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Avinza (Morphine Sulfate Extended Release) - Indications and Dosage

 
 



INDICATIONS & USAGE

AVINZA capsules are a modified-release formulation of morphine sulfate intended for once daily administration indicated for the relief of moderate to severe pain requiring continuous, around-the-clock opioid therapy for an extended period of time.

AVINZA is NOT intended for use as a prn analgesic.

The safety and efficacy of using AVINZA in the postoperative setting has not been evaluated. AVINZA is not indicated for postoperative use. If the patient has been receiving the drug prior to surgery, resumption of the pre-surgical dose may be appropriate once the patient is able to take the drug by mouth. Physicians should individualize treatment, moving from parenteral to oral analgesics as appropriate. (see American Pain Society guidelines)

DOSAGE AND ADMINISTRATION

AVINZA MUST BE SWALLOWED WHOLE (NOT CHEWED, CRUSHED, OR DISSOLVED) OR AVINZA MAY BE OPENED AND THE ENTIRE BEAD CONTENTS SPRINKLED ON A SMALL AMOUNT OF APPLESAUCE IMMEDIATELY PRIOR TO INGESTION. THE BEADS MUST NOT BE CHEWED, CRUSHED, OR DISSOLVED DUE TO RISK OF ACUTE OVERDOSE. INGESTING CHEWED OR CRUSHED AVINZA BEADS WILL LEAD TO THE RAPID RELEASE AND ABSORPTION OF A POTENTIALLY TOXIC DOSE OF MORPHINE

Patients must not consume alcoholic beverages while on AVINZA therapy. Additionally, patients must not use prescription or non-prescription medicine containing alcohol while on AVINZA therapy. Consumption of alcohol while taking AVINZA may result in the rapid release and absorption of a potentially fatal dose of morphine.

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. (see WARNINGS)

The 60, 90, and 120 mg capsules are for use only in opioid‑tolerant patients.

All doses are intended to be administered once daily. As with any opioid drug product, it is necessary to adjust the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience. In the selection of the initial dose of AVINZA, attention should be given to the following:

  1. the total daily dose, potency and specific characteristics of the opioid the patient has been taking previously;
  2. the reliability of the relative potency estimate used to calculate the equivalent morphine dose needed;
  3. the patient’s degree of opioid tolerance;
  4. the general condition and medical status of the patient;
  5. concurrent medications;
  6. the type and severity of the patient's pain.

The following dosing recommendations, therefore, can only be considered suggested approaches to what is actually a series of clinical decisions over time in the management of the pain of each individual patient.

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. As with conversion from any oral morphine formulation to another, supplemental pain medication may be required until the response to the patient's daily AVINZA dosage has stabilized (up to 4 days).

Conversion from Parenteral Morphine or Other Non-Morphine Opioids (Parenteral or Oral) to AVINZA

There is inter-patient variability in the potency of opioid drugs and opioid formulations. Therefore, a conservative approach is advised when determining the total daily dose of AVINZA. It is better to underestimate a patient’s 24-hour oral morphine dose and make available rescue medication than to overestimate the 24-hour oral morphine dose and manage an adverse experience or overdose. The following general points should be considered regarding opioid conversions.

Parenteral to oral morphine ratio: Anywhere from 3 to 6 mg of oral morphine may be required to provide pain relief equivalent to 1 mg of parenteral morphine. Based on this rationale, a reasonable starting dose of AVINZA would be approximately three times the previous daily parenteral morphine requirement.

Other parenteral or oral non-morphine opioids to oral morphine sulfate: Physicians and other healthcare professionals are advised to refer to published relative potency information, keeping in mind that conversion ratios are only approximate. In general, it is safest to administer half of the estimated daily morphine requirement as the initial AVINZA dose once per day and then manage insufficient pain relief by supplementation with immediate‑release morphine or other short-acting analgesics. (see Individualization of Dosage)

Individualization of Dosage

Physicians should individualize treatment using a progressive plan of pain management such as outlined by the World Health Organization, the American Pain Society and the Federation of State Medical Boards Model Guidelines. Healthcare professionals should follow appropriate pain management principles of careful assessment and ongoing monitoring. AVINZA (morphine sulfate) is on the third step of the WHO three step analgesic ladder and is of most benefit when a constant level of opioid analgesia is used as a platform from which break-through pain is managed. Once acceptable pain relief is no longer achieved from combinations of non-opioid medications (NSAIDs and acetaminophen) and intermittent usage of moderate or strong opioids, conversion to a 24-hour oral morphine equivalent is warranted.

The dose may be titrated as frequently as every other day to control analgesia. In the event that break-through pain occurs, AVINZA may be supplemented with a small dose (5-15% of the total daily dose of morphine) of a short-acting analgesic.

When AVINZA is chosen as the initial opioid for patients who do not have a proven tolerance to opioids, patients should be treated initially at a dose of 30 mg once-daily (at 24-hour intervals). For opioid-naïve patients, the dose should be increased conservatively. For such patients, it is recommended that the dose of AVINZA be adjusted in increments not greater than 30 mg every 4 days. Some degree of tolerance may occur, requiring dosage adjustment until the achievement of a balance between analgesia and opioid side effects. When necessary, the total dose of AVINZA should be increased until pain relief is reached or clinically significant opioid-related adverse reactions occur.

Alternative Methods of Administration

AVINZA beads sprinkled over applesauce were found to be bioequivalent to AVINZA capsules swallowed whole under fasting conditions in a study of healthy volunteers. Absorption of the beads sprinkled on other foods has not been tested. This method of administration may be beneficial for patients who have difficulty swallowing whole capsules or tablets.

  1. Sprinkle the entire contents of the capsule(s) onto a small amount of applesauce. The applesauce should be at room temperature or cooler. Use immediately. (see also CLINICAL PHARMACOLOGY, Food Effects)
  2. Swallow mixture without chewing or crushing beads.
  3. Rinse mouth and swallow to ensure all beads have been ingested.
  4. Patients should consume the entire portion and should not divide applesauce into separate doses.

Conversion from AVINZA to Other Pain Control Therapies

It is important to remember that the persistence of AVINZA-derived plasma morphine concentrations may be in excess of 36 hours when making a conversion to other pain control therapies.

Conversion from AVINZA to Other Controlled-Release Oral Morphine Formulations

For a given dose, the same total amount of morphine is available from AVINZA as from oral morphine solution or controlled-release morphine tablets. The extended duration of release of morphine from AVINZA results in reduced maximum and increased minimum plasma morphine concentrations than with shorter acting morphine products. Conversion from AVINZA to the same total daily dose of another controlled-release morphine formulation could lead to either excessive sedation at peak serum levels or inadequate analgesia at trough serum levels. Dosage adjustment with close observation is recommended.

Conversion from AVINZA to Parenteral Opioids

When converting from AVINZA to parenteral opioids, it is best to calculate an equivalent parenteral dose and then initiate treatment at half of this calculated value. As an example, an estimated total 24-hour parenteral morphine requirement of a patient receiving AVINZA is one-third of the dose of AVINZA. This is because the oral bioavailability of morphine is one-third that of parenteral morphine. This estimated dose should then be divided in half, and this last calculated dose is the total daily dose. This value should be further divided by six if the desire is to dose with parenteral morphine every four hours.

Consider a patient taking 360 mg of AVINZA daily. First, divide by 3, to account for differences in bioavailability between oral and parenteral morphine. This new figure, 120 mg, is the estimated total 24-hour requirement of parenteral morphine. Dividing by 2, the result gives the total daily dose of 60 mg. If it is decided to administer the drug at four-hour intervals, then administer 10 mg (60 divided by 6) every four hours.

Although this approach may require a dosage increase in the first 24 hours for many patients, this method is recommended, as it is less likely to result in overdose. Overdose is more likely to occur when administering an equivalent dose of parenteral morphine without titration. Provision for break-through pain should be made.

Cessation of Therapy

When the patient no longer requires therapy with AVINZA capsules, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient.

SAFETY AND HANDLING

AVINZA consists of hard gelatin capsules containing polymer-coated morphine sulfate beads that pose no known risk of handling to healthcare workers. All opioids are liable to diversion and misuse both by the general public and healthcare workers and should be handled accordingly.

HOW SUPPLIED

30 mg Capsule: size 3 capsule, yellow cap imprinted AVINZA and white, opaque body imprinted 30 mg and 505.

NDC 64365-505-03: Bottles of 100 capsules.

60 mg Capsule: size 3 capsule, bluish‑green cap imprinted AVINZA and white, opaque body imprinted 60 mg and 506.

NDC 64365-506-03: Bottles of 100 capsules.

90 mg Capsule: size 1 capsule, red cap imprinted AVINZA and white, opaque body imprinted 90 mg and 507.

NDC 64365-507-02: Bottles of 100 capsules.

120 mg Capsule: size 1 capsule, blue‑violet cap imprinted AVINZA and white, opaque body imprinted 120 mg and 508.

NDC 64365-508-02: 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.

Rx Only.





Manufactured for:


Ligand Pharmaceuticals Incorporated
San Diego, CA 92121
AVINZA® Information Service: 1-888-8-AVINZA


Utilizing technology developed by:

Elan Corporation plc.
Monksland, Athlone
Co Westmeath, Ireland
Rev. 12/05


AVINZA® is a registered trademark of Ligand® Pharmaceuticals Inc.


SODAS® is a registered trademark of Elan Corporation, plc.


U.S. Patent No.: 6,066,339


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