Exalgo

Exalgo Manufacturers

• Stat Rx Usa Llc
  

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  Selection of patients for treatment with EXALGO is governed by the same principles that apply to the use of similar opioid analgesics. Physicians should individualize treatment in every case, using non-opioid analgesics, opioids on an as-needed basis and/or combination products, and chronic opioid therapy in a progressive plan of pain management such as the guidelines outlined by the World Health Organization or the Federation of State Medical Boards Model Guidelines.

  EXALGO should be swallowed whole and should not be broken, crushed, dissolved, or chewed before swallowing.

  2.1 Conversion to EXALGO in Opioid Tolerant Patients

  The dose range of EXALGO studied in clinical trials is 8 mg to 64 mg. The tablets are to be administered every 24 hours with or without food. Discontinue all other extended-release opioids when beginning EXALGO therapy. As EXALGO is only for use in opioid tolerant patients, do not begin any patient on EXALGO as the first opioid.

  Use caution to avoid medication errors when prescribing or dispensing EXALGO 8 mg tablets, as 8 mg tablets are also available as immediate-release hydromorphone tablets.

  It is critical to initiate the dosing regimen individually for each patient. Overestimating the EXALGO dose when converting patients from another opioid medication can result in fatal overdose with the first dose [see Overdosage (10)].

  In the selection of the initial dose of EXALGO, give attention to the following:

  the 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 hydromorphone dose needed; the patient's degree of opioid tolerance; the age, general condition, and medical status of the patient; concurrent non-opioid analgesics and other medications, such as those with Central Nervous System (CNS) activity [see Drug Interactions (7)]; the type and severity of the patient's pain; the balance between pain control and adverse effects; risk factors for abuse, addiction, or diversion, including a prior history of abuse, addiction, or diversion.

  The following dosing recommendations, therefore, can only be considered as 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 Hydromorphone Formulations to EXALGO
  Patients receiving oral immediate-release hydromorphone may be converted to EXALGO by administering a starting dose equivalent to the patient’s total daily oral hydromorphone dose, taken once daily. The dose of EXALGO can be titrated every 3 to 4 days until adequate pain relief with tolerable side effects has been achieved [see Dosage and Administration (2.1)].

  Conversion from Oral Opioids to EXALGO
  For conversion from other opioids to EXALGO, 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, start EXALGO therapy by administering 50% of the calculated total daily dose of EXALGO (see conversion ratio table below) every 24 hours. The initial dose of EXALGO can be titrated until adequate pain relief with tolerable side effects has been achieved. The following table provides approximate equivalent doses, which may be used as a guideline for conversion.

  The conversion ratios and approximate equivalent doses in this conversion table (Table 1) are only to be used for the conversion from current oral opioid therapy to EXALGO. No fixed conversion ratio is likely to be satisfactory in all patients, especially in patients receiving large opioid doses. For patients on a regimen of mixed opioids, calculate the approximate oral hydromorphone dose for each opioid and sum the totals. For patients on a regimen of fixed-ratio opioid/non-opioid analgesic medications, only the opioid component of these medications should be used in the conversion. The non-opioid component may be continued as a separate drug, or a different non-opioid analgesic may be selected. There is substantial patient variation in the relative potency of different opioid drugs and formulations. It is extremely important to monitor all patients closely 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 tends to accumulate in the plasma. The recommended doses are only a starting point, and close observation and titration are indicated until a satisfactory dose is obtained on the new therapy. Table 1. Conversion Ratios to EXALGO* Previous Opioid Approximate Equivalent
  Oral Dose
  Oral
  Conversion Ratio† * The conversion ratios and approximate equivalent doses in this conversion table are only to be used for the conversion from current opioid therapy to EXALGO. † Ratio for conversion of oral opioid dose to approximate hydromorphone equivalent dose. ‡ It is extremely important to monitor all patients closely 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 tends to accumulate in the plasma. Hydromorphone 12 mg 1 Codeine 200 mg 0.06 Hydrocodone 30 mg 0.4 Methadone‡ 20 mg 0.6 Morphine 60 mg 0.2 Oxycodone 30 mg 0.4 Oxymorphone 20 mg 0.6

  Select opioid, sum the total daily dose, and then multiply the dose by the conversion ratio to calculate the approximate oral hydromorphone equivalent.

  Conversion from Transdermal Fentanyl to EXALGO
  Eighteen hours following the removal of the transdermal fentanyl patch, EXALGO treatment can be initiated. For each 25 mcg/hr fentanyl transdermal dose the equianalgesic dose of EXALGO is 12 mg every 24 hours. An appropriate starting dose of EXALGO is 50% of the calculated total daily dose every 24 hours.

  Individualization of Dosage

  Once therapy is initiated, assess pain relief and other opioid adverse reactions frequently. Titrate patients to adequate analgesia with dose increases not more often than every 3 to 4 days, in order to attain steady-state plasma concentrations of hydromorphone at each dose. As a guideline, consider dosage increases of 25% to 50% of the current daily dose of EXALGO for each titration step. If more than two doses of rescue medication are needed within a 24 hour period for two consecutive days, the dose of EXALGO may need to be titrated upward. Administer EXALGO no more frequently than every 24 hours.

  During periods of changing analgesic requirements, including initial titration, maintain frequent contact between physician, other members of the healthcare team, the patient and the caregiver/family.

  2.2 Maintenance of Therapy

  During chronic therapy with EXALGO, assess the continued need for around-the-clock opioid therapy periodically. Continue to assess patients for their clinical risks for opioid abuse, addiction, or diversion particularly with high-dose formulations. If patients need to titrate while on maintenance therapy, follow the same method outlined in Individualization of Dosage to re-establish pain control.

  2.3 Discontinuation of EXALGO

  When the patient no longer requires therapy with EXALGO, taper doses gradually, by 25 to 50% every 2 or 3 days down to a dose of 8 mg before discontinuation of therapy, to prevent signs and symptoms of withdrawal in the physically dependent patient.

  2.4 Renal and Hepatic Impairment

  Start patients with moderate and severe hepatic and moderate renal impairment on a reduced dose and closely monitor during dose titration. As EXALGO is only intended for once daily administration, consider use of an alternate analgesic that may permit more flexibility with the dosing interval in patients with severe renal impairment.

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• Physicians Total Care, Inc.
  

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  2.1          Initial Dosing

  Initiate the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience. Overestimating the EXALGO dose when converting patients from another opioid medication can result in fatal overdose with the first dose. Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy with EXALGO [see Warnings and Precautions (5.2)].

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

  Total daily dose and potency of the opioid the patient has been taking previously; Reliability of the relative potency estimate used to calculate the equivalent dose of hydromorphone 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.

  EXALGO is administered at a frequency of once daily (every 24 hours), approximately the same time every day, with or without food.

  To avoid medication errors, prescribers and pharmacists must be aware that hydromorphone is available as both immediate-release 8 mg tablets and extended-release 8 mg tablets.

  Discontinue or taper all other extended-release opioids when beginning EXALGO therapy. As EXALGO is only for use in opioid-tolerant patients, do not begin any patient on EXALGO as the first opioid.

  Conversion from Other Oral Hydromorphone Formulations to EXALGO

  Patients receiving oral immediate-release hydromorphone may be converted to EXALGO by administering a starting dose equivalent to the patient’s total daily oral hydromorphone dose, taken once daily.

  Conversion from Oral Opioids to EXALGO

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

  The following table was used in a clinical trial of EXALGO. The recommended starting dose of EXALGO is 50% of the calculated estimate of daily hydromorphone requirement. Calculate the estimated daily hydromorphone requirement using Table 1.

  The conversion ratios in this Table 1 are only to be used for the conversion from current oral opioid therapy to EXALGO. Do not use this table to convert patients from EXALGO to another opioid. Doing so may result in fatal overdose. For patients on a single opioid, sum the total daily dose of the opioid and then multiply the total daily dose by the conversion ratio to calculate the approximate oral hydromorphone equivalent. For patients on a regimen of mixed opioids, calculate the approximate oral hydromorphone dose for each opioid and sum the totals. For patients on a regimen of fixed-ratio opioid/non-opioid analgesic medications, only the opioid component of these medications should be used in the conversion. It is extremely important to monitor all patients closely 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 tends to accumulate in the plasma. Monitor patients for signs or symptoms of opioid withdrawal when converting patients to EXALGO.

  Example conversion from a single opioid to EXALGO:

  Step 1: Sum the total daily dose of the opioid

  30 mg of oxycodone twice daily equals a total daily dose of 60 mg of oxycodone

  Step 2: Calculate the approximately equivalent dose of oral hydromorphone based on the total daily dose of the opioid

  Multiply the 60 mg total daily dose of oxycodone by the conversion factor of 0.4 for a result of 24 mg of oral hydromorphone

  Step 3: Calculate the starting dose of EXALGO, which is 50% of the calculated oral hydromorphone dose

  50% of 24 mg results in an initial dose of 12 mg of EXALGO once daily Adjust individually for each patient

  Table 1.
  Conversion Ratios to EXALGO*

  Previous Opioid

  Approximate Equivalent

  Oral Dose

  Approximate Oral

  Conversion Ratio

  Hydromorphone

  12 mg

  1

  Codeine

  200 mg

  0.06

  Hydrocodone

  30 mg

  0.4

  Methadone†

  20 mg

  0.6

  Morphine

  60 mg

  0.2

  Oxycodone

  30 mg

  0.4

  Oxymorphone

  20 mg

  0.6

  * The conversion ratios and approximate equivalent doses in this conversion table are only to be used for the conversion from current opioid therapy to EXALGO.

  † It is extremely important to monitor all patients closely 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 tends to accumulate in the plasma. 

  Conversion from Transdermal Fentanyl to EXALGO

  Eighteen hours following the removal of the transdermal fentanyl patch, EXALGO treatment can be initiated. For each 25 mcg/hr fentanyl transdermal dose, the equianalgesic dose of EXALGO is 12 mg every 24 hours. An appropriate starting dose of EXALGO is 50% of the calculated total daily dose every 24 hours.

  2.2       Titration and Maintenance of Therapy

  Individually titrate EXALGO to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving EXALGO 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 EXALGO dose to decrease the level of pain. Plasma levels of EXALGO are sustained for 18 to 24 hours. Dosage adjustments may be made every 3 to 4 days. Patients who experience breakthrough pain may require dosage adjustment or rescue medication.

  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 EXALGO

  When a patient no longer requires therapy with EXALGO, taper doses gradually, by 25% to 50% every 2 or 3 days down to a dose of 8 mg before discontinuation of therapy, to prevent signs and symptoms of withdrawal in the opioid-tolerant patient.

  To dispose of unused EXALGO flush all remaining tablets down the toilet or remit to authorities at a certified drug take-back program.

  2.4       Hepatic Impairment

  Start patients with moderate hepatic impairment on 25% of the EXALGO dose that would be prescribed for patients with normal hepatic function. Closely monitor patients with moderate hepatic impairment for respiratory and central nervous system depression during initiation of therapy with EXALGO and during dose titration. Use of alternate analgesics is recommended for patients with severe hepatic impairment [see Use in Specific Populations (8.7)].

  2.5       Renal Impairment

  Start patients with moderate renal impairment on 50% and patients with severe renal impairment on 25% of the EXALGO dose that would be prescribed for patients with normal renal function. Closely monitor patients with renal impairment for respiratory and central nervous system depression during initiation of therapy with EXALGO and during dose titration. As EXALGO is only intended for once daily administration, consider use of an alternate analgesic that may permit more flexibility with the dosing interval in patients with severe renal impairment [see Use in Specific Populations (8.8)].

  2.6       Administration of EXALGO

  Instruct patients to swallow EXALGO tablets intact. The tablets are not to be crushed, dissolved, or chewed due to the risk of rapid release and absorption of a potentially fatal dose of hydromorphone [see Warnings and Precautions (5.2)].

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• Lake Erie Medical Dba Quality Care Products Llc
  

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  2.1 Initial Dosing

  Initiate the dosing regimen for each patient individually, taking into account the patient's prior analgesic treatment experience. Overestimating the EXALGO dose when converting patients from another opioid medication can result in fatal overdose with the first dose. Monitor patients closely for respiratory depression, especially within the first 24 to 72 hours of initiating therapy with EXALGO [see Warnings and Precautions (5.2)].

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

  Total daily dose and potency of the opioid the patient has been taking previously; Reliability of the relative potency estimate used to calculate the equivalent dose of hydromorphone 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.

  EXALGO is administered at a frequency of once daily (every 24 hours), approximately the same time every day, with or without food.

  To avoid medication errors, prescribers and pharmacists must be aware that hydromorphone is available as both immediate-release 8 mg tablets and extended-release 8 mg tablets.

  Discontinue or taper all other extended-release opioids when beginning EXALGO therapy. As EXALGO is only for use in opioid-tolerant patients, do not begin any patient on EXALGO as the first opioid.

  Conversion from Other Oral Hydromorphone Formulations to EXALGO

  Patients receiving oral immediate-release hydromorphone may be converted to EXALGO by administering a starting dose equivalent to the patient’s total daily oral hydromorphone dose, taken once daily.

  Conversion from Oral Opioids to EXALGO

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

  The following table was used in a clinical trial of EXALGO. The recommended starting dose of EXALGO is 50% of the calculated estimate of daily hydromorphone requirement. Calculate the estimated daily hydromorphone requirement using Table 1.

  The conversion ratios in this Table 1 are only to be used for the conversion from current oral opioid therapy to EXALGO. Do not use this table to convert patients from EXALGO to another opioid. Doing so may result in fatal overdose. For patients on a single opioid, sum the total daily dose of the opioid and then multiply the total daily dose by the conversion ratio to calculate the approximate oral hydromorphone equivalent. For patients on a regimen of mixed opioids, calculate the approximate oral hydromorphone dose for each opioid and sum the totals. For patients on a regimen of fixed-ratio opioid/non-opioid analgesic medications, only the opioid component of these medications should be used in the conversion. It is extremely important to monitor all patients closely 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 tends to accumulate in the plasma. Monitor patients for signs or symptoms of opioid withdrawal when converting patients to EXALGO.

  Example conversion from a single opioid to EXALGO:

  Step 1: Sum the total daily dose of the opioid

  30 mg of oxycodone twice daily equals a total daily dose of 60 mg of oxycodone

  Step 2: Calculate the approximately equivalent dose of oral hydromorphone based on the total daily dose of the opioid

  Multiply the 60 mg total daily dose of oxycodone by the conversion factor of 0.4 for a result of 24 mg of oral hydromorphone

  Step 3: Calculate the starting dose of EXALGO, which is 50% of the calculated oral hydromorphone dose

  50% of 24 mg results in an initial dose of 12 mg of EXALGO once daily Adjust individually for each patient

  Table 1. Conversion Ratios to EXALGO*

  Previous Opioid

  Approximate Equivalent

  Oral Dose

  Approximate Oral

  Conversion Ratio

  Hydromorphone

  12 mg

  1

  Codeine

  200 mg

  0.06

  Hydrocodone

  30 mg

  0.4

  Methadone†

  20 mg

  0.6

  Morphine

  60 mg

  0.2

  Oxycodone

  30 mg

  0.4

  Oxymorphone

  20 mg

  0.6

  * The conversion ratios and approximate equivalent doses in this conversion table are only to be used for the conversion from current opioid therapy to EXALGO.

  † It is extremely important to monitor all patients closely 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 tends to accumulate in the plasma. 

  Conversion from Transdermal Fentanyl to EXALGO

  Eighteen hours following the removal of the transdermal fentanyl patch, EXALGO treatment can be initiated. For each 25 mcg/hr fentanyl transdermal dose, the equianalgesic dose of EXALGO is 12 mg every 24 hours. An appropriate starting dose of EXALGO is 50% of the calculated total daily dose every 24 hours.

  2.2      Titration and Maintenance of Therapy

  Individually titrate EXALGO to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving EXALGO 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 EXALGO dose to decrease the level of pain. Plasma levels of EXALGO are sustained for 18 to 24 hours. Dosage adjustments may be made every 3 to 4 days. Patients who experience breakthrough pain may require dosage adjustment or rescue medication.

  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 EXALGO

  When a patient no longer requires therapy with EXALGO, taper doses gradually, by 25% to 50% every 2 or 3 days down to a dose of 8 mg before discontinuation of therapy, to prevent signs and symptoms of withdrawal in the opioid-tolerant patient.

  To dispose of unused EXALGO flush all remaining tablets down the toilet or remit to authorities at a certified drug take-back program.

  2.4       Hepatic Impairment

  Start patients with moderate hepatic impairment on 25% of the EXALGO dose that would be prescribed for patients with normal hepatic function. Closely monitor patients with moderate hepatic impairment for respiratory and central nervous system depression during initiation of therapy with EXALGO and during dose titration. Use of alternate analgesics is recommended for patients with severe hepatic impairment [see Use in Specific Populations (8.7)].

  2.5       Renal Impairment

  Start patients with moderate renal impairment on 50% and patients with severe renal impairment on 25% of the EXALGO dose that would be prescribed for patients with normal renal function. Closely monitor patients with renal impairment for respiratory and central nervous system depression during initiation of therapy with EXALGO and during dose titration. As EXALGO is only intended for once daily administration, consider use of an alternate analgesic that may permit more flexibility with the dosing interval in patients with severe renal impairment [see Use in Specific Populations (8.8)].

  2.6       Administration of EXALGO

  Instruct patients to swallow EXALGO tablets intact. The tablets are not to be crushed, dissolved, or chewed due to the risk of rapid release and absorption of a potentially fatal dose of hydromorphone [see Warnings and Precautions (5.2)].

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  2.1 Initial Dosing

  To avoid medication errors, prescribers and pharmacists must be aware that hydromorphone is available as both immediate-release 8 mg tablets and extended-release 8 mg tablets.

  EXALGO should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.

  Due to the risk of respiratory depression, EXALGO is only indicated for use in patients who are already opioid-tolerant. Discontinue or taper all other extended-release opioids when beginning EXALGO  therapy. As EXALGO is only for use in opioid-tolerant patients, do not begin any patient on EXALGO as the first opioid.

  Patients considered opioid-tolerant are those who are taking at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.

  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 to 72 hours of initiating therapy with EXALGO [see Warnings and Precautions (5.2)].

  EXALGO tablets must be taken whole. Crushing, chewing, or dissolving EXALGO extended-release tablets will result in uncontrolled delivery of hydromorphone and can lead to overdose or death [see Warnings and Precautions (5.2)].

  Conversion from Other Oral Hydromorphone Formulations to EXALGO
  Patients receiving oral immediate-release hydromorphone may be converted to EXALGO by administering a starting dose equivalent to the patient’s total daily oral hydromorphone dose, taken once daily.

  Conversion from Other Oral Opioids to EXALGO
  Discontinue all other around-the-clock opioid drugs when EXALGO therapy is initiated.

  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 hydromorphone requirements and provide rescue medication (e.g., immediate-release opioid) than to overestimate the 24-hour oral hydromorphone requirements, which could result in adverse reactions.

  In an EXALGO clinical trial with an open-label titration period, patients were converted from their prior opioid to EXALGO using the Table 1 as a guide for the initial EXALGO dose. The recommended starting dose of EXALGO is 50% of the calculated estimate of daily hydromorphone requirement. Calculate the estimated daily hydromorphone requirement using Table 1.

  Consider the following when using the information in Table 1:

  This is not a table of equianalgesic doses. The conversion factors in this table are only for the conversion from one of the listed oral opioid analgesics to EXALGO. The table cannot be used to convert from EXALGO to another opioid. Doing so will result in an overestimation of the dose of the new opioid and may result in fatal overdose.

  Table 1.
  Conversion Factors to EXALGO

  Prior Oral Opioid

  Approximate Oral Conversion Factor

  Hydromorphone

  1

  Codeine

  0.06

  Hydrocodone

  0.4

  Methadone

  0.6

  Morphine

  0.2

  Oxycodone

  0.4

  Oxymorphone

  0.6

  To calculate the estimated EXALGO dose using Table 1:

  For patients on a single opioid, sum the current total daily dose of the opioid and then multiply the total daily dose by the conversion factor to calculate the approximate oral hydromorphone daily dose. For patients on a regimen of more than one opioid, calculate the approximate oral hydromorphone dose for each opioid and sum the totals to obtain the approximate total hydromorphone daily dose. For patients on a regimen of fixed-ratio opioid/non-opioid analgesic products, use only the opioid component of these products in the conversion.

  Always round the dose down, if necessary, to the appropriate EXALGO strength(s) available.

  Example conversion from a single opioid to EXALGO:

  Step 1: Sum the total daily dose of the opioid

  30 mg of oxycodone 2 times daily = 60 mg total daily dose of  oxycodone

  Step 2: Calculate the approximate equivalent dose of oral hydromorphone based on the total daily dose of the current opioid using Table 1

  60 mg total daily dose of oxycodone x Conversion Factor of 0.4 = 24 mg of oral hydromorphone daily

  Step 3: Calculate the approximate starting dose of EXALGO to be given every 24 hours, which is 50% of the calculated oral hydromorphone dose. Round down, if necessary, to the appropriate EXALGO tablet strengths available.

  50% of 24 mg results in an initial dose of 12 mg of EXALGO once daily Adjust individually for each patient

  Close observation and frequent titration are warranted until pain management is stable on the new opioid. Monitor patients for signs and symptoms of opioid withdrawal or for signs of over-sedation/toxicity after converting patients to EXALGO.

  Conversion from Transdermal Fentanyl to EXALGO
  Eighteen hours following the removal of the transdermal fentanyl patch, EXALGO treatment can be initiated. To calculate the 24-hour EXALGO dose, use a conversion factor of 25 mcg/hr fentanyl transdermal patch to 12 mg of EXALGO. Then reduce the EXALGO dose by 50%.

  For example:

   Step 1:            Identify the dose of transdermal fentanyl.

  75 mg of transdermal fentanyl

  Step 2: Use the conversion factor of 25 mcg/hr fentanyl transdermal patch to 12 mg of EXALGO.

  75 mg of transdermal fentanyl : 36 mg total daily dose of EXALGO

  Step 3: Calculate the approximate starting dose of EXALGO to be given every 24 hours, which is 50% of the converted dose. Round down, if necessary, to the appropriate EXALGO tablet strengths available.

  50% of 36 mg results in an initial dose of 18 mg, which would be rounded down to
  16 mg of EXALGO once daily Adjust individually for each patient

  Conversion from Methadone to EXALGO
  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.

  2.2 Titration and Maintenance of Therapy

  Individually titrate EXALGO to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving EXALGO 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.

  Plasma levels of EXALGO are sustained for 18 to 24 hours. Dosage adjustments of EXALGO may be made in increments of 4 to 8 mg every 3 to 4 days as needed to achieve adequate analgesia.

  Patients who experience breakthrough pain may require a dose increase of EXALGO, 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 EXALGO dose.

  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 EXALGO

  When a patient no longer requires therapy with EXALGO, taper doses gradually, by 25% to 50% every 2 or 3 days down to a dose of 8 mg before discontinuation of therapy, to prevent signs and symptoms of withdrawal in the opioid-tolerant patient.

  To dispose of unused EXALGO flush all remaining tablets down the toilet or remit to authorities at a certified drug take-back program.

  2.4 Hepatic Impairment

  Start patients with moderate hepatic impairment on 25% of the EXALGO dose that would be prescribed for patients with normal hepatic function. Closely monitor patients with moderate hepatic impairment for respiratory and central nervous system depression during initiation of therapy with EXALGO and during dose titration. Use of alternate analgesics is recommended for patients with severe hepatic impairment [see Use in Specific Populations (8.6)].

  2.5 Renal Impairment

  Start patients with moderate renal impairment on 50% and patients with severe renal impairment on 25% of the EXALGO dose that would be prescribed for patients with normal renal function. Closely monitor patients with renal impairment for respiratory and central nervous system depression during initiation of therapy with EXALGO and during dose titration. As EXALGO is only intended for once daily administration, consider use of an alternate analgesic that may permit more flexibility with the dosing interval in patients with severe renal impairment [see Use in Specific Populations (8.7)].

  2.6 Administration of EXALGO

  Instruct patients to swallow EXALGO tablets intact. The tablets are not to be crushed, dissolved, or chewed due to the risk of rapid release and absorption of a potentially fatal dose of hydromorphone [see Warnings and Precautions (5.2)].

  2.1 Initial Dosing

  To avoid medication errors, prescribers and pharmacists must be aware that hydromorphone is available as both immediate-release 8 mg tablets and extended-release 8 mg tablets.

  EXALGO should be prescribed only by healthcare professionals who are knowledgeable in the use of potent opioids for the management of chronic pain.

  Due to the risk of respiratory depression, EXALGO is only indicated for use in patients who are already opioid-tolerant. Discontinue or taper all other extended-release opioids when beginning EXALGO  therapy. As EXALGO is only for use in opioid-tolerant patients, do not begin any patient on EXALGO as the first opioid.

  Patients considered opioid-tolerant are those who are taking at least 60 mg of morphine daily, or at least 30 mg of oral oxycodone daily, or at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.

  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 to 72 hours of initiating therapy with EXALGO [see Warnings and Precautions (5.2)].

  EXALGO tablets must be taken whole. Crushing, chewing, or dissolving EXALGO extended-release tablets will result in uncontrolled delivery of hydromorphone and can lead to overdose or death [see Warnings and Precautions (5.2)].

  Conversion from Other Oral Hydromorphone Formulations to EXALGO
  Patients receiving oral immediate-release hydromorphone may be converted to EXALGO by administering a starting dose equivalent to the patient’s total daily oral hydromorphone dose, taken once daily.

  Conversion from Other Oral Opioids to EXALGO
  Discontinue all other around-the-clock opioid drugs when EXALGO therapy is initiated.

  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 hydromorphone requirements and provide rescue medication (e.g., immediate-release opioid) than to overestimate the 24-hour oral hydromorphone requirements, which could result in adverse reactions.

  In an EXALGO clinical trial with an open-label titration period, patients were converted from their prior opioid to EXALGO using the Table 1 as a guide for the initial EXALGO dose. The recommended starting dose of EXALGO is 50% of the calculated estimate of daily hydromorphone requirement. Calculate the estimated daily hydromorphone requirement using Table 1.

  Consider the following when using the information in Table 1:

  This is not a table of equianalgesic doses. The conversion factors in this table are only for the conversion from one of the listed oral opioid analgesics to EXALGO. The table cannot be used to convert from EXALGO to another opioid. Doing so will result in an overestimation of the dose of the new opioid and may result in fatal overdose.

  Table 1.
  Conversion Factors to EXALGO

  Prior Oral Opioid

  Approximate Oral Conversion Factor

  Hydromorphone

  1

  Codeine

  0.06

  Hydrocodone

  0.4

  Methadone

  0.6

  Morphine

  0.2

  Oxycodone

  0.4

  Oxymorphone

  0.6

  To calculate the estimated EXALGO dose using Table 1:

  For patients on a single opioid, sum the current total daily dose of the opioid and then multiply the total daily dose by the conversion factor to calculate the approximate oral hydromorphone daily dose. For patients on a regimen of more than one opioid, calculate the approximate oral hydromorphone dose for each opioid and sum the totals to obtain the approximate total hydromorphone daily dose. For patients on a regimen of fixed-ratio opioid/non-opioid analgesic products, use only the opioid component of these products in the conversion.

  Always round the dose down, if necessary, to the appropriate EXALGO strength(s) available.

  Example conversion from a single opioid to EXALGO:

  Step 1: Sum the total daily dose of the opioid

  30 mg of oxycodone 2 times daily = 60 mg total daily dose of  oxycodone

  Step 2: Calculate the approximate equivalent dose of oral hydromorphone based on the total daily dose of the current opioid using Table 1

  60 mg total daily dose of oxycodone x Conversion Factor of 0.4 = 24 mg of oral hydromorphone daily

  Step 3: Calculate the approximate starting dose of EXALGO to be given every 24 hours, which is 50% of the calculated oral hydromorphone dose. Round down, if necessary, to the appropriate EXALGO tablet strengths available.

  50% of 24 mg results in an initial dose of 12 mg of EXALGO once daily Adjust individually for each patient

  Close observation and frequent titration are warranted until pain management is stable on the new opioid. Monitor patients for signs and symptoms of opioid withdrawal or for signs of over-sedation/toxicity after converting patients to EXALGO.

  Conversion from Transdermal Fentanyl to EXALGO
  Eighteen hours following the removal of the transdermal fentanyl patch, EXALGO treatment can be initiated. To calculate the 24-hour EXALGO dose, use a conversion factor of 25 mcg/hr fentanyl transdermal patch to 12 mg of EXALGO. Then reduce the EXALGO dose by 50%.

  For example:

   Step 1:            Identify the dose of transdermal fentanyl.

  75 mg of transdermal fentanyl

  Step 2: Use the conversion factor of 25 mcg/hr fentanyl transdermal patch to 12 mg of EXALGO.

  75 mg of transdermal fentanyl : 36 mg total daily dose of EXALGO

  Step 3: Calculate the approximate starting dose of EXALGO to be given every 24 hours, which is 50% of the converted dose. Round down, if necessary, to the appropriate EXALGO tablet strengths available.

  50% of 36 mg results in an initial dose of 18 mg, which would be rounded down to
  16 mg of EXALGO once daily Adjust individually for each patient

  Conversion from Methadone to EXALGO
  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.

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