"The U.S. Food and Drug Administration today approved Hysingla ER (hydrocodone bitartrate), an extended-release (ER) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternat"...
AVINZA 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 AVINZA 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.
- AVINZA is not indicated as an as-needed (prn) analgesic.
DOSAGE AND ADMINISTRATION
AVINZA should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.
AVINZA 90 mg and 120 mg capsules are for use only in patients in whom tolerance to an opioid of comparable potency has been established. 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.
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 AVINZA [see WARNINGS AND PRECAUTIONS].
AVINZA capsules must be taken whole. Crushing, chewing, or dissolving the pellets in AVINZA 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 AVINZA should be instructed to sprinkle the capsule contents on applesauce and immediately swallow without chewing [see Administration of AVINZA].
AVINZA is administered at a frequency of once daily (every 24 hours).
Use of AVINZA as the First Opioid Analgesic
Initiate treatment with AVINZA with 30 mg capsule orally every 24 hours. Adjust the dose of AVINZA in increments not greater than 30 mg every 3 to 4 days.
Use of AVINZA in Patients who are not Opioid Tolerant
The starting dose for patients who are not opioid tolerant is AVINZA 30 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 AVINZA
There are no established conversion ratios from other opioids to AVINZA defined by clinical trials. Discontinue all other around-the-clock opioid drugs when AVINZA therapy is initiated and initiate dosing using AVINZA 30 mg orally every 24 hours.
While there are useful tables of opioid equivalents readily available, there is substantial inter-patient variability in the relative potency of different opioid drugs and products. As such, it is safer to underestimate a patient's 24-hour oral morphine requirements and provide rescue medication (e.g., immediate-release morphine) than to overestimate the 24-hour oral morphine requirements which could result in adverse reactions.
Conversion from Other Oral Morphine Formulations to AVINZA
Patients receiving other oral morphine formulations may be converted to AVINZA by administering the patient's total daily oral morphine dose as AVINZA once-daily. AVINZA should not be given more frequently than every 24 hours.
Conversion from Parenteral Morphine or Other Non-Morphine Opioids (Parenteral or Oral) to AVINZA
When converting from parenteral morphine or other non-morphine opioids (parenteral or oral) to AVINZA, consider the following general points:
Parenteral to oral morphine ratio: Between 2 to 6 mg of oral morphine may be required to provide analgesia equivalent to 1 mg of parenteral morphine. Typically, a dose of morphine that is approximately three times the previous daily parenteral morphine requirement is sufficient.
Other parenteral or oral non-morphine 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 AVINZA
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 AVINZA may be taken with the last dose of any immediate-release opioid medication due to the extended-release characteristics of the AVINZA formulation.
Titration And Maintenance Of Therapy
Individually titrate AVINZA to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving AVINZA 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 AVINZA dose to decrease the level of pain. Because steady-state plasma concentrations are approximated within 2 to 3 days, AVINZA dosage adjustments may be done every 3 to 4 days.
Patients who experience breakthrough pain may require a dose increase of AVINZA, 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 AVINZA dose.
The daily dose of AVINZA must be limited to a maximum of 1600 mg/day. AVINZA doses of over 1600 mg/day contain a quantity of fumaric acid that has not been demonstrated to be safe, and which may result in serious renal toxicity.
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 AVINZA
When a patient no longer requires therapy with AVINZA, 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 AVINZA.
Administration Of AVINZA
AVINZA capsules must be taken whole. Crushing, chewing, or dissolving the pellets in AVINZA will result in uncontrolled delivery of morphine and can lead to overdose or death [see WARNINGS AND PRECAUTIONS].
Alternatively, the contents of the AVINZA 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 AVINZA capsules after the contents have been sprinkled on applesauce.
Do not administer AVINZA pellets through a nasogastric or gastric tubes.
Dosage Forms And Strengths
AVINZA contains white to off-white color pellets, have an outer opaque capsule with colors as identified below and are available in six dose strengths:
Each 30 mg extended-release capsule has a yellow opaque cap with “AVINZA” printed on it and a white opaque body printed with “30” and “505”.
Each 45 mg extended-release capsule has a light blue opaque cap with “AVINZA” printed on it and a white opaque body printed with “45” and “509”.
Each 60 mg extended-release capsule has a bluish-green opaque cap with “AVINZA” printed on it and a white opaque body printed with “60” and “506”.
Each 75 mg extended-release capsule has an orange opaque cap with “AVINZA” printed on it and a white opaque body printed with “75” and “510”.
Each 90 mg extended-release capsule has a red opaque cap with “AVINZA” printed on it and a white opaque body printed with “90” and “507”.
Each 120 mg extended-release capsule has a blue-violet opaque cap with “AVINZA” printed on it and a white opaque body printed with “120” and “508”.
Storage And Handling
30 mg extended-release capsule: size 3 capsule, yellow cap and white, opaque body imprinted AVINZA 30 mg and 505. NDC 60793-605-01: Bottles of 100 capsules.
45 mg extended-release capsule: size 3 capsule, light blue cap and white, opaque body imprinted AVINZA 45 mg and 509. NDC 60793-603-01: Bottles of 100 capsules.
60 mg extended-release capsule: size 3 capsule, bluish-green cap and white, opaque body imprinted AVINZA 60 mg and 506. NDC 60793-606-01: Bottles of 100 capsules.
75 mg extended-release capsule: size 1 capsule, orange cap and white, opaque body imprinted AVINZA 75 mg and 510. NDC 60793-604-01: Bottles of 100 capsules.
90 mg extended-release capsule: size 1 capsule, red cap and white, opaque body imprinted AVINZA 90 mg and 507. NDC 60793-607-01: Bottles of 100 capsules.
120 mg extended-release capsule: size 1 capsule, blue-violet cap and white, opaque body imprinted AVINZA 120 mg and 508. NDC 60793-608-01: Bottles of 100 capsules.
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). [see USP Controlled Room Temperature]
Protect from light and moisture.
Dispense in a tight, light-resistant container as defined in USP.
CAUTION: DEA Order Form Required.
Manufactured for: Pfizer Inc, New York, NY 10017 by: Alkermes Gainesville LLC, Gainesville, GA. Issued: April 2014
Last reviewed on RxList: 5/1/2014
This monograph has been modified to include the generic and brand name in many instances.
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