XEOMIN® (incobotulinumtoxinA) Treatment Patient Informed

XEOMIN® (incobotulinumtoxinA) Treatment Patient Informed Consent Form I, _______________________________________ understand that I will be injected with XEOMIN® (incobotulinumtoxinA) in
the glabellar lines.
XEOMIN® is an acetylcholine release inhibitor and neuromuscular blocking agent indicated for the temporary improvement
in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult
Risks and complications that may be associated with injection with XEOMIN® (incobotulinumtoxinA) include, but are not
limited to:
1. Headaches: I understand that headaches are possible and usually last one day but may persist longer in a very small
percentage of patients.
2. Injection Site Bruising: I understand that bruising in soft tissues is possible as a result of the needle puncture of the skin.
Bruising can last for several hours, days, weeks, months and, in rare cases, the effect of bruising could be permanent.
3. Facial Paresis (Eyelid Ptosis): I understand that local weakness of the injected muscles is the expected pharmacological
action of XEOMIN® and weakness of adjacent muscles may occur which may result in temporary eyelid “drooping.”
4. Injection Site Bruising, Pain, Swelling, Rash, Local Numbness: I understand that there is a risk of bruising, redness,
swelling, itching and pain associated with the procedure. These symptoms are usually mild and last less than a week
but can last longer. Patients who are using medications that can prolong bleeding, such as aspirin, warfarin, or certain
vitamins and supplements, may experience increased bruising or bleeding at the injection site.
5. Eye Disorder: I understand that injections of XEOMIN® may cause reduced blinking or effectiveness of blinking,
and that I should seek immediate medical attention if eye pain or irritation occur following treatment. An inability
blink the eyelids normally my result in corneal exposure and has been associated with damage to the eye as impaired
vision, or double vision, which is usually temporary. The reduced ability to blink has been associated with corneal
ulcerations. These side effects can last for several weeks or longer.
6. Infection: As with all transcutaneous procedures, I understand that injection of any material carries the risk of infection.
7. Hypersensitivity: XEOMIN® is contraindicated in patients with a known hypersensitivity to the active substance
botulinum toxin type A or to any of the components in the formulation such as human serum albumin. Hypersensitivity
reactions have been reported with botulinum toxin products (anaphylaxis, serum sickness, urticaria, soft tissue edema,
and dyspnea).
8. Swallowing and Breathing Difficulties: I understand that treatment with XEOMIN® and other botulinum toxin products
can result in swallowing or breathing difficulties. Patients with pre-existing swallowing or breathing difficulties may be
more susceptible to these complications. In most cases, this is a consequence of weakening of muscles in the area of
injection that are involved in breathing or swallowing. These reactions can occur within hours to weeks after injection
with botulinum toxin. Seek immediate medical care is swallowing, speech or respiratory disorders arise.
9. Pregnancy and Nursing: There are no adequate and well-controlled studies of XEOMIN® in pregnant or nursing
If you experience loss of strength, muscle weakness, blurred vision, or drooping eyelids occur, avoid driving a car or
engaging in other potentially hazardous activities. No studies of interactions of XEOMIN® with other drugs or substances or implants
have been conducted.
Patient Acknowledgements:
This above list is not meant to be inclusive of all possible risks associated with XEOMIN® (incobotulinumtoxinA) as there
are both known and unknown side effects and complications associated with any medication. I understand that medical
attention may be required to resolve complications associated with my injection.
I confirm that I have received and reviewed the XEOMIN® Medication Guide. I confirm that I have discussed the
potential risks and benefits of XEOMIN® with my doctor and that my doctor has satisfactorily answered all of my questions.
I understand that there is no guarantee of any particular results of any treatment. I understand the results of treatment with
XEOMIN® are temporary.
I acknowledge that I am not pregnant or possibly pregnant, lactating or nursing.
I understand and agree that all services rendered will be charged directly to me, and I am personally responsible for
payment. I further agree, in the event of non-payment, to bear the cost of collection, and/or court costs and reasonable
legal fees, should they be required.
By signing below, I acknowledge that I have read the foregoing informed consent,
have had the opportunity to discuss any questions that I have with my doctor to my satisfaction, and consent to the
treatment described above with its associated risks. I understand that I have the right not to consent to this treatment
and that my consent is voluntary. I hereby release the doctor, the person performing the XEOMIN® injection and the
facility from liability associated with this procedure.
Patient Signature__________________________________________________________________ Date____________
Witness Signature_________________________________________________________________ Date____________