Share on Facebook
Share on Twitter
Share on LinkedIn
Share by Email
Print
Hyqvia Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Mechanism of Action
The role of these antibodies and the mechanisms of action of IgG in the Immune Globulin Infusion 10% (Human) of HyQvia have not been fully elucidated.
Hyqvia Indications
Indications
Chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent relapse of neuromuscular disability and impairment.
Hyqvia Dosage and Administration
Adult
≥18yrs: Individualize. Infuse 2 components sequentially into abdomen or thighs using an infusion pump, beginning with recombinant human hyaluronidase then immune globulin within 10mins. Maximum infusion volume: (<40kg): 600mL; (≥40kg): 1200mL. If maximum daily dose limit is exceeded or the infusion volume is not tolerated: may give dose over multiple days in divided doses with 48–72hrs between doses at the site. May administer dose at 1, 2, or 3 infusion sites (max volume of 600mL/site or as tolerated). If using 3 sites, max is 400mL/site. Initial infusion rate (recombinant human hyaluronidase): 1–2mL/min per site or as tolerated; (immune globulin): see full labeling. Recommended dose: 80 U/g (rHuPH20/IgG). Prior to initiation, calculate the weekly equivalent dose to plan for the ramp-up schedule. Doses ≤0.4g/kg: may give without a ramp-up. Adjust dose and frequency based on clinical response. Switching from IGIV treatment (must be on stable IGIV doses): give the same dose and frequency as previous IGIV treatment. Give 1st infusion 2 weeks after the last IGIV infusion; 1 week after the 1st dose, give 2nd infusion; see full labeling.
Children
<18yrs: not established.
Hyqvia Contraindications
Contraindications
IgA deficiency with antibodies against IgA and history of hypersensitivity. Previous severe reactions to human immune globulin.
Hyqvia Boxed Warnings
Boxed Warning
Thrombosis.
Hyqvia Warnings/Precautions
Warnings/Precautions
Advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, cardiovascular disorders: increased risk of thrombosis. Monitor for signs/symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. Ensure adequate hydration prior to administration. Monitor for aseptic meningitis, hemolysis, delayed hemolytic anemia, transfusion-related acute lung injury (TRALI) (eg, pulmonary edema, dyspnea, hypoxemia). Pre-existing renal insufficiency, diabetes, >65yrs, hypovolemia, sepsis, paraproteinemia: increase risk of renal dysfunction/failure. Correct volume depletion; assess renal function, BUN, serum creatinine, urine output, before and during therapy; consider discontinuing if renal function deteriorates. Contains human plasma; monitor for possible infection transmission. Discontinue if hypersensitivity reactions occur. Pregnancy. Nursing mothers.
Hyqvia Pharmacokinetics
Absorption
The AUC of HyQvia compared to conventional IGSC administration was 20% higher. The bioavailability of HyQvia based on weekly AUC was 93.3% relative to IGIV. Time to reach maximum concentration of IgG following HyQvia administration was 5 (3.3–5.1) days.
Elimination
Mean (SD) clearance: 1.6 (0.5) mL/kg/day. Mean (SD) terminal half-life: 59.3 (36.1) days.
Hyqvia Interactions
Interactions
Hyqvia Adverse Reactions
Adverse Reactions
Local reactions, headache, pyrexia, nausea, fatigue; aseptic meningitis syndrome, hemolysis, infection, TRALI. Also for PI: antibody formation against recombinant human hyaluronidase, vomiting; also for CIDP: erythema, pruritus, increased lipase, abdominal pain, back pain, pain in extremity.
Hyqvia Clinical Trials
See Literature
Hyqvia Note
Not Applicable
Hyqvia Patient Counseling
See Literature
Hyqvia Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Mechanism of Action
The role of these antibodies and the mechanisms of action of IgG in the Immune Globulin Infusion 10% (Human) of HyQvia have not been fully elucidated.
Hyqvia Indications
Indications
Hyqvia Dosage and Administration
Adults and Children
<2yrs: not established. Individualize. Infuse 2 components sequentially into abdomen or thighs using an infusion pump, beginning with recombinant human hyaluronidase then immune globulin within 10 mins. Volume per site: (<40kg): may administer up to 300mL/site; (≥40kg): up to 600mL/site. Initial infusion rate (recombinant human hyaluronidase): 1–2mL/min per site or as tolerated; (immune globulin): see full labeling. Start treatment 1 week after last IgG infusion; increase dose and frequency from 1-week dose to a 3- or 4-week dose. ≥2yrs: Recommended dose: 80 U/g (rHuPH20/IgG). Initial interval/dosage ramp-up: 7.5g on Week 1, then 15g on Week 2, then 22.5g on Week 4, then 30g on Week 7. Switching from IGIV treatment: give at same dose and frequency as previous IV treatment after initial dose ramp-up. Exposed to measles: give 400mg/kg as soon as possible and within 6 days of exposure. At risk for future measles exposure: give at least 530mg/kg every 3 to 4 weeks. Switching from IGSC treatment or if IgG IGSC-naive: 300–600mg/kg at 3–4 week intervals after initial ramp-up. Renal dysfunction/failure or thrombosis risk: give at the minimum dose and infusion rate practicable.
Hyqvia Contraindications
Contraindications
IgA deficiency with antibodies against IgA and history of hypersensitivity. Previous severe reactions to human immune globulin.
Hyqvia Boxed Warnings
Boxed Warning
Thrombosis.
Hyqvia Warnings/Precautions
Warnings/Precautions
Advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, cardiovascular disorders: increased risk of thrombosis. Monitor for signs/symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity. Ensure adequate hydration prior to administration. Monitor for aseptic meningitis, hemolysis, delayed hemolytic anemia, transfusion-related acute lung injury (TRALI) (eg, pulmonary edema, dyspnea, hypoxemia). Pre-existing renal insufficiency, diabetes, >65yrs, hypovolemia, sepsis, paraproteinemia: increase risk of renal dysfunction/failure. Correct volume depletion; assess renal function, BUN, serum creatinine, urine output, before and during therapy; consider discontinuing if renal function deteriorates. Contains human plasma; monitor for possible infection transmission. Discontinue if hypersensitivity reactions occur. Pregnancy. Nursing mothers.
Hyqvia Pharmacokinetics
Absorption
The AUC of HyQvia compared to conventional IGSC administration was 20% higher. The bioavailability of HyQvia based on weekly AUC was 93.3% relative to IGIV. Time to reach maximum concentration of IgG following HyQvia administration was 5 (3.3–5.1) days.
Elimination
Mean (SD) clearance: 1.6 (0.5) mL/kg/day. Mean (SD) terminal half-life: 59.3 (36.1) days.
Hyqvia Interactions
Interactions
Hyqvia Adverse Reactions
Adverse Reactions
Local reactions, headache, pyrexia, nausea, fatigue; aseptic meningitis syndrome, hemolysis, infection, TRALI. Also for PI: antibody formation against recombinant human hyaluronidase, vomiting; also for CIDP: erythema, pruritus, increased lipase, abdominal pain, back pain, pain in extremity.
Hyqvia Clinical Trials
See Literature
Hyqvia Note
Not Applicable
Hyqvia Patient Counseling
See Literature
Images
