Standardized Mite D. Farinae

Standardized Mite D. Farinae

Standardized Mite D. Farinae Recall

Get an alert when a recall is issued.

Questions & Answers

Side Effects & Adverse Reactions

See warnings at the beginning of this package insert. 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.

A reduction in starting dose is recommended in the following circumstances:

  1. Changing to a new lot of extract from the same manufacturer
  2. Using product from a different manufacturer
  3. Using non-standardized extract or any other change in formula
  4. Changing to a product bearing a later expiration date
  5. When a prolonged lapse in time has occurred since the last injection

Withhold allergenic extracts temporarily or reduce the dose in patients with any one of the following conditions:

- Severe rhinitis or asthma symptoms;

- Infection or flu accompanied by fever;

- Exposure to excessive amounts of clinically relevant allergen prior to therapy.

Allergenic extracts slowly become less potent with age. During the course of treatment, it may be necessary to continue therapy with a vial of extract bearing a later expiration date. The initial dose of the extract bearing the later expiration date should be lowered to a safe non-reaction-eliciting level. When switching one standardized extract with another, at least 75% reduction in dose is suggested.

Patients should always be observed for at least 20 to 30 minutes after any injection. In the event of a marked systemic reaction such as urticaria, angioedema, wheezing, dyspnea, respiratory obstructions, hypotension and coma, application of a tourniquet above the injection site and administration of 0.2 mL to 1.0 mL (0.01 mg/kg) of Epinephrine Injection (1:1000) is recommended. Maximal recommended dose for children between 2 and 12 years of age is 0.3 mL. The tourniquet should not be left in place without loosening for 90 seconds every 15 minutes. Patients under treatment with beta-blockers may be refractory to the usual dose of epinephrine.

Volume expanders and vasopressor agents may be required to reverse hypotension. Inhalation bronchodilators and parenteral aminophylline may be required to reverse bronchospasm. In cases of respiratory obstruction, oxygen and intubation may be necessary. Life-threatening reactions unresponsive to the above may require cardiopulmonary resuscitation.  DO NOT GIVE INTRAVENOUSLY.

Mite Extracts (D. farinae and/or D. pteronyssinus) contain small (<1%) amounts of residual media components (pork and yeast). The physician should proceed with caution when using mite extract in mite sensitive individuals that also demonstrate sensitivity to these media components and only if clearly warranted.

In the presence of active symptoms such as rhinitis, wheezing, dyspnea, etc., the indications of immunotherapy must be weighed carefully against the risk of temporarily aggravating the symptoms by the injection itself. If the protective action of allergenic extract injections is considered essential for the patient's welfare, appropriate symptomatic therapy with antihistaminic, adrenergic or other drugs might be needed either prior to or in conjunction with allergenic extract injections.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

Uses

This product is indicated for the diagnosis and treatment of hypersensitivity in patients with symptoms compatible with dust mite allergy.

Hyposensitization (injection) therapy 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. Mixtures of standardized mite (D. farinae and D. pteronyssinus) should be considered for treatment of patients who are sensitive to both species.

Prior to the initiation of therapy, clinical sensitivity should be established by careful evaluation of the patient's history confirmed by diagnostic skin testing. Hyposensitization should not be prescribed for sensitivities to allergens which can be easily avoided.

History

There is currently no drug history available for this drug.

Other Information

Allergenic Extract Standardized Mite in the accompanying vial is a sterile solution and contains glycerin 50% v/v and phenol 0.4% (preservative). Inert ingredients include sodium chloride for isotonicity and sodium bicarbonates, as a buffer. The mites (D. farinae and/or D. pteronyssinus), used as source material for this extract, were cultured by Biopol Laboratories on a medium consisting of yeast and pork. The whole-body mites were separated from the culture medium and the harvested mites contained less than 1% culture medium material.

Several manufacturers submitted to FDA, intradermal skin test data on Biopol Laboratory’s mite medium extract using patients who were puncture test positive (sum of erythema equal to or greater than 40 mm) to either D. farinae or D. pteronyssinus extracts. By intradermal testing, there was 1 positive (sum of erythema equal to or greater than 20 mm) in 44 individuals at an estimated 1% level of medium contamination of mites, and 4 positives in 40 individuals at an estimated 10% contamination. Two of the individuals who were skin test positive also skin tested by the puncture method with an extract of yeast (Saccharomyces sp) and were positive.

In ten mite sensitive patients, ALK-Abelló, Inc. observed no puncture or intradermal reactions to media from the same source at a carryover concentration equivalent to 1% of the mite extract.

For ease in use, and for lot to lot consistency, potency value is expressed in allergy units per milliliter.

This ELISA standardized mite extract was compared to a mite reference preparation supplied by FDA which was labeled 10,000 AU/mL based on skin testing.1 The relative potency of this mite extract was determined by ELISA inhibition in comparison to the FDA Mite reference and is labeled in AU's (Allergy Units/mL).2 Dilutions made from this product can be administered intradermally for testing, or subcutaneously for immunotherapy.

In addition to the total allergen activity as described above, each Lot of Mite Extract @ 10,000 AU/mL is tested for two important specific allergens, Group I and Group II (Der f 1; Der p 1 and Der 2) (12, 13, 14, 15, 16, 17) by sandwich ELISA (18, 19, 20, 21, 22) .  

Specific Lot values of these allergens are available from ALK-Abelló, Inc. by calling the Scientific Affairs Department.

      Phone #       866-255-7722       or fax #       888-329-2551            

The tables below provide summary data of released lots including coefficient of variation (% CV), range (min and max), and ratios on lots manufactured from 2002 through 2006.

Table 1: Summary data: specific allergen content of 22 lots of Standardized Mite Allergenic Extract. Dermatophagoides farinae 10,000 AU/mL.
Der f 1 Der 2 1+2 Ratio 1:2
Average 67 89 156 0.76
% CV 36 27 29 22
Min 21 51 90 0.26
Max 140 141 281 0.99
Table 2: Summary data: specific allergen content of 24 lots of Standardized Mite Allergenic Extract. Dermatophagoides pteronyssinus 10,000 AU/mL.
Der p 1 Der 2 1+2 Ratio 1:2
Average 67 69 136 0.97
% CV 27 22 23 16
Min 41 45 90 0.70
Max 98 104 184 1.27
Table 3: Summary data: specific allergen content of 24 lots of Standardized Mite Allergenic Extract. Each mL contains 5,000 AU/mL D. pteronyssinus and 5,000 AU/mL D. farinae.
Der f 1 Der p 1 Der 2 1+2 Ratio 1:2
Average 34 34 79 146 0.87
% CV 31 27 21 19 15
Min 21 21 49 98 0.61
Max 58 46 106 203 1.11
Ratio max/min 2.8 2.2 2.1 2.1 1.8

Standardized Mite D. Farinae Manufacturers


  • Alk-abello, Inc.
    Standardized Mite D. Farinae Injection, Solution Standardized Mite D. Farinae Solution Standardized Mite D. Pteronyssinus Injection, Solution [Alk-abello, Inc.]

Login To Your Free Account