Drugs List

Therapeutic Indications

Uses

Hypogammaglobulinaemia pre/post stem cell transplant: Replacement therapy
Primary immunodeficiency syndromes with impaired antibody production
Secondary hypogammaglobulinaemia in CLL or Myeloma with recurrent infection

Replacement therapy in primary immunodeficiency syndromes such as:
Primary immunodeficiency syndrome with impaired antibody production.
Replacement therapy in myeloma or chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections.
Treatment of hypogammaglobulinaemia in patients pre and post-allogeneic haematopoietic stem cell transplantation.

Unlicensed Uses

Hepatitis - infective A - prophylaxis

Administration

For subcutaneous infusion only.

An unlicensed route of intramuscular injection may be used for the treatment of hepatitis A prophylaxis. Immunoglobulin human normal (Subgam) must not be administered intramuscularly in cases of severe thrombocytopenia and in other disorders of haemostasis.

It may be suitable or it may be required to use more than one pump simultaneously, more than one injection site can be used.

Contraindications

Severe Immunoglobulin A deficiency

Precautions and Warnings

Antibodies to immunoglobulin A
Predisposition to thromboembolic disease
Prolonged immobilisation
Breastfeeding
Diabetes mellitus
History of thrombosis
Hypertension
Immunoglobulin A deficiency
Pregnancy
Severe hypovolaemia

Live virus vaccine should not be given for 3 months after treatment
Advise ability to drive/operate machinery may be affected by side effects
Inject product slowly at start of treatment to test sensitivity
Treatment to be initiated and supervised by a specialist
Contains polysorbate
Derived from human proteins - transmission of infective agents possible
Do not use if any signs of precipitate or particulate matter apparent
Monitor throughout infusion and for 1 hour post first infusion
Record name and batch number of administered product
The rate of infusion is dose dependant follow administration instructions
Vary infusion site
Ensure adequate hydration prior to infusion
Monitor for hypersensitivity reactions during infusion
Monitor IgG trough levels to adjust dose and/or dose interval
Monitor patient for at least 20 minutes post injection
Advise patient to contact a doctor if symptoms of thromboembolism develop
Increased frequency of ADRs if first human normal immunoglobulin given
Increased frequency of adverse reactions if product is switched
Management of cases of shock should follow current medical standards
May affect immune response to live vaccines
May induce hypotension with anaphylaxis, even if prior treatment tolerated
May affect results of some laboratory tests
Discontinue if anaphylactoid reaction occurs
Discontinue if Aseptic Meningitis Syndrome occurs
Measles vaccine may not be effective for up to 1 year after treatment
Advise patient on the symptoms of Aseptic Meningitis Syndrome

Use with caution in patients deficient in IgA. These patients may produce anti-IgA antibodies, which could lead to anaphylactic reactions.

Treatment should be initiated and monitored under the supervision of a physician experienced in the treatment of immunodeficiency, and in the guidance of patients for home treatment if applicable. The patient will be instructed in the use of a syringe driver, infusion techniques, the keeping of a treatment diary, and measures to be taken in case of severe adverse events. Once the patient is familiar with the method and no unacceptable side effects have been observed during the training phase, the treatment may be continued at home by the patient or carer.

Intravenous administration is contraindicated and if accidental administration into a blood vessel occurs the patient could develop shock.

Pregnancy and Lactation

Pregnancy

Use immunoglobulin human normal (Subgam) with caution during pregnancy.

The manufacturer advises caution if immunoglobulin human normal (Subgam) is used during pregnancy. At the time of writing there is limited published information regarding the use of immunoglobulin human normal (Subgam) during pregnancy. Potential risks are unknown.

Lactation

Use immunoglobulin human normal (Subgam) with caution during breastfeeding.

The manufacturer states that immunoglobulins are present in human breast milk and may contribute to protecting the infant from pathogens which have mucosal portal of entry. However the quantity and the effects on exposed infants are unknown.

Side Effects

Abdominal pain
Allergic reaction
Anaphylactic shock
Anxiety
Arthralgia
Back pain
Blood pressure changes
Bruising at injection site
Chest tightness
Chills
Diarrhoea
Dizziness
Fatigue
Fever
Flushing
Headache
Heat and redness (injection site)
Hyperhidrosis
Hypersensitivity reactions
Hypertension
Infusion related reaction
Itching (injection site)
Local pain (injection site)
Migraine
Mouth ulcers
Musculoskeletal pain
Nausea
Pain
Paraesthesia
Positive Coombs test
Pruritus
Pyrexia
Rash
Rash at injection site
Sensation of cold
Stiffness
Swelling (injection site)
Vomiting
Wheezing

Presentation

Parenteral formulations containing human normal immunoglobulin.

Drugs List

Therapeutic Indications

Uses

Hypogammaglobulinaemia pre/post stem cell transplant: Replacement therapy
Primary immunodeficiency syndromes with impaired antibody production
Secondary hypogammaglobulinaemia in CLL or Myeloma with recurrent infection

Replacement therapy in primary immunodeficiency syndromes such as:
Primary immunodeficiency syndrome with impaired antibody production.
Replacement therapy in myeloma or chronic lymphatic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections.
Treatment of hypogammaglobulinaemia in patients pre and post-allogeneic haematopoietic stem cell transplantation.

Unlicensed Uses

Hepatitis - infective A - prophylaxis

Dosage

Treatment should be initiated and monitored under the supervision of a physician experienced in the treatment of immunodeficiency, and in the guidance of patients for home treatment if applicable.

The dose and dosage regimen is dependent on the indication, and may need to be individualised for each patient depending on the pharmacokinetic and clinical response.

IgG trough levels should be measured in order to adjust the dose and dosage interval.

The following dosage regimens are given as a guideline.

Adults

Children

Neonates

Additional Dosage Information

Administration

For subcutaneous infusion only.

An unlicensed route of intramuscular injection may be used for the treatment of hepatitis A prophylaxis. Immunoglobulin human normal (Subgam) must not be administered intramuscularly in cases of severe thrombocytopenia and in other disorders of haemostasis.

It may be suitable or it may be required to use more than one pump simultaneously, more than one injection site can be used.

Contraindications

Severe Immunoglobulin A deficiency

Precautions and Warnings

Antibodies to immunoglobulin A
Predisposition to thromboembolic disease
Prolonged immobilisation
Breastfeeding
Diabetes mellitus
History of thrombosis
Hypertension
Immunoglobulin A deficiency
Pregnancy
Severe hypovolaemia

Live virus vaccine should not be given for 3 months after treatment
Advise ability to drive/operate machinery may be affected by side effects
Inject product slowly at start of treatment to test sensitivity
Treatment to be initiated and supervised by a specialist
Contains polysorbate
Derived from human proteins - transmission of infective agents possible
Do not use if any signs of precipitate or particulate matter apparent
Monitor throughout infusion and for 1 hour post first infusion
Record name and batch number of administered product
The rate of infusion is dose dependant follow administration instructions
Vary infusion site
Ensure adequate hydration prior to infusion
Monitor for hypersensitivity reactions during infusion
Monitor IgG trough levels to adjust dose and/or dose interval
Monitor patient for at least 20 minutes post injection
Advise patient to contact a doctor if symptoms of thromboembolism develop
Increased frequency of ADRs if first human normal immunoglobulin given
Increased frequency of adverse reactions if product is switched
Management of cases of shock should follow current medical standards
May affect immune response to live vaccines
May induce hypotension with anaphylaxis, even if prior treatment tolerated
May affect results of some laboratory tests
Discontinue if anaphylactoid reaction occurs
Discontinue if Aseptic Meningitis Syndrome occurs
Measles vaccine may not be effective for up to 1 year after treatment
Advise patient on the symptoms of Aseptic Meningitis Syndrome

Use with caution in patients deficient in IgA. These patients may produce anti-IgA antibodies, which could lead to anaphylactic reactions.

Treatment should be initiated and monitored under the supervision of a physician experienced in the treatment of immunodeficiency, and in the guidance of patients for home treatment if applicable. The patient will be instructed in the use of a syringe driver, infusion techniques, the keeping of a treatment diary, and measures to be taken in case of severe adverse events. Once the patient is familiar with the method and no unacceptable side effects have been observed during the training phase, the treatment may be continued at home by the patient or carer.

Intravenous administration is contraindicated and if accidental administration into a blood vessel occurs the patient could develop shock.

Pregnancy and Lactation

Pregnancy

Use immunoglobulin human normal (Subgam) with caution during pregnancy.

The manufacturer advises caution if immunoglobulin human normal (Subgam) is used during pregnancy. At the time of writing there is limited published information regarding the use of immunoglobulin human normal (Subgam) during pregnancy. Potential risks are unknown.

Lactation

Use immunoglobulin human normal (Subgam) with caution during breastfeeding.

The manufacturer states that immunoglobulins are present in human breast milk and may contribute to protecting the infant from pathogens which have mucosal portal of entry. However the quantity and the effects on exposed infants are unknown.

Side Effects

Abdominal pain
Allergic reaction
Anaphylactic shock
Anxiety
Arthralgia
Back pain
Blood pressure changes
Bruising at injection site
Chest tightness
Chills
Diarrhoea
Dizziness
Fatigue
Fever
Flushing
Headache
Heat and redness (injection site)
Hyperhidrosis
Hypersensitivity reactions
Hypertension
Infusion related reaction
Itching (injection site)
Local pain (injection site)
Migraine
Mouth ulcers
Musculoskeletal pain
Nausea
Pain
Paraesthesia
Positive Coombs test
Pruritus
Pyrexia
Rash
Rash at injection site
Sensation of cold
Stiffness
Swelling (injection site)
Vomiting
Wheezing

Effects on Laboratory Tests

Following the use of immunoglobulin human normal (Subgam) the transitory rise of various passively transferred antibodies in the patient's blood may cause misleading positive results in serological testing for red blood cell antibodies, for example the direct anti-globulin test (DAT, direct Coomb's 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: March 2021

Reference Sources

Summary of Product Characteristics: Subgam, Human normal immunoglobulin solution. Bio Products Laboratory Ltd. Revised December 2020.

NICE Evidence Services Available at: www.nice.org.uk
Last accessed: 17 March 2021