Applies to immune globulin intravenous and subcutaneous: injectable solution.

Get emergency medical help if you have signs of an allergic reaction: hives; wheezing, difficulty breathing; dizziness, feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection. Tell your caregiver if you feel light-headed, itchy, chilled, sweaty, or have chest discomfort, fast heartbeats, severe headache, or pounding in your neck or ears.

Call your doctor at once if you have:

• a blood cell disorder--pale or yellowed skin, dark colored urine, fever, confusion or weakness;

• dehydration symptoms--feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;

• kidney problems--little or no urination, swelling, rapid weight gain, feeling short of breath;

• lung problems--chest pain, wheezing, 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:

• runny or stuffy nose, sinus pain, cough, sore throat;

• fever, chills, weakness;

• headache, back pain, muscle or joint pain;

• dizziness, tiredness, depressed mood;

• swelling in your hands or feet;

• skin rash, redness, or bruising;

• blisters or ulcers in your mouth, red or swollen gums, trouble swallowing;

• nausea, diarrhea, stomach pain, upset stomach;

• increased blood pressure; or

• redness, swelling, or itching where an injection was given.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to immune globulin intravenous and subcutaneous: injectable solution.

General

The most common adverse events were headache and injection/infusion site reactions.^[Ref]

Local

Very common (10% or more): Infusion site reaction (75%)

Common (1% to 10%): Injection site reaction

Frequency not reported: Hives/urticaria, itching

Nervous system

Very common (10% or more): Headache (58%)

Common (1% to 10%): Dizziness

Postmarketing reports: Aseptic meningitis, coma, loss of consciousness, seizures/convulsions, tremor^[Ref]

Dermatologic

Very common (10% or more): Ecchymosis/purpura (40%), petechiae (21%), rash (10%)

Common (1% to 10%): Pruritus, urticaria

Frequency not reported: Hives

Postmarketing reports: Stevens-Johnson syndrome, epidermolysis, erythema multiforme, bullous dermatitis^[Ref]

Hematologic

Very common (10% or more): Hemorrhage (all systems) (29%), thrombocytopenia (15%)

Common (1% to 10%): Anemia

Uncommon (0.1% to 1%): Coombs negative hypochromic anemia, autoimmune pure red cell aplasia, exacerbation of autoimmune pure red cell aplasia

Postmarketing reports: Hemolytic anemia, pancytopenia, leukopenia, hemolysis, positive direct antiglobulin (Coombs test)^[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (28%), nausea (21%), vomiting (21%)

Common (1% to 10%): Abdominal pain, dyspepsia^[Ref]

Respiratory

Very common (10% or more): Cough increased (54%), rhinitis (51%), pharyngitis (41%), asthma (29%), epistaxis (23%)

Common (1% to 10%): Influenza, flu syndrome, sinusitis

Postmarketing reports: Apnea, acute respiratory distress syndrome (ARDS), transfusion related acute lung injury (TRALI), cyanosis, hypoxemia, pulmonary edema, dyspnea, bronchospasm^[Ref]

Cardiovascular

Common (1% to 10%): Hypertension

Frequency not reported: Myocarditis

Postmarketing reports: Cardiac arrest, thromboembolism, vascular collapse, hypotension^[Ref]

Hepatic

Very common (10% or more): Elevated ALT (18%), alkaline phosphatase elevated (13%)

Common (1% to 10%): AST elevated, low alkaline phosphatase

Postmarketing reports: Hepatic dysfunction^[Ref]

Other

Very common (10% or more): Fever (28%), ear pain (18%), accidental injury (13%), asthenia (10%)

Common (1% to 10%): Fatigue

Postmarketing reports: Rigors

Musculoskeletal

Common (1% to 10%): Arthralgia, back pain, neck pain

Uncommon (0.1% to 1%): Severe chills^[Ref]

Psychiatric

Frequency not reported: Anxiety