Kimberly Langenbach

Question 1

BOTOX (onabotulinumtoxinA) for injection, for intramuscular, intradetrusor, or intradermal use
Initial U.S. Approval: 1989 is an _______ _______ ______ and _________ _________ __________

Answer 1

acetylcholine release inhibitor and a neuromuscular blocking agent

Question 2

Explain the Botox boxed warning?

Answer 2

WARNING: DISTANT SPREAD OF TOXIN EFFECT
See full prescribing information for complete boxed warning.
The effects of BOTOX and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. 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, particularly in those patients who have an underlying condition that would predispose them to these symptoms.

Question 3

What are the indications and usage of Botox?

Answer 3

-Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication (1.1)
• Treatment of urinary incontinence due to detrusor overactivity associated with a neurologic condition [e.g., spinal cord injury (SCI), multiple sclerosis (MS)] in adults who have an inadequate response to or are intolerant of an anticholinergic medication (1.1)
• Prophylaxis of headaches in adult patients with chronic migraine (≥15 days per month with headache lasting 4 hours a day or longer) (1.2)
• Treatment of upper and lower limb spasticity in adult patients (1.3)
• Treatment of upper limb spasticity in pediatric patients 2 to 17 years of age (1.4)
• Treatment of cervical dystonia in adult patients, to reduce the severity of abnormal head position and neck pain (1.5)
• Treatment of severe axillary hyperhidrosis that is inadequately managed by topical agents in adult patients (1.6)
• Treatment of blepharospasm associated with dystonia in patients 12 years of age and older (1.7)
• Treatment of strabismus in patients 12 years of age and older (1.7)
Important Limitations: Safety and effectiveness of BOTOX have not been established for:
• Prophylaxis of episodic migraine (14 headache days or fewer per month) (1.2)
• Treatment of hyperhidrosis in body areas other than axillary (1.6)

Question 4

What is the dosage interval of Botox?

Answer 4

3 month interval

Question 5

The maximum dose in a ____ month interval is ____ units in adults and ________________ in pediatrics.

Answer 5

3 month; 400 units and the lesser of 8 Units/kg or 300 Units

Question 6

Dosing for Overactive Bladder: Recommended total dose _______ injections across 20 sites into the _____

Answer 6

100 Units, as 0.5 mL (5 Units); detrusor

Question 7

Dosing for Detrusor Overactivity associated with a Neurologic Condition: Recommended total dose ________ injections across _____ into the detrusor

Answer 7

200 Units, as 1 mL (~6.7 Units) ; 30 sites

Question 8

Dosing for Chronic Migraine: Recommended total dose ________ injections per each site divided across 7 head/neck muscles

Answer 8

155 Units, as 0.1 mL (5 Units)

Question 9

What is the recommended dosing for Adult Upper Limb Spasticity?

Answer 9

Adult Upper Limb Spasticity: Select dose based on muscles affected, severity of muscle activity, prior response to treatment, and adverse event history; Electromyographic guidance recommended

Question 10

Dosing for Adult Lower Limb Spasticity: Recommended total dose __________ divided across ankle and toe muscles

Answer 10

300 Units to 400 Units