Description
LetibotulinumtoxinA-wlbg injection is used to temporarily improve the appearance of moderate to severe frown lines between the eyebrows (glabellar lines).
LetibotulinumtoxinA-wlbg is a botulinum toxin A product. It works on the nervous system to relax the muscles.
This medicine is to be given only by or under the direct supervision of your provider.
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of letibotulinumtoxinA-wlbg in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of letibotulinumtoxinA-wlbg in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- AbobotulinumtoxinA
- Aclidinium
- Amantadine
- Amikacin
- Amitriptyline
- Amoxapine
- Atropine
- Baclofen
- Belladonna
- Benztropine
- Biperiden
- Brompheniramine
- Capreomycin
- Carbinoxamine
- Carisoprodol
- Chlorpheniramine
- Chlorpromazine
- Chlorzoxazone
- Clemastine
- Clidinium
- Clomipramine
- Clozapine
- Cyclobenzaprine
- Cyclopentolate
- Cyproheptadine
- Dantrolene
- Darifenacin
- DaxibotulinumtoxinA-lanm
- Desipramine
- Dicyclomine
- Dimenhydrinate
- Diphenhydramine
- Doxepin
- Fesoterodine
- Flavoxate
- Fluphenazine
- Gentamicin
- Glycopyrrolate
- Glycopyrronium Tosylate
- Homatropine
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Amyotrophic lateral sclerosis (Lou Gehrig's disease) or
- Cornea or eye problems or
- Heart or blood vessel disease or
- Heart rhythm problem (eg, arrhythmia) or
- Lambert-Eaton syndrome (nerve-muscle disorder) or
- Motor neuropathy (muscle or nerve problem) or
- Myasthenia gravis (severe muscle weakness) or
- Surgery where the injection will be given (eg, face surgery)—May increase the risk for more serious side effects.
- Breathing problems (eg, asthma, emphysema) or
- Dysarthria (trouble with speaking) or
- Dysphagia (trouble with swallowing) or
- Dysphonia (voice problem) or
- Inflammation at the injection site or
- Ptosis (droopy eyelid) or
- Urinary incontinence (problems passing urine)—Use with caution. May make these conditions worse.
- Infection at the injection site—Should not be used in patients with this condition.
Proper Use
Your provider will give you this medicine in a medical facility. It is given as a shot into the muscles between your eyebrows. This medicine should not be received more than 1 time every 3 months.
This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your provider if you have any questions.
Your provider will only use Letybo® to treat your condition. Other botulinum toxin products may not work the same way and require a different dose.
Precautions
It is very important that your provider check your progress at regular visits. This will allow your provider to see if the medicine is working properly and to decide if you should continue to receive it. Blood tests may be needed to check for unwanted effects.
Serious muscle reactions have occurred within hours to weeks after receiving this medicine. If you start to have muscle weakness, loss of bladder control, or trouble with swallowing, talking, or breathing, call your doctor right away. In some patients, these problems could be life-threatening and may require immediate treatment in a hospital or clinic.
This medicine may cause a serious allergic reaction, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have chest tightness, a cough, difficulty swallowing, dizziness, fast heartbeat, fever, hives, itching, skin rash, inflammation of the joints, muscle aches, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, swollen lymph nodes, or unusual tiredness while you are receiving this medicine.
This medicine may increase the risk of heart rhythm problems (eg, arrhythmia) or heart attack. These are more likely to occur if you have heart or blood vessel disease. Check with your doctor right away if you have dizziness, fainting, fast, slow, or irregular heartbeat, chest pain or discomfort, pain or discomfort in the arms, jaw, back or neck, trouble breathing, nausea, or vomiting.
This medicine may cause eye dryness and reduce blinking of the eye, tear production, and cornea problems. Check with your doctor right away if you have blurred vision, eye irritation, increased sensitivity of the eyes to sunlight, or any other change in vision occurs during or after treatment. Your doctor may want your eyes to be checked by an ophthalmologist (eye doctor).
This medicine may cause muscle weakness, loss of strength, or vision problems. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
This medicine is made from donated human blood. Some human blood products have transmitted certain viruses (eg, Creutzfeldt-Jakob disease) to people who have received them, although the risk is low. Human donors and donated blood are both tested for viruses to keep the transmission risk low. Talk with your doctor if you have concerns about this risk.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
Rare
- Drooping upper eyelids
- increased blinking
- partial or slight paralysis of the face
- twitching of the eyelids
Incidence not known
- Blurred vision
- change in color vision
- changes in patterns and rhythms of speech
- chest pain, discomfort, or tightness
- cough
- difficulty seeing at night
- difficulty swallowing
- dizziness
- double vision
- dry eyes
- fainting
- fast, slow, or irregular heartbeat
- feeling of discomfort
- fever
- hives, itching, skin rash
- hoarseness
- increased sensitivity of the eyes to sunlight
- infection from breathing foreign substance into the lungs
- joint inflammation
- loss of bladder control
- muscle aches or weakness
- nausea
- pain or discomfort in the arms, jaw, back, or neck
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- red, sore eyes
- seeing double
- slurred speech
- sore throat
- sweating
- swollen lymph glands
- trouble breathing
- trouble in speaking
- unusual tiredness or weakness
- voice changes
- vomiting
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Less common
- Headache
Incidence not known
- Redness of the skin
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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