Note: Xeomin® 100 units is equivalent to Dysport® 500 units and Botox® 100 units
LINKS TO RELATED MONOGRAPHS AND OTHER INJECTABLE ROUTES:
MEDICINE NAME:
Botulinum toxin type A (Xeomin®)
TRADE NAME(S):
Xeomin®
PRESENTATION OF MEDICINE:
Powder for solution for injection.
Each vial contains 100 units of Clostridium Botulinum neurotoxin type A.
METHOD OF ADMINISTRATION:
- Detrusor overactivity – intradetrusal administration.
- Ophthalmology (blepharospasm) – injection into the medial and lateral orbicularis oculi of the upper lid and the lateral orbicularis of the lower lid (non-formulary).
- Spasticity – intramuscular injection into the affected muscle.
INSTRUCTIONS FOR RECONSTITUTION:
Xeomin® is reconstituted prior to use with sterile unpreserved sodium chloride 9 mg/ml (0.9%) solution for injection.(1,3)
Possible dilutions are indicated in the following table:(1)
Solvent added
(sodium chloride 9 mg/ml (0.9%) solution for injection) / Resulting concentration in units per 0.1 ml
0.5 ml
1.0 ml
2.0 ml
4.0 ml
8.0 ml / 20.0 units / 0.1ml
10.0 units / 0.1ml
5.0 units / 0.1ml
2.5 units / 0.1ml
1.25 units / 0.1ml
Vials should be gently rotated until the powder is completely dissolved.(3)
INSTRUCTIONS FOR DILUTION AND SUITABLE DILUENT:
Botulinum toxin does not require further dilution
FLUSHING:
Not applicable
ADVERSE EFFECTS WHICH MAY BE CAUSED BY AN INJECTABLE ADMINISTRATION AND SUGGESTED MONITORING:
· Pain / bruising at injection site. Local weakness. Advise patient in advance of possible effect.(2)
· Deep or misplaced injections may paralyse neighbouring muscle groups.(2)
· The most common adverse effects after injection into muscles around the eye, such as in the management of blepharospasm, hemifacial spasm, or strabismus are ptosis, lachrymation, photophobia, ocular irritation, and facial swelling.(2)
· Dysphagia is the most common adverse effect after injection into neck muscles.(2)
EXPIRY WHEN MADE UP IN A CLINICAL AREA:
Reconstituted solutions should be used immediately or stored at 2 – 8°C for up to 24 hours.(1)(3)
COMPATIBILITY INFORMATION USEFUL IN CLINICAL PRACTICE:
Not to be mixed or given with any other intravenous medicine
SPECIAL HANDLING PRECAUTIONS:
Immediately after treatment of the patient, any residual botulinum toxin which may be present in either vials or syringes should be inactivated using diluted sodium hypochlorite solution (0.5% or 1% sodium hypochlorite). Thereafter, all items should be disposed of in accordance with standard hospital practice.(1)
Spillage of botulinum toxin should be wiped up with an absorbent cloth soaked in solution of sodium hypochlorite (bleach) in case of the powder or with dry absorbent material in case of reconstituted product.(1)
SODIUM CONTENT (mmol): n/a
OSMOLARITY / OSMOLALITY: n/a
pH: n/a
OTHER COMMENTS:
PRODUCT RISK FACTORS: Risk Assessment of a common preparation (as required by NPSA Patient Safety Alert 20)
USUAL TOTAL RISK FACTORS: 2 OVERALL RISK RATING: Green
OTHER INJECTABLE ROUTES OF ADMINISTRATION:
Intradermally, Intracutaneously, subcutaneously, or directly into affected glands (3)
PHARMACY NOTES:
CURRENT MANUFACTURERS / DISTRIBUTORS / LICENCE HOLDERS:
Merz Pharma UK Ltd
260 Centennial Park,
Elstree Hill,
South Elstree,
Herts, WD6 3SR
Telephone: +44 (0)208 236 0000
DELETED MANUFACTURERS / DISTRIBUTORS / LICENCE HOLDERS:
REFERENCES:
1. Summary of Product Characteristics available on www.medicines.org.uk/emc last updated 12/09/2012.
2. Martindale "The Complete Drug Reference" online accessed via http://www.medicinescomplete.com on 6th June 2013.
3. American Hospital Formulary Service Drug Information accessed via http://www.medicinescomplete.com on 6th June 2013.
4. Trissel "Handbook on injectable drugs" online accessed via http://www.medicinescomplete.com
5. British National Formulary online accessed via http://www.medicinescomplete.com
Version
DATE PUBLISHED: / DATE PRINTED:
Written by Checked by
Breda Cronnolly Ajmal Daulatzai
July 2012. June 2013