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Augmentation therapy consists of weekly intravenous (IV) infusions of alpha1-antitrypsin (AAT) derived from human plasma. It is used to increase the concentration of the protein in the blood and lungs. Augmentation therapy is the only FDA-approved treatment for AAT deficiency. Long-term controlled clinical trials have not been done to show that augmentation therapy alters the course of lung disease; however, it is currently the standard of care for lung-affected patients under certain circumstances. You should discuss any questions you have about augmentation therapy with your doctor.
Clinical Criteria for Use
Currently, augmentation therapy can only be prescribed for patients with Alpha-1 related emphysema and certain other rare manifestations of Alpha-1. This is not a treatment option for Alpha-1 liver disease. Augmentation therapy cannot be recommended for individuals with normal lung function. It should be reserved for those patients with phenotypes PiZZ, PiZ(null), or Pi(null)(null), and/or patients who have AAT serum levels of less than 11 micromoles (µM). It is not generally given to people who have mildly deficient phenotypes.
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Augmentation can be administered in a doctor's office, hospital clinic, or in a facility where intravenous infusions are routinely given. Additionally, many companies offer home infusion services. You must check with your individual insurance carrier as criteria for services and benefits vary greatly.
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Patients who are motivated and physically able may be taught to administer augmentation therapy. A willing family member or significant other may also be trained and be involved in the process and care. It is imperative for individuals interested in self-infusion to discuss their intention with their physician and develop a plan of care. They must identify a nurse willing to work with them on a consistent basis to complete training on all aspects of therapy. Patient safety with home self-infusion is always a primary goal. |
Safety of augmentation therapy
Augmentation therapy is prepared from pooled human plasma that has been screened for hepatitis A, B, and C and tested for HIV. Additional antiviral procedures are utilized as a precaution against transmission of infectious agents. Since Prolastin® was introduced in 1988, over 2 million doses have been administered with no confirmed reports of viral transmission.
Known side effects
There are relatively few side effects that have been reported: headaches, muscle and joint pain, and lower-back pain are the most frequent complaints. For patients with severe chronic obstructive pulmonary disorder (COPD) or heart failure, worsening of shortness of breath may occur.
Your doctor will probably test you for IgA deficiency prior to starting augmentation therapy because if you have both AAT and IgA deficiency, you could develop a severe allergic reaction (anaphylaxis) to the Alpha-1 augmentation therapy.
Important Safety Information
Prolastin®, Alpha1-Proteinase Inhibitor (Human) is indicated for chronic replacement therapy of individuals having congenital deficiency of alpha-1 PI (alpha1-antitrypsin deficiency) with clinically demonstrable panacinar emphysema. Weekly Prolastin® therapy has demonstrated a low occurrence of side effects. In clinical studies with Prolastin®, reactions were observed in 1.16% of infusions, the most common events being fever (0.77%), light-headedness (0.19%), and dizziness (0.19%). As with all plasma-derived therapeutics, the potential to transmit infectious agents cannot be totally eliminated. Individuals with selective IgA deficiencies who have known antibody against IgA (anti-IgA antibody) should not receive Prolastin®, since these patients may experience severe reactions, including anaphylaxis, to IgA which may be present.
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.
Please click here for Prolastin® full Prescribing Information.
Remember, your doctor or healthcare provider is the single best source of information regarding you and your health. Please consult your doctor or healthcare provider if you have any questions about your health or any of your medications.
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