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How to administer PROLASTIN-C LIQUID

The recommended dosage of 60 mg/kg takes approximately 15 minutes to infuse on average when given at the recommended rate of 0.08 mL/kg/min.1

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Dosing regimen

The recommended dosing regimen for PROLASTIN®-C LIQUID is 60 mg/kg body weight by IV infusion administered once weekly.1

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Rate of administration

PROLASTIN-C LIQUID should be given intravenously at a rate 0.08 mL/kg/min as determined by the response and comfort of the patient.1

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Storage

PROLASTIN-C LIQUID is shipped in refrigerated packs. These packs should be stored refrigerated at 36-46°F (2-8°C) for the period indicated by the expiration date on its label.1

PROLASTIN-C LIQUID may be stored at room temperature not exceeding 77°F (25°C) for up to one month, after which the product must be used or immediately discarded. Do not freeze.1

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Dosing Calculator

Use the Dosing Calculator below to determine which dosing regimen is best suited for each of your patients.

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Enroll patients in the PROLASTIN DIRECT® program

PROLASTIN-C LIQUID is available only through the PROLASTIN DIRECT program. To order, call 1-800-305-7881.

ENROLL PATIENTS

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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 www.fda.gov/medwatch or call 1-800-FDA-1088.

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Reference:

1. PROLASTIN®-C LIQUID (alpha1-proteinase inhibitor [human]) Prescribing Information. Grifols.