes
- Simulect is given in two doses: the first within two hours before transplant surgery, the second four days after transplantation
- The second dose of Simulect should be withheld if a severe allergic reaction occurs or if the graft is lost
- No other medications should be added to or infused through the same IV line as Simulect
📊 Basiliximab Injection across the U.S. market
How Basiliximab Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
Share of FDA-listed product records by manufacturer — FDA National Drug Code Directory. Record counts are not sales or prescription volume.
🔍 Compare Basiliximab Injection products
A representative set of FDA-listed product records for Basiliximab Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 10 mg/2.5 mL | Intravenous | Novartis Pharmaceuticals Corporation × 3 listings | BLA | View NDC → |
| 20 mg/5 mL | Intravenous | Novartis Pharmaceuticals Corporation × 3 listings | BLA | View NDC → |
| 10 mg/2.5 mL | — | Novartis Pharma Stein AG | DRUG FOR FURTHER PROCESSING | View NDC → |
| 10 mg/2.5 mL | — | Patheon Italia S.p.A. | DRUG FOR FURTHER PROCESSING | View NDC → |
| 20 mg/5 mL | — | Patheon Italia S.p.A. | DRUG FOR FURTHER PROCESSING | View NDC → |
Showing 9 of 9 products — FDA National Drug Code Directory. See every product, package size and price: browse all 9 Basiliximab Injection NDCs →
📈 What people report — real-world data (FDA FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Basiliximab Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Basiliximab Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
🏛️ The road to your pharmacy
How Basiliximab Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
🚨 Recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
Source: openFDA drug enforcement (recall) reports.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 196102 1 dose form · 2 strengths
-
Dose form (SCDF) Injection RxCUI 1656642In current FDA listings
Look up RxCUI 196102 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
📦 Supply & shortage status
Whether Basiliximab Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
🏷️ Sold under these brand names
🏭 Manufacturers & labelers
RxNorm drug class
Basiliximab Injection belongs to the Interleukin-2 Receptor Blocking Antibody class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
🔬 Where this comes from
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How we combine label and product data
HelloPharmacist combines public FDA and NLM records; we don’t author the underlying clinical facts. We identified 1 FDA-filed SPL label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. The representative label is the starting point for the displayed reference monograph; the 12 largest stored in-scope SPL records, which may include that representative, are compared section by section, and the longest available version of each section is retained. Forms, routes, brands, labelers, product-listed strengths, and product-record counts are aggregated separately from ingredient-matched FDA NDC Directory records; package records listed above are associated with the linked SPL; and the normalized concept hierarchy comes from NLM RxNorm.
Where a section is identified as AI-written, its plain-language text is generated from bounded label evidence. New draft drug pages remain in the admin review queue before first publication. Novartis Pharmaceuticals Corporation is the representative DailyMed label linked for verification and dates; it is not the sole source used for the page.
This is general education, not medical advice — always consult your doctor or pharmacist about your medications and any medical condition. For the exact wording of the linked representative label, view that label on DailyMed; some displayed composite sections may come from other in-scope SPL labels. Learn how we use AI and our data sources & update cadence.