Incobotulinumtoxina (Injection)

Introduction

IncobotulinumtoxinA (in-koe-bot-ue-LYE-num-tox-in-ay)

Treats the abnormal head position and neck pain that result from cervical dystonia (severe muscle spasms of the neck). Also treats uncontrolled muscle spasms in the eyelids (blepharospasm) in patients who have already been treated with onabotulinumtoxinA (Botox®). Also used to improve the appearance of deep facial lines or wrinkles between the eyebrows (glabellar lines). This is a botulinum toxin A product.

Brand Name(s)

Xeomin

When This Medicine Should Not Be Used

How to Use This Medicine

Injectable

• Your doctor will prescribe your exact dose and tell you how often it should be given. This medicine is given as a shot into one of your muscles.
• A nurse or other trained health professional will give you this medicine.
• Your doctor will only use incobotulinumtoxinA (Xeomin®) to treat your condition. Other botulinum toxin products may not work the same way.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using medicine for an infection (such as amikacin, gentamicin, streptomycin, Amikin®, or Garamycin®), a muscle relaxant that would be used during surgery (such as atracurium, pancuronium, tubocurarine, vecuronium, Norcuron®, Pavulon®, or Tracrium®), atropine (Lomocot®, Lomotil®, Motofen®, or Sal-Tropine®), or dicyclomine (Bentyl®).
• If you need to receive an injection of any botulinum toxin product after receiving this medicine, tell the doctor when you last received a dose of incobotulinumtoxinA.

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have breathing problems (such as asthma or emphysema), cornea or eye problems, narrow angle glaucoma, nerve or muscle problems (such as ALS [Lou Gehrig's disease], Lambert-Eaton syndrome, myasthenia gravis), or trouble with swallowing. Make sure your doctor knows if you have received botulinum toxin for any reason in the past several months.
• Serious muscle reactions have been reported 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 situations, these problems could be life-threatening and may require treatment in a hospital or clinic.
• This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis 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 using this medicine.
• This medicine may make your muscles weak and cause vision problems. Avoid driving, using machines, or doing anything else that could be dangerous if you feel weak or are not able to see well.
• This medicine may reduce blinking of the eye which can lead to an increased risk of eye problems (such as corneal exposure and ulcers). Tell your doctor right away if you have a reduced blinking of the eye.
• After you have received this medicine and your vision or muscle spasms are better, you may find that you are a lot more active than you were before. You should slowly increase your activities to allow time for your body to get stronger. Also, before you start an exercise program, check with your doctor.
• 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. The risk of getting a virus from medicines made of human blood has been greatly reduced in recent years. This is the result of required testing of human donors for certain viruses, and testing during the manufacture of these medicines. Although the risk is low, talk with your doctor if you have concerns.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Eye pain, redness in the whites of your eyes.
• Fever, chills, cough, stuffy or runny nose, sore throat, and body aches.
• Loss of bladder control.
• Pain in the neck or face.
• Redness, pain, tenderness, bruising, swelling, or weakness where the shot was given.
• Severe trouble swallowing, breathing, or speaking.
• Shortness of breath or wheezing.
• Unusual weakness in other muscles (not where the shot was given).

If you notice these less serious side effects, talk with your doctor:

• Blurred vision.
• Change or loss of voice.
• Diarrhea.
• Drooping or swelling of the eyelids, or dry eyes.
• Dry mouth.
• Headache.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088