GRASTEK- timothy grass pollen allergen extract tablet

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

PHLEUM PRATENSE POLLEN (UNII: 65M88RW2EG) (PHLEUM PRATENSE POLLEN - UNII:65M88RW2EG)

Disponible desde:

ALK-Abello A S

Designación común internacional (DCI):

PHLEUM PRATENSE POLLEN

Composición:

PHLEUM PRATENSE POLLEN 2800 [BAU]

Vía de administración:

SUBLINGUAL

indicaciones terapéuticas:

      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.       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 [ s ee Description ( 11 )].       Risk Summary       All pregnancies have a risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated b

Resumen del producto:

      GRASTEK 2800 BAU tablets are white to off-white, circular sublingual tablets with a debossed round detail on one side.       GRASTEK is supplied as follows:       3 blister packages of 10 tablets (30 tablets total). NDC 52709-1501-3       Store at controlled room temperature 20ºC-25ºC (68ºF-77ºF); excursions permitted between 15ºC-30ºC (59ºF-86ºF). Store in the original package until use to protect from moisture.

Estado de Autorización:

Biologic Licensing Application

Información para el usuario

ALK-Abello A S
----------
MEDICATION GUIDE
GRASTEK® (GRAS-tek)
(Timothy Grass Pollen Allergen Extract)
Carefully read this Medication Guide before you or your child start
taking GRASTEK and each time you get
a refill. This Medication Guide does not take the place of talking to
your doctor about your medical condition
or treatment. Talk with your doctor or pharmacist if there is
something you do not understand or you want to
learn more about GRASTEK.
What is the Most Important Information I Should Know about GRASTEK?
GRASTEK can cause severe allergic reactions that may be
life-threatening. Stop taking GRASTEK and get
medical treatment right away if you or your child has any of the
following symptoms after taking
GRASTEK:
•
Trouble breathing
•
Throat tightness or swelling
•
Trouble swallowing or speaking
•
Dizziness or fainting
•
Rapid or weak heartbeat
•
Severe stomach cramps or pain, vomiting, or diarrhea
•
Severe flushing or itching of the skin
For home administration of GRASTEK, your doctor will prescribe
auto-injectable epinephrine, a medicine
you can inject if you or your child has a severe allergic reaction
after taking GRASTEK. Your doctor will
train and instruct you on the proper use of auto-injectable
epinephrine.
Talk to your doctor or read the epinephrine patient information if you
have any questions about the use of
auto-injectable epinephrine.
What is GRASTEK?
GRASTEK is a prescription medicine used for sublingual (under the
tongue) immunotherapy to treat
Timothy and related grass pollen allergies that can cause sneezing,
runny or itchy nose, stuffy or congested
nose, or itchy and watery eyes. GRASTEK may be prescribed for persons
5 through 65 years of age who are
allergic to grass pollen.
GRASTEK is taken for about 12 weeks before grass pollen season and
throughout grass pollen season.
GRASTEK may also be taken daily for 3 years to provide a sustained
effect for a fourth year in which you do
not have to take GRASTEK.
GRASTEK is NOT a medication that gives immediate relief for symptoms

Ficha técnica

GRASTEK- TIMOTHY GRASS POLLEN ALLERGEN EXTRACT TABLET
ALK-ABELLO A S
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
GRASTEK SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR GRASTEK.
GRASTEK® (TIMOTHY GRASS POLLEN ALLERGEN EXTRACT)
TABLET FOR SUBLINGUAL USE
INITIAL U.S. APPROVAL: 2014
WARNING: SEVERE ALLERGIC REACTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
• GRASTEK CAN CAUSE LIFE-THREATENING ALLERGIC REACTIONS SUCH AS
ANAPHYLAXIS AND
SEVERE LARYNGOPHARYNGEAL RESTRICTION. (5.1)
• DO NOT ADMINISTER GRASTEK TO PATIENTS WITH SEVERE, UNSTABLE OR
UNCONTROLLED
ASTHMA. (4)
• OBSERVE PATIENTS IN THE OFFICE FOR AT LEAST 30 MINUTES FOLLOWING
THE INITIAL DOSE.
(5.1)
• PRESCRIBE AUTO-INJECTABLE EPINEPHRINE, INSTRUCT AND TRAIN PATIENTS
ON ITS
APPROPRIATE USE, AND INSTRUCT PATIENTS TO SEEK IMMEDIATE MEDICAL CARE
UPON ITS USE.
(5.2)
• GRASTEK MAY NOT BE SUITABLE FOR PATIENTS WITH CERTAIN UNDERLYING
MEDICAL
CONDITIONS THAT MAY REDUCE THEIR ABILITY TO SURVIVE A SERIOUS ALLERGIC
REACTION. (5.2)
• GRASTEK MAY NOT BE SUITABLE FOR PATIENTS WHO MAY BE UNRESPONSIVE
TO
EPINEPHRINE OR INHALED BRONCHODILATORS, SUCH AS THOSE TAKING
BETA-BLOCKERS. (5.2)
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. (1)
DOSAGE AND ADMINISTRATION
FOR SUBLINGUAL USE ONLY. (2)
One tablet daily. (2.1)
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. (2.2)
Place the tablet immediately under the to