House dust mite allergen extract (subcutaneous route)


    Description

    Standardized mite, mixed injection is used to diagnose and treat allergic reactions in patients with symptoms similar to dust mite allergy. This medicine contains dust mite allergen extract from Dermatophagoides farinae and Dermatophagoides pteronyssinus. It works by exposing the patient's immune system (immunotherapy) to dust mite allergens to reduce the symptoms of certain allergies.

    This medicine is to be given only by or under the direct supervision of your doctor.

    This product is available in the following dosage forms:

    • Solution

    Before Using

    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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of standardized mite, mixed injection in children.

    Geriatric

    Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of standardized mite, mixed injection in the elderly. However, elderly patients are more likely to have heart or blood vessel problems, which may require caution in patients receiving this medicine.

    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:

    • Asthma, severe or
    • Infection—Use with caution. A lower dose may be needed in patients with these conditions.
    • Autoimmune disease or
    • Heart or blood disease or
    • Lung disease or breathing problems (eg, asthma)—Use is not recommended in patients with these conditions.

    Proper Use

    A nurse or other trained health professional will give you or your child this medicine in a hospital. This medicine is given as a shot under your skin.

    You will need to have a skin test for allergies before you receive this medicine.

    You will be observed for at least 20 to 30 minutes for any severe reactions after receiving an injection.


    Precautions

    Your doctor will check your or your child's progress closely while you are receiving this medicine. This will allow your doctor to check for any severe side effects.

    This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Tell your doctor right away if you or your child have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are receiving this medicine.

    Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.


    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:

    Incidence not known

    • Blurred vision
    • burning, dry, or itching eyes
    • confusion
    • cough
    • difficulty with breathing
    • difficulty with swallowing
    • discharge, excessive tearing
    • dizziness
    • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
    • fainting
    • fast heartbeat
    • hives or welts, itching, or skin rash
    • hoarseness
    • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
    • paleness of the skin
    • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
    • redness of the skin
    • redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
    • slow or irregular breathing
    • slow or irregular heartbeat
    • sneezing
    • stuffy or runny nose
    • sweating
    • tightness in the chest
    • unusual tiredness or weakness

    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:

    Incidence not known

    • Redness, swelling, or itching skin at the injection site

    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.






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