FDA-approved SLIT Tablets

  • Final approval and prescribing information pending, preliminary information from other countries and FDA advisory committee meetings below
Immunotherapy
Grastek
(Alk-Abello/Merck)
Oralair
(Stallergenes/Greer)
Ragwitek
(Alk-Abello/Merck)
Allergen (dosage)
Timothy grass (2800 BAU/tablet)
Cocksfoot, Sweet vernal, Rye, Meadow, Timothy grass (100 and 300 IR/tablet)
  • 100 IR = 3000 BAU
  • 300 IR = 9000 BAU
Short Ragweed (12 Amb a 1 Units/tablet)
FDA-approved indications
  • ≥5-65 years old
  • Allergic rhinitis due to Timothy grass (or cross-reactive Northern grass)
  • ≥10-65 years old
  • Allergic rhinitis due to Northern grass pollen allergy
  • ≥18-65 years old
    • No efficacy data for >50 yo
  • Allergic rhinitis due to Ragweed pollen allergy
Contraindications
  • Unstable or severe asthma
  • Eosinophilic esophagitis
  • Oral mucosal/dental lesions
  • Fish allergy (contains fish gelatin)
  • Gelatin or mannitol allergy
  • History of severe local or systemic reaction with previous SLIT
  • Beta blockers
  • Unstable or severe asthma
  • Oral mucosal/dental lesions
  • Milk allergy or lactose intolerance (contains lactose), mannitol allergy
  • Beta blockers
  • Use during pregnancy/nursing only if benefit justifies risk

Pregnancy/nursing
  • Category B
  • Use during pregnancy only if clearly needed
  • Unknown if excreted in human milk
  • Category B
  • Use during pregnancy only if clearly needed
  • Unknown if excreted in human milk

Dosing protocol
  • 2 schedules:
    • Pre/co-seasonal for symptom control only: start ≥12 weeks before pollen season and continue through season
    • Year-round for 3 years for symptomatic treatment and sustained effectiveness in 4th year off of treatment
  • No dose escalation (start at maintenance dose)
  • First dose with 30 minute office observation
  • Adult observation of children 30 minutes after each daily home dose
  • Keep under tongue until dissolved (few seconds), avoid swallowing for 1 minute and eating/drinking for 5 minutes, wash hands after handling
  • Hold doses during asthma exacerbations or while active/unhealed oral lesions are presents (e.g. dental extraction)
  • Pre/co-seasonal: start ≥16 weeks before pollen season and continue through season
  • Dose escalation:
    • Adults ≥18 yo: start at 300 IR (maintenance dose)
    • Children 10-17 yo: 100 IR day 1, 200 IR day 2, 300 IR (maintenance dose) on day 3 and subsequent days
  • First dose of each season with 30 minute office observation
  • Adult observation of children 30 minutes after each daily home dose
  • Keep tablet(s) (up to 2 at a time) under tongue for 1 minute, avoid swallowing for 1 minute and eating/drinking for 5 minutes, wash hands after handling
  • Hold doses during asthma exacerbations or while active/unhealed oral lesions are presents (e.g. dental extraction)
  • Pre/co-seasonal: start ≥12 weeks (max 16 weeks) before pollen season and continue through season
  • No dose escalation (start at maintenance dose)
  • First dose with 30 minute office observation
  • Keep under tongue until dissolved (few seconds), avoid swallowing for 1 minute and eating/drinking for 5 minutes, wash hands after handling
Dose adjustment for interruption
For interruption of any length, may resume at full dose at home
  • <7 days, resume at last dose at home
  • >7 days, resume at last dose under observation in office
For interruption of any length, may resume at full dose at home
Adverse effects
  • Oropharyngeal pruritus (~25%)
  • Throat irritation (~20%)
  • Anaphylaxis rare but possible
  • Local adverse effects are common and should be expected to occur within 30 minutes of dose on day 1-2
  • Oropharyngeal pruritus (~25%)
  • Throat irritation (~22%)
  • Anaphylaxis rare but possible
  • Oropharyngeal pruritus
  • Throat irritation
  • Anaphylaxis rare but possible
Epinephrine auto-injector required?
Yes
Yes
Yes



Grading SLIT Adverse Effects

SLIT local adverse effect grading.png



References