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HYQVIA is a brand name for Hyaluronidase, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: HyQvia is indicated for: • replacement therapy for primary humoral immunodeficiency (PI) and secondary humoral immunodeficiency (SI) in adult and pediatric patients 2 years of age or older. • chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy after stabilization with intravenous…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • Treatment should be commenced and initially monitored under the supervision of a physician experienced in the treatment of immunodeficiency. Patients should be closely monitored and carefully observed for any adverse reactions throughout the infusion period, particularly naïve patients starting therapy.
• The two components of HyQvia must be infused sequentially, beginning with the rHuPH20. The full contents of the rHuPH20 vial should be administered regardless of whether the full content of the immunoglobulin 10 % (IG, 10%) vial is administered.
If using two or three infusion sites, divide the rHuPH20 evenly between all infusion sites. 4 Geriatrics].. Do not exceed the recommended dose, and administer HyQvia at the minimum dose and infusion rate practicable. 2 Recommended Dose and Dosage Adjustment Primary and Secondary Immunodeficiency Patients naïve to immunoglobulin treatment: For patients naïve to IgG treatment, administer HyQvia gradually from a weekly equivalent dose to a 3 or 4 week interval at 300 to 800 mg/kg (Table 1).
Adjust dosage and treatment interval as necessary based on serum IgG trough levels and infection rates.
Table 1:
Example of an Initial Treatment Interval/Dosage Ramp-Up Schedule Week Infusion Number Dose Interval Proportion of the target dose for a 4-week dosing regimen 1 1st infusion 1-week-dose 25% 2 2nd infusion 2-week-dose 50% 3 No infusion 4 3rd infusion 3-week-dose 75% 5 No infusion 6 No infusion 7 4th infusion (if required) 4-week-dose 100% Patients previously treated with immunoglobulin administered intravenously: For patients switching directly from intravenous (IV) administration of immunoglobulin, or who have a previous intravenous dose of immunoglobulin that can be referenced, HyQvia should be administered at the same dose and at the same frequency as their previous intravenous immunoglobulin treatment.
When switching from IV treatment begin HyQvia 1 to 2 weeks after the last IV dose. 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 weekly immunoglobulin administered subcutaneously: For patients currently being administered immunoglobulin subcutaneously, the initial dose of HyQvia is the same as for subcutaneous treatment, but may be adjusted to 3- or 4-week intervals based on the weekly equivalents.
1 Clinical Trials by Indication, Primary Immunodeficiencies (PI) and Secondary Immunodeficiencies (SI)]. Chronic Inflammatory Demyelinating Polyradiculoneuropathy No data are available to Health Canada; therefore, Health Canada has not authorized this indication for pediatric use.
2 Geriatrics Primary Immunodeficiency HyQvia was evaluated in 7 subjects over age 65 in the clinical trial. 4 Geriatrics). Chronic Inflammatory Demyelinating Polyradiculoneuropathy HyQvia was evaluated in 13 subjects over age 65 in the pivotal trial.
The available data are too limited to draw safety conclusions. 4 Geriatrics]. HyQvia (Normal Immunoglobulin [Human] 10% and Recombinant Human Hyaluronidase) Page 6 of 49 2 CONTRAINDICATIONS HyQvia is contraindicated in: • patients with a history of anaphylactic or severe systemic reactions to immunoglobulin G (IgG), • IgA deficient patients with antibodies to IgA, • patients with known hypersensitivity to hyaluronidase, including recombinant human hyaluronidase (rHuPH20) of HyQvia, • patients who are hypersensitive to this drug or to any of the ingredients in the formulation, including any non-medicinal ingredients, or component of the containers.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Serious Warnings and Precautions • Thrombotic and thromboembolic events have been reported in association with immunoglobulin products including myocardial infarction, stroke, pulmonary embolism and deep vein thrombosis.
Therefore, caution should be exercised when prescribing and administering immunoglobulins. Thrombosis may occur even in the absence of known risk factors. • Thrombosis may occur with immunoglobulin products, including HyQvia. Risk factors for thromboembolic events include: obesity, advanced age, hypertension, diabetes mellitus, history of vascular disease or thrombotic episodes, acquired or inherited thrombophilic disorders, prolonged periods of immobilization, severe hypovolemia, hypercoagulable conditions, use of estrogens, indwelling central vascular catheters, and cardiovascular risk factors.
3 Pediatrics,
HyQvia is contraindicated in: • patients with a history of anaphylactic or severe systemic reactions to immunoglobulin G (IgG), • IgA deficient patients with antibodies to IgA, • patients with known hypersensitivity to hyaluronidase, including recombinant human hyaluronidase (rHuPH20) of HyQvia, • patients who are hypersensitive to this drug or to any of the ingredients in the formulation, including any non-medicinal ingredients, or component of the containers.
For a complete listing, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The first infusion of HyQvia should be given one week after the last treatment with the previous immunoglobulin. Pediatric Population The dosing schedule for children and adolescents (2 to < 18 years) with Primary and Secondary HyQvia (Normal Immunoglobulin [Human] 10% and Recombinant Human Hyaluronidase) Page 8 of 49 Humoral Immunodeficiencies is the same as for adults.
The dosing is based on body weight and adjusted to the clinical outcome. 3 Pharmacokinetics for description of currently available data. Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) Patients Treated Previously with Immune Globulin Administered Intravenously (IGIV): • Patients switching directly from intravenous administration of immune globulin must be on a stable doses of IGIV.
• Before initiating therapy with HyQvia, calculate the weekly equivalent dose by dividing the last IGIV dose by the IGIV dose interval in weeks. • The starting dose and dosing frequency of HyQvia is the same as the patient’s previous IGIV treatment.
The typical dosing interval range in the clinical trial for HyQvia was 2 to 4 weeks. For patients with less frequent IGIV dosing (greater than 4 weeks), the dosing interval can be converted to 3 or 4 weeks while maintaining the same monthly equivalent IgG dose.
• Administer the calculated one-week dose (first infusion) two weeks after the last IGIV infusion as directed in Table 2. One week after the first HyQvia dose, administer another weekly equivalent dose (second infusion). • A dose ramp-up schedule is recommended by gradually increasing the SC infusion volume until the full dose is reached to ensure the patients’ tolerability.
A ramp-up period can take up to 9 weeks (see Table 1), depending on the dosing interval and tolerability. The transition and ramp-up schedules for IGIV to HyQvia used in the pivotal trial is provided in Tables 2 and Table 3. Table 2.
IGIV to HyQvia Transition Schedule IGIV Infusion Schedule Target HyQvia Schedule Target HyQvia Dose Ramp-up Period to Reach Target HyQvia Dose Number of infusion visits during ramp-up period to reach target HyQvia dose Every 2 weeks Every 2 weeks The same dose as IGIV 4 weeks 3 Every 3 weeks Every 3 weeks The same dose as IGIV 6 weeks 4 Every 4 weeks Every 4 weeks The same dose as IGIV 9 weeks 5 Every 4 weeks (Accelerated ramp up) Every 4 weeks The same dose as IGIV 4 weeks 3 HyQvia (Normal Immunoglobulin [Human] 10% and Recombinant Human Hyaluronidase) Page 9 of 49 Table 3.
IGIV to HyQvia Infusion Dose Ramp-up Schedule HyQvia Infusion IGIV Infusion Schedule First Second Third Fourth Fifth Time Dose Time Dose Time Dose Time Dose Time Dose Every 2 weeks 2 weeks after the last IGIV infusion Half (1/2) of the dose at the last IGIV infusion 1 week after the first HyQvia infusion Half (1/2) of the dose at the last IGIV infusion 1 week after the second HyQvia infusion FULL DOSE REACHED Dose equivalent to the last IGIV infusion N/A N/A N/A N/A Every 3 weeks 2 weeks after the last IGIV infusion One third (1/3) of the dose at the last IGIV infusion […]
For further information please refer to 7 WARNINGS AND PRECAUTIONS, Cardiovascular. • Treating physician should discuss the risk and benefits of this product with the patient. For patients at risk of thrombosis, administer HyQvia at the minimum dose and infusion rate practicable.
Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk of hyperviscosity. 1 Dosing Considerations • Treatment should be commenced and initially monitored under the supervision of a physician experienced in the treatment of immunodeficiency.
Patients should be closely monitored and carefully observed for any adverse reactions throughout the infusion period, particularly naïve patients starting therapy. • The two components of HyQvia must be infused sequentially, beginning with the rHuPH20.
The full contents of the rHuPH20 vial should be administered regardless of whether the full content of the immunoglobulin 10 % (IG, 10%) vial is administered. If using two or three infusion sites, divide the rHuPH20 evenly between all infusion sites.
4 Geriatrics].. Do not exceed the recommended dose, and administer HyQvia at the minimum dose and infusion rate practicable. 2 Recommended Dose and Dosage Adjustment Primary and Secondary Immunodeficiency Patients naïve to immunoglobulin treatment: For patients naïve to IgG treatment, administer HyQvia gradually from a weekly equivalent dose to a 3 or 4 week interval at 300 to 800 mg/kg (Table 1).
Adjust dosage and treatment interval as necessary based on serum IgG trough levels and infection rates.
Table 1:
Example of an Initial Treatment Interval/Dosage Ramp-Up Schedule Week Infusion Number Dose Interval Proportion of the target dose for a 4-week dosing regimen 1 1st infusion 1-week-dose 25% 2 2nd infusion 2-week-dose 50% 3 No infusion 4 3rd infusion 3-week-dose 75% 5 No infusion 6 No infusion 7 4th infusion (if required) 4-week-dose 100% Patients previously treated with immunoglobulin administered intravenously: For patients switching directly from intravenous (IV) administration of immunoglobulin, or who have a previous intravenous dose of immunoglobulin that can be referenced, HyQvia should be administered at the same dose and at the same frequency as their previous intravenous immunoglobulin treatment.
When switching from IV treatment begin HyQvia 1 to 2 weeks after the last IV dose. 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 weekly immunoglobulin administered subcutaneously: For patients currently being administered immunoglobulin subcutaneously, the initial dose of HyQvia is the same as for subcutaneous treatment, but may be adjusted to 3- or 4-week intervals based […]