Safety Information

Contraindications

EMBEDA is contraindicated in patients with1:

  • Significant respiratory depression
  • Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment
  • Known or suspected paralytic ileus
  • Hypersensitivity (eg, anaphylaxis) to morphine or naltrexone
REFERENCE

1. Embeda [prescribing information]. New York, NY: Pfizer Inc; December 2016.

Adverse Reactions

The following serious adverse reactions are discussed in the Full Prescribing Information and Important Safety Information1:

  • Addiction, Abuse, and Misuse
  • Life-threatening Respiratory Depression
  • Neonatal Opioid Withdrawal Syndrome
  • Interactions With Benzodiazepines or Other CNS Depressants
  • Adrenal Insufficiency
  • Severe Hypotension
  • Gastrointestinal Adverse Reactions
  • Seizures
  • Withdrawal

Most common (≥10%) adverse reactions in clinical studies were constipation, nausea, and somnolence.1

REFERENCE

1. Embeda [prescribing information]. New York, NY: Pfizer Inc; December 2016.

Comprehensive Adverse Reactions

Adverse reactions from the pivotal trial in patients taking EMBEDA

Adverse reactions reported in ≥ 2% of subjects in the 12-week, randomized efficacy study1

ADVERSE
REACTION
TITRATION
EMBEDA (n=547)
MAINTENANCE
EMBEDA (n=171)
MAINTENANCE
PLACEBO (n=173)
CONSTIPATION 30% 7% 4%
NAUSEA 19% 11% 6%
SOMNOLENCE 14% 1% 3%
VOMITING 8% 4% 1%
DIZZINESS 8% 1% 1%
PRURITUS 6% 0% 1%
DRY MOUTH 6% 2% 1%
HEADACHE 4% 2% 1%
FATIGUE 3% 1% 1%
INSOMNIA 1% 3% 2%
DIARRHEA 1% 7% 7%
ABDOMINAL
PAIN
(UPPER)
1% 2% 2%
FLUSHING 0% 2% 1%
  • Patients (N=547) with moderate to severe pain due to OA of the hip or knee were titrated to effect on open-label EMBEDA.1
  • The primary efficacy measure was mean change in Brief Pain Inventory (BPI) diary average pain scored (0-10 scale) from baseline (at randomization) to the last 7 days of the maintenance period.1
  • Responders (n=344) were randomized to 12 weeks of maintenance with EMBEDA (n=171) or were tapered to placebo over 2 weeks followed by placebo for an additional 10 weeks (n=173).1,2

In a long-term open-label safety study

Adverse reactions reported in ≥ 2% of subjects1

ADVERSE
REACTION
EMBEDA (N=465)
CONSTIPATION 31%
NAUSEA 22%
VOMITING 8%
SOMNOLENCE 7%
HEADACHE 7%
PRURITUS 6%
FATIGUE 4%
DIZZINESS 4%
DRY MOUTH 4%
HYPERHIDROSIS 3%
INSOMNIA 3%
DIARRHEA 2%
ANXIETY 2%
  • The distribution of adverse reactions was similar to that seen in the randomized controlled studies and was consistent with the most common opioid-related adverse reactions.1
  • 465 patients with chronic nonmalignant pain were enrolled and 124 patients were treated for up to 1 year.1
  • Adverse reactions observed in the phase 2/3 studies.1
    • The most common (≥10%) adverse reactions were constipation, nausea, and somnolence.1
REFERENCES

1. Embeda [prescribing information]. New York, NY: Pfizer Inc; December 2016. 2. Katz N, Hale M, Morris D, Stauffer J. Morphine sulfate and naltrexone hydrochloride extended release capsules in patients with chronic osteoarthritis pain. Postgrad Med. 2010;122(4):112-128.