What is PROLASTIN-C LIQUID?2

PROLASTIN-C LIQUID is the #1 prescribed augmentation therapy that has been proven to effectively raise alpha1-antitrypsin protein levels in patients with alpha-1. It is a concentrated form of the protein alpha1-antitrypsin that is purified from human plasma, the fluid part of your blood. It involves a life-long, weekly infusion that takes approximately 15 minutes when given at the recommended rate.*

It is important to know that although there is no cure for alpha-1, it can be treated. PROLASTIN-C LIQUID has been demonstrated to raise the plasma level of alpha1-proteinase inhibitor (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.

Reasons you can trust PROLASTIN-C LIQUID

  • The #1 prescribed augmentation therapy trusted by patients with alpha-1 and their doctors for more than 25 years1
  • Offers the convenience of receiving your infusion at home, at work, at an infusion center, and even when you are traveling
  • Automatic enrollment in the PROLASTIN DIRECT® program, which provides you with a team who works exclusively on alpha-1 and is dedicated to your care
  • More than 4 million PROLASTIN-C infusions have been performed around the world1

The most common adverse reactions during PROLASTIN-C LIQUID clinical trials in >5% of subjects were diarrhea and fatigue, each of which occurred in 2 subjects (6%).

 

PROLASTIN-C LIQUID tolerability and safety2

PROLASTIN-C LIQUID has a tolerability and safety profile that is consistent with the PROLASTIN-C powder formulation.

The overall frequency of adverse events was similar between PROLASTIN-C LIQUID and lyophilized PROLASTIN-C, and no adverse events led to treatment withdrawal.

Because PROLASTIN-C LIQUID 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.

PROLASTIN-C LIQUID Patient Brochure

PROLASTIN-C LIQUID shipment and storage icon

PROLASTIN-C LIQUID shipment and storage

  • Every month, Dohmen Life Science Services (Dohmen), the only specialty pharmacy that fills PROLASTIN-C LIQUID prescriptions, will call you to check on supplies and confirm shipment
  • Your PROLASTIN-C LIQUID will ship in refrigerated packs
  • Store refrigerated at 36-46°F (2-8°C) for the period indicated by the expiration date on its label. Product may be stored at room temperatures not exceeding 77°F (25°C) for up to one month, after which the product must be used or immediately discarded. Do not freeze.

PROLASTIN-C LIQUID dosing and administration icon

PROLASTIN-C LIQUID dosing and administration2

  • The recommended dose of PROLASTIN-C LIQUID is 60 mg/kg of body weight infused intravenously once per week
  • You can receive PROLASTIN-C LIQUID at a rate of up to 0.08 milliliters for each kilogram per minute
  • The average infusion takes about 15 minutes when given at the recommended rate of 0.08 mL/kg/min

Starting your PROLASTIN-C LIQUID therapy

You may have questions about starting a new therapy, but it is important to remember that you are not alone.

When you are prescribed PROLASTIN-C LIQUID, your doctor sends in your prescription to Dohmen Life Science Services (Dohmen), the only specialty pharmacy that fills PROLASTIN-C LIQUID prescriptions and manages the PROLASTIN DIRECT program.

At this time, you are automatically enrolled in the PROLASTIN DIRECT program. This program provides you with a team dedicated to your alpha-1 care, and they will be there to support you every step of the way.

Once the PROLASTIN DIRECT team receives your prescription from your doctor, they will call you within 24 hours. When the PROLASTIN DIRECT team calls you, your caller ID may display "Unknown Caller," "Unavailable Caller," or "800-305-7881." Please answer the call, or call back as soon as possible, to take the next step in obtaining your PROLASTIN-C LIQUID.

Making the transition from PROLASTIN-C to PROLASTIN-C LIQUID

To transition to PROLASTIN-C LIQUID, your doctor will need to send in a new prescription. To make it easy for you, call the PROLASTIN DIRECT program. They will handle the entire process by working directly with your doctor's office. The following information will tell you more about the easy transition. Remember, PROLASTIN-C LIQUID is the same medicine you have been receiving in a powder formulation, but is now available in a convenient ready-to-use liquid formulation.2

After transitioning to PROLASTIN-C LIQUID:

  • Mixing is no longer required, making your preparation time shorter. Your infusion volume will stay the same
  • You will still receive the same ongoing, personalized support you have always received from the PROLASTIN DIRECT program
  • You will continue to work with your PROLASTIN DIRECT program Patient Service Coordinator, infusion nurse, and AlphaNet® Coordinator

Learn more about transitioning to PROLASTIN-C LIQUID

Sign up for alpha-1 and PROLASTIN-C LIQUID updates

PROLASTIN-C Liquid trusted by patients with alpha-1 and their doctors icon

PROLASTIN-C LIQUID: The trusted leader for more than 25 years

PROLASTIN-C LIQUID is the #1 prescribed augmentation therapy, trusted by patients with alpha-1 and their doctors for more than 25 years. More than 4 million PROLASTIN-C infusions have been performed around the world.1


IMPORTANT SAFETY INFORMATION

PROLASTIN®-C LIQUID is an alpha1-proteinase inhibitor (human) (alpha1-PI) 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).

Limitations of Use

  • The effect of augmentation therapy with any alpha1-PI, including PROLASTIN-C LIQUID, on pulmonary exacerbations and on the progression of emphysema in alpha1-PI 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 LIQUID are not available
  • PROLASTIN-C LIQUID is not indicated as therapy for lung disease in patients in whom severe alpha1-PI deficiency has not been established

PROLASTIN-C LIQUID is contraindicated in immunoglobulin A (IgA)-deficient patients with antibodies against IgA or patients with a history of anaphylaxis or other severe systemic reaction to alpha1-PI products.

Hypersensitivity reactions, including anaphylaxis, may occur. Monitor vital signs and observe the patient carefully throughout the infusion. If hypersensitivity symptoms occur, promptly stop PROLASTIN-C LIQUID infusion and begin appropriate therapy.

Because PROLASTIN-C LIQUID 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 adverse reactions during PROLASTIN-C LIQUID clinical trials in >5% of subjects were diarrhea and fatigue, each of which occurred in 2 subjects (6%).

Please see full Prescribing Information for PROLASTIN-C LIQUID.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit  http://www.fda.gov/medwatch, or call 1-800-FDA-1088.

 

References: 1. Data on file, Grifols. 2. PROLASTIN®-C LIQUID (alpha1-proteinase inhibitor [human]) Prescribing Information. Grifols.