AVINZA

AVINZA- morphine sulfate capsule, extended release
Pfizer Laboratories Div Pfizer Inc

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; and INTERACTION WITH ALCOHOL

Addiction, Abuse, and Misuse

AVINZA® exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient’s risk prior to prescribing AVINZA, and monitor all patients regularly for the development of these behaviors or conditions [see Warnings and Precautions (5.1)].

Life-threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of AVINZA. Monitor for respiratory depression, especially during initiation of AVINZA or following a dose increase. Instruct patients to swallow AVINZA capsules whole or to sprinkle the contents of the capsule on applesauce and swallow immediately without chewing. Crushing, chewing, or dissolving AVINZA can cause rapid release and absorption of a potentially fatal dose of morphine [see Warnings and Precautions (5.2)].

Accidental Ingestion

Accidental ingestion of even one dose of AVINZA, especially by children, can result in a fatal overdose of morphine [see Warnings and Precautions (5.2)].

Neonatal Opioid Withdrawal Syndrome

Prolonged use of AVINZA during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see Warnings and Precautions (5.3)].

Interaction with Alcohol

Instruct patients not to consume alcoholic beverages or use prescription or non-prescription products that contain alcohol while taking AVINZA. The co-ingestion of alcohol with AVINZA may result in increased plasma levels and a potentially fatal overdose of morphine [see Warnings and Precautions (5.4).

1 INDICATIONS AND USAGE

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.

2 DOSAGE AND ADMINISTRATION

2.1 Initial Dosing

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 (5.1)]. Monitor patients closely for respiratory depression, especially within the first 24–72 hours of initiating therapy with AVINZA [see Warnings and Precautions (5.2)].

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 (5.2)]. 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 (2.4)].

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.

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