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Ragweed pollen sublingual tablet: Drug information

Ragweed pollen sublingual tablet: Drug information
(For additional information see "Ragweed pollen sublingual tablet: Patient drug information" and see "Ragweed pollen sublingual tablet: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
ALERT: US Boxed Warning
Severe allergic reactions:

Short ragweed pollen allergen extract can cause life-threatening allergic reactions such as anaphylaxis and severe laryngopharyngeal restriction. Do not administer short ragweed pollen allergen extract 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 or parents/guardians on its appropriate use, and instruct patients or parents/guardians to seek immediate medical care upon its use. Short ragweed pollen allergen extract may not be suitable for patients with certain underlying medical conditions that may reduce their ability to survive a serious allergic reaction. Short ragweed pollen allergen extract may not be suitable for patients who may be unresponsive to epinephrine or inhaled bronchodilators, such as those taking beta-blockers.

Brand Names: US
  • Ragwitek
Brand Names: Canada
  • Ragwitek
Pharmacologic Category
  • Allergen-Specific Immunotherapy
Dosing: Adult
Ragweed pollen-induced allergic rhinitis

Ragweed pollen-induced allergic rhinitis: Adults ≤65 years: Sublingual: One tablet once daily.

Note: Initiate treatment ≥12 weeks before expected onset of each ragweed pollen season and continue throughout pollen season. Safety and efficacy of initiating treatment during ragweed pollen season have not been established. Data regarding restarting treatment after missing a dose are limited; in clinical trials, treatment interruptions ≤7 days were allowed.

Dosing: Kidney Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Pediatric

(For additional information see "Ragweed pollen sublingual tablet: Pediatric drug information")

Note: Patients should also be prescribed an epinephrine autoinjector for use in emergency.

Ragweed pollen-induced allergic rhinitis

Ragweed pollen-induced allergic rhinitis: Children ≥5 years and Adolescents: Sublingual: 1 tablet once daily. Initiate treatment ≥12 weeks before expected onset of each ragweed pollen season and continue throughout pollen season. Safety and efficacy of initiating treatment during ragweed pollen season have not been established.

Dosing: Kidney Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adults and pediatrics, unless otherwise noted.

>10%:

Dermatologic: Pruritus of ear (children and adolescents: 34%; adults: 10%)

Gastrointestinal: Mouth pain (children and adolescents: 19%), nausea (children and adolescents: 12%; adults: 1%), oral itching (children and adolescents: 48%; adults: 11%)

Hypersensitivity: Swelling of lips (children and adolescents: 14%; adults: 3%), swollen tongue (children and adolescents: 11%; adults: 3%)

Respiratory: Pharyngeal edema (children and adolescents: 10% to 11%, including enlarged uvula and swelling of mouth), throat irritation (children and adolescents: 48% [including throat tickle]; adults: 17%)

1% to 10%:

Cardiovascular: Chest discomfort (adults: 1%)

Dermatologic: Lip pruritus (adults: 2%), pruritus (adults: 2%)

Gastrointestinal: Diarrhea (children and adolescents: 3%), dysgeusia (children and adolescents: 4%), dysphagia (1% to 2%), oral mucosa ulcer (children and adolescents: 8%), oral paresthesia (adults: 10%; children and adolescents: 2%), palatal edema (adults: 1%), stomach pain (children and adolescents: 10%), tongue pruritus (5%), tongue ulcer (children and adolescents: 7%), vomiting (children and adolescents: 1%), xerostomia (adults: 1%)

Hypersensitivity: Mouth edema (adults: 6%; children and adolescents: 2%), tongue edema (adults: 1%)

Respiratory: Constriction of the pharynx (adults: 1%), oropharyngeal pain (2%), rhinorrhea (children and adolescents: 1%), sneezing (children and adolescents: 2%)

<1%: Hypersensitivity: Hypersensitivity reaction

Frequency not defined: Hypersensitivity: Severe hypersensitivity reaction (including anaphylaxis, angioedema and laryngeal edema)

Postmarketing:

Dermatologic: Urticaria

Gastrointestinal: Dyspepsia, gastroesophageal reflux disease, glossalgia, oral hypoesthesia

Nervous system: Foreign body sensation, paresthesia, voice disorder

Otic: Otalgia (including discomfort)

Respiratory: Cough, dry throat, exacerbation of asthma, pharyngeal erythema

Contraindications

Hypersensitivity to any of the inactive ingredients (gelatin, mannitol, sodium hydroxide) contained in this product or any other component of the formulation; severe, unstable, or uncontrolled asthma; history of any severe systemic allergic reaction or any severe local reaction to sublingual allergen immunotherapy; history of eosinophilic esophagitis.

Canadian labeling: Additional contraindications (not in US labeling): Unstable, severe chronic, or severe seasonal asthma (FEV1 <70% of predicted value); concomitant beta-blocker therapy; oral inflammation (eg, oral lichen planus, oral ulcerations, severe oral candidiasis, or dental extraction).

Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Warnings/Precautions

Concerns related to adverse effects:

• Esophagitis: Eosinophilic esophagitis has been reported with sublingual tablet immunotherapy; discontinue therapy in patients who experience severe or persistent gastroesophageal symptoms (eg, dysphagia, chest pain). Use is contraindicated in patients with a history of eosinophilic esophagitis.

• Hypersensitivity reactions: [US Boxed Warning]: Life-threatening allergic reactions, including anaphylaxis and severe laryngopharyngeal restrictions, may occur. Local reactions in the mouth or throat may occur; consider discontinuation in patients experiencing escalating and persistent adverse reactions in the mouth or throat. Increased risk of local or systemic adverse reactions may occur when given with concomitant allergen immunotherapy.

Disease-related concerns:

• Respiratory disease: [US Boxed Warning]: Do not administer to patients with severe, unstable, or uncontrolled asthma; use has not been studied in patients with severe asthma. Withhold treatment if patient is experiencing an acute asthma exacerbation. Re-evaluate patients with recurrent asthma exacerbations and consider discontinuation. Use is contraindicated in patients with unstable or uncontrolled asthma.

Other warnings/precautions:

• Administration: [US Boxed Warning]: Auto-injectable epinephrine should be prescribed to patients; instruct patients or parents/guardians on appropriate use and to obtain immediate medical care upon its use.

• Appropriate patient selection: [US Boxed Warning]: Use may not be suitable for patients with conditions that may reduce their ability to survive a serious allergic reaction, including but not limited to compromised lung function (either chronic or acute), mast cell disorder (severe), and cardiovascular conditions (eg, unstable angina, recent MI, arrhythmia, and uncontrolled hypertension).

• Appropriate use: [US Boxed Warning}: Use may not be suitable for patients who may be unresponsive to epinephrine or inhaled bronchodilators due to concomitant drug therapy. The effect of epinephrine may be potentiated or inhibited by the following medications: Beta blockers, alpha blockers, ergot alkaloids, tricyclic antidepressants, levothyroxine, monoamine oxidase inhibitors, antihistamines, cardiac glycosides, and diuretics.

• Experienced physician: Should be administered under the supervision of physicians experienced in the diagnosis and treatment of allergic diseases and prepared to manage a life-threatening systemic or local allergic reaction.

• Monitoring: [US Boxed Warning]: Monitor all patients for at least 30 minutes after initial dose in a healthcare setting.

• Oral inflammation/wounds: Discontinue therapy to allow for complete healing of the oral cavity due to oral inflammation (eg, oral lichen planus, mouth ulcers, or thrush) or oral wounds following oral surgery or dental extraction.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet Sublingual, Sublingual:

Ragwitek: 12 AMB A 1-U [contains gelatin (fish)]

Generic Equivalent Available: US

No

Pricing: US

Sublingual (Ragwitek Sublingual)

12 amb a 1-u (per each): $13.88

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet Sublingual, Sublingual:

Ragwitek: 12 AMB A 1-U [contains gelatin (fish)]

Administration: Adult

Administer the first dose in a healthcare setting due to the potential for allergic reactions; monitor patient for ≥30 minutes after first dose. If well tolerated, subsequent doses may be taken at home. With dry hands, remove sublingual tablet from blister immediately prior to administration. Place tablet under tongue until completely dissolved and then wait at least one minute before swallowing. Wash hands after handling tablet. Avoid food or beverage for 5 minutes following administration. Auto-injectable epinephrine should be made available to patients.

Administration: Pediatric

Note: Administer the first dose in a health care setting due to the potential for allergic reactions; monitor patient for ≥30 minutes after first dose. If well tolerated, subsequent doses may be taken at home. Auto-injectable epinephrine should be made available to patients.

Sublingual: With dry hands, remove sublingual tablet from blister immediately prior to administration. Place tablet under tongue until completely dissolved and then wait ≥1 minute before swallowing. Wash hands after handling tablet. Avoid food or beverage for 5 minutes following administration.

Missed doses: If 1 dose is missed, take the next dose at normal scheduled time; do not double dose. Data regarding restarting treatment after missing >1 dose are limited; in clinical trials, treatment interruptions ≤7 days were allowed.

Use: Labeled Indications

Ragweed pollen-induced allergic rhinitis: 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 in persons 5 to 65 years of age. Not indicated for the immediate relief of allergy symptoms.

Metabolism/Transport Effects

None known.

Drug Interactions

There are no known significant interactions.

Pregnancy Considerations

Animal reproduction studies have not been conducted. In general, allergen immunotherapy is not initiated during pregnancy (Cox 2011).

Breastfeeding Considerations

It is not known if ragweed pollen allergen extract is present in breast milk. According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother. In general, allergen immunotherapy does not increase risks to the breastfeeding child (Cox 2011).

Monitoring Parameters

Signs/symptoms of hypersensitivity; monitor patients for at least 30 minutes after administration of first dose.

Mechanism of Action

Ragweed pollen allergen extract contains extract from Short Ragweed (Ambrosia artemisiifolia). While the exact mechanism has not been fully elucidated, specific immunotherapy (SIT) may act by inducing a switch from T helper 2 cell response (Th2) to T helper 1 cell (Th1) response resulting in decreased interleukin-4 (IL-4) and interleukin-5 (IL-5) and increased interleukin-10 (IL-10), production of IgG-blocking antibodies that compete with IgE antibodies for allergen binding, proliferation of regulatory T lymphocytes and cytokines, and decreases in mast cells, eosinophils, and early- and late-phase allergic responses (Leith, 2006).

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (CZ) Czech Republic: Ragwizax;
  • (DE) Germany: Ragwizax;
  • (IT) Italy: Ragwizax;
  • (SI) Slovenia: Ragwizax;
  • (SK) Slovakia: Ragwizax
  1. Cox L, Nelson H, Lockey R, et al. Allergen immunotherapy: a practice parameter third update [published corection appears in J Allergy Clin Immunol. 2011;127(3):840]. J Allergy Clin Immunol. 2011;127(1 suppl):S1-S55. [PubMed 21122901] 10.1016/j.jaci.2010.09.034
  2. Leith E, Bowen T, Butchey J, et al. Consensus Guidelines on Practical Issues of Immunotherapy-Canadian Society of Allergy and Clinical Immunology (CSACI). Allergy Asthma Clin Immunol. 2006; 2(2): 47-61. [PubMed 20525157]
  3. Ragwitek (short ragweed pollen allergen extract) [prescribing information]. Whitehouse Station, NJ: Merck Sharp & Dohme Corp; August 2020.
  4. Ragwitek (short ragweed pollen allergen extract) [prescribing information]. Horsholm, Denmark: ALK-Abello A/S; April 2021.
  5. Ragwitek (short ragweed pollen allergen extract) [product monograph]. Horsholm, Denmark: ALK-Abello A/S; April 2021.
  6. Ragwitek (short ragweed pollen allergen extract) [prescribing information]. Horsholm, Denmark: ALK-Abello A/S; September 2022.
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