Pediatric Patients:
Does This Story Seem Familiar to You?


Consider XEOMIN.

Designed For Purity, XEOMIN Has Only The Ingredients
It Needs To Deliver Results

Designed For Purity, XEOMIN Has Only The Ingredients
It Needs To Deliver Results

Michael’s Story*:
Upper Limb Spasticity

“The upper limb spasticity makes Michael’s muscles stiff and sometimes painful, which is so heartbreaking to see. When he bagin treatment with XEOMIN, he was looser, more comfortable. He was more enthusiastic about activities like painting and cuddling with the dog.”

— Sarah, mother of Michael, a pediatric patient with upper limb spasticity treated with XEOMIN*

Individual results may vary.

*Images and fictionalized story are for illustration purposes only. Not an actual patient.

Now 6 years old, Michael had a traumatic brain injury (TBI) after an accidental fall from the stairs when he was just shy of his first birthday. Sarah, Michael’s mom, noticed early on that he had movement issues. He wasn’t sitting on his own, and he wasn’t crawling—he was sensitive and fearful of all movement.

Around his second birthday, he experienced motor difficulties, including increased muscle tone in his left arm and overactive reflexes. Seeing this, Sarah was overwhelmed. It was hard for her to know that her perfect baby was facing some tough physical challenges. When his symptoms didn’t resolve on their own, Sarah became determined to seek help for Michael from his pediatrician, specialists, and wherever else she could find it.

Michael was soon diagnosed with upper limb spasticity (not caused by cerebral palsy). Sarah began treatment for him at an early development rehabilitation center. She was looking for the physical therapist to provide her with a set of tools, a plan to get Michael moving on his own. Most of all, she was looking for hope.

As Sarah continued to explore treatments, she discovered XEOMIN. “With XEOMIN,” she says, “I was concerned that the shots might be stressful for Michael, but he was able to deal with them well. It’s a good thing, because after getting XEOMIN, he had less stiffness and pain. I could see him moving more naturally.” For Sarah, XEOMIN was one more valuable tool she could include in Michael’s toolkit.

Every patient’s experience with XEOMIN will vary, and there are potential risks and side effects with XEOMIN. Talk to your healthcare provider to see if XEOMIN is right for your child.

Michael is full of life, spontaneous, and very confident. When Sarah reflects on Michael’s experiences with diagnosis, therapy, and treatment with XEOMIN, what she notices most is how those experiences have added to his character and self-esteem. “When I think of Michael,” she says, “the first thing I think of is his smile. It could light up a town.”*

*Images and fictionalized story are for illustration purposes only. Not an actual patient.

Emma’s Story*:
Chronic Sialorrhea

“Chronic sialorrhea is really challenging, from skin irritation to trying to guide Emma on how to manage it. Since we started her on XEOMIN, I feel less anxious about Emma’s condition and can more fully enjoy our time together taking our dog, Bandit, to the park or watching Emma play dolls with her friends.”

— Vivian, mother of Emma, a pediatric patient with chronic sialorrhea treated with XEOMIN*

Individual results may vary.

emma story
*Images and fictionalized story are for illustration purposes only. Not an actual patient.

Emma was a happy baby—always smiling and wanting to be the center of attention. When she was born, her mom, Vivian, was excited to be a new parent to such a sweet and healthy little girl.

Throughout the first year of Emma’s life, Vivian noticed Emma wasn’t like other babies. Emma never learned to crawl or stand. By the age of 1, Emma was diagnosed with cerebral palsy.

Overwhelmed with fear about the challenges her daughter would face, Vivian enrolled Emma in a specialized rehabilitation center. As she got older and finished teething, Vivian noticed Emma continued to drool—her clothing, bibs, and bedding were always wet. When Emma was 2½ years old, Vivian asked Emma’s pediatrician about ways to help her manage her daughter’s drooling.

At the age of 3, Emma started receiving treatment for chronic sialorrhea. At first, Emma’s doctors tried acupuncture and oro-motor therapy. As time passed, Emma showed little sign of improvement. Vivian was worried that her daughter’s drooling could lead to other health issues. Vivian refused to sit back and watch, she was determined to find an answer and read everything she could to find the best care for Emma.

“Now that I’ve found XEOMIN, it’s brought me a sense of hope,” Vivian says. “I was always worried about constantly having to wipe her face so she wouldn’t get a rash. But after we started her on XEOMIN, I saw a real reduction in the amount of saliva, and I could tell it was working.”

For Vivian, XEOMIN was able to provide peace of mind that Emma can be free to grow up around her peers without her mom constantly wiping her face.

Every patient’s experience with XEOMIN will vary, and there are potential risks and side effects with XEOMIN. Talk to your healthcare provider to see if XEOMIN is right for your child.

Emma is an energetic, confident, and fun-loving 6-year-old. When Vivian thinks about Emma’s experiences as she’s getting older, she’s reminded how treatment with XEOMIN has made a big difference for her daughter. “Emma’s been through so much,” she says, “but you would never know it when you look at her. She’s just a big ball of energy.”*

*Images and fictionalized story are for illustration purposes only. Not an actual patient.

Jacob’s Story*: How XEOMIN Treatment Helped Me

“We needed a more targeted therapy that was effective, and that’s exactly what we got with XEOMIN. Now I get to watch my son grow up around his friends to be a teenager.”

— Paul, father of Jacob, an adolescent patient treated with XEOMIN for Chronic Sialorrhea*

Individual results may vary.

jacob story
*Images and fictionalized story are for illustration purposes only. Not an actual patient.

At birth, Jacob was diagnosed with a heart defect, and within hours, he had emergency surgery to treat his condition. Jacob’s father, Paul, was terrified for his son, but after the successful surgery and a few months in the NICU, he was relieved when his son was finally ready to go home.

Paul started noticing developmental challenges with Jacob. When Jacob was 10 months old, he crawled with one arm and one leg while dragging his other arm and leg behind him. Paul mentioned this to Jacob’s pediatrician, who ran a series of tests, and based on those test results, diagnosed Jacob with cerebral palsy.

After Jacob’s diagnosis, Paul noticed that his son drooled more than other kids his age. When it didn’t get better and began causing skin problems, Paul asked Jacob’s doctors for help. Paul was told chronic sialorrhea is a common problem for kids with cerebral palsy. Jacob’s doctors immediately started treating Jacob with oro-sensory therapy. The treatment was successful at managing Jacob’s drooling, but as he became a teenager, things started to get complicated.

“When Jacob started high school,” Paul says, “he was embarrassed to be around his friends, and because of his drooling, he stopped hanging out with them. No teenager wants to wear a bib or have their parent wiping their face all the time. I wanted him to live his life without always having to deal with embarrassment from drooling.”

Paul wanted to give his son independence, so he again asked Jacob’s doctors about other treatment options for chronic sialorrhea. After his 14th birthday, Jacob began treatment with XEOMIN. XEOMIN has made a real difference in Jacob’s life—helping him control excess drooling, which gives him the confidence to be himself.

Every patient’s experience with XEOMIN will vary, and there are potential risks and side effects with XEOMIN. Talk to your healthcare provider to see if XEOMIN is right for your child.

Jacob is your average teenage boy, obsessed with sports and the outdoors. He loves watching sports with his dad and inviting friends over to play basketball or go camping in the backyard. When Paul thinks about all the things Jacob has had to overcome in his life, he feels thankful for the quality time he now has with his son. “Our favorite thing to do together is watch basketball games,” Paul says. “I’m just happy he’s not embarrassed by his dad. Yet.”*

*Images and fictionalized story are for illustration purposes only. Not an actual patient.

XEOMIN® (incobotulinumtoxinA) 
IMPORTANT CONSUMER SAFETY INFORMATION

Warnings

XEOMIN may cause serious side effects that can be life threatening. Get medical help right away if you have any of these problems any time (hours to weeks) after injection of XEOMIN:

  • Problems swallowing, speaking, or breathing can happen if the muscles that you use to breathe and swallow become weak. Death can happen as a complication if you have severe problems with swallowing or breathing after treatment with XEOMIN.
    • People with certain breathing problems may need to use muscles in their neck to help them breathe and may be at greater risk for serious breathing problems with XEOMIN.
    • Swallowing problems may last for several months, and during that time you 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 XEOMIN have the highest risk of getting these problems.
  • 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, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing.

These symptoms can happen hours to weeks after you receive an injection of XEOMIN. These problems could make it unsafe for you to drive a car or do other dangerous activities.


Read the Medication Guide before you start receiving XEOMIN® (Zeo-min) and each time XEOMIN is given to you as there may be new information. The risk information provided here is not comprehensive. To learn more:

Uses

XEOMIN is a prescription medicine:

  • that is injected into glands that make saliva and is used to treat long-lasting (chronic) drooling (sialorrhea) in adults and in children 2 to 17 years of age.
  • that is injected into muscles and used to:
    • treat increased muscle stiffness in the arm because of upper limb spasticity in adults.
    • treat increased muscle stiffness in the arm in children 2 to 17 years of age with upper limb spasticity, excluding spasticity caused by cerebral palsy.
    • treat the abnormal head position and neck pain with cervical dystonia (CD) in adults.
    • treat abnormal spasm of the eyelids (blepharospasm) in adults.

It is not known if XEOMIN is safe and effective in children younger than:

  • 2 years of age for the treatment of chronic sialorrhea
  • 2 years of age for the treatment of upper limb spasticity
  • 18 years of age for the treatment of cervical dystonia or blepharospasm

Do not take XEOMIN if you: are allergic to XEOMIN or any of the ingredients in XEOMIN (see below for a list of ingredients in XEOMIN), had an allergic reaction to any other botulinum toxin product such as rimabotulinumtoxinB (Myobloc®), onabotulinumtoxinA (Botox®, Botox® Cosmetic), or abobotulinumtoxinA (Dysport®) or have a skin infection at the planned injection site.


Before receiving XEOMIN, tell your doctor about all of 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)
  • have had any side effect from any other botulinum toxin in the past
  • have a breathing problem, such as asthma or emphysema
  • have a history of swallowing problems or inhaling food or fluid into your lungs (aspiration)
  • have drooping eyelids
  • have had eye surgery
  • have had surgery on your face
  • are pregnant or plan to become pregnant. It is not known if XEOMIN can harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if XEOMIN passes into breast milk.

Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Talk to your doctor before you take any new medicines after you receive XEOMIN.


Using XEOMIN 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 XEOMIN 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 rimabotulinumtoxinB (MYOBLOC®), onabotulinumtoxinA (BOTOX®, BOTOX® COSMETIC) and abobotulinumtoxinA (DYSPORT®) in the past. Be sure your doctor knows exactly which product you received. The dose of XEOMIN may be different from other botulinum toxin products that you have received.
  • have recently received an antibiotic by injection or inhalation
  • take muscle relaxants
  • take an allergy or cold medicine
  • take a sleep medicine

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.


Possible Side Effects

XEOMIN can cause serious side effects including:

  • Injury to the cornea (the clear front surface of the eye) in people treated for blepharospasm. People who receive XEOMIN to treat spasm of the eyelid may have reduced blinking that can cause a sore on their cornea or other problems of the cornea. Call your healthcare provider or get medical care right away if you have eye pain or irritation after treatment with XEOMIN.
  • XEOMIN may cause other serious side effects including allergic reactions. Symptoms of an allergic reaction to XEOMIN may include: itching, rash, redness, swelling, wheezing, trouble breathing, or dizziness or feeling faint. Tell your doctor or get medical help right away if you get wheezing or trouble breathing, or if you get dizzy or faint.

The most common side effects of XEOMIN in adults with chronic sialorrhea include:

  • needing to have a tooth pulled (extracted)
  • dry mouth
  • diarrhea
  • high blood pressure

The most common side effects of XEOMIN in children 2 to 17 years of age with chronic sialorrhea include:

  • bronchitis
  • nausea
  • headache
  • vomiting

The most common side effects of XEOMIN in adults with upper limb spasticity include:

  • seizure
  • nasal congestion, sore throat and runny nose
  • dry mouth
  • upper respiratory infection

The most common side effects of XEOMIN in children 2 to 17 years of age with upper limb spasticity include:

  • nasal congestion, sore throat and runny nose
  • bronchitis

The most common side effects of XEOMIN in adults with cervical dystonia include:

  • difficulty swallowing
  • neck pain
  • muscle weakness
  • pain at the injection site
  • muscle and bone pain

The most common side effects of XEOMIN in adults with blepharospasm include:

  • drooping of the eyelid
  • dry eye
  • vision problems
  • dry mouth

These are not all the possible side effects of XEOMIN.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1–800–FDA–1088.


General information about the safe and effective use of XEOMIN

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or doctor for information about XEOMIN that is written for health professionals.


Active Ingredient: botulinum toxin type A

Inactive Ingredients: human albumin and sucrose


Please see Full Prescribing Information and Medication Guide.

XEOMIN® (incobotulinumtoxinA) 
IMPORTANT CONSUMER SAFETY INFORMATION

Warnings

XEOMIN may cause serious side effects that can be life threatening. Get medical help right away if you have any of these problems any time (hours to weeks) after injection of XEOMIN:

  • Problems swallowing, speaking, or breathing can happen if the muscles that you use to breathe and swallow become weak. Death can happen as a complication if you have severe problems with swallowing or breathing after treatment with XEOMIN.
    • People with certain breathing problems may need to use muscles in their neck to help them breathe and may be at greater risk for serious breathing problems with XEOMIN.
    • Swallowing problems may last for several months, and during that time you 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 XEOMIN have the highest risk of getting these problems.
  • 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, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing.

These symptoms can happen hours to weeks after you receive an injection of XEOMIN. These problems could make it unsafe for you to drive a car or do other dangerous activities.


Read the Medication Guide before you start receiving XEOMIN® (Zeo-min) and each time XEOMIN is given to you as there may be new information. The risk information provided here is not comprehensive. To learn more:

Uses

XEOMIN is a prescription medicine:

  • that is injected into glands that make saliva and is used to treat long-lasting (chronic) drooling (sialorrhea) in adults and in children 2 to 17 years of age.
  • that is injected into muscles and used to:
    • treat increased muscle stiffness in the arm because of upper limb spasticity in adults.
    • treat increased muscle stiffness in the arm in children 2 to 17 years of age with upper limb spasticity, excluding spasticity caused by cerebral palsy.
    • treat the abnormal head position and neck pain with cervical dystonia (CD) in adults.
    • treat abnormal spasm of the eyelids (blepharospasm) in adults.

It is not known if XEOMIN is safe and effective in children younger than:

  • 2 years of age for the treatment of chronic sialorrhea
  • 2 years of age for the treatment of upper limb spasticity
  • 18 years of age for the treatment of cervical dystonia or blepharospasm

Do not take XEOMIN if you: are allergic to XEOMIN or any of the ingredients in XEOMIN (see below for a list of ingredients in XEOMIN), had an allergic reaction to any other botulinum toxin product such as rimabotulinumtoxinB (Myobloc®), onabotulinumtoxinA (Botox®, Botox® Cosmetic), or abobotulinumtoxinA (Dysport®) or have a skin infection at the planned injection site.


Before receiving XEOMIN, tell your doctor about all of 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)
  • have had any side effect from any other botulinum toxin in the past
  • have a breathing problem, such as asthma or emphysema
  • have a history of swallowing problems or inhaling food or fluid into your lungs (aspiration)
  • have drooping eyelids
  • have had eye surgery
  • have had surgery on your face
  • are pregnant or plan to become pregnant. It is not known if XEOMIN can harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if XEOMIN passes into breast milk.

Tell your doctor about all of the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Talk to your doctor before you take any new medicines after you receive XEOMIN.


Using XEOMIN 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 XEOMIN 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 rimabotulinumtoxinB (MYOBLOC®), onabotulinumtoxinA (BOTOX®, BOTOX® COSMETIC) and abobotulinumtoxinA (DYSPORT®) in the past. Be sure your doctor knows exactly which product you received. The dose of XEOMIN may be different from other botulinum toxin products that you have received.
  • have recently received an antibiotic by injection or inhalation
  • take muscle relaxants
  • take an allergy or cold medicine
  • take a sleep medicine

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.


Possible Side Effects

XEOMIN can cause serious side effects including:

  • Injury to the cornea (the clear front surface of the eye) in people treated for blepharospasm. People who receive XEOMIN to treat spasm of the eyelid may have reduced blinking that can cause a sore on their cornea or other problems of the cornea. Call your healthcare provider or get medical care right away if you have eye pain or irritation after treatment with XEOMIN.
  • XEOMIN may cause other serious side effects including allergic reactions. Symptoms of an allergic reaction to XEOMIN may include: itching, rash, redness, swelling, wheezing, trouble breathing, or dizziness or feeling faint. Tell your doctor or get medical help right away if you get wheezing or trouble breathing, or if you get dizzy or faint.

The most common side effects of XEOMIN in adults with chronic sialorrhea include:

  • needing to have a tooth pulled (extracted)
  • dry mouth
  • diarrhea
  • high blood pressure

The most common side effects of XEOMIN in children 2 to 17 years of age with chronic sialorrhea include:

  • bronchitis
  • nausea
  • headache
  • vomiting

The most common side effects of XEOMIN in adults with upper limb spasticity include:

  • seizure
  • nasal congestion, sore throat and runny nose
  • dry mouth
  • upper respiratory infection

The most common side effects of XEOMIN in children 2 to 17 years of age with upper limb spasticity include:

  • nasal congestion, sore throat and runny nose
  • bronchitis

The most common side effects of XEOMIN in adults with cervical dystonia include:

  • difficulty swallowing
  • neck pain
  • muscle weakness
  • pain at the injection site
  • muscle and bone pain

The most common side effects of XEOMIN in adults with blepharospasm include:

  • drooping of the eyelid
  • dry eye
  • vision problems
  • dry mouth

These are not all the possible side effects of XEOMIN.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1–800–FDA–1088.


General information about the safe and effective use of XEOMIN

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or doctor for information about XEOMIN that is written for health professionals.


Active Ingredient: botulinum toxin type A

Inactive Ingredients: human albumin and sucrose


Please see Full Prescribing Information and Medication Guide.