This site is intended for UK healthcare professionals
Medscape UK Univadis Logo
Medscape UK Univadis Logo

Belatacept parenteral


Infusions containing belatacept

These products have been produced by recombinant technology using Chinese Hamster Ovary (CHO) cell lines.

Drugs List

  • belatacept 250mg powder for concentrate for solution for infusion
  • NULOJIX 250mg powder for concentrate for solution for infusion
  • Therapeutic Indications


    Renal transplant rejection - prevention

    Prophylaxis of graft rejection in adults receiving a renal transplant in combination with corticosteroids and mycophenolic acid. The manufacturer recommends the addition of an interleukin-2 receptor antagonist for induction therapy.


    Whilst the doses stated below are those recommended by the manufacturer, local protocols for the relevant indication should be consulted.


    Initial phase
    Initiate at 10 mg/kg:
    On day of transplant, prior to implantation (Day 1).
    On days 5, 14 and 28 after transplantation
    At the end of week 8 and week 12 after transplantation

    Maintenance phase
    Maintain at 6 mg/kg every 4 weeks (plus or minus 3 days), starting at the end of week 16 after transplantation.

    Additional Dosage Information

    The manufacturer advises that dose modifications are not required for body weight changes of less than 10%.

    Conversion from a calcineurin inhibitor-based regimen at least 6 months following transplant: 6 mg/kg every 2 weeks for the first 8 weeks, followed by 6 mg/kg every 4 weeks thereafter. The calcineurin inhibitor should be continued in tapering doses for a minimum of 4 weeks after the first initial dose of belatacept. More frequent monitoring for acute rejection is recommended for a minimum of 6 months after conversion to belatacept.


    For intravenous infusion over 30 minutes.

    Infusion of the first dose should be given in the immediate preoperative period or during surgery, but before completion of the vascular anastomoses.


    Children under 18 years
    EBV-VCA-sero negative patients

    Precautions and Warnings

    Cytomegalovirus infection
    Females of childbearing potential
    Panel reactive antibody titres >30%
    Latent or healed tuberculosis
    Liver transplant

    Administration of live vaccines is not recommended
    Cytomegalovirus prophylaxis recommended for 3 months following transplant
    Sodium content of formulation may be significant
    Advise ability to drive/operate machinery may be affected by side effects
    Consider prophylactic anti-tuberculosis therapy if appropriate
    Pneumocystis prophylaxis recommended for at least 6 months post transplant
    Prior to starting therapy screen for latent tuberculosis
    Treatment to be initiated and supervised by a specialist
    Do not give other medication through the same intravenous line
    Record name and batch number of administered product
    Ensure patient EBV seropositive before starting treatment
    Consider immunosuppressant adjustment in the event of PML
    Consider PTLD or PML if new or worsening neurological symptoms occur
    Advise patient to report headaches, seizures, confusion, visual disturbance
    Oversuppression of immune system may increase susceptibility to infection
    Risk of developing lymphoproliferative disorders
    Discontinue if Progressive multifocal leukoencephalopathy (PML) develops
    Discontinue if serious allergic or anaphylactic reaction occurs
    Female: Contraception required during and for 2 months after treatment
    Advise patient on appropriate sun protection methods
    Advise patient to avoid exposure to sunlight and UV rays during treatment

    Patients receiving belatacept therapy are at an increased risk of post-transplant lymphoproliferative disorder (PTLD). Risk factors for PTLD include cytomegalovirus (CMV), T-cell depleting therapy and negative Epstein-Barr virus (EBV) serostatus. PTLD should be considered in patients with new or worsening neurologic, cognitive or behavioural symptoms.

    Progressive multifocal leukoencephalopathy syndrome (PML) has been reported in some patients treated with this agent. If patients present with symptoms indicating PML such as worsening neurological, cognitive or behavioural signs or symptoms, an MRI should be performed. If PML is diagnosed, reduction or withdrawal of immunosuppression is recommended taking into account risk to the graft. Plasmapheresis may accelerate removal of belatacept when reduction of immunosuppression is required.

    Increased mortality has been observed in liver transplant patients receiving belatacept.

    The half-life of belatacept (8 to 10 days) should be taken into consideration when switching from belatacept to another immunosuppressant to avoid potential under or over immunosuppression.

    Pregnancy and Lactation


    Belatacept is contraindicated in pregnancy.

    Belatacept should be avoided in pregnancy unless clearly necessary due to limited data concerning its safety, although animal studies do not indicate harmful effects to foetal development. A pre and postnatal development study in rats observed limited immune function changes at 19 fold the typical human dose of 10 mg/kg.

    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 ( ) or if this is unavailable at the backup site ( ).


    Belatacept is contraindicated in breastfeeding.

    Data is limited concerning whether belatacept is excreted in human milk, however animal studies in rats show excretion of belatacept in milk. Women should not breastfeed while treated with belatacept.

    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

    Side Effects

    Abnormal liver function tests
    Adrenal suppression
    Attention disturbances
    Blood dyscrasias
    Blood pressure changes
    Breast changes
    Burning sensation
    Cardiac arrhythmias
    Cardiac disorders
    Cardiac failure
    Cerebrovascular accident
    Cervical dysplasia
    Cognitive impairment
    Cushingoid changes
    Decreased appetite
    Decreased blood glucose
    Demyelinating disorders
    Diabetes mellitus
    Dream abnormalities
    Electrolyte disturbances
    Eye disorder
    Facial palsy
    Fluid retention
    Gastro-intestinal symptoms
    Graft dysfunction
    Hair growth abnormal
    Hepatic disorders
    Hypercoagulability of the blood
    Impaired healing
    Increase in prostate specific antigen (PSA)
    Increased libido
    Increased sweating
    Increased uric acid level
    Infusion-related symptoms
    Intermittent claudication
    Local reaction at injection site
    Mood changes
    Musculoskeletal disturbances
    Possible alteration in tests for parathyroid function
    Progressive multifocal leukoencephalopathy (PML)
    Raised C-reactive protein
    Raised intracranial pressure
    Renal disorders
    Respiratory disorders
    Restless legs
    Serum creatinine increased
    Skin disorder
    Tendon rupture
    Urinary abnormalities
    Urinary dysfunction
    Vascular disorders
    Visual disturbances
    Weight changes


    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 ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: August 2015

    Reference Sources

    Joint Formulary Committee. British National Formulary(online) London: BMJ Group and Pharmaceutical Press Accessed on 13 August 2015.

    Summary of Product Characteristics: Nulojix 250mg powder for concentrate for solution for infusion. Bristol-Myers Squibb Pharma EEIG. Revised January 2022.

    Access the full UK drug database with a FREE Medscape UK Account
    It takes just a few minutes, and you’ll get unlimited access to information on over 11,000 UK drugs.
    Register for Free

    Already a member? Log in

    Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content

    FDB Logo

    FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.