Allergen extract House dust mites

Generic name
Allergen extract House dust mites
Brand name
ATC Code
V01AA03
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Allergen extract House dust mites

Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Pharmacokinetics in children

The main component of allergens consists of polypeptides and proteins, which are broken down in the digestive tract and in tissues. It is not expected that a substantial portion of the allergens will reach the bloodstream. Therefore, pharmacokinetic studies have not been performed. [SmPC]

dose recommendation of formulary compared to licensed use (on-label versus off-label)

On-label

Licensed use Licensed use

Registration Status Title

Matige tot ernstige allergische rhinitis door huisstofmijt:
> 12 jaar: 1 dd 1 dosis

Available formulations

Lyophilisaat, oraal 12 SQ-HDM

Dosages

Moderate to serious allergic rhinitis caused by dust mites
  • Sublingual
    • 5 years up to 18 years

      • Acarizax:
        12 SQ-HDM day in 1 dose (=one lyophilisate for oral use per day).

      • Duration of treatment:

        for 18 months, more usually 3 years in practice; clinical improvement occurs 8-14 weeks after commencing treatment; if no improvement is seen in the first year, the treatment should be discontinued.

  • Oral
    • 12 years up to 18 years

      • Actair:
        Day 1: 100 IR/day in 1 dose
        Day 2: 200 IR/day in 1 dose
        Day 3 and further: 300 IR/day in 1 dose

      • Duration of treatment:

        No efficacy data are available for treatment periods longer than 12 months. International treatment guidelines indicate that a favorable effect on the natural course of the disease can be achieved after a treatment period of 3 years. If there is no improvement in the first year, consider discontinuing treatment.

Renal impaiment in children > 3 months

No information available on dose adjustment in renal impairment.

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

The following side effects were observed more frequently in studies involving children compared to studies involving adults and adolescents:
Very common (≥1/10): Abdominal pain, diarrhea, dysgeusia, glossodynia, mouth ulcers, nausea, pharyngeal edema, and tongue edema.

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Adult Side Effects

Lokale allergische reacties treden op, vooral in de eerste paar dagen, meestal binnen 5 minuten na inname, en nemen af na enkele minuten tot uren. Deze reacties verdwijnen bij voortzetting van de behandeling (na 1–3 maanden).

Zeer vaak (> 10%): nasofaryngitis, keelirritatie, gezwollen lippen, oedeem en/of jeuk in de mond. Jeukende oren.

Vaak (1-10%): astma, dyspneu, dysfonie. Orofaryngeale pijn, faryngeaal oedeem. Rinitis, sinusitis, faryngitis, bronchitis. Jeukende ogen. Jeukende lippen, jeukende tong, oedeem van de tong, glossitis, glossodynie, pijn in de mond, mondzweren, onaangenaam gevoel in de mond, erytheem van het mondslijmvlies, stomatitis, dysfagie, orale paresthesie, misselijkheid, braken, buikpijn, diarree, dyspepsie, gastro-oesofageale refluxziekte. Onaangenaam gevoel op de borst, vermoeidheid. Jeuk op de huid, urticaria.

Soms (0,1-1%): anafylactische reactie. Hartkloppingen. Duizeligheid, paresthesie. Verstopte neus, rinorroe, niezen, onaangenaam gevoel in de neus, neusoedeem. Beklemd gevoel in de keel, faryngeaal erytheem, hypertrofie van de tonsillen. Laryngitis. Blaarvorming van het mondslijmvlies, droge mond, pijnlijke lippen, lipzweren, speekselkliervergroting, hypersecretie van speeksel, oesofageale irritatie. Onaangenaam gevoel van de oren. Erytheem op de huid. Allergische conjunctivitis. Malaise.

Zelden (0,01-0,1%): angio-oedeem. Laryngeaal/tracheaal oedeem. Neusobstructie.

Verder is gemeld: eosinofiele oesofagitis.

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications in adults

  • actieve of onvoldoende onder controle gebrachte aandoeningen die het immuunsysteem beïnvloeden (bv. maligniteiten, auto-immuunziekten of immunodeficiëntie);
  • ontstekingen in de mondholte met ernstige klachten zoals lichen planus, ulceraties of mycosis;
  • een FEV1 < 70% van de voorspelde waarde bij aanvang van de behandeling, ondanks adequate behandeling hiervoor
  • ernstige verergering van astma in de laatste drie maanden;
  • ten tijde van een acute luchtweginfectie bij astma-patiënten (dan de behandeling uitstellen tot de infectie over is).

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions

No information available on specific warnings and precautions in children.

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

ALLERGENS

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

Allergen extracts
V01AA02
v01aa

References

  1. ALK-Abelló A/S, SmPC Acarizax (RVG 118889) 12-05-2023, www.geneesmiddeleninformatiebank.nl
  2. Stallergenes, SmPC Actair (RVG 126703) 12-01-2023, www.geneesmiddeleninformatiebank.nl

Changes

Therapeutic Drug Monitoring


Overdose