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

Applies to immune globulin subcutaneous: subcutaneous solution.

Serious side effects of Vivaglobin

Along with its needed effects, immune globulin subcutaneous (the active ingredient contained in Vivaglobin) 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
• chest tightness
• chills
• cough
• cracked, dry, scaly skin
• difficulty breathing
• dizziness
• facial swelling
• fever
• headache
• nausea
• noisy breathing
• skin rash
• 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
• trouble breathing
• unexplained bleeding or bruising
• unusual bleeding or bruising
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
• upper stomach pain
• vision changes

Other side effects of Vivaglobin

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]