Uses of Gammaked:

• 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 multifocal muscle neuropathy.
• It may be given to you for other reasons. Talk with the doctor.

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

All products:

• If you are allergic to Gammaked (immune globulin injection (subcutaneous or IV)); any part of Gammaked (immune globulin injection (subcutaneous or 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.

Injection (subcutaneous):

• If you have low platelet levels.

Injection (I.V.):

• If you are not able to break down fructose, talk with the doctor. Some of these products have sorbitol.

This is not a list of all drugs or health problems that interact with Gammaked (immune globulin injection (subcutaneous or 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 Gammaked (immune globulin injection (subcutaneous or 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 Gammaked?

• Tell all of your health care providers that you take Gammaked (immune globulin injection (subcutaneous or IV)). This includes your doctors, nurses, pharmacists, and dentists.
• If you have a latex allergy, talk with your doctor. Some products have latex.
• Talk with your doctor before getting any vaccines. Use of some vaccines with Gammaked (immune globulin injection (subcutaneous or 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 Gammaked (immune globulin injection (subcutaneous or 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 Gammaked (immune globulin injection (subcutaneous or 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 Gammaked (immune globulin injection (subcutaneous or 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 (Gammaked) best taken?

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

Injection (subcutaneous):

• It is given as an infusion under the skin over a period of time.
• If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
• Do not shake the solution.
• Wash your hands before and after use.
• If stored in a refrigerator, let Gammaked (immune globulin injection (subcutaneous or IV)) come to room temperature before using it. Do not heat Gammaked (immune globulin injection (subcutaneous or IV)).
• Do not use if the solution is cloudy, leaking, or has particles.
• Do not use if solution changes color.
• Do not use if it has been frozen.
• Do not mix with any other liquid drugs.
• Do not give into skin that is irritated, bruised, red, infected, or scarred.
• Move the site where you give Gammaked (immune globulin injection (subcutaneous or IV)) as you were told by the doctor.
• Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.

Injection (I.V.):

• 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 Gammaked (immune globulin injection (subcutaneous or 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 Gammaked?

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 Gammaked (immune globulin injection (subcutaneous or 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 Gammaked?

Injection (subcutaneous):

• Follow how to store closely. Read the package insert that comes with Gammaked (immune globulin injection (subcutaneous or IV)). If you have questions about how to store Gammaked (immune globulin injection (subcutaneous or IV)), talk with your pharmacist.
• Store in the original container to protect from light.
• Do not freeze.

Injection (I.V.):

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

All products:

• 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.

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.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Gammaked (immune globulin injection (subcutaneous or 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.