Medical Editor: John P. Cunha, DO, FACOEP
Center-Al (allergenic extracts, alum precipitated) is a treatment for patients exhibiting allergic reactions to seasonal pollens, dust mites, molds, animal danders, and various other inhalants, in situations where the offending allergen cannot be avoided. Common side effects of Center-Al include:
- injection site reactions:
- a lump,
- swelling, or
Serious systemic reactions to Center-Al include:
- itching other than at the injection site,
- shortness of breath,
- bluish discoloration of the skin,
- fast heart rate,
- low blood pressure (hypotension),
- lightheadedness/fainting, and
- upper airway obstruction
The starting dose for immunotherapy with Center-Al is related directly to a patient's sensitivity as determined by carefully executed percutaneous (prick/puncture) and intracutaneous (intradermal) skin testing with non-alum adsorbed allergenic extract. A treatment schedule with Center-Al is related directly to the patient's degree of sensitivity, determined initially by clinical history and skin testing, and continuously by response to therapeutic doses. Center-Al may interact with beta-blockers. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Center-Al; it is unknown how it would affect a fetus. It is unknown if Center-Al passes into breast milk. Consult your doctor before breastfeeding.
Our Center-Al (allergenic extracts, alum precipitated) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Reactions at the site of injection may be immediate or delayed. Immediate wheal and erythema reactions are ordinarily of little consequence, but if very large may be the first manifestation of a systemic reaction. If large local reactions occur, the patient should be observed for systemic symptoms for which treatment is outlined below.
Delayed reactions start several hours after injection with local edema, erythema, itching or pain. They are usually at their peak at 24 hours and usually require no treatment. Antihistamine drugs may be administered orally.
The next therapeutic dose should be reduced to the dose which did not elicit a reaction, and subsequent doses increased more slowly, i.e., use of intermediate dilutions.
It should be noted that anaphylaxis and deaths following the injection of mite and other extracts, including pollen extracts, have been reported by The British Committee on Safety in Medicine.13 Fatalities from immunotherapy in the United States since 1945 have been extensively reviewed by Lockey, R.F., et al.14 and also more recently by Reid, M.J., et al.15 With careful attention to dosage and administration, such reactions occur infrequently, but it must be remembered that allergenic extracts are highly potent to sensitive individuals and OVERDOSE could result in anaphylactic symptoms. Therefore, it is imperative that physicians administering allergenic extracts understand and be prepared for the treatment of severe reactions.
Systemic reactions are characterized by one or more of the following symptoms: sneezing, mild to severe generalized urticaria, itching other than at the injection site, extensive or generalized edema, wheezing, asthma, dyspnea, cyanosis, tachycardia, lacrimation, marked perspiration, cough, hypotension, syncope and upper airway obstruction. Symptoms may progress to shock and death. Patients should always be observed for at least 20-30 minutes after any injection.
Volume expanders and vasopressor agents may be required to reverse hypotension. Inhalational bronchodilator and parenteral aminophylline may be required to reverse bronchospasm. Severe airway obstruction, unresponsive to bronchodilator, may require tracheal intubation.
In the event of a marked systemic reaction, application of a tourniquet above the injection site and administration of 0.2 mL to 1.0 mL of Epinephrine Injection (1:1,000) are recommended. Maximal recommended dose for children under 2 years of age is 0.3 mL. Maximal recommended dose for children between 2 and 12 years of age is 0.5 mL. The tourniquet is then gradually released.
The next therapeutic injection of extract should be reduced to the dose which did not elicit a reaction, and subsequent doses increased more slowly, i.e., use of intermediate dilutions.
Adverse Events should be reported via MedWatch (1-800-FDA-1088), Adverse Experience Reporting, Center for Biologics Evaluation & Research, Food & Drug Administration, 5600 Fishers Lane, Rockville, MD 20852-9787.
Read the entire FDA prescribing information for Center-Al (Allergenics Extracts Alum Precipitated Injection, Suspension)