Drug reference

Normal immunoglobulin

BNF 80 (2020–2021)

Source: BNF 80 (2020–2021)
PDF pages: 1380, 1381

Review source pages for extracted sections and age labels. BNF dose snippets show only their first line.

Overview

Indications And Dose

To control outbreaks of hepatitis A ▶BY DEEP INTRAMUSCULAR INJECTION ▶Adult: 500 mg Rubella in pregnancy, prevention of clinical attack ▶BY DEEP INTRAMUSCULAR INJECTION ▶Females of childbearing potential: 750 mg Antibody deficiency syndromes ▶BY SUBCUTANEOUS INFUSION ▶Adult: (consult product literature) SUBGAM ® Hepatitis A prophylaxis in outbreaks ▶BY INTRAMUSCULAR INJECTION ▶Adult: 750 mg l UNLICENSED USE SUBGAM ® Subgam ® is not licensed for prophylactic use, but due to difﬁculty in obtaining suitable immunoglobulin products, Public Health England recommends intramuscular use for prophylaxis against Hepatitis A or rubella.

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Contra Indications

Patients with selective IgA deﬁciency who have known antibody against IgA PRIVIGEN ® Hyperprolinaemia (contains L-proline) FLEBOGAMMA ® DIF Hereditary fructose intolerance (contains sorbitol) HIZENTRA ® Hyperprolinaemia (contains L-proline) GAMMAPLEX ® Hereditary fructose intolerance (contains sorbitol)

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Cautions

Agammaglobulinaemia with or without IgA deﬁciency. hypogammaglobulinaemia with or without IgA deﬁciency. interference with live virus vaccines CAUTIONS, FURTHER INFORMATION ▶Interference with live virus vaccines Normal immunoglobulin may interfere with the immune response to live virus vaccines which should therefore only be given at least 3 weeks before or 3 months after an injection of normal immunoglobulin (this does not apply to yellow fever vaccine since normal immunoglobulin does not contain antibody to this virus). OCTAGAM ® Falsely elevated results with blood glucose testing systems (contains maltose)

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Prescribing And Dispensing Information

Antibody titres can vary widely between normal immunoglobulin preparations from different manufacturers—formulations are not interchangeable; patients should be maintained on the same formulation throughout long-term treatment to avoid adverse effects. ▶With intramuscular use Available from the Centre for Infections and other regional Public Health England ofﬁces (for contacts and control of outbreaks only). l HANDLING AND STORAGE Care must be taken to store all immunological products under the conditions recommended in the product literature, otherwise the preparation may become ineffective. Refrigerated storage is usually necessary; many immunoglobulins need to be stored at 2–8°C and not allowed to freeze. Immunoglobulins should be protected from light. Opened multidose vials must be used within the period recommended in the product literature.

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Safety

Interactions

→Appendix 1: immunoglobulins

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Side Effects

▶Common or very common ▶With intramuscular use Chills ▶With subcutaneous use Diarrhoea. dizziness. drowsiness. fatigue. gastrointestinal discomfort. headaches. hypotension. local reaction. myalgia. nausea. pain. skin reactions ▶Uncommon ▶With intramuscular use Dizziness. fatigue. feeling hot. headache. nausea. pain. skin reactions ▶With subcutaneous use Paraesthesia ▶Rare or very rare ▶With intramuscular use Abdominal pain. arthralgia. musculoskeletal stiffness. myalgia. peripheral coldness. tremor ▶Frequency not known ▶With intramuscular use Chest discomfort. dyspnoea. facial swelling. fever. ﬂushing. hyperhidrosis. hypertension. hypotension. malaise. oral paraesthesia. pallor. paraesthesia. tachycardia. vomiting SIDE-EFFECTS, FURTHER INFORMATION Adverse reactions are more likely to occur in patients receiving normal immunoglobulin for the ﬁrst time, or following a prolonged period between treatments, or when a different brand of normal immunoglobulin is administered.

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Monitoring Requirements

Monitor for acute renal failure; consider discontinuation if renal function deteriorates. Intravenous preparations with added sucrose have been associated with cases of renal dysfunction and acute renal failure.

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Dose and formulations

Directions For Administration

Preparations for subcutaneous use May be administered by intramuscular injection if subcutaneous route not possible; intramuscular route not for patients with thrombocytopenia or other bleeding disorders. GAMUNEX ® Use Glucose 5% intravenous infusion if dilution prior to infusion is required. KIOVIG ® Use Glucose 5% intravenous infusion if dilution prior to infusion is required.

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Medicinal Forms

There can be variation in the licensing of different medicines containing the same drug. Solution for injection ELECTROLYTES: May contain Sodium ▶Hizentra (CSL Behring UK Ltd) Normal immunoglobulin human 200 mg per 1 ml Hizentra 2g/10ml solution for injection pre-filled syringes | 1 pre-filled disposable injection P £108.00 ▶Subgam (Bio Products Laboratory Ltd) Normal immunoglobulin human 160 mg per 1 ml Subgam 1.5g/9.375ml solution for injection vials | 1 vial P £75.00 Subgam 4g/25ml solution for injection vials | 1 vial P £200.00 Subgam 2g/12.5ml solution for injection vials | 1 vial P £100.00 Subgam 1g/6.25ml solution for injection vials | 1 vial P £50.00 Subgam 750mg/4.6875ml solution for injection vials | 1 vial P £37.50 Solution for infusion EXCIPIENTS: May contain Glucose, maltose, sorbitol, sucrose ▶Normal immunoglobulin (Non-proprietary) Normal immunoglobulin human 100 mg per 1 ml Normal immunoglobulin human 5g/50ml solution for infusion vials | 1 vial P s Normal immunoglobulin human 2.5g/25ml solution for infusion vials | 1 vial P s Normal immunoglobulin human 20g/200ml solution for infusion vials | 1 vial P s Normal immunoglobulin human 10g/100ml solution for infusion vials | 1 vial P s Normal immunoglobulin human 30g/300ml solution for infusion vials | 1 vial P s ▶Flebogammadif (Grifols UK Ltd) Normal immunoglobulin human 50 mg per 1 ml Flebogamma DIF 2.5g/50ml solution for infusion vials | 1 vial P £127.50 Flebogamma DIF 10g/200ml solution for infusion vials | 1 vial P £510.00 Flebogamma DIF 5g/100ml solution for infusion vials | 1 vial P £255.00 Flebogamma DIF 20g/400ml solution for infusion vials | 1 vial P £1,020.00 ▶Gammaplex (Bio Products Laboratory Ltd) Normal immunoglobulin human 50 mg per 1 ml Gammaplex 5g/50ml solution for infusion vials | 1 vial P £325.00 (Hospital only) Gammaplex 10g/200ml solution for infusion vials | 1 vial P £418.00 (Hospital only) Gammaplex 5g/100ml solution for infusion vials | 1 vial P £209.00 (Hospital only) Gammaplex 10g/100ml solution for infusion vials | 1 vial P £650.00 (Hospital only) Gammaplex 20g/200ml solution for infusion vials | 1 vial P £1,300.00 (Hospital only) Gammaplex 20g/400ml solution for infusion vials | 1 vial P £836.00 (Hospital only) ▶Gamunex (Grifols UK Ltd) Normal immunoglobulin human 100 mg per 1 ml Gamunex 10% 1g/10ml solution for infusion vials | 1 vial P £42.50 Gamunex 10% 10g/100ml solution for infusion vials | 1 vial P £425.00 Gamunex 10% 20g/200ml solution for infusion vials | 1 vial P £850.00 Gamunex 10% 5g/50ml solution for infusion vials | 1 vial P £212.50 ▶Hizentra (CSL Behring UK Ltd) Normal immunoglobulin human 200 mg per 1 ml Hizentra 2g/10ml solution for infusion vials | 1 vial P £108.00 Hizentra 1g/5ml solution for infusion vials | 1 vial P £54.00 Hizentra 4g/20ml solution for infusion vials | 1 vial P £216.00 ▶Kiovig (Baxalta UK Ltd) Normal immunoglobulin human 100 mg per 1 ml Kiovig 5g/50ml solution for infusion vials | 1 vial P £245.00 Kiovig 20g/200ml solution for infusion vials | 1 vial P £980.00 Kiovig 10g/100ml solution for infusion vials | 1 vial P £490.00 Kiovig 30g/300ml solution for infusion vials | 1 vial P £1,470.00 Kiovig 2.5g/25ml solution for infusion vials | 1 vial P £122.50 Kiovig 1g/10ml solution for infusion vials | 1 vial P £49.00 ▶Octagam (Octapharma Ltd) Normal immunoglobulin human 50 mg per 1 ml Octagam 5% 10g/200ml solution for infusion bottles | 1 bottle P £480.00 (Hospital only) Octagam 5% 5g/100ml solution for infusion bottles | 1 bottle P £240.00 (Hospital only) Normal immunoglobulin human 100 mg per 1 ml Octagam 10% 10g/100ml solution for infusion bottles | 1 bottle P £690.00 (Hospital only) Octagam 10% 20g/200ml solution for infusion bottles | 1 bottle P £1,380.00 (Hospital only) Octagam 10% 5g/50ml solution for infusion bottles | 1 bottle P £345.00 (Hospital only) Octagam 10% 2g/20ml solution for infusion vials | 1 vial P £138.00 (Hospital only) ▶Panzyga (Octapharma Ltd) A Normal immunoglobulin human 100 mg per 1 ml Panzyga 10g/100ml solution for infusion bottles | 1 bottle P £586.50 (Hospital only) Panzyga 20g/200ml solution for infusion bottles | 1 bottle P £1,173.00 (Hospital only) Panzyga 5g/50ml solution for infusion bottles | 1 bottle P £293.25 (Hospital only) ▶Privigen (CSL Behring UK Ltd) Normal immunoglobulin human 100 mg per 1 ml Privigen 5g/50ml solution for infusion vials | 1 vial P £270.00 Privigen 20g/200ml solution for infusion vials | 1 vial P £1,080.00 Privigen 10g/100ml solution for infusion vials | 1 vial P £540.00 Privigen 2.5g/25ml solution for infusion vials | 1 vial P £135.00

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Dose text by age group

Adult

500 mg

First-line fragment. Read the complete Indications and Dose section above.

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Adult

(consult product literature)

First-line fragment. Read the complete Indications and Dose section above.

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Adult

750 mg

First-line fragment. Read the complete Indications and Dose section above.

PDF page 1380

Age labels are extracted for navigation. Check the complete source section and current local guidance before clinical use.

Drug reference

Normal immunoglobulin

BNF 80 (2020–2021)

Source: BNF 80 (2020–2021)
PDF pages: 1380, 1381

Review source pages for extracted sections and age labels. BNF dose snippets show only their first line.

Overview

Indications And Dose

PDF page 1380

Contra Indications

PDF page 1380

Cautions

PDF page 1380

Prescribing And Dispensing Information

PDF page 1380

Safety

Interactions

→Appendix 1: immunoglobulins

PDF page 1380

Side Effects

PDF page 1380

Monitoring Requirements

PDF page 1380

Dose and formulations

Directions For Administration

PDF page 1380

Medicinal Forms

PDF pages 1380, 1381

Dose text by age group

Adult

500 mg

First-line fragment. Read the complete Indications and Dose section above.

PDF page 1380

Adult

(consult product literature)

First-line fragment. Read the complete Indications and Dose section above.

PDF page 1380

Adult

750 mg

First-line fragment. Read the complete Indications and Dose section above.

PDF page 1380

Age labels are extracted for navigation. Check the complete source section and current local guidance before clinical use.