Short and Giant Ragweed Pollen Mix: Package Insert and Label Information

SHORT AND GIANT RAGWEED POLLEN MIX- ambrosia artemisiifolia pollen and ambrosia trifida pollen solution
SHORT RAGWEED POLLEN- ambrosia artemisiifolia pollen solution
Greer Laboratories, Inc.

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use Short Ragweed Pollen Allergenic Extract and Short and Giant Ragweed Pollen Mix Allergenic Extract safely and effectively. See full prescribing information for Short Ragweed Pollen Allergenic Extract and Short and Giant Ragweed Pollen Mix Allergenic Extract.

Short Ragweed Pollen Allergenic Extract

Short and Giant Ragweed Pollen Mix Allergenic Extract

Solutions for percutaneous, intradermal, or subcutaneous administration.

Initial U.S. Approval: 1982

WARNING: SEVERE ALLERGIC REACTIONS

See full prescribing information for complete boxed warning.

  • Short Ragweed Pollen Allergenic Extract and Short and Giant Ragweed Pollen Mix Allergenic Extract can cause severe life-threatening systemic reactions, including anaphylaxis. (5.1)
  • Do not administer these products to patients with severe, unstable or uncontrolled asthma. (4)
  • Observe patients in the office for at least 30 minutes following treatment.Emergency measures and personnel trained in their use must be available immediately in the event of a life-threatening reaction. (5.1)
  • Patients with extreme sensitivity to these products, on an accelerated immunotherapy build-up, switching to another lot, receiving high doses of these products, or those also exposed to similar allergens may be at increased risk of a severe allergic reaction. (5.1)
  • These products may not be suitable for patients with certain underlying medical conditions that may reduce their ability to survive a serious allergic reaction, or for patients who may be unresponsive to epinephrine or inhaled bronchodilators, such as those taking beta-blockers. (5.1, 5.2)

INDICATIONS AND USAGE

Short Ragweed Pollen Allergenic Extract and Short and Giant Ragweed Pollen Mix Allergenic Extract are indicated for:

  • Skin test diagnosis of patients with a clinical history of allergy to ragweed pollen (Short Ragweed or Short and Giant Ragweed pollen). (1)
  • Immunotherapy for the reduction of ragweed pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Short and/or Giant Ragweed pollen. (1)

DOSAGE AND ADMINISTRATION

For percutaneous, intradermal or subcutaneous use only.

The extracts are diluted with sterile diluents when used for intradermal testing or subcutaneous immunotherapy. For percutaneous testing, the extracts are diluted with sterile diluents in patients expected to be at greater risk for systemic allergic reaction. Dosages vary by mode of administration and by individual response. See full prescribing information for instructions on preparation, administration, and adjustments of dose. (2.1)

DOSAGE FORMS AND STRENGTHS

Short Ragweed Pollen Allergenic Extract solution; stock concentrates at 1:20 weight/volume with Antigen E (Amb a 1) concentration labeled in Units/milliliter. (3)

Short and Giant Ragweed Pollen Mix Allergenic Extract solution: stock concentrates at 1:20 weight/volume with Antigen E (Amb a 1) concentration labeled in Units/milliliter. (3)

CONTRAINDICATIONS

  • Severe, unstable or uncontrolled asthma. (4)
  • History of any severe systemic allergic reaction or any severe local reaction to subcutaneous allergen immunotherapy. (4)

WARNINGS AND PRECAUTIONS

Severe allergic reactions have occurred following the administration of other allergenic extracts and may occur in individuals following the administration of Short Ragweed Pollen Allergenic Extract or Short and Giant Ragweed Pollen Mix Allergenic Extract in the following situations:

  • Extreme sensitivity to these products, receipt of high doses of these products, or concomitant exposure to similar environmental allergens. (5.1)
  • Receiving an accelerated immunotherapy build-up schedule (e.g., “rush” immunotherapy), or changing from one allergenic lot to another. (5.1)

ADVERSE REACTIONS

The most common adverse reactions occurring in 26 to 82% of all patients who receive subcutaneous immunotherapy are local adverse reactions at the injection site (e.g., erythema, itching, swelling, tenderness, pain). (6)

Systemic adverse reactions, occurring in < 7% of patients who receive subcutaneous immunotherapy, include generalized skin erythema, urticaria, pruritus, angioedema, rhinitis, wheezing, laryngeal edema, and hypotension. These can be fatal. (6)

To report SUSPECTED ADVERSE REACTIONS, contact GREER Laboratories, Inc. at 1-855-274-1322 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

DRUG INTERACTIONS

Antihistamines and other medications that suppress histamine, including topical corticosteroids, topical anesthetics and tricyclic antidepressants can interfere with skin test results. (7.1)

See 17 for PATIENT COUNSELING INFORMATION

FULL PRESCRIBING INFORMATION: CONTENTS*

WARNING: SEVERE ALLERGIC REACTIONS
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION

2.1 Preparation for Administration
2.2 Diagnostic Testing
2.3 Immunotherapy
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Serious Systemic Adverse Reactions
5.2 Epinephrine
5.3 Cross-Reactions and Dose Sensitivity
6 ADVERSE REACTIONS
7 DRUG INTERACTIONS
7.1 Antihistamines
7.2 Topical Corticosteroids and Topical Anesthetics
7.3 Tricyclic Antidepressants
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
14 CLINICAL STUDIES
15 REFERENCES
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1 How Supplied
16.2 Storage and Handling
17 PATIENT COUNSELING INFORMATION *Sections or subsections omitted from the Full Prescribing Information are not listed.

FULL PRESCRIBING INFORMATION

WARNING: SEVERE ALLERGIC REACTIONS

  • Short Ragweed Pollen Allergenic Extract and Short and Giant Ragweed Pollen Mix Allergenic Extract can cause severe life-threatening systemic reactions, including anaphylaxis. (5.1)
  • Do not administer these products to patients with severe, unstable or uncontrolled asthma. (4)
  • Observe patients in the office for at least 30 minutes following treatment.Emergency measures and personnel trained in their use must be available immediately in the event of a life-threatening reaction. (5.1)
  • Patients with extreme sensitivity to these products, those on an accelerated immunotherapy build-up schedule, those switching to another allergenic lot, those receiving high doses of these products, or those also exposed to similar allergens may be at increased risk of a severe allergic reaction. (5.1)
  • These products may not be suitable for patients with certain underlying medical conditions that may reduce their ability to survive a serious allergic reaction. (5.1)
  • These products may not be suitable for patients who may be unresponsive to epinephrine or inhaled bronchodilators, such as those taking beta-blockers. (5.2)

1 INDICATIONS AND USAGE

Short Ragweed Pollen Allergenic Extract and Short and Giant Ragweed Pollen Mix Allergenic Extract are indicated for:

  • Skin test diagnosis of patients with a clinical history of allergy to ragweed pollen (Short Ragweed or Short and Giant Ragweed Pollen).
  • Immunotherapy for the reduction of ragweed pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Short and/or Giant Ragweed pollen.

2 DOSAGE AND ADMINISTRATION

For percutaneous, intradermal or subcutaneous use only.

The extracts are diluted with sterile diluents when used for intradermal testing or subcutaneous immunotherapy. For percutaneous testing, the extracts are diluted with sterile diluents in patients expected to be at greater risk for systemic allergic reaction. Dosages vary by mode of administration and by individual response.

2.1 Preparation for Administration

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard solution if either of these conditions exist.

The extracts are diluted with sterile diluents when used for percutaneous and intradermal testing, or for subcutaneous immunotherapy.

Undiluted 1:20 weight/volume stock concentrate is used for percutaneous testing. To prepare 10-fold dilutions for percutaneous testing in patients suspected to be at greater risk for systemic allergic reaction, start with a 1:20 weight/volume stock concentrate. Proceed as in Table 1. The 10-fold dilution series uses 0.5 milliliters of concentrate added to 4.5 milliliters of sterile 50% glycerin diluent. Subsequent dilutions are made in a similar manner.

To prepare 10-fold dilutions for intradermal testing and immunotherapy, start with a 1:20 weight/volume stock concentrate. Proceed as in Table 1. The 10-fold dilution series uses 0.5 milliliter of concentrate added to 4.5 milliliters of sterile diluent (glycerin-free diluents for intradermal testing, glycerin-free or 10% glycerin saline diluents for immunotherapy). Subsequent dilutions are made in a similar manner.

Table 1: 10-fold Dilution Series
Dilution Extract Milliliters of Diluent Dilution Strength

Dilution Strength [AgE (Amb a 1) Units/mL]

Short Ragweed Pollen Short and Giant Ragweed Pollen Mix
0Concentrate1:20150 — 30075 — 150
10.5 mL Concentrate4.51:20015 — 307.5 — 15
20.5 mL Dilution 14.51:2,0001.5 — 30.75 — 1.5
30.5 mL Dilution 24.51:20,000

0.15 — 0.3

0.075 — 0.15
40.5 mL Dilution 34.51:200,000

0.015 — 0.03

0.0075 — 0.015

50.5 mL Dilution 44.51:2,000,0000.0015 — 0.0030.00075 — 0.0015
60.5 mL Dilution 54.51:20,000,0000.00015 — 0.00030.000075 — 0.00015

Undiluted 1:20 weight/volume stock concentrate is typically used for percutaneous testing. To prepare 5-fold dilutions for percutaneous testing in patients suspected to be at greater risk for systemic allergic reaction, start with a 1:20 weight/volume stock concentrate. Proceed as in Table 2. The 5-fold dilution series uses 1 milliliter of concentrate added to 4 milliliters of sterile 50% glycerin diluent. Subsequent dilutions are made in a similar manner.

To prepare 5-fold dilutions for intradermal testing or immunotherapy, start with a 1:20 weight/volume (w/v) stock concentrate. Proceed as in Table 2. The 5-fold dilution series uses 1 milliliter of concentrate added to 4 milliliters of sterile diluent (glycerin-free diluents for intradermal testing, glycerin-free or 10% glycerin saline diluents for immunotherapy). Subsequent dilutions are made in a similar manner.

Table 2: 5-fold Dilution Series
Dilution Extract Milliliters of Diluent Dilution Strength (w/v) Dilution Strength [AgE (Amb a 1) Units/mL]
Short Ragweed Pollen Short and Giant Ragweed Pollen Mix
0Concentrate1:20150 — 30075 — 150
11 mL Concentrate41:10030 — 6015 — 30
21 mL Dilution 141:5006 — 123 — 6
31 mL Dilution 241:2,5001.2 — 2.40.06 — 1.2
41 mL Dilution 341:12,5000.24 — 0.48

0.12 — 0.24

51 mL Dilution 541:62,5000.048 — 0.0960.024 — 0.048
61 mL Dilution 441:312,500

0.0096 — 0.0192

0.0048 — 0.0096

2.2 Diagnostic Testing

Diagnostic testing can be performed via percutaneous or intradermal administration of the Short Ragweed Pollen Allergenic Extract and Short and Giant Ragweed Pollen Mix Allergenic Extract. A positive skin test reaction must be interpreted in relation to the patient’s history and known exposure to the allergen.

If a skin test with the Short and Giant Ragweed Pollen Mix Allergenic Extract elicits a positive reaction, then the single-species ragweed pollen allergenic extracts can be used to determine the degree of sensitivity to each, and to guide in the selection of extracts and their concentration for immunotherapy, if indicated.

Percutaneous Skin Testing

Determine the patient’s sensitivity to the ragweed pollen allergens.

Prick or puncture testing: use 1:20 weight/volume extract stock concentrate.

In patients suspected to be at greater risk for systemic allergic reaction, initiate testing with serial 10-fold or 5-fold dilutions.

Preparation and Dose

For percutaneous testing (prick or puncture) use 1:20 weight/volume stock concentrate. If a lower concentration is desired in patients suspected to be at greater risk for a systemic allergic reaction, 10-fold or 5-fold dilutions of the concentrate can be tested.

Prick test: Place one drop of extract or control on the skin and, with a skin test device, pierce through the drop into the skin with a slight lifting motion. Alternatively, use skin test devices loaded with the extract from the storage trays in a similar manner, or in accordance with the device manufacturer’s recommendations.

Puncture test: Place one drop of extract or control on the skin and pierce the skin through the drop with a skin test device perpendicular to the skin. Alternatively, use skin test devices loaded with the extract from the storage trays in a similar manner, or in accordance with the device manufacturer’s recommendations.

Interpreting Results

When using percutaneous skin test devices, follow the directions provided with the test devices. A glycerinated histamine control solution (6 milligrams/milliliter or 1 milligram/milliliter histamine base) may be used as the positive control. A 50% glycerin saline solution may be used as the negative control.

Read and record skin test responses 15 to 20 minutes after exposure. Individual patient reactivity can vary with time, allergen potency, and/or immunotherapy, as well as testing technique. The most reliable method of recording a skin test reaction is to measure the largest diameter of both wheal and erythema. While some correlation exists between the size of the skin test reaction and the degree of sensitivity, other factors should be considered in the diagnosis of allergy to specific allergens (see Figure 1 below).

Figure 1: Measurement of Wheal and Flare

To measure the Wheal and Flare, use a paper or plastic millimeter skin reaction guide as shown below.

Figure_1
(click image for full-size original)

When the timer goes off 15 minutes after application of the skin test, measure the length and midpoint orthogonal width of each flare and wheal from the inner edge of the reaction.

Length_and_Midpoint_Orthogonal_Width
(click image for full-size original)

The length of the skin test is defined as the largest diameter and the width of the skin test is defined as the diameter perpendicular to the length at its midpoint. Consider the wheal and flare as separate entities. First measure the flare and then independently measure the wheal.

Measuring the Flare

Measure_the_Flare
(click image for full-size original)

Measuring the Wheal

Measuring_the_Wheal
(click image for full-size original)

The average diameter measurement in the example above of the flare is (26 mm + 36 mm)/2 = 31 mm and the average diameter of the wheal is (10 mm + 16 mm)/2 = 13 mm.

Responses to positive controls should be at least 3 millimeters larger than responses to the negative controls.

Negative controls should elicit no reaction or only reactions of small diameter (wheal less than 3 millimeters, erythema less than 5 millimeters).

If either the positive or negative control response does not meet the above criteria, results for allergenic extracts tested at the same time should be considered invalid and be repeated.

Intradermal Skin Testing

Preparation and Dose

For intradermal testing, use 1:20 weight/volume of Short Ragweed Pollen Allergenic Extract and Short and Giant Ragweed Pollen Mix Allergenic Extract stock concentrate solution. Dilute the stock concentrate solution with sterile diluent [see Dosage and Administration (2.1)]. Use normal or buffered saline or normal saline with human serum albumin (HSA) diluent. If the result from the initial test dose is negative, subsequent intradermal tests using increasingly stronger doses may be performed up to the maximum recommended strength of 1:25 volume to volume dilution of the extract concentrate solution.

Inject 0.02 milliliters of the following solutions intradermally as shown in Figure 2:

Figure 2: Algorithm for Dilution of Stock Concentrate Solution of Short Ragweed Pollen Allergenic Extract and Short and Giant Ragweed Pollen Mix Allergenic Extract for Intradermal Skin Testing

Figure_2
(click image for full-size original)

1 Corresponds to 1:10,000 — 1:15,625 volume to volume dilution of extract concentrate solution

2 Corresponds to 1:100 — 1:125 volume to volume dilution of extract concentrate solution

3 Corresponds to 1:50 — 1:100 volume to volume dilution of extract concentrate solution

4 Corresponds to 1:25 — 1:100 volume to volume dilution of extract concentrate solution

2.3 Immunotherapy

For subcutaneous administration only.

Preparation and Dose

Stock concentrates of Short Ragweed Pollen Allergenic Extract and Short and Giant Ragweed Pollen Mix Allergenic Extract are available at 1:20 weight/volume in 50% glycerin saline for immunotherapy. Stock concentrates are diluted in normal saline, buffered saline, HSA saline, or 10% glycerin saline, depending on the patient’s reactivity to the diluent. See Table 1 and Table 2 for dilution preparation.

Administration of Immunotherapy

Administer immunotherapy by subcutaneous injection in the lateral aspect of the upper arm or thigh. Avoid injection directly into any blood vessel.

The optimal interval between doses of allergenic extract varies among individuals. Injections are usually given 1 to 2 times per week until the maintenance dose is reached, at which time the injection interval is increased to 2, then 3, and finally 4 weeks. Dosages vary by mode of administration, and by clinical response and tolerance. The minimum course of treatment may be three to five years, depending on the clinical response.

Guidelines for Immunotherapy

The initial dose of the extract should be based on the skin test reactivity. In patients suspected to be at greater risk for systemic allergic reaction by history and skin test, the initial dose of the extract should be 0.05 milliliter of a 1:20,000,000 to 1:2,000,000 weight/volume extract dilution. Patients not suspected to be at greater risk for systemic allergic reaction may be started at a 0.1 milliliter of a 1:200,000 to 1:20,000 weight/volume extract dilution.

The dose of allergenic extract is increased at each injection by no more than 50% of the previous dose, and the next increment is governed by the response to the last injection.

Select the maximum tolerated maintenance dose based on the patient’s clinical response and tolerance. Doses larger than 0.2 milliliter of the stock concentrate are rarely administered because an extract mixed in 50% glycerin diluent can cause discomfort upon injection.

Dosage Modification Guidelines for Immunotherapy

The following conditions may indicate a need to withhold or reduce the dosage of immunotherapy.

  • Symptoms of rhinitis and/or asthma
  • Infection accompanied by fever
  • Exposure to excessive amounts of clinically relevant environmental allergen prior to a scheduled injection
  • Large local reactions that persist for longer than 24 hours can be an indication for repeating the previous dose or reducing the dose at the next administration

Any evidence of a systemic adverse reaction is an indication for a significant reduction (at least 75%) in the subsequent dose. Repeated systemic adverse reactions are sufficient reason for the cessation of further attempts to increase the dose.

Local adverse reactions require a decrease in the next dose by at least 50%. Proceed cautiously in subsequent dosing. In situations prompting dose reduction, once the reduced dose is tolerated, a cautious increase in dosage can be attempted.

Changing extract to a different lot or from a different manufacturer: When switching patients to a different lot of extract, or from another manufacturer’s extract, decrease the starting dose. Because manufacturing processes and sources of raw materials differ among manufacturers, the interchangeability of extracts from different manufacturers cannot be assured. In general, a dose reduction of 50 to 75% of the previous dose should be adequate, but each situation must be evaluated separately, considering the patient’s history of sensitivity, tolerance of previous injections, and other factors. Dose intervals should not exceed one week when rebuilding the dose.

Unscheduled gaps between treatments: Patients can lose tolerance for allergen injections during prolonged periods between doses, thus increasing their risk for an adverse reaction. The duration of tolerance between injections varies from patient to patient.

During the build-up phase, when patients receive injections 1 to 2 times per week, repeat or reduce the extract dosage if there has been a substantial time interval between injections. This depends on: 1) the concentration of allergen immunotherapy extract that is to be administered; 2) a previous history of systemic reactions; and 3) the degree of variation from the prescribed interval of time, with longer intervals since the last injection leading to greater reductions in the dose to be administered.

This suggested approach to dose modification, due to unscheduled gaps between treatments during the build-up phase, is not based on published evidence. The individual physician should use this or a similar protocol for the specific clinical setting.

Similarly, if unscheduled gaps occur during maintenance therapy, it may be necessary to reduce the dosage and bring the patient up to maintenance dosing using an established build-up protocol.

Changing from non-stabilized to human serum albumin (HSA) stabilized diluents: Allergenic extracts prepared with diluents containing HSA and 0.4% phenol are more stable than those prepared with diluents that do not contain stabilizers. When switching from a non-stabilized to an HSA‑stabilized diluent, consider lowering the dose for immunotherapy.

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