"The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, T"...
Only physicians experienced in immunosuppression therapy and management of organ transplantation patients should prescribe Simulect® (basiliximab). The physician responsible for Simulect (basiliximab) 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.
Simulect® (basiliximab) is a chimeric (murine/human) monoclonal antibody (IgG1K), produced by recombinant DNA technology, that functions as an immunosuppressive agent, specifically binding to and blocking the interleukin-2 receptor α-chain (IL-2Rα, also known as CD25 antigen) on the surface of activated T-lymphocytes. Based on the amino acid sequence, the calculated molecular weight of the protein is 144 kilodaltons. It is a glycoprotein obtained from fermentation of an established mouse myeloma cell line genetically engineered to express plasmids containing the human heavy and light chain constant region genes and mouse heavy and light chain variable region genes encoding the RFT5 antibody that binds selectively to the IL-2Rα.
The active ingredient, basiliximab, is water soluble. The drug product, Simulect (basiliximab) , is a sterile lyophilisate which is available in 6 mL colorless glass vials and is available in 10 mg and 20 mg strengths.
Each 10-mg vial contains 10 mg basiliximab, 3.61 mg monobasic potassium phosphate, 0.50 mg disodium hydrogen phosphate (anhydrous), 0.80 mg sodium chloride, 10 mg sucrose, 40 mg mannitol and 20 mg glycine, to be reconstituted in 2.5 mL of Sterile Water for Injection, USP. No preservatives are added.
Each 20-mg vial contains 20 mg basiliximab, 7.21 mg monobasic potassium phosphate, 0.99 mg disodium hydrogen phosphate (anhydrous), 1.61 mg sodium chloride, 20 mg sucrose, 80 mg mannitol and 40 mg glycine, to be reconstituted in 5 mL of Sterile Water for Injection, USP. No preservatives are added.
What are the possible side effects of basiliximab (Simulect)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing, difficult breathing and/or sneezing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- pain or burning when you urinate;
- easy bruising or bleeding, unusual weakness;
- tremors, shaking;
- fever, chills, body aches, flu symptoms, vomiting, diarrhea;
- trouble breathing;
- pale skin, feeling light-headed or short of breath, rapid heart rate, trouble...
What are the precautions when taking basiliximab (Simulect)?
Before using basiliximab, tell your doctor or pharmacist if you are allergic to it; or to mouse proteins; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: certain infection (cytomegalovirus).
Previous treatment with basiliximab may increase your risk of a serious allergic reaction (see Side Effects section). Before using this medication, tell your doctor or pharmacist if you have received basiliximab in the past. If you must stop using this drug due to an allergic reaction, do not use the drug again. Consult your doctor or pharmacist for more...
Last reviewed on RxList: 11/7/2008
This monograph has been modified to include the generic and brand name in many instances.
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