Note: This document contains side effect information about immune globulin intravenous and subcutaneous. Some dosage forms listed on this page may not apply to the brand name Gammaked.
Applies to immune globulin intravenous and subcutaneous: injectable solution.
Warning
This medicine can cause blood clots. The risk is highest in older adults or in people who have had blood clots, heart problems, or blood circulation problems. Blood clots are also more likely during long-term bedrest, while using birth control pills or hormone replacement therapy, or while having a central intravenous (IV) catheter in place.
Call your doctor at once if you have chest pain, trouble breathing, fast heartbeats, numbness or weakness, or swelling and warmth or discoloration in an arm or leg.
This medicine can also harm your kidneys, especially if you have kidney disease or if you also use certain medicines. Tell your doctor right away if you have signs of kidney problems, such as swelling, rapid weight gain, and little or no urination.
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:
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a blood cell disorder--pale or yellowed skin, dark colored urine, fever, confusion or weakness;
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dehydration symptoms--feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;
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kidney problems--little or no urination, swelling, rapid weight gain, feeling short of breath;
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lung problems--chest pain, wheezing, trouble breathing, blue colored lips, fingers, or toes;
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signs of a new infection--fever with a severe headache, neck stiffness, eye pain, and increased sensitivity to light; or
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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:
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runny or stuffy nose, sinus pain, cough, sore throat;
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fever, chills, weakness;
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headache, back pain, muscle or joint pain;
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dizziness, tiredness, depressed mood;
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swelling in your hands or feet;
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skin rash, redness, or bruising;
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blisters or ulcers in your mouth, red or swollen gums, trouble swallowing;
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nausea, diarrhea, stomach pain, upset stomach;
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increased blood pressure; or
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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