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Child Health Guideline Identifier

Rheumatology - Abatacept (Orencia)

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Background

Abatacept is a soluble fusion protein consisting of the extracellular domain of the human cytotoxic T lymphocyte antigen 4 (CLTA4) linked to the modified FC domain of human IgG1. It binds to the CD80/CD86 on antigen presenting cells and blocks co-stimulatory signal, inactivating T cells1.

Abatacept is used to treat active polyarthritis or aggressive oligo-arthritis (JIA) which has not responded to methotrexate and at least one anti-TNF alpha agent1,2. It can also be used to treat active non-infectious uveitis (in JIA and idiopathic uveitis) which has not responded to methotrexate and at least one anti-TNF alpha agent3.

The treatment regimen usually consists of intravenous infusions at 0, 2, and 4 weeks and then every 4 weeks. Once there is a clinical response, the interval between infusions may be increased1.

In adults, abatacept can be given by subcutaneous (SC) injection weekly but there is currently no data of SC injection in children.

Contraindications

Absolute contra-indications

  • Untreated chronic infection, such as tuberculosis
  • Any active infection
  • Known hypersensitivity to any component of the product

Relative contraindications/cautions

  • Chronic hepatitis B carriage
  • History of Guillain-Barré Syndrome, optic neuritis or Multiple Sclerosis
  • Pregnancy
  • Underlying conditions which predispose infection (e.g. Crohn's, diabetes)

Before treatment commences

Before starting Abatacept (or any other biologics), it is important to exclude possible pre-existing infections. Children should have the following:

  • TB excluded with serum quantiferon gold, Mantoux (preferred if ≤5yrs) and CXR
  • Viral serology - Measles Mumps and Rubella IgG, VZV IgG, Hep A, B, C, HIV. It is recommended that immunisations are up to date before commencing Abatacept if possible depending on degree of urgency and immunosuppression1Where possible any catch up immunizations should be given one month before starting Abatacept.
  • Medical review prior to infusion if unwell, particularly FEVER, active or suspected infection or recent exposure to infectious diseases
  • FBC and LFT results (taken the day before infusion)

Delay infusion and discuss with Consultant

  • If absolute neutrophil count <1 000/mm3
  • If platelets <50 000/mm3 (delay until count >100 000/mm3)
  • If ALT>3x upper limit normal (delay until <3x normal)

It is important that

  • The medical team have fully discussed the treatment with the patient and/or carer and that written patient information has been provided.
  • Responsible consultant to document discussion regarding risks/benefits of treatment (including serious risks) in full.

Abatacept needs to be ordered from Pharmacy at least 24 hours before the infusion.

On admission and prior to Abatacept infusion

  1. Check the patient and family have no outstanding questions regarding the infusion
  2. Check a rheumatologist is available on call during infusion
  3. Check that Abatacept and pre-medications are charted as per dosing outlined below.
  4. Check that adrenaline is charted - see anaphylaxis guideline for recommended adrenaline dosing
  5. Obtain the following:
    1. Baseline temperature, pulse rate, blood pressure and respiratory rate
    2. Height and weight
    3. IV access
    4. Blood tests if not done the day before (FBC, electrolytes, urea, creatinine, LFTs, ESR, CRP, ferritin). 
    5. History of any recent infections (colds, URTI's, fevers), exposure to infectious diseases such as chicken pox and measles
    6. Medical admission and review
  6. Delay infusion if:
    1. Patient is febrile and/or infection is present, especially if severe infection is suspected - discuss with Fellow or Consultant as infusion should be postponed for at least a week.
    2. Absolute neutrophil count <1 000/mm3
    3. If platelets <50 000/mm3 (delay until count >100 000/mm3)
    4. ALT>3x upper limit normal (delay until <3x normal)

Pre-medication prior to Abatacept infusion

Pre-medication may be needed for patients who have previously had reactions. Please discuss with SMO if unsure.

Pre-medication (oral, give 30-60mins before infusion)

  1. Loratadine or cetirizine
      1-2 years <30kg ≥30kg
    Loratidine (daily) 2.5mg 5mg 10mg
       <2 years  2-6 years  6-12 years  >12 years
    Cetirizine (twice daily*)  0.25mg/kg/dose  2.5mg  5mg  10mg
    *dose may be repeated in the event of a reaction    
  2. Paracetamol 15mg/kg/dose (maximum dose is 60mg/kg/day, or 4grams/day)

Abatacept dosage and administration

This is a hazardous medicine. Please ensure you follow your local policy with regards to protection when preparing and administering it

Abatacept needs to be ordered from Pharmacy at least 24 hours before the infusion.

  • The vials can be stored for up to 24 hours prior to infusion, in the refrigerator (2-8 °C).
  • All infusions must be administered at ROOM TEMPERATURE over 30-45 minutes. Infusions that have to be interrupted for safety reasons should be completed over a maximum of 6 hours.
  • The solution should be protected from light

Dosage

  • Paediatric patients < 75kg: 10mg/kg/dose.
  • Paediatric patients weighing 75kg or more should follow the adult dosing regimen, not exceeding the maximum dose of 1000mg:60-100kg is 750mg/dose, 100+kg is 1000mg/dose.

Administration

  • Use filter on line 1.2 microns or less (filter is provided with medication)
  • Administer intravenously at room temperature by controlled infusion over 30 minutes.
    • dilute in 0.9% sodium chloride solution up to 100mls
    • Infuse at 200ml/hr to complete in 30mins
    • Saline flush to ensure all medicine is through
  • First infusion:
    • Start at 50ml/hr for 10min
    • Increase to 100ml/hr for 10min
    • Increase to 200ml/hr to complete

Observations during infusion

  1. Record baseline TPR, BP
  2. Pulse and BP every 15 minutes for the first hour and then every 30 minutes thereafter
  3. Temperature every hour
  4. After first and second infusion, the patient should remain in unit/ward for at least 2 hours post infusion as delayed reactions can occur. For subsequent infusions, the patient should remain in unit/ward for at least 1 hour post infusion1.

Adverse reactions

These are more likely with first and second infusions.

If an anaphylactic reaction occurs (ie significant respiratory or haemodynamic instability), stop infusion and call 777. See  Starship Analphylaxis Clinical Guideline

If a reaction occurs, STOP the infusion until medical review.

Reported symptoms of adverse reactions to Abatacept include:

Rare

  • Fevers/chills
  • Itch
  • Chest pain, shortness of breath or changes in blood pressure
  • Serious infections

More common reactions

  • Headaches, runny nose, dizziness or cough
  • Sore throat, heartburn or nausea
  • Back, arm or leg pain
  • Urine infections
  • Rash
  • Stomach and bowel discomfort
  • Mild infections (e.g. colds, sinusitis)

If the patient has any of the signs and symptoms above and remains haemodynamically stable and maintains normal respiratory function:

  • The infusion rate must be slowed down (at least halved) and the infusion time extended.
  • If the patient continues to display signs and symptoms of hypersensitivity, an oral dose of antihistamine must be administered.

Discharge Planning

Rebook for next infusion in two - four weeks, depending on regimen. Ensure family have a blood test form to use the day prior to the next booked infusion date.

Patients and families should be reminded to avoid contact with infections and to notify the rheumatology service if there is a known or suspected chickenpox or measles contact.

Live vaccines and live attenuated vaccines are contraindicated for patients on Abatacept. An annual influenza vaccine is not a live vaccine and is recommended.

Review and Follow up

  • Rheumatology review at each infusion visit.
  • Clinic review at minimum of 6 monthly intervals with documentation of core set of variables.


References

  1. Medsafe. medsafe.govt.nz. [Online] February 2015. [Cited: 20 October 2016.] http://www.medsafe.govt.nz/profs/datasheet/o/orenciainj.pdf.
  2. Abatacept in children with juvenile ideopathic arthritis: a randomised, double-blind, placebo-controlled withdrawal trial. Ruperto N, Lovell D, Quartier P et al. s.l. : The Lancet, 2008, Vol. 372.
  3. Abatacept in the treatment of severe, longstanding and refractory uveitis assoicated with JIA. Tappeiner C, Miserocchi E, Bodaqhi B et al. 4, s.l. : Journal of Rheumatology, 2015, Vol. 42.
  4. ADHB policy for cytotoxic and hazardous medicine administration

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Document Control

  • Date last published: 07 June 2017
  • Document type: Clinical Guideline
  • Services responsible: Paediatric Rheumatology
  • Author(s): Jackie Yan, Rosalie Olding, Rebecca Dean
  • Owner: Paediatric Rheumatology
  • Editor: Greg Williams
  • Review frequency: 2 years

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