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 Octagam.

Applies to immune globulin intravenous: intravenous solution.

Serious side effects of Octagam

Along with its needed effects, immune globulin intravenous (the active ingredient contained in Octagam) 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

• Cough
• cough producing mucus
• difficulty breathing
• fever
• headache
• pain or tenderness around the eyes and cheekbones
• pale skin
• stuffy or runny nose
• tightness of the chest
• trouble breathing
• unusual bleeding or bruising
• unusual tiredness or weakness

Incidence not known

• Agitation
• anxiety
• back pain
• black, tarry stools
• blistering, peeling, or loosening of the skin
• bloody or cloudy urine
• bloody, black, or tarry stools
• blue lips and fingernails
• bluish lips or skin
• blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• change in color vision
• changes in skin color
• chest pain or discomfort
• chills
• confusion
• coughing that sometimes produces a pink frothy sputum
• dark urine
• decreased frequency or amount of urine
• decreased urination
• decreased urine output
• diarrhea
• difficult or painful urination
• difficult, fast, noisy breathing
• difficulty in speaking
• difficulty seeing at night
• difficulty swallowing
• dizziness or lightheadedness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• double vision
• drowsiness
• fainting
• fast or irregular heartbeat
• hallucinations
• high fever
• hives, itching, skin rash
• inability to move the arms, legs, or facial muscles
• inability to speak
• increased blood pressure
• increased sensitivity of the eyes to sunlight
• increased sweating
• increased thirst
• irritability
• joint or muscle pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals
• loss of appetite loss of consciousness
• lower back or side pain
• mood or mental changes
• muscle pain or cramps
• nausea
• nervousness
• noisy breathing
• noisy, rattling breathing
• pain, redness, or swelling in the arm or leg
• painful or difficult urination
• pounding in the ears
• puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
• red skin lesions, often with a purple center
• red, irritated eyes
• seizures
• slow heartbeat
• slow speech
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stiff neck or back
• stomach pain
• sudden decrease in the amount of urine
• swelling of the face, fingers, hands, feet, or lower legs
• swollen glands
• tenderness
• unusual bleeding or bruising
• unusual drowsiness, dullness, or feeling of sluggishness
• vomiting
• weight gain
• yellow eyes or skin

Other side effects of Octagam

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

• Blistering, crusting, irritation, itching, or reddening of the skin
• cracked, dry, scaly skin
• swelling
• upper stomach pain

Incidence not known

• Anxiety
• bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
• bone pain
• difficulty in moving
• hair loss, thinning of hair
• joint swelling
• nervousness

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]