Drugs List

Therapeutic Indications

Uses

Prophylaxis of acute organ rejection for allogeneic cardiac transplant
Renal transplant rejection - prevention
Treatment of steroid resistant graft rejection in renal transplantation

Administration

To be administered as a slow infusion (duration should not be less than 6 hours) into a high flow vein. Reducing the administration rate may minimise infusion reactions.

Contraindications

Infection
Neonates under 1 month
Breastfeeding

Precautions and Warnings

Children aged 1 month to 1 year
Leucocyte count below 3 x 10 to the power of 9 / L
Platelet count below 75 x 10 to the power of 9 / L
Aplastic anaemia
Pregnancy

Advise ability to drive/operate machinery may be affected by side effects
Premedicate with intravenous corticosteroids and antihistamines
Premedication with anti-infective recommended during treatment
Premedication with antipyretic recommended
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
Staff: Not to be handled by pregnant staff
Treatment to be administered under the supervision of a specialist
Monitor patient for infusion-associated reactions (IARs)
Perform regular white blood cell and platelet counts
Discontinue if severe cytokine release syndrome develops
Immunosuppressive drugs may increase risk of malignancy
May affect immune response to live vaccines
May affect results of some laboratory tests
Consider discontinuing if leucocyte count below 2 x 10 to the power 9/l
Consider discontinuing if platelet count below 50 x 10 to the power 9/l
Consider dose reduction if leucocyte count below 3 x 10 to the power 9/l
Consider dose reduction if platelet count below 75 x10 to the power 9/l
In obese patients dosing should be based on ideal weight
Not licensed for all indications in all age groups

Pregnancy and Lactation

Pregnancy

Use with caution in pregnancy.

At the time of publishing no studies have been conducted into the use of rabbit anti-human thymocyte immunoglobulin during pregnancy. It is unknown whether it can cause foetal harm or affect reproductive capacity. It should therefore be given to pregnant women only if clearly needed.

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 14-17 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 at https://www.toxbase.org/

Lactation

Contraindicated for use in breastfeeding.

It is unknown whether rabbit anti-human thymocyte immunoglobulin is excreted in human milk. However, as other immunoglobulins are excreted, it is recommended that breastfeeding be discontinued during treatment.

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

Adult respiratory distress syndrome
Anaphylactic reaction
Arthralgia
Cytokine release syndrome
Diarrhoea
Dysphagia
Dyspnoea
Erythema at injection site
Febrile neutropenia
Fever
Headache
Hypertension
Hypotension
Increased susceptibility to infection
Infusion-related symptoms
Local pain (injection site)
Lymphoma
Lymphopaenia
Lymphoproliferative disorders
Malaise
Malignancies
Myalgia
Myocardial infarction
Nausea
Neutropenia
Pruritus
Pulmonary oedema
Rash
Rigors
Sepsis
Serum sickness
Shivering
Swelling (injection site)
Tachycardia
Thrombocytopenia
Urticaria
Vomiting

Presentation

Anti-human thymocyte immunoglobulin (rabbit) infusion

Drugs List

Therapeutic Indications

Uses

Prophylaxis of acute organ rejection for allogeneic cardiac transplant
Renal transplant rejection - prevention
Treatment of steroid resistant graft rejection in renal transplantation

Dosage

Dosing of obese patients should be based on ideal body weight.

Adults

Children

Administration

To be administered as a slow infusion (duration should not be less than 6 hours) into a high flow vein. Reducing the administration rate may minimise infusion reactions.

Contraindications

Infection
Neonates under 1 month
Breastfeeding

Precautions and Warnings

Children aged 1 month to 1 year
Leucocyte count below 3 x 10 to the power of 9 / L
Platelet count below 75 x 10 to the power of 9 / L
Aplastic anaemia
Pregnancy

Advise ability to drive/operate machinery may be affected by side effects
Premedicate with intravenous corticosteroids and antihistamines
Premedication with anti-infective recommended during treatment
Premedication with antipyretic recommended
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
Staff: Not to be handled by pregnant staff
Treatment to be administered under the supervision of a specialist
Monitor patient for infusion-associated reactions (IARs)
Perform regular white blood cell and platelet counts
Discontinue if severe cytokine release syndrome develops
Immunosuppressive drugs may increase risk of malignancy
May affect immune response to live vaccines
May affect results of some laboratory tests
Consider discontinuing if leucocyte count below 2 x 10 to the power 9/l
Consider discontinuing if platelet count below 50 x 10 to the power 9/l
Consider dose reduction if leucocyte count below 3 x 10 to the power 9/l
Consider dose reduction if platelet count below 75 x10 to the power 9/l
In obese patients dosing should be based on ideal weight
Not licensed for all indications in all age groups

Pregnancy and Lactation

Pregnancy

Use with caution in pregnancy.

At the time of publishing no studies have been conducted into the use of rabbit anti-human thymocyte immunoglobulin during pregnancy. It is unknown whether it can cause foetal harm or affect reproductive capacity. It should therefore be given to pregnant women only if clearly needed.

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 14-17 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 at https://www.toxbase.org/

Lactation

Contraindicated for use in breastfeeding.

It is unknown whether rabbit anti-human thymocyte immunoglobulin is excreted in human milk. However, as other immunoglobulins are excreted, it is recommended that breastfeeding be discontinued during treatment.

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

Adult respiratory distress syndrome
Anaphylactic reaction
Arthralgia
Cytokine release syndrome
Diarrhoea
Dysphagia
Dyspnoea
Erythema at injection site
Febrile neutropenia
Fever
Headache
Hypertension
Hypotension
Increased susceptibility to infection
Infusion-related symptoms
Local pain (injection site)
Lymphoma
Lymphopaenia
Lymphoproliferative disorders
Malaise
Malignancies
Myalgia
Myocardial infarction
Nausea
Neutropenia
Pruritus
Pulmonary oedema
Rash
Rigors
Sepsis
Serum sickness
Shivering
Swelling (injection site)
Tachycardia
Thrombocytopenia
Urticaria
Vomiting

Effects on Laboratory Tests

Rabbit anti-human thymocyte immunoglobulin may induce production of anti-rabbit antibodies which may interfere with rabbit antibody-based immunoassays and with cross-match or panel-reactive antibody cytotoxicity assays. It may also interfere with enzyme linked immunosorbent assay (ELISA) tests.

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: March 2013

Reference Sources

Summary of Product Characteristics: Thymoglobuline 25mg. Genzyme. Revised April 2012.

NICE - Evidence Services
Available at: www.nice.org.uk
Last accessed: 21 June 2017