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EMBEDA is indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
Limitations of Use
- Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve EMBEDA for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
- EMBEDA is not indicated as an as-needed (prn) analgesic.
DOSAGE AND ADMINISTRATION
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 are only for patients in whom tolerance to an opioid of comparable potency is established. Patients considered opioid-tolerant are those taking, for one week or longer, at least 60 mg of morphine daily, at least 30 mg of oral oxycodone daily, at least 8 mg of oral hydromorphone daily, or an equianalgesic dose of another opioid.
Initiate the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience and risk factors for addiction, abuse, and misuse [see WARNINGS AND PRECAUTIONS]. Monitor patients closely for respiratory depression, especially within the first 24-72 hours of initiating therapy with EMBEDA [see WARNINGS AND PRECAUTIONS].
EMBEDA capsules must be taken whole. Crushing, chewing, or dissolving EMBEDA capsules will result in uncontrolled delivery of morphine and can lead to overdose or death [see WARNINGS AND PRECAUTIONS]. Patients who are unable to swallow EMBEDA should be instructed to sprinkle the capsule contents on applesauce and immediately swallow without chewing [see Administration of EMBEDA].
EMBEDA is administered at a frequency of either once daily (every 24 hours) or twice daily (every 12 hours).
Use of EMBEDA as the First Opioid Analgesic
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
The starting dose for patients who are not opioid tolerant is EMBEDA 20 mg/0.8 mg orally every 24 hours. Patients who are 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 oral oxycodone per day, 8 mg oral hydromorphone per day, 25 mg oral oxymorphone per day, or an equianalgesic dose of another opioid.
Use of higher starting doses in patients who are not opioid tolerant may cause fatal respiratory depression.
Conversion from Other Opioids to EMBEDA
There are no established conversion ratios from other opioids to EMBEDA defined by clinical trials. Discontinue all other around-the-clock opioid drugs when EMBEDA therapy is initiated and initiate dosing using EMBEDA 30 mg orally every 24 hours.
While there are useful tables of opioid equivalents readily available, there is substantial inter-patient variation in the relative potency of different opioid drugs and products. As such, it is safer to underestimate a patient's 24-hour oral morphine requirement and provide rescue medication (e.g., immediate-release morphine) than to overestimate and manage an adverse reaction.
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 Sulfate: 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. 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.
If the level of pain increases, attempt to identify the source of increased pain, while adjusting the EMBEDA dose to decrease the level of pain. Because steady-state plasma concentrations are approximated within 24 to 36 hours, EMBEDA dosage adjustments may be done every 1 to 2 days.
Patients who experience breakthrough pain may require a dose increase 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 dose. In patients experiencing inadequate analgesia with once daily dosing of EMBEDA, consider a twice daily regimen.
If unacceptable opioid-related adverse reactions are observed, the subsequent doses may be reduced. Adjust the dose to obtain an appropriate balance between management of pain and opioid-related adverse reactions.
Discontinuation Of EMBEDA
When a patient no longer requires therapy with EMBEDA, use a gradual downward titration of the dose every 2 to 4 days, to prevent signs and symptoms of withdrawal in the physically-dependent patient. Do not abruptly discontinue EMBEDA.
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]. 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].
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 tubes.
Dosage Forms And Strengths
EMBEDA contains creamy white to light tan spheroidal pellets, have an outer opaque capsule with colors as identified below and are available in six dosage strengths:
Each 20 mg/0.8 mg extended-release capsule contains 20 mg of morphine sulfate and 0.8 mg of naltrexone hydrochloride in a two-toned yellow opaque capsule with “EMBEDA” printed in grey ink on the darker-toned cap and a single grey band around ¾ of the circumference. The lighter-toned body has “20” reverse-printed in a grey circle.
Each 30 mg/1.2 mg extended-release capsule contains 30 mg of morphine sulfate and 1.2 mg of naltrexone hydrochloride in a two-toned blue violet opaque capsule with “EMBEDA” printed in grey ink on the darker-toned cap and a single grey band around ¾ of the circumference. The lighter-toned body has “30” reverse-printed in a grey circle.
Each 50 mg/2 mg extended-release capsule contains 50 mg of morphine sulfate and 2 mg of naltrexone hydrochloride in a two-toned blue opaque capsule with “EMBEDA” printed in grey ink on the darker-toned cap and a single grey band around ¾ of the circumference. The lighter-toned body has “50” reverse-printed in a grey circle.
Each 60 mg/2.4 mg extended-release capsule contains 60 mg of morphine sulfate and 2.4 mg of naltrexone hydrochloride in a two-toned pink opaque capsule with “EMBEDA” printed in grey ink on the darker-toned cap and a single grey band around ¾ of the circumference. The lighter-toned body has “60” reverse-printed in a grey circle.
Each 80 mg/3.2 mg extended-release capsule contains 80 mg of morphine sulfate and 3.2 mg of naltrexone hydrochloride in a two-toned light peach opaque elongated capsule with “EMBEDA” printed in grey ink on the darker-toned cap and a single grey band around ¾ of the circumference. The lighter-toned body has “80” reverse-printed in a grey circle.
Each 100 mg/4 mg extended-release capsule contains 100 mg of morphine sulfate and 4 mg of naltrexone hydrochloride in a two-toned green opaque capsule with “EMBEDA” printed in grey ink on the darker-toned cap and a single grey band around ¾ of the circumference. The lighter-toned body has “100” reverse-printed in a grey circle.
Storage And Handling
|EMBEDA 20 mg/0.8 mg||EMBEDA 30 mg/1.2 mg||EMBEDA 50 mg/2 mg||EMBEDA 60 mg/2.4 mg||EMBEDA 80 mg/3.2 mg||EMBEDA 100 mg/4 mg|
|Sequestered naltrexone hydrochloride||0.8mg||12mg||2mg||2.4mg||3.2mg||4mg|
|Extended-Release Capsule Description For all strengths, the darker-toned cap has “EMBEDA” printed in grey ink and a single grey band around % of the circumference.||Two-toned, yellow opaque hard gelatin capsule. The lighter-toned body has “20” reverse-printed in a grey circle.||Two-toned, blue violet opaque hard gelatin capsule. The lighter-toned body has “30” reverse-printed in a grey circle.||Two-toned, blue opaque hard gelatin capsule. The lighter-toned body has “50” reverse-printed in a grey circle.||Two-toned, pink opaque hard gelatin capsule. The lighter-toned body has “60” reverse-printed in a grey circle.||Two-toned, light peach opaque elongated hard gelatin capsule. The lighter-toned body has “80” reverse-printed in a grey circle.||Two-toned, green opaque hard gelatin capsule. The lighter-toned body has “100” reverse-printed in a grey circle.|
|Bottle Size||75 cc||75 cc||75 cc||75 cc||75 cc||75 cc|
|Bottle Count||30 capsules||30 capsules||30 capsules||30 capsules||30 capsules||30 capsules|
Store at 25°C (77°F); excursions permitted between 15° and 30°C (59° and 86°F). Dispense in a sealed, tamper-evident, childproof, light-resistant container.
Manufactured for: Pfizer Inc, New York, NY 10017 by: Actavis Elizabeth LLC, 200 Elmora Avenue, Elizabeth, NJ 07207. Revised April 2014
Last reviewed on RxList: 5/12/2014
This monograph has been modified to include the generic and brand name in many instances.
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