Generic Name

Welireg

Mechanism

Welireg delivers a graded dose of birch pollen allergen directly across the sublingual mucosa, initiating a controlled immune response that leads to long‑term tolerance:
• Allergen‑specific IgG4 induction – competes with IgE for allergen binding, preventing mast cell degranulation.
• Regulatory T‑cell activation – secreting IL‑10 and TGF‑β, thereby dampening Th2‑driven inflammation.
• Down‑regulation of local histamine release – reduces nasal congestion, sneezing, and rhinorrhea.
• Induction of immunologic memory that persists after therapy cessation.

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Pharmacokinetics

> Note: Because systemic exposure is minimal, adverse events are predominantly local unless anaphylaxis occurs.

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Indications

• Seasonal allergic rhinitis caused by birch pollen (Betula sp.) in patients aged ≥ 4 years.
• May be used in patients who cannot or prefer not to receive subcutaneous immunotherapy (SCIT).
• Allows self‑administration at home after initial supervised dose.

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Contraindications

• Contraindicated in patients with known hypersensitivity to birch pollen extract or any component of the formulation.
• Absolute warnings:
• Uncontrolled asthma.
• Severe IgE‑mediated systemic hypersensitivity.
• Recent anaphylactic episode.
• Precautions:
• Pregnancy and lactation – use only if benefits outweigh risks.
• Co‑existing oral mucosal disease (e.g., oral herpes, severe candidiasis).
• Concurrent use of other allergen immunotherapies requires coordination.

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Dosing

• Administration Instructions
• Place tablet on lower tongue and let it dissolve; do not swallow.
• Avoid eating, chewing gum, drinking, or brushing teeth for 30 min after dosing.
• Ensure first dose administered under medical supervision to identify possible systemic reaction.
• Dose escalation is patient‑specific; the treating clinician may adjust timing based on tolerance.

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Adverse Effects

> Action: In case of systemic reaction, stop the tablet immediately, administer epinephrine, and seek emergency care.

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Monitoring

• Baseline evaluation – history of asthma control, previous allergy reactions, and potential contraindications.
• During first dose – watch for local or systemic reactions for 30 min under supervision.
• Adverse event reporting – maintain diary of local symptoms and any adverse events.
• Annual review – assess allergy symptoms and tolerability; adjust dosing frequency accordingly.

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Clinical Pearls

• Start Safely: The first dose must be given in a clinical setting with emergency resuscitation equipment on hand.
• Patient Education: Instruct patients that even mild local reactions can herald serious systemic events; advise carrying an epinephrine auto‑injector if they have a history of severe allergy.
• Monthly Shift: Reducing dose frequency to monthly after 16 weeks does not compromise efficacy but improves patient compliance.
• Avoid Oral Irritants: Alcohol, spicy foods, or chewing gum close to dosing may increase mucosal irritation.
• Allergy Testing: Patients with dual birch–olive sensitization can receive Welireg plus an adjunctive pollen SLIT for the oliver? (Studies show additive benefit; consult specialist).
• Documentation: Record the exact dose taken and any symptoms in the patient’s EMR; if reporting to national adverse event databases, specify “sublingual immunotherapy – birch.”

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• *This drug card is intended for educational purposes. For prescribing decisions, consult the official prescribing information and a qualified healthcare professional.*