Octagam IGIV

Immune globulin intravenous (IGIV) is a sterilized solution made from human plasma. It contains the antibodies to help your body protect itself against infection from various diseases.

IGIV is used to treat primary immunodeficiency (PI), and to reduce the risk of infection in individuals with poorly functioning immune systems such as those with chronic lymphocytic leukemia (CLL). IGIV is also used to increase platelets (blood clotting cells) in people with idiopathic thrombocytopenic purpura (ITP) and to prevent aneurysm caused by a weakening of the main artery in the heart associated with Kawasaki syndrome.

IGIV is also used to treat chronic inflammatory demyelinating polyneuropathy (CIDP), a debilitating nerve disorder that causes muscle weakness and can affect daily activities.

IGIV may also be used for purposes not listed in this medication guide.

Call your doctor for instructions if you miss a dose of this medication.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Octagam is injected into a vein through an IV. You may be shown how to use an IV at home. Do not self-inject Octagam if you do not fully understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

Octagam should not be injected into a muscle or under the skin.

Octagam is usually given every 3 to 4 weeks. Your dosing schedule may be different. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Do not use Octagam if it has changed colors or has particles in it. Call your pharmacist for new medication. Throw away any unused medicine that is left over after injecting your dose.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

While using Octagam, you may need frequent blood tests. Your kidney function may also need to be checked.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using Octagam.

Octagam 5% liquid may be stored for 24 months at +2°C to + 25°C (36°F to 77°F) from the date of manufacture. Follow the storage instructions on your prescription label or ask your pharmacist if you have questions about how to store the medication. Do not allow the medicine to freeze. Do not use after the expiration date.

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

Stop using Octagam and call your doctor at once if you have:

• signs of a blood clot in the brain--sudden numbness or weakness (especially on one side of the body), slurred speech, problems with vision or balance;

• signs of a blood clot in the heart or lung--chest pain, rapid heart rate, sudden cough, wheezing, rapid breathing, coughing up blood;

• signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs;

• signs of a kidney problem--swelling, rapid weight gain, and little or no urinating;

• liver problems--fast heart rate, dark urine, jaundice (yellowing of the skin or eyes);

• lung problems--chest pain, trouble breathing, blue lips, pale or blue colored appearance in your fingers or toes; or

• signs of new infection--high fever, flu symptoms, mouth sores, severe headache, neck stiffness, increased sensitivity to light, nausea and vomiting.

Common Octagam side effects may include:

• mild headache;

• dizziness;

• tired feeling;

• back pain, muscle cramps;

• minor chest pain; or

• flushing (warmth, redness, or tingly feeling).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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]

Some side effects of Octagam may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.