Pronunciation: Le-tye-boe
Generic name: letibotulinumtoxinA-wlbg
Dosage form: intramuscular injection
Drug class: Skeletal muscle relaxants

Medically reviewed by Carmen Pope, BPharm. Last updated on Mar 4, 2024.

What is Letybo?

Letybo (letibotulinumtoxinA-wlbg) is injected into muscles to temporarily improve the appearance of moderate to severe brow furrows (glabellar lines) in adults. These frown lines are typically associated with corrugator and/or procerus muscle activity.

Letybo is a neurotoxin and works by blocking signals to the muscles, specifically by blocking the release of acetylcholine, a nerve transmitter that causes muscles to contract. Gradual muscle function recovery occurs due to the slow degradation of the letibotulinumtoxinA-wlbg and the formation of axonal sprouts, which reverses the effects of Letybo over several months.

Letybo was FDA approved on 29th February, 2024.

Warnings

Rarely, Letybo could spread outside of the corrugator and/or procerus muscle, in an unintended way, causing swallowing and breathing difficulties which may be fatal.

Letybo is NOT interchangeable with other botulinum toxin products due to differences in potency units. Potentially serious reactions have occurred when Letybo has been given for unapproved uses.

May cause hypersensitivity reactions. If one occurs, your healthcare provider will stop Letybo immediately and give you the appropriate medical treatment.

Serious cardiovascular side effects, some fatal, have occurred with botulinum toxin products. Use caution when administering to patients with pre-existing cardiovascular disease.

The effects of treatment may be exacerbated by other neuromuscular disorders.

Should be used with caution in patients who have problems with their breathing or difficulty swallowing (dysphagia).

It is not known if Letybo is safe and effective for use in children.

Before taking

Do not receive Letybo if you:

• are allergic to Letybo, letibotulinumtoxinA-wlbg, or any of the inactive ingredients in the product
• have had an allergic reaction to any other botulinum toxin product such as rimabotulinumtoxinB (Myoblock), onabotulinumtoxinA (Botox, Botox Cosmetic), abobotulinumtoxinA (Dysport), incobotulinumtoxinA (Xeomin), prabotulinumtoxinA-xvfs (Jeuveau), or daxibotulinumtoxinA-lanm (Daxxify).
• have a skin infection at the planned injection site.

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-Easton syndrome)
• had any side effects 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
• plan 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 eyes with the use of botulinum toxin products in the past
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Pregnancy

It is not known if Letybo can harm your unborn baby.

Breastfeeding

It is not known if Letybo passes into breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment.

How is Letybo administered?

Letybo is injected by a healthcare provider, usually in a clinic.

• It is injected into the muscles of your brow line.
• It should not be injected more than 1 time every 3 months. Your healthcare provider will tell you how often you should receive your dose.
• The exact dosage for you will be determined by your healthcare provider.

What should I avoid while receiving Letybo?

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

What are the side effects of Letybo?

Letybo may cause serious side effects that can be life-threatening. Call your healthcare provider or get medical help right away if you have any of these problems after treatment with Letybo:

• Problems swallowing, speaking, or breathing. These problems can happen hours, days, or weeks after an injection of Letybo 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 Letybo.
  • 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 Letybo.
  • 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 Letybo have the highest risk of getting these problems.

Other serious side effects include:

• Allergic reactions, including anaphylaxis. 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.
• An irregular heartbeat and heart attack that have caused death, have happened in some people who received botulinum toxin products. Tell your doctor if you have any pre-existing heart conditions.
• Dry eyes, reduced blinking, and corneal problems have happened in some people who receive Letybo. Tell your healthcare provider if you develop eye pain or irritation, sensitivity to light, or changes in your vision.

The most common side effect of Letybo was headache.

These are not all of the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Hugel, Inc. at 1-877-390-2906.

Related/similar drugs

What other drugs will affect Letybo?

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Using Letybo 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 Letybo in the past.

Especially tell your healthcare provider if you have received any other botulinum toxin product in the last several months, including rimabotulinumtoxinB (Myoblock), onabotulinumtoxinA (Botox, Botox Cosmetic), abobotulinumtoxinA (Dysport), incobotulinumtoxinA (Xeomin), prabotulinumtoxinA-xvfs (Jeuveau), or daxibotulinumtoxinA-lanm (Daxxify) in the past. Be sure your healthcare provider knows exactly which product you received.

Aminoglycoside antibiotics, anticholinergic agents, or any other agents that interfere with neuromuscular transmission may increase the effect of Letybo. 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.

See the Letybo Product Information for a complete list of interactions.

Storage

Store unopened Letybo vials in a refrigerator between 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze.

Ingredients

Active ingredient: letibotulinumtoxinA-wlbg

Inactive ingredients: albumin human and sodium chloride

Manufacturer

Hugel, Inc.

Letybo Biosimilars

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Letybo.

Frequently asked questions

• What is botulinum toxin used to treat?

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer