OnADose is an onabotulinumtoxinA dosing and reconstitution educational tool for US healthcare providers. The app allows physicians to perform straightforward dosing calculations for spasticity, cervical dystonia, and chronic migraine.
OnabotulinumtoxinA Important Safety Information
OnabotulinumtoxinA Indications
Chronic Migraine
-OnabotulinumtoxinA is indicated for the prophylaxis of headaches in adult patients with Chronic Migraine (≥ 15 days per month with headache lasting 4 hours a day or longer).
Limitations of Use
-Safety and effectiveness have not been established for the prophylaxis of episodic migraine (14 headache days or fewer per month) in 7 placebo-controlled studies.
Spasticity
-OnabotulinumtoxinA is indicated for the treatment of spasticity in patients 2 years of age and older.
Limitations of Use
-OnabotulinumtoxinA has not been shown to improve upper extremity functional abilities or range of motion at a joint affected by a fixed contracture.
Cervical Dystonia
-OnabotulinumtoxinA is indicated for the treatment of adults with Cervical Dystonia to reduce the severity of abnormal head position and neck pain associated with Cervical Dystonia.
IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING
WARNING: DISTANT SPREAD OF TOXIN EFFECT
Postmarketing reports indicate that the effects of onabotulinumtoxinA and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have an underlying condition that would predispose them to these symptoms. In unapproved uses and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and spasticity and at lower doses.
Contraindications
-Hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation
-Infection at the proposed injection site
Warnings and Precautions
-Spread of toxin effects; swallowing and breathing difficulties can lead to death. Seek immediate medical attention if respiratory, speech or swallowing difficulties occur
-Potency Units of onabotulinumtoxinA are not interchangeable with other preparations of botulinum toxin products
-Potential serious adverse reactions after onabotulinumtoxinA injections for unapproved uses
-Concomitant neuromuscular disorder may exacerbate clinical effects of treatment
-Use with caution in patients with compromised respiratory function
-Bronchitis and upper respiratory tract infections in patients treated for spasticity
Adverse Reactions
The most common adverse reactions (≥5% and >placebo, if applicable) are:
-Chronic Migraine: neck pain, headache
-Adult Spasticity: pain in extremity
-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 concomitant treatment of onabotulinumtoxinA and aminoglycosides or other agents interfering with neuromuscular transmission (e.g., curare-like agents), or muscle relaxants, should be observed closely because the effect of onabotulinumtoxinA may be potentiated
Use in Specific Populations
-Pregnancy: Based on animal data, may cause fetal harm
Please see full Prescribing Information for onabotulinumtoxinA. Available at http://www.rxabbvie.com.
Copyright ©2022 AbbVie. All rights reserved.
OnabotulinumtoxinA Important Safety Information
OnabotulinumtoxinA Indications
Chronic Migraine
-OnabotulinumtoxinA is indicated for the prophylaxis of headaches in adult patients with Chronic Migraine (≥ 15 days per month with headache lasting 4 hours a day or longer).
Limitations of Use
-Safety and effectiveness have not been established for the prophylaxis of episodic migraine (14 headache days or fewer per month) in 7 placebo-controlled studies.
Spasticity
-OnabotulinumtoxinA is indicated for the treatment of spasticity in patients 2 years of age and older.
Limitations of Use
-OnabotulinumtoxinA has not been shown to improve upper extremity functional abilities or range of motion at a joint affected by a fixed contracture.
Cervical Dystonia
-OnabotulinumtoxinA is indicated for the treatment of adults with Cervical Dystonia to reduce the severity of abnormal head position and neck pain associated with Cervical Dystonia.
IMPORTANT SAFETY INFORMATION, INCLUDING BOXED WARNING
WARNING: DISTANT SPREAD OF TOXIN EFFECT
Postmarketing reports indicate that the effects of onabotulinumtoxinA and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have an underlying condition that would predispose them to these symptoms. In unapproved uses and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and spasticity and at lower doses.
Contraindications
-Hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation
-Infection at the proposed injection site
Warnings and Precautions
-Spread of toxin effects; swallowing and breathing difficulties can lead to death. Seek immediate medical attention if respiratory, speech or swallowing difficulties occur
-Potency Units of onabotulinumtoxinA are not interchangeable with other preparations of botulinum toxin products
-Potential serious adverse reactions after onabotulinumtoxinA injections for unapproved uses
-Concomitant neuromuscular disorder may exacerbate clinical effects of treatment
-Use with caution in patients with compromised respiratory function
-Bronchitis and upper respiratory tract infections in patients treated for spasticity
Adverse Reactions
The most common adverse reactions (≥5% and >placebo, if applicable) are:
-Chronic Migraine: neck pain, headache
-Adult Spasticity: pain in extremity
-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 concomitant treatment of onabotulinumtoxinA and aminoglycosides or other agents interfering with neuromuscular transmission (e.g., curare-like agents), or muscle relaxants, should be observed closely because the effect of onabotulinumtoxinA may be potentiated
Use in Specific Populations
-Pregnancy: Based on animal data, may cause fetal harm
Please see full Prescribing Information for onabotulinumtoxinA. Available at http://www.rxabbvie.com.
Copyright ©2022 AbbVie. All rights reserved.
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