Alpha-1 proteinase inhibitor

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# Overview
Alpha-1 proteinase inhibitor is an enzyme that is FDA approved for the treatment of patients having congenital deficiency of 1PI with clinically evident emphysema.   Common adverse reactions include chest discomfort, dizziness, headache, cough, sinusitis, upper respiratory infection.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)
- Alpha-1 proteinase inhibitor is indicated for chronic augmentation therapy in patients having congenital deficiency of 1PI with clinically evident emphysema.
- Clinical and biochemical studies have demonstrated that with such therapy, alpha-1 proteinase inhibitor is effective in maintaining target serum 1PI trough levels and increasing 1PI levels in epithelial lining fluid (ELF). Alpha-1 proteinase inhibitor pharmacokinetics are comparable with the pharmacokinetics of alpha-1 proteinase inhibitor after single-dose administration in 25 subjects with congenital deficiency of 1PI. Clinical data demonstrating the longterm effects of chronic augmentation or replacement therapy of individuals with alpha-1 proteinase inhibitor  or alpha-1 proteinase inhibitor are not available.
- The effect of augmentation therapy with alpha-1 proteinase inhibitor on pulmonary exacerbations and on the progression of emphysema in alpha1-antitrypsin deficiency has not been demonstrated in randomized, controlled clinical trials.
- Alpha-1 proteinase inhibitor is not indicated as therapy for lung disease patients in whom congenital 1PI deficiency has not been established.
- Dose ranging studies using efficacy endpoints have not been performed.
- FOR INTRAVENOUS USE ONLY. The recommended dosage of alpha-1 proteinase inhibitor is 60 mg/kg body weight administered once weekly by intravenous infusion. Each vial of alpha-1 proteinase inhibitor  has the functional activity, as determined by inhibition of porcine pancreatic elastase, stated on the label. Administration of alpha-1 proteinase inhibitor within three hours after reconstitution is recommended to avoid the potential ill effect of any inadvertent microbial contamination occurring during reconstitution. Discard any unused contents.
- Alpha-1 proteinase inhibitor should be administered at a rate not exceeding 0.08 mL/kg body weight/minute. If adverse events occur, the rate should be reduced or the infusion interrupted until the symptoms subside. The infusion may then be resumed at a rate tolerated by the subject.

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Alpha-1 proteinase inhibitor in adult patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Alpha-1 proteinase inhibitor in adult patients.

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Alpha-1 proteinase inhibitor FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

## Off-Label Use and Dosage (Pediatric)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Alpha-1 proteinase inhibitor in pediatric patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Alpha-1 proteinase inhibitor in pediatric patients.

# Contraindications
- Alpha-1 proteinase inhibitor is contraindicated in IgA deficient patients with antibodies against IgA, due to the risk of severe hypersensitivity.

# Warnings
- Because alpha-1 proteinase inhibitor is derived from pooled human plasma, it may carry a risk of transmitting infectious agents, e.g., viruses and theoretically, the CreutzfeldtJakob disease (CJD) agent. Stringent procedures designed to reduce the risk of adventitious agent transmission have been employed in the manufacture of this product, from the screening of plasma donors and the collection and testing of plasma through the application of viral elimination/reduction steps such as ethanol fractionation, PEG precipitation, solvent detergent treatment, and nanofiltration. Despite these measures, such products can still potentially transmit disease; therefore, the risk of infectious agents cannot be totally eliminated. ALL infections thought by a physician possibly to have been transmitted by this product should be reported to the manufacturer at 1-800-423-2090 (US). The physician should weigh the risks and benefits of the use of this product and should discuss these with the patient.
- Alpha-1 proteinase inhibitor  may contain trace amounts of IgA. Patients with known antibodies to IgA, which can be present in patients with selective or severe IgA deficiency, have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions. Alpha-1 proteinase inhibitor is contraindicated in patients with antibodies against IgA due to risk of severe hypersensitivity.
- The rate of administration should be closely followed, at least until the physician has had sufficient experience with a given patient. Vital signs should be monitored continuously and the patient should be carefully observed throughout the infusion. IF ANAPHYLACTIC OR SEVERE ANAPHYLACTOID REACTIONS OCCUR, THE INFUSION SHOULD BE DISCONTINUED IMMEDIATELY. Epinephrine and other appropriate supportive therapy should be available for the treatment of any acute anaphylactic or anaphylactoid reaction.

# Adverse Reactions

## Clinical Trials Experience
There is limited information regarding Alpha-1 proteinase inhibitor Clinical Trials Experience in the drug label.

## Postmarketing Experience
- The safety of alpha-1 proteinase inhibitor was evaluated with alpha-1 proteinase inhibitor after a single dose IV infusion in a multicenter, randomized, double-blind, crossover clinical PK comparability study (Study 460501). The number of subjects with one or more adverse events, regardless of causality, was 23 of 25 (92%) when receiving alpha-1 proteinase inhibitor and 19 of 25 (76%) when receiving alpha-1 proteinase inhibitor. Treatment-related adverse events were reported in 8 of 25 subjects (32%) for alpha-1 proteinase inhibitor and 7 of 25 subjects (28%) for alpha-1 proteinase inhibitor. Of a total of 61 adverse events reported for alpha-1 proteinase inhibitor, 43 (70%) were mild, 16 (26%) moderate, and 2 (3%) severe. Seventeen of 61 (28%) adverse events were deemed possibly or probably related to alpha-1 proteinase inhibitor of which 14 (82%) were mild and 3 (18%) were moderate. Of a total of 60 adverse events reported for alpha-1 proteinase inhibitor, 45 (75%) were mild, 12 (20%) moderate, and 3 (5%) severe. Eleven of 60 (18%) adverse events were deemed possibly or probably related to alpha-1 proteinase inhibitor of which 8 (73%) were mild and 3 (27%) were moderate. No serious adverse events or deaths were reported in the study. No clinically significant changes in the peri-infusion vital signs (blood pressure, heart rate, or respiratory rate) were reported. The most common adverse events deemed related to alpha-1 proteinase inhibitor included: headache (4 of 61  events) and musculoskeletal discomfort (4 of 61  events). These adverse events, as well as most of the other adverse events, were also reported in subjects treated with alpha-1 proteinase inhibitor.
- In Clinical Study ATC 97-01, alpha-1 proteinase inhibitor was evaluated for up to 96 weeks in 27 subjects with a congenital deficiency of 1PI and clinically evident emphysema. The number of subjects with an adverse event, regardless of causality, was 22 of 27 (81.5%). The number of subjects with an adverse event deemed possibly, probably, or definitely related to study drug was 7 of 27 (25.9%).
- The frequency of infusions associated with an adverse event, regardless of causality, was 108 of 1127 (9.6%) infusions administered per protocol. The most common symptoms were pharyngitis (1.6%), headache (0.7%), and increased cough (0.6%). Symptoms of bronchitis, sinusitis, pain, rash, back pain, viral infection, peripheral edema, bloating, dizziness, somnolence, asthma, and rhinitis were each associated with 0.2% but < 0.6% of infusions. All symptoms were mild to moderate in severity.
- The overall frequency of adverse events deemed to be possibly, probably, or definitely related to study drug was 15 of 1127 (1.3%) infusions. The most common symptoms included headache (0.3%) and somnolence (0.3%). Symptoms of chills and fever, vasodilation, dizziness, pruritus, rash, abnormal vision, chest pain, increased cough, and dyspnea were each associated with one (0.1%) infusion. Five (5) of 27 (18.5%) subjects experienced eight (8) serious adverse reactions during the study. None of these serious adverse events were considered to be causally related to the administration of alpha-1 proteinase inhibitor.
- Twenty-six (26) of 27 (96.3%) subjects experienced a total of 94 upper and lower respiratory-tract infections during the 96-week study (median: 3.0; range: 1 to 8; mean  SD: 3.6  2.3 infections). Twenty-eight (29.8%) of the respiratory infections occurred in 19 (70.4%) subjects during the first 24 weeks of the 96-week study suggesting that the risk of infection did not change with time on alpha-1 proteinase inhibitor. In a post-hoc analysis, subjects experienced a range of 0 to 8 exacerbations of COPD over the 96-week study with a median of less than one exacerbation per year (median: 0.61; mean  SD: 0.83  0.87 exacerbations per year).
- Treatment-emergent elevations (> two times the upper limit of normal) in aminotransferases (ALT or AST), up to 3.7 times the upper limit of normal, were noted in 3 of 27 (11.1%) subjects. Elevations were transient lasting three months or less. No subject developed any evidence of viral hepatitis or hepatitis seroconversion while being treated with alpha-1 proteinase inhibitor, including 13 evaluable subjects who were not vaccinated against hepatitis B.
- No clinically relevant alterations in blood pressure, heart rate, respiratory rate, or body temperature occurred during infusion of alpha-1 proteinase inhibitor. Mean hematology and laboratory parameters were little changed over the duration of the study, with individual variations not clinically meaningful.
- During the initial 10 weeks of the study, subjects were randomized to receive either alpha-1 proteinase inhibitor or a commercially available preparation of 1-PI (Prolastin). The overall frequency, severity and symptomatology of adverse reactions were similar in both the alpha-1 proteinase inhibitor groups. There were two serious adverse events in the alpha-1 proteinase inhibitor group, both of which were considered to be possibly related to alpha-1 proteinase inhibitor.
- These included chest pain, dyspnea and bilateral pulmonary infiltrates in one individual that withdrew from the study prematurely following an unscheduled bronchoscopy to remove a foreign body and the other, a positive seroconversion to Parvovirus B-19. There were no serious adverse events or seroconversions reported for the alpha-1 proteinase inhibitor group during the 96 week study period. No subject developed an antibody to 1PI.

# Drug Interactions
There is limited information regarding Alpha-1 proteinase inhibitor Drug Interactions in the drug label.

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA): C
Animal reproduction studies have not been conducted with alpha-1 proteinase inhibitor. It is also not known whether alpha-1 proteinase inhibitor can cause fetal harm when administered to pregnant women or can affect reproductive capacity.
Pregnancy Category (AUS): 
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Alpha-1 proteinase inhibitor in women who are pregnant.

### Labor and Delivery
There is no FDA guidance on use of Alpha-1 proteinase inhibitor during labor and delivery.

### Nursing Mothers
It is not known whether alpha1-proteinase inhibitor is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when alpha-1 proteinase inhibitor is administered to a nursing woman.

### Pediatric Use
There is no FDA guidance on the use of Alpha-1 proteinase inhibitor in pediatric settings.

### Geriatic Use
- Clinical studies of alpha-1 proteinase inhibitor NP did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. As for all patients, dosing for geriatric patients should be appropriate to their overall situation. Safety and effectiveness in patients over age 65 years of age have not been established.

### Gender
There is no FDA guidance on the use of Alpha-1 proteinase inhibitor with respect to specific gender populations.

### Race
There is no FDA guidance on the use of Alpha-1 proteinase inhibitor with respect to specific racial populations.

### Renal Impairment
There is no FDA guidance on the use of Alpha-1 proteinase inhibitor in patients with renal impairment.

### Hepatic Impairment
There is no FDA guidance on the use of Alpha-1 proteinase inhibitor in patients with hepatic impairment.

### Females of Reproductive Potential and Males
There is no FDA guidance on the use of Alpha-1 proteinase inhibitor in women of reproductive potentials and males.

### Immunocompromised Patients
There is no FDA guidance one the use of Alpha-1 proteinase inhibitor in patients who are immunocompromised.

# Administration and Monitoring

### Administration
- Oral

### Monitoring
- Vital signs should be monitored continuously and the patient should be carefully observed throughout the infusion.

# IV Compatibility
There is limited information regarding the compatibility of Alpha-1 proteinase inhibitor and IV administrations.

# Overdosage
There is limited information regarding Alpha-1 proteinase inhibitor overdosage.  If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

# Pharmacology

## Mechanism of Action
- Alpha-1 proteinase inhibitor functions in the lungs to inhibit serine proteases such as neutrophil elastase (NE), which is capable of degrading protein components of the alveolar walls and which is chronically present in the lung. In the normal lung, 1PI is thought to provide more than 90% of the antiNE protection in the lower respiratory tract

## Structure
- Alpha-1 proteinase inhibitor NP is a sterile, stable, lyophilized preparation of purified human alpha1proteinase inhibitor (1PI), also known as alpha1antitrypsin.1 alpha-1 proteinase inhibitor NP is a similar product to alpha-1 proteinase inhibitor, containing the same active components of plasma 1-PI with identical formulations.
- Alpha-1 proteinase inhibitor is prepared from large pools of human plasma by using the cold ethanol fractionation process, followed by purification steps including polyethylene glycol and zinc chloride precipitations and ion exchange chromatography. All U.S. licensed 1-PI plasma derived products contain chemical modifications which arise during manufacturing and occur in varying levels from product to product.11 alpha-1 proteinase inhibitor contains approximately 2% 1-PI with truncated C-terminal lysine (removal of Lys394), whereas alpha-1 proteinase inhibitor contains approximately 67% 1-PI with the C-terminal lysine truncation.12 No known data suggest influence of these structural modifications on the functional activity and immunogenicity of 1-PI.13
- To reduce the risk of viral transmission, the manufacturing process includes treatment with a solvent detergent (S/D) mixture  to inactivate enveloped viral agents such as human immunodeficiency virus (HIV), hepatitis B (HBV), and hepatitis C (HCV). In addition, a nanofiltration step is incorporated into the manufacturing process to reduce the risk of transmission of enveloped and nonenveloped viral agents. Based on in vitro studies, the process used to produce alpha-1 proteinase inhibitor  has been shown to inactivate and/or partition various viruses as shown in TABLE 1 below.2

## Pharmacodynamics
- 1PI deficiency is an autosomal, co-dominant, hereditary disorder characterized by low serum and lung levels of 1PI. Severe forms of the deficiency are frequently associated with slowly progressive, moderate-to-severe panacinar emphysema that most often manifests in the third to fourth decades of life, resulting in a significantly lower life expectancy. However, an unknown percentage of individuals with severe 1PI deficiency are not diagnosed with or may never develop clinically evident emphysema during their lifetimes.
- Individuals with 1PI deficiency have little protection against NE released by a chronic, lowlevel of neutrophils in their lower respiratory tract, resulting in a protease:protease inhibitor imbalance in the lung. The emphysema associated with severe 1PI deficiency is typically worse in the lower lung zones. It is believed to develop because there are insufficient amounts of 1PI in the lower respiratory tract to inhibit NE. This imbalance allows relatively unopposed destruction of the connective tissue framework of the lung parenchyma.
- There are a large number of phenotypic variants of this disorder. Individuals with the PiZZ variant typically have serum 1PI levels less than 35% of the average normal level. Individuals with the Pi(null) variant have undetectable 1PI protein in their serum. Individuals with these low serum 1-PI levels, i.e., less than 11 M, have an increased risk of developing emphysema over their lifetimes. In addition, PiSZ individuals, whose serum 1-PI levels range from approximately 9 to 23 14, are considered to have moderately increased risk for developing emphysema, regardless of whether their serum 1-PI levels are above or below 11 . Two Registry studies have shown 54% and 72% of 1-PI deficient individuals had emphysema and pulmonary symptoms such as cough, phlegm, wheeze, breathlessness, and chest colds, respectively.9,10 The risk of accelerated development and progression of emphysema in individuals with severe 1PI deficiency is higher in smokers than in ex-smokers or non-smokers.
- Not all individuals with severe genetic variants of 1-PI deficiency have emphysema. Augmentation therapy with Alpha1-Proteinase Inhibitor (Human) is indicated only in patients with congenital 1-PI deficiency who have clinically evident emphysema.
- Augmenting the levels of functional 1-proteinase inhibitor by intravenous infusion is an approach to therapy for patients with 1-PI deficiency. However, the efficacy of augmentation therapy in affecting the progression of emphysema has not been demonstrated in randomized, controlled clinical trials. The intended theoretical goal is to provide protection to the lower respiratory tract by correcting the imbalance between neutrophil elastase and protease inhibitors. Whether augmentation therapy with alpha-1 proteinase inhibitor actually protects the lower respiratory tract from progressive emphysematous changes has not been evaluated. Although the maintenance of blood serum levels of 1-PI (antigenically measured) above 11 M has been historically postulated to provide therapeutically relevant anti-neutrophil elastase protection, this has not been proven. Individuals with severe 1-PI deficiency have been shown to have increased neutrophil and neutrophil elastase concentrations in lung epithelial lining fluid compared to normal PiMM individuals, and some PiSZ individuals with 1-PI above 11 M have emphysema attributed to 1-PI deficiency. These observations underscore the uncertainty regarding the appropriate therapeutic target serum level of 1-PI during augmentation therapy. The clinical benefit of the increased blood levels of  Alpha1-Proteinase Inhibitor at the recommended dose has not been established.
- The clinical efficacy of alpha-1 proteinase inhibitor in influencing the course of pulmonary emphysema or the frequency, duration, or severity of pulmonary exacerbations has not been demonstrated in randomized, controlled clinical trials.

## Pharmacokinetics
- The pharmacokinetics of alpha-1 proteinase inhibitor were compared with alpha-1 proteinase inhibitor in a multicenter, single-dose, randomized, double-blind, crossover clinical study (Study 460501).
- Twenty-five subjects with congenital 1-PI deficiency received a single intravenous (IV) infusion of 60 mg/kg alpha-1 proteinase inhibitor. The 25 subjects in this study were between 20 and 75 years old, with a median age of 59. Plasma 1-PI concentrations were measured using an enzyme linked immunosorbent assay (ELISA). Figure 1 shows that the mean  standard deviation (SD) plasma 1-PI concentration-time profiles after a single IV infusion of alpha-1 proteinase inhibitor at 60 mg/kg were comparable. TABLE 2 summarizes the pharmacokinetic parameters of alpha-1 proteinase inhibitor NP and alpha-1 proteinase inhibitor. The 90% confidence intervals for Cmax and AUC 0 inf/dose were well within the pre-defined acceptance limits of 80 to 125%.The pharmacokinetics of alpha-1 proteinase inhibitor were compared with alpha-1 proteinase inhibitor in a multicenter, single-dose, randomized, double-blind, crossover clinical study (Study 460501). Twenty-five subjects with congenital 1-PI deficiency received a single intravenous (IV) infusion of 60 mg/kg alpha-1 proteinase inhibitor.
- The 25 subjects in this study were between 20 and 75 years old, with a median age of 59. Plasma 1-PI concentrations were measured using an enzyme linked immunosorbent assay (ELISA).
- Figure 1 shows that the mean  standard deviation (SD) plasma 1-PI concentration-time profiles after a single IV infusion of alpha-1 proteinase inhibitor at 60 mg/kg were comparable. TABLE 2 summarizes the pharmacokinetic parameters of alpha-1 proteinase inhibitor NP and alpha-1 proteinase inhibitor. The 90% confidence intervals for Cmax and AUC 0 inf/dose were well within the pre-defined acceptance limits of 80 to 125%.
- A clinical study (ATC 97-01) was conducted to compare alpha-1 proteinase inhibitor to a commercially available preparation of 1PI (alpha-1 proteinase inhibitor, manufactured by Bayer Corporation). All subjects were to have been diagnosed as having congenital 1PI deficiency and emphysema but no 1PI augmentation therapy within the preceding six months.
- Twenty-eight subjects were randomized to receive either alpha-1 proteinase inhibitor, 60 mg/kg intravenously per week, for 10 consecutive weeks. Two subjects withdrew from the study prematurely: 1 subject receiving alpha-1 proteinase inhibitor withdrew consent after 6 infusions; 1 subject receiving alpha-1 proteinase inhibitor withdrew after 1 infusion due to pneumonia following unscheduled bronchoscopy to remove a foreign body. Trough levels of 1PI (antigenic determination) and antiNE capacity (functional determination) were measured prior to treatment at Weeks 8 through 11. Following their first 10 weekly infusions, the subjects who were receiving alpha-1 proteinase inhibitor were switched to alpha-1 proteinase inhibitor while those who already were receiving alpha-1 proteinase inhibitor continued to receive it. Maintenance of mean serum 1PI trough levels was assessed prior to treatments at Weeks 12 through 24.
- Bronchoalveolar lavages (BALs) were performed on subjects at baseline and prior to treatment at Week 7. The epithelial lining fluid (ELF) from each BAL meeting acceptance criteria was analyzed for the 1PI level and antiNE capacity.
- With weekly augmentation therapy with alpha-1 proteinase inhibitor, a gradual increase in peak and trough serum 1PI levels was noted, with stabilization after several weeks.
- The metabolic halflife of alpha-1 proteinase inhibitor was 5.9 days. Serum antiNE capacity trough levels rose substantially in all subjects by Week 2, and by Week 3, serum antiNE capacity trough levels exceeded 11 M in the majority of subjects. With few exceptions, levels remained above this recommended threshold level in individual subjects for the duration of the period Weeks 3 through 24 on study. Although only five of fourteen subjects (35.7%) receiving alpha-1 proteinase inhibitor had BALs meeting acceptance criteria for analysis at both baseline and Week 7, a statistically significant increase in the antigenic level of 1PI in the ELF was observed. No statistically significant increase in the anti-NE capacity in the ELF was detected.
- Viral serology of all subjects was determined periodically throughout the study, including testing for antibodies to hepatitis A (HAV) and C (HCV), presence of circulating HBsAg, and presence of antibodies to HIV1, HIV2, and Parvovirus B19.
- Subjects who were seronegative to parvovirus B19 at enrollment were retested by PCR at Week 2. There were no seroconversions in subjects treated with alpha-1 proteinase inhibitor through Week 24. None of the subjects became HBsAg positive during the study, although five of 13 (38%) evaluable subjects treated with alpha-1 proteinase inhibitor and eight of 13 (62%) treated with Prolastin had not been vaccinated to hepatitis B. No patient developed antibodies against 1PI.
- It was concluded that at a dose of 60 mg/kg administered intravenously once weekly, alpha-1 proteinase inhibitor and Prolastin had similar effects in maintaining target serum 1PI trough levels and increasing antigenic levels of 1PI in epithelial lining fluid (ELF) with maintenance augmentation therapy.

## Nonclinical Toxicology
There is limited information regarding Alpha-1 proteinase inhibitor Nonclinical Toxicology in the drug label.

# Clinical Studies
There is limited information regarding Alpha-1 proteinase inhibitor Clinical Studies in the drug label.

# How Supplied
- Alpha-1 proteinase inhibitor is supplied as a sterile, non-pyrogenic, lyophilized powder in singledose vials. The following product packages are available: 0.5 g (NDC 0944-2802-01) and 1 g (NDC 0944-2802-02). A suitable volume of Sterile Water for Injection, USP diluent is provided (25 mL/0.5 g vial; 50 mL/1 g vial). Each vial is labeled with the total 1PI functional activity in mg. Alpha-1 proteinase inhibitor is packaged with a sterile doubleended transfer needle and a sterile 20-micron filter.

## Storage
- Alpha-1 proteinase inhibitor should be stored at temperatures not to exceed 25C (77F). Do not freeze. Do not use after the expiration date printed on the label.

# Images

## Drug Images

## Package and Label Display Panel

# Patient Counseling Information
There is limited information regarding Alpha-1 proteinase inhibitor Patient Counseling Information in the drug label.

# Precautions with Alcohol
Alcohol-Alpha-1 proteinase inhibitor interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

# Brand Names
- ARALAST NP

# Look-Alike Drug Names
There is limited information regarding Alpha-1 proteinase inhibitor Look-Alike Drug Names in the drug label.

# Drug Shortage Status

# Price