Hizentra Solution For Injection 4G Drug Medication Dosage Information
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Hizentra: Solution for injection (4g)

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What is this Medicine?

IMMUNE GLOBULIN (im MUNE GLOB yoo lin) helps to prevent or reduce the severity of certain infections in patients who are at risk. This medicine is collected from the pooled blood of many donors. It is used to treat immune system problems, thrombocytopenia, and Kawasaki syndrome.

In-Depth Information

Hizentra 20% Solution for Injection

NDC: 442060454
  • Prescription Required
  • Not a Controlled Drug
    (CSA Schedule)
  • FDA Approved




FDA approved for the following conditions:
Hepatitis A Prophylaxis, Measles Prophylaxis, Rubella Prophylaxis, Immunoglobulin Deficiency, Varicella (chickenpox) Infection Prophylaxis

Storage Information
Store at room temperature (up to 77 degrees F)
Protect from light
Discard product if it contains particulate matter, is cloudy, or discolored
Do not use if product has been frozen
Store in carton until time of use
Hizentra 20% Solution for Injection

Reported Side Effects for Hizentra 20% Solution for Injection

Vomiting Incidence:
<6.1%*
Severity: MILD
Onset: EARLY
Low Platelet Count Incidence:
<15.0%*
Severity: MODERATE
Onset: DELAYED
Hives Incidence:
<4.1%*
Severity: MILD
Onset: RAPID
Stomach Pain Incidence:
<15.0%*
Severity: MILD
Onset: EARLY
Bleeding Incidence:
<29.0%*
Severity: MODERATE
Onset: EARLY
Flu Incidence:
<1.0%*
Severity: MILD
Onset: DELAYED
Red Spotted Rash Incidence:
<21.0%*
Severity: MILD
Onset: DELAYED
Bruises Incidence:
<40.0%*
Severity: MILD
Onset: DELAYED
Upset Stomach Incidence:
<8.2%*
Severity: MILD
Onset: EARLY
Joint Pain Incidence:
<6.0%*
Severity: MILD
Onset: DELAYED
Fever Incidence:
<33.3%*
Severity: MILD
Onset: EARLY
Yeast Infection Incidence:
<9.0%*
Severity: MODERATE
Onset: DELAYED
Cough Incidence:
<8.2%*
Severity: MILD
Onset: DELAYED
Sinus Infection Incidence:
<50.0%*
Severity: MILD
Onset: DELAYED
Blood Clot In Lung Incidence:
<1.0%*
Severity: SEVERE
Onset: DELAYED
Migraine Incidence:
<6.1%*
Severity: MODERATE
Onset: EARLY
Low Blood Pressure Incidence:
2.2-25.0%*
Severity: MODERATE
Onset: RAPID
Rapid Heart Rate Incidence:
2.2-25.0%*
Severity: MODERATE
Onset: RAPID
Elevated Hepatic Enzymes Incidence:
3.0-18.0%*
Severity: MODERATE
Onset: DELAYED
Stomach Pain Incidence:
3.9-6.1%*
Severity: MILD
Onset: EARLY
Joint Pain Incidence:
3.9-4.1%*
Severity: MILD
Onset: DELAYED
Back Pain Incidence:
3.9-8.2%*
Severity: MILD
Onset: DELAYED
Loose Stools Incidence:
3.9-10.2%*
Severity: MILD
Onset: EARLY
Skin Rash Incidence:
4.1-7.8%*
Severity: MILD
Onset: EARLY
Back Pain Incidence:
4.3-16.7%*
Severity: MILD
Onset: DELAYED
High Blood Pressure Incidence:
4.3-8.3%*
Severity: MODERATE
Onset: EARLY
Bladder Infection Incidence:
5.0%*
Severity: MODERATE
Onset: DELAYED
Rhinitis Incidence:
5.0-51.0%*
Severity: MILD
Onset: EARLY
Feeling Sick Incidence:
5.0%*
Severity: MILD
Onset: EARLY
Injection Site Reaction Incidence:
5.0-60.0%*
Severity: MILD
Onset: RAPID
Upset Stomach Incidence:
5.0-66.7%*
Severity: MILD
Onset: EARLY
Hives Incidence:
5.0-6.0%*
Severity: MILD
Onset: RAPID
Weakness Incidence:
5.0-15.0%*
Severity: MILD
Onset: DELAYED
Chest Pain Incidence:
5.0-15.0%*
Severity: MODERATE
Onset: EARLY
Chills Incidence:
5.0-33.3%*
Severity: MILD
Onset: RAPID
Lightheadedness Incidence:
5.0-13.0%*
Severity: MILD
Onset: EARLY
Eczema Vaccinatum Incidence:
5.0-7.0%*
Severity: SEVERE
Onset: DELAYED
Muscle Pain Incidence:
5.0-6.0%*
Severity: MILD
Onset: EARLY
Painful Urination Incidence:
5.0%*
Severity: MODERATE
Onset: EARLY
High Bilirubin Level Incidence:
5.3-10.5%*
Severity: MODERATE
Onset: DELAYED
Throat Irritation Incidence:
5.5-7.0%*
Severity: MILD
Onset: EARLY
Tired Incidence:
5.9-8.2%*
Severity: MILD
Onset: EARLY
Skin Rash Incidence:
6.0-10.0%*
Severity: MILD
Onset: EARLY
Upset Stomach Incidence:
6.0-9.0%*
Severity: MILD
Onset: EARLY
Excessive Sweating Incidence:
6.0%*
Severity: MILD
Onset: DELAYED
Vomiting Incidence:
6.0-41.7%*
Severity: MILD
Onset: EARLY
Tired Incidence:
6.0-16.0%*
Severity: MILD
Onset: EARLY
Flushing Incidence:
6.0%*
Severity: MILD
Onset: RAPID
Inability To Sleep Incidence:
6.0-9.0%*
Severity: MILD
Onset: EARLY
Cough Incidence:
6.0-54.0%*
Severity: MILD
Onset: DELAYED
Anemia Incidence:
6.0-11.0%*
Severity: MODERATE
Onset: DELAYED
Loose Stools Incidence:
6.0-28.0%*
Severity: MILD
Onset: EARLY
Itching Incidence:
6.0-8.0%*
Severity: MILD
Onset: RAPID
Infection Incidence:
6.0-33.0%*
Severity: MILD
Onset: DELAYED
Stuffy Nose Incidence:
6.0-52.0%*
Severity: MILD
Onset: EARLY
Eye Irritation Incidence:
6.5-7.0%*
Severity: MILD
Onset: RAPID
Runny Nose Incidence:
6.5-17.0%*
Severity: MILD
Onset: EARLY
Eye Drainage Incidence:
7.0%*
Severity: MILD
Onset: DELAYED
Migraine Incidence:
7.0%*
Severity: MODERATE
Onset: EARLY
Shortness Of Breath Incidence:
7.0-11.0%*
Severity: MODERATE
Onset: EARLY
Heartburn Incidence:
7.0%*
Severity: MILD
Onset: DELAYED
Enlarged Lymph Nodes Incidence:
7.0%*
Severity: MODERATE
Onset: DELAYED
Rash With Pustules Incidence:
7.0%*
Severity: MILD
Onset: EARLY
Headache Incidence:
8.0-91.7%*
Severity: MILD
Onset: EARLY
Bruise Incidence:
8.7-40.0%*
Severity: MILD
Onset: DELAYED
Ear Pain Incidence:
9.0-18.0%*
Severity: MILD
Onset: EARLY
Conjunctivitis Incidence:
9.0-13.0%*
Severity: MODERATE
Onset: DELAYED
Skin Redness Incidence:
9.0%*
Severity: MODERATE
Onset: EARLY
Infusion-related Reactions Incidence:
>10.0%*
Severity: MODERATE
Onset: RAPID
Sore Throat Incidence:
10.0-41.0%*
Severity: MILD
Onset: DELAYED
Nose Bleed Incidence:
11.0-23.0%*
Severity: MILD
Onset: DELAYED
Breathing Difficulties Incidence:
14.0-29.0%*
Severity: SEVERE
Onset: RAPID
Wheezing Incidence:
14.0%*
Severity: MODERATE
Onset: RAPID
Muscle And/Or Bone Pain Incidence:
15.0-25.0%*
Severity: MILD
Onset: EARLY
Slow Heart Beat Incidence:
16.0%*
Severity: SEVERE
Onset: RAPID
Headache Incidence:
17.6-24.5%*
Severity: MILD
Onset: EARLY
Injection Site Reaction Incidence:
47.1-100.0%*
Severity: MILD
Onset: RAPID
*This is an approximate aggregated range of reported side effects from clinical studies performed on this drug. Your experience with this drug may be different.
Pregnancy & Lactation Information
FIRST Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

SECOND Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

THIRD Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

Lactation

Caution - Not enough information is available to rule out harm to infants when this drug is taken by nursing mothers.


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