PrabotulinumtoxinA-xvfs Injection

IMPORTANT WARNING:

PrabotulinumtoxinA-xvfs injection may spread from the area of injection and cause symptoms of botulism, including severe or life-threatening difficulty breathing or swallowing. People who develop difficulty swallowing during their treatment with this medication may continue to have this difficulty for several months. They may need to be fed through a feeding tube to avoid getting food or drink into their lungs. Tell your doctor if you have or have ever had swallowing problems, or breathing problems, such as asthma or emphysema; or any condition that affects muscles or nerves such as amyotrophic lateral sclerosis (ALS, Lou Gehrig's disease; condition in which the nerves that control muscle movement slowly die, causing the muscles to shrink and weaken), myasthenia gravis (condition that causes certain muscles to weaken, especially after activity), or Lambert-Eaton syndrome (condition that causes muscle weakness that may improve with activity).

Spread of prabotulinumtoxinA-xvfs into untreated areas can cause other symptoms in addition to difficulty breathing or swallowing. Symptoms may occur within hours of an injection or as late as several weeks after treatment. If you experience any of the following symptoms, call your doctor immediately or get emergency medical treatment: loss of strength or muscle weakness all over the body; double or blurred vision; drooping eyelids or brow; difficulty swallowing or breathing; or difficulty speaking or saying words clearly.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with prabotulinumtoxinA-xvfs injection and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

WHY is this medicine prescribed?

PrabotulinumtoxinA-xvfs injection is used to temporarily smooth frown lines (wrinkles between the eyebrows) in adults. It is in a class of medications called neurotoxins. It works by blocking the nerve signals that cause uncontrollable tightening and movement of the muscles.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

PrabotulinumtoxinA-xvfs injection comes as a powder to be mixed with a liquid to be injected into the muscle by a doctor. You may receive additional injections, not more often than every 3 months, depending on how long the effects of the treatment last.

Your doctor will select your dose of prabotulinumtoxinA-xvfs injection based on your condition and later may change it to find the dose that will work best for you.

One brand or type of botulinum toxin cannot be substituted for another.

PrabotulinumtoxinA-xvfs injection may help control your condition but will not cure it. It may take a few days or up to several weeks before you feel the full benefit of prabotulinumtoxinA-xvfs injection. Ask your doctor when you can expect to see improvement, and call your doctor if your symptoms do not improve during the expected time.

What SPECIAL PRECAUTIONS should I follow?

Before receiving prabotulinumtoxinA-xvfs injection,

• tell your doctor and pharmacist if you are allergic to prabotulinumtoxinA-xvfs injection, abobotulinumtoxinA (Dysport), incobotulinumtoxinA (Xeomin), onabotulinumtoxinA (Botox), or rimabotulinumtoxinB (Myobloc). Also, tell your doctor if you are allergic to any other medications or any of the ingredients in prabotulinumtoxinA-xvfs injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: aminoglycoside antibiotics such as amikacin, gentamicin, kanamycin, neomycin , streptomycin, or vancomycin; medications for allergies, colds, or sleep; medications for glaucoma, inflammatory bowel disease, motion sickness, Parkinson's disease, ulcers, or urinary problems; or muscle relaxants. Also tell your doctor if you have received injections of any botulinum toxin product including abobotulinumtoxinA (Dysport), incobotulinumtoxinA (Xeomin), or rimabotulinumtoxinB (Myobloc) previously, especially within the past four months. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor if you have swelling or other signs of infection in the area where prabotulinumtoxinA-xvfs injection will be injected. Your doctor will not inject the medication into an area that is infected.

• tell your doctor if you have or have ever had any side effect from any botulinum toxin product, bleeding problems, or heart disease.

• your doctor will examine you to see if the medication is likely to work for you. PrabotulinumtoxinA-xvfs injection may not smooth your wrinkles or may cause other problems if you have drooping eyelids; trouble raising your eyebrows; or swelling or weakness of your forehead muscles.

• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while receiving prabotulinumtoxinA-xvfs injection, call your doctor.

• you should know that prabotulinumtoxinA-xvfs injection may cause loss of strength or muscle weakness all over the body or impaired vision. If you have any of these symptoms, do not drive a car, operate machinery, or do other dangerous activities.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What SIDE EFFECTS can this medicine cause?

PrabotulinumtoxinA-xvfs injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• nasal congestion, runny nose, sneezing, or sore throat
• pain, swelling, redness, bleeding, bruising, or tenderness in the area where the medication was injected

Some side effects can be serious. If you experience any of these symptoms, or those listed in the IMPORTANT WARNING section, at any time during the first several weeks after your treatment, call your doctor immediately or get emergency medical treatment:

• hives
• itching
• rash
• shortness of breath
• swelling of the hands, feet, ankles, or lower legs
• dizziness or fainting

PrabotulinumtoxinA-xvfs injection may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose usually do not appear right after receiving the injection. If you received too much prabotulinumtoxinA-xvfs or if you swallowed the medication, tell your doctor right away and also tell your doctor if you experience any of the following symptoms during the next several weeks:

• muscle weakness
• difficulty breathing

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Ask your pharmacist any questions you have about prabotulinumtoxinA-xvfs injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.