PROLASTIN-C Therapy

PROLASTIN-C is a concentrated form of alpha1-antitrypsin (AAT) that is purified from human plasma—the fluid part of your blood.2

When given as prescribed, PROLASTIN-C raises the levels of AAT in your blood and lungs. Because PROLASTIN® "augments" or replaces missing AAT, it is referred to as "augmentation therapy" or "replacement therapy."

It is important to know that PROLASTIN-C is not a cure for Alpha-1. PROLASTIN-C has been demonstrated to raise the plasma level of Alpha1-PI, but the effect of this augmentation on pulmonary exacerbations and on the rate of progression of emphysema has not been demonstrated in adequately powered, randomized, controlled clinical trials for any Alpha1-PI product.

PROLASTIN-C

Since its introduction in 1988, PROLASTIN® has been the leading augmentation therapy in the United States1 for people with Alpha-1.

The infusion time for PROLASTIN-C is approximately 15 minutes when given at the recommended rate. Because PROLASTIN-C is made from human plasma, it may carry a risk of transmitting infectious agents, eg, viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. This also applies to unknown or emerging viruses and other pathogens.

The most common drug-related adverse reaction observed at a rate of >5% in subjects receiving PROLASTIN-C was upper respiratory tract infection. The most serious adverse reaction observed during clinical trials with PROLASTIN-C was an abdominal and extremity rash in 1 subject.

Learn more about the benefits of treating Alpha-1 with PROLASTIN-C.

When you receive PROLASTIN-C, the product is administered intravenously (through a vein with a needle) once a week or as prescribed by your doctor. Find out more about the dosing and administration and where you can receive infusions of PROLASTIN-C.


PROLASTIN DIRECT® PATIENT SERVICES

One-stop PROLASTIN-C enrollment, delivery and support.

Prolastin Direct® Patient Services secures insurance authorization, coordinates infusion services, ships PROLASTIN-C directly to the location of your choice, and connects you to health management coordinators who are experienced Alpha-1 patients themselves. Find out more about Prolastin Direct® Patient Services now.


PROLASTIN®-C (alpha1-proteinase inhibitor [human]) is indicated for chronic augmentation and maintenance therapy in adults with clinical evidence of emphysema due to severe hereditary deficiency of alpha1-PI (alpha1-antitrypsin deficiency).

The effect of augmentation therapy with any alpha1-proteinase inhibitor (alpha1-PI), including PROLASTIN-C, on pulmonary exacerbations and on the progression of emphysema in alpha1-antitrypsin deficiency has not been conclusively demonstrated in randomized, controlled clinical trials. Clinical data demonstrating the long-term effects of chronic augmentation or maintenance therapy with PROLASTIN-C are not available.

PROLASTIN-C is not indicated as therapy for lung disease in patients in whom severe alpha1-PI deficiency has not been established.

PROLASTIN-C is contraindicated in IgA-deficient patients with antibodies against IgA due to the risk of severe hypersensitivity and in patients with a history of anaphylaxis or other severe systemic reactions to alpha1-PI.

Hypersensitivity reactions, including anaphylaxis, may occur. Monitor vital signs and observe the patient carefully throughout the infusion. Should hypersensitivity symptoms be observed, promptly stop infusion and begin appropriate therapy. Have epinephrine and other appropriate therapy available for the treatment of any acute anaphylactic or anaphylactoid reaction.

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.

The most common drug-related adverse reaction observed at a rate of >5% in subjects receiving PROLASTIN-C was upper respiratory tract infection. The most serious adverse reaction observed during clinical trials with PROLASTIN-C was an abdominal and extremity rash in 1 subject.

Because PROLASTIN-C is made from human plasma, it may carry a risk of transmitting infectious agents, eg, viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. This also applies to unknown or emerging viruses and other pathogens.

Please click here for full Prescribing Information for PROLASTIN-C.


References

  1. MRB, US Plasma Fractions Market, January 1-December 31, 2007, page 161. July, 2008.
  2. PROLASTIN-C [package insert]. Grifols
  3. American Thoracic Society/European Respiratory Society. American Thoracic Society/European Respiratory Society statement: standards for the diagnosis and management of individuals with alpha-1 antitrypsin deficiency. Am J Respir Crit Care Med. 2003;168(7):818-900.
  4. Wewers MD, Casolaro MA, Sellers SE, et al. Replacement therapy for alpha1-antitrypsin deficiency associated with emphysema. N Engl J Med. 1987;316(17):1055-1062.