brand:
NABOTA® (JEUVEAU®)
manufacturer:
Daewoong Pharmaceutical Co. Ltd
active substances:
BOTULINUM TOXIN TYPE A
strength:
100u
pack size:
1 x 100 Units Vial
NAVOTA® (JEUVEAU®) (prabotulinumtoxinA-xvfs) is a neuromuscular blocking agent, indicated for the temporary improvement in the appearance of moderate to severe glabellar lines in adults. Glabellar lines are the vertical lines between the eyebrows, often caused by the activity of the corrugator and procerus muscles.
Key Indications:
NAVOTA® (JEUVEAU®) is supplied as a 100-unit vacuum-dried powder for intramuscular injection. Before administration, it must be reconstituted with preservative-free 0.9% sodium chloride. The recommended dose for glabellar lines is 20 units, administered as 0.1 mL (4 units) per injection at five different sites.
Dosage Summary:
The treatment should not be repeated more than every three months to minimize potential side effects.
NAVOTA® (JEUVEAU®) has been associated with both mild and severe side effects, some of which may be life-threatening. The most common side effects are headache and eyelid ptosis (drooping). Severe reactions, although rare, can include breathing difficulties and swallowing problems, which may occur due to the spread of botulinum toxin beyond the injection site.
Common Side Effects:
Serious Side Effects:
Precautions:
Two pivotal randomized, multi-center, placebo-controlled trials (EV-001 and EV-002) evaluated the safety and efficacy of NAVOTA® (JEUVEAU®) in treating moderate to severe glabellar lines. These trials included 654 adults aged 18 to 81, with most participants being female.
Efficacy Data:
Adverse Events: In both trials, adverse events occurred within the first week post-injection and were generally mild, resolving within a few weeks. The most commonly reported adverse events were headache and eyelid ptosis.
NAVOTA® (JEUVEAU®) has not been extensively studied in drug interaction trials, but the potential for interactions with medications affecting neuromuscular transmission should be considered. Certain medications, such as aminoglycosides and muscle relaxants, may increase the risk of adverse effects when used with NAVOTA® (JEUVEAU®).
Key Drug Interactions:
Patients receiving NAVOTA® (JEUVEAU®) should follow post-treatment care guidelines to ensure optimal outcomes and minimize complications.
Post-Treatment Guidelines:
What to Expect:
Patients who are satisfied with the results of NAVOTA® (JEUVEAU®) may consider follow-up treatments every three to four months to maintain the desired appearance. Overuse should be avoided to minimize the risk of antibody development or toxin resistance.
Recommended Schedule:
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