Severe systemic reactions
Due to the possible risk of severe anaphylactic reactions, all resuscitation equipment and medicinal products, including epinephrine injections, and trained medical personnel must be immediately available.
If symptoms of a systemic reaction such as urticaria, angioedema or severe asthma appear, symptomatic treatment should be initiated immediately.
On the day of injection administration, the patient must avoid physical exertion and alcohol, as these cofactors may potentially increase the risk of anaphylaxis.
The drug of choice for severe allergic reactions is epinephrine. The effect of epinephrine may be potentiated with potentially fatal consequences in patients treated with tricyclic antidepressants, monoamine oxidase inhibitors (MAOIs) and/or COMT inhibitors. The effect of epinephrine may be diminished in patients treated with beta-blockers.
Malignant neoplastic disease
No controlled studies are available on the effect of malignant neoplastic disease on the efficacy of allergen immunotherapy (AIT), nor studies investigating whether malignant neoplastic disease is a predisposition for severe adverse reactions during allergen immunotherapy with Alutard SQ birch. The risk-benefit ratio must be evaluated individually in patients with neoplastic disease.
In patients with cardiac disease and inflammatory respiratory disease, the risk of systemic allergic reactions may be increased. Clinical experience with Alutard SQ birch treatment in patients with cardiac disease and respiratory inflammation is limited. This must be taken into account before initiating allergen immunotherapy.
Asthma
Asthma is a known risk factor for severe systemic allergic reactions.
Clinical experience with Alutard SQ birch treatment in patients with asthma is limited.
In patients with a history of asthma, asthma symptoms must be adequately monitored for at least 3 months before initiating treatment with Alutard SQ birch.
Before each injection administration, the asthma status must be evaluated. Immunotherapy injections should be postponed if the patient's asthma has not been adequately controlled in the week before the planned injection.
Patients with a history of asthma must be informed of the necessity of consulting a physician in the event of worsening asthma.
In patients with a history of asthma and an acute respiratory illness, initiation of treatment with Alutard SQ birch should be delayed until the infection has resolved.
Autoimmune disease in remission
Only limited data are available on allergen immunotherapy in patients with autoimmune disease in remission. In these patients, Alutard SQ birch should therefore be prescribed with caution.
Special populations
Alutard SQ birch contains aluminium (maximum 1.13 mg/ml in the 100,000 SQ-U/ml vial). In patients at increased risk of aluminium accumulation (i.e. patients with renal impairment or patients concomitantly using aluminium-containing medicinal products (e.g. antacids)), insufficient clearance of aluminium and its accumulation in the body may occur. This must be considered before initiating treatment with Alutard SQ birch.
The effect of long-term aluminium intake on the immune system is not known. For information regarding concomitant administration with other AIT and vaccines, see section 4.5.
Treatment precautions
Conditions requiring dose adjustment or postponement of injection
In the event of severe allergic reactions to a previous injection of Alutard SQ birch, the subsequent dose should be reduced and administered with caution (for details on the extent of dose reduction, see section 4.2);
if the patient has a fever or other clinical signs of acute or chronic infection;
if the patient has reduced lung function (FEV1 < 70% of predicted value in adults and FEV1 < 80% of predicted value in children and adolescents) or has symptoms suggesting asthma exacerbation;
if the patient's atopic dermatitis has worsened (see sections 4.2 and 4.8);
if the interval between scheduled doses has been exceeded (see section 4.2);
if current lung function is reduced by more than 20% of the patient's best value.
Before injection administration
Before each injection of Alutard SQ birch, the asthma status of patients with a history of asthma should be evaluated and lung function assessed (see section 4.3);
allergic reactions (both local and systemic) following the previous administration of Alutard SQ birch must be documented, and dosing must be evaluated before the next administration (see section 4.2);
the patient's health status and allergy status should be assessed based on changes in other medications since the last injection (see section 4.2);
before each injection, a double-check of the declared allergen, concentration, volume, and date of the previous injection (dosing interval) must be performed;
before each administration, the vial should be inspected for any turbidity or other signs of contamination, particularly for vials that have already been opened;
Alutard SQ birch is intended for subcutaneous administration; intravenous injection must be avoided due to the increased risk of allergic reactions.
After each injection administration
After each injection, the patient must be monitored for at least 30 minutes. If symptoms of a systemic reaction such as urticaria, angioedema or severe asthma appear during this time, symptomatic treatment should be initiated;
the patient must be instructed to monitor any local or systemic reactions and to seek medical attention or emergency care if needed;
any allergic reactions (local or systemic) must be recorded before the patient leaves the clinic.
This medicinal product contains less than 1 mmol (23 mg) sodium per dose, that is to say essentially "sodium-free".
