Drugs List

Therapeutic Indications

Uses

Rabies - prophylaxis after exposure

Administration

For intramuscular injection.

If intramuscular administration is contraindicated (bleeding disorders), the injection can be administered subcutaneously. However, it should be noted that there are no clinical efficacy data to support administration by the subcutaneous route.

Contraindications

None known

Precautions and Warnings

Immunoglobulin A antibodies
Breastfeeding
Coagulopathy
Immunoglobulin A deficiency
Pregnancy

Live virus vaccine should not be given for 3 months after treatment
Derived from human plasma. Transmission of infective agents possible.
Do not mix with other drugs or substances
Record name and batch number of administered product
Use only if the solution is clear
Warm to room temperature prior to use
Management of cases of shock should follow current medical standards
May induce hypotension with anaphylaxis, even if prior treatment tolerated
May interfere with antibody tests
Discontinue if allergic reaction occurs

Pregnancy and Lactation

Pregnancy

Use human rabies immunoglobulin with caution in pregnancy.

The safety of this product for use during human pregnancy has not been established in controlled clinical trials. Therefore, it should only be given with caution in pregnant women if clearly indicated. Clinical experience with immunoglobulins suggests that no harmful effects on the course of the pregnancy, or to the foetus or neonate are to be expected.

Human immunoglobulins cross the placenta. The amounts that cross to the foetus vary in the course of the pregnancy, possibly as a function of gestational age, duration of treatment and/or the method of preparation of the immunoglobulins (Briggs 2011, Schaefer 2007).

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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use human rabies immunoglobulin with caution in breastfeeding.

There is inadequate evidence of safety in breastfeeding. It may be assumed that immunoglobulin G will be transferred into the newborn during breastfeeding.

Human rabies immunoglobulin should only be given to breastfeeding women if clearly needed.

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

Anaphylactic reaction
Arthralgia
Buccal ulceration
Chest tightness
Chills
Dizziness
Dyspnoea
Erythema
Facial oedema
False positive Coombs test
Fatigue
Fever
Glossitis
Headache
Hypersensitivity reactions
Hypotension
Induration (injection site)
Influenza-like syndrome
Local pain (injection site)
Malaise
Nausea
Pruritus
Shock
Skin reactions
Swelling (injection site)
Tachycardia
Tremor
Vomiting

Presentation

Injection containing human rabies immunoglobulin

Drugs List

Therapeutic Indications

Uses

Rabies - prophylaxis after exposure

Dosage

Post-exposure prophylaxis consists of a regimen of one dose of immunoglobulin and full courses of rabies vaccination. Rabies immunoglobulin and the first dose of rabies vaccine should be given as soon as possible after exposure. Additional doses of rabies vaccine should be given according to official guidelines or the manufacturer's instructions.

Adults

Elderly

Children

Additional Dosage Information

Administration

For intramuscular injection.

If intramuscular administration is contraindicated (bleeding disorders), the injection can be administered subcutaneously. However, it should be noted that there are no clinical efficacy data to support administration by the subcutaneous route.

Contraindications

None known

Precautions and Warnings

Immunoglobulin A antibodies
Breastfeeding
Coagulopathy
Immunoglobulin A deficiency
Pregnancy

Live virus vaccine should not be given for 3 months after treatment
Derived from human plasma. Transmission of infective agents possible.
Do not mix with other drugs or substances
Record name and batch number of administered product
Use only if the solution is clear
Warm to room temperature prior to use
Management of cases of shock should follow current medical standards
May induce hypotension with anaphylaxis, even if prior treatment tolerated
May interfere with antibody tests
Discontinue if allergic reaction occurs

Pregnancy and Lactation

Pregnancy

Use human rabies immunoglobulin with caution in pregnancy.

The safety of this product for use during human pregnancy has not been established in controlled clinical trials. Therefore, it should only be given with caution in pregnant women if clearly indicated. Clinical experience with immunoglobulins suggests that no harmful effects on the course of the pregnancy, or to the foetus or neonate are to be expected.

Human immunoglobulins cross the placenta. The amounts that cross to the foetus vary in the course of the pregnancy, possibly as a function of gestational age, duration of treatment and/or the method of preparation of the immunoglobulins (Briggs 2011, Schaefer 2007).

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 ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use human rabies immunoglobulin with caution in breastfeeding.

There is inadequate evidence of safety in breastfeeding. It may be assumed that immunoglobulin G will be transferred into the newborn during breastfeeding.

Human rabies immunoglobulin should only be given to breastfeeding women if clearly needed.

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

Anaphylactic reaction
Arthralgia
Buccal ulceration
Chest tightness
Chills
Dizziness
Dyspnoea
Erythema
Facial oedema
False positive Coombs test
Fatigue
Fever
Glossitis
Headache
Hypersensitivity reactions
Hypotension
Induration (injection site)
Influenza-like syndrome
Local pain (injection site)
Malaise
Nausea
Pruritus
Shock
Skin reactions
Swelling (injection site)
Tachycardia
Tremor
Vomiting

Effects on Laboratory Tests

After injection of immunoglobulin the transitory rise of the various passively transferred antibodies in the patient's blood may result in misleading positive results in serological testing.

Passive transmission of antibodies to erythrocyte antigens e.g. A,B,D may interfere with some serological tests for red cell antibodies e.g. Coombs test.

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: September 2013

Reference Sources

British National Formulary, 66th Edition (September - March 2014) Pharmaceutical Press, London.

BNF for Children (2013-2014) Pharmaceutical Press, London.

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Summary of Product Characteristics: Human Rabies Immunoglobulin. Bio Products Laboratory. Revised July 2012

Immunisation against infectious disease - the Green Book, April 2013.
Available at: https://www.gov.uk/government/publications/green-book-the-complete-current-edition
Last accessed: September 6, 2013