ODACTRA- dermatophagoides pteronyssinus and dermatophagoides farinae tablet

Држава: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

DERMATOPHAGOIDES PTERONYSSINUS (UNII: 57L1Z5378K) (DERMATOPHAGOIDES PTERONYSSINUS - UNII:57L1Z5378K), DERMATOPHAGOIDES FARINAE (UNII: PR9U2YPF3Q) (DERMATOPHAGOIDES FARINAE - UNII:PR9U2YPF3Q)

Доступно од:

ALK-Abello A S

INN (Међународно име):

DERMATOPHAGOIDES PTERONYSSINUS

Састав:

DERMATOPHAGOIDES PTERONYSSINUS 6 [arb'U]

Пут администрације:

SUBLINGUAL

Терапеутске индикације:

ODACTRA™ is an allergen extract indicated as immunotherapy for the treatment of house dust mite (HDM)-induced allergic rhinitis, with or without conjunctivitis, confirmed by positive in vitro testing for IgE antibodies to Dermatophagoides   farinae or Dermatophagoides   pteronyssinus house dust mites, or by positive skin testing to licensed house dust mite allergen extracts. ODACTRA is approved for use in persons 12 through 65 years of age.  ODACTRA is not indicated for the immediate relief of allergic symptoms. ODACTRA 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 contained in this product [see 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 background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Available data on ODACTRA administered to pregnant women are insufficient to inform associated risks in pregnancy. In an embryo/fetal developmental toxicity study performed in mice, administration of ODACTRA during gestation did not reveal adverse developmental outcomes in fetuses (see 8.1 Data ). Data Animal Data In a developmental toxicity study, the effect of ODACTRA on embryo/fetal development was evaluated in mice. Animals were administered ODACTRA subcutaneously daily from day 6 to day 17 of the gestation period at doses up to 5 times the human sublingual dose. There were no ODACTRA-related post-implantation losses, fetal malformations or variations. Risk Summary It is not known whether ODACTRA is excreted in human milk. Data are not available to assess the effects of ODACTRA on the breastfed child or on milk production and excretion in the nursing woman. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for ODACTRA and any potential adverse effects on the breastfed child from ODACTRA or from the underlying maternal condition. The safety and effectiveness of ODACTRA have been established in adolescents 12 through 17 years of age. The safety and effectiveness have not been established in persons below 12 years of age. Safety and effectiveness have not been established in persons older than 65 years of age.

Резиме производа:

ODACTRA 12 SQ-HDM tablets are white to off-white, circular freeze-dried sublingual tablets with a debossed pentagon detail on one side. ODACTRA is supplied as follows: 3 blister packages of 10 tablets (30 tablets total). NDC 52709-1701-3 Store at controlled room temperature, 20ºC-25ºC (68ºF-77ºF). Store in the original package until use to protect from moisture.

Статус ауторизације:

Biologic Licensing Application

Информативни летак

ALK-Abello A S
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MEDICATION GUIDE
ODACTRA™ (OH-dack-trah)
House Dust Mite (Dermatophagoides farinae and Dermatophagoides
pteronyssinus) Allergen Extract
Sublingual Tablets
Carefully read this Medication Guide before you start taking ODACTRA
and each time you get a refill.
This Medication Guide does not take the place of talking with your
doctor about your medical condition
or treatment. Talk with your doctor or pharmacist if there is
something you do not understand or if you
want to learn more about ODACTRA.
What is the Most Important Information I Should Know about ODACTRA?
ODACTRA can cause severe allergic reactions that may be
life-threatening. Stop taking ODACTRA and
get medical treatment right away if you have any of the following
symptoms after taking ODACTRA:
•
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 ODACTRA, your doctor will prescribe
auto-injectable epinephrine, a
medicine you can inject if you have a severe allergic reaction after
taking ODACTRA. 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 ODACTRA?
ODACTRA is a prescription medicine used for sublingual (under the
tongue) immunotherapy to treat
house dust mite allergies that can cause sneezing, runny or itchy
nose, stuffy or congested nose, or itchy
and watery eyes. ODACTRA may be prescribed for persons 12 through 65
years of age who are allergic
to house dust mites.
ODACTRA is NOT a medication that gives immediate relief for symptoms
of house dust mite allergy.
Who Should Not Take ODACTRA?
You should not take ODACTRA if:
•
You have severe, unstable or uncontrolled asthma
•
You had a severe allergic reaction in the past that inc

Карактеристике производа

ODACTRA- DERMATOPHAGOIDES PTERONYSSINUS AND DERMATOPHAGOIDES
FARINAE TABLET
ALK-ABELLO A S
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ODACTRA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ODACTRA.
ODACTRA™ HOUSE DUST MITE _(DERMATOPHAGOIDES FARINAE AND_
_DERMATOPHAGOIDES PTERONYSSINUS)_ ALLERGEN EXTRACT
TABLET FOR SUBLINGUAL USE
INITIAL U.S. APPROVAL: 2017
WARNING: SEVERE ALLERGIC REACTIONS
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
• ODACTRA CAN CAUSE LIFE-THREATENING ALLERGIC REACTIONS SUCH AS
ANAPHYLAXIS AND
SEVERE LARYNGOPHARYNGEAL RESTRICTION. (5.1)
• DO NOT ADMINISTER ODACTRA 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
OR
PARENTS/GUARDIANS ON ITS APPROPRIATE USE, AND INSTRUCT PATIENTS OR
PARENTS/GUARDIANS
TO SEEK IMMEDIATE MEDICAL CARE UPON ITS USE. (5.1)
• ODACTRA MAY NOT BE SUITABLE FOR PATIENTS WITH CERTAIN UNDERLYING
MEDICAL CONDITIONS
THAT MAY REDUCE THEIR ABILITY TO SURVIVE A SERIOUS ALLERGIC REACTION.
(5.1)
• ODACTRA MAY NOT BE SUITABLE FOR PATIENTS WHO MAY BE UNRESPONSIVE
TO EPINEPHRINE
OR INHALED BRONCHODILATORS, SUCH AS THOSE TAKING BETA-BLOCKERS. (5.1)
RECENT MAJOR CHANGES
INDICATIONS AND USAGE (1)
------------------------------------------------
1/2023
WARNINGS AND PRECAUTIONS (5.1 SEVERE ALLERGIC REACTIONS)--------1/2023
INDICATIONS AND USAGE
ODACTRA is an allergen extract indicated as immunotherapy for the
treatment of house dust mite (HDM)-
induced allergic rhinitis, with or without conjunctivitis, confirmed
by positive _in vitro_ testing for IgE
antibodies to _Dermatophagoides farinae_ or _Dermatophagoides
pteronyssinus_ house dust mites or by
positive skin testing to licensed house dust mite allergen extracts.
ODACTRA is approved for use in
persons 12 through 65 years of age. (1)
DOSAGE AND ADMINI