Pregnancy Registry: There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to VYVGART HYTRULO or VYVGART during pregnancy. Healthcare providers and patients may call 1-855-272-6524 or go to https://www.vyvgartpregnancy.com to enroll in or to obtain information about the registry.
VYVGART had a demonstrated safety profile in the ADAPT clinical trial1
VYVGART is given through IV infusions
Adverse reactions in ≥5% of patients treated with VYVGART and occurred more frequently than placebo
| Adverse reaction | VYVGART (n=84) | Placebo (n=83) |
|---|---|---|
| Respiratory tract infection | 33% | 29% |
| Headache* | 32% | 29% |
| Urinary tract infection | 10% | 5% |
| Paraesthesia† | 7% | 5% |
| Myalgia | 6% | 1% |
*Headache includes migraine and procedural headache.
†Paraesthesia includes oral hypoesthesia, hypoesthesia, and hyperesthesia.
A higher frequency of patients who received VYVGART compared to placebo were observed to have below normal levels for white blood cell counts (12% vs 5%), lymphocyte counts (28% vs 19%), and neutrophil counts (13% vs 6%).
The majority of infections and hematologic abnormalities were mild to moderate in severity.
In clinical trials, hypersensitivity reactions, including rash, angioedema, and dyspnea were observed in VYVGART-treated patients. Hypersensitivity reactions were mild or moderate, occurred within one hour to three weeks of administration, and did not lead to treatment discontinuation.
Postmarketing experience with VYVGART included reports of anaphylaxis and hypotension leading to syncope, as well as infusion-related reactions including hypertension, chills, shivering, and thoracic, abdominal, and back pain. These reactions occurred during or within an hour of administration and led to infusion discontinuation and in some cases to permanent treatment discontinuation.
IV=intravenous.
The overall safety profile of VYVGART Hytrulo, except for a higher rate of injection site reactions, was consistent with the proven safety profile of VYVGART1-4
In the ADAPT clinical trial, the most common adverse reactions for VYVGART-treated patients were respiratory tract infection, headache, and urinary tract infection. Additionally, a higher frequency of patients who received VYVGART compared to placebo were observed to have below normal levels for white blood cell counts, lymphocyte counts, and neutrophil counts that were mild to moderate in severity.2
In ADAPT-SC, injection site reactions occurred in 38% of patients receiving VYVGART Hytrulo. These were injection site rash, erythema, pruritus, bruising, pain, and urticaria.
In ADAPT-SC and its open-label extension (n=168):
- Injection site reactions were mild to moderate in severity and did not lead to treatment discontinuation
- The majority occurred within 24 hours after administration and resolved spontaneously
- Most injection site reactions occurred during the first treatment cycle, and the incidence of injection site reactions decreased with each subsequent cycle
- Cycle 1: 34.1% (n=56); cycle 2: 16.9% (n=24); cycle 3: 13.3% (n=14); and cycle 4: 11.8% (n=8)*
*Interim results presented April 2023. The ADAPT-SC+ Open-label Extension study is still ongoing.
In clinical trials, hypersensitivity reactions, including rash, angioedema, and dyspnea were observed in patients treated with VYVGART Hytrulo or VYVGART. Urticaria was also observed in patients treated with VYVGART Hytrulo. Hypersensitivity reactions were mild or moderate, occurred within one hour to three weeks of administration, and did not lead to treatment discontinuation.
Postmarketing experience with VYVGART included reports of anaphylaxis and hypotension leading to syncope, as well as infusion-related reactions including hypertension, chills, shivering, and thoracic, abdominal, and back pain. These reactions occurred during or within an hour of administration and led to infusion discontinuation and in some cases to permanent treatment discontinuation.
