Pollen Extracts

 

WARNING: SEVERE ALLERGIC REACTIONS GRASTEK can cause life-threatening allergic reactions such as anaphylaxis and severe laryngopharyngeal restriction. Do not administer GRASTEK to patients with severe, unstable or uncontrolled asthma. Observe patients in the office for at least 30 minutes following the initial dose. Prescribe auto-injectable epinephrine, instruct and train patients on its appropriate use, and instruct patients to seek immediate medical care upon its use. GRASTEK may not be suitable for patients with certain underlying medical conditions that may reduce their ability to survive a serious allergic reaction. GRASTEK may not be suitable for patients who may be unresponsive to epinephrine or inhaled bronchodilators, such as those taking beta-blockers.

INDICATIONS AND USAGE:
GRASTEK® is an allergen extract indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for Timothy grass or cross-reactive grass pollens. GRASTEK is approved for use in persons 5 through 65 years of age.

GRASTEK is not indicated for the immediate relief of allergic symptoms.

DOSAGE AND ADMINISTRATION:
 For sublingual use only.
Dose:  One GRASTEK tablet daily.

Administration:
Administer the first dose of GRASTEK in a healthcare setting under the supervision of a physician with experience in the diagnosis and treatment of allergic diseases. After receiving the first dose of GRASTEK, observe the patient for at least 30 minutes to monitor for signs or symptoms of a severe systemic or a severe local allergic reaction. If the patient tolerates the first dose, the patient may take subsequent doses at home.

• Administer GRASTEK to children under adult supervision.
• Take the tablet from the blister unit after carefully removing the foil with dry hands.
• Place the tablet immediately under the tongue. Allow it to remain there until completely dissolved. Do not swallow for at least 1 minute.
• Wash hands after handling the tablet.
• Do not take the tablet with food or beverage. Food or beverage should not be taken for the following 5 minutes after taking the tablet.

Initiate treatment at least 12 weeks before the expected onset of each grass pollen season and continue treatment throughout the season. For sustained effectiveness for one grass pollen season after cessation of treatment, GRASTEK may be taken daily for three consecutive years (including the intervals between the grass pollen seasons). The safety and efficacy of initiating treatment in season have not been established.

Data regarding the safety of restarting treatment after missing a dose of GRASTEK are limited. In the clinical trials, treatment interruptions for up to seven days were allowed.

Prescribe auto-injectable epinephrine to patients prescribed GRASTEK and instruct them in the proper use of emergency self-injection of epinephrine.

CONTRAINDICATIONS: GRASTEK is contraindicated in patients with:

• Severe, unstable or uncontrolled asthma
• A history of any severe systemic allergic reaction
• A history of any severe local reaction after taking any sublingual allergen immunotherapy
• A history of eosinophilic esophagitis
• Hypersensitivity to any of the inactive ingredients [gelatin, mannitol and sodium hydroxide] contained in this product

WARNINGS AND PRECAUTIONS:
Inform patients of the signs and symptoms of serious allergic reactions and instruct them to seek immediate medical care and discontinue therapy should any of these occur.

In case of oral inflammation or wounds, stop treatment with GRASTEK to allow complete healing of the oral cavity.

ADVERSE REACTIONS:
Adverse reactions reported in ≥5% of patients were: ear pruritus, oral pruritus, tongue pruritus, mouth edema, throat irritation.

To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

See package insert for PATIENT COUNSELING INFORMATION and Medication Guide.

USE IN SPECIFIC POPULATIONS:
Pregnancy
Pregnancy Category B: Reproductive and developmental toxicity studies performed in female mice have revealed no evidence of harm to the fetus due to GRASTEK. In these studies, the effect of Timothy grass (Phleum pratense) pollen allergen extract, the active component of GRASTEK, on embryo-fetal development was evaluated. Mice were administered approximately 460,000 BAU/kg/day of Timothy grass pollen allergen extract by oral gavage on days 0 to 15 of gestation. A dose of 460,000 BAU/kg/day of Timothy grass pollen allergen extract corresponds to approximately 8,200-fold a human dose on a BAU/kg/day basis. No adverse effects on embryo-fetal development were observed. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, GRASTEK should be used during pregnancy only if clearly needed.

Because systemic and local adverse reactions with immunotherapy may be poorly tolerated during pregnancy, GRASTEK should be used during pregnancy only if clearly needed.

Nursing Mothers
It is not known if GRASTEK is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when GRASTEK is administered to a nursing woman.

Pediatric Use
Efficacy and safety of GRASTEK have been established in children and adolescents 5 through 17 years of age.

The safety and efficacy in pediatric patients below 5 years of age have not been established.

Geriatric Use
There is no clinical trial experience with GRASTEK in patients over 65 years of age.

DOSAGE FORMS AND STRENGTHS:
GRASTEK is available as 2800 Bioequivalent Allergy Unit (BAU) tablets that are white to off-white, circular with a debossed round detail on one side.

SOURCE:
Package insert data: accessed: June 2014
Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

Manufactured by:
Catalent Pharma Solutions Limited, Blagrove,
Swindon, Wiltshire, SN5 8RU UK

For patent information: www.merck.com/product/patent/home.html

Copyright © 2014 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.  Revised: 4/2014

WARNING: SEVERE ALLERGIC REACTIONS  See full prescribing information for complete boxed warning

• ORALAIR can cause life - threatening allergic reactions such as anaphylaxis and sever e laryngopharyngeal edema .
• Do not administer ORALAIR to patients with severe unstable or uncontrolled asthma .
• Observe patients in the office for at least 30 minutes following the initial dose .
• Prescribe auto - injectable epinephrine instruct and train patients on its appropriate use and instruct patients to seek immediate medical care upon its use .
• ORALAIR may not be suitable for patients with certain underlying medical conditions that may reduce their ability to survive a serious allergic reaction.
• ORALAIR may not be suitable for patients who may be unresponsive to epinephrine or inhaled bronchodila tors such as t hose taking beta - blockers.

 

INDICATIONS AND USAGE:
ORALAIR is an allergen extract indicated as immunotherapy for the treatment of grass pollen - induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen - specific IgE antibodies for any of the five grass sp ecies contained in this product . ORALAIR is approved for use in persons 10 through 65 years of age

DOSAGE AND ADMINISTRATION:
Recommended Dose and Dosage Adjustment - For sublingual use only
For adults 18 through 65 years of age, the dose is 300 IR (index of reactivity) daily. For children and adolescents 10 through 17 years of age, the dose is increased over the first three days as shown in Table 1.
Table 1: Dosage for Adults and Children for the Days 1-3 (and following)

Age (years)	Dose
	Day 1	Day 2	Day 3 and following
10-17	100 IR	2x 100 IR	300 IR
18-65	300 IR	300 IR	300 IR

 

• Initiate treatment 4 months before the expected onset of each grass pollen season and continue treatment throughout the season.
• Place the tablet under the tongue for at least 1 minute until complete dissolution and then swallow .
• Administer the first dose of ORALAIR under the supervision of a physician with experience in the diagnosis and treatment of severe allergic reactions . Observe the patient for at least 30 minutes .

 

Administration
Administer the first dose of ORALAIR in a healthcare setting in which acute allergic reactions can be treated under the supervision of a physician with experience in the diagnosis and treatment of severe allergic reactions. After receiving the first dose of ORALAIR, observe the patient for at least 30 minutes to monitor for signs or symptoms of a severe systemic or a severe local allergic reaction. If the patient tolerates the first dose, the patient may take subsequent doses at home.

Administer ORALAIR to children under adult supervision.

Remove the ORALAIR tablet from the blister just prior to dosing.

Place the ORALAIR tablet immediately under the tongue until complete dissolution for at least 1 minute before swallowing.

Wash hands after handling the ORALAIR tablet.

Do not take the ORALAIR tablet with food or beverage. To avoid swallowing allergen extract, food or beverage should not be taken for 5 minutes following dissolution of the tablet.

Initiate treatment 4 months before the expected onset of each grass pollen season and maintain it throughout the grass pollen season.

Data regarding the safety of starting treatment during the pollen season or restarting treatment after missing a dose of ORALAIR are not available.

It is recommended that auto-injectable epinephrine be made available to patients prescribed ORALAIR. Patients who are prescribed epinephrine while receiving immunotherapy should be instructed in the proper use of emergency self-injection of epinephrine [See WARNINGS AND PRECAUTIONS].

 

CONTRAINDICATIONS:
Immunotherapy with specific antigens is not indicated in those individuals who do not exhibit positive cutaneous test and clinical history of disease to the particular antigens see WARNINGS AND PRECAUTIONS . A patient should not be immunized with preparations of allergens to which the patient has not demonstrated symptoms IgE antibodies positive skin tests or properly controlled challenge testing. In most cases immunotherapy is not indicated for those allergens that can be eliminated or minimized by environmental control.

 

ORALAIR is contraindicated in patients with:

 

• Severe, unstable or uncontrolled asthma
• History of any severe systemic allergic reaction
• History of any severe local reaction to sublingual allergen immunotherapy
• Hypersensitivity to any of the inactive ingredients (mannitol, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate and lactose monohydrate) contained in this product

 

WARNINGS AND PRECAUTIONS:

• Treatment with ORALAIR should only be prescribed and initiated by physicians with adequate training and experience in the treatment of respiratory allergic diseases. In case of pediatric treatment the physicians should have the corresponding training and experience in children.
• The first tablet of ORALAIR must be taken at the physician's office under medical supervision and the patient must be monitored for at least 30 minutes.
• Extra precautions must be taken while treating pediatric patients including: each administration of ORALAIR must be given under direct adult supervision for at least 30 minutes.
• When treated with ORALAIR the patient is exposed to the allergen that causes the allergic symptoms. Therefore mild or moderate local allergic reactions are to be expected during the treatment period.
• Patients should be instructed in recognizing adverse reactions and their possible severity. If the patient experiences moderate local adverse reactions from the treatment anti- allergic medication e.g. antihista mines should be considered.
• Hypersensitivity diarrhea and angioneurotic edema have occurred during clinical trials within the first year of treatment with ORALAIR. If severe systemic reactions occur emergency medical treatment should be sought immediately an d treatment with ORALAIR should be discontinued.

ADVERSE REACTIONS:
Adverse reactions reported in ≥5% of patients were: oral pruritus, throat irritation, ear pruritus, mouth edema, tongue pruritus, cough, oropharyngeal pain.

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

USE IN SPECIFIC POPULATIONS:  SEE PACKAGE INSERT:

• Pregnancy  -Pregnancy Category B: Reproductive and developmental toxicity studies performed in female rats and rabbits have revealed no evidence of harm to the fetus due to ORALAIR . In these stud ies the effect of ORALAIR on embryo - fetal development was evaluated. Animals were administered 1000 IR/kg/day of ORALAIR by oral gavage on days 6 - 17 of gestation for rats and days 6 - 18 of gestation for rabbits. A dose of 1000 IR/kg/day of ORALAIR corresponds to approximately 200 fold a human dose on a n IR /kg/day basis. No adverse effects on embryo - fetal development were observed. There are however no adequate and well control led studies in pregnant women. Because animal reproduction studies are not always predictive of human response ORALAIR should be used during pregnancy only if clearly needed. Because systemic and local adverse reactions with immunotherapy may be poorly tolerated during pregnancy ORALAIR should be used during pregnancy only if clearly needed
• Labor and Delivery - Safety and effectiveness of ORALAIR in labor and delivery have not been established.
• Nursing Mothers -It is not known if ORALAIR is excreted in human milk. Because many dr ugs are excreted in human milk caution should be exercised when ORALAIR is administered to a nursing woman.
• Pediatric Use - Efficacy and safety of ORALAIR have been established in children and adolescents 10 through 17 years of age . ORALAIR is not approved for use in children younger than 10 years of age because safety has not been established.
• Geriatric Use - ORALAIR has not been studied in patients over 65 years of age

DOSAGE FORMS AND STRENGTHS:
100 IR tablet is engraved “100” on both surfaces
300 IR tablet is engraved “300” on both surfaces

SOURCE:
Package insert data: accessed June 2014.

WARNING: SEVERE ALLERGIC REACTIONS

• RAGWITEK can cause life-threatening allergic reactions such as anaphylaxis and severe laryngopharyngeal restriction.
• Do not administer RAGWITEK to patients with severe, unstable or uncontrolled asthma.
• Observe patients in the office for at least 30 minutes following the initial dose.
• Prescribe auto-injectable epinephrine, instruct and train patients on its appropriate use, and instruct patients to seek immediate medical care upon its use.
• RAGWITEK may not be suitable for patients with certain underlying medical conditions that may reduce their ability to survive a serious allergic reaction.
• RAGWITEK may not be suitable for patients who may be unresponsive to epinephrine or inhaled bronchodilators, such as those taking beta-blockers. 

INDICATIONS AND USAGE:
RAGWITEK™ is an allergen extract indicated as immunotherapy for the treatment of short ragweed pollen-induced allergic rhinitis, with or without conjunctivitis, confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for short ragweed pollen. RAGWITEK is approved for use in adults 18 through 65 years of age.

RAGWITEK is not indicated for the immediate relief of allergic symptoms.

DOSAGE AND ADMINISTRATION:
For sublingual use only.
Dose: One RAGWITEK tablet daily.

Administration:  Administer the first dose of RAGWITEK in a healthcare setting under the supervision of a physician with experience in the diagnosis and treatment of allergic diseases. After receiving the first dose of RAGWITEK, observe the patient for at least 30 minutes to monitor for signs or symptoms of a severe systemic or a severe local allergic reaction. If the patient tolerates the first dose, the patient may take subsequent doses at home.

• Take the tablet from the blister unit after carefully removing the foil with dry hands.
• Place the tablet immediately under the tongue. Allow it to remain there until completely dissolved. Do not swallow for at least 1 minute.
• Wash hands after handling the tablet.
• Do not take the tablet with food or beverage. Food or beverage should not be taken for the following 5 minutes after taking the tablet.

Initiate treatment at least 12 weeks before the expected onset of ragweed pollen season and continue treatment throughout the season. The safety and efficacy of initiating treatment in season have not been established.

Data regarding the safety of restarting treatment after missing a dose of RAGWITEK are limited. In the clinical trials, treatment interruptions for up to seven days were allowed.

Prescribe auto-injectable epinephrine to patients prescribed RAGWITEK and instruct them in the proper use of emergency self-injection of epinephrine.

CONTRAINDICATIONS:
RAGWITEK is contraindicated in patients with:

• Severe, unstable or uncontrolled asthma
• A history of any severe systemic allergic reaction
• A history of any severe local reaction after taking any sublingual allergen immunotherapy
• A history of eosinophilic esophagitis
• Hypersensitivity to any of the inactive ingredients [gelatin, mannitol, and sodium hydroxide] contained in this product

WARNINGS AND PRECAUTIONS:
Inform patients of the signs and symptoms of serious allergic reactions and instruct them to seek immediate medical care and discontinue therapy should any of these occur.

In case of oral inflammation or wounds, stop treatment with RAGWITEK to allow complete healing of the oral cavity.

ADVERSE REACTIONS::
 Adverse reactions reported in ≥5% of patients were: throat irritation, oral pruritus, ear pruritus, oral paraesthesia, mouth edema, and tongue pruritus.

To report SUSPECTED ADVERSE REACTIONS, contact Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-877-888-4231 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

See package insert for PATIENT COUNSELING INFORMATION and Medication Guide.

USE IN SPECIFIC POPULATIONS:
Pregnancy
Pregnancy Category C:
Animal reproduction studies have not been performed with RAGWITEK. It is also not known whether RAGWITEK can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. RAGWITEK should be used during pregnancy only if clearly needed.

Because systemic and local adverse reactions with immunotherapy may be poorly tolerated during pregnancy, RAGWITEK should be used during pregnancy only if clearly needed.

Nursing Mothers
It is not known if RAGWITEK is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when RAGWITEK is administered to a nursing woman.

Pediatric Use
RAGWITEK is not approved for use in pediatric patients because safety and efficacy have not been established.

Geriatric Use
RAGWITEK is not approved for use in patients over 65 years of age because safety and efficacy have not been established.

DOSAGE FORMS AND STRENGTHS:
RAGWITEK is available as 12 Amb a 1-Unit (Amb a 1-U) tablets that are white to off-white, circular with a debossed double hexagon on one side.

SOURCE:
Package insert data: Accessed: June 2014
Manufactured for: Merck Sharp & Dohme Corp., a subsidiary of
MERCK & CO., INC., Whitehouse Station, NJ 08889, USA

Manufactured by:
Catalent Pharma Solutions Limited, Blagrove,
Swindon, Wiltshire, SN5 8RU UK

For patent information: www.merck.com/product/patent/home.html

Copyright © 2014 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.

Revised: 04/2014