Version May 2024
Tree pollen (alder, birch, and/or hazel)–induced allergic rhinitis: Sublingual: Adults ≤65 years of age: 1 tablet once daily.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adolescents and adults.
>10%:
Dermatologic: Pruritus of ear (13%)
Gastrointestinal: Oral paresthesia (11%), tongue pruritus (13%)
Local: Local pruritus (oral: 39%)
Respiratory: Throat irritation (29%; including chronic throat clearing and larynx irritation)
1% to 10%:
Cardiovascular: Chest discomfort (1%), lip edema (1%)
Dermatologic: Urticaria (1%)
Gastrointestinal: Dysgeusia (1%), dyspepsia (1%), dysphagia (3%), glossalgia (3%), lip pruritus (4%), oral discomfort (6%), oral hypoesthesia (5%), stomatitis (2%), swelling of lips (7%), swelling of mouth (9%), swollen tongue (6%)
Hypersensitivity: Mouth edema (3%)
Nervous system: Foreign body sensation (2%), voice disorder (2%)
Ophthalmic: Allergic conjunctivitis (1%), increased lacrimation (1%)
Respiratory: Cough (6%), dry throat (2%), dyspnea (1%), oropharyngeal pain (6%), pharyngeal disease (paresthesia: 1%; hypoesthesia), pharyngeal edema (8%; including oropharyngeal edema), rhinitis (1%), rhinorrhea (2%)
<1%:
Cardiovascular: ECG abnormality, flushing, tachycardia
Dermatologic: Atopic dermatitis, eczema, erythema of skin, skin rash, xeroderma
Endocrine & metabolic: Abnormal aspartate transaminase, abnormal lactate dehydrogenase, abnormal transaminase
Gastrointestinal: Acid regurgitation, change in appetite, diarrhea, esophageal pain, flatulence, gastric hyperacidity (gastric pH decreased), gastric irritation (esophageal irritation), gastritis, gastroesophageal reflux disease, gastrointestinal distress (esophageal discomfort), gastrointestinal pain, gingival erythema, gingival swelling, glossitis, lip blister, oral herpes simplex infection, oral inflammation (enlarged uvula), oral mucosa ulcer, oropharyngeal blister, palatal edema, tongue ulcer (including blister), upper abdominal pain, vomiting, xerostomia
Hematologic & oncologic: Mucocutaneous hemorrhage
Hepatic: Abnormal bilirubin levels
Hypersensitivity: Angioedema, seasonal allergy (exacerbation), tongue edema
Local: Local swelling (can be severe or may increase in severity over time)
Nervous system: Burning sensation, choking sensation, dysarthria, fatigue, feeling hot, malaise, restlessness, speech disturbance
Neuromuscular & skeletal: Joint swelling, limb pain, musculoskeletal pain, myalgia
Ophthalmic: Conjunctival hyperemia, conjunctivitis, eye irritation, eyelid edema, foreign body sensation of eye
Otic: Ear sign or symptom (discomfort), tinnitus
Respiratory: Asthma, epistaxis, increased bronchial secretions (catarrh), laryngeal edema, nasal discomfort, oropharyngeal irritation (discomfort), paranasal sinus hypersecretion (upper airway), pharyngeal erythema, sinusitis
Miscellaneous: Swelling, wound
Frequency not defined: Hypersensitivity: Hypersensitivity reaction (may be severe hypersensitivity reaction)
Postmarketing: Gastrointestinal: Eosinophilic esophagitis, nausea
Hypersensitivity to white birch allergen extract or any component of the formulation; previous severe systemic allergic reaction to birch or related tree pollen immunotherapy; unstable, severe, or uncontrolled chronic or seasonal asthma (FEV1 <70% of predicted value after adequate pharmacologic treatment); concurrent use with beta blockers; active inflammatory conditions in the oral cavity (eg, oral lichen planus with ulcerations, severe oral candidiasis, dental extraction); history of eosinophilic esophagitis.
Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Concerns related to adverse effects:
• Allergic reactions: [Canadian Boxed Warning]: Systemic allergic reactions, including severe local allergic reactions, may occur. Some reactions may be life threatening. Depending on the reaction severity, temporarily or permanently discontinue treatment in any patient that develops clinical evidence of a severe systemic or severe local allergic reaction. Emergency administration of epinephrine, antihistamines, bronchodilators, or systemic corticosteroids may be necessary.
• 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).
• Localized effects: Local administration site reactions (eg, itching, irritation, sensation changes, discomfort, swelling, pain) of the mouth, throat, and ears may occur.
Disease-related concerns:
• Cardiovascular disease: Use with caution in patients with severe cardiovascular disease, unstable angina, recent myocardial infarction, or uncontrolled hypertension; may be at increased risk of severe hypersensitivity.
• Respiratory disease: In patients with controlled asthma and who are experiencing an acute respiratory infection, delay treatment initiation until the infection has resolved.
Special populations:
• Immunocompromised patients: Use with caution in patients with active systemic autoimmune disorders, immune defects, immunodeficiencies, immunosuppression, or malignancy.
Other warnings/precautions:
• Appropriate use: Initiate therapy at least 16 weeks prior to the tree pollen season and maintain treatment throughout the season. The first dose of therapy should be administered in a health care setting under the supervision of a physician. Use with caution in patients previously administered epinephrine to treat severe allergic reactions; use of allergen immunotherapy has not been studied in these patients. Additionally, the effect of epinephrine may be potentiated or inhibited by tricyclic antidepressants, monoamine oxidase inhibitors, catechol-O-methyltransferase inhibitors, and/or beta blockers, which may be life threatening. Instruct patients on appropriate use of epinephrine and to obtain immediate medical care upon its use.
• Experienced physician: [Canadian Boxed Warning]: Should only be prescribed and initiated by physicians adequately trained and experienced in the treatment of respiratory allergic diseases.
• Food allergy: Tree pollen allergic patients may experience oral allergy symptoms (eg, oropharyngeal pruritus, swelling) from consumption of tree pollen cross-reacting foods. Patients with tree pollen-related food allergy may more often experience local reactions and temporary treatment interruptions compared to patients without tree pollen-related food allergy.
• Monitoring: [Canadian Boxed Warning]: Monitor all patients for at least 30 minutes after initial dose in a health care setting.
• Oral inflammation/wounds: Temporarily interrupt therapy to allow for complete healing of the oral cavity due to oral inflammation (eg, oral lichen planus, mouth ulcers, thrush) or oral wounds following oral surgery, tooth loss, or dental extraction.
Not available in the United States.
No
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet Sublingual, Sublingual:
Itulatek: 12 SQ-BET [contains gelatin (fish)]
Oral: 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. With dry hands, remove sublingual tablet from blister immediately prior to administration. Place tablet under tongue until completely dissolved and then wait at least 1 minute before swallowing. Wash hands after handling tablet. Avoid food or beverage for 5 minutes following administration.
Tree pollen (alder, birch, and/or hazel)–induced allergic rhinitis: Treatment of moderate to severe seasonal allergic rhinitis, with or without conjunctivitis, induced by pollen from birch, alder, and/or hazel, in adults 18 to 65 years of age who have a clinical history of symptoms of allergic rhinitis, despite use of symptom-relieving medication, and a positive test of sensitization to ≥1 of the pollen of birch, alder, or hazel (skin prick test and/or specific IgE).
ALERT: Canadian Boxed Warning: Health Canada–approved labeling includes a boxed warning. See Warnings/Precautions section for a concise summary of this information. For verbatim wording of the boxed warning, consult the product labeling.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Beta-Blockers: May enhance the adverse/toxic effect of White Birch Allergen Extract. Specifically, beta-blockers may reduce the effectiveness of beta-agonists that may be required to treat systemic reactions to white birch allergen extract. Risk X: Avoid combination
In general, allergen immunotherapy should not be initiated during pregnancy (Dykewicz 2020; Pitsios 2019).
It is not known if white birch allergen extract is present in breast milk.
Signs/symptoms of hypersensitivity; monitor patients for at least 30 minutes after administration of first dose.
The effects of allergy immunotherapy may include changes in allergen specific antibodies and regulatory T-cells leading to long-term tolerance.
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