PLIAGLIS
Generic: LIDOCAINE AND TETRACAINE
Basic Information
Manufacturer
IPG PHARMACEUTICALS, INC.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
d854faa5-0af8-4684-b5cd-a0b8a91fb7cd
Indications & Usage
1 INDICATIONS AND USAGE PLIAGLIS is indicated for use on intact skin in adults to provide topical local analgesia for superficial dermatological procedures such as dermal filler injection, pulsed dye laser therapy, facial laser resurfacing, and laser-assisted tattoo removal.
PLIAGLIS is a combination of lidocaine, an amide local anesthetic, and tetracaine, an ester local anesthetic, indicated for use on intact skin in adults to provide topical local analgesia for superficial dermatological procedures such as dermal filler injection, pulsed dye laser therapy, facial laser resurfacing, and laser-assisted tattoo removal.
( 1 )
PLIAGLIS is a combination of lidocaine, an amide local anesthetic, and tetracaine, an ester local anesthetic, indicated for use on intact skin in adults to provide topical local analgesia for superficial dermatological procedures such as dermal filler injection, pulsed dye laser therapy, facial laser resurfacing, and laser-assisted tattoo removal.
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Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are described elsewhere in the labeling: Methemoglobinemia [see Warnings and Precautions (5.1) ] Overexposure [see Warnings and Precautions (5.2) ] Risks of Secondary Exposure in Children and Pets [see Warnings and Precautions (5.3) ] Anaphylactic Reactions [see Warnings and Precautions (5.4) ] Eye Irritation [see Warnings and Precautions (5.5) ] Most common local reactions were erythema (47%), skin discoloration (16%), and edema (14%).
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact IPG Pharmaceuticals, Inc.
at 1-888-711-7116 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
However, the adverse reaction information from clinical trials does provide a basis for identifying the adverse events that appear to be related to drug use and for approximating their incidence in clinical practice.
PLIAGLIS has been evaluated for safety in 2159 persons undergoing a superficial dermal procedure.
PLIAGLIS was studied in 11 placebo-controlled and 1 active-controlled trials, and in open-label safety trials.
All 2159 persons were exposed to only a single application of PLIAGLIS.
Adverse reactions were assessed by collecting spontaneously reported adverse reactions, and observations made on formal evaluation of the skin for specific reactions.
Most common adverse reactions in clinical trials Localized Reactions: In clinical studies, the most common local reactions were erythema (47%), skin discoloration (e.g., blanching, ecchymosis, and purpura) (16%), and edema (14%).
There were no serious adverse reactions.
However, one patient withdrew due to burning pain at the treatment site.
Other Localized Reactions: The following dermal adverse reactions occurred in 1% or less of PLIAGLIS-treated patients: ecchymosis, petechial rash, vesiculobullous rash, perifollicular erythema, perifollicular edema, pruritus, rash, maculopapular rash, dry skin, contact dermatitis, and acne.
Systemic (Dose-Related) Reactions: Across all trials, 19 subjects experienced a systemic adverse reaction, 15 of whom were treated with PLIAGLIS and 4 with placebo.
The frequency of systemic adverse reactions was greater for the PLIAGLIS group (1%) than the placebo group (0.3%).
The most common systemic adverse events were headache, vomiting, dizziness, and fever, all of which occurred with a frequency of <1%.
Other systemic reactions were syncope, nausea, confusion, dehydration, hyperventilation, hypotension, nervousness, paresthesia, pharyngitis, stupor, pallor, and sweating.
Systemic adverse reactions of lidocaine and tetracaine are similar in nature to those observed with other amide and ester local anesthetic agents, including CNS excitation and/or depression (lightheadedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensation of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and arrest).
Excitatory CNS reactions may be brief or not occur at all, in which case the first manifestation may be drowsiness merging into unconsciousness.
Signs of CNS toxicity may start at plasma concentrations of lidocaine at 1000 ng/mL.
The plasma concentrations at which tetracaine toxicity may occur are less well characterized; however, systemic toxicity with tetracaine is thought to occur with much lower plasma concentrations compared with lidocaine.
The toxicity of co-administered local anesthetics is thought to be at least additive.
Cardiovascular manifestations may include bradycardia, hypotension and cardiovascular collapse leading to arrest.
6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of PLIAGLIS.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Eye disorders: Eyelid swelling Skin: Pruritus, Rash, Skin Burning Sensation, Erythema, Urticaria Other: Drug ineffective
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact IPG Pharmaceuticals, Inc.
at 1-888-711-7116 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
However, the adverse reaction information from clinical trials does provide a basis for identifying the adverse events that appear to be related to drug use and for approximating their incidence in clinical practice.
PLIAGLIS has been evaluated for safety in 2159 persons undergoing a superficial dermal procedure.
PLIAGLIS was studied in 11 placebo-controlled and 1 active-controlled trials, and in open-label safety trials.
All 2159 persons were exposed to only a single application of PLIAGLIS.
Adverse reactions were assessed by collecting spontaneously reported adverse reactions, and observations made on formal evaluation of the skin for specific reactions.
Most common adverse reactions in clinical trials Localized Reactions: In clinical studies, the most common local reactions were erythema (47%), skin discoloration (e.g., blanching, ecchymosis, and purpura) (16%), and edema (14%).
There were no serious adverse reactions.
However, one patient withdrew due to burning pain at the treatment site.
Other Localized Reactions: The following dermal adverse reactions occurred in 1% or less of PLIAGLIS-treated patients: ecchymosis, petechial rash, vesiculobullous rash, perifollicular erythema, perifollicular edema, pruritus, rash, maculopapular rash, dry skin, contact dermatitis, and acne.
Systemic (Dose-Related) Reactions: Across all trials, 19 subjects experienced a systemic adverse reaction, 15 of whom were treated with PLIAGLIS and 4 with placebo.
The frequency of systemic adverse reactions was greater for the PLIAGLIS group (1%) than the placebo group (0.3%).
The most common systemic adverse events were headache, vomiting, dizziness, and fever, all of which occurred with a frequency of <1%.
Other systemic reactions were syncope, nausea, confusion, dehydration, hyperventilation, hypotension, nervousness, paresthesia, pharyngitis, stupor, pallor, and sweating.
Systemic adverse reactions of lidocaine and tetracaine are similar in nature to those observed with other amide and ester local anesthetic agents, including CNS excitation and/or depression (lightheadedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensation of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and arrest).
Excitatory CNS reactions may be brief or not occur at all, in which case the first manifestation may be drowsiness merging into unconsciousness.
Signs of CNS toxicity may start at plasma concentrations of lidocaine at 1000 ng/mL.
The plasma concentrations at which tetracaine toxicity may occur are less well characterized; however, systemic toxicity with tetracaine is thought to occur with much lower plasma concentrations compared with lidocaine.
The toxicity of co-administered local anesthetics is thought to be at least additive.
Cardiovascular manifestations may include bradycardia, hypotension and cardiovascular collapse leading to arrest.
6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of PLIAGLIS.
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Eye disorders: Eyelid swelling Skin: Pruritus, Rash, Skin Burning Sensation, Erythema, Urticaria Other: Drug ineffective