Alpha-1-Proteinase Inhibitor (Human) (Prolastin-C)

Trade Name : PROLASTIN-C

GRIFOLS USA, LLC

KIT, PLASMA DERIVATIVE

Strength
In Stock

Storage/Handling:

Store Prolastin-C Liquid in your refrigerator at 2°C -8°C.


Uses of Alpha-1-Proteinase Inhibitor (Human) (Prolastin-C):

Used to treat alpha-1 antitrypsin deficiency (AAT deficiency)


Product Introduction:

Alpha-1-Proteinase Inhibitor (Human) (Prolastin-C) is a medication used to treat alpha-1 antitrypsin deficiency (AATD), a genetic condition that can lead to serious lung damage.

AATD occurs when someone inherits a faulty gene that prevents them from producing enough alpha-1 antitrypsin (AAT), a protein that protects the lungs from harmful enzymes. This lack of AAT can lead to early-onset emphysema, a chronic lung disease characterized by damaged air sacs, making it difficult to breathe.

Prolastin-C is a purified form of AAT extracted from human plasma. It acts as a replacement for the missing AAT in people with AATD. By providing additional AAT, Prolastin-C can help protect the lungs from the harmful enzymes and slow down the progression of emphysema.

Prolastin-C is primarily used for adults with severe AATD who have already developed lung damage due to emphysema. It's not a cure for AATD, but it can help manage symptoms and improve quality of life.

Prolastin-C is administered intravenously (through a vein) once a week. The exact dosage is determined by the doctor based on the patient's individual needs and response to treatment.


Delivery Process

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Confirmation and Payment

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Submit a Request

You can fill in a request for your medicine through the form provided. You can access the form by clicking on the ‘Get Price’ button.

Side Effects of Alpha-1-Proteinase Inhibitor (Human) (Prolastin-C):

Common side effects of alpha 1-proteinase inhibitor may include:

cold symptoms such as runny or stuffy nose, sneezing, cough, sore throat
headache
muscle or joint pain
weakness
flushing (sudden warmth, redness, or tingly feeling)
nausea or
bruising or bleeding where the medicine was injected

Alpha 1-proteinase inhibitor may cause serious side effects. Stop using alpha 1-proteinase inhibitor and call your doctor at once if you have:
wheezing, chest pain, trouble breathing
dizziness, severe headache
a seizure or
sudden numbness or weakness, slurred speech, problems with vision or balance.

You may feel faint during the injection. You may need to rest for a short time afterward.


Drug Interactions:

When taking Alpha-1-Proteinase Inhibitor (Human) (Prolastin-C), it's essential to be aware of potential drug interactions that can affect its effectiveness or increase the risk of side effects.

Always inform your doctor about all medications you are taking, including over-the-counter drugs and herbal supplements, before starting Prolastin-C treatment. This allows them to assess potential interactions and adjust your treatment plan accordingly.


How Alpha-1-Proteinase Inhibitor (Human) (Prolastin-C) Works:

Alpha-1-Proteinase Inhibitor (Human), known as Prolastin-C, operates as a treatment for alpha-1 antitrypsin deficiency (AATD). In individuals with AATD, there is a deficiency or malfunction of the protective protein alpha-1-proteinase inhibitor (A1PI), leading to an imbalance of enzymes called proteases that can damage lung tissue. Prolastin-C, administered intravenously, serves as a replacement therapy by providing purified A1PI derived from human plasma. This supplementation restores the balance of proteases, protecting lung tissue from degradation and slowing the progression of lung disease associated with AATD.

Prolastin-C therapy is designed to preserve lung function and improve respiratory health in affected individuals, offering a targeted approach to address the underlying cause of the genetic disorder.


Safety Instructions For Alpha-1-Proteinase Inhibitor (Human) (Prolastin-C):

Alcohol svgALCOHOL (Avoid)Limit or avoid alcohol consumption. Alcohol can increase the risk of side effects like dizziness and bleeding. Discuss your intake with your doctor and follow their recommendations. Pregnancy svgPREGNANCY (unsafe) Do not use Prolastin-C during pregnancy. The potential risks to the developing fetus outweigh any possible benefits. Explore alternative AAT augmentation methods with your doctor if needed. BREAST FEEDINGBREAST FEEDING (unsafe)Stop breastfeeding while taking Prolastin-C. The medication can pass through breast milk and harm your baby. Discuss safer feeding options with your doctor. Driving svgDRIVING (caution) Refrain from driving or operating machinery after receiving Prolastin-C. Dizziness and other side effects can impair your judgment and coordination.
LIVER svgLIVER (cautious) Inform your doctor of any pre-existing liver conditions. Prolastin-C can affect liver function, and your doctor may need to adjust the dosage or monitor you closely. KIDNEY svgKIDNEY (cautious) Disclose any kidney problems to your doctor. Similar to the liver, kidneys can be impacted by Prolastin-C, requiring dosage adjustments or close monitoring. Children svgChildren (not recommended) Prolastin-C is not approved for use in children. Its safety and effectiveness haven't been established in this age group.


Habit Forming:

No


Remember:

1. Prolastin-C is a purified form of human A1PI derived from plasma. Administered intravenously, it acts as replacement therapy, supplementing deficient or malfunctioning A1PI.
Prolastin-C is not a cure for AAT deficiency, but it can manage the condition and prevent further lung damage.
While primarily focused on lung protection, Prolastin-C therapy may offer benefits for liver health in individuals with AATD-related liver disease.
It's a lifelong treatment requiring regular injections.
It only works for AAT deficiency and not other lung diseases.


FAQs:

1. Are there potential side effects of Alpha-1-Proteinase Inhibitor therapy?

Like any medication, Alpha-1-Proteinase Inhibitor may have potential side effects. Common side effects include injection site reactions, fever, and respiratory tract infections. Serious allergic reactions are rare but possible.

2. Does Alpha-1-Proteinase Inhibitor therapy address liver complications?

While the primary focus is on lung protection, Alpha-1-Proteinase Inhibitor therapy may offer benefits for individuals with AATD-related liver disease. However, its effectiveness in treating liver complications varies.

3. Can Alpha-1-Proteinase Inhibitor be used during pregnancy?

Pregnant individuals or those planning to become pregnant should consult their healthcare provider before starting or continuing Alpha-1-Proteinase Inhibitor therapy, as its safety during pregnancy is not well-established.

4. Is Alpha-1-Proteinase Inhibitor therapy a cure for AATD?

Alpha-1-Proteinase Inhibitor therapy is not a cure for AATD but aims to manage and slow the progression of lung disease associated with the condition, preserving lung function.

5. How often should individuals undergo monitoring during Alpha-1-Proteinase Inhibitor therapy?

Regular monitoring, including lung function tests and medical check-ups, is essential during Alpha-1-Proteinase Inhibitor therapy to assess its effectiveness and make any necessary adjustments.

Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Alpha-1-Proteinase Inhibitor (Human) (Prolastin-C) which is also known as PROLASTIN-C and Manufactured by GRIFOLS USA, LLC. It is available in strength of per ml. Read more

Alpha-1-Proteinase Inhibitor (Human) (Prolastin-C) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • PROLASTIN-C is an Alpha-Proteinase Inhibitor (Human) (Alpha-PI) indicated for chronic augmentation and maintenance therapy in adults with clinical evidence of emphysema due to severe hereditary deficiency of Alpha-PI (alpha-antitrypsin deficiency).
  • PROLASTIN-C increases antigenic and functional (anti-neutrophil elastase capacity, ANEC) serum levels and antigenic lung epithelial lining fluid levels of Alpha-PI.
  • Limitations of Use
  • PROLASTIN-C is an Alpha-Proteinase Inhibitor (Human) (Alpha-PI) indicated for chronic augmentation and maintenance therapy in adults with clinical evidence of emphysema due to severe hereditary deficiency of Alpha-PI (alpha-antitrypsin deficiency). u00a0
  • PROLASTIN-C increases antigenic and functional (anti-neutrophil elastase capacity, ANEC) serum levels and antigenic lung epithelial lining fluid levels of Alpha-PI.
  • Limitations of Use:
  • The effect of augmentation therapy with any Alpha-PI, including PROLASTIN-C, on pulmonary exacerbations and on the progression of emphysema in Alpha-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 Alpha-PI deficiency has not been established.
  • Warnings and Precautions, Hypersensitivity Reactions ()u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0 2/2017u00a0u00a0
  • For intravenous use after reconstitution only.
  • For intravenous use after reconstitution only.
  • Dose: 60 mg/kg body weight intravenously once per week.
  • Administration: 0.08 mL/kg/min as determined by patient response and comfort.
  • If small particles are visible after reconstitution, remove them by passage through a sterile filter, such as a 15 micron filter used for administering blood products (not supplied).
  • Dose ranging studies using efficacy endpoints have not been performed with any Alpha-PI product, including PROLASTIN-C. ()
  • PROLASTIN-C is available as a lyophilized powder in a single-use vial of approximately 1,000 mg. Reconstitute with Sterile Water for Injection, USP, provided in a separate 20 mL vial. The actual amount of functionally active Alpha-PI in milligrams is printed on the vial label and carton.
  • For injection: approximately 1,000 mg as lyophilized powder in a single-use vial.
  • Reconstitute with Sterile Water for Injection, USP, provided in a separate 20 mL vial. ()
  • PROLASTIN-C is contraindicated in:
  • Immunoglobulin A (IgA) deficient patients with antibodies against IgA. ()
  • History of anaphylaxis or other severe systemic reaction to Alpha-PI.
  • No data
  • Severe hypersensitivity and anaphylactic reactions may occur in IgA deficient patients with antibodies against IgA. u00a0Discontinue administration of the product and initiate appropriate emergency treatment if hypersensitivity reactions occur. n
  • Because PROLASTIN-C is made from human plasma, it may carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent, and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent. n
  • The most serious adverse reaction observed during clinical trials with PROLASTIN-C was an abdominal and extremity rash in one subject. n
  • The most common adverse reaction observed at a rate of > 5% in subjects receiving PROLASTIN-C was upper respiratory tract infection.
  • The most common adverse reaction during clinical trials in > 5% of subjects was upper respiratory tract infection.u00a0n
  • u00a0
  • To report SUSPECTED ADVERSE REACTIONS, contact Grifols Therapeuticsu00a0LLC at 1-800-520-2807 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatchu00a0u00a0n u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0u00a0
  • No data
  • PROLASTIN-C is a sterile, white to beige-colored concentrate of Alpha-PI in lyophilized powder form for reconstitution for intravenous infusion. Each vial contains approximately 1,000 mg of functionally active Alpha-PI as determined by capacity to neutralize porcine pancreatic elastase. u00a0The specific activity of PROLASTIN-C is u2265 0.7 mg functional Alpha-PI per mg of total protein. PROLASTIN-C has a purity of u2265 90% Alpha-PI (Alpha-PI protein/total protein). When reconstituted with 20 mL of Sterile Water for Injection, USP, PROLASTIN-C has a pH of 6.6u20137.4, a sodium content of 100u2013210 mM, a chloride content of 60u2013180 mM and a sodium phosphate content of 13u201325 mM. PROLASTIN-C contains no preservative.
  • 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. 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, 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 Alpha-PI as well as removing potential virus contaminants. 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). 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. 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 u2265 5.4 log of West Nile virus, a clinically relevant enveloped virus.
  • 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 log 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.
  • No data
  • The clinical efficacy of PROLASTIN-C in influencing the course of pulmonary emphysema or pulmonary exacerbations has not been demonstrated in adequately powered, randomized, controlled clinical trials.
  • A total of 23 subjects with the PiZZ variant and documented emphysema were studied in a single-arm, open label clinical trial with PROLASTIN, the predecessor product. Nineteen of the subjects received PROLASTIN, 60 mg/kg, once weekly for up to 26 weeks (average 24 weeks). Blood levels of Alpha-PI were maintained above 11 u00b5M. Bronchoalveolar lavage studies demonstrated statistically significant increased levels of Alpha-PI and functional ANEC in the epithelial lining fluid of the lower respiratory tract of the lung, as compared to levels prior to dosing.
  • A total of 62 individual subjects were studied in 2 clinical trials. In addition to the crossover pharmacokinetic study , a multi-center, open-label single arm safety study was conducted to evaluate the safety and tolerability of PROLASTIN-C. In this study, 38 subjects were treated with weekly intravenous infusions of 60 mg/kg body weight of PROLASTIN-C for 20 weeks. Half the subjects were nau00efve to previous Alpha-PI augmentation prior to study entry and the other half were receiving augmentation with PROLASTIN prior to entering the study. A diagnosis of severe Alpha-PI deficiency was confirmed by the demonstration of the PiZZ genotype in 32 of 38 (84.2%) subjects, and 6 of 38 (15.8%) subjects presented with other alleles known to result in severe Alpha-PI deficiency. These groups were distributed evenly between the nau00efve and non-nau00efve cohorts.
  • No data
  • No data
  • No data
  • NDC n- Arrayn- PROLASTIN Cn n- Solvent detergent treatedn n- Nanofilteredn n- GRIFOLSn n- Rx onlyn- NDC
  • NDCn- Alpha-Proteinase Inhibitor (Humann- PROLASTIN Cn n- Solvent detergent treatedn n- Nanofilteredn n- GRIFOLSn n
  • NDC 13533-200-20n n n n n n n n n n n n Single-Dose Container, Nonpyrogenicn Do not use unless clear. No antimicrobial agent or other substance has been added. Do not use for intravascular injection without making approximately isotonic by addition of suitable solute. Discard unused portion.n Mfd by: , Parets del Vallu00e8s, Barcelona, 08150 SpainMfd for: , Research Triangle Park, NC, 27709 USAn 3048468n Lot / Exp.n

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