Immunoglobulin human normal and recombinant human hyaluronidase parenteral
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Infusions containing human normal immunoglobulin and recombinant human hyaluronidase.
These products have been produced by recombinant technology using Chinese Hamster Ovary (CHO) cell lines.
Primary immunodeficiency syndromes with impaired antibody production
Secondary immunodeficiencies with severe or recurrent infections
Primary immunodeficiency syndromes with impaired antibody production.
Secondary immunodeficiencies (SID) in patients who suffer from severe or recurrent infections, ineffective antimicrobial treatment and either proven specific antibody failure (PSAF) or serum IgG level of less than 4g/L.
Each vial of immunoglobulin human normal 10% is supplied with the appropriate corresponding quantity of recombinant human hyaluronidase.
The full contents of the recombinant human hyaluronidase vial should be administered regardless of whether the full content of the immunoglobulin human normal 10% vial is administered.
The dose level may need to be individualised for each patient, depending on the pharmacokinetic and clinical response.
First, the full dose of recombinant human hyaluronidase solution is infused at a rate of 1 to 2ml/minute per infusion site. Within 10 minutes of completing the infusion of recombinant human hyaluronidase, the infusion of the required dose of immunoglobulin human normal 10% has to be initiated at the same needle site.
A full therapeutic dose can be administered in one to two sites up to every four weeks. Adjust the frequency and number of infusion sites taking into consideration volume, total infusion time, and tolerability so that the patient receives the same weekly equivalent dose. If a patient misses a dose, administer the missed dose as soon as possible and then resume scheduled treatments as applicable.
Patients naive to immunoglobulin therapy
The dose required to achieve a trough level of 6g/l is of the order of 0.4 to 0.8g/kg/month. The dosage interval to maintain steady state levels varies from 2 to 4 weeks.
Trough levels should be measured and assessed in conjunction with the incidence of infection. To reduce the rate of infection, it may be necessary to increase the dosage and aim for higher trough levels (greater than 6g/l).
At the initiation of therapy, it is recommended that the treatment intervals for the first infusions be gradually prolonged from a 1 week dose to up to a 3 or 4 week dose. The cumulative monthly dose of immunoglobulin human normal 10% should be divided into 1 week, 2 week etc. doses according to the planned treatment intervals with this medication.
Patients previously treated with immunoglobulin administered intravenously
For patients switching directly from intravenous administration of immunoglobulin, or who have a previous intravenous dose of immunoglobulin that can be referenced, the medicinal product should be administered at the same dose and at the same frequency as their previous intravenous immunoglobulin treatment. If patients were previously on a 3 week dosing regimen, increasing the interval to 4 weeks can be accomplished by administering the same weekly equivalents.
Patients previously treated with immunoglobulin administered subcutaneously
For patients currently being administered immunoglobulin subcutaneously, the initial dose of this medication is the same as for subcutaneous treatment but adjusted to 3 or 4 weeks interval.
For patients switching directly from an immunoglobulin treatment administered subcutaneously, the first infusion of this medication should be given one week after the last treatment with the previous immunoglobulin.
0.2g/kg to 0.4g/kg every 3 to 4 weeks.
(See Dosage; Adult)
Additional Dosage Information
If a dose is missed, administer the missed dose as soon as possible and then resume scheduled treatments as applicable.
For administration by subcutaneous use only.
The suggested site(s) for the infusion of this product are the middle to upper abdomen and thighs. If two sites are used, the two infusion sites should be on contra lateral sides of the body.
During or after subcutaneous administration, infusion site leakage may occur. To help prevent this, consider using longer needles and/or more than one infusion site.
Precautions and Warnings
Immunoglobulin A antibodies
Predisposition to thromboembolic disease
Restricted sodium intake
History of thrombosis
Immunoglobulin A deficiency
Live virus vaccine should not be given for 3 months after treatment
Sodium content of formulation may be significant
Advise ability to drive/operate machinery may be affected by side effects
Dose adjustment may be required in underweight or overweight patients
Inject product slowly at start of treatment to test sensitivity
Treatment to be initiated and supervised by a specialist
Derived from human plasma. Transmission of infective agents possible.
Avoid injection into infected areas
Do not mix with other drugs or substances
If adverse reactions occur, reduce rate or temporarily stop infusion
Monitor throughout infusion and for 1 hour post first infusion
Record name and batch number of administered product
Warm to room temperature prior to use
Advise patient to report prolonged infusion site inflammation or nodules
Ensure adequate hydration prior to infusion
Monitor for signs and symptoms of thrombosis
Monitor IgG trough levels to adjust dose and/or dose interval
Monitor patient closely for haemolysis
Remain alert to possible coincidental meningitis
Advise patient of thromboembolic symptoms and to report them if they occur
Advise patient to report symptoms of allergic type hypersensitivity
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
May interfere with antibody tests
Advise patient to seek advice at first indications of pregnancy
Measles vaccine may not be effective for up to 1 year after treatment
Advise patient on the symptoms of Aseptic Meningitis Syndrome
Pregnancy and Lactation
Use immunoglobulin human normal and hyaluronidase with caution during pregnancy.
The safety of this medicinal product for use in pregnancy has not been established in clinical trials and therefore should only be given with caution to pregnant women.
Human immunoglobulins cross the placenta, increasingly during the third trimester. Clinical experience with immunoglobulins suggests that no harmful effects on the course of pregnancy, or on the neonate are to be expected.
Development and reproductive toxicology studies have been conducted with recombinant human hyaluronidase in mice and rabbits. No adverse effects on pregnancy and foetal development were associated with anti-rHuPH20 antibodies. In these studies, maternal antibodies to recombinant human hyaluronidase were transferred to offspring in utero. The effects of antibodies to the recombinant human hyaluronidase on the human embryo or on human foetal development are currently unknown.
If a woman becomes pregnant, the treating physician should encourage her to participate in the pregnancy registry.
Use immunoglobulin human normal and hyaluronidase with caution during breastfeeding.
Immunoglobulins are excreted into the milk and may contribute to protecting the neonate from pathogens which have a mucosal port of entry.
Acute renal failure
Alanine aminotransferase increased
Bruising at injection site
Decrease in blood pressure
Deep vein thrombosis (DVT)
Discolouration (injection site)
Haematoma (injection site)
Heat and redness (injection site)
Increased blood pressure
Induration (injection site)
Infusion site leakage
Itching (injection site)
Local reaction at injection site
Nodules (injection site)
Pain / soreness (injection site)
Positive Coombs test
Rash at injection site
Serum creatinine increased
Swelling (injection site)
Effects on Laboratory Tests
Passive transmission of antibodies to erythrocyte antigens (e.g. A, B, D) may interfere with some serological tests for red cell antibodies, such as the direct antiglobulin test (DAT, direct Coombs' test).
Infusions of immunoglobulin products may lead to false positive readings in assays that depend on detection of beta-D-glucans for diagnosis of fungal infections; this may persist during the weeks following infusion of the product.
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 ).
Last Full Review Date: January 2019
Summary of Product Characteristics: HyQvia 100 mg/ml. Baxalta Innovations GmbH. Revised September 2020.
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