"The U.S. Food and Drug Administration yesterday approved Obizur [Antihemophilic Factor (Recombinant), Porcine Sequence] for the treatment of bleeding episodes in adults with acquired hemophilia A (acquired Factor VIII [FVII] deficiency).
Gamunex Patient Information including How Should I Take
In this Article
- What is immune globulin intravenous (IVIG) (Gamunex)?
- What are the possible side effects of immune globulin?
- What is the most important information I should know about immune globulin?
- What should I discuss with my health care provider before using immune globulin?
- How is immune globulin intravenous given?
- What happens if I miss a dose?
- What happens if I overdose?
- What should I avoid while using immune globulin?
- What other drugs will affect immune globulin?
- Where can I get more information?
What should I discuss with my health care provider before using immune globulin?
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.
To make sure you can safely use immune globulin, tell your doctor if you have any of these other conditions:
- 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 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 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.
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.
How is immune globulin intravenous given?
Immune globulin intravenous 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.
IVIG should not be injected into a muscle or under the skin.
Do not use the medication if it has changed colors or has 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.
IVIG is usually given every 3 to 4 weeks. Your dosing schedule may be different. Follow your doctor's instructions.
Your doctor may occasionally change your dose to make sure you get the best results.
To be sure this medicine is helping your condition and is not causing harmful effects, your blood will need to be tested often. Your kidney function may also need to be tested. Visit your doctor regularly.
This medication can cause unusual results with certain blood glucose tests. Tell any doctor who treats you that you are using immune globulin.
Some brands of immune globulin should be stored in a refrigerator, while others can be kept at room temperature. Follow the directions 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.
Additional Gamunex Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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