Zemaira

DRUG DESCRIPTION

Alpha1-Proteinase Inhibitor (Human), Zemaira™, is a sterile, stable, lyophilized preparation of highly purified human alpha1-proteinase inhibitor (A1-PI), also known as alpha1-antitrypsin, derived from human plasma. Zemaira™ is manufactured from large pools of human plasma by cold ethanol fractionation according to a modified Cohn process followed by additional purification steps.

Zemaira (alpha-proteinase inhibitor human) is supplied as a sterile, white, lyophilized powder to be administered by the intravenous route. The specific activity of Zemaira (alpha-proteinase inhibitor human) is ?0.7 mg of functional A1-PI per milligram of total protein. The purity is ?90% A1-PI.Following reconstitution with 20 mL of Sterile Water for Injection, U.S.P., each vial contains approximately 1000 mg of functionally active A1-PI, 81 mM sodium, 38 mM chloride, 17 mM phosphate, and 144 mM mannitol. Hydrochloric acid and/or sodium hydroxide may have been added to adjust the pH. Zemaira (alpha-proteinase inhibitor human) contains no preservatives.

Each vial of Zemaira (alpha-proteinase inhibitor human) contains the labeled amount of functionally active A1-PI in milligrams as stated on the vial label as determined by its capacity to neutralize human neutrophil elastase.

The plasma used in the manufacture of this product has been tested and found to be nonreactive to HBsAg, nonreactive for antibody to Hepatitis C Virus (Anti-HCV), and negative for antibody to Human Immunodeficiency Virus (Anti-HIV-1/HIV-2).

Two viral reduction steps are employed in the manufacture of Zemaira (alpha-proteinase inhibitor human) : pasteurization at 60°C for 10 hours in an aqueous solution with stabilizers and two sequential ultrafiltration steps. These viral reduction steps have been validated in a series of in vitro experiments for their capacity to inactivate/remove Human Immunodeficiency Virus (HIV), Hepatitis A Virus (HAV), and the following model viruses: Bovine Viral Diarrhea Virus (BVDV) as a model virus for HCV, Canine Parvovirus (CPV) as a model virus for Parvovirus B19, and Pseudorabies Virus (PRV) as a nonspecific model virus to cover a wide range of physiochemical properties of the viruses studied. Total mean log10 reductions range from 6.8 to >12.2 log10 as shown in Table 1.

Table 1: Mean (cumulative) virus reduction factors

 

Mean Reduction Factor

Mean Reduction Factor

Cumulative Reduction

 

Pasteurization

Two Ultrafiltration

Factor [log10]

 

[log10]

Steps [log10]

 

HIV-1

? 6.7

? 5.5

? 12.2

BVDV

? 5.9

5.1

? 11.0

PRV

4.3

? 6.9

? 11.2

HAV

? 5.4

? 6.3

? 11.7

CPV

(0.9)

6.8

6.8

What are the possible side effects of alpha 1-proteinase inhibitor (Aralast, Aralast NP, Prolastin, Zemaira)?

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.

Call your doctor at once if you have a serious side effect such as:

  • chest pain, severe headache, buzzing in your ears, uneven heartbeats;
  • fast heart rate;
  • problems with vision; or
  • fever, chills, runny nose, skin rash, and joint...

Read All Potential Side Effects and See Pictures of Zemaira »

What are the precautions when taking alpha-proteinase inhibitor (human) (Zemaira)?

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 Zemaira »


Zemaira Consumer (continued)

SIDE EFFECTS: Pain at the injection site, fever, dizziness, headache, drowsiness, numb/tingling skin, and muscle aches may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects.

This medication is made from human blood. There is a very small chance that you may get infections from this medication (including viral infections such as hepatitis, parvovirus B19), even though careful screening of blood donors, special manufacturing processes, and many tests are all used to reduce this risk. Discuss the benefits and risks of treatment with your doctor. Tell your doctor immediately if you develop any signs of hepatitis or other infection, including persistent fever, persistent sore throat, stuffy nose, unusual tiredness, unusual drowsiness, joint pain, persistent nausea/vomiting, stomach/abdominal pain, yellowing eyes/skin, dark urine.

A very serious allergic reaction to this drug is rare. However, stop receiving the drug and seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: hives, rash, itching/swelling (especially of the face/tongue/throat), chest tightness, severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: 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 infections from it (such as viral infections like hepatitis). It is recommended that you get the appropriate vaccinations (such as for hepatitis A and B) and that people giving this medication handle the medication with special caution to prevent virus infections. Consult your doctor for more details.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Zemaira Patient Information Including Side Effects

Brand Names: Aralast, Aralast NP, Prolastin, Zemaira

Generic Name: alpha 1-proteinase inhibitor (Pronunciation: AL fa 1-PRO tee nase in HIB i tor)

  • What is alpha 1-proteinase inhibitor (Zemaira)?
  • What are the possible side effects of alpha 1-proteinase inhibitor (Zemaira)?
  • What is the most important information I should know about alpha 1-proteinase inhibitor (Zemaira)?
  • What should I discuss with my health care provider before using alpha 1-proteinase inhibitor (Zemaira)?
  • How should I use alpha 1-proteinase inhibitor (Zemaira)?
  • What happens if I miss a dose (Zemaira)?
  • What happens if I overdose (Zemaira)?
  • What should I avoid while taking alpha 1-proteinase inhibitor (Zemaira)?
  • What other drugs will affect alpha 1-proteinase inhibitor (Zemaira)?
  • Where can I get more information?

What is alpha 1-proteinase inhibitor (Zemaira)?

Alpha 1-proteinase inhibitor is a protein, also called alpha 1-antitrypsin. This protein occurs naturally in the body and is important for preventing the breakdown of tissues in the lungs.

In people who lack the alpha 1-antitrypsin protein, breakdown of lung tissues can lead to emphysema (damage to the air sacs in the lungs).

Alpha 1-proteinase inhibitor is used to treat alpha 1-antitrypsin deficiency in people who have symptoms of emphysema.

Alpha 1-antitrypsin deficiency is a genetic (inherited) disorder and alpha 1-proteinase inhibitor will not cure this condition.

Alpha 1-proteinase inhibitor may also be used for other purposes not listed in this medication guide.

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

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.

Call your doctor at once if you have a serious side effect such as:

  • chest pain, severe headache, buzzing in your ears, uneven heartbeats;
  • fast heart rate;
  • problems with vision; or
  • fever, chills, runny nose, skin rash, and joint pain.

Less serious side effects may include:

  • drowsiness, dizziness, weakness;
  • cough, sore throat, stuffy nose;
  • pain or bleeding where the medication was injected;
  • warmth, redness, or tingly feeling under your skin;
  • nausea, diarrhea, stomach pain;
  • headache; or
  • mild itching.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about alpha 1-proteinase inhibitor (Zemaira)?

You should not use this medication if you have ever had an allergic reaction to alpha 1-proteinase inhibitor, or if you have an IgA deficiency or antibody against IgA.

Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of needles, IV tubing, and other items used in giving the medicine.

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.

You will most likely receive your first few doses of this medication in a hospital or clinic setting where your vital signs can be watched closely in case the medication causes serious side effects.

Alpha 1-proteinase inhibitor is made from human plasma (part of the blood) and may contain viruses and other infectious agents that can cause disease. Although donated human plasma is screened, tested, and treated to reduce the risk of it containing anything that could cause disease, there is still a small possibility it could transmit disease. Talk with your doctor about the risks and benefits of using this medication.

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