Prolastin-c
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Uses
PROLASTIN-C is an Alpha1-Proteinase Inhibitor (Human) indicated for chronic augmentation and maintenance therapy in adults with clinically evident emphysema due to severe deficiency of alpha1-proteinase inhibitor (Alpha1-PI; the deficiency condition is also known as alpha1-antitrypsin deficiency and AAT deficiency).
PROLASTIN-C increases antigenic and functional (anti-neutrophil elastase capacity, ANEC) serum levels and antigenic lung epithelial lining fluid levels of Alpha1-PI.
- The effect of augmentation therapy with any Alpha1-PI, including PROLASTIN-C, 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 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.
History
There is currently no drug history available for this drug.
Other Information
PROLASTIN-C is a sterile, white to beige-colored, lyophilized powder of Alpha1-PI. PROLASTIN-C is produced from pooled human plasma through modifications of the PROLASTIN process using purification by polyethylene glycol (PEG) precipitation, anion exchange chromatography, and cation exchange chromatography. The PROLASTIN-C process results in improved product purity and a higher concentration of the same active substance, Alpha1-PI, in the reconstituted product.(1,2)
The specific activity of PROLASTIN-C is ≥ 0.7 mg functional Alpha1-PI per mg of total protein. PROLASTIN-C has a purity of ≥ 90% Alpha1-PI (Alpha1-PI protein/total protein). Each vial contains approximately 1,000 mg of functionally active Alpha1-PI as determined by capacity to neutralize porcine pancreatic elastase. When reconstituted with 20 mL of Sterile Water for Injection, USP, PROLASTIN-C has a pH of 6.6–7.4, a sodium content of 100–210 mM, a chloride content of 60–180 mM and a sodium phosphate content of 13–25 mM.
PROLASTIN-C contains no preservative and must be administered by the intravenous route.
All Source Plasma used in the manufacture of PROLASTIN-C is non-reactive (negative) by FDA-licensed serological test methods for hepatitis B surface antigen (HBsAg) and antibodies to hepatitis C virus (HCV) and human immunodeficiency virus types 1 and 2 and negative by FDA-licensed Nucleic Acid Technologies (NAT) for HCV and human immunodeficiency virus type 1 (HIV-1). In addition, all Source Plasma is negative for hepatitis B virus (HBV) by either an FDA-licensed or investigational NAT assay. The goal of the investigational HBV NAT test is to detect low levels of viral nucleic acid; however, the significance of a negative result for the investigational HBV NAT test has not been established. By in-process NAT, all Source Plasma is negative for hepatitis A virus (HAV). As a final plasma safety step, all plasma manufacturing pools are tested by serological test methods and NAT.
To evaluate further the virus safety profile of PROLASTIN-C, in vitro studies have been conducted to validate the capacity of the manufacturing process to reduce the infectious titer of a wide range of viruses with diverse physicochemical properties. These studies evaluated the inactivation/removal of clinically relevant viruses, including human immunodeficiency virus type 1 (HIV-1) and hepatitis A virus (HAV), as well as the following model viruses: bovine viral diarrhea virus (BVDV), a surrogate for hepatitis C virus; pseudorabies virus (PRV), a surrogate for large enveloped DNA viruses (e.g., herpes viruses); vesicular stomatitis virus (VSV), a model for enveloped viruses; reovirus type 3 (Reo3), a non-specific model for non-enveloped viruses; and porcine parvovirus (PPV), a model for human parvovirus B19.
The PROLASTIN-C manufacturing process has several steps (Cold Ethanol Fractionation, PEG Precipitation, and Depth Filtration) that are important for purifying Alpha1-PI as well as removing potential virus contaminants.(3) Two additional steps, Solvent/Detergent Treatment and 15 nm Virus Removal Nanofiltration, are included in the process as dedicated pathogen reduction steps. The Solvent/Detergent Treatment step effectively inactivates enveloped viruses (such as HIV-1, VSV, HBV, and HCV).(4) The 15 nm Virus Removal Nanofiltration step has been implemented to reduce the risk of transmission of enveloped and non-enveloped viruses as small as 18 nm. The table below presents the virus reduction capacity of each process step and the accumulated virus reduction for the process as determined in viral validation studies in which virus was deliberately added to a process model in order to study virus reduction. In addition, the Solvent/Detergent Treatment step inactivates ≥ 5.4 log10 of West Nile virus, a clinically relevant enveloped virus. Studies have demonstrated that each step provides robust virus reduction across the production range for key operating parameters.
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| Process Step | Enveloped Viruses | Non-enveloped Viruses | |||||
| HIV-1 | BVDV | PRV | VSV | Reo3 | HAV | PPV | |
| Cold Ethanol Fractionation | 1.5 | 1.7 | 2.5 | ND* | ≥ 2.1 | 1.4 | 1.0 |
| PEG Precipitation | 4.3 | 2.8 | 3.3 | ND | 3.3 | 3.0 | 3.2 |
| Depth Filtration | ≥ 4.7 | 4.0 | ≥ 4.8 | ND | ≥ 4.0 | ≥ 2.8 | ≥ 4.4 |
| Solvent/Detergent Treatment | ≥ 6.2 | ≥ 4.6 | ≥ 4.3 | 5.1 | NA† | NA | NA |
| 15 nm Virus Removal Nanofiltration | ≥ 6.9 | ≥ 4.7 | ≥ 5.2 | ≥ 5.1 | ≥ 4.3 | ≥ 5.5 | 4.2 |
| Accumulated Virus Reduction | ≥ 23.6 | ≥ 17.8 | ≥ 20.1 | ≥ 10.2 | ≥ 13.7 | ≥ 12.7 | ≥ 12.8 |
Additionally, the manufacturing process was investigated for its capacity to decrease the infectivity of an experimental agent of transmissible spongiform encephalopathy (TSE), considered as a model for the variant Creutzfeldt-Jakob disease (vCJD) and Creutzfeldt-Jakob disease (CJD) agents. Studies of the PROLASTIN-C manufacturing process demonstrate that a minimum of 6 log10 reduction of TSE infectivity is achieved. These studies provide reasonable assurance that low levels of vCJD/CJD agent infectivity, if present in the starting material, would be removed.
Sources
Prolastin-c Manufacturers
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Grifols Usa, Llc
![Prolastin-c (Alpha-1-proteinase Inhibitor Human) Kit [Grifols Usa, Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Prolastin-c | Grifols Usa, Llc
For intravenous use only.
2.1 Dose The recommended dose of PROLASTIN-C is 60 mg/kg body weight administered intravenously once weekly. Dose ranging studies using efficacy endpoints have not been performed with any alpha1-proteinase inhibitor product. The label on each vial of PROLASTIN-C shows the amount of functionally active Alpha1-PI in milligrams (as determined by the capacity to neutralize porcine pancreatic elastase). 2.2 Reconstitution Allow unopened PROLASTIN-C and diluent vials to warm up to room temperature before reconstitution. Remove the plastic flip tops from each vial. Swab the exposed stopper surfaces with alcohol and allow to dry. Remove the plastic cover from the short end of the transfer needle. Insert the exposed end of the needle through the center of the stopper in the diluent vial. Remove the cover at the other end of the transfer needle by twisting it carefully. Invert the diluent vial and insert the attached needle into the PROLASTIN-C vial at a 45° angle (Figure A below). This will direct the stream of diluent against the wall of the product vial and minimize foaming. The vacuum will draw the diluent into the PROLASTIN-C vial. Remove the diluent vial and transfer needle. Immediately after adding the diluent, swirl vigorously for 10-15 seconds to thoroughly break up cake, then swirl continuously until the powder is completely dissolved (Figure B below). Some foaming will occur, but does not affect the quality of the product. Inspect the reconstituted PROLASTIN-C visually for particulate matter and discoloration prior to pooling. A few small particles may remain after reconstitution. If particles are visible, remove by passage through a sterile filter, such as a 15 micron filter used for administering blood products (not supplied). Pool reconstituted PROLASTIN-C from several vials into an empty, sterile intravenous solution container using aseptic technique. Use the sterile filter needle provided for this purpose. Keep reconstituted solution at room temperature for administration within three hours. 2.3 AdministrationVisually inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit.
Infuse PROLASTIN-C intravenously at 0.08 mL/kg/min as determined by patient response and comfort. The recommended dosage of 60 mg/kg takes approximately 15 minutes to infuse.
Infuse PROLASTIN-C separately, without mixing with other agents or diluting solutions.
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