OnADose 1.1.0

OnADose serves as an educational tool specifically designed for the dosing and reconstitution of onabotulinumtoxinA, focusing on applications in spasticity, cervical dystonia, and chronic migraine. This app is exclusively intended for training purposes by healthcare professionals in the United States. Patients are strongly advised to consult their physicians before making any medical decisions.

OnabotulinumtoxinA Important Safety Information

Indications for OnabotulinumtoxinA

• Chronic Migraine: Indicated for the prophylaxis of headaches in adult patients experiencing chronic migraine (≥ 15 headache days per month, with headache episodes lasting 4 hours or longer).
  • Limitations of Use: The safety and efficacy of onabotulinumtoxinA for episodic migraine (14 headache days or fewer per month) have not been established in placebo-controlled studies.
• Spasticity: Approved for the treatment of spasticity in patients aged 2 years and older.
  • Limitations of Use: OnabotulinumtoxinA has not demonstrated improvements in upper extremity functional abilities or joint range of motion affected by fixed contractures.
• Cervical Dystonia: Indicated for adults to reduce the severity of abnormal head positions and associated neck pain.

Important Safety Information, including Boxed Warning

WARNING: DISTANT SPREAD OF TOXIN EFFECT

Reports indicate that the effects of onabotulinumtoxinA may extend beyond the injection site, leading to symptoms consistent with botulinum toxin effects. These can include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence, and respiratory difficulties. Symptoms may manifest hours to weeks after injection. Severe swallowing and breathing complications can be life-threatening; there have been fatalities reported. While children receiving treatment for spasticity are at heightened risk, adult patients with pre-existing conditions may also experience similar effects from both approved and unapproved uses at various dosages.

Contraindications:

• Hypersensitivity to onabotulinumtoxinA or any components within its formulation
• Infection at the proposed injection site

Warnings and Precautions:

• The spread of toxin effects can result in life-threatening complications; immediate medical attention is warranted if respiratory or swallowing difficulties arise.
• Potency Units of onabotulinumtoxinA are not interchangeable with other botulinum toxin preparations.
• The risk of serious adverse reactions may increase with unapproved applications.
• A concomitant neuromuscular disorder may exacerbate clinical responses to treatment.
• Caution is advised when treating patients with compromised respiratory function and those with bronchitis or upper respiratory infections while managing spasticity.

Adverse Reactions:

The most frequently reported adverse reactions (≥5% and greater than placebo when applicable) include:

• Chronic Migraine: Neck pain, headache
• Pediatric Spasticity: Upper respiratory tract infection
• Cervical Dystonia: Dysphagia, upper respiratory infection, neck pain, headache, increased cough, flu syndrome, back pain, rhinitis

Drug Interactions:

Patients receiving concurrent treatment with onabotulinumtoxinA and aminoglycosides or other agents impacting neuromuscular transmission (e.g., curare-like agents), or muscle relaxants should be closely monitored due to a potential potentiation of effects.

Use in Specific Populations:

• Pregnancy: Based on animal studies, there may be a risk of fetal harm.

Please refer to the full Prescribing Information for onabotulinumtoxinA available at http://www.rxabbvie.com.

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