WARNING

An injection of prabotulinumtoxinA-xvfs may induce symptoms of botulism to spread from the injection site, including severe or life-threatening difficulty breathing or swallowing. For several months, those who experience trouble swallowing while taking this drug may continue to do so. To prevent ingesting food or liquids into their lungs, they might need to be fed through a feeding tube. Inform your doctor if you have or have ever had difficulty swallowing, breathing issues like asthma or emphysema, or any condition that affects muscles or nerves like Lambert-Eaton syndrome, ALS, or Lou Gehrig’s disease, in which the nerves that control muscle movement slowly die.

In addition to making breathing or swallowing difficult, prabotulinumtoxinA-xvfs can spread to untreated areas and produce other symptoms. After receiving an injection, symptoms may start to show up right away or weeks later. Call your doctor right away or seek emergency medical attention if you have any of the following symptoms: body-wide muscle weakness or lack of strength; double or blurred vision; drooping eyelids or brows; trouble breathing; or trouble speaking or pronouncing words clearly.

When you start receiving prabotulinumtoxinA-xvfs injectable and each time you get a prescription refill, your doctor or pharmacist will provide you the manufacturer’s patient information leaflet (Medication Guide).

Why is this medication prescribed?

Adults can temporarily get rid of frown lines (wrinkles between the brows) by getting a prabotulinumtoxinA-xvfs injection. It belongs to a group of medicines known as neurotoxins. It functions by obstructing the nerve signals that cause the muscles to contract and move in an unregulated manner.

How should this medicine be used?

A doctor will combine a liquid with a powder form of prabotulinumtoxinA-xvfs injection before injecting it into the muscle. Depending on how long the benefits of the treatment last, you might require additional injections, but not more frequently than every 3 months.

Based on your situation, your doctor will choose the dose of prabotulinumtoxinA-xvfs injection you will receive; afterwards, he or she may adjust it to find the dose that will work best for you.

It is not possible to switch from one botulinum toxin brand or kind to another.

Although it won’t cure your illness, prabotulinumtoxinA-xvfs injection may help regulate it. You might not experience all of the benefits of the prabotulinumtoxinA-xvfs injection for a few days or perhaps a few weeks. You should call your doctor if your symptoms do not subside within the anticipated time frame after asking your doctor when you might expect to experience improvement.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you think this drug may be recommended for other conditions.

What special precautions should I follow?

• If you have an allergy to any of the ingredients in prabotulinumtoxinA-xvfs injectable, Dysport, Xeomin, Botox, or rimabotulinumtoxinB (Myobloc), let your doctor and pharmacist know. Additionally, let your doctor know if you have any drug allergies or if any of the components in prabotulinumtoxinA-xvfs injection cause you any discomfort. For a list of the ingredients, consult your pharmacist or the Medication Guide.
• Inform your doctor and pharmacist about any additional prescription and over-the-counter medications, vitamins, herbal items, nutritional supplements, and any drugs you are now taking or intend to take. Mention any of the following: muscle relaxants, glaucoma medications, ibd, motion sickness, Parkinson’s disease, kanamycin, gentamicin, neomycin, streptomycin, or antibiotics with aminoglycosides such as amikacin, gentamicin, kanamycin, neomycin, streptomycin, or vancomycin; medications for allergies, colds, or sleep. Additionally, let your doctor know if you have ever had injections of any botulinum toxin, particularly abobotulinumtoxinA (Dysport), incobotulinumtoxinA (Xeomin), or rimabotulinumtoxinB (Myobloc). Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects.
• Swelling or other indications of infection in the location where the prabotulinumtoxinA-xvfs injection will be administered should be reported to your doctor. Your doctor won’t inject the drug into an infected area.
• If you develop bleeding issues, heart illness, or any negative effects from using a product containing botulinum toxin, let your doctor know.
• If the drug is likely to be effective for you, your doctor will evaluate you. If you have drooping eyelids, difficulty raising your eyebrows, swelling or weakness of your forehead muscles, or if you have any of these conditions, a prabotulinumtoxinA-xvfs injection may not be able to smooth out your wrinkles or may create other issues.
• If you are breastfeeding a child or intend to become pregnant, let your doctor know. Call your doctor right away if you find out you’re pregnant while receiving prabotulinumtoxinA-xvfs.
• Inform the surgeon or dentist that you are receiving a prabotulinumtoxinA-xvfs injection if you are having surgery, including dental surgery.
• You should be aware that prabotulinumtoxinA-xvfs injection can weaken muscles all over the body, impair vision, or cause a loss of strength. Do not operate machinery, operate a vehicle, or engage in any other risky activity if you have any of these symptoms.

What special dietary instructions should I follow?

Maintain your regular diet unless your doctor instructs you otherwise.

What side effects can medication cause?

Injection of prabotulinumtoxinA-xvfs may result in adverse reactions. If any of these symptoms are severe or do not go away, consult your doctor:

• Headache
• Sneezing, a runny nose, nasal congestion, or a painful throat
• Wherever the drug was injected, there may be discomfort, bruising, bleeding, redness, swelling, or tenderness

Some adverse effects may be severe. During the initial few weeks following your treatment, call your doctor right away or seek emergency medical attention if you suffer any of these symptoms, including those in the IMPORTANT WARNING section:

• Hives
• Itching
• Rash
• Respiration difficulty
• Hands, feet, ankles, or lower legs swelling
• Fainting or dizziness

In case of emergency/overdose

Call 1-800-222-1222 to reach the poison control hotline in the event of an overdose. Call emergency services at 911 right away if the sufferer has fallen, experienced a seizure, is having problems breathing, or cannot be roused.

Overdose signs typically take time to manifest itself after receiving an injection. Tell your doctor straight away if you received an excessive dose of prabotulinumtoxinA-xvfs or if you swallowed the drug. Also let them know if you develop any of the following symptoms over the following few weeks:

• Muscular tremor
• Having trouble breathing

What other information should I know?

Do not miss any of your doctor’s appointments.

Any queries you may have regarding the injection of prabotulinumtoxinA-xvfs, ask your pharmacist.

You should keep a written record of every drug you take, including prescription and nonprescription (over-the-counter) medications, vitamins, minerals, and other dietary supplements. Every time you see a doctor or are admitted to the hospital, you should carry this list with you. Additionally, it is crucial to have this knowledge on hand in case of emergency.