Consumer Information

Octagam

Generic Name: immune globulin (intravenous) (IGIV) (im MYOON GLOB yoo lin)
Brand Names: Carimune, Flebogamma, Gamimune N 10%, Gammagard, Gammagard S/D, Gammar-P I.V., Gamunex, Iveegam En, Octagam, Panglobulin NF, Polygam S/D, Privigen, Sandoglobulin

What is Octagam?

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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 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). Octagam 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.

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

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

Important information about Octagam

Octagam can be harmful to the kidneys, and these effects are increased when Octagam is used together with other medicines that can harm the kidneys. Before using Octagam, tell your doctor about all other medications you use. Many other drugs (including some over-the-counter medicines) can be harmful to the kidneys.

Before you use Octagam, tell your doctor if you have kidney disease, diabetes (especially if you use insulin), a history of stroke or blood clot, heart disease, high blood pressure, a condition called paraproteinemia, or if you are over 65 years old.

To be sure this medication is helping your condition and is not causing harmful effects, your blood will need to be tested on a regular basis. Your kidney function may also need to be checked. Do not miss any scheduled appointments.

Using Octagam can cause you to have unusual results with certain blood glucose tests. Tell any doctor who treats you that you are using Octagam.

Octagam is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although Octagam is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

Before using Octagam

You should not use Octagam 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.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before you use Octagam, tell your doctor if you have:

  • kidney disease;

  • diabetes (especially if you use insulin);

  • a history of stroke or blood clot;

  • heart disease or high blood pressure;

  • a condition called paraproteinemia; or

  • if you are over 65 years old.

FDA pregnancy category C. It is not known whether Octagam is harmful to an unborn baby. Before using this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment It is not known if immune globulin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.



How is Octagam given?

Use Octagam exactly as it was prescribed for you. Do not use it in larger doses or for longer than recommended by your doctor. Follow the directions on your prescription label.

Octagam is given as an injection through a needle placed into a vein. Your doctor, nurse, or other healthcare provider will give you this injection. You may be shown how to use your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of needles, IV tubing, and other items used in giving the medicine.

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

Octagam is usually given every 3 to 4 weeks. Your dosing schedule may be different. Follow your doctor's instructions.

To be sure this medication is helping your condition and is not causing harmful effects, your blood will need to be tested on a regular basis. Your kidney function may also need to be checked. Do not miss any scheduled appointments.

Using Octagam can cause you to have unusual results with certain blood glucose tests. Tell any doctor who treats you that you are using Octagam.

Do not use the medication if it has changed colors or has any particles in it. Call your doctor for a new prescription. 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.

Octagam can be stored for 24 months at room temperature - 36° F to 77° F (+2° C to +25° C) - from the date of manufacture. Do not use after the expiration date. Do not freeze.

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

What should I avoid while using Octagam?

Do not receive live-virus vaccines such as measles, mumps, or rubella. The live vaccine may not work as well during this time, and may not fully protect you from disease.

Octagam side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have a serious side effect such as:

  • urinating less than usual or not at all, swelling, weight gain, feeling short of breath;

  • drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting;

  • trouble breathing, blue lips;

  • fever with headache, neck stiffness, chills, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions);

  • pale or yellowed skin, dark colored urine, fever, confusion or weakness;

  • slow heart rate, weak pulse, fainting, slow breathing (breathing may stop);

  • sudden numbness or weakness, especially on one side of the body;

  • sudden headache, confusion, problems with vision, speech, or balance;

  • feeling like you might pass out;

  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or

  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

Less serious Octagam side effects may include:

  • headache;

  • dizziness;

  • upset stomach, mild nausea, vomiting, diarrhea;

  • back pain, joint pain, minor chest pain;

  • mild itching or skin rash; or

  • runny or stuffy nose, cough, sore throat;

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.

What other drugs will affect Octagam?

Octagam can be harmful to the kidneys, and these effects are increased when Octagam is used together with other medicines that can harm the kidneys. Before taking Octagam, tell your doctor if you are also using:

  • lithium (Lithobid);

  • methotrexate (Rheumatrex, Trexall);

  • pain or arthritis medicines such as aspirin (Anacin, Excedrin), acetaminophen (Tylenol), diclofenac (Cataflam, Voltaren), etodolac (Lodine), ibuprofen (Advil, Motrin), indomethacin (Indocin), naproxen (Aleve, Naprosyn), and others;

  • medicines used to treat ulcerative colitis, such as mesalamine (Pentasa) or sulfasalazine (Azulfidine);

  • medicines used to prevent organ transplant rejection, such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune) or tacrolimus (Prograf);

  • IV antibiotics such as amphotericin B (Fungizone, AmBisome, Amphotec, Abelcet), amikacin (Amikin), bacitracin (Baci-IM), capreomycin (Capastat), gentamicin (Garamycin), kanamycin (Kantrex), streptomycin, or vancomycin (Vancocin, Vancoled);

  • antiviral medicines such as adefovir (Hepsera), cidofovir (Vistide), or foscarnet (Foscavir); or

  • cancer medicine such as aldesleukin (Proleukin), carmustine (BiCNU, Gliadel), cisplatin (Platinol), ifosfamide (Ifex), oxaliplatin (Eloxatin), plicamycin (Mithracin), streptozocin (Zanosar), or tretinoin (Vesanoid).

This list is not complete and there may be other drugs that can interact with Octagam. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist can provide more information about Octagam.
  • 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 is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. 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. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects.

Copyright 1996-2009 Cerner Multum, Inc. Version: 2.03. Revision Date: 03/31/2009 9:53:46 AM.








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