UpToDate خرید پکیج
تعداد آیتم قابل مشاهده باقیمانده:
4
September 2025
Dosage guidance:
Dosage form information: Itulatek is not available in the United States.
Tree pollen (alder, birch, hazel, and/or oak)–induced allergic rhinitis, moderate to severe: Canadian labeling: Children ≥5 years and Adolescents: Sublingual: 1 tablet once daily. Initiate treatment ≥16 weeks prior to tree pollen season and maintain treatment throughout the season; if no improvement after 1 year, discontinue treatment.
There are no dosage adjustments provided in the manufacturer's labeling.
There are no dosage adjustments provided in the manufacturer's labeling.
(For additional information see "White birch sublingual tablet (United States: Not available): Drug information")
Tree pollen (alder, birch, hazel, and/or oak)–induced allergic rhinitis: Sublingual: Adults ≤65 years of age: 1 tablet once daily.
Missed dose: If interruption in therapy is >15 days, advise patients to contact health care provider prior to restarting therapy.
The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.
Altered kidney function: No dosage adjustment necessary for any degree of kidney dysfunction (no systemic absorption) (Ref).
Hemodialysis, intermittent (thrice weekly): No supplemental dose or dosage adjustment necessary (no systemic absorption) (Ref).
Peritoneal dialysis: No dosage adjustment necessary (no systemic absorption) (Ref).
CRRT: No dosage adjustment necessary (Ref).
PIRRT (eg, sustained, low-efficiency diafiltration): No dosage adjustment necessary (Ref).
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 children, adolescents, and adults, unless otherwise indicated.
>10%:
Dermatologic: Pruritus of ear (4% to 13%)
Gastrointestinal: Oral paresthesia (4% to 11%), tongue pruritus (12% to 13%)
Local: Local pruritus (oral: children, adolescents: 23% to 28%; adults: 38%)
Respiratory: Throat irritation (children: 19%; adolescents, adults: 29% to 31%; including chronic throat clearing [<1%], larynx irritation [<1%])
1% to 10%:
Dermatologic: Lip pruritus (2% to 5%), pruritus of nose (≤1%), skin rash (≤1%), urticaria (children, adults: 1%)
Gastrointestinal: Abdominal pain (≤3%; including upper abdominal pain), dysgeusia (≤1%), dyspepsia (≤2%), dysphagia (children, adults: 2% to 3%; adolescents: <1%), glossalgia (≤2%; including tongue discomfort), glossitis (≤1%), mouth pain (≤2%), nausea (children, adults: ≤2%), oral discomfort (3% to 6%), oral hypoesthesia (children: <1%; adolescents, adults: 2% to 5%; pharyngeal hypoesthesia: adolescents, adults: [<1%]), oral mucosal erythema (children, adolescents: ≤1%; including lip, tongue), stomatitis (≤2%), swelling of mouth (4% to 9%), vomiting (children, adults: ≤1%)
Hypersensitivity: Hypersensitivity reaction (oral allergy syndrome: ≤2%), lip edema (children, adults: 1%), mouth edema (adolescents: <1%; adults: 3%), swelling of lips (3% to 7%), swollen tongue (children: <1%; adolescents, adults: 3% to 6%)
Nervous system: Foreign body sensation (≤2%), voice disorder (children, adults: ≤2%)
Ophthalmic: Allergic conjunctivitis (children, adults: 1%), eye pruritus (children, adults: 2% to 3%), increased lacrimation (adults: 1%)
Respiratory: Allergic rhinitis (children, adults: ≤1%), cough (2% to 5%), dry throat (≤2%), dyspnea (adolescents, adults: ≤1%), oropharyngeal pain (children, adolescents: 2%; adults: 6%; including oropharyngeal discomfort), pharyngeal disease (paresthesia: ≤2%), pharyngeal edema (children: <1%; adolescents, adults: 1% to 6%), rhinitis (adults: 2%), rhinorrhea (≤2%)
<1% (any population):
Cardiovascular: Chest discomfort, chest pain, ECG abnormality, flushing, tachycardia
Dermatologic: Dermatitis (including atopic dermatitis), eczema, erythema of skin, lip blister, maculopapular rash, molluscum contagiosum, pruritic rash, pruritus, xeroderma
Endocrine & metabolic: Abnormal lactate dehydrogenase, weight loss
Gastrointestinal: Acid regurgitation, aerophagia, change in appetite, diarrhea, esophageal pain (including discomfort, irritation), flatulence, gastric hyperacidity (gastric pH decreased), gastritis, gastroesophageal reflux disease, gastrointestinal pain, gingival erythema, gingival swelling, odynophagia, oral herpes simplex infection, oral inflammation (enlarged uvula), oral mucosa ulcer (including oral mucosal blistering), palatal edema (including swelling), sialorrhea, tongue ulcer (including blister), xerostomia
Hematologic & oncologic: Mucocutaneous hemorrhage
Hepatic: Abnormal bilirubin levels, abnormal transaminase
Hypersensitivity: Anaphylaxis, angioedema, facial swelling, tongue edema
Nervous system: Asthenia, burning sensation, choking sensation, disturbance in attention, dysarthria, fatigue, feeling hot, headache, malaise, neurosis, noncardiac chest pain, panic attack, restlessness, sleep disturbance, speech disturbance
Neuromuscular & skeletal: Arthralgia, joint swelling, limb pain, myalgia
Ophthalmic: Blepharitis, conjunctival hyperemia, conjunctivitis, eye irritation, eyelid edema, foreign body sensation of eye, ocular hyperemia
Otic: Ear sign or symptom (discomfort), tinnitus
Respiratory: Abnormal breath sounds (grunting), asthma, bronchospasm, epistaxis, increased bronchial secretions (catarrh), laryngeal edema, nasal congestion, nasal discomfort, nasal obstruction, nasopharyngitis, oropharyngeal edema, paranasal sinus hypersecretion (upper airway), pharyngeal erythema, respiratory congestion, sinusitis, sneezing, tightness in chest or throat
Miscellaneous: Fever
Postmarketing (any population): Gastrointestinal: Eosinophilic esophagitis
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.
• Epinephrine: [Canadian Boxed Warning]: Availability of an epinephrine device should be discussed with the recipient of white birch allergen extract (or their caregiver).
• 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. Adequately monitor patients reinitiating therapy after a pause of >15 days.
• Oral allergy syndrome: Patients with preexisting oral allergy syndrome may experience local adverse reactions with increased severity; consider the use of antihistamines if reactions occur.
• 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)]
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 for signs and symptoms of severe systemic or severe local allergic reactions. If well tolerated, subsequent doses may be taken at home; subsequent doses in children 5 to <12 years must be done under adult supervision and children should be monitored for signs of allergic reaction, including respiratory distress for ≥15 minutes. Auto-injectable epinephrine should be made available to patients.
Sublingual: With dry hands, remove sublingual tablet from blister immediately prior to administration. Do not take tablet with food or beverage. Place tablet under tongue until completely dissolved (will occur within seconds) and then wait at least 1 minute before swallowing. Wash hands after handling tablet. Avoid food or beverage for 5 minutes following administration.
Missed dose: Return to normal schedule the next day; do not take more than one dose daily. If treatment is interrupted >15 days, consult physician before resuming treatment.
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.
Store at 15°C to 30°C (59°F to 86°F). Store in the original blister until use to protect from moisture.
Note: Not approved in the United States.
Canadian labeling: Treatment of moderate to severe seasonal allergic rhinitis, with or without conjunctivitis, induced by pollen from birch, alder, hazel, and/or oak, in patients 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, hazel, or oak (skin prick test and/or specific IgE) (indicated in ages 5 to 65 years).
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 drug interactions program by clicking on the “Launch drug interactions program” link above.
Beta-Blockers: May increase adverse/toxic effects 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
Ustekinumab: May decrease therapeutic effects of Allergen Immunotherapy. Risk C: Monitor
In general, allergen immunotherapy should not be initiated during pregnancy (Dykewicz 2020; Pitsios 2019).
Signs and symptoms of hypersensitivity; monitor patients for ≥30 minutes after administration of first dose; for subsequent doses, children <12 years should be monitored ≥15 minutes.
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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