QIVIGY (immune globulin intravenous, human-kthm) 10% solution is indicated for the treatment of adults with Primary Humoral Immunodeficiency (PI). This includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.
From the U.S. FDA-approved label for Diphtheria antitoxin (immunoglobulin). Full label: DailyMed.
QIVIGY (immune globulin intravenous, human-kthm) 10% solution is indicated for the treatment of adults with Primary Humoral Immunodeficiency (PI). This includes, but is not limited to, congenital agammaglobulinemia, common variable immunodeficiency (CVID), X-linked agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.
From the U.S. FDA-approved label for Diphtheria antitoxin (immunoglobulin). Full label: DailyMed.
Intravenous Administration Only. Dose Infusion number Initial Infusion Rate Maintenance Infusion Rate (as tolerated) 300 - 800 mg/kg every 3-4 weeks For the 1 st infusion 1 mg/kg/min (0.01 mL/kg/min) for 30 minutes Increase every 30 minutes to a maximum of 8 mg/kg/min (0.08 mL/kg/min) 300 - 800 mg/kg every 3-4 weeks From the 2 nd infusion 2 mg/kg/min (0.02 mL/kg/min) for 15 minutes Increase every 15 minutes to a maximum of 8 mg/kg/min (0.08 mL/kg/min) 2.1 Recommended Dosage Table 1.
Directions from the U.S. FDA-approved label — your doctor or pharmacist may advise differently.
QIVIGY is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin. QIVIGY is contraindicated in IgA deficient patients with antibodies against IgA and history of hypersensitivity. Patients with history of anaphylactic or severe systemic reactions to human immune globulins. IgA deficient patients with antibodies against IgA and a history of hypersensitivity.
Excerpt from the U.S. FDA-approved label. Talk to a pharmacist or doctor before use.
Hypersensitivity Reactions: In case of a severe hypersensitivity reaction, discontinue QIVIGY infusion, and manage as appropriate. IgA deficient patients with antibodies against IgA are at greater risk of developing severe hypersensitivity and anaphylactic reactions. Thrombotic events: Monitor patients with known risk factors for thrombotic events; consider baseline assessment of blood viscosity for patients at risk of hyperviscosity. Hyperproteinemia, hyperviscosity, hyponatremia, or pseudohyponatremia may occur in patients receiving IGIV therapy.
Warnings and precautions excerpt from the U.S. FDA-approved label — not a complete list. Talk to a pharmacist or doctor before use.
The most common adverse reactions observed in ≥ 5% of patients were headache, fatigue, nausea, infusion-related reaction, Coombs direct test positive, sinusitis, dizziness and diarrhea. To report SUSPECTED ADVERSE REACTIONS, contact Kedrion Biopharma Inc.
Excerpt from the U.S. FDA-approved label — not a complete list. Talk to a pharmacist or doctor about side effects.
Do not use QIVIGY after the expiration date which is stated on the carton and label after "EXP." The expiration date refers to the last day of that month. Store QIVIGY at 2 °C - 8 °C (36 °F - 46 °F) for up to 36 months. Keep the vial stored in the outer carton in order to protect from light. Do not freeze.
Storage information from the U.S. FDA-approved label.
This page is information only and is not medical advice. Medicine details come from the sources listed above and may change — always confirm the medicine, strength and dose with a pharmacist or doctor before use. NLEM listing does not guarantee that a medicine is in stock at any pharmacy.
