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

Octagam 5% is used to treat primary humoral immunodeficiency (PI).

Octagam 10% is used to chronic immune thrombocytopenic purpura (ITP) and dermatomyositis (DM) in adults.

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

Octagam 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 Octagam 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.

Octagam 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 Octagam to help improve your blood flow and keep your kidneys working properly.

Before using Octagam

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

Octagam 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 Octagam 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.

Octagam 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.

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

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

Octagam is given at different dosing schedules depending on why it is being used. 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 Octagam 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 Octagam, 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 Octagam.

Octagam 5% liquid may be stored for 24 months at +2°C to + 25°C (36°F to 77°F) from the date of manufacture. 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. Do not use after the expiration date.

Octagam 10% liquid may be for 24 months at +2°C to + 8°C (36°F to 46°F) from the date of manufacture. Within the first 12 months of this shelf-life, the product may be stored up to 9 months at ≤ +25°C (77°F). After storage at ≤ +25°C (77°F) the product must be used or discarded. Do not allow the medicine to freeze. Do not use after the expiration date. 

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

Octagam 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 Octagam 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.

Octagam 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.

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

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

Do not receive a "live" vaccine while using Octagam. The vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

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

Stop using Octagam 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 Octagam side effects may include:

• pain and swelling at injection site;

• mild headache;

• dizziness;

• tired feeling;

• back pain, abdominal 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.

Octagam can harm your kidneys, especially if you also use certain medicines for infections, cancer, osteoporosis, organ transplant rejection, bowel disorders, high blood pressure, or pain or arthritis (including Advil, Motrin, and Aleve).

Other drugs may interact with immune globulin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.