Hizentra Side Effects Center

Last updated on RxList: 12/13/2021
Hizentra Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Hizentra?

Hizentra Immune Globulin Subcutaneous (Human) 20% Liquid is an Immune Globulin indicated for the treatment of primary immunodeficiency (PI) in adults and pediatric patients 2 years of age and older.

What Are Side Effects of Hizentra?

Common side effects of Hizentra include:

Dosage for Hizentra

The dose of Hizentra is individualized based on the patient's clinical response to Hizentra therapy and serum immunoglobulin G (IgG) trough levels.

What Drugs, Substances, or Supplements Interact with Hizentra?

Hizentra may interact with live virus vaccines. Tell your doctor all medications and supplements you use and all vaccines you recently received.

Hizentra During Pregnancy or Breastfeeding

During pregnancy Hizentra should be administered only if prescribed. Consult your doctor before breastfeeding.

Additional Information

Our Hizentra Immune Globulin Subcutaneous (Human) 20% Liquid Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Hizentra Consumer Information

Stop using this medicine and get emergency medical help if you have signs of an allergic reaction: hives; wheezing, chest tightness, difficult breathing; dizziness, feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • a blood cell disorder--pale or yellowed skin, dark colored urine, fever, confusion or weakness;
  • kidney problems--little or no urination, swelling, rapid weight gain, feeling short of breath;
  • lung problems--chest pain, trouble breathing, blue colored lips, fingers, or toes;
  • signs of a new infection--fever with a severe headache, neck stiffness, eye pain, and increased sensitivity to light; or
  • signs of a blood clot--shortness of breath, chest pain with deep breathing, rapid heart rate, numbness or weakness on one side of the body, swelling and warmth or discoloration in an arm or leg.

Common side effects may include:

  • wheezing, trouble breathing;
  • pain, redness, bruising, itching, swelling, or a hard lump where the medicine was injected;
  • fever, tiredness, dizziness;
  • nausea, vomiting, diarrhea, bloating, stomach pain;
  • itching, rash, or other skin problems;
  • cold or flu symptoms such as stuffy nose, sneezing, sore throat, cough;
  • headache, migraine; or
  • pain anywhere in your body.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Hizentra Professional Information

SIDE EFFECTS

The most common adverse reactions (ARs), observed in ≥ 5% of study subjects receiving Hizentra, were local reactions (e.g., swelling, redness, heat, pain, and itching at the injection site), headache, diarrhea, fatigue, back pain, nausea, pain in extremity, cough, rash, pruritus, vomiting, abdominal pain (upper), migraine, and pain.

Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, AR rates observed in clinical studies of a product cannot be directly compared to rates in the clinical studies of another product and may not reflect the rates observed in clinical practice.

US Study

The safety of Hizentra was evaluated in a clinical study in the US for 15 months (3-month wash-in/wash-out period followed by a 12-month efficacy period) in subjects with PI who had been treated previously with IGIV every 3 or 4 weeks. The safety analyses included 49 subjects in the intention-to-treat (ITT) population. The ITT population consisted of all subjects who received at least one dose of Hizentra [see Clinical Studies].

Subjects were treated with Hizentra at weekly median doses ranging from 66 to 331 mg/kg body weight (mean: 181.4 mg/kg) during the wash-in/wash-out period and from 72 to 379 mg/kg (mean: 213.2 mg/kg) during the efficacy period. The 49 subjects received a total of 2264 weekly infusions of Hizentra.

Table 2 summarizes the most frequent adverse reactions (ARs) (experienced by at least 2 subjects) occurring during or within 72 hours after the end of an infusion. Local reactions were assessed by the investigators 15 to 45 minutes post-infusion and by the subjects 24 hours post-infusion. The investigators then evaluated the ARs arising from the subject assessments. Local reactions were the most frequent ARs observed, with injection-site reactions (e.g., swelling, redness, heat, pain, and itching at the site of injection) comprising 98% of local reactions.

Table 2: Incidence of Subjects with Adverse Reactions (ARs)* (Experienced by 2 or More Subjects) and Rate per Infusion (ITT Population), US Study

AR ( ≥ 2 Subjects) ARs* Occurring During or Within 72 Hours of Infusion
Number (%) of Subjects
(n=49)
Number (Rate*) of ARs (n=2264 Infusions)
Local reactions‡ 49 (100) 1322 (0.584)
Other ARs:
  Headache 12 (24.5) 32 (0.014)
  Diarrhea 5 (10.2) 6 (0.003)
  Fatigue 4 (8.2) 4 (0.002)
  Back pain 4 (8.2) 5 (0.002)
  Nausea 4 (8.2) 4 (0.002)
  Pain in extremity 4 (8.2) 6 (0.003)
  Cough 4 (8.2) 4 (0.002)
  Vomiting 3 (6.1) 3 (0.001)
  Abdominal pain, upper 3 (6.1) 3 (0.001)
  Migraine 3 (6.1) 4 (0.002)
  Pain 3 (6.1) 4 (0.002)
  Arthralgia 2 (4.1) 3 (0.001)
  Contusion 2 (4.1) 3 (0.001)
  Rash 2 (4.1) 3 (0.001)
  Urticaria 2 (4.1) 2 ( < 0.001)
* Excluding infections.
† Rate of ARs per infusion.
‡ Includes injection-site reactions as well as bruising, scabbing, pain, irritation, cysts, eczema, and nodules at the injection site.

The ratio of infusions with ARs, including local reactions, to all infusions was 1303 to 2264 (57.6%). Excluding local reactions, the corresponding ratio was 56 to 2264 (2.5%).

Table 3 summarizes injection-site reactions based on investigator assessments 15 to 45 minutes after the end of the 683 infusions administered during regularly scheduled visits (every 4 weeks).

Table 3: Investigator Assessments* of Injection-Site Reactions by Infusion, US Study

Injection-Site Reaction Number† (Rate‡) of Reactions (n=683 Infusions§)
Edema/induration 467 (0.68)
Erythema 346 (0.51)
Local heat 108 (0.16)
Local pain 88 (0.13)
Itching 64 (0.09)
* 15 to 45 minutes after the end of infusions administered at regularly scheduled visits (every 4 weeks).
† For multiple injection sites, every site was judged, but only the site with the strongest reaction was recorded.
‡ Rate of injection-site reactions per infusion.
§ Number of infusions administered during regularly scheduled visits.

Most local reactions were either mild (93.4%) or moderate (6.3%) in intensity.

No deaths or serious ARs occurred during the study. Two subjects withdrew from the study due to ARs. One subject experienced a severe injection-site reaction one day after the third weekly infusion, and the other subject experienced moderate myositis. Both reactions were judged to be “at least possibly related” to the administration of Hizentra.

European Study

In a clinical study conducted in Europe, the safety of Hizentra was evaluated for 10 months (3-month wash-in/wash-out period followed by a 7-month efficacy period) in 51 subjects with PI who had been treated previously with IGIV every 3 or 4 weeks or with IGSC weekly. Subjects were treated with Hizentra at weekly median doses ranging from 59 to 267 mg/kg body weight (mean: 118.8 mg/kg) during the wash-in/wash-out period and from 59 to 243 mg/kg (mean: 120.1 mg/kg) during the efficacy period. The 51 subjects received a total of 1831 weekly infusions of Hizentra.

Table 4 summarizes the most frequent ARs (experienced by at least 2 subjects) occurringduring or within 72 hours after the end of an infusion. Local reactions were assessed by the subjects between 24 and 72 hours post-infusion. The investigators then evaluated the ARs arising from the subject assessments.

Table 4: Incidence of Subjects with Adverse Reactions (ARs)* (Experienced by 2 or More Subjects) and Rate per Infusion, European Study

AR ( ≥ 2 Subjects) ARs* Occurring During or Within 72 Hours of Infusion
Number (%) of Subjects
(n=51)
Number (Ratet) of ARs
(n=1831 Infusions)
Local reactions‡ 24 (47.1) 105 (0.057)
Other ARs:
  Headache 9 (17.6) 20 (0.011)
  Rash 4 (7.8) 4 (0.002)
  Pruritus 4 (7.8) 13 (0.007)
  Fatigue 3 (5.9) 5 (0.003)
  Abdominal pain, upper 2 (3.9) 3 (0.002)
  Arthralgia 2 (3.9) 2 (0.001)
  Erythema 2 (3.9) 4 (0.002)
  Abdominal discomfort 2 (3.9) 3 (0.002)
  Back pain 2 (3.9) 2 (0.001)
  Hematoma 2 (3.9) 3 (0.002)
  Hypersensitivity 2 (3.9) 4 (0.002)
* Excluding infections.
† Rate of ARs per infusion.
‡ Includes infusion-related reaction; infusion-site mass; infusion/injection-site erythema, hematoma, induration, inflammation, edema, pain, pruritus, rash, reaction, swelling; injection-site extravasation, nodule; puncture-site reaction.

The proportion of subjects reporting local reactions decreased over time from approximately 20% following the first infusion to < 5% by the end of the study.

Three subjects withdrew from the study due to ARs of mild to moderate intensity. One subject experienced injection-site pain and injection-site pruritus; the second subject experienced injection-site reaction, fatigue, and feeling cold; and the third subject experienced injection-site reaction and hypersensitivity. All reactions were judged by the investigator to be “at least possibly related” to the administration of Hizentra.

Biweekly (Every Two Weeks) Or Frequent (2 To 7 Times per Week) Dosing

No data regarding ARs are available for these alternative Hizentra dosing regimens because no clinical trials using these regimens were conducted; however, it is unlikely that the safety profile is qualitatively different from that of weekly dosing.

Postmarketing Experience

Because postmarketing reporting of adverse reactions is voluntary and from a population of uncertain size, it is not always possible to reliably estimate the frequency of these reactions or establish a causal relationship to product exposure.

Hizentra

The following adverse reactions have been identified during postmarketing use of Hizentra.This list does not include reactions already reported in clinical studies with Hizentra [see Clinical Trials Experience above].

  • Infusion reactions: Allergic-anaphylactic reactions such as swollen face or tongue and pharyngeal edema, pyrexia, chills, dizziness, hypertension/changes in blood pressure, malaise.
  • Cardiovascular: Chest discomfort (including chest pain)
  • Respiratory: Dyspnea
  • Neurological: Tremor, burning sensation

The following adverse reactions have been reported during postmarketing use of immune globulin products5:

To report SUSPECTED ADVERSE REACTIONS, contact CSL Behring Pharmacovigilance at 1-866-915-6958 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

REFERENCES

5. Pierce LR, Jain N. Risks associated with the use of intravenous immunoglobulin. Trans Med Rev 2003;17:241-251.

Read the entire FDA prescribing information for Hizentra (Immune Globulin Subcutaneous (Human) Injection)

© Hizentra Patient Information is supplied by Cerner Multum, Inc. and Hizentra Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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