The #1-prescribed augmentation therapy EVERY YEAR for over 25 years1*


Why augmentation therapy?

Augmentation therapy is proven to effectively raise alpha-1 antitrypsin (AAT) levels in alpha-1 patients and help keep neutrophil elastase in check1

Treatment of Alpha-1

  • Augmentation therapy is the only treatment specifically approved for adults with emphysema due to deficiency of alpha-1 protein2
  • The intended theoretical goal is to correct the imbalance between neutrophil elastase and AAT2

Why PROLASTIN-C?

#1-prescribed augmentation therapy EVERY YEAR for over 25 years1*

15-minute average infusion time at the recommended rate of 0.08 mL/kg/min2

Effectively raises alpha-1 and antineutrophil elastase activity2

  • PROLASTIN-C therapy raises AAT levels and antineutrophil elastase activity in the lungs. Although the maintenance of blood serum levels of alpha1-PI above 11 μM has been historically postulated to provide therapeutically relevant antineutrophil elastase protection, this has not been proven

A well-established safety profile2

  • The most common drug-related adverse reaction observed at a rate of >5% in subjects receiving PROLASTIN-C was upper respiratory tract infection2

PROLASTIN-C is available only through the PROLASTIN DIRECT ® program

Just 1 number connects you and your patients to fully comprehensive, personalized alpha-1 support: 1-800-305-7881

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. Data on file, Grifols.
  2. PROLASTIN®-C (alpha1-proteinase inhibitor [human]) Prescribing Information. Grifols.