shunned [65:<10% in pooled analysis of patients treated with Simulect in the four controlled clinical trials, or in an analysis of the two dual-therapy trials: Body as a Whole-General: accidental trauma, asthenia, chest pain, increased drug level, infection, face edema, fatigue, dependent edema, generalized edema, leg edema, malaise, rigors, sepsis; Cardiovascular: abnormal heart sounds, aggravated hypertension, angina pectoris, cardiac failure, chest pain, hypotension; Endocrine: increased glucocorticoids; Gastrointestinal : enlarged abdomen, esophagitis, flatulence, gastrointestinal disorder, gastroenteritis, GI hemorrhage, gum hyperplasia, melena, moniliasis, ulcerative stomatitis; Heart Rate and Rhythm: arrhythmia, atrial fibrillation, tachycardia; Metabolic and Nutritional: acidosis, dehydration, diabetes mellitus, fluid overload, hypercalcemia, hyperlipemia, hypertriglyceridemia, hypocalcemia, hypoglycemia, hypomagnesemia, hypoproteinemia, weight increase; Musculoskeletal: arthralgia, arthropathy, back pain, bone fracture, cramps, hernia, myalgia, leg pain; Nervous System: dizziness, neuropathy, paraesthesia, hypoesthesia; Platelet and Bleeding: hematoma, hemorrhage, purpura, thrombocytopenia, thrombosis; Psychiatric: agitation, anxiety, depression; Red Blood Cell: polycythemia; Reproductive Disorders, Male: genital edema, impotence; Respiratory: bronchitis, bronchospasm, abnormal chest sounds, coughing, pharyngitis, pneumonia, pulmonary disorder, pulmonary edema, rhinitis, sinusitis; Skin and Appendages: cyst, herpes simplex, herpes zoster, hypertrichosis, pruritus, rash, skin disorder, skin ulceration; Urinary: albuminuria, bladder disorder, dysuria, frequent micturition, hematuria, increased non-protein nitrogen, oliguria, abnormal renal function, renal tubular necrosis, surgery, ureteral disorder, urinary retention; Vascular Disorders: vascular disorder; Vision Disorders: cataract, conjunctivitis, abnormal vision; White Blood Cell: leucopenia. Among these events, leucopenia and hypertriglyceridemia occurred more frequently in the two triple-therapy studies using azathioprine and mycophenolate mofetil than in the dual-therapy studies. Malignancies The incidence of malignancies in the controlled clinical trials of renal transplant was not significantly different between groups at 1 year (9/590 Simulect-treated patients vs. 12/594 placebo-treated patients) or among patients with 5-year follow-up from Studies 1 and 2 (21/295 Simulect-treated patients vs. 21/291 placebo-treated patients). The incidence of lymphoproliferative disease was not significantly different between groups, and less than 1% in the Simulect-treated patients. Infections The overall incidence of cytomegalovirus infection was similar in Simulect- and placebo-treated patients (15% vs. 17%) receiving a dual- or triple-immunosuppression regimen. However, in patients receiving a triple-immunosuppression regimen, the incidence of serious cytomegalovirus infection was higher in Simulect-treated patients compared to placebo-treated patients (11% vs. 5%). The rates of infections, serious infections, and infectious organisms were similar in the Simulect - and placebo-treatment groups among dual- and triple-therapy treated patients. Post-Marketing Experience Severe acute hypersensitivity reactions including anaphylaxis characterized by hypotension, tachycardia, cardiac failure, dyspnea, wheezing, bronchospasm, pulmonary edema, respiratory failure, urticaria, rash, pruritus, and/or sneezing, as well as capillary leak syndrome and cytokine release syndrome, have been reported during post-marketing experience with Simulect. Overdosage 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. Simulect Dosage and Administration 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 normal saline or dextrose 5% 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 for 24 hours or at room temperature for 4 hours. Discard the reconstituted solution if not used within 24 hours. No incompatibility between Simulect and polyvinyl chloride bags or infusion sets has been observed. No data are available on the compatibility of Simulect with other intravenous substances. Other drug substances should not be added or infused simultaneously through the same intravenous line. Adults In adult patients, the recommended regimen is two doses of 20 mg each. The first 20-mg dose should be given within 2 hours prior to transplantation surgery. The recommended second 20-mg dose should be given 4 days after transplantation. The second dose should be withheld if complications such as severe hypersensitivity reactions to Simulect or graft loss occur. Pediatric In pediatric patients weighing less than 35 kg, the recommended regimen is two doses of 10 mg each. In pediatric patients weighing 35 kg or more, the recommended regimen is two doses of 20 mg each. The first dose should be given within 2 hours prior to transplantation surgery. The recommended second dose should be given 4 days after transplantation. The second dose should be withheld if complications such as severe hypersensitivity reactions to Simulect or graft loss occur. Reconstitution of 10 mg Simulect Vial To prepare the reconstituted solution, add 2.5 mL of Sterile Water for Injection, USP, using aseptic technique, to the vial containing the Simulect powder. Shake the vial gently to dissolve the powder. The reconstituted solution is isotonic and may be given either as a bolus injection or diluted to a volume of 25 mL with normal saline or dextrose 5% for infusion. When mixing the solution, gently invert the bag in order to avoid foaming; DO NOT SHAKE. Reconstitution of 20 mg Simulect Vial To prepare the reconstituted solution, add 5 mL of Sterile Water for Injection, USP, using aseptic technique, to the vial containing the Simulect powder. Shake the vial gently to dissolve the powder. The reconstituted solution is isotonic and may be given either as a bolus injection or diluted to a volume of 50 mL with normal saline or dextrose 5% for infusion. When mixing the solution, gently invert the bag in order to avoid foaming; DO NOT SHAKE. How is Simulect Supplied Simulect (basiliximab) is supplied in a single-use glass vial. Each carton contains one of the following 1 Simulect 10 mg vial .NDC 0078-0393-61 1 Simulect 20 mg vial .NDC 0078-0331-84 Store lyophilized Simulect under refrigerated conditions (2ºC to 8ºC; 36ºF to 46ºF). Do not use beyond the expiration date stamped on the vial. REFERENCES Kahan, B.D., Rajagopalan P.R. and Hall M., Transplantation, 67, 276-284 (1999). Nashan, B., Moore R., Amlot P., Schmidt A.-G., Abeywickrama K. and Soulillou J.-P., Lancet 350, 1193-1198 (1997). T2005-28 2027722 US License No. 1244 REV: September 2005 Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936 Novartis PRINCIPAL DISPLAY PANEL Package Label 10 mg Rx Only NDC 0078-0393-61 Simulect (basiliximab) for injection 10 mg (single use vial) PRINCIPAL DISPLAY PANEL Package Label 20 mg Rx Only NDC 0078-0331-84 Simulect (basiliximab) for injection 20 mg (single use vial) Simulect basiliximab injection, powder, for solution Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0078-0393 Route of Administration INTRAVENOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BASILIXIMAB (BASILIXIMAB) BASILIXIMAB 10 mg in 2.5 mL Inactive Ingredients Ingredient Name Strength SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 0.5 mg in 2.5 mL GLYCINE 20 mg in 2.5 mL MANNITOL 40 mg in 2.5 mL POTASSIUM PHOSPHATE, MONOBASIC 3.61 mg in 2.5 mL SODIUM CHLORIDE 0.8 mg in 2.5 mL SUCROSE 10 mg in 2.5 mL Packaging # Item Code Package Description 1 NDC:0078-0393-61 1 VIAL, SINGLE-USE in 1 CARTON 1 2.5 mL in 1 VIAL, SINGLE-USE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103764 05/12/1998 Simulect basiliximab injection, powder, for solution Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0078-0331 Route of Administration INTRAVENOUS DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BASILIXIMAB (BASILIXIMAB) BASILIXIMAB 20 mg in 5 mL Inactive Ingredients Ingredient Name Strength SODIUM PHOSPHATE, DIBASIC, ANHYDROUS 0.99 mg in 5 mL GLYCINE 40 mg in 5 mL MANNITOL 80 mg in 5 mL POTASSIUM PHOSPHATE, MONOBASIC 7.21 mg in 5 mL SODIUM CHLORIDE 1.61 mg in 5 mL SUCROSE 20 mg in 5 mL Packaging # Item Code Package Description 1 NDC:0078-0331-84 1 VIAL, SINGLE-USE in 1 CARTON 1 5 mL in 1 VIAL, SINGLE-USE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103764 05/12/1998 Labeler - Novartis Pharmaceuticals Corporation (002147023) Revised: 10/2009 Novartis Pharmaceuticals Corporation Next Interactions Print this page Add to My Med List More about Simulect (basiliximab) Side Effects During Pregnancy Dosage Information Drug Interactions Support Group Pricing & Coupons En Español 0 Reviews Add your own review/rating Drug class: interleukin inhibitors Consumer resources Simulect Simulect (Advanced Reading) Professional resources Simulect (AHFS Monograph) Related treatment guides Organ Transplant, Rejection Prophylaxis> ]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only B Pregnancy Category No proven risk in humans N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Manufacturer Novartis Pharmaceuticals Corporation Drug Class Interleukin inhibitors Related Drugs interleukin inhibitors Stelara , Actemra , Cosentyx , Dupixent , tocilizumab , Taltz Organ Transplant, Rejection Prophylaxis azathioprine , cyclosporine , tacrolimus , CellCept , mycophenolate mofetil , Imuran , Prograf , sirolimus , Rapamune , everolimus , Neoral , Gengraf , Sandimmune , Zortress , Azasan , Zenapax , daclizumab , Hecoria , basiliximab , Astagraf XL , Envarsus XR , More... Simulect Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first!} } feel sorry about
a fairly large Simulect expenditures
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