Bee venom allergen injection suspension
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Injection suspension containing bee venom allergen adsorbed to aluminium hydroxide, hydrated.
Drugs List
Therapeutic Indications
Uses
Bee venom allergy
Allergy immunotherapy treatment in patients with a documented history of generalised and/or systemic IgE mediated allergic reaction due to sensitisation to honey bee venom (Apis mellifera).
Dosage
Adults
Treatment is divided into two phases, and up-dosing phase and a maintenance phase. The up-dosing phase is used to gradually increase the dose until the highest tolerated maintenance dose is reached. The highest recommended maintenance dose is 1 ml of 100,000 SQ-U/ml. There are three different length up-dosing schedules, the choice depending on the patient's sensitivity.
Up-dosing phase
7-week up-dosing (accelerated)
Week 1, injection number 1: 10 SQ-U
Week 1, injection number 2: 100 SQ-U
Week 1, injection number 3: 1000 SQ-U
Week 2, injection number 4: 2,000 SQ-U
Week 2, injection number 5: 2,000 SQ-U
Week 3, injection number 6: 5,000 SQ-U
Week 3, injection number 7: 5,000 SQ-U
Week 4, injection number 8: 20,000 SQ-U
Week 5, injection number 9: 40,000 SQ-U
Week 6, injection number 10: 60,000 SQ-U
Week 7, injection number 11: 100,000 SQ-U
15-week up-dosing (conventional)
Week 1, injection number 1: 20 SQ-U
Week 1, injection number 2: 40 SQ-U
Week 1, injection number 3: 80 SQ-U
Week 2, injection number 4: 200 SQ-U
Week 2, injection number 5: 400 SQ-U
Week 2, injection number 6: 800 SQ-U
Week 3, injection number 7: 2,000 SQ-U
Week 3, injection number 8: 4,000 SQ-U
Week 3, injection number 9: 8,000 SQ-U
Week 4, injection number 10: 10,000 SQ-U
Week 4, injection number 11: 20,000 SQ-U
Week 4, injection number 12: 40,000 SQ-U
Week 4, injection number 13: 60,000 SQ-U
Week 4, injection number 14: 80,000 SQ-U
Week 4, injection number 15: 100,000 SQ-U
25-week up-dosing (extended conventional)
Week 1, injection number 1: 20 SQ-U
Week 1, injection number 2: 40 SQ-U
Week 1, injection number 3: 80 SQ-U
Week 2, injection number 4: 200 SQ-U
Week 2, injection number 5: 400 SQ-U
Week 2, injection number 6: 800 SQ-U
Week 3, injection number 7: 1,000 SQ-U
Week 3, injection number 8: 2,000 SQ-U
Week 3, injection number 9: 3,000 SQ-U
Week 3, injection number 10: 4,000 SQ-U
Week 3, injection number 11: 5,000 SQ-U
Week 3, injection number 12: 6,000 SQ-U
Week 3, injection number 13: 7,000 SQ-U
Week 3, injection number 14: 8,000 SQ-U
Week 3, injection number 15: 9,000 SQ-U
Week 4, injection number 16: 10,000 SQ-U
Week 4, injection number 17: 20,000 SQ-U
Week 4, injection number 18: 30,000 SQ-U
Week 4, injection number 19: 40,000 SQ-U
Week 4, injection number 20: 50,000 SQ-U
Week 4, injection number 21: 60,000 SQ-U
Week 4, injection number 22: 70,000 SQ-U
Week 4, injection number 23: 80,000 SQ-U
Week 4, injection number 24: 90,000 SQ-U
Week 4, injection number 25: 100,000 SQ-U
When following recommendations for the up-dosing phase, the product literature should be consulted.
Maintenance phase
For the maintenance phase, the interval between injections of the maintenance dose is gradually increased. The interval is increased from 1 to 2, 4 and 6 to 8 weeks. Subsequently, the dosing of the injection is given every 6 to 8 weeks, and is continued for 3 to 5 years.
Children
(See Dosage; Adult)
Additional Dosage Information
If the patient responds to the up-dosing phase with severe allergic reaction, the highest recommended dose of 100,000 SQ-U may not be reached. In this case, a lower dose should be used as the maximal tolerated dose will be used as the maintenance dose.
Exceeded time interval between doses
If the recommended time interval between doses has been exceeded, the following injection is amended according to the following:
Up-dosing phase
Up to 2 weeks between doses: Continue up-dosing according to relevant schedule.
2 to 3 weeks between doses: Repeat previous dose.
3 to 4 weeks between doses: Reduce to 50% of previous dose.
4 weeks or longer between doses: Re-start up-dosing phase.
Maintenance phase
Up to 8 weeks between doses: Continue with the maintenance dose.
8 to 10 weeks between doses: Reduce to 75% of previous dose.
10 to 12 weeks between doses: Reduce to 50% of previous dose.
12 to 14 weeks between doses: Reduce to 25% of previous dose.
14 to 16 weeks between doses: Reduce to 10% of previous dose.
16 weeks or longer between doses: Re-start up-dosing phase.
Dose reduction in case of allergic reactions
Local reactions
If an injection site reaction persists for longer than 6 hours following the injection, the following dose reduction is recommended:
Maximum diameter of swelling less than 5cm in children or less than 8cm in adults: Continue upward titration according to up-dosing schedule.
Maximum diameter of swelling 5-7cm in children or 8-12cm in adults: Repeat dose last given.
Maximum diameter of swelling 7-12cm in children or 12-20cm in adults: Reduce dose to dose given the time before last.
Maximum diameter of swelling 12-17cm in children or greater than 20cm in adults: Reduce dose to dose given 2 times before last.
Maximum diameter of swelling greater than 17cm in children: Reduce dose to dose given 3 times before last.
Systemic reactions
If a serious systemic reaction occurs after injection, treatment should only be continued after careful consideration. If treatment is continued, the following dose should be reduced to 10% of the dose that provoked the serious systemic reaction.
Administration
For subcutaneous injection only, administered laterally in the distal part of the upper arm or dorsally in the proximal part of the forearm.
The vial must be inverted up and down 10 to 20 times before use.
Aspiration must be performed before injection and repeated for every 0.2ml during the injection in order to avoid intravascular injection.
Contraindications
Acute infection
Chronic infection
Pyrexia
Severe immunosuppression
Severe active autoimmune disorder
Severe cardiovascular disorder
Uncontrolled asthma
Precautions and Warnings
Autoimmune disease
Children under 18 years
Asthma
Breastfeeding
Cardiovascular disorder
Exacerbation of atopic dermatitis
History of asthma
Immunodeficiency syndromes
Malignant neoplasm
Mastocytosis
Pregnancy
Renal impairment
Do not give other vaccines within 7 days before or after a dose
Therapy should not be initiated during exacerbation of asthma
Advise ability to drive/operate machinery may be affected by side effects
Consider prophylactic antihistamines for high risk patients
Different brands of this product are not interchangeable
Aspirate prior to injection to avoid intravascular administration
Have adrenaline injection ready for use in case of anaphylaxis
Inject other vaccines at different sites
Resuscitation facilities must be immediately available
Treatment to be administered under the supervision of a specialist
Baseline assessment of lung function advised
Exclude pregnancy prior to initiation of treatment
Monitor for signs and symptoms of allergic reaction
Monitor lung function in patients with asthma
Monitor patient for 30 minutes after administration
Risk of aluminium accumulation in renal impairment
Advise patient to report if allergic reaction occurs
Advise patient to seek medical advice if asthma seems to be worsening
Beta blockers may reduce the response to adrenaline in anaphylaxis
Advise patient to seek advice at first indications of pregnancy
Discontinue if serious allergic or anaphylactic reaction occurs
Advise patient to avoid aluminium containing antacids
Avoid strenuous exercise, hot baths and alcohol on day of treatment
Advise patient to seek medical advice if delayed adverse event(s) occurs
Pregnancy and Lactation
Pregnancy
Use bee venom allergen injection suspension with caution during pregnancy.
The manufacturer recommends that the up-dosing treatment should not be initiated during pregnancy. If pregnancy occurs during the maintenance treatment, the maintenance treatment may continue after careful evaluation. There is no clinical experience of bee venom allergen vaccine during pregnancy.
Lactation
Use bee venom allergen injection suspension with caution during breastfeeding.
The manufacturer states that no effects on breastfed infants are anticipated, although at the time of writing there is no clinical data available on the used of bee venom allergen during breastfeeding.
Side Effects
Abdominal pain
Allergic reaction
Anaphylactic shock
Angioedema
Arthralgia
Asthma
Bronchospasm
Chest discomfort
Conjunctivitis
Cough
Diarrhoea
Dizziness
Dysphagia
Dyspnoea
Erythema
Erythema at injection site
Eye pruritus
Eyelid oedema
Facial oedema
Fatigue
Feeling hot
Flushing
Granuloma (injection site)
Headache
Hypertrichosis
Hypotension
Itching (injection site)
Joint swelling
Local pain (injection site)
Localised urticaria
Malaise
Nasal congestion
Nausea
Nodules (injection site)
Pallor
Palpitations
Paraesthesia
Peripheral oedema
Pruritus
Rash
Rhinitis
Sensation of foreign body
Sneezing
Swelling (injection site)
Tachycardia
Throat irritation
Throat tightness
Urticaria
Vertigo
Vomiting
Wheezing
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: September 2020
Reference Sources
Summary of Product Characteristics: Alutard Bee Venom Initial. ALK-Abello Ltd. Revised January 2020.
Summary of Product Characteristics: Alutard Bee Venom Maintenance. ALK-Abello Ltd. Revised January 2020.
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