Xeomin

Xeomin is a prescription botulinum toxin type A injection used to treat chronic sialorrhea and upper limb spasticity in adults and children, and cervical dystonia, blepharospasm, and upper facial lines in adults. Xeomin is injected by a healthcare provider.

Xeomin contains incobotulinumtoxinA (botulinum toxin type A), which works by blocking the release of acetylcholine, the chemical signal that nerves use to tell a muscle to contract or a gland to produce saliva. This reduces muscle activity and saliva production in the treated area. The effect is temporary because the nerve endings gradually form new connections and normal signaling returns.

Xeomin (botulinum toxin type A) first received FDA approval on July 30, 2010. There is no generic or biosimilar incobotulinumtoxinA.

Xeomin (botulinum toxin type A) is FDA-approved to treat or improve:

• Chronic sialorrhea (long-lasting drooling) in patients 2 years of age and older
• Upper limb spasticity (increased muscle stiffness in the arm) in patients 2 years of age and older
• Cervical dystonia (abnormal head position and neck pain) in adults
• Blepharospasm (abnormal spasm of the eyelids) in adults
• The appearance of upper facial lines in adults: moderate-to-severe glabellar lines (frown lines between the eyebrows) moderate-to-severe horizontal forehead lines Moderate-to-severe lateral canthal lines (crow's feet).

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 upper facial lines (glabellar lines, horizontal forehead lines, and lateral canthal lines), cervical dystonia, or blepharospasm.

Xeomin is an injection that your healthcare provider will give you.

• It is injected into your affected muscles or glands.
• Your healthcare provider may change your dose of Xeomin during treatment.

Xeomin (botulinum toxin type A) may cause serious side effects that can be life-threatening and has a Boxed Warning for distant spread of toxin effect. Call your healthcare provider or get medical help right away if you have any of these problems after treatment with Xeomin:

• Problems with swallowing, speaking, or breathing. These problems can happen hours to weeks after an injection of Xeomin if the muscles that you use to breathe and swallow become weak after the injection. 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. These people may be at greater risk for serious breathing problems with Xeomin. 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 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.

See also "What should I avoid while receiving Xeomin?"

Do not receive Xeomin (botulinum toxin type A) if you:

• are allergic to Xeomin or any of the ingredients in the injection. See the end of this Medication Guide for a complete list of ingredients
• had an allergic reaction to any other botulinum toxin products
• have a skin infection at the planned injection site.

Before receiving Xeomin, tell your healthcare provider 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). See Important Information above
• have had any side effects 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 your breast milk.

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

Serious side effects

Xeomin (botulinum toxin type A) may cause serious side effects (see also Important Information above), including:

• Injury to the cornea (the clear front surface of the eye) in people treated for blepharospasm. People who receive Xeomin to treat spasms 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.
• Allergic reactions. Symptoms of an allergic reaction to Xeomin may include itching, rash, redness, swelling, wheezing, trouble breathing, dizziness, or feeling faint.

Tell your healthcare provider or get medical help right away if you get wheezing or trouble breathing, or if you get dizzy or faint.

Common side effects

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.

The most common side effects of Xeomin in adults with upper facial lines (glabellar lines, horizontal forehead lines, and lateral canthal lines) include:

• injection site bruising.

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 the FDA at 1-800-FDA-1088

Dosing of Xeomin (botulinum toxin type A) is individualized. The information below reflects the recommended doses in the prescribing information. The Units of Xeomin cannot be converted to those of any other botulinum toxin product.

Chronic sialorrhea

• Adults: 100 Units by intraglandular injection per treatment session, divided into 30 Units for each parotid gland and 20 Units for each submandibular gland, no sooner than every 16 weeks.
• Children: the dose is based on body weight and divided in a 3:2 ratio between the parotid and submandibular glands, no sooner than every 16 weeks. Ultrasound guidance is recommended. Xeomin has not been studied in children weighing less than 12 kg.

Upper limb spasticity

• Adults: up to 400 Units intramuscularly per session, divided among the affected muscles, no sooner than every 12 weeks.
• Children: 8 Units/kg (maximum 200 Units) intramuscularly for a single arm, or 16 Units/kg (maximum 400 Units) if both arms are treated, divided among the affected muscles, no sooner than every 12 weeks.

Cervical dystonia

• Recommended starting dose in adults: 120 Units per treatment session. Repeat treatment is generally no more often than every 12 weeks.

Blepharospasm

• Recommended starting dose in treatment-naive adults: 50 Units (25 Units per eye).
• Do not exceed 100 Units per session (50 Units per eye).
• Repeat treatment is no more often than every 12 weeks.

Upper facial lines

• When all three areas are treated at the same time, the maximum dose in adults is 64 Units (20 Units for glabellar lines, 20 Units for horizontal forehead lines, and 24 Units for lateral canthal lines).
• When areas are treated on their own, glabellar lines use up to 20 Units, horizontal forehead lines are treated together with glabellar lines for a maximum of 40 Units, and lateral canthal lines use up to 24 Units (12 Units per side).
• Do not retreat more often than every three months.

Xeomin may cause loss of strength, general muscle weakness, blurred vision, or drooping eyelids within hours to weeks of treatment. If this happens, do not drive a car, operate machinery, or do other dangerous activities.

• See Important information, above.

Tell your provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal products. Talk to your healthcare provider before you take any new medicinesafter 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 healthcare provider that you have received Xeomin in the past.

Especially tell your healthcare provider if you:

• have received any other botulinum toxin product in the last four months
• have received injections of botulinum toxin in the past. Be sure your healthcare provider 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 healthcare provider if you are not sure if you take any of the medicines listed above. Know the medicines you take. Keep a list of your medicines with you to show your healthcare provider and pharmacist each time you get a new medicine.

Active ingredient: botulinum toxin type A (incobotulinumtoxinA).

Inactive ingredients: human albumin and sucrose.

Xeomin is manufactured by Merz Pharmaceuticals GmbH, Eckenheimer Landstraße 100, 60318 Frankfurt am Main, Germany. U.S. License Number 1830. It is distributed in the U.S. by Merz Pharmaceuticals, LLC, 6601 Six Forks Road, Suite 400, Raleigh, NC 27615, and Merz North America, Inc., 4133 Courtney Street, Suite 10,Franksville, WI 53126.