PROLASTIN®-C
alpha1-proteinase inhibitor (human)

Your Alpha-1 Partner



Concentrated form of alpha1 antitrypsin (AAT) that raises the levels of AAT in blood and lungs

Indication: 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).

Broad Pathogen Safety Margin:

  • Two dedicated steps with virus clearance capacity:
    • Solvent/Detergent Treatment
    • Nanofiltration
  • Steps important for purifying alpha1-PI as well as removing potential viral contaminants
    • Cold ethanol fractionation; PEG precipitation and depth filtration 
  • FDA-approved labeling for removal of pathogenic prions

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.

Related Information:

  • Unmatched experience in alpha-1
    • The #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
  • Comprehensive, personalized support through the PROLASTIN DIRECT® program
    • Devoted Alpha-1 Care Team
    • Insurance and Reimbursement Specialists
    • Specialty Pharmacy and Infusion Experts
    • Fully Integrated Disease Management program
    • For more information go to www.prolastin.com
  • World-class testing protocol
    • AlphaKitTM test kits are free, easy, and confidential
    • AlphaKit test kits are processed at the Alpha-1 Antitrypsin Genetics Laboratory at GeneAidyx LLC in Florida, which is solely dedicated to testing for alpha-13

References:

  1. Data on file, Grifols
  2. PROLASTIN®-C (alpha1-proteinase inhibitor [human]) Prescribing Information. Grifols.
  3. Data on file, Alpha-1 Antitrypsin Genetics Laboratory at GeneAidyx LLC

 

How Supplied:

Diluent Size Product Description NDC Numbers
20 mL 1 g 13533-700-02 & 13533-703-10

Storage Conditions:

  • Room temperature (25°C / 77°F) for the period indicated by the expiration date on its label
  • Do not freeze

IMPORTANT SAFETY INFORMATION:

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.

Contact Information

Do not use the contact information on this website for medical emergencies. For medical emergencies, dial 911 or contact your healthcare professional.

For Grifols USA Customer Service during regular business hours, 8:30 AM – 5:00 PM Eastern Standard Time, at 1-800-243-4153 and 1-888-325-8579, option 3, during regular business hours, 5:00 PM – 8:00 PM Eastern Standard Time.

For questions about the PROLASTIN DIRECT program, including Customer Service and reimbursement, please call 1-800-305-7881 during business hours, 7:00 AM – 6:00 PM Central Standard Time.

For clinical or technical information or to report an adverse drug event involving a Grifols biological product, please contact Grifols Medical Information at 1-800-520-2807.

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 download full Prescribing Information from the link below.

Prescribing Information

  • 31 Aug, 2017

    Prescribing information Download (308.22 Kb)