Jeuveau

Jeuveau is a prescription medication used to improve the appearance of moderate to severe glabellar (frown) lines in adults. Jeuveau belongs to a group of drugs called acetylcholine release inhibitors and neuromuscular blocking agents. These work by blocking nerves to muscles in the face. This allows wrinkles to relax and soften.

This medication is available in an injectable form to be given directly into the muscle by a healthcare professional.

Common side effects of Jeuveau include headache, drooping of the eyelids, upper respiratory tract infection, or increased white blood cell counts.

Jeuveau is a prescription medication used to improve the appearance of moderate to severe glabellar (frown) lines in adults.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Jeuveau. See the “Jeuveau Precautions” section.

Common side effects of Jeuveau nclude the following:

• headache

• eyelid ptosis (drooping)

• upper respiratory tract infection

• white blood cell count increase

This is not a complete list of Jeuveau side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• have received any other botulinum toxin product in the last 4 months

• have received injections of botulinum toxin, such as onabotulinumtoxinA (BOTOX, BOTOX COSMETIC) rimabotulinumtoxinB (MYOBLOC), abobotulinumtoxinA (DYSPORT) or incobotulinumtoxinA (XEOMIN). Be sure your healthcare provider knows exactly which product you received.

This is not a complete list of Jeuveau drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Jeuveau including the following:

• Problems swallowing, speaking, or breathing. These problems can happen hours, days, or weeks after an injection of Jeuveau 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 Jeuveau.
  • 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 Jeuveau.
  • 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 Jeuveau 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 
  • blurred vision and drooping eyelids
  • trouble saying words clearly
  • trouble breathing
  • double vision
  • hoarseness or change or loss of voice 
  • loss of bladder control
  • trouble swallowing

These symptoms can happen hours, days, or weeks after you receive an injection of Jeuveau.

These problems could make it unsafe for you to drive a car or do other dangerous activities.

• Allergic reactions. Symptoms of an allergic reaction to Jeuveau may include: itching, rash, hives, wheezing, trouble breathing, or you may become dizzy or faint. Tell your healthcare provider or get emergency medical help right away if you develop wheezing or trouble breathing, or if you feel dizzy or faint.

• Heart problems. Irregular heart beat and heart attack that have caused death, have happened in some people who received botulinum toxin products.

• Eye problems. Dry eye, reduced blinking, and corneal problems have happened in some people who receive Jeuveau to treat glabellar lines. Tell your healthcare provider if you develop eye pain or irritation, sensitivity to light, or changes in your vision.

Do not receive Jeuveau if you:

• are allergic to Jeuveau or any of the ingredients in Jeuveau. See the end of the Medication Guide for a list of ingredients in Jeuveau.
• had an allergic reaction to any other botulinum toxin product such as rimabotulinumtoxinB (MYOBLOC), onabotulinumtoxinA (BOTOX, BOTOX COSMETIC), abobotulinumtoxinA (DYSPORT), or incobotulinumtoxinA (XEOMIN).
• have a skin infection at the planned injection site.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Jeuveau, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Jeuveau, tell your doctor about all of your medical conditions. Especially tell your doctor 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-Easton syndrome).
• are allergic to Jeuveau or to any of its ingredients, including botulinum toxin
• 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 or have had heart problems
• have plans to have surgery
• have weakness of your forehead muscles, such as trouble raising your eyebrows
• have drooping eyelids
• have had surgery on your face
• have had dry eye with use of botulinum toxin products in the past
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if Jeuveau can harm your unborn baby.

There are no well-done studies that have been done in humans with Jeuveau. In animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Jeuveau crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Jeuveau.

Take Jeuveau exactly as prescribed.

• Jeuveau is an injection that your healthcare provider will give you.
• Jeuveau is injected into your affected muscles.
• Jeuveau should not be received more than 1 time every 3 months.
• Your healthcare provider may change your dose of Jeuveau, until you and your healthcare provider find the best dose for you.
• Your healthcare provider will tell you how often you will receive your dose of Jeuveau injections.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

The recommended dose/dose range of Jeuveau for the treatment of improving the appearance of glabellar lines is 0.1 mL (4 units) injected under the muscle into five sites on the face, amounting to a total dose of 20 units.

Jeuveau is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

The effects of all botulinum toxin products, including JEUVEAU, 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. JEUVEAU is not approved for the treatment of spasticity or any conditions other than glabellar lines.