Sandoglobulin

In the U.S.

• Baygam
• Bivigam
• Carimune
• Cuvitru
• Flebogamma 10% DIF
• Flebogamma 5%
• Flebogamma 5% DIF
• Gamastan S/D
• Gamimune N
• Gammagard
• Gammagard S/D
• Gammaplex
• Gammaplex 10%
• Gammar-P
• Gamunex
• Hizentra
• Iveegam EN
• Octagam
• Octagam 10%
• Panglobulin NF
• Polygam S/D
• Privigen
• Sandoglobulin
• Venoglobulin-S
• Vivaglobin

Available Dosage Forms:

• Solution
• Powder for Solution

Therapeutic Class: Immune Serum

Immune globulin injection is used to prevent or treat diseases that occur when your body has a weak immune system. Immune globulin contains antibodies that make your immune system stronger. It is used for patients who have primary humoral immunodeficiency (PI), idiopathic thrombocytopenic purpura (ITP), chronic immune thrombocytopenic purpura, or chronic inflammatory demyelinating polyneuropathy (CIDP). It is also used to improve muscle strength and disability in patients with multifocal motor neuropathy (MMN). Immune globulin injection belongs to a group of medicines known as immunizing agents.

This medicine is to be given only by or under the supervision of your doctor.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of immune globulin injection in children. Some of the products are only used in children who are 2 or 3 years of age and older, and other products are not approved for use in children. Immune globulin injection is used to treat primary humoral immunodeficiency (PI), idiopathic thrombocytopenic purpura (ITP), and chronic immune thrombocytopenic purpura in children. Safety and efficacy have not been established for use in chronic inflammatory demyelinating polyneuropathy (CIDP) or multifocal motor neuropathy (MMN).

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of immune globulin injection in the elderly. However, elderly patients are more likely to have age-related blood clotting problems, kidney disease, or heart disease, which may require caution for patients receiving immune globulin injection.

Pregnancy

Breast Feeding

Studies in women suggest that this medication poses minimal risk to the infant when used during breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to corn—Use with caution. May cause an allergic reaction to occur again.

• Anemia, history of or
• Bleeding problems, history of or
• Hyponatremia (low sodium in the blood) or
• Kidney problems—Use with caution. May make these conditions worse.

• Atherosclerosis (hardening of the arteries), history of or
• Blood clotting problems, history of or
• Diabetes or
• Heart attack or stroke, recent or
• Heart or blood vessel disease or
• Hyperproteinemia (high protein in the blood) or
• Hyperviscosity (thick blood), known or suspected or
• Hypovolemia (low blood volume or major loss of body fluids) or
• IgA (immunoglobulin A) deficiency with antibodies against IgA or
• Paraproteinemia (paraproteins in the blood) or
• Sepsis (serious infection in the body)—Use with caution. May cause side effects to become worse.

• Hereditary intolerance to fructose or sucrose or
• IgA (immunoglobulin A) deficiency with antibodies against IgA—Gammaplex® should not be used in patients with these conditions.

• Hyperprolinemia (too much proline in the blood) or
• IgA (immunoglobulin A) deficiency with antibodies against IgA—Hizentra® should not be used in patients with these conditions.

• IgA (immunoglobulin A) deficiency with antibodies against IgA—Octagam® should not be used in patients with this condition.

It is very important that your doctor check your progress at regular visits for any problems that may be caused by this medicine. Blood and urine tests may be needed to check for unwanted effects.

Patients with idiopathic thrombocytopenic purpura (ITP) should not be treated with Gammaked™ or Gamunex®-C that is injected under the skin (subcutaneously). Doing so may increase the risk of having a hematoma (buildup of blood under the skin).

This medicine may cause fever, chills, flushing, headaches, nausea, and vomiting, especially if you are receiving it for the first time or if you have not received it for more than 8 weeks. Check with your doctor or nurse right away if you have any of these symptoms.

This medicine is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them, although the risk is low. Human donors and donated blood are both tested for viruses to keep the transmission risk low. Talk with your doctor about this risk if you are concerned.

This medicine may cause a serious type of allergic reaction, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, hives, chest pain, dizziness or lightheadedness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving this medicine. Certain people, including those with IgA (an immunoglobulin) deficiency and antibodies against IgA and a history of hypersensitivity to human immunoglobulin products should not use this medicine.

Check with your doctor right away if you start to have a stiff neck, drowsiness, fever, severe headache, nausea or vomiting, painful eye movements, or eye sensitivity to light. These could be symptoms of a serious condition called aseptic meningitis syndrome (AMS).

This medicine may cause bleeding (hemolysis) or hemolytic anemia. Tell your doctor right away if you have stomach or back pain, dark urine, decreased urination, difficulty with breathing, an increased heart rate, tiredness, or yellow eyes or skin after you receive the medicine.

Check with your doctor right away if you start having chest pain, difficult, fast, or noisy breathing, sometimes with wheezing, blue lips and fingernails, fever, pale skin, increased sweating, coughing that sometimes produces a pink frothy sputum, shortness of breath, or swelling of the legs and ankles after receiving this medicine. These may be symptoms of a serious lung problem.

This medicine may cause blood clots. This is more likely to occur if you have a history of blood clotting problems, heart disease, or atherosclerosis (hardening of the arteries), or if you are obese, take medicines containing estrogen, or must stay in bed for a long time because of surgery or illness. Check with your doctor right away if you suddenly have chest pain, shortness of breath, a severe headache, leg pain, or problems with vision, speech, or walking.

Check with your doctor right away if you start having red or dark brown urine, lower back or side pain, a sudden weight gain, a swollen face, arms, or legs, decreased urine output, or any problems with urination after you receive this medicine. These may be symptoms of a serious kidney problem.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

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