Uses of Bivigam:

• It is used to stop or lower the harshness of other infections in people with a weak immune system.
• It is used to treat immune thrombocytopenia (ITP).
• It is used treat chronic inflammatory demyelinating polyneuropathy (CIDP).
• It is used to treat Kawasaki disease.
• It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Bivigam?

For all patients taking Bivigam (immune globulin injection (IV)):

• If you are allergic to Bivigam (immune globulin injection (IV)); any part of Bivigam (immune globulin injection (IV)); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have IgA deficiency.
• If you have too much proline in your blood (hyperprolinemia).
• If you have too much fluid in the body or have been told to watch how much fluid you drink.
• If you are not able to break down fructose, talk with the doctor. Some of these products have sorbitol.

Children:

• If the patient is an infant or baby and it is not known if they are able to break down sucrose or fructose. Do not give Bivigam (immune globulin injection (IV)) to your child if this is the case.

This is not a list of all drugs or health problems that interact with Bivigam (immune globulin injection (IV)).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Bivigam (immune globulin injection (IV)) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Bivigam?

• Tell all of your health care providers that you take Bivigam (immune globulin injection (IV)). This includes your doctors, nurses, pharmacists, and dentists.
• If you have a latex allergy, talk with your doctor.
• Talk with your doctor before getting any vaccines. Use of some vaccines with Bivigam (immune globulin injection (IV)) may either raise the chance of an infection or make the vaccine not work as well.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Bivigam (immune globulin injection (IV)).
• This medicine is made from human plasma (part of the blood) and may have viruses that may cause disease. This medicine is screened, tested, and treated to lower the chance that it carries an infection. Talk with the doctor.
• If you are on a low-sodium or sodium-free diet, talk with your doctor. Some of these products have sodium.
• If you have high blood sugar (diabetes), talk with your doctor about which glucose tests are best to use.
• Some patients who have immune globulin therapy for the first time or who have not had it within the past 8 weeks may have a risk for certain side effects. These may be fever, chills, nausea, or vomiting. This may also happen in people who switch brands of immune globulin. Tell the doctor right away if any of these side effects occur.
• Dehydration and low sodium levels have happened when Bivigam (immune globulin injection (IV)) has been given into a vein. Call your doctor right away if you have signs of dehydration like dry skin, mouth, or eyes; thirst; fast heartbeat; dizziness; fast breathing; or confusion. Call your doctor right away if you have signs of low sodium levels like headache, trouble focusing, memory problems, feeling confused, weakness, seizures, or change in balance.
• If you are 65 or older, use Bivigam (immune globulin injection (IV)) with care. You could have more side effects.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is this medicine (Bivigam) best taken?

Use Bivigam (immune globulin injection (IV)) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given as an infusion into a vein over a period of time.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Signs of high or low blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Fever, chills, or sore throat; any unexplained bruising or bleeding; or feeling very tired or weak.
• Change in color of skin to a bluish color like on the lips, nail beds, fingers, or toes.
• Seizures.
• Bloating.
• Feeling confused.
• Swelling.
• A heartbeat that does not feel normal.
• Mood changes.
• Muscle or joint pain.
• Change in speech.
• Change in eyesight.
• Shakiness.
• Sweating a lot.
• Very bad belly pain.
• Dark urine or yellow skin or eyes.
• Lung problems have happened with Bivigam (immune globulin injection (IV)). Call your doctor right away if you have lung or breathing problems like trouble breathing, shortness of breath, or a cough that is new or worse.
• This medicine may raise the chance of a very bad brain problem called aseptic meningitis. Call your doctor right away if you have a headache, fever, chills, very upset stomach or throwing up, stiff neck, rash, bright lights bother your eyes, feeling sleepy, or feeling confused.

What are some other side effects of Bivigam?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Irritation where Bivigam (immune globulin injection (IV)) is given.
• Feeling dizzy, tired, or weak.
• Headache.
• Upset stomach or throwing up.
• Stomach pain or diarrhea.
• Back pain.
• Signs of a common cold.
• Flushing.
• Cramps.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Bivigam?

• If you need to store Bivigam (immune globulin injection (IV)) at home, talk with your doctor, nurse, or pharmacist about how to store it.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Bivigam (immune globulin injection (IV)), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.