- Protection from Infection
- Potential Reactions
This is equivalent to 25 acute serious bacterial infections (ASBIs) out of 1000 patients over the course of the 12-month study period.
No patients taking HyQvia were hospitalized due to infection during the study.
On average, patients taking HyQvia missed 3.41 days of work or school due to an infection.
*ASBIs included 2 episodes of pneumonia. Both episodes were treated as outpatients with oral antibiotics. An additional episode of pneumonia requiring hospitalization occurred during the ramp-up.
with HyQvia in clinical trials
The rate of systemic side effects per HyQvia infusion was 0.20 (222/1129) vs 0.42 (154/365) per IVIg infusion.
“Systemic” is when a side effect happens throughout the body, not just in one part.
A headache or feeling more tired than usual are both examples of systemic side effects.
†Every 3 or 4 weeks.
considered mild to moderate.
Local side effects like pain, swelling, itching, and redness occur on the body where the medicine is given and generally go away in a few hours. Local reactions are less likely after the first few infusions.
Mild side effect causes temporary discomfort that goes away on its own, or with little medical intervention.
Moderate side effect causes a slight decline in function that goes away on its own, or with little medical intervention, and has no further consequences.
Severe side effect results in impairment of function and can lead to temporary inability to resume a normal lifestyle as it requires prolonged medical intervention and/or results in further consequences.§
‡HyQvia was studied in a clinical trial of 83 adults with PI with the main goal of measuring how many acute serious bacterial infections (ASBIs) they experienced over the course of 1 year. ASBIs are short-term but serious infections caused by bacteria that require immediate medical care. The FDA standard for efficacy—that is, if an immunoglobulin works—is less than 1 ASBI per year. In the clinical trial, people taking HyQvia experienced significantly less than that.
§Three local severe reactions occurred during the clinical study: local infusion site pain, infusion site swelling, and infusion site swelling that extended from the abdominal infusion site to the genitalia.
side effects per infusion
Headache Headaches have been reported during or after the infusion with HyQvia.
Fatigue People have reported feeling more tired than usual after infusing with HyQvia, and may need to rest.
Nausea Some people have reported feeling stomach discomfort or the sensation of wanting to vomit during or after the infusion.
Fever People have reported experiencing a fever, or a temporary increase in body temperature, during or after the infusion.
Vomiting Some people have vomited (or thrown up) during or after the infusion.
Local Some people had irritation where the medicine is given.
HyQvia was studied in a clinical trial of 83 adults with PI with the main goal of measuring how many acute serious bacterial infections (ASBIs) they experienced over the course of 1 year.
ASBIs are short-term but serious infections caused by bacteria that require immediate medical care. The FDA standard for efficacy—that is, if an immunoglobulin works—is less than 1 ASBI per year. In the clinical trial, people taking HyQvia experienced significantly less than that.
Percentage/Rate = total number of events divided by total number of infusions (% = Rate x 100)
IVIg was administered for a median of 91 days and HyQvia for a median of 366 days per subject during the efficacy period.
These adverse events occurred within 72 hours of infusion or were considered to be caused by the infusion.
reported in more than 1% of infusions
|Percentage (per infusion) and number of local side effects|
Local side effects may occur at the site of infusion and generally go away in a few hours. These side effects are less likely to occur after the first few infusions.
- Hives, swelling in the mouth or throat, itching, trouble breathing, wheezing, fainting or dizziness. These could be signs of a serious allergic reaction.
- Bad headache with nausea, vomiting, stiff neck, fever, and sensitivity to light. These could be signs of irritation and swelling of the lining around your brain.
- Reduced urination, sudden weight gain, or swelling in your legs. These could be signs of a kidney problem.
- Pain, swelling, warmth, redness, or a lump in your legs or arms, other than at the infusion site(s). These could be signs of a blood clot. Brown or red urine, fast heart rate, yellow skin or eyes. These could be signs of a liver or blood problem.
- Chest pain or trouble breathing, blue lips or extremities. These could be signs of a serious heart or lung problem.
- Fever over 100°F. This could be a sign of an infection.
These are not the only possible side effects. Talk to your doctor about any side effects that you may experience.
Your doctor is your best resource
Your doctor is your best resource
The more you communicate, the more you’ll learn about your PI and be better able to tailor your treatment.
A “cheat sheet,” if you will, to get acquainted and reacquainted with the monthly infusion process.