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 0.08mL/kg/min.1
The recommended dosing regimen for PROLASTIN®-C LIQUID is 60 mg/kg body weight by IV infusion administered once weekly.1
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
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
Including anaphylaxis, may occur. Monitor vital signs and observe the patient carefully throughout the infusion. If hypersensitivity symptoms occur, promptly stop PROLASTIN-C LIQID infusion and begin appropriate therapy.
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.
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.
1. PROLASTIN®-C LIQUID (alpha1-proteinase inhibitor [human]) Prescribing Information. Grifols.