EXALGO

EXALGO — hydromorphone hydrochloride tablet, extended release
STAT Rx USA LLC

WARNING: POTENTIAL FOR ABUSE, IMPORTANCE OF PROPER PATIENT SELECTION AND LIMITATIONS OF USE

Potential for Abuse
EXALGO contains hydromorphone, an opioid agonist and a Schedule II controlled substance with an abuse liability similar to other opioid analgesics. EXALGO can be abused in a manner similar to other opioid agonists, legal or illicit. These risks should be considered when administering, prescribing, or dispensing EXALGO in situations where the healthcare professional is concerned about increased risk of misuse, abuse, or diversion. Schedule II opioid substances which include hydromorphone, morphine, oxycodone, fentanyl, oxymorphone and methadone have the highest potential for abuse and risk of fatal overdose due to respiratory depression [see Drug Abuse and Dependence (9)].

Proper Patient Selection
EXALGO is an extended-release formulation of hydromorphone hydrochloride indicated for the management of moderate to severe pain in opioid tolerant patients when a continuous around-the-clock opioid analgesic is needed for an extended period of time. Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day or an equianalgesic dose of another opioid, for a week or longer [see Indications and Usage (1) and Dosage and Administration (2)].

EXALGO is for use in opioid tolerant patients only [see Indications and Usage (1) and Dosage and Administration (2)].

Fatal respiratory depression could occur in patients who are not opioid tolerant.

Accidental consumption of EXALGO, especially in children, can result in a fatal overdose of hydromorphone [see Warnings and Precautions (5.1)].

Limitations of Use
EXALGO is not indicated for the management of acute or postoperative pain [see Indications and Usage (1)].

EXALGO is not intended for use as an as-needed analgesic [see Indications and Usage (1)].

EXALGO tablets are to be swallowed whole and are not to be broken, chewed, dissolved, crushed or injected. Taking broken, chewed, dissolved or crushed EXALGO or its contents leads to rapid release and absorption of a potentially fatal dose of hydromorphone [see Warnings and Precautions (5)].

1 INDICATIONS AND USAGE

EXALGO is an extended-release oral formulation of hydromorphone hydrochloride indicated for the management of moderate to severe pain in opioid tolerant patients requiring continuous, around-the-clock opioid analgesia for an extended period of time.

Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine per day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day or an equianalgesic dose of another opioid, for a week or longer.

EXALGO is NOT intended for use as an as-needed analgesic.

EXALGO is not indicated for the management of acute or postoperative pain.

2 DOSAGE AND ADMINISTRATION

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 EquivalentOral Dose OralConversion 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.

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