DaxibotulinumtoxinA-lanm

(dax" i bot" ue lye' num tox" in ay")

Brand Name(s): Daxxify^®

IMPORTANT WARNING:

DaxibotulinumtoxinA-lanm injection is given as a number of tiny injections intended to affect only the specific area where injected. However, it is possible that the medication may spread from the area of injection and affect muscles in other areas of the body. If the muscles that control breathing and swallowing are affected, you may develop severe problems breathing or swallowing that may last for several months and may cause death. If you have difficulty swallowing, you may need to be fed through a feeding tube to avoid getting food or drink into your lungs.

DaxibotulinumtoxinA-lanm injection may spread and cause symptoms in people of any age who are being treated for any condition, although no one has yet developed these symptoms after receiving the medication at recommended doses to treat wrinkles. The risk that the medication will spread beyond the area of injection is probably highest in children being treated for spasticity (muscle stiffness and tightness) and in people who 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), motor neuropathy (condition in which the muscles weaken over time), 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). Tell your doctor if you have or have ever had any of these conditions.

Spread of daxibotulinumtoxinA-lanm injection 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; hoarseness or change or loss of voice; difficulty speaking or saying words clearly; or inability to control urination.

Your doctor will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with daxibotulinumtoxinA-lanm injection and each time you receive treatment. 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?

DaxibotulinumtoxinA-lanm injection is used to temporarily smooth frown lines (wrinkles between the eyebrows) in adults 18 years of age and older. DaxibotulinumtoxinA-lanm injection is in a class of medications called neurotoxins. It blocks the nerve signals that cause uncontrollable tightening and movements of the muscle.

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?

DaxibotulinumtoxinA-lanm injection comes as a powder to be mixed with a liquid and injected into a muscle by a healthcare provider. Your healthcare provider may adjust the dose until they find the best dose for you. DaxibotulinumtoxinA-lanm injection should not be administered more frequently than every 3 months.

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

DaxibotulinumtoxinA-lanm injection may help to 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 daxibotulinumtoxinA-lanm injection.

What SPECIAL PRECAUTIONS should I follow?

Before receiving daxibotulinumtoxinA-lanm injection,

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

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while receiving daxibotulinumtoxinA-lanm. Also tell your doctor if you have received injections of any botulinum toxin product in the past 4 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 daxibotulinumtoxinA-lanm injection will be injected. Your doctor will not inject the medication into an area that is infected.

• tell your doctor if you have ever had any side effect from any botulinum toxin product, eye or face surgery, or bleeding problems. Also tell your doctor if you have or have ever had heart disease. Irregular heartbeat and heart attack have occurred after receiving daxibotulinumtoxinA-lanm injection, which may be more likely to occur in patients who already have or had a history of heart disease.

• if you will be receiving daxibotulinumtoxinA-lanm injection to treat wrinkles, your doctor will examine you to see if the medication is likely to work for you. DaxibotulinumtoxinA-lanm injection may not smooth your wrinkles or may cause other problems if you have drooping eyelids, trouble raising your eyebrows, or any other change in the way your face normally looks.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while receiving daxibotulinumtoxinA-lanm, call your doctor.

• you should know that daxibotulinumtoxinA 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 after receiving an injection.

What SPECIAL DIETARY instructions should I follow?

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

What SIDE EFFECTS can this medicine cause?

DaxibotulinumtoxinA-lanm injection may cause side effects. Ask your doctor which side effects you are most likely to experience, since some side effects may be related to (or occur more often in) the part of the body where you received the injection. Tell your doctor if any of these symptoms are severe or do not go away:

• pain, tenderness, swelling, redness, bleeding, or bruising in the place where you received the injection
• headache
• back, bone, muscle, or joint pain
• nasal congestion, sore throat, or runny nose
• frequent urination or pain when you urinate

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:

• double, blurred, or decreased vision
• eyelid swelling
• vision changes (such as light sensitivity or blurred vision)
• difficulty moving the face
• dry, irritated, or painful eyes
• irregular heartbeat
• chest pain
• difficulty moving the face
• shortness of breath
• wheezing
• fainting
• dizziness
• rash
• hives
• itching

DaxibotulinumtoxinA-lanm injection may cause other side effects. Call your doctor if you have any unusual problems while taking 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 daxibotulinumtoxinA-lanm 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:

• weakness
• difficulty moving any part of your body
• difficulty breathing
• difficulty swallowing

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Ask your pharmacist any questions you have about daxibotulinumtoxinA-lanm 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.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: September 15, 2023.