Privigen

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.

This medicine can cause blood clots. A blood clot may be more likely if you have risk factors such as heart disease, blood circulation problems, estrogen use, a history of blood clots, if you are 65 years or older, if you have been bed-ridden, or if you are using a catheter.

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

Immune globulin intravenous can also harm your kidneys, especially if you already have kidney disease or if you also use certain other medicines. Many other drugs (including some over-the-counter medicines) can be harmful to the kidneys.

Call your doctor at once if you have signs of a kidney problem, such as swelling, rapid weight gain, and little or no urinating.

Drink plenty of liquids while you are using this medicine to help improve your blood flow and keep your kidneys working properly.

You should not use this medication if you have ever had an allergic reaction to an immune globulin or if you have immune globulin A (IgA) deficiency with antibody to IgA.

IGIV can harm your kidneys or cause blood clots. To make sure this medicine is safe for you, tell your doctor if you have:

• heart disease, blood circulation problems or a blood vessel disorder;
• a history of stroke or blood clot;
• if you use estrogens (birth control pills or hormone replacement therapy);
• kidney disease;
• diabetes;
• a serious infection called sepsis;
• hyperproteinemia (too much protein in the blood);
• paraproteinemia (abnormal proteins in the blood);
• if you are dehydrated;
• if you are 65 years or older;
• if you have been bed-ridden due to severe illness; or
• if you are using a catheter.

FDA pregnancy category C. It is not known whether immune globulin will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether immune globulin passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Immune globulin is made from human plasma (part of the blood) which may contain viruses and other infectious agents. Donated plasma is tested and treated to reduce the risk of it containing infectious agents, but there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

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

Stop using this medicine 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 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.

IGIV is injected into a vein through an IV. You may be shown how to use an IV at home. Do not self-inject this medicine 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.

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

IGIV 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 IGIV 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 IGIV, 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 IGIV.

Some brands of IGIV should be stored in a refrigerator, while others can be kept at room temperature. 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.

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

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

Inform patients of the early signs of hypersensitivity reactions to Privigen (including hives, generalized urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis), and advise them to notify their physician if they experience any of these symptoms. Inform patients to immediately report the following signs and symptoms to their physician:

• Decreased urine output, sudden weight gain, fluid retention/edema, and/or shortness of breath, which may suggest kidney problems
• Instruct patients to immediately report symptoms of thrombosis. These symptoms may include: pain and/or swelling of an arm or leg with warmth over the affected area, discoloration of an arm or leg, unexplained shortness of breath, chest pain or discomfort that worsens on deep breathing, unexplained rapid pulse, numbness or weakness on one side of the body.
• Severe headache, neck stiffness, drowsiness, fever, sensitivity to light, painful eye movements, nausea, and vomiting, which may suggest aseptic meningitis syndrome
• Fatigue, increased heart rate, yellowing of skin or eyes, and dark-colored urine, which may suggest hemolysis
• Severe breathing problems, lightheadedness, drops in blood pressure, and fever, which may suggest TRALI (a condition typically occurring within 1 to 6 hours following transfusion)

Inform patients that Privigen is made from human blood and may contain infectious agents that can cause disease (e.g., viruses and, theoretically the CJD agent). Explain that the risk that Privigen may transmit an infectious agent has been reduced by screening the plasma donors, by testing donated plasma for certain virus infections, and by inactivating or removing certain viruses during manufacturing, and counsel patients to report any symptoms that concern them.

Inform patients that administration of IgG may interfere with the response to live virus vaccines (e.g., measles, mumps, rubella, and varicella), and instruct them to notify their immunizing physician of recent therapy with Privigen.

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

Immune globulin is used to treat primary immune deficiency, 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.

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

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

Your pharmacist can provide more information about immune globulin intravenous.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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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 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.

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Privigen is supplied in a single-use, tamper-evident vial containing the labeled amount of functionally active IgG. The components used in the packaging for Privigen are latex-free.

The following presentations of Privigen are available:

Each vial has an integral suspension band and a label with two peel-off strips showing the product name, lot number, and expiration date.

When stored at room temperature (up to 25ºC [77ºF]), Privigen is stable for up to 36 months, as indicated by the expiration date printed on the outer carton and vial label.

Keep Privigen in its original carton to protect it from light.

Do not freeze.