Drugs List

Therapeutic Indications

Uses

Prophylaxis of acute organ rejection in de novo allogeneic renal transplantation in adult and paediatric patients, in conjunction with other immunosuppressant therapy.

Basiliximab must be used in one of the following combinations:
1) Concurrently with ciclosporin microemulsion and corticosteroid-based immunosuppression in patients with panel reactive antibodies less than 80%
2) In a triple maintenance immunosuppressive regimen containing ciclosporin microemulsion, corticosteroids and either azathioprine or mycophenolate mofetil.

Administration

Reconstituted basiliximab can be administered as an intravenous bolus injection or diluted and administered as an intravenous infusion over 20-30 minutes.

Reconstitution

Each 10mg of basiliximab powder should be dissolved in the 2.5ml of water for injections diluent provided, and shaken gently to avoid foaming.

The reconstituted solution is isotonic and may be given as a bolus injection or diluted further (to at least 25ml for 10mg/2.5ml solution or to at least 50ml for 20mg/5ml solution) with 0.9% sodium chloride injection or 5% glucose injection, and administered as an intravenous infusion.

It is recommended that the reconstituted solution should be used immediately.
If not used immediately, it may be stored at 2 - 8 degrees C for 24 hours or at room temperature for 4 hours.

Incompatibilities

Since no data are available on the compatibility of basiliximab with other intravenous substances, basiliximab should not be mixed with other medications/substances and should always be given through a separate infusion line.

Contraindications

Pregnancy - see Pregnancy section
Breastfeeding - see Lactation section
Children under 1 year

Precautions and Warnings

Basiliximab should be prescribed only by physicians who are experienced in the use of immunosuppressive therapy following organ transplantation.

Basiliximab should be administered under qualified medical supervision.

Patients receiving basiliximab must be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources, including medications for the treatment of severe hypersensitivity reactions.

Severe acute (less than 24 hours) hypersensitivity reactions have been observed both on initial exposure to basiliximab and on re-exposure to a subsequent course of therapy. These include anaphylactoid-type reactions such as urticaria, pruritus, sneezing, hypotension, tachycardia, dyspnoea, bronchospasm, pulmonary oedema and respiratory failure. If a severe hypersensitivity reaction occurs, therapy with basiliximab must be permanently discontinued and no further dose administered.

Patients may have an increased risk of hypersensitivity if concurrent immunosuppressive medication are discontinued prematurely due to abandoned transplantation, or early loss of graft. Basiliximab treatment should therefore not be started unless absolutely certain that the transplant will occur.

Patients on immunosuppressive therapy following transplantation are at an increased risk of developing lymphoproliferative disorders and opportunistic infections, although, to date, no increase has been seen with the use of basiliximab.

Women of child-bearing potential must use adequate contraception to prevent pregnancy and continue its use for at least 8 weeks and up to an additional 16 weeks after the last dose of basiliximab.

Pregnancy and Lactation

Pregnancy

Basiliximab is contraindicated during pregnancy.

Basiliximab has potentially hazardous immunosuppressive effects with respect to the course of gestation. There is conflicting evidence as to the degree of risk for the infant. Schaefer concludes that inadvertent use does not justify termination of pregnancy or invasive diagnostic procedures

Manufacturers guidelines suggest patients avoid becoming pregnant for up to 4 months following treatment with basiliximab. However the UK National Kidney Federation recommends women to avoid pregnancy for the first year following transplantation irrespective of the immunosuppressant regimen.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Basiliximab is contraindicated during breastfeeding.

Basiliximab has potentially hazardous immunosuppressive effects with respect to the suckling infant 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 milk should be expected. Breastfeeding must therefore be avoided.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Constipation
Urinary tract infections
Pain - generalised
Nausea
Peripheral oedema
Hypertension
Anaemia
Headache
Hyperkalaemia
Lymphoma
Lymphoproliferative disorders
Malignancies
Cytomegalovirus infection
Hypercholesterolaemia
Surgical wound complication
Weight gain
Serum creatinine increased
Hypophosphataemia
Diarrhoea
Viral infection
Upper respiratory tract infection
Hypertrichosis
Rhinitis
Pyrexia
Sepsis
Hypersensitivity reactions
Anaphylactoid-like reaction
Rash
Urticaria
Pruritus
Wheezing
Sneezing
Hypotension
Tachycardia
Dyspnoea
Bronchospasm
Pulmonary oedema
Cardiac failure
Respiratory failure
Capillary leak syndrome
Cytokine release syndrome
Infections
Myocardial infarction

Presentation

Powder for solution for infusion or injection containing 10mg basiliximab plus solvent
Powder for solution for infusion or injection containing 20mg basiliximab plus solvent

When reconstituted in accordance with the manufacturer's instructions, the solution contains basiliximab 4mg per ml.

Drugs List

Therapeutic Indications

Uses

Prophylaxis of acute organ rejection in de novo allogeneic renal transplantation in adult and paediatric patients, in conjunction with other immunosuppressant therapy.

Basiliximab must be used in one of the following combinations:
1) Concurrently with ciclosporin microemulsion and corticosteroid-based immunosuppression in patients with panel reactive antibodies less than 80%
2) In a triple maintenance immunosuppressive regimen containing ciclosporin microemulsion, corticosteroids and either azathioprine or mycophenolate mofetil.

Dosage

Basiliximab should be prescribed only by physicians who are experienced in the use of immunosuppressive therapy following organ transplantation.

Basiliximab should be administered under qualified medical supervision.

Adults

Elderly

Children

Administration

Reconstituted basiliximab can be administered as an intravenous bolus injection or diluted and administered as an intravenous infusion over 20-30 minutes.

Reconstitution

Each 10mg of basiliximab powder should be dissolved in the 2.5ml of water for injections diluent provided, and shaken gently to avoid foaming.

The reconstituted solution is isotonic and may be given as a bolus injection or diluted further (to at least 25ml for 10mg/2.5ml solution or to at least 50ml for 20mg/5ml solution) with 0.9% sodium chloride injection or 5% glucose injection, and administered as an intravenous infusion.

It is recommended that the reconstituted solution should be used immediately.
If not used immediately, it may be stored at 2 - 8 degrees C for 24 hours or at room temperature for 4 hours.

Incompatibilities

Since no data are available on the compatibility of basiliximab with other intravenous substances, basiliximab should not be mixed with other medications/substances and should always be given through a separate infusion line.

Contraindications

Pregnancy - see Pregnancy section
Breastfeeding - see Lactation section
Children under 1 year

Precautions and Warnings

Basiliximab should be prescribed only by physicians who are experienced in the use of immunosuppressive therapy following organ transplantation.

Basiliximab should be administered under qualified medical supervision.

Patients receiving basiliximab must be managed in facilities equipped and staffed with adequate laboratory and supportive medical resources, including medications for the treatment of severe hypersensitivity reactions.

Severe acute (less than 24 hours) hypersensitivity reactions have been observed both on initial exposure to basiliximab and on re-exposure to a subsequent course of therapy. These include anaphylactoid-type reactions such as urticaria, pruritus, sneezing, hypotension, tachycardia, dyspnoea, bronchospasm, pulmonary oedema and respiratory failure. If a severe hypersensitivity reaction occurs, therapy with basiliximab must be permanently discontinued and no further dose administered.

Patients may have an increased risk of hypersensitivity if concurrent immunosuppressive medication are discontinued prematurely due to abandoned transplantation, or early loss of graft. Basiliximab treatment should therefore not be started unless absolutely certain that the transplant will occur.

Patients on immunosuppressive therapy following transplantation are at an increased risk of developing lymphoproliferative disorders and opportunistic infections, although, to date, no increase has been seen with the use of basiliximab.

Women of child-bearing potential must use adequate contraception to prevent pregnancy and continue its use for at least 8 weeks and up to an additional 16 weeks after the last dose of basiliximab.

Pregnancy and Lactation

Pregnancy

Basiliximab is contraindicated during pregnancy.

Basiliximab has potentially hazardous immunosuppressive effects with respect to the course of gestation. There is conflicting evidence as to the degree of risk for the infant. Schaefer concludes that inadvertent use does not justify termination of pregnancy or invasive diagnostic procedures

Manufacturers guidelines suggest patients avoid becoming pregnant for up to 4 months following treatment with basiliximab. However the UK National Kidney Federation recommends women to avoid pregnancy for the first year following transplantation irrespective of the immunosuppressant regimen.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Basiliximab is contraindicated during breastfeeding.

Basiliximab has potentially hazardous immunosuppressive effects with respect to the suckling infant 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 milk should be expected. Breastfeeding must therefore be avoided.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Effects on Ability to Drive and Operate Machinery

No studies have been performed regarding the effects of basiliximab on a patient's ability to drive or operate machinery.

Side Effects

Constipation
Urinary tract infections
Pain - generalised
Nausea
Peripheral oedema
Hypertension
Anaemia
Headache
Hyperkalaemia
Lymphoma
Lymphoproliferative disorders
Malignancies
Cytomegalovirus infection
Hypercholesterolaemia
Surgical wound complication
Weight gain
Serum creatinine increased
Hypophosphataemia
Diarrhoea
Viral infection
Upper respiratory tract infection
Hypertrichosis
Rhinitis
Pyrexia
Sepsis
Hypersensitivity reactions
Anaphylactoid-like reaction
Rash
Urticaria
Pruritus
Wheezing
Sneezing
Hypotension
Tachycardia
Dyspnoea
Bronchospasm
Pulmonary oedema
Cardiac failure
Respiratory failure
Capillary leak syndrome
Cytokine release syndrome
Infections
Myocardial infarction

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Shelf Life and Storage

Store at 2-8 degrees C

Further Information

Last Full Review Date: June 2012

Reference Sources

British National Formulary, 63rd Edition (2012) Pharmaceutical Press, London.

BNF for Children (2011-2012) Pharmaceutical Press, London.

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Summary of Product Characteristics: Simulect. Novartis Pharmaceuticals UK Ltd. Revised September 2014.

https://www.kidney.org.uk/Medical-Info/transplant/txsexkids.html
Last reviewed March 20, 2012
Last accessed June 7, 2012