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Cuvitru Side Effects

Generic name: immune globulin subcutaneous

Medically reviewed by Drugs.com. Last updated on Sep 9, 2020.

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 Cuvitru.

For the Consumer

Applies to immune globulin subcutaneous: subcutaneous solution

Warning

Subcutaneous route (Solution)

Warning: ThrombosisThrombosis may occur with immune globulin products, including immune globulin-hipp. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling central vascular catheters, hyperviscosity, and cardiovascular risk factors. Thrombosis may occur in the absence of known risk factors.For patients at risk of thrombosis, administer immune globulin-hipp at the minimum dose and infusion rates practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk of hyperviscosity.

Side effects requiring immediate medical attention

Along with its needed effects, immune globulin subcutaneous (the active ingredient contained in Cuvitru) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking immune globulin subcutaneous:

More common

  • Blistering, crusting, irritation, itching, or reddening of the skin
  • chills
  • cough
  • cracked, dry, scaly skin
  • difficulty breathing
  • dizziness
  • facial swelling
  • fever
  • headache
  • nausea
  • noisy breathing
  • skin rash
  • tightness in the chest
  • vomiting

Incidence not known

  • Agitation
  • anxiety
  • blistering, peeling, or loosening of the skin
  • bloody, black, or tarry stools
  • blue lips, fingernails, or skin
  • blurred vision
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • chest discomfort or pain
  • collection of blood under the skin
  • confusion
  • coughing that sometimes produces a pink frothy sputum
  • decreased awareness or responsiveness
  • decreased urine output
  • deep, dark purple bruise
  • depression
  • diarrhea
  • difficult, fast, noisy breathing
  • difficulty swallowing
  • fast, pounding, or irregular heartbeat or pulse
  • headache, severe and throbbing
  • high fever
  • hives or welts, itching
  • hostility
  • increased sweating
  • irregular, fast or slow, or shallow breathing
  • irritability
  • joint or muscle pain
  • lightheadedness or fainting
  • loss of consciousness
  • muscle twitching
  • nervousness
  • pain in the chest, groin, or legs, especially the calves
  • pain, redness, or swelling of the skin
  • painful or difficult urination
  • pale skin
  • pounding in the ears
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rapid weight gain
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • seizures
  • severe sleepiness
  • slow heartbeat
  • slurred speech
  • sore throat
  • sores, ulcers, or white spots in the mouth or on the lips
  • stiff neck or back
  • sudden loss of coordination
  • sudden, severe weakness or numbness in the arm or leg
  • swelling of the legs, ankles, or hands
  • swollen glands
  • tenderness, pain, swelling, warmth, skin discoloration, and prominent superficial veins over the affected area
  • troubled breathing with exertion
  • unexplained bleeding or bruising
  • unusual bleeding or bruising
  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
  • upper stomach pain
  • vision changes

Side effects not requiring immediate medical attention

Some side effects of immune globulin subcutaneous may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

  • Skin abrasion

Incidence not known

  • Back pain
  • difficulty in moving
  • feeling of warmth
  • increased sweating
  • loss or thinning of hair
  • muscle cramping
  • pain in the arms or legs
  • redness of the face, neck, arms, and occasionally, upper chest
  • skin discoloration
  • stomach distension
  • swollen joints

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.

Frequently asked questions

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.