PRISTIQ® Adverse Reactions

(desvenlafaxine succinate)

6 ADVERSE REACTIONS

The following adverse reactions are discussed in greater detail in other sections of the label.

•
Hypersensitivity [see Contraindications (4)]
•
Suicidal Thoughts and Behaviors in Pediatric and Young Adult Patients [see Warnings and Precautions (5.1)]
•
Serotonin Syndrome [see Warnings and Precautions (5.2)]
•
Elevated Blood Pressure [see Warnings and Precautions (5.3)]
•
Increased Risk of Bleeding [see Warnings and Precautions (5.4)]
•
Angle Closure Glaucoma [see Warnings and Precautions (5.5)]
•
Activation of Mania/Hypomania [see Warnings and Precautions (5.6)]
•
Discontinuation Syndrome [see Warnings and Precautions (5.7)]
•
Seizure [see Warnings and Precautions (5.8)]
•
Hyponatremia [see Warnings and Precautions (5.9)]
•
Interstitial Lung Disease and Eosinophilic Pneumonia [see Warnings and Precautions (5.10)]
•
Sexual Dysfunction [see Warnings and Precautions (5.11)]

6.1 Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice.

Patient Exposure

PRISTIQ was evaluated for safety in 8,394 patients diagnosed with major depressive disorder who participated in multiple-dose pre-marketing studies, representing 2,784 patient-years of exposure. Of the total 8,394 patients exposed to at least one dose of PRISTIQ; 2,116 were exposed to PRISTIQ for 6 months, representing 1,658 patient-years of exposure, and 421 were exposed for one year, representing 416 patient-years of exposure.

Adverse Reactions Reported as Reasons for Discontinuation of Treatment

In the pre-marketing pooled 8-week placebo-controlled studies in patients with MDD, 1,834 patients were exposed to PRISTIQ (50 to 400 mg). Of the 1,834 patients, 12% discontinued treatment due to an adverse reaction, compared with 3% of the 1,116 placebo-treated patients. At the recommended dose of 50 mg, the discontinuation rate due to an adverse reaction for PRISTIQ (4.1%) was similar to the rate for placebo (3.8%). For the 100 mg dose of PRISTIQ the discontinuation rate due to an adverse reaction was 8.7%.

The most common adverse reactions leading to discontinuation in at least 2% and at a rate greater than placebo of the PRISTIQ treated patients in the short-term studies, up to 8 weeks, were: nausea (4%); dizziness, headache and vomiting (2% each). In a longer-term study, up to 9 months, the most common was vomiting (2%).

Common Adverse Reactions in Placebo-Controlled MDD Studies

The most commonly observed adverse reactions in PRISTIQ treated MDD patients in pre-marketing pooled 8-week, placebo-controlled, fixed-dose studies (incidence ≥ 5% and at least twice the rate of placebo in the 50 or 100 mg dose groups) were: nausea, dizziness, insomnia, hyperhidrosis, constipation, somnolence, decreased appetite, anxiety, and specific male sexual function disorders.

Table 2 shows the incidence of common adverse reactions that occurred in ≥ 2% of PRISTIQ treated MDD patients and twice the rate of placebo at any dose in the pre-marketing pooled 8-week, placebo-controlled, fixed dose clinical studies.

Table 2: Common Adverse Reactions (≥ 2% in any Fixed-Dose Group and Twice the Rate of Placebo) in Pre-marketing Pooled MDD 8-Week Placebo-Controlled Studies
Percentage of Patients Reporting Reaction
PRISTIQ
System Organ Class
Preferred Term		Placebo
(n=636)		50 mg
(n=317)		100 mg
(n=424)		200 mg
(n=307)		400 mg
(n=317)

Cardiac disorders

  Blood pressure increased

1

1

1

2

2

Gastrointestinal disorders

  Nausea

10

22

26

36

41

  Dry mouth

9

11

17

21

25

  Constipation

4

9

9

10

14

  Vomiting

3

3

4

6

9

General disorders and administration site conditions

  Fatigue

4

7

7

10

11

  Chills

1

1

<1

3

4

  Feeling jittery

1

1

2

3

3

Metabolism and nutrition disorders

  Decreased appetite

2

5

8

10

10

Nervous system disorders

  Dizziness

5

13

10

15

16

  Somnolence

4

4

9

12

12

  Tremor

2

2

3

9

9

  Disturbance in attention

<1

<1

1

2

1

Psychiatric disorders

  Insomnia

6

9

12

14

15

  Anxiety

2

3

5

4

4

  Nervousness

1

<1

1

2

2

  Abnormal dreams

1

2

3

2

4

Renal and urinary disorders

  Urinary hesitation

0

<1

1

2

2

Respiratory, thoracic and mediastinal disorders

  Yawning

<1

1

1

4

3

Skin and subcutaneous tissue disorders

  Hyperhidrosis

4

10

11

18

21

Special Senses

  Vision blurred

1

3

4

4

4

  Mydriasis

<1

2

2

6

6

  Vertigo

1

2

1

5

3

  Tinnitus

1

2

1

1

2

  Dysgeusia

1

1

1

1

2

Vascular disorders

  Hot flush

<1

1

1

2

2

Sexual Function Adverse Reactions

Table 3 shows the incidence of sexual function adverse reactions that occurred in ≥ 2% of PRISTIQ treated MDD patients in any fixed-dose group (pre-marketing pooled 8-week, placebo-controlled, fixed -dose, clinical studies) [see Warnings and Precautions (5.11)].

Table 3: Sexual Function Adverse Reactions (≥ 2% in Men or Women in any PRISTIQ Group) During the On-Therapy Period

PRISTIQ

Placebo
(n=239)

50 mg
(n=108)

100 mg
(n=157)

200 mg
(n=131)

400 mg
(n=154)

Men only

  Anorgasmia

0

0

3

5

8

  Libido decreased

1

4

5

6

3

  Orgasm abnormal

0

0

1

2

3

  Ejaculation delayed

<1

1

5

7

6

  Erectile dysfunction

1

3

6

8

11

  Ejaculation disorder

0

0

1

2

5

  Ejaculation failure

0

1

0

2

2

  Sexual dysfunction

0

1

0

0

2

PRISTIQ

Placebo
(n=397)

50 mg
(n=209)

100 mg
(n=267)

200 mg
(n=176)

400 mg
(n=163)

  Women only

  Anorgasmia

0

1

1

0

3

Other Adverse Reactions Observed in Premarketing and Postmarketing Clinical Studies

Other infrequent adverse reactions, not described elsewhere in the label, occurring at an incidence of < 2% in MDD patients treated with PRISTIQ were:

Cardiac disorders – Tachycardia.

General disorders and administration site conditions – Asthenia.

Investigations – Weight increased, liver function test abnormal, blood prolactin increased.

Musculoskeletal and connective tissue disorders – Musculoskeletal stiffness.

Nervous system disorders –Syncope, convulsion, dystonia.

Psychiatric disorders – Depersonalization, bruxism.

Renal and urinary disorders – Urinary retention.

Skin and subcutaneous tissue disorders – Rash, alopecia, photosensitivity reaction, angioedema.

In clinical studies, there were uncommon reports of ischemic cardiac adverse reactions, including myocardial ischemia, myocardial infarction, and coronary occlusion requiring revascularization; these patients had multiple underlying cardiac risk factors. More patients experienced these events during PRISTIQ treatment as compared to placebo.

Laboratory, ECG and Vital Sign Changes Observed in MDD Clinical Studies

The following changes were observed in pre-marketing placebo-controlled, short-term MDD studies with PRISTIQ.

Lipids

Elevations in fasting serum total cholesterol, LDL (low density lipoproteins) cholesterol, and triglycerides occurred in the controlled studies. Some of these abnormalities were considered potentially clinically significant.

The percentage of patients who exceeded a predetermined threshold value is shown in Table 4.

Table 4: Incidence (%) of Patients With Lipid Abnormalities of Potential Clinical Significance*
PRISTIQ
Placebo50 mg100 mg200 mg400 mg

Total Cholesterol
*(Increase of ≥ 50 mg/dl and an absolute value of ≥ 261 mg/dl)

2

3

4

4

10

LDL Cholesterol
*(Increase ≥ 50 mg/dl and an absolute value of ≥ 190 mg/dl)

0

1

0

1

2

Triglycerides, fasting
*(Fasting: ≥ 327 mg/dl)

3

2

1

4

6

Proteinuria

Proteinuria, greater than or equal to trace, was observed in the pre-marketing fixed-dose controlled studies (see Table 5). This proteinuria was not associated with increases in BUN or creatinine and was generally transient.

Table 5: Incidence (%) of Patients with Proteinuria in the Fixed-dose Clinical Studies
PRISTIQ
Placebo50 mg100 mg200 mg400 mg

Proteinuria

4

6

8

5

7

Vital Sign Changes

Table 6 summarizes the changes that were observed in placebo-controlled, short-term, pre-marketing studies with PRISTIQ in patients with MDD (doses 50 to 400 mg).

Table 6: Mean Changes in Vital Signs at Final on Therapy for All Short-term, Fixed-dose Controlled Studies
PRISTIQ
Placebo50 mg100 mg200 mg400 mg

Blood pressure

Supine systolic bp (mm Hg)

-1.4

1.2

2.0

2.5

2.1

Supine diastolic bp (mm Hg)

-0.6

0.7

0.8

1.8

2.3

Pulse rate

Supine pulse (bpm)

-0.3

1.3

1.3

0.9

4.1

Weight (kg)

0.0

-0.4

-0.6

-0.9

-1.1

Treatment with PRISTIQ at all doses from 50 mg per day to 400 mg per day in controlled studies was associated with sustained hypertension, defined as treatment-emergent supine diastolic blood pressure (SDBP) ≥90 mm Hg and ≥10 mm Hg above baseline for 3 consecutive on-therapy visits (see Table 7). Analyses of patients in PRISTIQ pre-marketing short-term controlled studies who met criteria for sustained hypertension revealed a consistent increase in the proportion of patients who developed sustained hypertension. This was seen at all doses with a suggestion of a higher rate at 400 mg per day.

Table 7: Proportion of Patients with Sustained Elevation of Supine Diastolic Blood Pressure
Treatment GroupProportion of Patients with Sustained Hypertension

Placebo

0.5%

PRISTIQ 50 mg per day

1.3%

PRISTIQ 100 mg per day

0.7%

PRISTIQ 200 mg per day

1.1%

PRISTIQ 400 mg per day

2.3%

Orthostatic Hypotension

In the pre-marketing short-term, placebo-controlled clinical studies with doses of 50 to 400 mg, systolic orthostatic hypotension (decrease ≥30 mm Hg from supine to standing position) occurred more frequently in patients ≥65 years of age receiving PRISTIQ (8%, 7/87) versus placebo (2.5%, 1/40), compared to patients <65 years of age receiving PRISTIQ (0.9%, 18/1,937) versus placebo (0.7%, 8/1,218).

6.2 Postmarketing Experience

The following adverse reaction has been identified during post-approval use of PRISTIQ. 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:

Skin and subcutaneous tissue disorders – Stevens-Johnson syndrome

Gastrointestinal disorders – Pancreatitis acute

Cardiovascular system – Takotsubo cardiomyopathy

Respiratory, thoracic and mediastinal disorders - Anosmia, hyposmia

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Adverse Reactions

6 ADVERSE REACTIONS

The following adverse reactions are discussed in greater detail in other sections of the label.

•
Hypersensitivity [see Contraindications (4)]
•
Suicidal Thoughts and Behaviors in Pediatric and Young Adult Patients [see Warnings and Precautions (5.1)]
•
Serotonin Syndrome [see Warnings and Precautions (5.2)]
•
Elevated Blood Pressure [see Warnings and Precautions (5.3)]
•
Increased Risk of Bleeding [see Warnings and Precautions (5.4)]
•
Angle Closure Glaucoma [see Warnings and Precautions (5.5)]
•
Activation of Mania/Hypomania [see Warnings and Precautions (5.6)]
•
Discontinuation Syndrome [see Warnings and Precautions (5.7)]
•
Seizure [see Warnings and Precautions (5.8)]
•
Hyponatremia [see Warnings and Precautions (5.9)]
•
Interstitial Lung Disease and Eosinophilic Pneumonia [see Warnings and Precautions (5.10)]
•
Sexual Dysfunction [see Warnings and Precautions (5.11)]

6.1 Clinical Studies Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice.

Patient Exposure

PRISTIQ was evaluated for safety in 8,394 patients diagnosed with major depressive disorder who participated in multiple-dose pre-marketing studies, representing 2,784 patient-years of exposure. Of the total 8,394 patients exposed to at least one dose of PRISTIQ; 2,116 were exposed to PRISTIQ for 6 months, representing 1,658 patient-years of exposure, and 421 were exposed for one year, representing 416 patient-years of exposure.

Adverse Reactions Reported as Reasons for Discontinuation of Treatment

In the pre-marketing pooled 8-week placebo-controlled studies in patients with MDD, 1,834 patients were exposed to PRISTIQ (50 to 400 mg). Of the 1,834 patients, 12% discontinued treatment due to an adverse reaction, compared with 3% of the 1,116 placebo-treated patients. At the recommended dose of 50 mg, the discontinuation rate due to an adverse reaction for PRISTIQ (4.1%) was similar to the rate for placebo (3.8%). For the 100 mg dose of PRISTIQ the discontinuation rate due to an adverse reaction was 8.7%.

The most common adverse reactions leading to discontinuation in at least 2% and at a rate greater than placebo of the PRISTIQ treated patients in the short-term studies, up to 8 weeks, were: nausea (4%); dizziness, headache and vomiting (2% each). In a longer-term study, up to 9 months, the most common was vomiting (2%).

Common Adverse Reactions in Placebo-Controlled MDD Studies

The most commonly observed adverse reactions in PRISTIQ treated MDD patients in pre-marketing pooled 8-week, placebo-controlled, fixed-dose studies (incidence ≥ 5% and at least twice the rate of placebo in the 50 or 100 mg dose groups) were: nausea, dizziness, insomnia, hyperhidrosis, constipation, somnolence, decreased appetite, anxiety, and specific male sexual function disorders.

Table 2 shows the incidence of common adverse reactions that occurred in ≥ 2% of PRISTIQ treated MDD patients and twice the rate of placebo at any dose in the pre-marketing pooled 8-week, placebo-controlled, fixed dose clinical studies.

Table 2: Common Adverse Reactions (≥ 2% in any Fixed-Dose Group and Twice the Rate of Placebo) in Pre-marketing Pooled MDD 8-Week Placebo-Controlled Studies
Percentage of Patients Reporting Reaction
PRISTIQ
System Organ Class
Preferred Term		Placebo
(n=636)		50 mg
(n=317)		100 mg
(n=424)		200 mg
(n=307)		400 mg
(n=317)

Cardiac disorders

  Blood pressure increased

1

1

1

2

2

Gastrointestinal disorders

  Nausea

10

22

26

36

41

  Dry mouth

9

11

17

21

25

  Constipation

4

9

9

10

14

  Vomiting

3

3

4

6

9

General disorders and administration site conditions

  Fatigue

4

7

7

10

11

  Chills

1

1

<1

3

4

  Feeling jittery

1

1

2

3

3

Metabolism and nutrition disorders

  Decreased appetite

2

5

8

10

10

Nervous system disorders

  Dizziness

5

13

10

15

16

  Somnolence

4

4

9

12

12

  Tremor

2

2

3

9

9

  Disturbance in attention

<1

<1

1

2

1

Psychiatric disorders

  Insomnia

6

9

12

14

15

  Anxiety

2

3

5

4

4

  Nervousness

1

<1

1

2

2

  Abnormal dreams

1

2

3

2

4

Renal and urinary disorders

  Urinary hesitation

0

<1

1

2

2

Respiratory, thoracic and mediastinal disorders

  Yawning

<1

1

1

4

3

Skin and subcutaneous tissue disorders

  Hyperhidrosis

4

10

11

18

21

Special Senses

  Vision blurred

1

3

4

4

4

  Mydriasis

<1

2

2

6

6

  Vertigo

1

2

1

5

3

  Tinnitus

1

2

1

1

2

  Dysgeusia

1

1

1

1

2

Vascular disorders

  Hot flush

<1

1

1

2

2

Sexual Function Adverse Reactions

Table 3 shows the incidence of sexual function adverse reactions that occurred in ≥ 2% of PRISTIQ treated MDD patients in any fixed-dose group (pre-marketing pooled 8-week, placebo-controlled, fixed -dose, clinical studies) [see Warnings and Precautions (5.11)].

Table 3: Sexual Function Adverse Reactions (≥ 2% in Men or Women in any PRISTIQ Group) During the On-Therapy Period

PRISTIQ

Placebo
(n=239)

50 mg
(n=108)

100 mg
(n=157)

200 mg
(n=131)

400 mg
(n=154)

Men only

  Anorgasmia

0

0

3

5

8

  Libido decreased

1

4

5

6

3

  Orgasm abnormal

0

0

1

2

3

  Ejaculation delayed

<1

1

5

7

6

  Erectile dysfunction

1

3

6

8

11

  Ejaculation disorder

0

0

1

2

5

  Ejaculation failure

0

1

0

2

2

  Sexual dysfunction

0

1

0

0

2

PRISTIQ

Placebo
(n=397)

50 mg
(n=209)

100 mg
(n=267)

200 mg
(n=176)

400 mg
(n=163)

  Women only

  Anorgasmia

0

1

1

0

3

Other Adverse Reactions Observed in Premarketing and Postmarketing Clinical Studies

Other infrequent adverse reactions, not described elsewhere in the label, occurring at an incidence of < 2% in MDD patients treated with PRISTIQ were:

Cardiac disorders – Tachycardia.

General disorders and administration site conditions – Asthenia.

Investigations – Weight increased, liver function test abnormal, blood prolactin increased.

Musculoskeletal and connective tissue disorders – Musculoskeletal stiffness.

Nervous system disorders –Syncope, convulsion, dystonia.

Psychiatric disorders – Depersonalization, bruxism.

Renal and urinary disorders – Urinary retention.

Skin and subcutaneous tissue disorders – Rash, alopecia, photosensitivity reaction, angioedema.

In clinical studies, there were uncommon reports of ischemic cardiac adverse reactions, including myocardial ischemia, myocardial infarction, and coronary occlusion requiring revascularization; these patients had multiple underlying cardiac risk factors. More patients experienced these events during PRISTIQ treatment as compared to placebo.

Laboratory, ECG and Vital Sign Changes Observed in MDD Clinical Studies

The following changes were observed in pre-marketing placebo-controlled, short-term MDD studies with PRISTIQ.

Lipids

Elevations in fasting serum total cholesterol, LDL (low density lipoproteins) cholesterol, and triglycerides occurred in the controlled studies. Some of these abnormalities were considered potentially clinically significant.

The percentage of patients who exceeded a predetermined threshold value is shown in Table 4.

Table 4: Incidence (%) of Patients With Lipid Abnormalities of Potential Clinical Significance*
PRISTIQ
Placebo50 mg100 mg200 mg400 mg

Total Cholesterol
*(Increase of ≥ 50 mg/dl and an absolute value of ≥ 261 mg/dl)

2

3

4

4

10

LDL Cholesterol
*(Increase ≥ 50 mg/dl and an absolute value of ≥ 190 mg/dl)

0

1

0

1

2

Triglycerides, fasting
*(Fasting: ≥ 327 mg/dl)

3

2

1

4

6

Proteinuria

Proteinuria, greater than or equal to trace, was observed in the pre-marketing fixed-dose controlled studies (see Table 5). This proteinuria was not associated with increases in BUN or creatinine and was generally transient.

Table 5: Incidence (%) of Patients with Proteinuria in the Fixed-dose Clinical Studies
PRISTIQ
Placebo50 mg100 mg200 mg400 mg

Proteinuria

4

6

8

5

7

Vital Sign Changes

Table 6 summarizes the changes that were observed in placebo-controlled, short-term, pre-marketing studies with PRISTIQ in patients with MDD (doses 50 to 400 mg).

Table 6: Mean Changes in Vital Signs at Final on Therapy for All Short-term, Fixed-dose Controlled Studies
PRISTIQ
Placebo50 mg100 mg200 mg400 mg

Blood pressure

Supine systolic bp (mm Hg)

-1.4

1.2

2.0

2.5

2.1

Supine diastolic bp (mm Hg)

-0.6

0.7

0.8

1.8

2.3

Pulse rate

Supine pulse (bpm)

-0.3

1.3

1.3

0.9

4.1

Weight (kg)

0.0

-0.4

-0.6

-0.9

-1.1

Treatment with PRISTIQ at all doses from 50 mg per day to 400 mg per day in controlled studies was associated with sustained hypertension, defined as treatment-emergent supine diastolic blood pressure (SDBP) ≥90 mm Hg and ≥10 mm Hg above baseline for 3 consecutive on-therapy visits (see Table 7). Analyses of patients in PRISTIQ pre-marketing short-term controlled studies who met criteria for sustained hypertension revealed a consistent increase in the proportion of patients who developed sustained hypertension. This was seen at all doses with a suggestion of a higher rate at 400 mg per day.

Table 7: Proportion of Patients with Sustained Elevation of Supine Diastolic Blood Pressure
Treatment GroupProportion of Patients with Sustained Hypertension

Placebo

0.5%

PRISTIQ 50 mg per day

1.3%

PRISTIQ 100 mg per day

0.7%

PRISTIQ 200 mg per day

1.1%

PRISTIQ 400 mg per day

2.3%

Orthostatic Hypotension

In the pre-marketing short-term, placebo-controlled clinical studies with doses of 50 to 400 mg, systolic orthostatic hypotension (decrease ≥30 mm Hg from supine to standing position) occurred more frequently in patients ≥65 years of age receiving PRISTIQ (8%, 7/87) versus placebo (2.5%, 1/40), compared to patients <65 years of age receiving PRISTIQ (0.9%, 18/1,937) versus placebo (0.7%, 8/1,218).

6.2 Postmarketing Experience

The following adverse reaction has been identified during post-approval use of PRISTIQ. 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:

Skin and subcutaneous tissue disorders – Stevens-Johnson syndrome

Gastrointestinal disorders – Pancreatitis acute

Cardiovascular system – Takotsubo cardiomyopathy

Respiratory, thoracic and mediastinal disorders - Anosmia, hyposmia
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