Pronunciation:

pra-bot-ue-LYE-num-tox-in-ay - xvfs

Brand Names:

• Jeuveau

Warnings:

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

Classifications:

Pharmacologic—

PrabotulinumtoxinA

Uses of This Medicine:

PrabotulinumtoxinA-xvfs is used cosmetically to temporarily improve the appearance of deep facial lines or wrinkles between the eyebrows (glabellar lines). This medicine is not approved for use in other conditions, including upper limb spasticity (muscle spasms in the upper arms) in children.

PrabotulinumtoxinA-xvfs is a botulinum toxin A product. It works on the nervous system to relax the muscles.

This medicine is available only with your doctor's prescription and will be given by your doctor.

Before Using This Medicine:

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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of prabotulinumtoxinA-xvfs in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of prabotulinumtoxinA-xvfs in the elderly.

Breast-feeding—

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.

Other medicines—

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.

• LetibotulinumtoxinA-wlbg

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
• Lambert-Eaton syndrome (nerve-muscle disorder) or
• Motor neuropathy (muscle and nerve problem) or
• Myasthenia gravis (severe muscle weakness)—May increase risk for more serious side effects.

• Breathing problems or
• Dysarthria (trouble with speaking) or
• Dysphagia (trouble with swallowing) or
• Dysphonia (voice problem) or
• Glaucoma, narrow angle or
• Ptosis (droopy eyelid) or
• Urinary incontinence (problems passing urine)—Use with caution. May make these conditions worse.

• Dermatochalasis (excess skin in the upper or lower eyelid) or
• Facial asymmetry, obvious or
• Patients with thick oily skin or deep scars or
• Ptosis (droopy eyelid), obvious or
• Thinning, weakness, or wasting away of the skin, severe at the injection site—Use with caution. May not work as well in patients with these conditions.

• Infection at the injection site—Should not be used in patients with this condition.

Proper Use of This Medicine:

Your doctor will give you this medicine in a medical facility. It is given as a shot into one of the muscles in your face. This medicine is injected no sooner than every 3 months.

Your doctor will only use prabotulinumtoxinA-xvfs (Jeuveau™) to treat your condition. Other botulinum toxin products may not work the same way.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits. This will allow your doctor 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 treatment in a medical facility.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are receiving this medicine.

This medicine may increase the risks 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, troubled breathing, nausea, or vomiting.

This medicine may reduce blinking of the eye, tear production, and cornea problems. Check with your doctor right away if 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 be checked by an ophthalmologist (eye doctor).

This medicine may make your muscles weak and cause eye or vision problems. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

One part of this medicine is made from donated human blood. Some human blood products have transmitted certain viruses 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 about this risk if you are concerned.

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 of This Medicine:

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:

Less common

Body aches or pain

chills

cough

difficulty in breathing

drooping upper eyelids

ear congestion

fever

headache

loss of voice

runny or stuffy nose

sneezing

sore throat

unusual tiredness or weakness

Incidence not known

Blurred vision

changes in patterns and rhythms of speech

double vision

fast heartbeat

hives, itching, skin rash

hoarseness

irritation

joint pain, stiffness, or swelling

lack or loss of strength

loss of bladder control

muscle weakness

redness of the skin

seeing double

slurred speech

swelling of the eyelids, face, lips, hands, or feet

tightness in the chest

trouble in speaking

trouble swallowing

voice changes

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:

Incidence not known

Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

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.