Itulatek® sublingual tablets
This product is taken sublingually.
Why is it prescribed?
Itulatek® is an under-the-tongue immunotherapy to treat birch, alder and/or hazel pollen allergies that can cause sneezing, runny or itchy nose, stuffy or congested nose, or itchy and watery eyes. It can be prescribed for people 18 through 65 years of age.
- Remove the tablet from the package with dry hands by carefully removing the foil. (If your hands are wet or damp, the tablet will break or dissolve too soon). Wash your hands after handling the tablet
- Place the tablet under the tongue right away. It will rapidly dissolve
- Try not to swallow for about 1 minute
- Do not drink or eat for 5 minutes after taking the tablet
- Store in the original blister at room temperature (15 to 30°C)
Place one tablet under the tongue once daily, usually until at least the end of the yearly tree pollen season. Itulatek® should be started at least 16 weeks before the tree pollen season usually begins.
The immune system is the target of immunotherapy. The aim is to prevent or suppress allergic symptoms, such as allergic rhinitis, through repeated administration of the allergen. The effect of sublingual immunotherapy is thought to be mediated through local and systemic immunomodulatory mechanisms (immune deviation) including changes in allergen specific antibodies and regulatory T- cells leading to long-term tolerance development.
The most common side effects include:
- itching of the ears, mouth, tongue
- swelling of the mouth, tongue and lips
- cough or swelling in the throat
- painful or irritated throat or numb or prickling sensation in the mouth
Get emergency treatmen if you experience:
- swelling of the throat, mouth or tongue
- difficulty swallowing or breathing
- asthma attack/wheezing
- hives/itchy rash
- rapid heart rate
Do not use rhis medication if:
- you are allergic to any of the ingredients in this product
- you have had a serious allergic reaction to tree pollen allergy shots
- you have severe or unstable asthma
- you are taking beta-blockers
- you have any swelling or sores in your mouth or have recently had any mouth injury or mouth surgery (such as a tooth removal).
- you have a history of eosinophilic esophagitis
Your doctor may decide that this is not the best treatment for you if you have diseases affecting the immune system or have malignant diseases (e.g. cancer)
This is NOT a medication that gives immediate relief from symptoms of an allergy.
You should have auto-injectable epinephrine available to inject in case of a severe allergic reaction to this medication.
The first tablet must be taken at the physician's office under medical supervision and the patient must be monitored for at least 30 minutes.
Use in pregnancy: No clinical data are available for use during pregnancy. Do not start use during pregnancy because of the risk of severe systemic reactions which may be harmful to the mother or fetus.
Use in breastfeeding: It is not known if this medication appears in breast milk. Consult with doctor or pharmacist before use.