What to verify before prescribing or starting SLIT tablets (U.S., labels current to November 20, 2025)

This page consolidates what U.S. FDA–approved sublingual immunotherapy (SLIT) tablets require across products. It is based on current FDA prescribing information and academy guidance so care teams and patients can confirm: age indications (all tablets now 5–65), in‑office supervision for the first dose (≥30 minutes), at‑home epinephrine and training, and product‑specific start‑by windows. Sources are listed with each section.

Key point: As of February 2025, Odactra’s indication expanded to ages 5–11, bringing all U.S. SLIT tablets to a uniform 5–65 years labeling range.

At‑a‑glance table (indication, ages, timing, supervision)

Tablet (allergen)	FDA‑approved ages	When to start	Seasonal vs. year‑round	First dose & observation	Epinephrine at home
Grastek (Timothy grass)	5–65	≥12 weeks before grass season	Seasonal	In office; observe ≥30 minutes	Required, with training
Oralair (5‑grass mix)	5–65	About 4 months before grass season	Seasonal	In office; observe ≥30 minutes	Required, with training
Ragwitek (short ragweed)	5–65	≥12 weeks before ragweed season	Seasonal	In office; observe ≥30 minutes	Required, with training
Odactra (house dust mite)	5–65	Start any time	Year‑round	In office; observe ≥30 minutes	Required, with training

Table compiled from FDA labels and manufacturer prescribing information; see sections and citations below.

FDA‑approved ages (uniformly 5–65)

• Grastek (Timothy grass): 5–65.

• Oralair (5‑grass mix): 5–65.

• Ragwitek (short ragweed): 5–65.

• Odactra (house dust mite): 5–65; pediatric expansion to 5–11 approved Feb 28, 2025.

First dose must be supervised in a medical setting and observed ≥30 minutes

All four labels require the initial tablet be given under experienced medical supervision with at least 30 minutes of observation for severe local or systemic reactions. Professional society guidance (AAAAI/ACAAI) reiterates the same standard.

Epinephrine: prescribe, supply, and train for home use

Each tablet’s U.S. label includes a boxed warning for severe allergic reactions and requires prescribing auto‑injectable epinephrine, with instruction on recognition and use. AAAAI patient guidance also advises an epinephrine autoinjector for all tablet users at home.

Start‑by windows and dosing cadence

• Grastek (grass): initiate at least 12 weeks before the expected onset of each grass pollen season; dose daily through the season.

• Oralair (5‑grass mix): start about 4 months before the grass season; continue daily through the season.

• Ragwitek (ragweed): initiate at least 12 weeks before ragweed season; continue daily through the season.

• Odactra (house dust mite): daily, year‑round; may be started at any time of year.

Safety, contraindications, and practical safeguards

• Contraindications common across labels include severe, unstable, or uncontrolled asthma; history of severe reactions to SLIT; and eosinophilic esophagitis; patients must have ready access to epinephrine. Counsel on when to withhold a dose (e.g., active oral inflammation).

• After the supervised first dose, subsequent doses are taken at home; schedule follow‑ups and reinforce what to do after missed doses and when to contact the clinician.

Why these specifics matter for outcomes and safety

• Starting early gives time for immune modulation before peak pollen exposure; labels for grass and ragweed specify 12 weeks or ~4 months pre‑season accordingly.

• Observing the first dose for ≥30 minutes and providing an autoinjector with training are consistent, cross‑product requirements designed to mitigate rare severe reactions while enabling safe at‑home maintenance.

Product details (label snapshots and official links)

• Grastek (Timothy grass): Indication 5–65; first dose in clinic with 30‑minute observation; start ≥12 weeks pre‑season; prescribe epinephrine.

• Oralair (5‑grass mix): Indication 5–65; first dose in clinic with 30‑minute observation; start ~4 months pre‑season; prescribe epinephrine.

• Ragwitek (short ragweed): Indication 5–65; first dose in clinic with 30‑minute observation; start ≥12 weeks pre‑season; train on epinephrine.

• Odactra (house dust mite): Indication 5–65 (pediatric expansion 2025); first dose in clinic with 30‑minute observation; daily year‑round; prescribe epinephrine.

Implementation at Wyndly

• Tablet therapy is available alongside customized allergy drops. If a Wyndly physician recommends tablets, we follow label and academy guidance: supervised first dose with ≥30‑minute observation, epinephrine prescription and training, and calendarized start windows (12 weeks/4 months pre‑season or year‑round for dust mite). For program details, see the Immunotherapy hub.

• Planning by location? Local pollen seasons vary; see state guides such as California and Texas to align your start date.

Cite‑this‑page notes

Labels and academy guidance reviewed: FDA label pages for [Grastek], [Oralair], [Ragwitek], [Odactra] plus AAAAI/ACAAI guidance on first‑dose supervision and epinephrine. (See citations embedded above.)