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Hizentra Side Effects

Generic Name: immune globulin subcutaneous

Note: This document contains side effect information about immune globulin subcutaneous. Some of the dosage forms listed on this page may not apply to the brand name Hizentra.

For the Consumer

Applies to immune globulin subcutaneous: subcutaneous solution

Warning

  • The chance of blood clots may be raised with this drug. The chance may be higher in older people, if you have to be in a bed or chair for a long time, if you take estrogen products, or if you have certain catheters. Some health problems like thick blood, heart problems, or a history of blood clots raise the chance of having blood clots. Blood clots can happen if you do not have any of these health problems. Call your doctor right away if you have numbness or weakness on 1 side of your body; pain, redness, tenderness, warmth, or swelling in the arms or legs; change in color of an arm or leg; chest pain or pressure; shortness of breath; fast heartbeat; or coughing up blood. Talk with your doctor.
  • Kidney problems have happened with human immune globulin. Sometimes, these problems have been deadly. Kidney problems are more common in people using products that have sucrose. Most immune globulin products do not have sucrose. The chance of these problems may be raised if you have kidney problems, high blood sugar (diabetes), fluid loss (dehydration) or low blood volume, a blood infection, or proteins in the blood that are not normal. The chance may be raised if you are 65 or older, or if you take other drugs that may harm the kidneys. Talk with your doctor if you have questions about this information or about if your product has sucrose.
  • You will need to be sure that you are not dehydrated before getting this drug. Check with your doctor to see if you need to drink extra fluids before getting this drug.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

  • Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
  • Signs of high or low blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
  • Fever or chills.
  • Change in color of skin to a bluish color like on the lips, nail beds, fingers, or toes.
  • Feeling very tired or weak.
  • Seizures.
  • Bloating.
  • Feeling confused.
  • Swelling.
  • A heartbeat that does not feel normal.
  • Any unexplained bruising or bleeding.
  • Mood changes.
  • Muscle or joint pain.
  • Change in speech.
  • Change in eyesight.
  • Blurred eyesight.
  • Shakiness.
  • Sweating a lot.
  • Very bad belly pain.
  • Dark urine or yellow skin or eyes.
  • Very bad irritation where the shot was given.
  • Lung problems have happened with this drug. Call your doctor right away if you have lung or breathing problems like trouble breathing, shortness of breath, or a cough that is new or worse.
  • This drug may raise the chance of a very bad brain problem called aseptic meningitis. Call your doctor right away if you have a headache, fever, chills, very upset stomach or throwing up, stiff neck, rash, bright lights bother your eyes, feeling sleepy, or feeling confused.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Irritation where this drug is given.
  • Feeling tired or weak.
  • Headache.
  • Upset stomach or throwing up.
  • Diarrhea.
  • Back pain.
  • Sore throat.
  • Runny nose.
  • Stuffy nose.
  • Dizziness.
  • Flushing.
  • Cramps.
  • Belly pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

For Healthcare Professionals

Applies to immune globulin subcutaneous: subcutaneous solution

General

The most common adverse events were local reactions, headache, diarrhea, fatigue, back pain, nausea, pain in extremity, and cough.[Ref]

Local

Very common (10% or more): Local reactions (49%), infusion site erythema, injection site pain

Common (1% to 10%): Injection site swelling, injection site bruising

Uncommon (0.1% to 1%): Injection site edema

Postmarketing reports: Infusion site ulcer[Ref]

Nervous system

Very common (10% or more): Headache (29.2%)

Common (1% to 10%): Migraine, dizziness, somnolence

Uncommon (0.1% to 1%): Burning sensation

Postmarketing reports: Tremor, paresthesia[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (18.8%), nausea (12.2%), vomiting, abdominal pain

Common (1% to 10%): Abdominal pain upper, abdominal discomfort, abdominal pain lower[Ref]

Dermatologic

Very common (10% or more): Erythema (10.8%)

Common (1% to 10%): Rash, pruritus, urticaria[Ref]

Hypersensitivity

Common (1% to 10%): Hypersensitivity

Postmarketing reports: Allergic-anaphylactic reactions (e.g. swollen face or tongue and pharyngeal edema, pyrexia, chills, dizziness, hypertension or changes in blood pressure, malaise)[Ref]

Cardiovascular

Common (1% to 10%): Hypotension

Rare (less than 0.1%): Hot flush

Postmarketing reports: Chest discomfort (including chest pain), tachycardia[Ref]

Other

Very common (10% or more): Fatigue (12.5%)

Common (1% to 10%): Pain in extremity, pain, contusion, hematoma

Uncommon (0.1% to 1%): Anti-GAD antibody positive

Rare (less than 0.1%): Hematoma[Ref]

Respiratory

Very common (10% or more): Cough (10.4%)

Common (1% to 10%): Oropharyngeal pain

Rare (less than 0.1%): Nasopharyngitis

Postmarketing reports: Dyspnea, laryngospasm[Ref]

Musculoskeletal

Very common (10% or more): Pain in extremity

Common (1% to 10%): Back pain, arthralgia, chills, myalgia[Ref]

Hematologic

Uncommon (0.1% to 1%): Coombs direct test positive[Ref]

References

1. "Product Information. Hizentra (immune globulin subcutaneous)." CSL Behring, King of Prussia, PA.

2. "Product Information. Vivaglobin (immune globulin subcutaneous)." ZLB Bioplasma Inc, Glendale, CA.

3. Cerner Multum, Inc. "Australian Product Information." O 0

4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

5. "Product Information. Cuvitru (immune globulin subcutaneous)." Baxter Healthcare Corporation, Deerfield, IL.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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