SAROCLADIUM STRICTUM: Package Insert and Label Information (Page 2 of 2)

OVERDOSAGE

Signs and symptoms of overdose are typically local and systemic reactions. For a description and management of overdose reactions, refer to “Adverse Reaction” section above.

DOSAGE AND ADMINISTRATION

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

When diluting bulk extracts, use of Sterile Diluent for Allergenic Extracts or Sterile Diluent for Allergenic Extracts Normal Saline with HSA (albumin saline) is recommended. Dilutions should be made with sterile disposable syringes using aseptic technique. Commonly, 10 fold dilutions are used to achieve a desired concentration for initiation and continuation of immunotherapy. For example, transferring 0.5 mL of a 10,000 PNU/mL extract into 4.5 mL of diluent will yield 5 mL of extract at 1,000 PNU/mL. For weight volume products, a 1:100 w/v dilution may be prepared from a 1:10 w/v by transferring 0.5 mL of the 1:10 w/v to 4.5 mL of diluent. Prepare as many additional serial dilutions as necessary to reach the appropriate concentration.

Starting dose for immunotherapy is related directly to a patient’s sensitivity as determined by carefully executed skin testing. Degree of sensitivity can be established by determination of D₅₀ .¹¹ A general rule is to begin at 1/10 of the dose that produces sum of erythema of 50 mm (approximately a 2+ positive skin test reaction).

For example, if a patient exhibits a 2+ intradermal reaction to 1 AU/mL, the first dose should be no higher than 0.05 mL of 0.1 AU/mL. Dosage may be increased by 0.05 mL each time until 0.5 mL is reached, at which time the next 10-fold more concentrated dilution can be used, beginning with 0.05 mL, if no untoward reaction is observed.

Interval between doses in the early stages of immunotherapy is no more than once to twice a week, and may gradually be increased to once every two weeks. Generally, maintenance injections may be given as infrequently as once every two weeks to once a month.

Injections are given subcutaneously, preferably in the arm. It is advantageous to give injections in alternate arms and routinely in the same area. In some patients, a local tolerance to the allergen may develop thus preventing a possible severe local reaction.

Formal stability studies for diluted and undiluted forms of unstandardized extracts have not been performed; therefore, it is recommended that minimal amounts of the concentrate be diluted so that the diluted product is used up within a relatively short period of time; i.e., preferably not more than four weeks.

PRE-SEASONAL METHOD OF TREATMENT

Treatment of hay fever by the pre-seasonal method should be started 6-10 weeks prior to the usual onset of symptoms. Therapy should be started early enough to permit a graduated series of doses at 2-7 day intervals. It is recommended that the larger doses be spaced 5-7 days apart.

Some physicians continue therapy into or through the season by repeating a reduced or MAINTENANCE dose at weekly or biweekly intervals. If during the season, hay fever symptoms develop, relief may be provided by giving supplemental treatment. If the last dose was well-tolerated and not more than 2 weeks has elapsed since it was given, this dose may be given again and repeated every 4 to 7 days.

PERENNIAL TREATMENT

The patient’s tolerance to the offending pollen or pollens is first established by the injection of a series of graduated doses as outlined in the PRE-SEASONAL METHOD, not necessarily given pre-seasonally, since perennial therapy may be begun at any time. After completion of the ascending series of injections, from 1/4 to 1/2 of the highest well-tolerated dose is continued at 2 to 3 week intervals throughout the year. Shortly before the usual onset of symptoms (4 to 5 weeks prior to the season) the interval between injections is shortened and the dosage is gradually increased, according to the Pre-Seasonal schedule, until maximum well-tolerated dose is again attained. This top dose should be reached just before the usual onset of symptoms at which time the treatment is discontinued. If patient’s symptoms persist, therapy may be continued at a reduced dosage level, usually 1/4 to 1/2 of the top dose.

DOSAGE ADJUSTMENTS

For Products Containing Short Ragweed.

In transferring patients from unstandardized to standardized product, the physician should establish the potency relationships, perhaps by comparative skin testing, prior to injecting the first standardized dose.

AgE is important in adjusting dosage of Short Ragweed extracts to accurately transfer a patient from older extracts to fresher material. In such cases, the dosage of AgE should be considered in addition to the W/V dilution or protein nitrogen units. Antigen E concentration continuously declines in Short Ragweed Pollen extracts at a rate that varies with the formulation of the product. Aqueous extracts retain Antigen E potency less effectively than glycerin 50% (v/v) extracts. These differences are reflected in the expiration date declared on the vial. The continuous decline should be considered. Also, where ragweed is a component of an allergen mixture, clinical response to the other components must be considered in adjustment of dosage based on AgE content alone. The usual course of immunotherapy is three to five years.

Caution: A small percent of individuals allergic to Short Ragweed are more sensitive to minor antigens such as Ra3 Ra5 than AgE. There is no correlation between the amount of these antigens and either AgE or PNU content.

NOTE: For extracts of Short Ragweed or equal part mixture of Short and Tall Ragweed refer to AgE dosage schedule. The AgE content for those products is indicated on the vial label. The physician may use the formula below to determine the AgE dosage for each injection.

AgE dosage can be monitored by using the following formula:

W/V compounded products:

Labeled AgE X Dose (mL) = dose in AgE

PNU compounded products:

Labeled AgE/mL X dose in PNU = dose in AgE

Labeled PNU/mL

HOW SUPPLIED

1. Concentrate in multiple dose vials:
   10 mL and 50 mL, single antigens or specified mixtures, potency expressed in PNU/mL (up to and including 100,000 PNU/mL) or W/V (up to and including 1:10 W/V), aqueous or in 50% glycerin, to be diluted prior to use. 1:10 w/v short ragweed extracts contain ≥ 300 units/mL of AgE.
   
2. Sterile Diluent for Allergenic Extracts (Phenol Saline) is supplied in vials of 4.5 mL, 9.0 mL, 30 mL and 100 mL.

STORAGE: To maintain stability of allergenic extracts, proper storage conditions are essential. Bulk concentrates and diluted extracts are to be stored at 2° to 8° C even during use. Bulk or diluted extracts are not to be frozen. Do not use after the expiration date shown on the vial label.

REFERENCES

1. Norman, P.S. et al: Immunotherapy of hayfever with ragweed antigen E. Comparisons with whole pollen extract and placebo. J. Allergy 42:93, 1968.
   
2. Van Metre, T.E. et al: A controlled study of the effectiveness of the Rinkel method of immunotherapy for ragweed pollen hayfever. J. Allergy Clin. Immunol. 65:288, 1980.
   
3. Umetsu, D.T. et al: Serum sickness triggered by anaphylaxis: a complication of immunotherapy. J. Allergy Clin. Immunol. 76:713, 1985.
   
4. Phannphak, P. and Kohler, P.F.: Onset of polyarteritis nodosa during allergic hyposenitization treatment. Am. J. Med. 68:479, 1980.
   
5. Kohler, P.F.: Immune complexes and allergic disease. In: Middleton et al: Allergy Principles and Practice 3rd Ed. St. Louis: CV Mosby, 1988:167.
   
6. Bousquet, J.: In vivo methods for the study of allergy: skin test, techniques, and interpretation. In: Middleton et al: Allergy Principles and Practice 3rd Ed. St. Louis: CV Mosby, 1988:167.
   
7. Committee on the Safety of Medicines. CSM update: desensitising vaccines. Brit Med. J. 293:948,1986.
   
8. Lockey, R.F. et al: Fatalities from immunotherapy (IT) and skin testing (ST). J. Allergy Clin. Immunol. 79:660, 1987.
   
9. Reid, M.J. et al: Survey of fatalities from skin testing and immunotherapy. 1985-1989. J. Allergy Clin. Immunol. ;92:6, 1993.
   
10. Van Metre, T.E. et al: A controlled study of the effectiveness of the Rinkel method and the current standard method of immunotherapy for ragweed pollen hayfever. J. Allergy Clin. Immunol. 66:500, 1980.
    
11. Turkeltaub, P.C., Rastogi, S.C., Baer, H., et al: A standardized quantitative skin-test assay of allergen potency and stability: studies on the allergen dose-response curve and effect of wheal, erythema, and patient selection on assay results, J. Allergy Clin. Immunol. 70:343, 1982.

Revised April 2017 158M

© ALK-Abelló, Inc.

Distributed in Canada by:

ALK-Abelló Pharmaceuticals, Inc.

#35-151 Brunel Road

Mississauga, Ontario

Canada L4Z 2H6

PRINCIPAL DISPLAY PANEL

ALLERGENIC EXTRACTmL sterile multiple dose vial

PRINCIPAL DISPLAY PANEL

ALLERGENIC EXTRACTmL sterile multiple dose vial

SAROCLADIUM STRICTUM sarocladium strictum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-8080 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SAROCLADIUM STRICTUM (SAROCLADIUM STRICTUM) SAROCLADIUM STRICTUM 0.1 g in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE 0.005 g in 1 mL SODIUM BICARBONATE 0.0027 g in 1 mL PHENOL 0.004 mL in 1 mL HYDROCHLORIC ACID SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0268-8080-50 53 mL in 1 VIAL None 2 NDC:0268-8080-10 10.5 mL in 1 VIAL None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ALTERNARIA ALTERNATA alternaria alternata injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-8082 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ALTERNARIA ALTERNATA (ALTERNARIA ALTERNATA) ALTERNARIA ALTERNATA 0.1 g in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE 0.005 g in 1 mL SODIUM BICARBONATE 0.0027 g in 1 mL PHENOL 0.004 mL in 1 mL HYDROCHLORIC ACID SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0268-8082-50 53 mL in 1 VIAL None 2 NDC:0268-8082-10 10.5 mL in 1 VIAL None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

ASPERGILLUS FUMIGATUS aspergillus fumigatus injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-8084 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPERGILLUS FUMIGATUS (ASPERGILLUS FUMIGATUS) ASPERGILLUS FUMIGATUS 0.1 g in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE 0.005 g in 1 mL SODIUM BICARBONATE 0.0027 g in 1 mL PHENOL 0.004 mL in 1 mL HYDROCHLORIC ACID SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0268-8084-50 53 mL in 1 VIAL None 2 NDC:0268-8084-10 10.5 mL in 1 VIAL None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

AUREOBASIDIUM PULLULANS aureobasidium pullulans var. pullutans injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-8086 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AUREOBASIDIUM PULLULANS VAR. PULLUTANS (AUREOBASIDIUM PULLULANS VAR. PULLUTANS) AUREOBASIDIUM PULLULANS VAR. PULLUTANS 0.1 g in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE 0.005 g in 1 mL SODIUM BICARBONATE 0.0027 g in 1 mL PHENOL 0.004 mL in 1 mL HYDROCHLORIC ACID SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0268-8086-50 53 mL in 1 VIAL None 2 NDC:0268-8086-10 10.5 mL in 1 VIAL None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

BIPOLARIS SOROKINIANA cochliobolus sativus injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-8088 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength COCHLIOBOLUS SATIVUS (COCHLIOBOLUS SATIVUS) COCHLIOBOLUS SATIVUS 0.1 g in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE 0.005 g in 1 mL SODIUM BICARBONATE 0.0027 g in 1 mL PHENOL 0.004 mL in 1 mL HYDROCHLORIC ACID SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0268-8088-50 53 mL in 1 VIAL None 2 NDC:0268-8088-10 10.5 mL in 1 VIAL None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

BOTRYTIS CINEREA botrytis cinerea injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-8090 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BOTRYTIS CINEREA (BOTRYTIS CINEREA) BOTRYTIS CINEREA 0.1 g in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE 0.005 g in 1 mL SODIUM BICARBONATE 0.0027 g in 1 mL PHENOL 0.004 mL in 1 mL HYDROCHLORIC ACID SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0268-8090-50 53 mL in 1 VIAL None 2 NDC:0268-8090-10 10.5 mL in 1 VIAL None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CANDIDA ALBICANS candida albicans injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-8092 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CANDIDA ALBICANS (CANDIDA ALBICANS) CANDIDA ALBICANS 0.1 g in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE 0.005 g in 1 mL SODIUM BICARBONATE 0.0027 g in 1 mL PHENOL 0.004 mL in 1 mL HYDROCHLORIC ACID SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0268-8092-50 53 mL in 1 VIAL None 2 NDC:0268-8092-10 10.5 mL in 1 VIAL None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

CLADOSPORIUM CLADOSPORIOIDES cladosporium cladosporioides injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-8094 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLADOSPORIUM CLADOSPORIOIDES (CLADOSPORIUM CLADOSPORIOIDES) CLADOSPORIUM CLADOSPORIOIDES 0.1 g in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE 0.005 g in 1 mL SODIUM BICARBONATE 0.0027 g in 1 mL PHENOL 0.004 mL in 1 mL HYDROCHLORIC ACID SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0268-8094-50 53 mL in 1 VIAL None 2 NDC:0268-8094-10 10.5 mL in 1 VIAL None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

EPICOCCUM NIGRUM epicoccum nigrum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-8096 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength EPICOCCUM NIGRUM (EPICOCCUM NIGRUM) EPICOCCUM NIGRUM 0.1 g in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE 0.005 g in 1 mL SODIUM BICARBONATE 0.0027 g in 1 mL PHENOL 0.004 mL in 1 mL HYDROCHLORIC ACID SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0268-8096-50 53 mL in 1 VIAL None 2 NDC:0268-8096-10 10.5 mL in 1 VIAL None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

GIBBERELLA PULICARIS gibberella zeae injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-8098 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GIBBERELLA ZEAE (GIBBERELLA ZEAE) GIBBERELLA ZEAE 0.1 g in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE 0.005 g in 1 mL SODIUM BICARBONATE 0.0027 g in 1 mL PHENOL 0.004 mL in 1 mL HYDROCHLORIC ACID SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0268-8098-50 53 mL in 1 VIAL None 2 NDC:0268-8098-10 10.5 mL in 1 VIAL None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

MUCOR PLUMBEUS mucor plumbeus injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-8100 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MUCOR PLUMBEUS (MUCOR PLUMBEUS) MUCOR PLUMBEUS 0.1 g in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE 0.005 g in 1 mL SODIUM BICARBONATE 0.0027 g in 1 mL PHENOL 0.004 mL in 1 mL HYDROCHLORIC ACID SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0268-8100-50 53 mL in 1 VIAL None 2 NDC:0268-8100-10 10.5 mL in 1 VIAL None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

PENICILLIUM NOTATUM penicillium chrysogenum var. chrysogenum injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-8102 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM) PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM 0.1 g in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE 0.005 g in 1 mL SODIUM BICARBONATE 0.0027 g in 1 mL PHENOL 0.004 mL in 1 mL HYDROCHLORIC ACID SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0268-8102-50 53 mL in 1 VIAL None 2 NDC:0268-8102-10 10.5 mL in 1 VIAL None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

RHODOTORULA MUCILAGINOSA rhodotorula mucilaginosa injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-8104 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RHODOTORULA MUCILAGINOSA (RHODOTORULA MUCILAGINOSA) RHODOTORULA MUCILAGINOSA 0.1 g in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE 0.005 g in 1 mL SODIUM BICARBONATE 0.0027 g in 1 mL PHENOL 0.004 mL in 1 mL HYDROCHLORIC ACID SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0268-8104-50 53 mL in 1 VIAL None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

TRICHOPHYTON MENTAGROPHYTES trichophyton mentagrophytes injection, solution

Product Information Product Type NON-STANDARDIZED ALLERGENIC Item Code (Source) NDC:0268-8107 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TRICHOPHYTON MENTAGROPHYTES (TRICHOPHYTON MENTAGROPHYTES) TRICHOPHYTON MENTAGROPHYTES 0.1 g in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE 0.005 g in 1 mL SODIUM BICARBONATE 0.0027 g in 1 mL PHENOL 0.004 mL in 1 mL HYDROCHLORIC ACID SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0268-8107-50 53 mL in 1 VIAL None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date BLA BLA103753 01/01/1965

Labeler — ALK-Abello, Inc. (809998847)

Revised: 05/2023 ALK-Abello, Inc.