Description
IncobotulinumtoxinA is used to treat the abnormal head position and neck pain that result from cervical dystonia (severe muscle spasms of the neck). It is also used to treat upper limb spasticity (muscle spasms in the upper arms). This medicine is also used to treat blepharospasm, a condition wherein the eyelid will not stay open because of a muscle spasm. It is also used to treat long-lasting sialorrhea (excessive drooling). IncobotulinumtoxinA is also used cosmetically to improve the appearance of upper facial lines or wrinkles (including glabellar lines, horizontal forehead lines, and lateral canthal lines) for a short period of time.
IncobotulinumtoxinA is a botulinum toxin A product. It works on the nervous system to relax the muscles.
This medicine is to be given only by or under the direct supervision of 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 children with lower limb spasticity, cervical dystonia, blepharospasm, or upper facial lines. Safety and efficacy have not been established.
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of incobotulinumtoxinA in children 2 to 17 years of age with sialorrhea or upper limb spasms, excluding spasms caused by cerebral palsy. Safety and efficacy have not been established in children younger than 2 years of age.
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 sensitive to the effects of this medicine than younger adults and are more likely to have side effects (eg, difficulty with swallowing, lack or loss of strength, or dizziness), which may require caution in patients receiving incobotulinumtoxinA.
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. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- LetibotulinumtoxinA-wlbg
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 (eg, ulcers) or
- Lambert-Eaton syndrome (nerve-muscle disorder) or
- Motor neuropathy (muscle and nerve problem) or
- Myasthenia gravis (severe muscle weakness) or
- Surgery where the injection will be given (eg, eye or face surgery)—May increase risk for more serious side effects.
- Breathing problems (eg, asthma, emphysema) or
- Dysphagia (trouble with swallowing) or
- Glaucoma, narrow angle or
- Muscle weakness or atrophy at the injection site or
- Ptosis (droopy eyelid)—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 medical facility. It is given as a shot into one of your muscles or as a needle placed into your saliva gland.
This medicine should come with a Medication Guide. Read and follow the instructions carefully. Ask your doctor if you have any questions.
Your doctor will only use incobotulinumtoxinA (Xeomin®) to treat your condition. Other botulinum toxin products may not work the same way.
You may be given medicine to numb the area where the shot will be injected. If you receive the medicine around your eyes, you may be given eye drops or ointment to numb the area. After your injection, you may need to wear a protective contact lens or eye patch.
You may see the effects of this medicine for your condition within 7 days after the injection, which may last up to 12 to 16 weeks. However, the duration of the effects may differ from person to person.
Precautions
It is very important that your doctor check your progress closely and 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 occurred 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 patients, these problems could be life-threatening and may require treatment in a hospital or clinic.
This medicine may cause serious allergic reactions, including anaphylaxis and serum sickness, which can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, hives, itching, hoarseness, trouble breathing or swallowing, fever, joint swelling, muscle aches, or any swelling of your hands, face, or mouth while you are receiving this medicine.
This medicine may make your muscles weak and cause eye or vision problems (eg, bleeding inside the eye). Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
This medicine may reduce blinking of the eye which can lead to an increased risk of eye problems (eg, 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 get 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, talk with your doctor.
A part of this medicine is made from donated human blood. Some human blood products have transmitted certain viruses to people who have received them, although the risk is low. Human donors and donated blood are both tested for viruses to keep the transmission risk low. Talk with your doctor about this risk if you are concerned.
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 blepharospasm
- Dry eyes
- fever
More common—for cervical dystonia
- Chills
- cough
- difficulty with swallowing
- lower back or side pain
- muscle or bone pain
- muscle weakness
- painful or difficult urination
- pain in the neck
Less common—for blepharospasm
- Difficult or labored breathing
- muscle aches
- sneezing
- sore throat
- stuffy or runny nose
- unusual tiredness or weakness
Less common—for sialorrhea
- Blurred vision
- chest tightness
- cough producing mucus
- difficulty breathing
- dizziness
- falls
- headache
- nervousness
- pounding in the ears
- slow or fast heartbeat
- sore throat
Less common—for upper limb spasticity
- Body aches or pain
- chills
- cough
- ear congestion
- fever
- headache
- loss of voice
- muscle aches
- seizures
- sore throat
- stuffy or runny nose
- unusual tiredness or weakness
Rare—for glabellar lines
- Itching, pain, redness, or swelling at the injection site
- pain in the face
- swelling of the eyelids
Incidence not known
- Changes in patterns and rhythms of speech
- chest tightness
- fast heartbeat
- fever
- hives, itching, or rash
- hoarseness
- irritation
- joint pain, stiffness, or swelling
- muscle spasm
- pain at the injection site
- redness of the skin
- slurred speech
- swelling of the eyes or eyelids
- swelling of the face, lips, hands, or feet
- trouble with speaking
- trouble breathing or swallowing
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 blepharospasm
- Blurred vision
- diarrhea
- drooping upper eyelids
- dry mouth
- headache
Less common—for sialorrhea
- Back pain
- diarrhea
- dry eye
- dry mouth
- hoarseness
- voice changes
Less common—for upper limb spasticity
- Dry mouth
Rare—for glabellar lines
- Drooping of the eyelids
- increased blinking
- twitching of the eyelids
Incidence not known
- Difficulty with moving
- joint pain or swelling
- muscle ache, cramps, pain, or stiffness
- nausea
- painful blisters on the trunk of the body
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.
DRG-20074437
