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HomeEfficacyATGAM® efficacyEfficacy homeTrial: ATGAM® versus rabbit ATGTrial: ATGAM® ± sirolimusTrial: ATGAM® other pivotal studiesSafetyDosing & administrationSupport & resourcesMaterialVideo

Information on how to access prescribing information and adverse event reporting can be found towards the bottom of the page.

ATGAM®▼ (horse anti-human T-lymphocyte immunoglobulin) safety profile

ATGAM® has a well-documented profile, based on five clinical studies and published reports1

Adverse reactions1

Some of the most common adverse reactions from clinical studies with ATGAM are infection, serum sickness and abnormal liver function tests. Please see the list of most common adverse reactions below.

Most commonly reported adverse reactions in clinical studies1

Infection

Neutropenia

Serum sickness

Hypertension

Diarrhoea

Rash

Arthralgia

Oedema

Pyrexia

Headache and pain

Chills

Abnormal liver function tests

For full details regarding adverse events please refer to the Summary of Product Characteristics.

Special warnings and precautions for use1

  • To identify patients at greatest risk of serious immune-mediated reactions, skin testing before treatment is strongly recommended, especially in atopic patients. The patient should be kept under continuous observation during and after the infusion for possible allergic reactions
  • There is a potential risk of cytokine release syndrome, which can be fatal
  • Opportunistic infections are very common due to the nature of the disease and the immunosuppressive effects of ATGAM®
  • The risk of infections is increased when ATGAM® is combined with other immunosuppressants and there is an increased risk of viral reactivation. Patients should be carefully monitored for evidence of infection and treatment should be instituted in accordance with local guidelines.
  • Treatment with ATGAM may exacerbate thrombocytopenia and neutropenia.
  • ATGAM is made from horse plasma and also employs human blood-derived reagents in the process; the possibility of transmitting infective agents cannot be totally excluded.

Contraindications1

  • Hypersensitivity to the active substance or to any of the excipients
  • Hypersensitivity to any other horse gamma globulin preparation

Special considerations for particular types of patient groups when using
ATGAM®1

Paediatric patients 
  • ATGAM® is indicated for use in adults and in children aged 2 years and older for the treatment of acquired moderate-to-severe aplastic anaemia of known or suspected immunologic aetiology as part of standard IST in patients who are unsuitable for HSCT or for whom a suitable HSC donor is not available1
  • Published studies suggest that ATGAM has a similar safety profile in children to that in adults when treated with dosages comparable to those used in adults over similar treatment durations1
  • However, based on data from a compassionate use program, achieving haematological response could be less successful in children between the ages of 2 and 11 years in the subgroup of very severe aplastic anaemia paediatric patients compared with older children or adult patients with very severe aplastic anaemia.1
Elderly patients 
  • Clinical experience in elderly patients has not identified differences in responses between elderly patients (>65 years) and younger patients1
  • Quality of life is an important factor for elderly patients. It is for this reason that treatment should be as individualised as possible, with their personal wishes adhered to2
Pregnant patients 
  • Clinical experience with ATGAM® is limited in pregnant women, therefore, it is recommended to avoid the use of ATGAM® during pregnancy1
  • Women of childbearing potential should use effective contraception during and up to 10 weeks after finishing treatment with ATGAM®1
HSC, haematopoietic stem-cell; HSCT, haematopoietic stem-cell transplantation; IST, immunosuppressive therapy.References:ATGAM® Summary of Product Characteristics. Pfizer Inc.Killick SB, et al. Br J Haematol. 2016;172(2):187–207. 

Prescribing Information
Click here for Prescribing Information for ATGAM (horse anti-human T-lymphocyte immunoglobulin).Explore ATGAM® efficacy Find out more LoadingLearn about ATGAM® dosing & administration Find out more LoadingMore information is available in support & resources Explore resources Loading
PP-ATG-GBR-0026. February 2023

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search 

for MHRA Yellow Card in Google Play or Apple App Store

 

Adverse events should also be reported to Pfizer Medical Information on 01304 616161

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