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.

Learn More About XEOMIN >

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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.

Learn More About XEOMIN >

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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.

Learn More About XEOMIN >

Find a Doctor >

IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING
WARNING:
DISTANT SPREAD OF TOXIN EFFECT

See full prescribing information for complete BOXED WARNING.

The effects of XEOMIN and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults, particularly in those patients who have underlying conditions that would predispose them to these symptoms.

INDICATIONS

XEOMIN® (incobotulinumtoxinA) for injection is indicated for the treatment of:

  • Chronic sialorrhea in patients 2 years of age and older
  • Upper limb spasticity in adults
  • Upper limb spasticity in pediatric patients 2 years of age and older, excluding spasticity caused by cerebral palsy
  • Cervical dystonia in adults
  • Blepharospasm in adults
CONTRAINDICATIONS
  • Known hypersensitivity to any botulinum toxin product or to any of the components in the formulation.
  • Infection at the proposed injection site(s) because it could lead to severe local or disseminated infection.
WARNINGS AND PRECAUTIONS
  • The potency units of XEOMIN are specific to the preparation and assay method used and are not interchangeable with other preparations of botulinum toxin products. Therefore, Units of biological activity of XEOMIN cannot be compared to or converted into Units of any other botulinum toxin products.
  • Serious hypersensitivity reactions have been reported with botulinum toxin products (anaphylaxis, serum sickness, urticaria, soft tissue edema, and dyspnea). If serious and/or immediate hypersensitivity reactions occur, discontinue further injection of XEOMIN and institute appropriate medical therapy immediately. The use of XEOMIN in patients with a known hypersensitivity to any botulinum neurotoxin or to any of the excipients (human albumin, sucrose), could lead to a life-threatening allergic reaction.
  • 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. When distant effects occur, additional respiratory muscles may be involved. Patients may require immediate medical attention should they develop problems with swallowing, speech, or respiratory disorders. Dysphagia may persist for several months, which may require use of a feeding tube. Aspiration may result from severe dysphagia [See BOXED WARNING].
  • Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junctional disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome) may be at increased risk for severe dysphagia and respiratory compromise from typical doses of XEOMIN.
  • Caution should be taken when XEOMIN is used where the targeted muscle shows excessive weakness or atrophy.
  • Cervical Dystonia: Treatment with botulinum toxins may weaken neck muscles that serve as accessory muscles of ventilation. This may result in critical loss of breathing capacity in patients with respiratory disorders who may have become dependent upon these accessory muscles. There have been post- marketing reports of serious breathing difficulties, including respiratory failure, in patients with cervical dystonia treated with botulinum toxin products. Patients with smaller neck muscle mass and patients who require bilateral injections into the sternocleidomastoid muscles are at greater risk of dysphagia. Limiting the dose injected into the sternocleidomastoid muscle may decrease the occurrence of dysphagia.
  • Blepharospasm: Injection of XEOMIN into the orbicularis oculi muscle may lead to reduced blinking and corneal exposure with possible ulceration or perforation. To decrease the risk for ectropion, XEOMIN should not be injected into the medial lower eyelid area.
  • XEOMIN contains human serum albumin. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would also be considered extremely remote. No cases of transmission of viral diseases, CJD, or vCJD have ever been reported for albumin.
ADVERSE REACTIONS

The most commonly observed adverse reactions at rates specified below and greater than placebo are:

  • Chronic Sialorrhea:
    • in adults (≥4% of patients): tooth extraction, dry mouth, diarrhea, and hypertension.
    • in pediatric patients (≥1% of patients): bronchitis, headache, and nausea/vomiting.
  • Upper Limb Spasticity
    • in adults (≥2% of patients): seizure, nasopharyngitis, dry mouth, and upper respiratory tract infection.
    • in pediatric patients (≥3% of patients): nasopharyngitis and bronchitis.
  • Cervical Dystonia in adults (≥5% of patients): dysphagia, neck pain, muscle weakness, injection site pain, and musculoskeletal pain.
  • Blepharospasm in adults (≥10% of patients): eyelid ptosis, dry eye, visual impairment, and dry mouth.
DRUG INTERACTIONS

Co-administration of XEOMIN and aminoglycoside or other agents interfering with neuromuscular transmission, (e.g., muscle relaxants), should only be performed with caution as these agents may potentiate the effect of the toxin.

Use of anticholinergic drugs after administration of XEOMIN may potentiate systemic anticholinergic effects.

The effect of administering different botulinum toxin products at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin.

USE IN PREGNANCY

There are no adequate data on the developmental risk associated with the use of XEOMIN in pregnant women. XEOMIN should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

PEDIATRIC USE

Safety and effectiveness of XEOMIN in patients less than 18 years of age have not been established for lower limb spasticity, cervical dystonia, or blepharospasm. Safety and effectiveness have been established in pediatric patients 2 to 17 years of age in patients with chronic sialorrhea and upper limb spasticity. A pediatric assessment for XEOMIN in upper limb spasticity demonstrates that XEOMIN is safe and effective in another pediatric population. However, XEOMIN is not approved for such patient population due to marketing exclusivity for another botulinum toxin.

IMPORTANT SAFETY INFORMATION INCLUDING BOXED WARNING
WARNING:
DISTANT SPREAD OF TOXIN EFFECT

See full prescribing information for complete BOXED WARNING.

The effects of XEOMIN and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults, particularly in those patients who have underlying conditions that would predispose them to these symptoms.

INDICATIONS

XEOMIN® (incobotulinumtoxinA) for injection is indicated for the treatment of:

  • Chronic sialorrhea in patients 2 years of age and older
  • Upper limb spasticity in adults
  • Upper limb spasticity in pediatric patients 2 years of age and older, excluding spasticity caused by cerebral palsy
  • Cervical dystonia in adults
  • Blepharospasm in adults
CONTRAINDICATIONS
  • Known hypersensitivity to any botulinum toxin product or to any of the components in the formulation.
  • Infection at the proposed injection site(s) because it could lead to severe local or disseminated infection.
WARNINGS AND PRECAUTIONS
  • The potency units of XEOMIN are specific to the preparation and assay method used and are not interchangeable with other preparations of botulinum toxin products. Therefore, Units of biological activity of XEOMIN cannot be compared to or converted into Units of any other botulinum toxin products.
  • Serious hypersensitivity reactions have been reported with botulinum toxin products (anaphylaxis, serum sickness, urticaria, soft tissue edema, and dyspnea). If serious and/or immediate hypersensitivity reactions occur, discontinue further injection of XEOMIN and institute appropriate medical therapy immediately. The use of XEOMIN in patients with a known hypersensitivity to any botulinum neurotoxin or to any of the excipients (human albumin, sucrose), could lead to a life-threatening allergic reaction.
  • 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. When distant effects occur, additional respiratory muscles may be involved. Patients may require immediate medical attention should they develop problems with swallowing, speech, or respiratory disorders. Dysphagia may persist for several months, which may require use of a feeding tube. Aspiration may result from severe dysphagia [See BOXED WARNING].
  • Individuals with peripheral motor neuropathic diseases, amyotrophic lateral sclerosis, or neuromuscular junctional disorders (e.g., myasthenia gravis or Lambert-Eaton syndrome) may be at increased risk for severe dysphagia and respiratory compromise from typical doses of XEOMIN.
  • Caution should be taken when XEOMIN is used where the targeted muscle shows excessive weakness or atrophy.
  • Cervical Dystonia: Treatment with botulinum toxins may weaken neck muscles that serve as accessory muscles of ventilation. This may result in critical loss of breathing capacity in patients with respiratory disorders who may have become dependent upon these accessory muscles. There have been post- marketing reports of serious breathing difficulties, including respiratory failure, in patients with cervical dystonia treated with botulinum toxin products. Patients with smaller neck muscle mass and patients who require bilateral injections into the sternocleidomastoid muscles are at greater risk of dysphagia. Limiting the dose injected into the sternocleidomastoid muscle may decrease the occurrence of dysphagia.
  • Blepharospasm: Injection of XEOMIN into the orbicularis oculi muscle may lead to reduced blinking and corneal exposure with possible ulceration or perforation. To decrease the risk for ectropion, XEOMIN should not be injected into the medial lower eyelid area.
  • XEOMIN contains human serum albumin. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would also be considered extremely remote. No cases of transmission of viral diseases, CJD, or vCJD have ever been reported for albumin.
ADVERSE REACTIONS

The most commonly observed adverse reactions at rates specified below and greater than placebo are:

  • Chronic Sialorrhea:
    • in adults (≥4% of patients): tooth extraction, dry mouth, diarrhea, and hypertension.
    • in pediatric patients (≥1% of patients): bronchitis, headache, and nausea/vomiting.
  • Upper Limb Spasticity
    • in adults (≥2% of patients): seizure, nasopharyngitis, dry mouth, and upper respiratory tract infection.
    • in pediatric patients (≥3% of patients): nasopharyngitis and bronchitis.
  • Cervical Dystonia in adults (≥5% of patients): dysphagia, neck pain, muscle weakness, injection site pain, and musculoskeletal pain.
  • Blepharospasm in adults (≥10% of patients): eyelid ptosis, dry eye, visual impairment, and dry mouth.
DRUG INTERACTIONS

Co-administration of XEOMIN and aminoglycoside or other agents interfering with neuromuscular transmission, (e.g., muscle relaxants), should only be performed with caution as these agents may potentiate the effect of the toxin.

Use of anticholinergic drugs after administration of XEOMIN may potentiate systemic anticholinergic effects.

The effect of administering different botulinum toxin products at the same time or within several months of each other is unknown. Excessive neuromuscular weakness may be exacerbated by administration of another botulinum toxin prior to the resolution of the effects of a previously administered botulinum toxin.

USE IN PREGNANCY

There are no adequate data on the developmental risk associated with the use of XEOMIN in pregnant women. XEOMIN should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

PEDIATRIC USE

Safety and effectiveness of XEOMIN in patients less than 18 years of age have not been established for lower limb spasticity, cervical dystonia, or blepharospasm. Safety and effectiveness have been established in pediatric patients 2 to 17 years of age in patients with chronic sialorrhea and upper limb spasticity. A pediatric assessment for XEOMIN in upper limb spasticity demonstrates that XEOMIN is safe and effective in another pediatric population. However, XEOMIN is not approved for such patient population due to marketing exclusivity for another botulinum toxin.