Baygam

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.

This section provides information on the proper use of a number of products that contain immune globulin. It may not be specific to Baygam. Please read with care.

A doctor or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins, as a shot into one of your muscles, or as a shot under your skin.

This medicine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

While you are being treated with immune globulin injection, do not have any immunizations (vaccines) without your doctor's approval. Live virus vaccines should not be given for 3 months after receiving immune globulin.

The Gammagard Liquid, Gammaked™, Gamunex®-C, and Hizentra® products may be given at home to patients who do not need to be in the hospital or clinic. They are given as an infusion under your skin once every week. The Hizentra® product may also be given once every 2 weeks. If you are using this medicine at home, your doctor will teach you how to prepare and infuse the medicine. You will be shown the body areas where the medicine can be given. Use a different body area for each infusion. Keep track of where you give an infusion to make sure you rotate sites. This will help prevent skin problems.

Do not change the brand or type of your immune globulin unless your doctor tells you to. If you must change the brand of medicine, talk to your doctor before giving yourself an infusion. Make sure you understand the instructions on how to use the new brand.

Allow the Gammagard Liquid, Gammaked™, or Gamunex®-C brand to reach room temperature before using it.

To use Gammagard Liquid, Gammaked™, Gamunex®-C, or Hizentra®:

• First, gather the items you will need on a clean, flat surface using a cloth or towel in a well-lighted area.
• Wash your hands with soap and water before and after using this medicine.
• If you have been told to wear gloves when preparing your infusion, put the gloves on.
• Check the liquid in the vial (glass container). It should be clear and slightly yellow to light brown in color. If it is cloudy, discolored, or contains large flecks (particles), do not use the vial. Select another vial.
• If the liquid is clear, place it on the clean, flat surface. Do not heat up or shake the medicine.
• Follow your doctor's instructions on how to prepare the correct amount of medicine.
• Choose an injection site on your body (eg, abdomen or stomach area, thigh, upper arm, upper leg, hip). Clean the injection site with a fresh alcohol wipe, and let it dry.
• With two fingers, pinch together the skin at the injection site. Insert the needle with the tube under the skin.
• Put sterile gauze and tape over the injection site to keep the needle from coming out.
• Before starting the infusion, make sure no blood is flowing into the infusion tube. If blood is present, remove and throw away the used needle and tube.
• Follow your doctor's instructions on how to use the infusion pump.
• Remove the peel-off portion of the label from the used vial. Place this label in your treatment diary or log book. Write down the amount of medicine you used, the date, and the time of your treatment.
• It usually takes about 60 minutes for each infusion.
• When all of the medicine has been infused, turn off the pump.
• Take the gauze off and remove the needle and tube from your skin.
• Clean and store the infusion pump.
• Throw away used needles and tubes in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.

Missed Dose

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the Hizentra® product at room temperature, away from heat and moisture, for up to 30 months. Keep from freezing. Protect the product from direct light. Keep the medicine in the original package until you are ready to use it.

Store the Gamunex®-C product in the original container and in the refrigerator, but do not freeze it.

You may store the Gammagard Liquid or Gammaked™ product in the refrigerator or at room temperature. Check the box or label of the vials for expiration dates. Store it in the original container. Do not freeze. Talk with your pharmacist if you have questions about storage of this product.

Along with its needed effects, a medicine 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:

• Chills
• cough
• fast, pounding, or irregular heartbeat or pulse
• fever
• noisy breathing
• tightness in the chest
• troubled breathing
• unusual tiredness or weakness

• Bluish coloring of the lips or nail beds
• burning sensation in the head
• faintness or lightheadedness

• Difficulty with swallowing
• hives or welts
• itching, especially of the feet or hands
• reddening of the skin, especially around the ears
• swelling of the eyes, face, or inside of the nose

• Back, leg, or stomach pains
• blistering, peeling, or loosening of the skin
• change in vision
• changes in urination
• chest pain or discomfort
• cold, clammy, or pale skin
• confusion
• convulsions
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• fever
• headache that is severe and occurs suddenly
• light-colored stools
• loss of consciousness
• low blood pressure or pulse
• muscle spasm or jerking of all extremities
• nausea or vomiting
• pains in the chest, groin, or legs, especially calves of the legs
• shakiness in the legs, arms, hands, or feet
• skin blisters
• slow breathing
• slurred speech that occurs suddenly
• sores, ulcers, or white spots in the mouth or on the lips
• sudden, severe weakness or numbness in the arm or leg
• sweating
• swelling in the legs and ankles
• tightness in the chest
• unusual bleeding or bruising
• yellow eyes or skin

Some side effects 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:

• Diarrhea
• dizziness
• headache
• joint pain
• muscle pain
• redness, swelling, itching, or pain at the injection site
• skin rash

• Hip pain
• leg cramps

• Feeling of warmth
• redness of the face, neck, arms, and occasionally, upper chest
• stomach pain
• swollen glands
• tiredness
• weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as a shot into a muscle.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

• If you need to store this medicine at home, talk with your doctor, nurse, or pharmacist about how to store it.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

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

Data not available

US BOXED WARNING(S):
THROMBOSIS, RENAL DYSFUNCTION, and ACUTE RENAL FAILURE
-THROMBOSIS may occur with immune globulin products.
-Thrombosis risk factors include: advanced age, prolonged immobilization, hypercoagulable conditions, history of venous or arterial thrombosis, use of estrogens, indwelling vascular catheters, hyperviscosity, and cardiovascular risk factors.
-For patients at risk of thrombosis, administer this product at the minimum dose and infusion rate practicable.
-Ensure adequate hydration in patients before administration.
-Monitor for signs and symptoms of thrombosis and assess blood viscosity in at-risk patients.
-RENAL DYSFUNCTION, acute renal failure, osmotic nephrosis, and death may occur with immune globulin intravenous (IGIV) products in predisposed patients.
-Patients predisposed to renal dysfunction include those with any degree of preexisting renal insufficiency, diabetes mellitus, age greater than 65, volume depletion, sepsis, paraproteinemia, or patients on known nephrotoxic drugs.
-Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. The manufacturer product information should be consulted.
-For patients at risk of renal dysfunction or failure, administer at the minimum concentration available and the minimum infusion rate practicable.

Safety and efficacy of Bivigam(R) have not been established in PI patients younger than 6 years.
Safety and efficacy of Gammagard S/D(R) have not been established in pediatric ITP patients.
Safety and efficacy of Gammaplex(R) have not been established in PI patients younger than 2 years.
Safety and efficacy of Octagam(R) have not been established in pediatric ITP patients.
Safety and efficacy of Privigen(R) have not been established in ITP patients younger than 3 years.

Consult WARNINGS section for additional precautions.

Use is not recommended unless clearly needed. AU TGA pregnancy category: C US FDA pregnancy category: C

Animal studies have not been performed. There are no controlled data in human pregnancy. Intact immune globulins cross the placenta increasingly after 30 weeks gestation. Clinical experience with immunoglobulins does not suggest a harmful effect on pregnancy or the fetus. When administered prior to delivery in mothers with immune thrombocytopenic purpura, the platelet response and clinical effect were similar in the mother and the neonate. AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details. US FDA pregnancy category C: Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

The safety and efficacy of immune globulin intramuscular have not been established in pediatric patients. However, immune globulin intramuscular may be appropriate for use in some situations.

Susceptible persons exposed < 6 days previously:
0.2 mL/kg. Maximum dose: 15 mL.

Susceptible and immunocompromised child: 0.5 mL/kg. Maximum dose: 15 mL.