Alpha-1-Proteinase Inhibitor (Human)

What is Alpha-1-Proteinase Inhibitor (Human)?

GLASSIA is an Alpha1-Proteinase Inhibitor (Human) (Alpha1-PI) used to increase the levels of the alpha1-antitrypsin (AAT) protein in your blood and lungs.

What are the uses of this medicine?

• GLASSIA is a liquid medicine containing human Alpha1-Proteinase Inhibitor (Alpha1-PI) also known as alpha1-antitrypsin (AAT), which is purified from human blood.
• The main purpose of infusing GLASSIA is to increase the levels of the AAT protein in your blood and lungs.
• AAT protein protects the lung tissue by blocking certain enzyme-caused damage.
• Such damage can lead to severe lung disease, such as emphysema.

Limitation of Use:

• The effects of increasing the AAT protein levels with GLASSIA or any other Alpha1-PI product on worsening pulmonary function and progression of emphysema have not been proven in clinical trials.
• The long-term effects of AAT replacement and maintenance therapy with GLASSIA have not been studied.
• GLASSIA is not intended as a therapy in individuals with lung disease other than severe Alpha1-PI deficiency.

How does this medicine work?

• Alpha1-PI deficiency is a chronic, autosomal, co-dominant hereditary disorder characterized by reduced levels of Alpha1-PI in the blood and lungs.
• Smoking is an important risk factor for the development of emphysema in patients with Alpha1-PI deficiency3.
• Because emphysema affects many, but not all individuals with the more severe genetic variants of Alpha1-PI deficiency (AAT deficiency), augmentation therapy with Alpha1-Proteinase Inhibitor (Human) is indicated only in patients with severe Alpha1-PI deficiency who have clinically evident emphysema.
• The main purpose of infusing GLASSIA is to increase the levels of the AAT protein in your blood and lungs.
• AAT protein protects the lung tissue by blocking certain enzyme-caused damage.
• Such damage can lead to severe lung disease, such as emphysema.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• Have IgA deficiency with antibodies to IgA
• Have had a severe allergic reaction to human Alpha1-PI products

What drug interactions can this medicine cause?

• No formal drug interaction studies have been conducted with GLASSIA.

Is this medicine FDA approved?

• Initial U.S. Approval: 2010

How should this medicine be used?

Recommended dosage:

• Administer 60 mg/kg body weight of GLASSIA once weekly by intravenous infusion.
• Dose ranging studies using efficacy endpoints have not been performed.
• The carton and label on each vial of GLASSIA show the actual amount of functionally active Alpha1-PI in milligrams.

Administration:

• GLASSIA is given directly into the bloodstream.
• You can get GLASSIA at your healthcare professional's office, clinic, hospital, or delivered directly to your home by a healthcare professional from a limited network of specialty pharmacy providers.
• Your healthcare professional will decide if self-infusion in your home is right for you. You should be trained on how to do infusions by your healthcare professional.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As injection: Approximately 1 gram of functional Alpha1-PI in 50 mL of ready to use solution in a single-dose vial.

This medicine is available in fallowing brand namesː

• GLASSIA

What side effects can this medication cause?

The most common side effects of this medicine include:

• worsening or flare-up of your chronic obstructive pulmonary disease (COPD)
• headache
• upper respiratory tract infections

Other possible side effects of GLASSIA include:

• cough
• sinus infection
• chest discomfort
• dizziness
• increased liver enzymes
• shortness of breath
• nausea
• fatigue

What special precautions should I follow?

• Severe hypersensitivity and anaphylactic reactions may occur in IgA deficient patients with antibodies against IgA and in patients with a history of hypersensitivity to other Alpha1-PI products.
• Because this product is made from human plasma, it may carry a risk of transmitting infectious agents, such as viruses, the variant Creutzfeldt-Jakob disease (vCJD) and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• There is no data with GLASSIA use in pregnant women to inform a drug-associated risk.
• It is also not known whether GLASSIA can cause fetal harm when administered to pregnant women or can affect reproductive capacity.
• GLASSIA should be given to a pregnant woman only if clearly needed.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredients:

ALPHA.1-PROTEINASE INHIBITOR HUMAN

• Inactive ingredients:

SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE SODIUM CHLORIDE WATER

Who manufactures and distributes this medicine?

• Manufactured by:

Takeda Pharmaceuticals U.S.A., Inc. Lexington, MA USA

What should I know about storage and disposal of this medication?

• Store GLASSIA refrigerated or at room temperature.
• You can store GLASSIA in the refrigerator (36°F to 46°F [2°C to 8°C]).
• Do not freeze.
• You can store GLASSIA at room temperature (up to 77°F [25°C]) for up to one month.
• You must use GLASSIA within one month once you remove it from the refrigerator.
• Do not re-refrigerate GLASSIA once the product has been stored at room temperature.
• Keep the GLASSIA vial in the box until you are ready to administer the product.

• Dailymed label info on Alpha-1-Proteinase Inhibitor (Human)
• FDA Alpha-1-Proteinase Inhibitor (Human)

Alpha-1-Proteinase Inhibitor (Human) Resources
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