Prabotulinumtoxina-xvfs (Intramuscular)

PrabotulinumtoxinA-xvfs is used to temporarily improve the look of deep facial lines or wrinkles between the eyebrows (glabellar lines). This medicine is not approved for other uses, 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 a doctor's prescription and will be given by your doctor.

It is very important that your doctor checks your progress at regular visits. This will help your doctor see if the medicine is working properly and to decide if you should continue taking 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 swallowing, talking, or breathing, call your doctor right away. For some patients, these issues 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 receiving this medicine.

This medicine may increase the risks of heart rhythm problems (e.g., arrhythmia) or heart attack. These risks are higher if you have heart or blood vessel disease. Check with your doctor right away if you experience dizziness, fainting, a 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 cause 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 during or after treatment. Your doctor may want your eyes 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. Both human donors and donated blood are 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.

In deciding to use a medicine, you and your doctor must consider the risks versus the benefits. For this medicine, think about the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your health care professional know about any other allergies you may have, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on how age affects the use of prabotulinumtoxinA-xvfs in children. Its safety and effectiveness have not been established in this age group.

Geriatric

Current studies have not shown any specific problems in elderly patients that would limit the usefulness of prabotulinumtoxinA-xvfs.

Breast Feeding

There are no adequate studies to determine the risk to infants when this medication is used during breastfeeding. Consider the potential benefits and risks before using this medicine while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together with caution. In these cases, your doctor might adjust the dose or take other precautions. Inform your healthcare professional about any other prescription or nonprescription (over-the-counter [OTC]) medicines you are taking.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around mealtimes or with specific foods due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Discuss with your healthcare professional how to use your medicine in relation to food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may influence how this medicine works for you. Be sure to tell your doctor about 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)—These conditions may increase the risk of 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 as it may worsen these conditions.

• Dermatochalasis (excess skin in the upper or lower eyelid) or
• Obvious facial asymmetry or
• Patients with thick oily skin or deep scars or
• Obvious ptosis (droopy eyelid) or
• Severe thinning, weakness, or wasting away of the skin at the injection site—Use with caution as it may not be as effective in these patients.

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

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.

In the U.S.

• Jeuveau

Pharmacologic Class: PrabotulinumtoxinA

Find detailed information on biosimilars for this medication.

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.

• What is botulinum toxin used to treat?