Basiliximab

Registered South African indications:

• Prophylaxis of acute organ rejection in de novo renal transplantation

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Pregnancy
• Breastfeeding

Cautions

• Renal impairment
• Hepatic impairment
• Previous administration of basiliximab and re-exposure to a subsequent course of therapy
• Live or inactive vaccination
• Heart transplant

Forms avail. in SA and covered in this monograph: inj

Prophylaxis of acute organ rejection in de novo allogeneic renal transplantation (additional agents required)
- Concomitant use with ciclosporin for microemulsion- and corticosteroid-based immunosuppression
- Panel reactive antibodies <80%
- Triple maintenance immunosuppressive regimen containing ciclosporin for microemulsion, corticosteroids and either azathioprine or mycophenolate mofetil

• IV: 40mg, to be given as 2 doses of 20mg; First dose to be given within 2 hours prior to transplantation surgery, second dose to be given 4 days after transplantation surgery

Withhold second dose if severe hypersensitivity reaction or post-operative complications such as graft loss occurs

Basiliximab must not be administered unless it is absolutely certain that the patient will receive the graft and concomitant immunosuppression

Paed. forms avail. in SA and covered in this monograph: inj

Prophylaxis of acute organ rejection in de novo allogeneic renal transplantation (additional agents required)
- Concomitant use with ciclosporin for microemulsion- and corticosteroid-based immunosuppression
- Panel reactive antibodies <80%
- Triple maintenance immunosuppressive regimen containing ciclosporin for microemulsion, corticosteroids and either azathioprine or mycophenolate mofetil

<35kg

• IV: 20mg, to be given as 2 doses of 10mg; First dose to be given within 2 hours prior to transplantation surgery, second dose to be given 4 days after transplantation surgery

>35kg

• See adult dosage

Withhold second dose if severe hypersensitivity reaction or post-operative complications such as graft loss occurs

Basiliximab must not be administered unless it is absolutely certain that the patient will receive the graft and concomitant immunosuppression

Pregnancy

• Contraindicated
• Basiliximab is contraindicated in pregnancy. Basiliximab has potentially hazardous immunosuppressive effects with respect to the course of gestation
• Women of childbearing potential must use effective contraception during and up to 16 weeks after treatment

Breastfeeding

• Contraindicated 
• Basiliximab is contraindicated in breastfeeding women. Basiliximab has potentially hazardous immunosuppressive effects with respect to the breastfeeding neonate exposed to basiliximab in breast milk
• There is no animal or human data available concerning excretion of basiliximab into breast milk. However, based on the IgG1 nature of basiliximab, excretion into the milk should be expected. Breastfeeding must therefore be avoided

Renal Impairment

• Caution; no information available

Hepatic Impairment

• Caution; no information available

Elderly

• No dose adjustment recommended
  Limited data available on use in patients >65 years, but there is no evidence that elderly patients require a different dosage from younger adult patients

Porphyria Information

• Probably not porphyrinogenic (PNP)
  Immunosuppressive therapy increases infection risk and may trigger acute cases of porphyria

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Headache

Respiratory Disorders

• Upper respiratory tract infection
• Rhinitis

Cardiovascular Disorders

• Hypertension

Gastrointestinal Disorders

• Constipation
• Nausea
• Diarrhoea

Genitourinary Disorders

• Urinary tract infection

Endocrine and Metabolic Disorders

• Hyperkalaemia
• Hypercholesterolaemia
• Increased weight
• Increased blood creatinine
• Hypophosphataemia

Skin and Subcutaneous Tissue Disorders

• Post-operative wound complication
• Hypertrichosis

Immune, Blood and Lymphatic System Disorders

• Anaemia
• Fever
• Viral infection
• Sepsis
• Lymphoma
• Lymphoproliferative disease
• Opportunistic infections
  - Cytomegalovirus
  - BK virus
• Hypersensitivity reactions
  - Rash
  - Urticaria
  - Pruritis
  - Sneezing
  - Wheezing
  - Hypotension
  - Tachycardia
  - Dyspnoea
  - Bronchospasm
  - Pulmonary oedema
  - Cardiac failure
  - Respiratory failure
  - Capillary leak syndrome
• Cytokine release syndrome
• Peripheral oedema

Other

• Pain

• Live vaccines
• Inactivated vaccines

None routine

Basiliximab is a murine/human chimeric monoclonal antibody (IgG1κ) that is directed against the interleukin-2 receptor α-chain (CD25 antigen), which is expressed on the surface of T-lymphocytes in response to antigenic challenge. Basiliximab specifically binds with high affinity to the CD25 antigen on activated T-lymphocytes expressing the high affinity interleukin-2 receptor (IL-2R) and thereby prevents binding of interleukin-2, a critical signal for T-cell proliferation in the cellular immune response involved in allograft rejection. 

Injection (per vial) 20mg

• Simulect (Novartis) originator