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Simulect
Basiliximab
$1900.00
20mg · 1 ampules
BrandBranded medicine· By Novartis
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FDA boxed warning
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.
About Simulect
Overview
Simulect (basiliximab) is a monoclonal antibody medicine that suppresses the immune system. It is used to help prevent acute rejection after a kidney transplant, alongside modified cyclosporine and corticosteroids. It works by blocking a receptor called CD25 on activated T cells, which are part of the immune system. Its effectiveness in preventing acute rejection after other solid organ transplants has not been demonstrated.
What it treats
Prevention of acute organ rejection in patients receiving a kidney transplant, used with modified cyclosporine and corticosteroids as part of an immunosuppressive regimen.
Safety information
Side effects
Commonly reported side effects in patients receiving Simulect (basiliximab) included constipation, nausea, abdominal pain, vomiting, diarrhea, indigestion, pain, swelling of the limbs, fever, headache, tremor and difficulty sleeping. Other common reports included high blood pressure, anemia, urinary tract and respiratory infections, shortness of breath, acne and surgical wound complications. Blood tests sometimes showed changes in potassium, phosphate, blood sugar, cholesterol or uric acid levels. Serious events reported included severe infection, including sepsis and pneumonia; heart failure, chest pain and irregular heartbeat; gastrointestinal bleeding; blood clots; low platelet or white blood cell counts; kidney problems; and fluid in the lungs or narrowing of the airways. Contact a doctor promptly for these problems, particularly chest pain, breathing difficulties, bleeding or reduced urine output. These events were reported in kidney transplant patients also taking other immunosuppressive medicines, so they were not necessarily caused by Simulect. Overall, the types and frequency of reported events were similar in the Simulect and placebo groups.
FDA boxed warning
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.
A boxed warning is the strongest warning the US Food and Drug Administration requires on a medicine label. Text is taken from the official label, with internal section references removed.
When to call your doctor
If symptoms are severe or getting worse quickly, seek emergency care rather than waiting.
Before taking this medicine
Do not use Simulect if you have a known allergy to basiliximab or any other ingredient in the medicine.
Interactions
Azathioprine and mycophenolate mofetil can slow the removal of Simulect from the body when used with cyclosporine and corticosteroids. The label states that adding Simulect to these combinations does not require a dose adjustment. In clinical trials, no increase in adverse reactions was seen when Simulect was given with ATG/ALG, azathioprine, corticosteroids, cyclosporine, mycophenolate mofetil or muromonab-CD3.
Using Simulect
Dosing
Dosing is set by your prescriber. Each health care professional may prescribe medication differently according to a patient's medical history and condition, so follow the directions on your prescription label and speak to your doctor or pharmacist before changing anything.
Storage
Store in the original carton below 25°C, protected from light. Do not freeze, and use immediately once opened. Keep all medicines out of the sight and reach of children.
Clinical information on this page is summarised from the US FDA label SIMULECT (BASILIXIMAB) INJECTION, POWDER, FOR SOLUTION [NOVARTIS PHARMACEUTICALS CORPORATION] (DailyMed, retrieved 19 September 2026).
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