Description and Brand Names

Drug information provided by: Micromedex

US Brand Name

  1. Xeomin

Descriptions


IncobotulinumtoxinA is used to treat the abnormal head position and neck pain that result from cervical dystonia (severe muscle spasms of the neck). This medicine is also used to treat certain eye condition called blepharospasm (a condition where the eyelid will not stay open because of a muscle spasm) in patients who have already been treated with onabotulinumtoxinA (Botox®). IncobotulinumtoxinA is also used cosmetically to improve the appearance of deep facial lines or wrinkles between the eyebrows (glabellar lines).

IncobotulinumtoxinA is a botulinum toxin A product. It works on the nervous system to relax the muscles.

This medicine is available only with your doctor's prescription and will be administered by your doctor.

This product is available in the following dosage forms:

  • Powder for Solution

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

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

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of incobotulinumtoxinA in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of incobotulinumtoxinA in the elderly. However, elderly patients are more likely to have side effects such as difficulty with swallowing, lack or loss of strength, or dizziness, which may require caution in patients receiving incobotulinumtoxinA.

Pregnancy

Information about this incobotulinumtoxina-intramuscular-route
Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Amyotrophic lateral sclerosis (Lou Gehrig's disease) or
  • Cornea or eye problems (e.g., ulcers) or
  • Lambert-Eaton syndrome (nerve-muscle disorder) or
  • Motor neuropathy (muscle and nerve problem) or
  • Myasthenia gravis (severe muscle weakness)—May increase risk for more serious side effects.
  • Breathing problems (e.g., asthma, emphysema) 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. May make these conditions worse.
  • Infection at the injection site—Should not be used in patients with this condition.

Proper Use

Your doctor will give you this medicine in a hospital or clinic setting. This medicine is given as a shot into one of your muscles.

This medicine should come with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Your doctor will only use incobotulinumtoxinA (Xeomin®) to treat your condition. Other botulinum toxin products may not work the same way.

Precautions

It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it.

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.

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.

Side Effects

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:

More common—for cervical dystonia

  1. Difficulty with swallowing
  2. muscle or bone pain
  3. muscle weakness
  4. pain in the neck

More common—for blepharospasm

  1. Dry eyes

Rare—for glabellar lines

  1. Itching, pain, redness, or swelling at the injection site
  2. pain in the face
  3. swelling of the eyelids

Incidence not known

  1. Changes in patterns and rhythms of speech
  2. fast heartbeat
  3. fever
  4. hives
  5. hoarseness
  6. irritation
  7. itching
  8. joint pain, stiffness, or swelling
  9. muscle spasm
  10. pain at the injection site
  11. rash
  12. redness of the skin
  13. shortness of breath
  14. slurred speech
  15. swelling of the eyes or eyelids
  16. swelling of the face, lips, hands, or feet
  17. tightness in the chest
  18. trouble with speaking
  19. troubled breathing or swallowing
  20. wheezing

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:

More common—for cervical dystonia

  1. Chills
  2. cough
  3. lower back or side pain
  4. painful or difficult urination

More common—for blepharospasm

  1. Blurred vision
  2. diarrhea
  3. drooping upper eyelids
  4. dry mouth
  5. headache

Less common—for blepharospasm

  1. Difficult or labored breathing
  2. muscle aches
  3. sneezing
  4. sore throat
  5. stuffy or runny nose
  6. unusual tiredness or weakness

Rare—for glabellar lines

  1. Drooping of the eyelids
  2. increased blinking
  3. twitching of the eyelids

Incidence not known

  1. Difficulty with moving
  2. joint pain
  3. muscle aching or cramping
  4. muscle pains or stiffness
  5. nausea
  6. painful blisters on the trunk of the body
  7. swollen joints

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.