Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS 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.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Kedrion Biopharma Inc.
at 1-855-3KDRION (1-855-353-7466) or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of one drug cannot be directly compared to rates in other clinical trials of another drug and may not reflect the rates observed in clinical practice.
The safety data described in this section reflects exposure to QIVIGY in one clinical study.
A total of 47 patients with PI received intravenous infusion of QIVIGY at a dose range of 266 to 826 mg/kg every 3 or 4 weeks for up to 12 months [see Clinical Studies (14) ] .
A total of 643 infusions of QIVIGY were administered, 136 in the every 3-week schedule and 507 in the 4-week schedule.
During the study, 4 out of 47 (9%) patients received premedication.
The most common product-related adverse events observed in ≥ 5% of clinical study patients with PI were headache, infusion-related reaction, Coombs direct test positive, fatigue, and nausea.
Table 2 lists the most common adverse reactions reported in ≥5% of patients.
Table 2: Adverse Reactions Adverse reactions were defined as adverse events occurring during or within 72 hours of infusion or any causally related event occurring within the study period.
5 WARNINGS AND PRECAUTIONS 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.
( 5.1 ) Thrombotic events: Monitor patients with known risk factors for thrombotic events;
consider baseline assessment of blood viscosity for patients at risk of hyperviscosity.
( 5.2 ) Hyperproteinemia, hyperviscosity, hyponatremia, or pseudohyponatremia may occur in patients receiving IGIV therapy.
Like all medications, Qivigy Kthm can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: