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Prolastin

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Prolastin

Prolastin®
(Alpha1-Proteinase Inhibitor [Human])

DRUG DESCRIPTION

Alpha1-Proteinase Inhibitor (Human), Prolastin (alpha) is a sterile, stable, lyophilized preparation of purified human Alpha1-Proteinase Inhibitor (alpha1-PI), also known as alpha1-antitrypsin. Prolastin (alpha) is intended for use in therapy of congenital alpha1-antitrypsin deficiency.

Prolastin (alpha) is prepared from pooled human plasma of normal donors by modification and refinements of the cold ethanol method of Cohn.1 Part of the fractionation may be performed by another licensed manufacturer. In order to reduce the potential risk of transmission of infectious agents, Prolastin (alpha) has been heat-treated in solution at 60±0.5°C for not less than 10 hours. However, no procedure has been found to be totally effective in removing viral infectivity from plasma fractionation products. In vitro studies designed to evaluate the capacity of the Prolastin (alpha) manufacturing process to remove/inactivate viruses have been conducted to provide additional assurance of the viral safety profile as shown in the table below.

Process Step Log10 Virus Reduction
HIV-1* BVDV** PRV*** Reo† HAV† † PPV‡
Fractionation of Effluent I to II+III 3.4 3.5 3.9 2.1 1.4 1.0
PEG Precipitation 4.4 3.2 3.4 3.4 3.1 3.3
Depth Filtration ≥ 4.7 4.1 ≥ 4.7 ≥ 4.0 ≥ 2.8 ≥ 4.3
Pasteurization ≥ 6.3 4.8 ≥ 4.8 N/A N/A N/A
Accumulated Log10 Reduction ≥ 18.8 15.6 ≥ 16.8 ≥ 9.5 ≥ 7.3 ≥ 8.6
*Human immunodeficiency virus, type 1
**Bovine viral diarrhea virus (BVDV) was chosen to model hepatitis C virus
***Pseudorabies virus (PRV) was used as a surrogate for hepatitis B virus and the human herpes viruses
† Reovirus type 3 (Reo) was chosen to model non-enveloped viruses
† † Human hepatitis A virus (HAV).
‡Porcine parvovirus (PPV) was selected as a surrogate for human parvovirus B19

The specific activity of Prolastin is ≥ 0.35 mg functional alpha1-PI/mg protein and when reconstituted as directed, the concentration of alpha1-PI is ≥ 20 mg/mL. When reconstituted, Prolastin (alpha) has a pH of 6.6–7.4, a sodium content of 100–210 mEq/L, a chloride content of 60–180 mEq/L, a sodium phosphate content of 0.015–0.025 M, a polyethylene glycol content of not more than (NMT) 5 ppm, and NMT 0.1% sucrose. Prolastin (alpha) contains small amounts of other plasma proteins including alpha2-plasmin inhibitor, alpha1- antichymotrypsin, C1-esterase inhibitor, haptoglobin, antithrombinIII, alpha1-lipoprotein, albumin, and IgA.1 Each vial of Prolastin (alpha) contains the labeled amount of functionally active alpha1-PI in milligrams per vial (mg/vial), as determined by capacity to neutralize porcine pancreatic elastase.1 Prolastin (alpha) contains no preservative and must be administered by the intravenous route.

What are the possible side effects of alpha 1-proteinase inhibitor?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing, difficulty breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Stop using alpha 1-proteinase inhibitor and call your doctor at once if you have a serious side effect such as:

  • fever, chills, body aches, flu symptoms, sores in your mouth and throat;
  • pain or burning when you urinate;
  • wheezing, chest pain or tightness, trouble breathing; or
  • vision changes.

Less serious side effects may...

Read All Potential Side Effects and See Pictures of Prolastin »

What are the precautions when taking alpha (Prolastin)?

Before using alpha-1-proteinase inhibitor, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: selective IgA deficiency with antibodies to IgA, liver disease, heart problems (such as heart failure).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Since this medication is made from human blood, there is a very small chance that you may get...

Read All Potential Precautions of Prolastin »

REFERENCES

What are the possible side effects of alpha 1-proteinase inhibitor?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing, difficulty breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Stop using alpha 1-proteinase inhibitor and call your doctor at once if you have a serious side effect such as:

  • fever, chills, body aches, flu symptoms, sores in your mouth and throat;
  • pain or burning when you urinate;
  • wheezing, chest pain or tightness, trouble breathing; or
  • vision changes.

Less serious side effects may...

Read All Potential Side Effects and See Pictures of Prolastin »

What are the precautions when taking alpha (Prolastin)?

Before using alpha-1-proteinase inhibitor, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: selective IgA deficiency with antibodies to IgA, liver disease, heart problems (such as heart failure).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Since this medication is made from human blood, there is a very small chance that you may get...

Read All Potential Precautions of Prolastin »

1.Coan MH, Brockway WJ, Eguizabal H, et al: Preparation and properties of alpha1-proteinase inhibitor concentrate from human plasma. Vox Sang 48(6):333-42, 1985.

What are the possible side effects of alpha 1-proteinase inhibitor?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing, difficulty breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Stop using alpha 1-proteinase inhibitor and call your doctor at once if you have a serious side effect such as:

  • fever, chills, body aches, flu symptoms, sores in your mouth and throat;
  • pain or burning when you urinate;
  • wheezing, chest pain or tightness, trouble breathing; or
  • vision changes.

Less serious side effects may...

Read All Potential Side Effects and See Pictures of Prolastin »

What are the precautions when taking alpha (Prolastin)?

Before using alpha-1-proteinase inhibitor, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: selective IgA deficiency with antibodies to IgA, liver disease, heart problems (such as heart failure).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Since this medication is made from human blood, there is a very small chance that you may get...

Read All Potential Precautions of Prolastin »

Last reviewed on RxList: 10/6/2008
This monograph has been modified to include the generic and brand name in many instances.

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Prolastin - User Reviews

Prolastin User Reviews

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