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SIMULECT is a brand name for Basiliximab, supplied as a powder for solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS ................................................................................................... 3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. SIMULECT® (basiliximab) does not appear to add to the background of adverse events seen in organ transplant patients as a consequence of their underlying disease and the concurrent administration of immunosuppressants and other medications.
In two controlled, double-blind, multicenter trials, the pattern of adverse events in 363 SIMULECT®-treated patients was indistinguishable from that of 359 placebo-treated patients. The cumulative incidence of adverse events which occurred in ≥ 6% in either treatment group during the first 12 months post-transplantation for the pooled studies is summarized in Table 1.
Serious adverse events occurred with similar incidence and profile in both the SIMULECT® and placebo treatment groups (SIMULECT® 59%, placebo 63% overall). The rates of malignancies, reported infections, serious infections and infectious organisms were similar in the SIMULECT® and placebo treatment groups.
No specific SIMULECT®-related risk was identified.
Incidence of death:
In a pooled analysis of two five-year extension studies, the incidence and cause of death remained similar in both treatment groups (SIMULECT® 15%, placebo 11%). The primary cause of death being cardiac-related disorders (SIMULECT® 5%, placebo 4%) such as cardiac failure and myocardial infarction.
Incidence of Malignant Neoplasms:
The incidence of malignancies among the 722 patients in the two 12-month controlled trials was not significantly different between the SIMULECT® and placebo- treatment groups, and compared to the incidence reported in the literature for renal allograft recipients.
6%) in the placebo group. 9%) in patients treated with placebo. No differences were found in the incidence of malignancies and lymphoproliferative disease between SIMULECT® 7% (21/295) and placebo 7% (21/291) in a pooled analysis of two five-year extension studies.
General SIMULECT® (basiliximab) should be prescribed only by physicians who are experienced in the use of immunosuppressive therapy following organ transplantation. Patients receiving SIMULECT® should be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources including medications for the treatment of severe hypersensitivity reactions.
The addition of agents other than NEORAL® (cyclosporine for microemulsion) and corticosteroids to SIMULECT® therapy may increase the risk of overimmunosuppression. Please note that following initiation of treatment with NEORAL®, due to the different bioavailabilities of the different oral cyclosporine formulations, patients should not be converted to any other oral formulation of cyclosporine without appropriate monitoring of cyclosporine blood concentrations, serum creatinine levels and blood pressure.
This does not apply to the conversion between NEORAL® soft gelatine capsule and NEORAL® oral solution as these two dosage forms are bioequivalent. It is therefore important that prescribers, pharmacists and patients be aware that substitution of NEORAL® with any other oral formulation of cyclosporine is not recommended as this may lead to alterations in cyclosporine blood concentrations.
For this reason, it might be appropriate to prescribe by brand. Carcinogenesis and Mutagenesis Transplant patients receiving immunosuppressive regimens involving combinations with or without SIMULECT® are at increased risk of developing lymphoproliferative disorders (LPDs) (such as lymphoma) and opportunistic infections (such as cytomegalovirus, CMV).
In clinical trials, the incidence of opportunistic infections was similar in patients using immunosuppressive regimens with or without SIMULECT®. In a pooled analysis of two five-year extension studies, no differences were found in the incidence of malignancies and LPDs between immunosuppressive regimens with or without SIMULECT®.
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Incidence of Infectious Episodes:
Cytomegalovirus infection was reported in 14% of SIMULECT®- treated patients and 18% of placebo-treated patients. 3%) and infectious organisms were similar in the SIMULECT® and placebo treatment groups. Page 7 of 24 Table 1 - Adverse Events in Controlled Clinical Trials (≥ 6%) Organ System/Adverse Experience SIMULECT® (N=363) % PLACEBO (N=359) % Body as a Whole Asthenia 35 (10%) 28 (8%) Chest Pain 25 (7%) 27 (8%) Drug Level Increased 21 (6%) 26 (7%) Fatigue 30 (8%) 29 (8%) Infection Viral 44 (12%) 54 (15%) Edema 78 (21%) 71 (20%) Edema Generalised 25 (7%) 24 (7%) Edema - Legs 40 (11%) 29 (8%) Edema - Peripheral 104 (29%) 109 (30%) Pain 152 (42%) 141 (39%) Pyrexia 73 (20%) 87 (24%) Cardiovascular Hypertension 97 (27%) 93 (26%) Hypotension 30 (8%) 38 (11%) Nervous System Dizziness 40 (11%) 33 (9%) Headache 87 (24%) 80 (22%) Paraesthesia 27 (7%) 31 (9%) Tremor 52 (14%) 66 (18%) Gastro-Intestinal System Addomen Enlarged 28 (8%) 27 (8%) Abdominal pain 76 (21%) 97 (27%) Constipation 175 (48%) 177 (49%) Diarrhea 75 (21%) 68 (19%) Dyspepsia 50 (14%) 64 (18%) Moniliasis 36 (10%) 29 (8%) Nausea 123 (34%) 143 (40%) Page 8 of 24 Vomiting 73 (20%) 79 (22%) Heart Rate and Rhythm Disorders Tachycardia 28 (8%) 21 (6%) Metabolic and Nutritional Acidosis 37 (10%) 46 (13%) Dehydration 22 (6%) 20 (6%) Hypercholesterolemia 41 (11%) 38 (11%) Hyperglycemia 58 (16%) 43 (12%) Hyperkalemia 80 (22%) 85 (24%) Hyperlipaemia 31 (9%) 25 (7%) Hyperuricemia 49 (13%) 52 (14%) Hypocalcemia 39 (11%) 41 (11%) Hypokalemia 66 (18%) 85 (24%) Hypomagnesemia 34 (9%) 43 (12%) Hypophosphatemia 45 (12%) 46 (13%) Weight Increase 40 (11%) 46 (13%) Musculo-Skeletal Arthralgia 21 (6%) 23 (6%) Back Pain 36 (10%) 48 (13%) Cramps 33 (9%) 28 (8%) Pain Leg(s) 46 (13%) 40 (11%) Psychiatric Insomnia 86 (24%) 102 (28%) Red Blood Cell Anemia 93 (26%) 101 (28%) Polycythaemia 24 (7%) 16 (4%) Respiratory System Chest Sounds Abnormal 29 (8%) 25 (7%) Coughing 41 (11%) 37 (10%) Dyspnea 59 (16%) 50 (14%) Pharyngitis 35 (10%) 29 (8%) Page 9 of 24 Rhinitis 38 (10%) 39 (11%) Sinusitis 26 (7%) 23 (6%) Upper Respiratory Tract Infection 71 (20%) 64 (18%) Skin and Appendages Disorders Acne 53 (15%) 56 (16%) Herpes Simplex 30 (8%) 32 (9%) Post-operative Wound Complication 58 (16%) 63 (18%) Pruritus 29 (8%) 31 (9%) Rash 24 (7%) 30 (8%) Skin Disorder 29 (8%) 25 (7%) Urinary System Bladder disorders 34 (9%) 38 (11%) Dysuria 36 (10%) 30 (8%) Hematuria 33 (9%) 41 (11%) NPN increased 36 (10%) 23 (6%) Oliguria 25 (7%) 25 (7%) Surgery 21 (6%) 27 (8%) Urinary tract infection 168 (46%) 166 (46%) Post-Market Adverse Drug Reactions The following adverse drug reactions have been identified based on post-marketing spontaneous reports.
Because these reactions are reported voluntary from a population of uncertain size, it is not always possible to reliably estimate their frequency. Immune system disorders Cytokine release syndrome has been reported. Hypersensitivity/anaphylactoid reaction such as rash, urticaria, pruritus, sneezing, wheezing, bronchospasm, dyspnoea, pulmonary oedema, cardiac failure, hypotension, tachycardia, respiratory failure, capillary leak syndrome have also been reported (see WARNINGS AND PRECAUTIONS).
Some reports of anaphylaxis and other infusion-related adverse events suggest that patients receiving subsequent courses of therapy with SIMULECT® […]
Immune Severe acute (less than 24 hours) hypersensitivity reactions have been observed both on initial exposure to SIMULECT® and on reexposure to a subsequent course of therapy. These included anaphylactoid type reactions such as rash, urticaria, pruritis, sneezing, wheezing, hypotension, tachycardia, dyspnea, bronchospasm, pulmonary edema, cardiac failure, respiratory failure and capillary leak syndrome.
If severe hypersensitivity occurs, therapy with SIMULECT® should be permanently discontinued and no further dose should be administered. Therefore, physicians prescribing SIMULECT® for a second course of therapy should be fully aware of the risks of anaphylactic reaction and should exercise caution.
There is accumulating evidence that a subgroup of patients is at increased risk of developing hypersensitivity reactions. These are patients Page 5 of 24 in whom, following the initial administration of SIMULECT®, the concomitant immunosuppression was discontinued prematurely, for example, due to abandoned transplantation or due to early loss of the graft.
Acute hypersensitivity reactions were observed on re-administration of SIMULECT® for a subsequent transplantation in some of these patients. Individual cases of suspected cytokine release syndrome (CRS) have been reported during post- marketing experience with SIMULECT® (see Post-Market Adverse Drug Reactions).
Review of the clinical symptoms for each of the cases does not support the diagnosis of CRS. However, the contribution of SIMULECT® could not be excluded. Vaccination No data are available on either the effects of live and inactive vaccination or the transmission of infection by live vaccines in patients receiving SIMULECT®.
Nevertheless, live vaccines are not recommended for immunosuppressed patients. Inactivated vaccines may be administered to immunosuppressed patients; however, response to the vaccine may depend on the degree of the immunosuppression.
Special Populations Pregnant Women:
There is no adequate information for use in pregnant women. SIMULECT® (basiliximab) should not be given to pregnant women except in cases where the potential benefit for the mother outweighs the potential risk for the fetus.
Nursing Women:
There are no data in lactating women. Since basiliximab is an immunoglobulin G (IgG1k) antibody, it may cross the human placenta and may be excreted in human milk. Women receiving SIMULECT® should not breast feed for 4 months following the last dose.
Pediatrics:
No adequate and well-controlled studies have been completed in pediatric patients. Safety and efficacy in pediatric patients have not been established and pharmacokinetic data is very limited (See ACTION AND CLINICAL PHARMACOLOGY - Pharmacokinetics).
No studies have been performed in neonates or children aged less than two years.
Geriatrics:
Controlled clinical trials of SIMULECT® have included a small number of patients 65 years and older (SIMULECT® 15; placebo 19). From the available data comparing SIMULECT® and placebo-treated patients, the adverse event profile in patients ≥65 years of age is not different from patients < 65 years of age and no initial age-related dosing adjustment is required.
Caution must be used in giving immunosuppressive drugs to elderly patients.
Use in Women of Childbearing Potential:
Women of childbearing potential should use effective contraception before beginning SIMULECT® therapy, during therapy and for 4 months after completion of SIMULECT® therapy.
Fertility:
No human data on the effect of basiliximab on fertility are available. Formal studies of the potential effect of SIMULECT® on animal fertility have not been conducted (see TOXICOLOGY). Page 6 of