Antithymocyte immunoglobulin (equine) parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Infusion of anti-human T lymphocyte immunoglobulin (equine).
Drugs List
Therapeutic Indications
Uses
Anaemia - aplastic
Treatment of acquired moderate to severe aplastic anaemia of known or suspected immunologic aetiology in adult and children aged 2 years and older as part of standard immunosuppressive therapy in patients who are unsuitable for haematopoietic stem cell transplantation (HSCT) or for those whom a HSC donor is not available.
Dosage
Adults
Aplastic anaemia
Total recommended dose: 160 mg/kg, as part of a standard immunosuppressive therapy. To be given as 16 mg/kg/day over 10 days or, 20 mg/kg/day over 8 days or 40 mg/kg/day over 4 days.
Children
Aplastic anaemia
Total recommended dose for children aged 2 years and older: 160 mg/kg, as part of a standard immunosuppressive therapy. To be given as 16 mg/kg/day over 10 days or, 20 mg/kg/day over 8 days or 40 mg/kg/day over 4 days.
Administration
To be administered as a slow infusion (duration should not be less than 4 hours) into a high flow central vein.
Contraindications
Children under 2 years
Breastfeeding
Precautions and Warnings
Pregnancy
Administration of live vaccines is not recommended
Advise ability to drive/operate machinery may be affected by side effects
Premedication with corticosteroid, antihistamine & antipyretic recommended
Sensitivity skin test strongly recommended prior to treatment
Derived from human blood - transmission of infectious agents possible
Dilute and use as an infusion
Record name and batch number of administered product
Reducing the infusion rate may minimise severity of infusion reactions
Resuscitation facilities must be immediately available
Treatment to be administered under the supervision of a specialist
Monitor and manage cytomegalovirus reactivation during treatment
Monitor for signs and symptoms of infection after treatment
Monitor patient for infusion-associated reactions (IARs)
Monitor patient for signs and symptoms of respiratory distress
Discontinue if severe cytokine release syndrome develops
Discontinue if thrombocytopenia occurs
Reactivation of herpes simplex may occur
Risk of developing opportunistic infections
Discontinue if clinical/laboratory evidence of neutropenia
Discontinue if serious allergic or anaphylactic reaction occurs
Female: Contraception required during and for 10 weeks after treatment
Pregnancy and Lactation
Pregnancy
Use equine anti-human thymocyte immunoglobulin with caution in pregnancy.
The manufacturer recommends that as a precautionary measure, it is preferable for equine anti-human thymocyte immunoglobulin to be avoided during pregnancy, therefore the outcome of pregnancies cannot be determined. At the time of publishing there are limited data into the use of equine anti-human thymocyte immunoglobulin during pregnancy. Studies in animals have shown reproductive toxicities, however, these effects are not considered relevant to humans.
Lactation
Equine anti-human thymocyte immunoglobulin is contraindicated during breastfeeding.
The manufacturer recommends that breastfeeding should be discontinued during treatment with equine anti-human thymocyte immunoglobulin. It is unknown whether equine anti-human thymocyte immunoglobulin is excreted in human milk. However, as other immunoglobulins are excreted, it is recommended that breastfeeding be discontinued during treatment.
Side Effects
Abdominal pain
Abnormal liver function tests
Agitation
Allergic dermatitis
Alterations in renal function tests
Anaemia
Anaphylactic reaction
Apnoea
Arthralgia
Asthenia
Back pain
Bradycardia
Chest pain
Chills
Confusion
Congestive cardiac failure
Convulsions
Cough
Cytomegalovirus infection
Deep vein thrombosis (DVT)
Dehiscence
Diarrhoea
Disorientation
Dizziness
Dyskinesia
Dyspnoea
Encephalitis
Eosinophilia
Epistaxis
Epstein-Barr virus
Erythema at injection site
Extremity pain
Fever
Flank pain
Gastro-intestinal haemorrhage
Gastro-intestinal perforation
Granulocytopenia
Haemolysis
Haemolytic anaemia
Headache
Hepatitis
Herpes simplex
Hiccough
Hyperglycaemia
Hyperhidrosis
Hypertension
Hypotension
Infection
Laryngospasm
Leucopenia
Local pain (injection site)
Lymphadenopathy
Malaise
Muscle rigidity
Myalgia
Nausea
Neutropenia
Night sweats
Oedema
Oral pain
Oropharyngeal pain
Pain
Pancytopenia
Paraesthesia
Periorbital oedema
Pleural effusion
Proteinuria
Pruritus
Pulmonary oedema
Pyrexia
Rash
Renal artery thrombosis
Renal failure
Sepsis
Serum sickness
Stomatitis
Swelling (injection site)
Syncope
Tachycardia
Thrombocytopenia
Thrombophlebitis
Toxic epidermal necrolysis
Tremor
Urticaria
Vasculitis
Vomiting
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 ).
Further Information
Last Full Review Date: December 2022
Reference Sources
Summary of Product Characteristics: Atgam 50 mg/ml concentrate for solution for infusion. Pfizer Limited. Revised October 2022.
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