"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).
Vivaglobin Patient Information Including Side Effects
Brand Names: Hizentra, Vivaglobin
Generic Name: immune globulin (subcutaneous) (Pronunciation: im MYOON GLOB yoo lin (sub koo TANE ee us))
- What is immune globulin (Vivaglobin)?
- What are the possible side effects of immune globulin (Vivaglobin)?
- What is the most important information I should know about immune globulin (Vivaglobin)?
- What should I discuss with my health care provider before using immune globulin (Vivaglobin)?
- How is immune globulin given (Vivaglobin)?
- What happens if I miss a dose (Vivaglobin)?
- What happens if I overdose (Vivaglobin)?
- What should I avoid while using immune globulin (Vivaglobin)?
- What other drugs will affect immune globulin (Vivaglobin)?
- Where can I get more information?
What is immune globulin (Vivaglobin)?
Immune globulin 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 subcutaneous (for injection under the skin) is used to treat primary immune deficiency.
Immune globulin may also be used for other purposes not listed in this medication guide.
What are the possible side effects of immune globulin (Vivaglobin)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing, difficulty breathing; dizziness, feeling like you might pass out; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- swelling, rapid weight gain, feeling short of breath, urinating less than usual or not at all;
- pain, swelling, redness, warmth, or a lump in your arms or legs;
- pale or yellowed skin, dark colored urine, fast heart rate;
- fever, severe headache, sore throat, neck stiffness, chills, increased sensitivity to light, confusion, and general ill feeling;
- chest pain or tightness, trouble breathing; or
- signs of new infection such as high fever, chills, body aches, flu symptoms, or sores in your mouth and throat.
Less serious side effects may include:
- pain, redness, warmth, itching, and swelling of skin where the injection was given;
- nausea, vomiting, diarrhea, stomach pain;
- mild skin rash;
- back pain;
- joint or muscle pain; or
- tired 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.
Read the Vivaglobin (immune globulin subcutaneous (human)) Side Effects Center for a complete guide to possible side effects
What is the most important information I should know about immune globulin (Vivaglobin)?
You should not use this medication 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 if you have a condition called hyperprolinemia (high level of a certain amino acid in the blood).
Before using this medication, tell your doctor if you have blood circulation problems or a blood vessel disorder, a history of stroke or blood clot, or if you have been bed-ridden due to severe illness.
Immune globulin is usually given once every week. You may be shown how to use injections 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, tubing, and other items used to inject the medicine.
Subcutaneous immune globulin is for injection only under the skin. Do not inject this medicine into a vein.
If you use this medication at home, keep a diary of the days and times you used the medication and where you injected it on your body.
You may need a dose adjustment if you are exposed to measles, or if you travel to an area where this disease is common.
Additional Vivaglobin Information
Vivaglobin - User Reviews
Vivaglobin User Reviews
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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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