Generic name: MORPHINE SULFATE 20mg, NALTREXONE HYDROCHLORIDE 0.8mg
Dosage form: capsule, extended release
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Important Dosage and Administration Instructions
EMBEDA should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.
EMBEDA 100 mg/4 mg capsules, a single dose greater than 60 mg/2.4 mg, or a total daily dose greater than 120 mg/5 mg, are only for use in patients in whom tolerance to an opioid of comparable potency is established. Patients considered opioid-tolerant are those receiving, for one week or longer, at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl per hour, 30 mg of oral oxycodone per day, 8 mg of oral hydromorphone per day, 25 mg oral oxymorphone per day, 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid.
- Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions (5.1)].
- Initiate the dosing regimen for each patient individually; taking into account the patient's severity of pain, patient response, prior analgesic treatment experience, and risk factors for addiction, abuse, and misuse [see Warnings and Precautions (5.1)].
- Monitor patients closely for respiratory depression, especially within the first 24–72 hours of initiating therapy and following dosage increases with EMBEDA and adjust the dosage accordingly [see Warnings and Precautions (5.2)].
Instruct patients to swallow EMBEDA capsules whole [see Patient Counseling Information (17)]. Crushing, chewing, or dissolving EMBEDA capsules will result in uncontrolled delivery of morphine and can lead to overdose or death [see Warnings and Precautions (5.1)].
Instruct patients who are unable to swallow EMBEDA to sprinkle the capsule contents on applesauce and immediately swallow without chewing [see Dosage and Administration (2.6)].
EMBEDA is administered orally at a frequency of either once daily (every 24 hours) or twice daily (every 12 hours).
Use of EMBEDA as the First Opioid Analgesic (opioid naive patients)
Initiate treatment with EMBEDA with 20 mg/0.8 mg capsule orally every 24 hours.
Use of EMBEDA in Patients who are not Opioid Tolerant (opioid-non-tolerant patients)
The starting dose for patients who are not opioid tolerant is EMBEDA 20 mg/0.8 mg orally every 24 hours.
Use of higher starting doses in patients who are not opioid tolerant may cause fatal respiratory depression [see Warnings and Precautions (5.2)].
Conversion from Other Opioids to EMBEDA
Discontinue all other around-the-clock opioid drugs when EMBEDA therapy is initiated.
There are no established conversion ratios from other opioids to EMBEDA defined by clinical trials. Initiate dosing using EMBEDA 30 mg orally every 24 hours.
It is safer to underestimate a patient's 24-hour oral morphine dosage and provide rescue medication (e.g., immediate-release morphine) than to overestimate the 24-hour morphine dosage and manage an adverse reaction due to an overdose. While there are useful tables of opioid equivalents readily available, there is inter-patient variability in the relative potency of opioid drugs and opioid formulations.
Close observation and frequent titration are warranted until pain management is stable on the new opioid. Monitor patients for signs and symptoms of opioid withdrawal and for signs of over sedation/toxicity after converting patients to EMBEDA.
Conversion from Other Oral Morphine Formulations to EMBEDA
Patients receiving other oral morphine formulations may be converted to EMBEDA by administering one-half of the patient's total daily oral morphine dose as EMBEDA twice daily, or by administering the total daily oral morphine dose as EMBEDA once daily. There are no data to support the efficacy or safety of prescribing EMBEDA more frequently than every 12 hours.
Conversion from Parenteral Morphine, or Other Opioids, to EMBEDA
When converting from parenteral morphine or other non-morphine opioids (parenteral or oral) to EMBEDA, consider the following general points:
- Parenteral to Oral Morphine Ratio: Between 2 mg and 6 mg of oral morphine may be required to provide analgesia equivalent to 1 mg of parenteral morphine. Typically, a dose of oral morphine that is three times the daily parenteral morphine requirement is sufficient.
- Other Oral or Parenteral Opioids to Oral Morphine Ratios: Specific recommendations are not available because of a lack of systematic evidence for these types of analgesic substitutions. Published relative potency data are available, but such ratios are approximations. In general, begin with half of the estimated daily morphine requirement as the initial dose, managing inadequate analgesia by supplementation with immediate-release morphine.
Conversion from Methadone to EMBEDA
Close monitoring is of particular importance when converting from methadone to other opioid agonists. The ratio between methadone and other opioid agonists may vary widely as a function of previous dose exposure. Methadone has a long half-life and can accumulate in the plasma.
The first dose of EMBEDA may be taken with the last dose of any immediate-release opioid medication due to the extended-release characteristics of the EMBEDA formulation.
Titration and Maintenance of Therapy
Individually titrate EMBEDA to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving EMBEDA to assess the maintenance of pain control and the relative incidence of adverse reactions, as well as monitoring for the development of addiction, abuse, or misuse [see Warnings and Precautions (5.1)]. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration. During chronic therapy, periodically reassess the continued need for opioid analgesics.
Patients who experience breakthrough pain may require a dosage adjustment of EMBEDA, or may need rescue medication with an appropriate dose of an immediate-release analgesic. If the level of pain increases after dose stabilization, attempt to identify the source of increased pain before increasing the EMBEDA dosage. In patients experiencing inadequate analgesia with once-daily dosing of EMBEDA, consider a twice-daily regimen. Because steady-state plasma concentrations are approximated within 24 to 36 hours, EMBEDA dose may be adjusted every 1 to 2 days.
If unacceptable opioid-related adverse reactions are observed, consider reducing the dosage. Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions.
Dosage Modifications with Concomitant Use of Central Nervous System Depressants
If the patient is currently taking a central nervous system (CNS) depressant and the decision is made to begin EMBEDA, start with 1/3 to 1/2 the recommended starting dosage of EMBEDA, monitor patients for signs of respiratory depression, sedation, and hypotension, and consider using a lower dosage of the concomitant CNS depressant [see Warnings and Precautions (5.4), Drug Interactions (7)].
Discontinuation of EMBEDA
When a patient no longer requires therapy with EMBEDA, taper the dose gradually, by 25% to 50% every 2 to 4 days, while monitoring carefully for signs and symptoms of withdrawal. If the patient develops these signs or symptoms, raise the dose to the previous level and taper more slowly, either by increasing the interval between decreases, decreasing the amount of change in dose, or both. Do not abruptly discontinue EMBEDA [see Warnings and Precautions (5.12), Drug Abuse and Dependence (9.3)].
Administration of EMBEDA
Instruct patients to swallow EMBEDA capsules intact. The capsules contain pellets that consist of morphine and sequestered naltrexone. The pellets in the capsules are not to be crushed, dissolved, or chewed due to the risk of rapid release and absorption of a potentially fatal dose of morphine [see Warnings and Precautions (5.2)]. Consuming EMBEDA capsules that have been altered by crushing, chewing, or dissolving the pellets can release sufficient naltrexone to precipitate withdrawal in opioid-dependent individuals [see Warnings and Precautions (5.12)].
Alternatively, the contents of the EMBEDA capsules (pellets) may be sprinkled over applesauce and then swallowed. This method is appropriate only for patients able to reliably swallow the applesauce without chewing. Other foods have not been tested and should not be substituted for applesauce. Instruct the patient to:
- Sprinkle the pellets onto a small amount of applesauce and consume immediately without chewing.
- Rinse the mouth to ensure all pellets have been swallowed.
- Discard any unused portion of the EMBEDA capsules after the contents have been sprinkled on applesauce.
Do not administer EMBEDA pellets through a nasogastric or gastric tube.
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