Before Using

Drug information provided by: Merative, Micromedex®

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of onabotulinumtoxinA in children. However, safety and effectiveness have not been established in children younger than 2 years of age for upper limb spasticity and lower limb spasticity (except spasms caused by cerebral palsy), in children younger than 5 years of age for overactive bladder caused by a nervous system disorder, in children younger than 12 years of age for blepharospasm or strabismus, in children younger than 16 years of age for cervical dystonia, or in children younger than 18 years of age for chronic migraine, hyperhidrosis, or overactive bladder with symptoms. Use of onabotulinumtoxinA to treat glabellar lines, forehead lines, and lateral canthal lines is not recommended in children.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of onabotulinumtoxinA in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving onabotulinumtoxinA.

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
  • Dermatochalasis (a skin problem) or
  • Diabetes or
  • Lambert-Eaton syndrome (nerve-muscle disorder) or
  • Motor neuropathy (muscle or nerve problem) or
  • Myasthenia gravis (severe muscle weakness) or
  • Sebaceous skin, thick (oily or fatty skin) or
  • Surgery on the face, history of—May increase risk for more serious side effects.
  • Bleeding problems or
  • Breathing problems (eg, asthma, emphysema) or
  • Dysarthria (trouble with speaking) or
  • Dysphagia (trouble with swallowing) or
  • Dysphonia (voice problem) or
  • Heart attack, recent or history of or
  • Heart or blood vessel disease or
  • Heart rhythm problems or
  • Lung problems (eg, bronchitis) or
  • Ptosis (droopy eyelid) or
  • Urinary incontinence (problems passing urine)—Use with caution. May make these conditions worse.
  • Infection at the injection site or
  • Urinary retention (not able to urinate) or
  • Urinary tract infection—Should not be used in patients with these conditions.