Letybo: Uses, Side Effects and Dosage

What is Letybo used for?

• Letybo is for use in adults to temporarily improve the look of moderate to severe frown lines (wrinkles) between the eyebrows (glabellar lines).

How does Letybo work?

Letybo temporarily relaxes muscles that cause wrinkles.

What are the ingredients in Letybo?

Medicinal ingredients: LetibotulinumtoxinA

Non-medicinal ingredients: Human serum albumin, sodium chloride

Serious Warnings and Precautions

Letybo comes in the following dosage forms:

Single use, sterile 50 Unit and 100 Unit vials.

Do not use Letybo if:

• you are allergic or sensitive to any of the ingredients,
• you have an infection in the place which is the injection site or close to the injection sites
• you have any muscle or nerve disorders in other parts of your body, such as myasthenia gravis, Eaton Lambert Syndrome or amyotrophic lateral sclerosis (ALS) or Lou Gehrig’s disease

Letybo treatment is not recommended if

• you are pregnant or become pregnant during treatment with this drug. Animal studies with daily repeated doses of Letybo or other botulinum toxin product have shown reproductive toxicity.

• you are nursing. It is not known whether this drug is excreted in human milk

To help avoid side effects and ensure proper use, talk to your healthcare professional before you have Letybo treatment. Talk about any health conditions or problems you may have, including if you:

• have received any other botulinum toxin product in the last four months
• have eye disorders including drooping eyelids, dry eyes
• have bleeding problems
• have pre-existing swallowing or breathing difficulties
• have or have had heart problems
• have weakness of your forehead muscles, such as trouble raising your eyebrows
• have had surgery on your face
• are allergic or sensitive to any botulinum toxin product
• are scheduled to have surgery using a general anesthetic
• are pregnant or become pregnant while taking this drug
• are nursing. It is not known whether this drug is excreted in human milk

Other warnings you should know about:

Letybo is for intramuscular use only.

Letybo should only be injected by a physician with the appropriate qualifications and experience in the treatment and use of botulinum toxin products.

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

Seek immediate medical attention if swallowing, speech, or respiratory problems arise.

Tell your doctor if you are taking other medicines, including those you have bought at your pharmacy, supermarket, or health food shop.

Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

The following may interact with Letybo:

• The effect of Letybo may be increased by aminoglycoside antibiotics (e.g., streptomycin, tobramycin, neomycin, gentamicin, netilmicin, kanamycin, amikacin), spectinomycin, polymyxins, tetracyclines, lincomycin, muscle relaxant, or other drugs that interfere with neuromuscular transmission.

How to take Letybo:

• Letybo can only be injected by physicians experienced in the injection of botulinum toxin products.

Usual dose:

The optimum dosage and number of injection sites in the treated muscle will be chosen by your doctor.

Overdose:

Intramuscular injection of doses that exceeds the recommended dose, injection of the drug into blood or other conditions that increase the risk of the toxin spread in the body can cause overdose. Symptoms of overdose may not be immediately apparent after the injection and may include general weakness, drooping eyelid, double vision, swallowing, speech and/or breathing difficulties, and pneumonia.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

What are possible side effects from using Letybo?

These are not all the possible side effects you may have when taking Letybo. If you experience any side effects not listed here, tell your healthcare professional.

The most commonly reported side effect (≥ 1%) with Letybo is headaches.

Other potential side effects can include allergic reactions (e.g., swollen eyelids, wheezing), temporary muscle weakness close to injection site, injection site reactions (e.g., pain, bruising, itchy skin, swelling), upper respiratory tract infection, and sinus infection.

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:

• 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
  • drooping eyelids
  • hoarseness or change or loss of voice
  • trouble saying words clearly
  • loss of bladder control
  • trouble breathing
  • trouble swallowing

If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.

Reporting Side Effects

Storage:

Letybo must be stored under refrigeration at 2-8°C in the original carton to protect from exposure to light. Once reconstituted, it can be stored under refrigeration at 2-8°C for up to 24 hours. Do not freeze after reconstitution.

Keep out of reach and sight of children.

If you want more information about Letybo:

• Talk to your healthcare professional
• Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website [website], or by calling 1-877-674-5355

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