Aralast NP

Name: Aralast NP

What should I discuss with my health care provider before using Aralast NP (alpha 1-proteinase inhibitor)?

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 (immunoglobulin A) deficiency or antibody against IgA.

To make sure you can safely use alpha 1-proteinase inhibitor, tell your doctor if you have any of these other conditions:

  • liver disease; or

  • asthma, chronic obstructive pulmonary disease (COPD), or other breathing disorder.

FDA pregnancy category C. It is not known whether alpha 1-proteinase inhibitor will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether alpha 1-proteinase inhibitor passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

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

How should I use Aralast NP (alpha 1-proteinase inhibitor)?

Alpha 1-proteinase inhibitor is injected into a vein through an IV. You may be shown how to use an IV at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles, IV tubing, and other items used to inject the medicine.

Alpha 1-proteinase inhibitor is usually given once per week. Follow your doctor's dosing instructions very carefully.

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.

The Aralast, Prolastin, and Zemaira brands are powder forms of alpha 1-proteinase inhibitor. The powder form of this medication must be mixed with a liquid (diluent) before preparing your dose.

Do not shake the mixture or you may ruin the medicine. Prepare your dose in a syringe only when you are ready to give yourself an injection. Do not use the medication if it has changed colors or has particles in it. Call your doctor for a new prescription.

Glassia is a liquid form of alpha 1-proteinase inhibitor that does not need to be mixed with a diluent.

If you are using the injections at home, be sure you understand how to properly mix and store the medicine.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Each single use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

Store the powder medicine (Aralast, Prolastin, Zemaira) at cool room temperature, away from moisture and heat. Do not freeze. The diluent bottle can break if it becomes frozen.

After mixing alpha 1-proteinase inhibitor powder with a diluent, you must use the mixture within 3 hours.

Store the liquid medicine (Glassia) in its original container in the refrigerator. Do not freeze. Take the medication out of the refrigerator and allow it to reach room temperature before preparing your dose. Use the medication within 3 hours after you have punctured the rubber stopper in the vial with a needle or IV spike.

Do not use alpha 1-proteinase inhibitor after the expiration date on the medicine label has passed.

Proper Use of alpha-1 proteinase inhibitor human

This section provides information on the proper use of a number of products that contain alpha-1 proteinase inhibitor human. It may not be specific to Aralast NP. Please read with care.

A nurse or other trained health professional will give you this medicine in a hospital or clinic setting. This medicine is given through a needle placed in one of your veins.

This medicine is usually given once a week on a regular schedule. If you have any questions about this, check with your doctor.

You may be taught how to give your medicine at home. Make sure you understand all instructions before you give yourself this medicine. Do not use more medicine or use it more often than your doctor tells you to.

This medicine should come with patient information leaflet. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Record and keep a treatment infusion log. This includes information, such as lot number, time, date, and any reactions.

Aralast NP Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common
  • Bladder pain
  • bloody or cloudy urine
  • body aches or pain
  • chills
  • cough
  • difficult, burning, or painful urination
  • difficulty with breathing
  • ear congestion
  • fever
  • frequent urge to urinate
  • headache
  • loss of voice
  • lower back or side pain
  • nasal congestion
  • runny nose
  • sneezing
  • sore throat
  • unusual tiredness or weakness
Rare
  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • blurred vision
  • chest pain
  • cough producing mucus
  • diarrhea
  • difficult or labored breathing
  • dizziness
  • feeling faint, dizzy, or lightheadedness
  • flushing or redness of the skin, especially on the face and neck
  • general feeling of discomfort or illness
  • joint pain
  • loss of appetite
  • muscle aches and pains
  • nausea
  • nervousness
  • noisy breathing
  • pounding in the ears
  • rapid weight gain
  • shivering
  • slow or fast heartbeat
  • sweating
  • tightness in the chest
  • tingling of the hands or feet
  • trouble sleeping
  • unusual weight gain or loss
  • vomiting
Incidence not known
  • Confusion
  • difficulty with swallowing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fast, pounding, or irregular heartbeat or pulse
  • hives
  • itching, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • skin rash

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Feeling of warmth
  • itching skin
  • muscle or bone pain
  • pain or tenderness around the eyes and cheekbones
  • redness of the face, neck, arms, and occasionally, upper chest
  • sudden sweating
Rare
  • Back pain
  • bloating
  • change in taste
  • changes in vision
  • fever
  • hives or welts
  • loss of taste
  • pain
  • redness of the skin
  • sleepiness or unusual drowsiness
  • swelling of the joints
  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

What do I need to tell my doctor BEFORE I take Aralast NP?

  • If you have an allergy to alpha1-proteinase inhibitor or any other part of Aralast NP (alpha-proteinase inhibitor powder for injection).
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you have a lack of immunoglobulin A.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Aralast NP with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Indications and Usage for Aralast NP

Congenital Alpha1–Proteinase Inhibitor Deficiency

Aralast NP is indicated for chronic augmentation therapy in patients having congenital deficiency of α1–PI with clinically evident emphysema. Clinical and biochemical studies have demonstrated that with such therapy, ARALAST is effective in maintaining target serum α1–PI trough levels and increasing α1–PI levels in epithelial lining fluid (ELF). Aralast NP pharmacokinetics are comparable with the pharmacokinetics of ARALAST after single-dose administration in 25 subjects with congenital deficiency of α1–PI. Clinical data demonstrating the long–term effects of chronic augmentation or replacement therapy of individuals with Aralast NP or ARALAST are not available.

The effect of augmentation therapy with Aralast NP on pulmonary exacerbations and on the progression of emphysema in alpha1-antitrypsin deficiency has not been demonstrated in randomized, controlled clinical trials.

Aralast NP is not indicated as therapy for lung disease patients in whom congenital α1–PI deficiency has not been established.

References

  1. Brantly M, Nukiwa T, Crystal RG. Molecular basis of alpha–1–antitrypsin deficiency. Am J Med 1988 (Suppl 6A);84:13–31.
  2. Data on file at Baxter Healthcare Corporation.
  3. Crystal RG, Brantly ML, Hubbard RC, Curiel DT, et al. The alpha1–antitrypsin gene and its mutations: Clinical consequences and strategies for therapy. Chest 1989;95:196–208.
  4. Crystal RG. α1–Antitrypsin deficiency: pathogenesis and treatment. Hospital Practice 1991;Feb.15:81–94.
  5. Hutchison DCS. Natural history of alpha–1–protease inhibitor deficiency. Am J Med 1988;84(Suppl 6A):3–12.
  6. Hubbard RC, Crystal RG. Alpha–1–antitrypsin augmentation therapy for alpha–1– antitrypsin deficiency. Am J Med 1988;84(Suppl 6A):52–62.
  7. Buist SA, Burrows B, Cohen A, et al. Guidelines for the approach to the patient with severe hereditary alpha–1–antitrypsin deficiency. Am Rev Respir Dis 1989;140:1494–1497.
  8. Gadek JE, Fells GA, Zimmerman RL, et al. Antielastases of the human alveolar structures: Implications for the protease-antiprotease theory of emphysema. J Clin Invest 1981;68:889-898.
  9. Stoller JK, Brantly M, Fleming LE, et al. Formation and current results of a patient-organized registry for α1–antitrypsin deficiency. Chest 2000; 118(3):843-848.
  10. McElvaney NG, Stoller JK, Buist AS, et al. Baseline characteristics of enrollees in the National Heart, Lung and Blood Institute Registry of α1-antitrypsin deficiency. Chest 1997;111:394-403.
  11. FDA/CBER “Heterogeneity of Alpha-1-Proteinase Inhibitor Products” 27 Mar 2006 <http://www.fda.gov/cber/infosheets/alph1pi.htm>
  12. Kolarich D, et al. Biochemical, molecular characterization, and glycoproteomic analyses of α1-proteinase inhibitor products used for replacement therapy. Transfusion 2006;46:1959-1977.
  13. Transcript of Blood Products Advisory Committee (BPAC) 85th Meeting; 3-4 Nov 2005.
  14. Turino GM, Barker AF, Brantly ML, et al: Clinical features of individuals with Pi*SZ phenotype of α1-antitrypsin deficiency. Am J Respir Crit Care Med 154: 1718-25, 1996.

BAXTER, Aralast NP, BAXJECT are trademarks of Baxter International Inc.

Made by the method of U.S. Patent No. 5,616,693 and 5,981,715

DATE OF REVISION: August 2010

Baxter Healthcare Corporation

Westlake Village, CA 91362

U.S. License No. 140

For the Consumer

Applies to alpha 1-proteinase inhibitor: intravenous powder for solution, intravenous solution

Along with its needed effects, alpha 1-proteinase inhibitor (the active ingredient contained in Aralast NP) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking alpha 1-proteinase inhibitor:

More common
  • Bladder pain
  • bloody or cloudy urine
  • body aches or pain
  • chills
  • cough
  • difficult, burning, or painful urination
  • difficulty with breathing
  • ear congestion
  • fever
  • frequent urge to urinate
  • headache
  • loss of voice
  • lower back or side pain
  • nasal congestion
  • runny nose
  • sneezing
  • sore throat
  • unusual tiredness or weakness
Rare
  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • blurred vision
  • chest pain
  • cough producing mucus
  • diarrhea
  • difficult or labored breathing
  • dizziness
  • feeling faint, dizzy, or lightheadedness
  • flushing or redness of the skin, especially on the face and neck
  • general feeling of discomfort or illness
  • joint pain
  • loss of appetite
  • muscle aches and pains
  • nausea
  • nervousness
  • noisy breathing
  • pounding in the ears
  • rapid weight gain
  • shivering
  • slow or fast heartbeat
  • sweating
  • tightness in the chest
  • tingling of the hands or feet
  • trouble sleeping
  • unusual weight gain or loss
  • vomiting
Incidence not known
  • Confusion
  • difficulty with swallowing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • fast, pounding, or irregular heartbeat or pulse
  • hives
  • itching, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • skin rash

Some side effects of alpha 1-proteinase inhibitor may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Feeling of warmth
  • itching skin
  • muscle or bone pain
  • pain or tenderness around the eyes and cheekbones
  • redness of the face, neck, arms, and occasionally, upper chest
  • sudden sweating
Rare
  • Back pain
  • bloating
  • change in taste
  • changes in vision
  • fever
  • hives or welts
  • loss of taste
  • pain
  • redness of the skin
  • sleepiness or unusual drowsiness
  • swelling of the joints
  • unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

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