Aralast NP - Alpha-1 Proteinase Inhibitor Human (Intravenous Route)

    Aralast NP – Alpha-1 Proteinase Inhibitor Human (Intravenous Route)

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    Description and Brand Names of Aralast NP – Alpha-1 Proteinase Inhibitor Human (Intravenous Route)

    US Brand Name

    1. Aralast
    2. Aralast NP
    3. Glassia
    4. Prolastin
    5. Prolastin-C
    6. Zemaira

    Descriptions

    Alpha-1 proteinase inhibitor injection, also called alpha 1-PI, is used to treat a certain type of emphysema (a lung condition). The emphysema is caused by the lack of a protein called alpha 1-antitrypsin (AAT) in the body. This medicine replaces the protein when the body does not produce enough.

    This medicine is administered only by or under the immediate supervision of your doctor.

    This product is available in the following dosage forms:

    • Powder for Solution
    • Solution

    Before Using Aralast NP – Alpha-1 Proteinase Inhibitor Human (Intravenous Route)

    In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

    Allergies

    Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

    Pediatric

    Appropriate studies have not been performed on the relationship of age to the effects of alpha-1 proteinase inhibitor in the pediatric population. Safety and efficacy have not been established.

    Geriatric

    Appropriate studies have not been performed on the relationship of age to the effects of alpha-1 proteinase inhibitor in the geriatric population. Safety and efficacy have not been established.

    Pregnancy

    Breastfeeding

    There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

    Drug Interactions

    Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

    Other Interactions

    Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

    Other Medical Problems

    The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

    • IgA deficiency with antibodies against IgA – Should not be used in patients with this condition.

    Proper Use of Aralast NP – Alpha-1 Proteinase Inhibitor Human (Intravenous Route)

    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.

    Precautions

    It is very important that your doctor check you closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to use it.

    This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; lightheadedness, dizziness, or fainting; trouble with breathing; trouble with swallowing; or any swelling of your hands, face, or mouth after you receive this medicine.

    Alpha 1-PI is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them. The risk of getting a virus from alpha 1-PI is very low and has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and testing during the manufacture of these medicines. Although the risk is low, talk with your doctor if you have concerns. Your doctor may give you a hepatitis B vaccine before receiving this medicine.

    Side Effects of Aralast NP – Alpha-1 Proteinase Inhibitor Human (Intravenous Route)

    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

    1. Bladder pain
    2. bloody or cloudy urine
    3. body aches or pain
    4. chills
    5. cough
    6. difficult, burning, or painful urination
    7. difficulty with breathing
    8. ear congestion
    9. fever
    10. frequent urge to urinate
    11. headache
    12. loss of voice
    13. lower back or side pain
    14. nasal congestion
    15. runny nose
    16. sneezing
    17. sore throat
    18. unusual tiredness or weakness

    Rare

    1. Bloating or swelling of the face, arms, hands, lower legs, or feet
    2. blurred vision
    3. chest pain
    4. cough producing mucus
    5. diarrhea
    6. difficult or labored breathing
    7. dizziness
    8. feeling faint, dizzy, or lightheadedness
    9. flushing or redness of the skin, especially on the face and neck
    10. general feeling of discomfort or illness
    11. joint pain
    12. loss of appetite
    13. muscle aches and pains
    14. nausea
    15. nervousness
    16. noisy breathing
    17. pounding in the ears
    18. rapid weight gain
    19. shivering
    20. shortness of breath
    21. slow or fast heartbeat
    22. stuffy nose
    23. sweating
    24. tightness in the chest
    25. tingling of the hands or feet
    26. trouble sleeping
    27. unusual weight gain or loss
    28. vomiting
    29. wheezing

    Incidence not known

    1. Confusion
    2. difficulty with swallowing
    3. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
    4. fast, pounding, or irregular heartbeat or pulse
    5. hives
    6. itching, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
    7. 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

    1. Feeling of warmth
    2. itching skin
    3. muscle or bone pain
    4. pain or tenderness around the eyes and cheekbones
    5. redness of the face, neck, arms, and occasionally, upper chest
    6. sudden sweating

    Rare

    1. Back pain
    2. bloating
    3. change in taste
    4. changes in vision
    5. fever
    6. hives or welts
    7. loss of taste
    8. pain
    9. redness of the skin
    10. sleepiness or unusual drowsiness
    11. swelling of the joints
    12. 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.