What is Chronic Drooling or Sialorrhea and Why is it Important?

What is Chronic Drooling or Sialorrhea and Why is it Important?

illustration of the inside of someone's nose, throat and airway. Salivary glands are highlighted in pink

This blog is sponsored by Merz Pharmaceuticals, LLC, a distributor of XEOMIN (incobotulinumtoxinA).

Many children with cerebral palsy (CP) have difficulty controlling saliva. Drooling varies in severity and can be distressing for the children, families and caregivers. Chronic drooling is referred to as Sialorrhea and occurs as a result of limitations in a person’s ability to control and swallow oral secretions.

In children with CP, sialorrhea is usually the result of limited oromotor control as a result of muscle incoordination and sensory perception difficulties. Sialorrhea occurs in approximately 40% of children/youth with CP and can have significant medical and psychosocial impact.  

Excessive drooling or Sialorrhea can cause constant damp soiled clothing, unpleasant odor, irritated, skin around the mouth and chin, skin and mouth infections, difficulties chewing, and interference with speech. There is also risk of social rejection and social isolation for children including the need for frequent clothing changes, damage to books, computers, toys and other equipment, as well as spray from the mouth while talking. 

Treatment Options

Fortunately, there are a number of treatment strategies available that may help improve Sialorrhea. Goals of treatment can include: 1) improved control of secretions; 2) enhancement of a child’s ability to behaviorally manage secretions; and 3) reduction of saliva production or rerouting of salivary flow. 

When possible, a multidisciplinary team approach is recommended, progressing from conservative to more invasive treatments until saliva control is improved and side effects, if present, are manageable.  Treatment can include the following options:

  • Optimizing conditions - Optimize positioning and consider other medical factors that may affect drooling. Consider whether medications being used for other conditions, such as epilepsy, are increasing drooling.
  • Oromotor and orosensory strategies - Active and passive exercises as well as sensory applications are widely used by clinicians, although there is no agreement about the theoretical basis and effectiveness of these interventions. 
  • Behavioral strategies - Multiple types of behavioral procedures have been shown to be effective. Please consult with your clinician for more information and guidance. 
  • Intraglandular Botulinum toxin injections to the submandibular +/- parotid glands. XEOMIN® (incobotulinumtoxinA) is the first and only FDA-approved Botulinum Toxin for children (ages 2-17) with Chronic Sialorrhea*. It is often injected using ultrasound guidance for assistance. Consult with your doctor regarding your child’s eligibility and any possible side effects, which can be serious. Please review the Important Consumer Safety Information below for additional safety information. *Every person's experience will vary, and there are potential risks and side effects with intraglandular botulinum toxin injections. In clinical studies pediatric patients had significant and sustained reduction in saliva over 16 weeks. While XEOMIN can help improve chronic sialorrhea (drooling) symptoms it is important to talk to your healthcare provider to see what is right for you or your child. 

  • Surgical intervention. Surgery is usually reserved for patients with profuse, persistent drooling that continues despite other treatments. 

XEOMIN® (incobotulinumtoxinA) IMPORTANT CONSUMER SAFETY INFORMATION

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:

  • Talk to your health care provider or pharmacist
  • Visit www.xeomin.com to obtain the FDA-approved product labeling
  • Call 1-844-4MYMERZ (1-844-469-6379)

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

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.

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

 

Copyright © 2020 Merz Pharmaceuticals, LLC. All rights reserved.  MERZ, the MERZ logo, and XEOMIN are registered trademarks of Merz Pharma GmbH & Co. KGaA. Botox, Dysport and Myobloc are registered trademarks of their respective owners.