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Gamimune N 10% Side Effects

Generic name: immune globulin intravenous

Medically reviewed by Drugs.com. Last updated on Nov 6, 2023.

Note: This document contains side effect information about immune globulin intravenous. Some dosage forms listed on this page may not apply to the brand name Gamimune N 10%.

Applies to immune globulin intravenous: intravenous solution.

Warning

Intravenous route (Solution)

Warning: Thrombosis, Renal Dysfunction, and Acute Renal FailureThrombosis may occur with immune globulin intravenous (IGIV) products, including immune globulin-ifas. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors.Renal dysfunction, acute renal failure, osmotic nephropathy, and death may occur with the administration of IGIV products in predisposed patients. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. Immune globulin-ifas does not contain sucrose.For patients at risk of thrombosis, renal dysfunction, or renal failure, administer immune globulin-ifas at the minimum infusion rate practicable. Ensure adequate hydration in patients before administration. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for hyperviscosity.

Serious side effects of Gamimune N 10%

Along with its needed effects, immune globulin intravenous (the active ingredient contained in Gamimune N 10%) 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 or nurse immediately if any of the following side effects occur while taking immune globulin intravenous:

More common

Incidence not known

Other side effects of Gamimune N 10%

Some side effects of immune globulin intravenous 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

Incidence not known

For Healthcare Professionals

Applies to immune globulin intravenous: intravenous powder for injection, intravenous solution.

General

The most common adverse events were headache, cough, fatigue, infusion site reaction, nausea, urticaria, sinusitis, blood pressure increased, diarrhea, dizziness, and lethargy.[Ref]

Respiratory

Very common (10% or more): Cough increased (54%), rhinitis (51%), pharyngitis (41%), asthma (29%), upper respiratory tract infection (25%), cough (22%), bronchitis (19%), epistaxis (10.5%)

Common (1% to 10%): Sinusitis, pharyngolaryngeal pain, pharyngitis, nasal congestion

Uncommon (0.1% to 1%): Bronchospasm

Frequency not reported: Dyspnea, wheezing

Postmarketing reports: Apnea, acute respiratory distress syndrome (ARDS), transfusion associated lung injury (TRALI), cyanosis, hypoxemia, pulmonary edema, bronchospasm, pulmonary embolism, hyperventilation, hypoxia, throat tightness, respiratory failure[Ref]

Cardiovascular

Very common (10% or more): Hypotension (25%), tachycardia (25%), diastolic hypertension (21%)

Common (1% to 10%): Blood pressure increased, blood pressure diastolic decreased, palpitations

Uncommon (0.1% to 1%): Tachycardia, hypertension, blood pressure systolic decreased, blood pressure systolic increased, blood pressure fluctuation

Frequency not reported: Myocardial infarction

Postmarketing reports: Cardiac arrest, thromboembolism, vascular collapse, changes in blood pressure, flushing, cyanosis, bradycardia, thrombophlebitis, pallor vena cava thrombosis, arterial thrombosis, deep vein thrombosis[Ref]

Nervous system

Very common (10% or more): Headache (64.9%)

Common (1% to 10%): Dizziness, lethargy, migraine, vertigo, sensory disturbance

Uncommon (0.1% to 1%): Tinnitus, tremor, dysgeusia

Frequency not reported: Aseptic meningitis, death from cerebrovascular hemorrhage, sleepiness

Postmarketing reports: Coma, loss of consciousness, seizures, photophobia, cerebrovascular accident, transient ischemic attack, convulsion, paresthesia, syncope, dysesthesia[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (28%), nausea (22.2%)

Common (1% to 10%): Vomiting, upper abdominal pain, stomach discomfort

Uncommon (0.1% to 1%): Abdominal distension, flatulence

Frequency not reported: Gingival bleeding

Postmarketing reports: Abdominal pain, dyspepsia[Ref]

Other

Very common (10% or more): Fatigue (38%), fever/pyrexia (38.6%), pain (25.5%), ear pain (18%), chills (19.4%), asthenia (10%)

Common (1% to 10%): Influenza-like illness, blood lactate dehydrogenase increased

Uncommon (0.1% to 1%): Hot flush, feeling jittery

Frequency not reported: Increased body temperature

Postmarketing reports: Rigors, chest pain/discomfort[Ref]

Hepatic

Very common (10% or more): Transient borderline elevation in liver enzyme (13%), blood unconjugated bilirubin increased (10.5%)

Common (1% to 10%): Blood conjugated bilirubin increased, blood total bilirubin increased, hyperbilirubinemia, alanine aminotransferase increased, aspartate aminotransferase increased, hepatic enzymes increased

Postmarketing reports: Hepatic dysfunction, jaundice, non-infectious hepatitis[Ref]

Hematologic

Very common (10% or more): Anemia (10.5%)

Common (1% to 10%): Hematocrit decreased, positive direct antiglobulin (Coombs/DAT) test

Uncommon (0.1% to 1%): Hemoglobin decreased, white blood cell count increased, anisocytosis

Frequency not reported: Autoimmune pure red cell aplasia, Coombs negative hypochromic anemia, hemolysis, decrease in hemoglobin level, active bleeding, anemia, thrombocytopenia, hemolytic anemia

Postmarketing reports: Pancytopenia, leukopenia, hemoglobinuria/hematuria/chromaturia, lymphadenopathy[Ref]

Local

Very common (10% or more): Local pain and/or irritation (15.2%), injection site reaction (13%)

Common (1% to 10%): Infusion site pain

Uncommon (0.1% to 1%): Infusion site inflammation, injection site edema, injection site pruritus, injection site swelling, migration of implant[Ref]

Dermatologic

Common (1% to 10%): Hyperhidrosis, flushing, urticaria, pruritus, dermatitis exfoliative NOS, rash macular, eczema

Uncommon (0.1% to 1%): Exanthema, erythema multiforme, acne

Frequency not reported: Mild to moderate hives, itching, recurrence of chronic cellulitis

Postmarketing reports: Stevens-Johnson syndrome, epidermolysis, bullous dermatitis, rash, angioedema, dermatitis, erythema[Ref]

Hypersensitivity

Common (1% to 10%): Hypersensitivity

Postmarketing reports: Anaphylactic shock, anaphylactic/anaphylactoid reaction[Ref]

Musculoskeletal

Very common (10% or more): Backache (11.8%)

Common (1% to 10%): Joint pain/effusion, back pain, fibromyalgia, myalgia, arthralgia, muscle spasms, neck pain

Uncommon (0.1% to 1%): Leg cramps, musculoskeletal stiffness, pain in extremity[Ref]

Metabolic

Common (1% to 10%): Fluid retention, dehydration

Uncommon (0.1% to 1%): Loss of appetite

Postmarketing reports: Fluid overload[Ref]

Renal

Uncommon (0.1% to 1%): Urinary hemosiderin positive, proteinuria

Frequency not reported: Increase in serum creatinine

Postmarketing reports: Renal failure[Ref]

Psychiatric

Uncommon (0.1% to 1%): Anxiety, agitation, insomnia

Postmarketing reports: Restlessness[Ref]

Ocular

Uncommon (0.1% to 1%): Vision blurred, conjunctivitis, maculopathy

Postmarketing reports: Photophobia, retinal vein thrombosis, eye pain, visual disturbance[Ref]

Immunologic

Frequency not reported: Infection[Ref]

More about Gamimune N 10% (immune globulin intravenous)

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Related treatment guides

References

1. Cerner Multum, Inc. UK Summary of Product Characteristics.

2. Cerner Multum, Inc. Australian Product Information.

3. Product Information. Bivigam (immune globulin intravenous). Biotest Pharmaceuticals Corporation. 2013.

4. Product Information. Gammagard S/D (immune globulin intravenous). Baxter Healthcare Corporation. 2016.

5. Product Information. Privigen (immune globulin intravenous). CSL Behring Canada Inc. 2016.

6. Product Information. Flebogamma (immune globulin intravenous). Grifols USA LLC. 2016.

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.