Avinza

Avinza Manufacturers

• Stat Rx Usa Llc
  

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  Avinza | Stat Rx Usa Llc

  

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  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 45, 60, 75, 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:

  the total daily dose, potency and specific characteristics of the opioid the patient has been taking previously; the reliability of the relative potency estimate used to calculate the equivalent morphine dose needed; the patient’s degree of opioid tolerance; the general condition and medical status of the patient; concurrent medications; 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.

  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) Swallow mixture without chewing or crushing beads. Rinse mouth and swallow to ensure all beads have been ingested. 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.

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• Lake Erie Medical Dba Quality Care Products Llc
  

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  Avinza | Lake Erie Medical Dba Quality Care Products Llc

  

  ---

  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 45, 60, 75, 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:

  the total daily dose, potency and specific characteristics of the opioid the patient has been taking previously; the reliability of the relative potency estimate used to calculate the equivalent morphine dose needed; the patient’s degree of opioid tolerance; the general condition and medical status of the patient; concurrent medications; 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.

  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) Swallow mixture without chewing or crushing beads. Rinse mouth and swallow to ensure all beads have been ingested. 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.

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• Bryant Ranch Prepack
  

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  Avinza | Bryant Ranch Prepack

  

  ---

  2.1 Initial Dosing

  Initiate the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience. Monitor patients closely for respiratory depression, especially within the first 24–72 hours of initiating therapy with AVINZA [see Warnings and Precautions (5.2)].

  Consider the following factors when selecting an initial dose of AVINZA:

  Total daily dose, potency, and any prior opioid the patient has been taking previously; Reliability of the relative potency estimate used to calculate the equivalent dose of morphine needed (Note: potency estimates may vary with the route of administration); Patient's degree of opioid experience and opioid tolerance; General condition and medical status of the patient; Concurrent medication; Type and severity of the patient's pain.

  AVINZA is administered at a frequency of once daily (every 24 hours).

  Use of AVINZA as the First Opioid Analgesic

  Initiate AVINZA therapy with the 30 mg capsule once daily (at 24-hour intervals). Adjust the dose of AVINZA in increments not greater than 30 mg every 4 days.

  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

  While there are useful tables of oral and parenteral equivalents, there is substantial inter-patient variability in the relative potency of different opioid drugs and formulations. As such, it is safer to underestimate a patient's 24-hour oral morphine dose and provide rescue medication (e.g., immediate-release morphine) than to overestimate the 24-hour oral morphine dose and manage an adverse reaction. 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.

  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.

  2.2 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. During chronic therapy, especially for non-cancer-related pain (or pain associated with other terminal illnesses), periodically reassess the continued need for the use of 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 dosage adjustment or rescue medication with a small dose of an immediate-release medication.

  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 signs of excessive opioid-related adverse reactions are observed, the next dose may be reduced. Adjust the dose to obtain an appropriate balance between management of pain and opioid-related adverse reactions.

  2.3 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.

  2.4 Administration of AVINZA

  Instruct patients to swallow AVINZA capsules intact. 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)].

  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.

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  No Recall

  More Info
• Bryant Ranch Prepack
  

  ×

  Avinza | Bryant Ranch Prepack

  

  ---

  2.1 Initial Dosing

  Initiate the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience. Monitor patients closely for respiratory depression, especially within the first 24–72 hours of initiating therapy with AVINZA [see Warnings and Precautions (5.2)].

  Consider the following factors when selecting an initial dose of AVINZA:

  Total daily dose, potency, and any prior opioid the patient has been taking previously; Reliability of the relative potency estimate used to calculate the equivalent dose of morphine needed (Note: potency estimates may vary with the route of administration); Patient's degree of opioid experience and opioid tolerance; General condition and medical status of the patient; Concurrent medication; Type and severity of the patient's pain.

  AVINZA is administered at a frequency of once daily (every 24 hours).

  Use of AVINZA as the First Opioid Analgesic

  Initiate AVINZA therapy with the 30 mg capsule once daily (at 24-hour intervals). Adjust the dose of AVINZA in increments not greater than 30 mg every 4 days.

  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

  While there are useful tables of oral and parenteral equivalents, there is substantial inter-patient variability in the relative potency of different opioid drugs and formulations. As such, it is safer to underestimate a patient's 24-hour oral morphine dose and provide rescue medication (e.g., immediate-release morphine) than to overestimate the 24-hour oral morphine dose and manage an adverse reaction. 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.

  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.

  2.2 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. During chronic therapy, especially for non-cancer-related pain (or pain associated with other terminal illnesses), periodically reassess the continued need for the use of 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 dosage adjustment or rescue medication with a small dose of an immediate-release medication.

  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 signs of excessive opioid-related adverse reactions are observed, the next dose may be reduced. Adjust the dose to obtain an appropriate balance between management of pain and opioid-related adverse reactions.

  2.3 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.

  2.4 Administration of AVINZA

  Instruct patients to swallow AVINZA capsules intact. 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)].

  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.

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  No Recall

  More Info
• Bryant Ranch Prepack
  

  ×

  Avinza | Bryant Ranch Prepack

  

  ---

  2.1 Initial Dosing

  Initiate the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience. Monitor patients closely for respiratory depression, especially within the first 24–72 hours of initiating therapy with AVINZA [see Warnings and Precautions (5.2)].

  Consider the following factors when selecting an initial dose of AVINZA:

  Total daily dose, potency, and any prior opioid the patient has been taking previously; Reliability of the relative potency estimate used to calculate the equivalent dose of morphine needed (Note: potency estimates may vary with the route of administration); Patient's degree of opioid experience and opioid tolerance; General condition and medical status of the patient; Concurrent medication; Type and severity of the patient's pain.

  AVINZA is administered at a frequency of once daily (every 24 hours).

  Use of AVINZA as the First Opioid Analgesic

  Initiate AVINZA therapy with the 30 mg capsule once daily (at 24-hour intervals). Adjust the dose of AVINZA in increments not greater than 30 mg every 4 days.

  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

  While there are useful tables of oral and parenteral equivalents, there is substantial inter-patient variability in the relative potency of different opioid drugs and formulations. As such, it is safer to underestimate a patient's 24-hour oral morphine dose and provide rescue medication (e.g., immediate-release morphine) than to overestimate the 24-hour oral morphine dose and manage an adverse reaction. 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.

  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.

  2.2 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. During chronic therapy, especially for non-cancer-related pain (or pain associated with other terminal illnesses), periodically reassess the continued need for the use of 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 dosage adjustment or rescue medication with a small dose of an immediate-release medication.

  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 signs of excessive opioid-related adverse reactions are observed, the next dose may be reduced. Adjust the dose to obtain an appropriate balance between management of pain and opioid-related adverse reactions.

  2.3 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.

  2.4 Administration of AVINZA

  Instruct patients to swallow AVINZA capsules intact. 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)].

  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.

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• Pfizer Laboratories Div Pfizer Inc
  

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  Avinza | Pfizer Laboratories Div Pfizer Inc

  

  ---

  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.

  2.2 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.

  2.3 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.

  2.4 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 (5.2)].

  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.

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