ACARIZAX Tablets/Oral Lyophilisate

What is ACARIZAX

ACARIZAX is an immunotherapy tablet that contains a standardized allergen extract derived from the house dust mites Dermatophagoides pteronyssinus and Dermatophagoides farinae. It is available in a lyophilized (freeze-dried) form and intended for sublingual (under the tongue) administration. ACARIZAX is primarily used for the treatment of house dust mite-induced allergic rhinitis and allergic asthma.

• ACARIZAX is indicated for adults and adolescents (12–65 years) with a confirmed diagnosis of house dust mite allergy.
• The medication works by gradually desensitizing the immune system to the allergens, reducing the severity of symptoms over time.
• It is typically used as part of an allergen immunotherapy program for long-term symptom relief.
• Each tablet contains a defined and consistent amount of allergens to ensure accurate dosing and safety.

This product is not intended for immediate symptom relief but rather as a disease-modifying treatment to reduce allergic sensitivity in the long term.

How to use ACARIZAX

ACARIZAX tablets are designed for sublingual use and should not be swallowed whole. Correct administration is essential to ensure efficacy and minimize side effects.

• Administration: Place the tablet under the tongue and allow it to dissolve completely without swallowing for at least 1 minute.
• First Dose: Should be taken under medical supervision in case of any immediate allergic reaction.
• Timing: Take the tablet once daily at the same time each day, preferably in the morning.
• Eating/Drinking: Avoid eating or drinking for at least 5 minutes after taking the tablet.
• Hygiene: Ensure your hands are dry when handling the tablet. Do not chew or swallow it whole.
• Missed Dose: If a dose is missed, take it as soon as you remember unless it is close to the next dose. Do not double the dose.

Consistency in daily usage is crucial for the immunotherapy to be effective over the treatment course.

Mode of Action ACARIZAX

ACARIZAX functions through the principles of allergen-specific immunotherapy. The goal is to desensitize the immune system to house dust mite allergens and reduce hypersensitivity reactions over time.

• Allergen Exposure: The tablet contains standardized extracts of house dust mites that act as controlled exposures to the allergen.
• Immune Tolerance: Regular sublingual exposure trains the immune system to tolerate the allergen, reducing the exaggerated immune response.
• T-Cell Modulation: ACARIZAX promotes a shift from Th2-dominant immune responses (associated with allergy) to Th1 responses, thereby reducing inflammation and IgE production.
• IgG4 Antibody Production: Increased production of IgG4 antibodies helps to neutralize allergens before they trigger an allergic reaction.
• Symptom Reduction: Over time, patients may experience decreased nasal congestion, sneezing, itchy eyes, and wheezing related to dust mite allergy.

This mechanism offers long-term relief and may modify the natural course of allergic diseases if treatment is continued for several years.

ACARIZAX Interactions ACARIZAX

While ACARIZAX is generally well tolerated, interactions may occur when used with other medications, particularly those that affect immune function or increase the risk of allergic reactions.

• Beta-Blockers: Concomitant use may reduce the effectiveness of epinephrine if used for anaphylaxis. Use with caution and under close supervision.
• Immunosuppressants: May interfere with the development of immune tolerance and reduce the efficacy of ACARIZAX.
• Antihistamines: While not contraindicated, regular use of antihistamines may mask early signs of an allergic reaction. Consult your doctor before combining them.
• Allergy Vaccines: Simultaneous use with other forms of allergen immunotherapy is not recommended unless directed by an allergy specialist.
• Corticosteroids: Systemic corticosteroids may dampen immune responses and potentially diminish the long-term benefits of ACARIZAX.

Always inform your healthcare provider about all medications, including over-the-counter products and herbal supplements, before starting ACARIZAX.

Dosage of ACARIZAX

The standard dosage of ACARIZAX is one tablet (12 SQ-HDM) per day. The duration and continuity of treatment are crucial for its success in allergy management.

• Initial Dose: First dose must be administered under medical supervision to monitor for allergic reactions.
• Maintenance Dose: 1 tablet daily, taken at the same time each day.
• Recommended Duration: Treatment should be continued for at least 3 years for long-term benefits.
• Monitoring: Regular follow-ups are necessary to assess efficacy and side effects. Adjustments may be made based on the patient's response.
• Children: Not recommended for children under 12 years of age.

Do not increase or skip doses unless directed by a healthcare professional. Adherence to the regimen is vital for therapeutic success.

Possible side effects of ACARIZAX

As with all allergen immunotherapies, ACARIZAX may cause allergic reactions, particularly in the early phase of treatment. Most side effects are mild and temporary.

• Common Side Effects:
  • Mouth itching or swelling
  • Throat irritation
  • Nausea or abdominal pain
  • Ear itching or discomfort
  • Sneezing or nasal congestion
• Less Common Side Effects:
  • Heartburn
  • Fatigue
  • Headache
• Serious Side Effects (Rare):
  • Anaphylaxis (requires immediate medical attention)
  • Severe swelling of the tongue or throat
  • Difficulty breathing or swallowing

Patients are advised to report any side effects, especially signs of hypersensitivity, to their doctor immediately. Carrying an epinephrine auto-injector may be recommended in some cases.

ACARIZAX Contraindications ACARIZAX

ACARIZAX should not be used in certain individuals due to the risk of severe reactions or reduced efficacy.

• Known hypersensitivity: Do not use in patients with hypersensitivity to any of the excipients or the active allergen extract.
• Severe uncontrolled asthma: Patients with poorly controlled asthma are at increased risk of severe systemic reactions.
• Active oral inflammation: Conditions such as oral ulcers, infections, or post-dental surgery should delay treatment initiation.
• Autoimmune diseases: Use is generally not recommended in individuals with autoimmune disorders unless benefits outweigh risks.
• Beta-blocker therapy: Patients taking beta-blockers may not respond to epinephrine if a serious allergic reaction occurs.
• Children under 12: Safety and efficacy have not been established in this age group.

Always undergo a complete medical evaluation before starting ACARIZAX to determine appropriateness of therapy.

Storage of ACARIZAX

Proper storage of ACARIZAX is essential to maintain its stability and efficacy.

• Temperature: Store at temperatures below 25°C (77°F). Do not freeze.
• Packaging: Keep the tablets in their original blister packs until use to protect from moisture and light.
• Humidity: Protect from excessive humidity. Do not store in the bathroom or other damp areas.
• Expiry: Do not use after the expiration date printed on the packaging.
• Child Safety: Keep out of reach and sight of children.

If any tablet appears damaged or discolored, discard it and consult a pharmacist for guidance. Do not use damaged tablets.