Dosage Forms:

• Solution

Warnings:

Standardized allergenic extract is intended for use by physicians who are experienced in the administration of standardized (AU/mL) allergenic extracts for immunotherapy and the emergency care of anaphylaxis, or for use under the guidance of an allergy specialist. Standardized allergenic extracts are not directly interchangeable with allergenic extracts of the same labeled potency from different manufacturers. The patient must be re-evaluated with the newly selected extract. The initial dose must be based on skin testing. Patients being switched from other types of extracts to standardized allergenic extracts should be started as though they were coming under treatment for the first time. Patients should be instructed to recognize adverse reaction symptoms and cautioned to contact the physician's office if reaction symptoms occur. As with all allergenic extracts, severe systemic reactions may occur. Patients with unstable asthma or steroid dependent asthmatics and patients with underlying cardiovascular disease are at greater risk. In certain individuals, these life-threatening reactions may result in death. Patients should be observed for 20 to 30 minutes following treatment, and emergency measures, as well as personnel trained in their use, should be immediately available in the event of a life-threatening reaction. This product should not be injected intravenously. Deep subcutaneous routes have proven to be safe. Sensitive patients may experience severe anaphylactic reactions resulting in respiratory obstruction, shock, coma and/or death. Patients receiving beta-blockers may not be responsive to epinephrine or inhaled bronchodilators. Respiratory obstruction not responding to parenteral or inhaled bronchodilators may require theophylline, oxygen, intubation and the use of life support systems. Parenteral fluid and/or plasma expanders may be utilized for treatment of shock. Adrenocorticosteroids may be administered parenterally or intravenously .

Classifications:

Therapeutic—

Immunological Agent

Uses of This Medicine:

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.

Before Using This Medicine:

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.

Children—

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

Older adults—

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.

Breast-feeding—

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.

Other medicines—

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 of This Medicine:

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 While Using This Medicine:

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 of This Medicine:

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.