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Restylane Lyft

Last reviewed on RxList: 6/22/2017
Restylane Lyft Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 6/22/2017

Restylane Lyft with Lidocaine (injectable hyaluronic acid gel with 0.3% lidocaine) is a dermal filler indicated for implantation into the deep dermis to superficial subcutis for the correction of moderate to severe facial folds and wrinkles, such as nasolabial folds, and for subcutaneous to supraperiosteal implantation for cheek augmentation and correction of age-related midface contour deficiencies in patients over the age of 21. Common side effects of Restylane Lyft include:

  • bruising,
  • redness,
  • swelling,
  • pain,
  • headache,
  • tenderness,
  • itching,
  • acne,
  • lumps on the skin,
  • red or purple marks,
  • bleeding,
  • hyperpigmentation at the injection site,
  • aches, and
  • feeling unwell (malaise).

For the treatment of moderate to severe facial wrinkles and folds, the maximum recommended dose of Restylane Lyft per treatment is 6.0 mL based on U.S. clinical studies. Restylane Lyft may interact with other drugs. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Restylane Lyft. The safety of Restylane Lyft with Lidocaine for use during pregnancy or while breastfeeding has not been established.

Our Restylane Lyft with Lidocaine (injectable hyaluronic acid gel with 0.3% lidocaine) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Restylane Lyft Professional Information

SIDE EFFECTS

Restylane® Lyft with Lidocaine is indicated for implantation into the deep dermis to superficial subcutis for the correction of moderate to severe facial folds and wrinkles, such as nasolabial folds and for subcutaneous to supraperiosteal implantation for cheek augmentation and correction of age-related midface contour deficiencies in patients over the age of 21. Adverse event information for Restylane® Lyft with Lidocaine use in the correction of moderate to severe facial folds and wrinkles, such as nasolabial folds is presented in Tables 1-10 and for cheek augmentation and correction of age-related midface contour deficiencies is presented in Tables 11-13.

Restylane® Lyft with Lidocaine for the correction of moderate to severe facial folds and wrinkles, such as nasolabial folds.

There were five US studies that reported adverse events in support of the indication for treatment of moderate to severe facial folds and wrinkles, such as nasolabial folds.

In two U.S. studies (i.e., Study MA-1400-01 and Study MA-1400-02) involving 433 patients at 25 centers, the adverse outcomes reported in patient diaries during 14 days after treatment are presented in Tables 1–4. The physician diagnosed adverse events identified in these studies at 72 hours after injection are presented in Table 7. In Study MA-1400-01, 150 patients were injected with Perlane® on one side of the face and Restylane® on the other side of the face. In study MA-1400-02, 283 patients were randomized to receive either Perlane® or Restylane® injection on both sides of the face. Table 8 presents all investigator-identified adverse events recorded at study visits 2 weeks or more after injection in studies MA-1400-01, MA-1400-02, 31GE0101 and 31GE0002. In Study 31GE0101, 150 Canadian patients were injected with both Perlane® and HylaformR. In Study 31GE0002, 68 Scandinavian patients underwent both Perlane® and Zyplast® injections.

In a fifth U.S. study (Study MA-1400-03) 60 patients at three centers randomly received Restylane® Lyft with Lidocaine injections on one side of the face and Perlane® injections on the other side of the face. The adverse events reported in patient diaries during 14 days after treatment are presented in Tables 5 and 6. The physician-recorded adverse events identified in study MA-1400-03 at 14 days after injection are presented in Table 9.

Table 1. Maximum Intensity of Symptoms after Initial Treatment, Patient Diary (Study MA-1400-02)1

  Perlane Restylane Perlane Patients Restylane Patients
Total patients reporting symptoms
n
(%)
Total patients reporting symptoms
n
(%)
None Tolerable2 Affected Daily Activity2 Disabling2 None Tolerable2 Affected Daily Activity2 Disabling2
n
(%)
n
(%)
n
(%)
n
(%)
n
(%)
n
(%)
n
(%)
n
(%)
Bruising 122
(86.5%)
111
(78.2%)
17
(12.2%)
97
(69.8%)
24
(17.3%)
1
(0.7%)
28
(20.1%)
82
(59%)
28
(20.1%)
1
(0.7%)
Redness 118
(83.7%)
114
(80.3%)
21
(15.1%)
105
(75.5%)
12
(8.6%)
1
(0.7%)
25
(18%)
96
(69.1%)
17
(12.2%)
1
(0.7%)
Swelling 128
(90.8%)
127
(89.4%)
11
(7.9%)
107
(77%)
19
(13.7%)
2
(1.4%)
12
(8.6%)
102
(73.4%)
23
(16.5%)
2
(1.4%)
Pain 114
(80.9%)
108
(76.1%)
25
(18%)
96
(69.1%)
18
(12.9%)
0
(0%)
31
(22.3%)
93
(66.9%)
14
(10.1%)
1
(0.7%)
Tenderness 130
(92.2%)
123
(86.6%)
9
(6.5%)
112
(80.6%)
18
(12.9%)
0
(0%)
16
(11.5%)
109
(78.4%)
12
(8.6%)
2
(1.4%)
Itching 45
(31.9%)
67
(47.2%)
94
(67.6%)
40
(28.8%)
3
(2.2%)
2
(1.4%)
72
(51.8%)
66
(47.5%)
1
(0.7%)
0
(0%)
Other3 1
(0.7%)
3
(2.1%)
NA NA NA NA NA NA NA NA
1Missing values are not reported.
2Prospective definitions for: tolerable, affected daily activity and disabling were not provided in the diary or protocol.
3Two patients reported pimples (one Perlane/one Restylane); one Restylane patient reported a sore throat; one Restylane patient reported a runny nose; degree of disability was not reported for any of the four events.

Table 2. Duration of Adverse Events after Initial Treatment, Patient Diary (Study MA-1400-02) 1

  Perlane Restylane Perlane Patients Restylane Patients
Total patients reporting symptoms
n
(%)
Total patients reporting symptoms
n
(%)
Number of days2 Number of days2
1
n
(%)
2-7
n
(%)
8-13
n
(%)
14
n
(%)
1
n
(%)
2-7
n
(%)
8-13
n
(%)
14
n
(%)
Bruising 122
(86.5%)
111
(78.2%)
6
(4.9%)
81
(66.4%)
28
(23%)
7
(5.7%)
9
(8.1%)
69
(62.2%)
30
(27%)
3
(2.7%)
Redness 118
(83.7%)
114
(80.3%)
19
(16.1%)
87
(73.7%)
8
(6.8%)
4
(3.4%)
31
(27.2%)
71
(62.3%)
9
(7.9%)
3
(2.6%)
Swelling 128
(90.8%)
127
(89.4%)
6
(4.7%)
100
(78.1%)
17
(13.3%)
5
(3.9%)
12
(9.4%)
93
(73.2%)
19
(15.0%)
3
(2.4%)
Pain 114
(80.9%)
108
(76.1%)
46
(40.4%)
66
(57.9%)
2
(1.8%)
0
(0%)
37
(34.3%)
69
(63.9%)
2
(1.9%)
0
(0%)
Tenderness 130
(92.2%)
123
(86.6%)
24
(18.5%)
89
(68.5%)
16
(12.3%)
1
(0.8%)
21
(17.1%)
92
(74.8%)
9
(7.3%)
1
(0.8%)
Itching 45
(31.9%)
67
(47.2%)
19
(42.2%)
23
(51.1%)
3
(6.7%)
0
(0%)
22
(32.8%)
38
(56.7%)
6
(9.0%)
1
(1.5%)
Other3 1
(0.7%)
3
(2.1%)
1
(100%)
0
(0%)
0
(0%)
0
(0%)
3
(100%)
0
(0%)
0
(0%)
0
(0%)
1Missing values are not reported.
2Prospective definitions for: tolerable, affected daily activity and disabling were not provided in the diary or protocol.
3Two patients reported pimples (one Perlane/one Restylane); one Restylane patient reported a sore throat; one Restylane patient reported a runny nose; degree of disability was not reported for any of the four events.

Table 3. Maximum Intensity of Symptoms after Initial Treatment, Patient Diary (Study MA-1400-01)1,2

  Perlane Restylane Perlane Patients Restylane Patients
Total patients reporting symptoms
n (%)
Total patients reporting symptoms
n (%)
None Tolerable3 Affected Daily Activity3 Disabling3 None Tolerable3 Affected Daily Activity3 Disabling3
n (%) n (%) n (%) n (%) n (%) n (%) n (%) n (%)
Bruising 74
(49.3%)
70
(46.7%)
75
(50.3%)
67
(45%)
7
(4.7%)
0
(0%)
79
(53%)
66
(44.3%)
4
(2.7%)
0
(0%)
Redness 92
(61.3%)
87
(58%)
57
(38.3%)
85
(57%)
7
(4.7%)
0
(0%)
62
(41.6%)
81
(54.4%)
6
(4%)
0
(0%)
Swelling 121
(80.7%)
125
(83.3%)
28
(18.8%)
108
(72.5%)
11
(7.4%)
2
(1.3%)
24
(16.1%)
109
(73.2%)
14
(9.4%)
2
(1.3%)
Pain 103
(68.7%)
96
(64%)
46
(30.9%)
90
(60.4%)
12
(8.1%)
1
(0.7%)
53
(35.6%)
84
(56.4%)
11
(7.4%)
1
(0.7%)
Tenderness 130
(86.7%)
122
(81.3%)
19
(12.8%)
116
(77.9%)
13
(8.7%)
1
(0.7%)
27
(18.1%)
110
(73.8%)
11
(7.4%)
1
(0.7%)
Itching 58
(38.7%)
53
(35.3%)
91
(61.1%)
54
(36.2%)
4
(2.7%)
0
(0%)
96
(64.4%)
49
(32.9%)
4
(2.7%)
0
(0%)
Other4 3
(2%)
3
(2%)
NA 3
(100%)
0
(0%)
0
(0%)
NA 3
(100%)
0
(0%)
0
(0%)
1Missing values are not reported.
2Events are reported as local events; because of the design (split-face) of the study, causality of the systemic adverse events cannot be assigned.
3Prospective definitions for: tolerable, affected daily activity and disabling were not provided in the diary or protocol.
4Two patients reported mild transient headache and one patient reported mild ‘twitching’; neither could be associated with a particular product.

Table 4. Duration of Adverse Events after Initial Treatment, Patient Diary (Study MA-1400-01)1,2

  Perlane Restylane Perlane Patients Restylane Patients
Total patients reporting symptoms
n
(%)
Total patients reporting symptoms
n
(%)
Number of days3 Number of days3
1
n
(%)
2-7
n
(%)
8-13
n
(%)
14
n
(%)
1
n
(%)
2-7
n
(%)
8-13
n
(%)
14
n
(%)
Bruising 74
(49.3%)
70
(46.7%)
23
(31.1%)
44
(59.5%)
6
(8.1%)
1
(1.4%)
13
(18.6%)
51
(72.9%)
6
(8.6%)
0
(0%)
Redness 92
(61.3%)
87
(58%)
38
(41.3%)
52
(56.5%)
2
(2.2%)
0
(0%)
33
(37.9%)
52
(59.8%)
2
(2.3%)
0
(0%)
Swelling 121 (80.7%) 125
(83.3%)
22
(18.2%)
85
(70.2%)
11
(9.1%)
3
(2.5%)
23
(18.4%)
89
(71.2%)
12
(9.6%)
1
(0.8%)
Pain 103 (68.7%) 96
(64%)
32
(31.1%)
67
(65%)
2
(1.9%)
2
(1.9%)
27
(28.1%)
67
(69.8%)
2
(2.1%)
0
(0%)
Tenderness 130
(86.7%)
122
(81.3%)
26
(20%)
94
(72.3%)
6
(4.6%)
4
(3.1%)
28
(23%)
87
(71.3%)
7
(5.7%)
0
(0%)
Itching 58
(38.7%)
53
(35.3%)
29
(50%)
26
(44.8%)
2
(3.4%)
1
(1.7%)
22
(41.5%)
27
(50.9%)
4
(7.5%)
0
(0%)
Other4 3
(2%)
3
(2%)
3
(100%)
0
(0%)
0
(0%)
0
(0%)
3
(100%)
0
(0%)
0
(0%)
0
(0%)
1Missing values are not reported.
2Events are reported as local events; because of the design (split-face) of the study, causality of the systemic adverse events cannot be assigned.
3 Data are cumulated from up to two injection sites per patient with earliest and latest time point for any reaction provided.
4Two patients reported mild transient headache and one patient reported mild ‘twitching’; neither could be associated with a particular product.

Table 5. Maximum Intensity of Symptoms after Initial Treatment, Patient Diary (Study MA-1400-03)1

  Restylane® Lyft with Lidocaine Perlane Restylane® Lyft with Lidocaine Patients Perlane Patients
Total patients reporting symptoms
n
(%)
Total patients reporting symptoms
n
(%)
None Tolerable2 Affected Daily Activity2 Disabling2 None Tolerable2 Affected Daily Activity2 Disabling2
n
(%)
n
(%)
n
(%)
n
(%)
n
(%)
n
(%)
n
(%)
n
(%)
Bruising 36
(60.0%)
33
(55.0%)
24
(40.0%)
32
(53.3%)
4
(6.7%)
0
(0%)
27
(45.0%)
29
(48.3%)
4
(6.7%)
0
(0%)
Redness 34
(56.7%)
31
(51.7%)
26
(43.3%)
31
(51.7%)
3
(5.0%)
0
(0%)
29
(48.3%)
29 (48.3%) 2
(3.3%)
0
(0%)
Swelling 42
(70.0%)
39
(65.0%)
18
(30.0%)
34
(56.7%)
8
(13.3%)
0
(0%)
21 (35.0%) 34
(56.7%)
5
(8.3%)
0
(0%)
Pain 28
(46.7%)
26
(43.3%)
32
(53.3%)
25
(41.7%)
3
(5.0%)
0
(0%)
34
(56.7%)
24
(40.0%)
2
(3.3%)
0
(0%)
Tenderness 50
(83.3%)
49
(81.7%)
10
(16.7%)
45
(75.0%)
5
(8.3%)
0
(0%)
11
(18.3%)
47
(78.3%)
2
(3.3%)
0
(0%)
Itching 16
(26.7%)
12
(20.0%)
44
(73.3%)
15
(25.0%)
1
(1.7%)
0
(0%)
48 (80.0%) 12 (20.0%) 0
(0%)
0
(0%)
Other3 3
(5.0%)
1
(1.7%)
NA NA NA NA NA NA NA NA
1Missing values are not reported.
2Prospective definitions for: tolerable, affected daily activity and disabling were not provided in the diary or protocol.
3Other included symptoms of acne, lumpiness, and red/purple mark. Diary entries of hurts to swallow, lack of energy, feeling of sickness, achy, headache, and broken capillaries could not be associated with a particular product.

Table 6. Duration of Adverse Events after Initial Treatment, Patient Diary (Study MA-1400-03) 1

  Restylane® Lyft with Lidocaine Perlane Restylane® Lyft with Lidocaine Patients Perlane Patients
Total patients reporting symptoms
n
(%)
Total patients reporting symptoms
n
(%)
Number of days3 Number of days3
1 n
(%)
2-7
n
(%)
8-13
n
(%)
14
n
(%)
1
n
(%)
2-7
n
(%)
8-13
n
(%)
14
n
(%)
Bruising 36
(60.0%)
33
(55.0%)
6
(16.7%)
27
(75.0%)
3
(8.3%)
0
(0.0%)
5
(15.2%)
23
(69.7%)
4
(12.1%)
1
(3.0%)
Redness 34
(56.7%)
31
(51.7%)
9
(26.5%)
24
(70.6%)
0
(0.0%)
1
(2.9%)
9
(29.0%)
18
(58.1%)
3
(9.7%)
1
(3.2%)
Swelling 42
(70.0%)
39
(65.0%)
4
(9.5%)
33
(78.6%)
4
(9.5%)
1
(2.4%)
6
(15.4%)
29
(74.4%)
3
(7.7%)
1
(2.6%)
Pain 28
(46.7%)
26
(43.3%)
17
(60.7%)
11
(39.3%)
0
(0.0%)
0
(0.0%)
15
(57.7%)
11
(42.3%)
0
(0.0%)
0
(0%)
Tenderness 50
(83.3%)
49
(81.7%)
6
(12.0%)
40
(80.0%)
4
(8.0%)
0
(0.0%)
8
(16.3%)
35
(71.4%)
6
(12.2%)
0
(0%)
Itching 16
(26.7%)
12
(20.0%)
5
(31.3%)
10
(62.5%)
1
(6.3%)
0
(0.0%)
5
(41.7%)
7
(58.3%)
0
(0%)
0
(0%)
Other2,4 3
(5.0%)
1
(1.7%)
0
(0.0%)
3
(100.0%)
0
(0.0%)
0
(0%)
0
(0.0%)
1
(100.0%)
0
(0%)
0
(0%)
1 Missing values are not reported.
2 Events are reported as local events; because of the design (split-face) of the study, causality of the systemic adverse events cannot be assigned.
3 Data are cumulated from up to two injection sites per patient with earliest and latest time point for any reaction provided.
4 Other included symptoms of acne, lumpiness, and red/purple mark. Diary entries of hurts to swallow, lack of energy, feeling of sickness, achy, headache, and broken capillaries could not be associated with a particular product.

Table 7 shows the number of adverse events identified by investigators at 72 hours after injection for Studies MA-1400-01 and MA-1400-02. Some patients had multiple adverse events or had the same adverse event at multiple injection sites. No adverse events were of severe intensity.

Table 7. All Investigator-Identified Adverse Events (72 Hours) Number of Events per Patient per Study

Study Term MA-1400-01 MA-1400-02
  Number of Events
Perlane
(n=150)
Number of Events
Restylane
(n=150)
Number of Events
Perlane
(n=141)
Number of Events
Restylane
(n=142)
Ecchymosis 10 9 44 48
Edema 4 4 10 6
Erythema 13 13 5 3
Tenderness 4 4 5 7
Pain 2 2 2 2
Hyperpigmentation 3 2 1 0
Pruritus 1 2 0 1
Papule 0 1 2 2
Burning 0 1 0 0
Hypopigmentation 0 1 0 0
Injection site scab 0 3 0 0

Table 8 presents the number of patients and per patient incidence of all adverse events identified by investigators at visits occurring two or more weeks after injection.

Table 8. Investigator-Identified Adverse Events (2 Weeks or More After Implantation) (Number of Patients) (Perlane v. Specified Active Controls – All Studies)

Study Term MA-1400-01
Perlane
(n=150)
(%)
MA-1400-01
Restylane
(n=150)
(%)
MA-1400-02
Perlane
(n=141)
(%)
MA-1400-02
Restylane
(n=142)
(%)
31GE0101
Perlane
(n=150)
(%)
31GE0101
Hylaform
(n=150)
(%)
31GE0002
Perlane
(n=68)
(%)
31GE0002
Zyplast
(n=68)
(%)
Ecchymosis 7
(4.6%)
4
(2.7%)
15
(10.6%)
14
(9.9%)
6
(4.0%)
2
(1.3%)
0
(0%)
0
(0%)
Edema 0
(0%)
0
(0%)
3
(2.1%)
2
(1.4%)
14
(9.3%)
6
(4.0%)
4
(5.9%)
9
(13.2%)
Erythema 2
(1.3%)
2
(1.3%)
2
(1.4%)
1
(0.7%)
13
(8.7%)
8
(5.3%)
6
(8.8%)
8
(11.8%)
Tenderness 1
(0.7%)
0
(0%)
1
(0.7%)
0
(0%)
2
(1.3%)
0
(0%)
0
(0%)
0
(0%)
Pain 0
(0%)
0
(0%)
0
(0%)
1
(0.7%)
13
(8.7%)
3
(2.0%)
0
(0%)
2
(2.9%)
Papule 0
(0%)
1
(0.7%)
1
(0.7%)
2
(1.4%)
11
(7.3%)
1
(0.7%)
1
(1.5%)
6
(8.8%)
Pruritus 0
(0%)
1
(0.7%)
0
(0%)
1
(0.7%)
2
(1.3%)
3
(2.0%)
3
(4.4%)
5
(7.4%)
Rash 0
(0%)
0
(0%)
0
(0%)
0
(0%)
1
(0.7%)
0
(0%)
0
(0%)
0
(0%)
Hyperpigmentation 7
(4.7%)
8
(5.3%)
0
(0%)
0
(0%)
0
(0%)
0
(0%)
0
(0%)
0
(0%)
Injection site scab 0
(0%)
1
(0.7%)
0
(0%)
0
(0%)
0
(0%)
0
(0%)
0
(0%)
0
(0%)
Skin exfoliation 0
(0%)
0
(0%)
0
(0%)
0
(0%)
0
(0%)
1
(0.7%)
0
(0%)
0
(0%)

In two studies (i.e., 31GE0101 and 31GE0002) with repeat administration of Perlane® at 6–9 months following the initial correction, the incidence and severity of adverse events were similar in nature and duration to those recorded during the initial treatment sessions.

In all four studies, investigators reported the following local and systemic events that were judged unrelated to treatment and occurred at an incidence of less than 1%, i.e., acne; tooth disorders (e.g., pain, infection, abscess, fracture); dermatitis (e.g., rosacea, unspecified, contact, impetigo, herpetic); unrelated injection site reactions (e.g., desquamation, rash, anesthesia); facial palsy with co-administration of botulinum toxin; headache/migraine; nausea (with or without vomiting); syncope; gastroenteritis; upper respiratory or influenza-like illness; bronchitis; sinusitis; pharyngitis; otitis; viral infection; cystitis; diverticulitis; injuries; lacerations; back pain; rheumatoid arthritis; and various medical conditions such as chest pain, depression, renal stones, and uterine fibroids.

Table 9 shows the number of adverse events identified by investigators during Day 1 through Day 14 after injection in Study MA-1400-03.

Table 9. All Investigator-Identified Adverse Events (14 Days) Number of Events per Patient per Study

Study Term MA-1400-03
  Number of Events
Restylane® Lyft with Lidocaine
(n=142)
Number of Events
Perlane
(n=141)
Ecchymosis 19 23
Edema 24 24
Erythema 25 25
Pain 14 14
Papule 1 1
Pruritus 9 5
Tenderness 30 30

Some patients had multiple adverse events or had the same adverse events at bilateral injection sites. No adverse events were of severe intensity. Patients were queried on adverse events on the day of injection and at the Day 14 visit.

Study MA-1400-03, included 47 subjects who had no prior cosmetic treatment and 13 subjects who had prior dermal filler treatment. There were no statistical differences in the proportion of subjects with adverse events who had prior treatment and those with no prior treatment.

Table 10. MA-1400-03¡XRelated AE by prior procedure. By Subjects

Prior procedure Related AE p-value*
Yes No
Yes 9 (69.2%) 4 1.00
No 31 (66.0%) 16
* Fisher’s exact test

Restylane® Lyft with Lidocaine for cheek augmentation and correction of midface contour deficiencies in patients over the age of 21.

One U.S. study reported adverse events in support of Restylane® Lyft with Lidocaine for the indication of cheek augmentation and correction of midface contour deficiencies.

In the U.S. pivotal study (MA-1400-05) involving 200 patients at 12 centers, patients received Restylane® Lyft with Lidocaine in both the right and left midface at baseline or in the control group at Month 12. Subjects were asked to record symptoms of bruising, redness, swelling, pain, tenderness and itching in a 14-Day patient diary. Subject’s scores for the severity of these events are presented in Table 11 and durations are provided in Table 12. The majority of events were mild considered tolerable and resolved in 2 – 7 days. Bruising tended to have a longer duration with the majority of subjects resolving between 8 and 14 days.

Table 11. MA-1400-05 Overall Summary of Selected Adverse Events* as Reported in Subject’s Diary by Maximum Severity – Safety Population

    Treatment Group
No Treatment at Baseline
(N=49)
First Treatment with Restylane® Lyft with Lidocaine
(N=199)
Second Treatment with Restylane® Lyft with Lidocaine
(N=128)
Right and Left Midface Combined (N=198)
Maximum Severity Reported for any Diary Symptom 49 198 127
  None 47 (96%) 3 (2%) 1 (<1%)
  Tolerable 2 (4%) 146 (74%) 94 (74%)
  Affects Daily Activities 0 45 (23%) 26 (20%)
  Disabling 0 4 (2%) 6 (5%)
Pain (Including Burning) 49 198 127
  None 48 (98%) 41 (21%) 28 (22%)
  Tolerable 1 (2%) 134 (68%) 84 (66%)
  Affects Daily Activities 0 22 (11%) 13 (10%)
  Disabling 0 1 (<1%) 2 (2%)
Tenderness 49 198 127
  None 49 (100%) 9 (5%) 10 (8%)
  Tolerable 0 171 (86%) 104 (82%)
  Affects Daily Activities 0 17 (9%) 12 (9%)
  Disabling 0 1 (<1%) 1 (<1%)
Redness 49 198 127
  None 49 (100%) 43 (22%) 27 (21%)
  Tolerable 0 139 (70%) 88 (69%)
  Affects Daily Activities 0 16 (8%) 10 (8%)
  Disabling 0 0 2 (2%)
Bruising 49 198 127
  None 49 (100%) 35 (18%) 28 (22%)
  Tolerable 0 130 (66%) 79 (62%)
  Affects Daily Activities 0 32 (16%) 16 (13%)
  Disabling 0 1 (<1%) 4 (3%)
Swelling 49 198 127
  None 49 (100%) 19 (10%) 18 (14%)
  Tolerable 0 145 (73%) 94 (74%)
  Affects Daily Activities 0 30 (15%) 11 (9%)
  Disabling 0 4 (2%) 4 (3%)
Itching 49 198 127
  None 48 (98%) 131 (66%) 92 (72%)
  Tolerable 1 (2%) 63 (32%) 33 (26%)
  Affects Daily Activities 0 3 (2%) 1 (<1%)
  Disabling 0 1 (<1%) 1 (<1%)
Note: Percentages are based on the number of Subjects in the Safety Population with any non-missing assessment for location and parameter (if applicable).
Note: For right and left combined, the overall maximum severity is taken as the maximum of overall right severity and overall left severity. The combined maximum severity within symptom category is taken as the maximum of right severity and left severity within the symptom category.
* Selected Adverse Events are those that were pre-listed in the diary (bruising, redness, swelling, pain, tenderness, itching) and required a recording of “none” or the presence and extent. These diary recordings were handled separately from adverse events that were elicited from an interview about any medical occurrence that meets the definition of Adverse Event.

Table 12: Duration of Selected Adverse Events* as Reported in the Subject’s Diary – Safety Population

  No Treatment at Baseline (N = 49)
Number of Days
Location/ Adverse Event Any1
n (%)
1
n (%)
2-7
n (%)
8-13
n (%)
14
n (%)
Right and Left Midface Combined
  Pain (Including Burning) 1 (2%) 1 (100%) 0 0 0
  Tenderness 0 0 0 0 0
  Redness 0 0 0 0 0
  Bruising 0 0 0 0 0
  Swelling 0 0 0 0 0
  Itching 1 (2%) 0 1 (100%) 0 0
  First Treatment with Restylane® Lyft with Lidocaine (N = 199)
  Number of Days
Location/ Adverse Event Any1
n (%)
1
n (%)
2-7
n (%)
8-13
n (%)
14
n (%)
  Pain (Including Burning) 157(79%) 34 (22%) 109 (69%) 12 (8%) 2 (1%)
  Tenderness 189(95%) 17 (9%) 112 (59%) 47 (25%) 13 (7%)
  Redness 155(78%) 39 (25%) 96 (62%) 18 (12%) 2 (1%)
  Bruising 163(82%) 10 (6%) 66 (40%) 70 (43%) 17 (10%)
  Swelling 179(90%) 14 (8%) 132 (74%) 26 (15%) 7 (4%)
  Itching 67(34%) 16 (24%) 42 (63%) 9 (13%) 0
  Second Treatment with Restylane® Lyft with Lidocaine (N=128)
  Number of Days
Location/ Adverse Event Any1
n (%)
1
n (%)
2-7
n (%)
8-13
n (%)
14
n (%)
  Pain (Including Burning) 99 (77%) 17 (17%) 70 (71%) 10 (10%) 2 (2%)
  Tenderness 117 (91%) 9 (8%) 71 (61%) 29 (25%) 8 (7%)
  Redness 100 (78%) 19 (19%) 67 (67%) 11 (11%) 3 (3%)
  Bruising 99 (77%) 5 (5%) 46 (46%) 35 (35%) 13 (13%)
  Swelling 109 (85%) 15 (14%) 72 (66%) 20 (18%) 2 (2%)
  Itching 35 (27%) 9 (26%) 19 (54%) 5 (14%) 2 (6%)
1 Percentages are based on the number of subjects in the Safety population.
Note: Percentages for duration categories are based on the number of subjects reporting the symptom (“Any”) for the specified location, unless otherwise noted.
Note: Second Treatment with Restylane® Lyft with Lidocaine column only includes diary summaries from subjects who actually received a second treatment at Month 12.
* Selected Adverse Events are those that were pre-listed in the diary (bruising, redness, swelling, pain, tenderness, itching) and required a recording of “none” or the presence and extent. These diary recordings were handled separately from adverse events that were elicited from an interview about any medical occurrence that meets the definition of Adverse Event.

Midface safety assessments, such as firmness, symmetry, function (movement), mass formation and sensation were evaluated at the screening visit, optional touch up visit, 2 week follow up visit, 4 week follow up visit, 2, 4, 6, 8 and 10 month follow up visits, and the 12 month follow up visit. In addition, midface safety assessments, such as firmness, symmetry, function, mass formation and sensation were evaluated at the following month 12 post treatment visits: optional touch up visit, 2 week post-treatment visit, 4 week post-treatment visit, and the 12 week post- treatment visit. Device palpability was assessed at each scheduled visit listed above with the exception of the screening visit. One subject reported greater than mild for the midface safety assessments of firmness, symmetry, function, mass formation and abnormal device palpability. This subject reported a mild hematoma in the right cheek starting five days after the initial treatment that progressed to a moderate hematoma starting 26 days later and lasting 16 days. Reported treatment included antibiotics. The investigator believed that the hematoma was exacerbated by self-manipulation. There were no signs of inflammation in subjects reporting mild or moderate abnormality in the safety assessments of midface.

The physician diagnosed adverse events identified in this study are presented in Table 13. Of the 200 subjects enrolled in the study, 199 subjects received their first treatment with Restylane® Lyft with Lidocaine at either baseline/Day 0 or at Month 12, and 128 subjects received a second treatment at Month 12. Forty-nine percent (49%) of subjects receiving their first treatment reported a total of 269 TEAEs while 29% of subjects that received a second treatment reported a total of 77 TEAEs. The majority of these TEAEs were mild in intensity (212/269; 79%, and 70/77; 91%; first and second treatment respectively), and were transient in nature. The most common TEAEs occurring after initial treatment with Restylane® Lyft with Lidocaine were implant site haematoma (18%), implant site haemorrhage (5%), implant site pain (9%), implant site swelling (8%), and headache (7%). There was no increased risk with additional treatment with Restylane® Lyft with LidocaineR.

Subjects with Fitzpatrick Skin Types IV, V and VI (n=61) and had safety results similar to the general study population.

Table 13. MA-1400-05 Summary of Treatment Emergent Adverse Events Occurring in . 2% of Treated Subjects – Safety Population

  Treatment Group
No Treatment at Baseline
(N=50)
First Treatment with Restylane® Lyft with Lidocaine
(N=199)
Second Treatment with Restylane® Lyft with Lidocaine
(N=128)
Events Subjects1 Events Subjects1 Events Subjects1
Any TEAE 18 15 (30%) 269 97 (48.7%) 77 37 (28.9%)
General Disorders and Administration Site Conditions
  Implant Site Haematoma 0 0 52 36 (18%) 18 10 (8%)
  Implant Site Haemorrhage 0 0 18 10 (5%) 22 9 (7%)
  Implant Site Mass 0 0 6 5 (2.5%) 1 1 (0.8%)
  Implant Site Pain 0 0 36 17 (9%) 10 6 (5%)
  Implant Site Swelling 0 0 36 15 (8%) 6 4 (3%)
Infections and Infestations
  Nasopharyngitis 1 1 (2%) 4 4 (2%) 0 0
  Upper Respiratory Tract Infection 0 0 4 4 (2%) 0 0
Nervous System Disorders
  Headache 3 3 (6%) 14 13 (7%) 1 1 (<1%)
  Hypoaesthesia 0 0 5 4 (2%) 0 0
1 A subject with more than one treatment emergent adverse event within a system organ class and/or preferred term is only counted once.
Note: For the No Treatment at Baseline group an adverse event is considered treatment emergent if the start date is on or after the Visit 2 (Day 0) date. For the First Treatment with Restylane® Lyft with Lidocaine group an adverse event is considered treatment emergent if the start date is on or after the date of initial treatment injection and before the date of Month 12 injection. For the Second Treatment with Restylane® Lyft with Lidocaine group an adverse event is considered treatment emergent if the start date is on or after the date of the Month 12 injection.

Two subjects (1%, 2/199) reported four serious adverse events (SAEs) that were considered to be related to the device and/or the procedure. One subject reported implant site inflammation (late onset inflammatory reactions) in both cheeks at separate times. The second subject experienced implant site hematomas in the right cheek and implant site infection/abscess. Treatment of the SAEs included NSAIDs, antibiotics, incision and drainage and, hyaluronidase. All events resolved.

Approximately 3% of subjects had a delayed onset (> 21 days after treatment) of implant site erythema, implant site hematoma, implant site inflammation, implant site mass, implant site pain, implant site swelling, implant site warmth, induration, twitching or rosacea that occurred up to 138 days after treatment.

Adverse events associated with the use of the device and occurring in < 2% of subjects whether related or not related were sunken eyes, nausea, implant site infection/abscess, implant site inflammation, implant site mass, implant site warmth, implant site irritation, induration, muscle tightness, muscle twitching, pain in jaw, presyncope, 7th nerve paralysis, acne, needle track marks, rosacea, conjunctivitis, eyelid cyst, colitis ischemic, dental carries, gingival swelling, tooth ache, cyst, discomfort, injection site pain, general swelling, ulcer, acarodermatitis, bronchitis, eye infection, implant site cellulitis, influenza, oral herpes, pneumonia, soft tissue infection, arthropod sting, incision site pain, exposure to toxic agent, facial injury, ligament sprain, meniscus lesion, thermal burn, tooth fracture, type 2 diabetes, arthralgia, back pain, bursitis, myalgia, neck pain, pain in extremity, basal cell carcinoma, pancreatic carcinoma, metastatic carcinoma, carpal tunnel syndrome, abortion spontaneous, depression, prostatitis, pulmonary vascular disorder, dermatitis contact, rash, urticaria, neurectomy, and hypertension.

Post-Marketing Surveillance

The adverse events received from post-marketing surveillance for the use of Restylane® Lyft with Lidocaine when used outside the US for cheek augmentation were infrequent and included mostly reports of swelling and mass/induration. Serious adverse events which occurred ≥ 5 times were the following, in descending order of frequency: implant site swelling, implant site abscess, implant site infection, implant site erythema, implant site mass purulent discharge, implant site nodule, medical device implantation (i.e. events reported as overcorrection, overfill, skin depression, or irregular skin).

The incidence of post market events potentially related to treatment with Restylane® Lyft with Lidocaine for all indications and that occurred in greater than 5 subjects included the following, in descending order of frequency: swelling, device ineffective, accidental exposure, mass/induration, nondermatological events, erythema, pain/tenderness, infection/abscess, bruising/abscess, bruising/bleeding, papules/nodules, inflammation, neurological symptoms, medical device implantation (i.e. events reported as overcorrection, overfill, skin depression, or irregular skin), injection site reactions, hypersensitivity, pruritus, discoloration, eye disorders, ischemia/necrosis, scar/scab/skin atrophy, procedural complications, herpes, device dislocation, device misuse, and rash. Reported treatments have included systemic steroids or systemic antibiotics administered intravenously, orally or by injection. Serious adverse events have been rarely reported. The most commonly reported serious adverse events (by MedDRA Preferred Term) were hypersensitivity, and implant and/ or injection site swelling, ischemia and discoloration. Serious abscess formations have also been reported.

Vision abnormalities including blindness have been reported following injection of hyaluronic acid, with and without lidocaine, into the nose, glabella, periorbital areas, and/or cheek, with a time to onset ranging from immediate to 1 week following injection. Reported treatments include anticoagulant, epinephrine, aspirin, hyaluronidase, corticosteroid treatment, hyperbaric oxygen and surgery. Outcomes ranged from resolved to ongoing at the time of last contact. Events requiring medical intervention, and events where resolution information is not available were reported after injection of hyaluronic acid with or without lidocaine. In these cases, the product was injected into the highly vascularized areas of the glabella, nose, and periorbital area, which are outside the device indications for use (See WARNINGS).

Implant and injection site reactions, mostly non-serious events, have also been reported. These include: discoloration, bruising, swelling, mass formation, erythema, pain, scarring and ischemia. Most instances of discoloration including hyperpigmentation, sometimes described as a blue or brown color and ranging from mild to severe, have occurred within the same day as treatment but have also occurred up to 6 months post treatment. These events typically resolve within a few days but with some infrequent instances lasting up to 18 months. Implant and/or injection site bruising, swelling, erythema and pain generally occurred on the same day as treatment usually resolving within 1 to 4 weeks. Some occurrences have persisted for up to 6 months. Severity for these events is generally mild to moderate although some cases have been severe.

Adverse reactions should be reported to Galderma Laboratories, L.P. at 1-855-425-8722.

Read the entire FDA prescribing information for Restylane Lyft (Sterile Gel of Hyaluronic Acid)

Related Resources for Restylane Lyft

© Restylane Lyft Patient Information is supplied by Cerner Multum, Inc. and Restylane Lyft Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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