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

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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.

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: