Advanced Search


The leading alpha1 augmentation therapy for 20 years is now improved

  • Shorter Infusion Time: delivers twice the active protein per milliliter as Prolastin, cutting infusion volume and time in half when given at the recommended rate of 0.08 mL/kg/min
  • Higher Purity: delivers ≥ 90% pure Alpha-1 protein allowing it to be more concentrated than Prolastin

Find out more about new PROLASTIN-C

Treatment of Alphas

While there is no cure for Alpha-1, there is a lot you can do to treat and manage it, as well as a rich network of resources in place to support patients and caregivers.

Augmentation therapy

  • Specific treatment with an infusion of purified pooled human plasma alpha1-antitrypsin6
  • Goal of therapy:
  • Elevate levels of alpha1-antitrypsin in plasma and lung interstitium, and correct the deficiency state1,6
  • IV infusion of purified pooled human plasma alpha1-antitrypsin6 results in increased levels of AAT in the lungs1
  • When given at 60 mg/kg body weight once weekly
  • Antineutrophil elastase capacity in lung epithelial lining fluid obtained by bronchoalveolar lavage increased to 60% to 70% of normal in Alpha-1– deficient individuals1
  • AAT serum trough levels remained >11 μM7

Pulmonary rehabilitation

  • Assessment, exercise training, education, nutritional counseling2,3
  • Individualized exercise program
  • Duration of 4 to 12 weeks, 2 to 5 times/week3
  • Percentage of VO2 max
  • High intensity (≥60% VO2 max) best3
  • Low intensity also works3
  • Combined endurance and strength better than either one alone4
  • Supplemental O2 only if needed for SaO23
  • Long-term maintenance: modest benefit5

Drug therapy for lung disorders

  • Bronchodilators
  • Inhaled steroids
  • Antibiotics
  • Oxygen

Vaccinations

  • Influenza/pneumococcal
  • Hepatitis A/B

Surgical procedures

  • Lung transplantation in end-stage lung disease
  • Lung volume reduction surgery

Is it time to start your Alphas on PROLASTIN-C?

next: Lifestyle Management of Alphas >

Important Safety Information

PROLASTIN-C, Alpha1-Proteinase Inhibitor (Human) is indicated for chronic augmentation and maintenance therapy in adults with emphysema due to deficiency of alpha1-proteinase inhibitor (alpha1-antitrypsin deficiency). The effect of augmentation therapy with any alpha1-proteinase inhibitor (alpha1-PI) on pulmonary exacerbations and on the progression of emphysema in alpha1-antitrypsin deficiency has not been demonstrated in randomized, controlled clinical trials. PROLASTIN-C is not indicated as therapy for lung disease in patients in whom severe Alpha1-PI deficiency has not been established.

PROLASTIN-C may contain trace amounts of IgA. Patients with known antibodies to IgA, which can be present in patients with selective or severe IgA deficiency, have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions. PROLASTIN-C is contraindicated in patients with antibodies against IgA.

The most common drug related adverse reactions during clinical trials in ≥ 1% of subjects were chills, malaise, headache, rash, hot flush, and pruritus.

PROLASTIN-C is made from human plasma. Products made from human plasma may carry a risk of transmitting infectious agents, e.g., viruses, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

Please see accompanying PROLASTIN-C Full Prescribing Information for complete prescribing details.

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.

References
  1. American Thoracic Society, European Respiratory Society. Am J Respir Crit Care Med. 2003;168(7):818-900.
  2. Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease. Updated 2007. www.goldcopd.org. Accessed February 18, 2008.
  3. British Thoracic Society. Pulmonary rehabilitation. Thorax. 2001;56(11):827-834.
  4. Ortega F, et al. Comparison of effects of strength and endurance training in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2002;166(5):669-674.
  5. Ries AL, et al. Maintenance after pulmonary rehabilitation in chronic lung disease: a randomized trial Am J Respir Crit Care Med. 2003;167(6):880-888.
  6. Stoller JK, Aboussouan LS. Alpha-1-antitrypsin deficiency. Lancet. 2005;365(9478):2225-2236.
  7. Wewers MD, Casolaro MA, Sellers SE, et al. Replacement therapy for alpha 1-antitrypsin deficiency associated with emphysema. N Engl J Med. 1987;316(17):1055-1062.
  8. Yang P, Sun Z, Krowka MJ, et al. Alpha1-antitrypsin deficiency carriers, tobacco smoke, chronic obstructive pulmonary disease, and lung cancer risk. Arch Intern Med. 2008;168(10):1097-1103.
  9. University of Florida College of Medicine AAT Deficiency Detection Laboratory.
  10. Wise RA. α1-Antitrypsin deficiency. The Merck Manuals Online Medical Library. http://www.merck.com/mmpe/sec05/ch049/ch049b.html#CIHFAGBJ. Accessed July 6, 2008.
  11. PROLASTIN-C [package insert]. Grifols.