1/19. PrabotulinumtoxinA- @-(JEUVEAU ) - (Feb- 2019)- Neuromuscular blocking agent
Drug Name:1/19. PrabotulinumtoxinA- @-(JEUVEAU ) - (Feb- 2019)- Neuromuscular blocking agent
List Of Brands:
Indication Type Description:
Drug Interaction
Indication
Adverse Reaction
Contra-Indications
Dosages/ Overdosage Etc
Patient Information
Pharmacology/ Pharmacokinetics
Pregnancy and lactation
Drug Interaction:
DRUG INTERACTIONS
Patients receiving concomitant treatment of JEUVEAU 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 JEUVEAU may be potentiated
Indication:
SHORT SUMMARY
PRABOTULINUMTOXIN-A ( Feb 2019)
Indn- For the temporary improvement in the appearance of moderate to severe glabelar lines as associated with corrugator and/or procerus muscle activity in adult patients
Comp- For Injection: 100 Units vacuum-dried powder in a single- dose vial. Glabellar Lines Administration: 0.1 mL (4 Units) by intramuscular injection into each of five sites, for a total dose of 20 Units
CI- • Hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation ) • Infection at the injection site
WARNINGS-
•Potency Units are not interchangeable with other preparations of botulinum toxin products
• Spread of toxin effects; swallowing and breathing difficulties can lead to death. Seek immediate medical attention if respiratory, speech or swallowing difficulties occur
Pat Inform-
Advise patients to inform their doctor or pharmacist if they develop any unusual symptoms (including difficulty with swallowing, speaking or breathing), or if any known symptom persists or worsens
Inform patients that injection may cause eye dryness.
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U.S. FDA APPROVED DRUGS DURING 2019
Sr.No- 1
Date of Approval - 2/1/2019
Adverse Reaction:
ADVERSE REACTIONS
The most common adverse reactions are :
• Headache (9.3%) • Eyelid Ptosis (2%) • Upper Respiratory Tract Infection (3%) • Increase White Blood Cell count (1%)
Contra-Indications:
CONTRAINDICATIONS
• Hypersensitivity to any botulinum toxin preparation or to any of the components in the formulation (4.1) • Infection at the injection site (4.2)
WARNINGS AND PRECAUTIONS
•Potency Units of JEUVEAU are not interchangeable with other preparations of botulinum toxin products
• Spread of toxin effects; swallowing and breathing difficulties can lead to death. Seek immediate medical attention if respiratory, speech or swallowing difficulties occur
• Potential serious adverse reactions after JEUVEAU injections for unapproved uses
• Adverse event reports have been received involving the cardiovascular system, some with fatal outcomes. Use caution when administering to patients with pre-existing cardiovascular disease.
• Concomitant neuromuscular disorder may exacerbate clinical effects of treatment
• Use with caution in patients with compromised respiratory function or dysphagia
Dosages/ Overdosage Etc:
Patient Information:
PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Advise patients to inform their doctor or pharmacist if they develop any unusual symptoms (including difficulty with swallowing, speaking or breathing), or if any known symptom persists or worsens
Inform patients that JEUVEAU injection may cause eye dryness.
Advise patients to report symptoms of eye dryness (e.g., eye pain, eye irritation, photosensitivity, or changes in vision) to their doctor
Inform patients that if loss of strength, muscle weakness, blurred vision or drooping eyelids occur, they should avoid driving a car or engaging in other potentially hazardous activities.
Manufactured by:
Evolus Inc. 1027 Garden St., Santa Barbara, CA 93101 U.S. License Number 2070 at: Daewoong Pharmaceutical Co., Ltd. 12, Bongeunsa-ro 114-gil 12, Gangnam-gu,
Pharmacology/ Pharmacokinetics:
CLINICAL PHARMACOLOGY
1. Mechanism of Action
JEUVEAU blocks neuromuscular transmission by binding to acceptor sites on motor nerve terminals, entering the nerve terminals, and inhibiting the release of acetylcholine. This inhibition occurs as the neurotoxin cleaves SNAP-25, a protein integral to the successful docking and release of acetylcholine from vesicles situated within nerve endings.
When injected intramuscularly at therapeutic doses, JEUVEAU produces partial chemical denervation of the muscle resulting in a localized reduction in muscle activity.
In addition, the muscle may atrophy, axonal sprouting may occur, and extrajunctional acetylcholine receptors may develop. There is evidence that reinnervation of the muscle may occur, thus slowly reversing muscle denervation produced by JEUVEAU.
2 Pharmacodynamics
No formal pharmacodynamic studies have been conducted with JEUVEAU.
3. Pharmacokinetics
Using currently available analytical technology, it is not possible to detect JEUVEAU in the peripheral blood following intramuscular injection at the recommended doses. No drug interaction studies have been conducted with JEUVEAU.
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
1 Pregnancy Risk Summary
The limited available data on JEUVEAU use in pregnant women a
An embryofetal developmental study conducted with JEUVEAU in pregnant rats revealed no treatment-related effects to the developing fetus when JEUVEAU was administered intramuscularly during organogenesis at doses up to 12 times the maximum recommended human dose (MRHD)
The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
2. Lactation
There is no information regarding the presence of prabotulinumtoxinA in human or animal milk, its effects on the breastfed infant or on milk production.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for JEUVEAU and any potential adverse effects on the breastfed infant from JEUVEAU or from the underlying maternal condition
3.Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
4.Geriatric Use
The two clinical trials of JEUVEAU included 68 subjects age 65 and greater. Although no differences in safety or efficacy were observed between older and younger subjects. Clinical studies of JEUVEAU did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects.
OVERDOSAGE
There is no information regarding overdose from clinical studies of JEUVEAU. Excessive doses of JEUVEAU (prabotulinumtoxinA-xvfs) Injection may be expected to produce neuromuscular weakness with a variety of symptoms.
Symptoms of overdose are likely not to be present immediately following injection. Should accidental injection or oral ingestion occur, or overdose be suspected, these patients should be considered for further medical evaluation and appropriate medical therapy immediately instituted, which may include hospitalization.
The person should be medically supervised for several weeks for signs and symptoms of systemic muscular weakness which could be local, or distant from the site of injection
If the musculature of the oropharynx and esophagus are affected, aspiration may occur which may lead to development of aspiration pneumonia. If the respiratory muscles become paralyzed or sufficiently weakened, intubation and assisted respiration may be necessary until recovery takes place.
Supportive care could involve the need for a tracheostomy and/or prolonged mechanical ventilation, in addition to other general supportive care.