MEDICATION GUIDE for BOTOX/XEOMIN and MYOBLOC
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MEDICATION GUIDE for BOTOX®/XEOMIN® and MYOBLOC®
(Boe-tox) (OnabotulinumtoxinA/XEOMIN®(incobotulinumtoxinA)
(My-o-block)(rimabotulinumtoxinB)
(For Injection)
Read the Medication Guide that comes with BOTOX®/XEOMIN®/MYOBLOC® before you start using it and each
time it is given to you. There may be new information. This information does not take the place of talking with
your doctor about your medical condition or your treatment. You should share this information with your
family members and caregivers.
What is the most important information I should know about BOTOX®/XEOMIN®/MYOBLOC®.
BOTOX®/XEOMIN®/MYOBLOC® may cause serious side effects that can be life threatening, including:
Problems breathing or swallowing
Spread of toxin effects
These problems can happen hours, days to weeks after an injection of BOTOX®/XEOMIN®/MYOBLOC®. Call
your doctor or get medical help right away if you have any of these problems after treatment with
BOTOX®/XEOMIN®/MYOBLOC®.
1. Problems swallowing, speaking, or breathing.
These problems can happen hours, days to weeks after an injection of BOTOX®/XEOMIN®/ MYOBLOC®
usually because the muscles that you use to breathe and swallow can become weak after the injection.
Death can happen as a complication if you have severe problems with swallowing or breathing after
treatment with
People with certain breathing problems may need to use muscles in their neck to help them breathe.
These people may be at greater risk for serious breathing problems with BOTOX®/
XEOMIN®/MYOBLOC®.
Swallowing problems may last for several months. People who cannot swallow well may need a
feeding tube to receive food and water. If swallowing problems are severe, food or liquids may go into
your lungs. People who already have swallowing or breathing problems before receiving
BOTOX®/XEOMIN®/MYOBLOC® have the highest risk of getting these problems.
2. Spread of toxin effects. In some cases, the effect of botulinum toxin may affect areas of the body away
from the injection site and cause symptoms of a serious condition called botulism. The symptoms of
botulism include:
loss of strength and muscle weakness all over the body
double vision
blurred vision and drooping eyelids
hoarseness or change or loss of voice (dysphonia)
trouble saying words clearly (dysarthria)
loss of bladder control
trouble breathing
trouble swallowing
These symptoms can happen hours, days to weeks after you receive an injection of BOTOX®/XEOMIN®/
MYOBLOC®. These problems could make it unsafe for you to drive a car or do other dangerous activities. See
"What should I avoid while receiving BOTOX®/XEOMIN®/MYOBLOC®
BOTOX_XEOMIN_MYOBLOC PATIENT PACKET: 1/6 EFFECTIVE: 1/2/2019
REVISED: 6/29/2021
There has not been a confirmed serious case of spread of toxin effect away from the injection site when
BOTOX®/XEOMIN®/MYOBLOC® has been used at the recommended dose to treat chronic migraine, severe
underarm sweating, blepharospasm or strabismus.
What is BOTOX®/XEOMIN®?
BOTOX®/XEOMIN® is a prescription medicine that is injected into muscles and used:
To treat leakage of urine (incontinence) in adults with overactive bladder due to neurologic disease.
To prevent headaches in adults with chronic migraine who have 15 or more days each month with
headache lasting 4 or more hours each day.
To treat increased muscle stiffness in elbow, wrist, and finger muscles in adults with upper limb
spasticity.
To treat the abnormal head position and neck pain that happens with cervical dystonia (CD) in adults.
To treat certain types of eye muscle problems (strabismus) or abnormal spasm of the eyelids
(blepharospasm) in people 12 years and older.
BOTOX®/XEOMIN®/MYOBLOC® is also injected into the skin to treat the symptoms of severe underarm
sweating (severe primary axillary hyperhidrosis) when medicines used on the skin (topical) do not work well
enough. It is not known whether BOTOX®/XEOMIN®/MYOBLOC® is safe or effective in people younger than:
18 years of age for treatment of urinary incontinence
18 years of age for treatment of chronic migraine
18 years of age for treatment of spasticity
16 years of age for treatment of cervical dystonia
18 years of age for treatment of hyperhidrosis
12 years of age for treatment of strabismus or blepharospasm
It is not known whether BOTOX®/XEOMIN®/MYOBLOC® is safe or effective to prevent headaches in people
with migraine who have 14 or fewer headache days each month (episodic migraine). It is not known whether
BOTOX®/XEOMIN®/MYOBLOC® is safe or effective for other types of muscle spasms or for severe sweating
anywhere other than your armpits.
What is MYOBLOC®?
MYOBLOC is a prescription medicine that is injected into muscles and used to treat the abnormal head position
and neck pain that happens with cervical dystonia (CD) in adults.
It is not known whether MYOBLOC is safe or effective in children.
It is not known whether MYOBLOC is safe or effective for other types of muscle spasms.
Who should not take BOTOX®/MYOBLOC®?
Do not take if you:
Are allergic to any of the ingredients in BOTOX®/XEOMIN®/MYOBLOC®. See the end of this Medication
Guide for a list of ingredients in BOTOX®/XEOMIN®/MYOBLOC®.
Had an allergic reaction to any other botulinum toxin product such as Botox® Myobloc®, Dysport®, or
Xeomin®
Have a skin infection at the planned injection site
Are being treated for urinary incontinence and have a urinary tract infection (UTI)
Are being treated for urinary incontinence and find that you cannot empty your bladder on your own
(only applies to people who are not routinely catheterizing)
BOTOX_XEOMIN_MYOBLOC PATIENT PACKET: 2/6 EFFECTIVE: 1/2/2019
REVISED: 6/29/2021
What should I tell my doctor before taking BOTOX®/XEOMIN®/MYOBLOC® ?
Tell your doctor about all your medical conditions, including if you:
Have a disease that affects your muscles and nerves (such as amyotrophic lateral sclerosis [ALS or Lou
Gehrig's disease], myasthenia gravis or Lambert-Eaton syndrome). See "What is the most important
information I should know about BOTOX®/XEOMIN®/MYOBLOC®".
Have allergies to any botulinum toxin product
Had any side effect from any botulinum toxin product in the past
Have or have had a breathing problem, such as asthma or emphysema
Have or have had swallowing problems
Have or have had bleeding problems
Have plans to have surgery
Had surgery on your face
Have weakness of your forehead muscles, such as trouble raising your eyebrows
Have drooping eyelids
Have any other change in the way your face normally looks
Have symptoms of a urinary tract infection (UTI) and are being treated for urinary incontinence.
Symptoms of a urinary tract infection may include pain or burning with urination, frequent urination,
or fever.
Have problems emptying your bladder on your own and are being treated for urinary incontinence
Are pregnant or plan to become pregnant. It is not known if BOTOX®/XEOMIN®/MYOBLOC® can harm
your unborn baby.
Are breast-feeding or plan to breastfeed. It is not known if BOTOX®/XEOMIN®/MYOBLOC® passes into
breast milk.
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines,
vitamins and herbal products. Using BOTOX®/XEOMIN®/MYOBLOC® with certain other medicines may cause
serious side effects. Do not start any new medicines until you have told your doctor that you have received
BOTOX®/XEOMIN®/MYOBLOC® in the past. Especially tell your doctor if you:
Have received any other botulinum toxin product in the last four months
Have received injections of botulinum toxin, such as Botox® (onabotulinumtoxinA), Myobloc®
(rimabotulinumtoxinB), Dysport® (abobotulinumtoxinA), or Xeomin® (incobotulinumtoxinA) in the
past. Be sure your doctor knows exactly which product you received.
Have recently received an antibiotic by injection
Take muscle relaxants
Take an allergy or cold medicine
Take a sleep medicine
Take anti-platelets (aspirin-like products) and/or anti-coagulants (blood thinners)
Ask your doctor if you are not sure if your medicine is one that is listed above. Know the medicines you take.
Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.
BOTOX_XEOMIN_MYOBLOC PATIENT PACKET: 3/6 EFFECTIVE: 1/2/2019
REVISED: 6/29/2021BOTOX (Botulinum A Toxin)/MYOBOC (Botulinum B Toxin)/
Xeomin (Botulinum A Toxin)
INFORMED CONSENT FORM
I, _______________________________________, understand that I will be
injected with Botulinum A Toxin (Botox or Xeomin) or Botulinum B (Myobloc) in the
area of the _______________________________________ muscles to paralyze
these muscles temporarily in an effort to provide pain relief.
Botulinum A Toxin (Botox or Xeomin) and Botulinum B (Myobloc) injections have been
FDA approved for use in treatment of musculoskeletal issues, pain and headaches.
Injection of Botox, Xeomin or Myobloc into muscles causes those specific muscles to
halt their function (be paralyzed), thereby helping to decrease and/or eliminate pain and
improve function. I understand the goal is to decrease pain and restriction or
dysfunction in the treated area. This paralysis is temporary, and re-injection is
necessary within three to four months. It has been explained to me that other temporary
and more permanent treatments are available.
The possible side effects of Botox/Xeomin/Myobloc include but are not limited to:
1. Risks: I understand there is a risk of swelling, rash, headache, local
numbness, pain at the injection site, bruising, respiratory problems,
and allergic reaction.
2. Infection: Infections can occur which in most cases are easily treatable but
in rare cases a permanent scarring in the area can occur.
3. Most people have lightly swollen pinkish bumps where the injections went
in, for a couple of hours or even several days.
4. Although many people with chronic headaches or migraines often get relief
from Botox/Xeomin/Myobloc, a small percent of patients get headaches
following treatment, for the first day. In a very small percentage of patients
these headaches can persist for several days or weeks.
5. Local numbness, rash, pain at the injection site, flu like symptoms with mild
fever, back pain.
6. Respiratory problems such as bronchitis or sinusitis, nausea, dizziness, and
tightness or irritation of the skin.
BOTOX_XEOMIN_MYOBLOC PATIENT PACKET: 4/6 EFFECTIVE: 1/2/2019
REVISED: 6/29/20217. Bruising is possible anytime you inject a needle into the skin. This bruising
can last for several hours, days, weeks, months and in rare cases the effect
of bruising could be permanent.
8. While local weakness of the injected muscles is representative of the
expected pharmacological action of Botox, weakness of adjacent muscles
may occur as a result of the spread of the toxin.
9. Treatments: I understand more than one injection may be needed to
achieve a satisfactory result.
10. I will follow all aftercare instructions as it is crucial I do so for healing.
As Botox, Xeomin and Myobloc are not exact sciences, there might be an uneven
appearance with some muscles more affected by the Botox than others. In most cases
this uneven appearance can be corrected by injecting Botox in the same or nearby
muscles. However in some cases this uneven appearance can persist for several weeks
or months.
This list is not meant to be inclusive of all possible risks associated with Botox/Myobloc
as there are both known and unknown side effects associated with any medication or
procedure.
Botox, Xeomin and Myobloc should not be administered to a pregnant or nursing
woman.
Additionally, the number of units injected is an estimate of the amount of
Botox/Xeomin/Myobloc required to paralyze the muscles. I understand there is no
guarantee of results of any treatment. I understand the regular charge applies to all
subsequent treatments.
I understand and agree that all services rendered to me are charged directly to me and
that I am personally responsible for payment. I further agree in the event of non-
payment, to bear the cost of collection, and/or Court cost and reasonable legal fees,
should this be required.
By signing below, I acknowledge that I have read the foregoing informed consent,
and that I was offered the Medication Guide for Botox, Xeomin or Myobloc to
review, and agree to the treatment with its associated risks. I hereby give consent to
perform this and all subsequent Botox/Xeomin/Myobloc treatments with the above
understood. I hereby release the doctor, the person injecting the Botox/Xeomin/Myobloc
and the facility from liability associated with this procedure.
Patient Signature ______________________________________ Date:_______
BOTOX_XEOMIN_MYOBLOC PATIENT PACKET: 5/6 EFFECTIVE: 1/2/2019
REVISED: 6/29/2021COVID-19 SCREENING
Please answer yes or no to the following:
Are you currently experiencing any of the following symptoms? YES NO
• A new fever (100.4 oF or higher) or a sense of having a fever
• A new cough that you cannot attribute to another health condition
• New shortness of breath or difficulty breathing that you cannot attribute to another
health condition.
• New chills that you cannot attribute to another health condition
• A new sore throat that you cannot attribute to another health condition
• New muscle aches (myalgia) that you cannot attribute to another health condition,
or that may have been caused by a specific activity (such as physical exercise)
• A new loss of taste or smells
• Have you had a positive test for the virus that causes COVID-19 disease within
the past 10 days
• In the past 14 days, have you had close contact (within 6 feet for 15 minutes or
more) with someone with suspected or confirmed COVID-19?
If you have answered YES to any of the above questions, we will not be able to see you for
today’s visit, and you will have to reschedule for another time.
During your visit, do you agree to: YES NO
• Wear a face covering when entering, exiting, traveling through and
spending time inside the COVA Spine and Pain facilities (Unless an
exception exists per Executive Order 63)
• Maintain appropriate physical distance between yourself and others, as
much as possible (at least 6 feet)
• Limit physical contact between yourself and others, as much as possible
• Practice proper hand hygiene.
• Immediately notify a staff member if you develop symptoms of COVID-19.
I have reviewed and agree to the above criteria.
*Patient Name: (Printed) _______________________________ *Date of Birth: ___________
Patient Signature: ____________________________________ *Today’s Date: __________
Responsible Person Signature: __________________________ Today’s Date: ___________
Relationship to patient: ________________________________
Forehead Temperature: ______ oF
Office use Only
BOTOX_XEOMIN_MYOBLOC PATIENT PACKET: 6/6 EFFECTIVE: 1/2/2019
REVISED: 6/29/2021You can also read
