Biotest Pharmaceuticals Corporation has been issued a J-Code from CMS for BIVIGAM®[Immune Globulin Intravenous (Human), 10% Liquid].
The BIVIGAM issued J-Code is J1556 and is effective as of January 1, 2014.
|J1556||Injection, immune globulin (BIVIGAM), intravenous, non-lyophilized (e.g., liquid),||500 mg||1/1/2014|
If you have any questions or require additional information about BIVIGAM, please contact the BIVIGAM CareLine at 1-855-BIVIGAM (855-248-4426).
As a provider of therapies for chronic disorder, Biotest Pharmaceuticals Corporation is sensitive to your privacy. The BIVIGAM Cares® Program is being administered by a third party, independent provider that specializes in support and advocacy programs for families taking care of family members with chronic illnesses. The third-party Program Administrator manages the Program website. As soon as you push the I AGREE button, you will leave BIVIGAM.com and you will be redirected to www.BIVIGAMCares.com, which is completely independent from BIVIGAM.COM. As soon as you have finished the enrollment process for the BIVIGAM Cares® Program and/or have read the program information, you will not be automatically returned to the BIVIGAM.com website. If you want to return to the BIVIGAM.COM website, you would have to actively decide to come back to this site.
Biotest Pharmaceuticals Corporation will not have access to any of the confidential information associated with your participation in the BIVIGAM Cares® Program without your consent. The Program Administrator will use your confidential information only with your consent and in accordance with the terms of the Program, the Program website and applicable law.
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Nearly all of us get an infection once in a while – perhaps it’s a minor cold, cough, or a cut that gets infected, or it may be something more serious like pneumonia.
Most people expect to recover quickly from an infection. Our body’s immune defenses (sometimes with help from antibiotics) can usually eliminate germs that cause infection and protect us against new germs in the future.
But some of us are born with an immune defense system that is not able to fight infections as in healthy people. Such people are missing some of the body’s immune defense weapons. They are said to have a primary humoral immunodeficiency, which is also known as a PI.
The number of Americans now living with a primary immune deficiency is estimated to be between 25,000 and 50,000. And every year it is estimated that about 400 children are born in the United States with a serious PI.
Currently, the World Health Organization recognizes over 150 PIs.2 Each type has somewhat different symptoms, depending on which parts of the immune defense system are affected. Some deficiencies are deadly, while some are mild. But they all have one thing in common: they may open the door to multiple infections.
Individuals with PI– many of them infants and children – get one infection after another. Ear, sinus, and other infections may not improve with treatment as expected, but keep coming back or occurring with less common but severe infections, such as recurrent pneumonia. Besides being painful, frightening, and frustrating, these constant infections can cause permanent damage to the ears or to the lungs.
In the more severe forms of PI, germs which cause only mild infections in people with healthy immune systems may cause severe or life-threatening infections.
Although infections are the hallmark of PIs, they are not always the only health problem, or even the main one. Some PIs are associated with other immune system disorders, such as anemia, arthritis, or autoimmune diseases. Other PIs involve more than the immune system; some, for instance, are associated with symptoms involving the heart, digestive tract, or the nervous system. Some PIs retard growth and increase the risk of cancer.
Today, physicians realize that PIs are not uncommon. They are sometimes relatively mild, and they can occur in teenagers and adults as often as in infants and children.
Thanks to rapid advances in medicine, many PI diseases can be successfully treated or even cured. With proper treatment, most people with PIs are not only surviving once-deadly diseases, they are usually able to lead normal lives.
Children with PI can usually go to school, interact with playmates, and participate in sports. Most adults with PI are leading productive lives in their communities.
Successfully controlling PI, however, depends on prompt detection. Physicians, parents, and adult patients alike need to recognize when infections are more than "ordinary," so that treatment can be started in time to prevent permanent damage or life-threatening complications. Rapid advances in detection and confirmatory lab tests have been successful, along with recommendations to screen people early (including newborns) for PI.
As soon as someone with primary immune deficiency has been identified in your family, you should also check for similar symptoms in other family members so that they can be evaluated for PI as quickly as possible.
This information is not intended to be a substitute for professional medical care. You should consult your family physician or pediatrician for specific information on the diagnosis, treatment, and clinical care of patients with PI.
1. National Institute of Child Health and Human Development, National Institutes of Health. Primary immunodeficiency: when the body’s defenses are missing. http://www.nichd.nih.gov/publications/pubs/primary_immuno.cfm. Updated April 7, 2008. Accessed January 3, 2012.
2. Immune Deficiency Foundation.About Primary Immunodeficiency Diseases. http://primaryimmune.org/about-primary-immunodeficiency-diseases. Accessed February 11, 2012.
3. Jeffrey Modell Foundation. National Primary Immunodeficiency Resource Center. 10 Warning signs of primary immunodeficiency. http//www.info4pi.org/aboutPI/index.cfm?section=aboutPI&content=warningsigns&CFID=114235&CFTOKEN=c9dc5ac3ae0c1fe6-D6387E8B-06D3-D594-11EB24FE231F87DE. Accessed December 27, 2012.
BIVIGAM® [Immune Globulin Intravenous (Human), 10% Liquid] is indicated for the treatment of primary humoral immunodeficiency (PI). This includes, but is not limited to, the humoral immune defect in common variable immunodeficiency (CVID), X-linked agammaglobulinemia, congenital agammaglobulinemia, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.
Warning: Thrombosis may occur with immune globulin intravenous (IGIV) products, including BIVIGAM®. Risk factors may include: advanced age, prolonged immobilization, hypercoagulable conditions, a history of venous or arterial thrombosis, the use of estrogens, indwelling vascular catheters, hyperviscosity and cardiovascular risk factors. Renal dysfunction, acute renal failure, osmotic nephrosis, and death may occur with the administration of Immune Globulin Intravenous (Human) (IGIV) products in predisposed patients. Renal dysfunction and acute renal failure occur more commonly in patients receiving IGIV products containing sucrose. BIVIGAM does not contain sucrose. For patients at risk of thrombosis, renal dysfunction, or renal failure, administer BIVIGAM at the minimum dose recommended and infusion rate practicable. Ensure adequate hydration in patients before administrations. Monitor for signs and symptoms of thrombosis and assess blood viscosity in patients at risk for viscosity. See full Prescribing Information for complete boxed warning.
BIVIGAM is contraindicated in patients who have had an anaphylactic or severe systemic reaction to the administration of human immune globulin and in IgA-deficient patients with antibodies to IgA and history of hypersensitivity.
Hyperproteinemia, increased serum viscosity, and hyponatremia or pseudohyponatremia can occur in patients receiving IGIV therapy.
Aseptic meningitis syndrome (AMS) has been reported with IGIV treatments; AMS may occur more frequently in association with high doses (2 g/kg) and/or rapid infusion of IGIV.
As hemolysis can develop subsequent to treatment with IGIV products, monitor patients for hemolysis and hemolytic anemia.
Monitor patients for pulmonary adverse reactions (transfusion-related acute lung injury [TRALI]). If TRALI is suspected, test the product and patient for antineutrophil antibodies.
Because BIVIGAM is made from human blood, it may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
Serious adverse reactions observed in clinical trial subjects receiving BIVIGAM were vomiting and dehydration in one subject. The most common adverse reactions to BIVIGAM (reported in ≥ 5% of clinical study subject) were headache, fatigue, infusion site reaction, nausea, sinusitis, blood pressure increase, diarrhea, dizziness, and lethargy.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
For more information about BIVIGAM® please see full Prescribing Information.