Basiliximab (Simulect) is a chimeric monoclonal antibody that inhibits the binding of IL-2 to its receptors. It is primarily used as an immunosuppressant in patients with organ transplantation.
A It is used in the following conditions:
- For the prophylactic treatment of acute Renal transplant rejection in combination with cyclosporin and corticosteroids.
- Except in patients at high immunologic risk, KDIGO recommendations advise against using interleukin 2 receptor antagonist (basiliximab/simulect) as the first-line induction medication to prevent acute kidney transplant rejection.
- It is also used as an Off Label medicine in the following conditions:
- for the purpose of treating acute graft-versus-host disease that is refractory
- for the preventative management of acute heart transplant rejection
- for the preventative management of acute liver transplant rejection
- for the preventative management of acute lung transplant rejection
Basiliximab Dose in Adults
Note: Re-exposure is associated with severe anaphylactic reactions and should be used with extreme caution.
Basiliximab dose in the prophylactic treatment of acute Renal transplant rejection:
- 20 mg intravenously two hours prior to the transplant procedure, and a second 20 mg dosage four days following the transplant.
- Patients who develop severe allergic reactions to the first dose should not be given the second dose.
Basiliximab dose for off-label use in patients with refractory acute graft-versus-host disease (aGVHD)
- 20 mg intravenous on days 1 and 4.
- The dose may be repeated.
Off-label use to prevent acute Heart transplant rejection:
- 20 mg intravenous on the day of the transplant, immediately and preferably within one hour after the transplant.
- The second 20 mg dose is administered on the fourth day after transplantation along with other immunosuppressants.
Off-label use to prevent acute rejection of Liver transplant:
- 20 mg intravenous on the day of the transplant, administered during the procedure after securing hemostasis, immediately after the transplant, or within 6 hours of organ perfusion.
- The second dose is given as 20 mg intravenous on the fourth day after transplantation along with other immunosuppressants.
Off-label use to prevent acute rejection of lung transplant:
- 20 mg intravenous before the transplant.
- A second dose of 20 mg should be administered 4 days after the transplant along with other immunosuppressants.
Basiliximab (Simulect) Dose in Children
Note: Re-exposure is associated with severe anaphylactic reactions and should be used with extreme caution.
Simulect Dose in the Treatment of Heart Transplantation:
- Patients weighing less than 35 kgs:
- 10 mg given either before surgery or six hours after organ perfusion followed by a repeat dose after 4 days of transplantation.
- Patients weighing more than 35 kg:
- 20 milligrams; administered IV either before the surgery or six hours after perfusion, followed by a repeat dose four days after the transplantation.
Basiliximab Dose in the Treatment of Liver Transplantation:
- Patients weighing less than 35 kgs:
- 10 mg IV within six hours of organ perfusion, followed by 10 mg four days after the surgery.
- A third dose may be given 8 to 10 days after transplantation to patients who have ascites of more than 5 liters or who lose more than 70 ml/kg of body fluid during the surgery.
- Patients weighing more than 35 kg:
- 20 mg IV within six hours of organ perfusion, followed by 20 mg four days after the surgery.
- A third dose may be given 8 to 10 days after transplantation to patients who have ascites of more than 5 liters or who lose more than 70 ml/kg of body fluid during the surgery.
Basiliximab dose for kidney transplantation in children:
- Children and Adolescents:
- Patients weighing more than 35 kg:
- 20 mg administered IV two hours before the kidney transplant, followed by a repeat 20 mg four days after the procedure.
- Patients weighing less than 35 kgs:
- 10 mg given IV two hours prior to the kidney transplant procedure, followed by 10 mg four days after the procedure.
- Patients weighing more than 35 kg:
Pregnancy Risk Factor: B
- It is an IL-2 receptor-specific monoclonal chimeric IgG antibody.
- The manufacturer suggests that effective contraception be used before and for at least 4 months following the last dose.
- IgG antibodies cross over the placental boundary, but adverse fetal events were not observed in animal studies.
Use Basiliximab while breastfeeding
- It is not clear if the drug can be absorbed into breast milk.
- However, there is a risk of serious adverse events due to the fact that immunoglobulins can be found in breast milk.
- During the treatment, it is important to stop breastfeeding.
Basiliximab Dose in Renal Disease:
No recommendations are available regarding dose adjustment in renal disease.
Basiliximab Dose in Liver Disease:
No recommendations are available regarding dose adjustment in liver disease.
Side Effects of Basiliximab Include:
- Central Nervous System:
- Headache
- Insomnia
- Pain
- Endocrine & Metabolic:
- Hyperuricemia,
- Hypokalemia
- Hypercholesterolemia
- Hyperglycemia
- Hyperkalemia
- Hypophosphatemia
- Cardiovascular:
- Hypertension
- Peripheral Edema
- Dermatologic:
- Acne Vulgaris
- Genitourinary:
- Urinary Tract Infection
- Gastrointestinal:
- Nausea and vomiting
- Abdominal Pain
- Constipation or Diarrhea
- Dyspepsia
- Hematologic & Oncologic:
- Anemia
- Neuromuscular & Skeletal:
- Tremor
- Respiratory:
- Dyspnea
- Upper Respiratory Infection
- Infection:
- Viral Infection
- Miscellaneous:
- Fever
- Postoperative Wound Complication
Less Common Side Effects Of Basiliximab:
- Cardiovascular:
- Cardiac
- Low BP
- Tachycardia
- Thrombosis
- Arrhythmia
- Cardiac Failure
- Abnormal Heart Sounds
- Angina Pectoris
- Atrial Fibrillation
- Chest Pain
- Central Nervous System:
- Blackouts
- Fatigue
- Hypoesthesia
- Agitation
- Anxiety
- Depression
- Malaise
- Rigors
- Dermatologic:
- Hypertrichosis
- Pruritus
- Dermal Ulcer
- Dermatological Disease
- Skin Rash
- Endocrine & Metabolic:
- Diabetes Mellitus
- Hypertriglyceridemia
- Acidosis
- Albuminuria
- Anasarca
- Dehydration
- Hypervolemia
- Hypocalcemia
- Hypoglycemia
- Hypomagnesemia
- Hyponatremia
- Increased Nonprotein Nitrogen
- Increased
- Serum Glucocorticoids
- Hypercalcemia
- Hyperlipidemia
- Weight Gain
- Gastrointestinal:
- Gastroenteritis
- Melena
- Stomatitis
- Gastrointestinal Hemorrhage
- Gi Moniliasis
- Gingival Hyperplasia
- Enlargement Of Abdomen
- Esophagitis
- Flatulence
- Hernia
- Hematologic & Oncologic:
- Polycythemia
- Purpura
- Thrombocytopenia
- Infection
- Hematoma
- Hemorrhage
- Sepsis
- Hypoproteinemia
- Leukopenia
- Cytomegalovirus Disease
- Herpes simplex and herpes Zoster Virus Infection
- Genitourinary:
- Urinary Frequency
- Urinary Retention
- Hematuria
- Impotence
- Oliguria
- Ureteral Disease
- Bladder Dysfunction
- Dysuria
- Genital Edema (Male)
- Ophthalmic:
- Cataract
- Conjunctivitis
- Visual Disturbance
- Neuromuscular & Skeletal:
- Bone Fracture
- Leg Pain
- Neuropathy
- Paresthesia
- Muscle
- Cramps
- Myalgia
- Arthralgia
- Arthropathy
- Back Pain
- Weakness
- Miscellaneous:
- Accidental Injury
- Cyst
- Renal:
- Renal Insufficiency
- Renal Tubular Necrosis
- Respiratory:
- Pharyngitis
- Pneumonia
- Pulmonary Edema
- Bronchitis
- Bronchospasm
- Cough
- Rhinitis
- Sinusitis
Contraindications to Basiliximab (Simulect):
- allergies to basiliximab and any of the components of the formulation
Cautions and alerts
Anaphylactoid reactions and hypersensitivity reactions
- Severe allergic reactions can occur, especially during the first 24 hours of administering the drug. Allergic reactions can occur even months after the dose is administered.
- Patients who have been previously exposed to basiliximab should be cautious when using it. If you notice serious adverse reactions, they should be stopped immediately.
- Anaphylactic reactions such as epinephrine should be treated with medication.
Diabetes:
- NODAT (New-onset Diabetes Mellitus after Transplant) and PTDM (Post-Transplant Diabetes Mellitus), are well-known entities.
- It could be due to the transplant or drugs such as basiliximab plus prednisone and cyclosporine.
Opportunistic Infections
- The use of immunosuppressive therapy can lead to opportunistic infections that could be potentially life-threatening.
Anti-human antibodies against murine (HAMA)
- Although HAMA may be developed through its use, it is not yet known if HAMA has any clinical value.
Lymphoproliferative diseases:
- Immunosuppressive treatment may cause a rise in lymphoproliferative diseases.
Monitoring Parameters:
- Monitor for allergic reactions during the infusion and clinical features of rejection.
How to administer Basiliximab?
- It should only be administered via the intravenous route.
- It may be infused over 20 - 30 minutes as a bolus through a peripheral or a central venous line.
- Bolus infusion may be associated with pain at the injection site, nausea, and vomiting.
Mechanism of action of Basiliximab:
- Basiliximab, a monoclonal immunosuppressant monoclonal anti-immune suppressant chimeric (combined human and murine antibody), is called.
- It prevents the interleukin-2 receptor complex's alpha chain from functioning (IL-2).
- On activated T lymphocytes, the Interleukin-2 receptor can be found.
- It is one of the key steps that results in cell-mediated rejection.
It has a median duration of action of 36 days +/- 14 days.
It has a half-life of 5-13 days for children and 4-10 days for adults. A significant amount of drugs is lost in the liver of patients undergoing liver transplants. This increases the total body clearance and decreases the duration of CD 25 (IL-2R) receptor saturation. These cases may require that the dose be adjusted.
International Brands of Basiliximab:
- Simulect
Basiliximab Brands in Pakistan:
Basiliximab [Inj 20 mg/vial] |
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Simulect |
Novartis Pharma (Pak) Ltd |