hydromorphone hydrochloride injection, USP (HIGH POTENCY) Highlights

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use HYDROMORPHONE HYDROCHLORIDE INJECTION [high potency formulation (HPF)] safely and effectively. See full prescribing information for HYDROMORPHONE HYDROCHLORIDE INJECTION [high potency formulation (HPF)].

HYDROMORPHONE HYDROCHLORIDE INJECTION [high potency formulation (HPF)], for intravenous, intramuscular, or subcutaneous use, CII

Initial U.S. Approval: January 1984

WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF HYDROMORPHONE HYDROCHLORIDE INJECTION [HIGH POTENCY FORMULATION (HPF)]

See full prescribing information for complete boxed warning.

Do not confuse Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] with standard parenteral formulations of Hydromorphone Hydrochloride Injection or other opioids, as overdose and death could result. (5.1)
Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient's risk before prescribing and reassess regularly for these behaviors and conditions. (5.2)
Serious, life-threatening, or fatal respiratory depression may occur, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] are essential. (5.3)
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate. (5.4, 7)
If opioid use is required for an extended period of time in a pregnant woman, advise the patient of the risk of Neonatal Opioid Withdrawal Syndrome, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery. (5.5)

RECENT MAJOR CHANGES

Boxed Warning

Indications and Usage (1)

Dosage and Administration (2.1, 2.2, 2.5)

Warnings and Precautions (5.6)

12/2023

12/2023

12/2023

12/2023

INDICATIONS AND USAGE

Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] is an opioid agonist indicated for use in opioid-tolerant patients who require higher doses of opioids for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate.

Patients considered opioid tolerant are those who are taking, for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg/hr of transdermal fentanyl per hour, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, at least 25 mg oral oxymorphone per day, at least 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid daily for a week or longer. Patients must remain on around-the-clock opioids when administering Hydromorphone Hydrochloride Injection [high potency formulation (HPF)].

Limitations of Use: (1)

Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration (5.2), reserve Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products):

Have not been tolerated or are not expected to be tolerated,
Have not provided adequate analgesia or are not expected to provide adequate analgesia.

Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.

DOSAGE AND ADMINISTRATION

Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] should be prescribed only by healthcare professionals who are knowledgeable about the use of opioids and how to mitigate the associated risks. (2.1)
Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals. Reserve titration to higher doses of Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks. (2.1, 5)
Many acute pain conditions (e.g., the pain that occurs with a number of surgical procedures or acute musculoskeletal injuries) require no more than a few days of an opioid analgesic. Clinical guidelines on opioid prescribing for some acute pain conditions are available. (2.1)
Initiate the dosing regimen for each patient individually, taking into account the patient’s underlying cause and severity of pain, prior analgesic treatment and response, and risk factors for addiction, abuse, and misuse. (2.1, 5.2)
Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with Hydromorphone Hydrochloride Injection [high potency formulation (HPF)]. Consider this risk when selecting an initial dose and when making dose adjustments. (2.1, 5.3)
Initial Dosage:
o
Intramuscular or Subcutaneous Use: The usual starting dose is 1 mg to 2 mg every 2 to 3 hours as necessary. (2.2)
o
Intravenous Use: The usual starting dose is 0.2 mg to 1 mg every 2 to 3 hours. The injection should be given slowly, over at least 2 to 3 minutes. (2.2)
Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] is for opioid-tolerant patients only and should be used only if the amount of hydromorphone required can be delivered accurately with this formulation. (2.2)
Hepatic Impairment: Initiate treatment with one-fourth to one-half the usual starting dose, depending on degree of hepatic impairment. (2.3)
Renal Impairment: Initiate treatment with one-fourth to one-half the usual starting dose, depending on degree of renal impairment. (2.4)
Do not abruptly discontinue Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] in a physically-dependent patient. (2.6, 5.13)

DOSAGE FORMS AND STRENGTHS

Hydromorphone Hydrochloride Injection, USP [high potency formulation (HPF)], 10 mg/mL available in 1 mL, 5 mL or 50 mL vials. (3)

CONTRAINDICATIONS

Significant respiratory depression. (4)
Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment. (4)
Known or suspected gastrointestinal obstruction, including paralytic ileus. (4)
Known hypersensitivity to hydromorphone, hydromorphone salts, or any other components of the product. (4)
Hydromorphone Hydrochloride Injection [high potency formulation (HPF)]: Patients who are not opioid tolerant. (4)

WARNINGS AND PRECAUTIONS

Opioid-Induced Hyperalgesia and Allodynia: Opioid-Induced Hyperalgesia (OIH) occurs when an opioid analgesic paradoxically causes an increase in pain, or an increase in sensitivity to pain. If OIH is suspected, carefully consider appropriately decreasing the dose of the current opioid analgesic, or opioid rotation. (5.6)
Life-Threatening Respiratory Depression in Patients With Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: Monitor closely, particularly during initiation and titration. (5.7)
Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. (5.8)
Severe Hypotension: Monitor during dosage initiation and titration. Avoid use of Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] in patients with circulatory shock. (5.9)
Risks of Use in Patients With Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness: Monitor for sedation and respiratory depression. Avoid use of Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] in patients with impaired consciousness or coma. (5.10)

ADVERSE REACTIONS

Most common adverse reactions are lightheadedness, dizziness, sedation, nausea, vomiting, sweating, flushing, dysphoria, euphoria, dry mouth, and pruritus. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Serotonergic Drugs: Concomitant use may result in serotonin syndrome. Discontinue Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] if serotonin syndrome is suspected. (7)
Monoamine Oxidase Inhibitors (MAOIs): Can potentiate the effects of hydromorphone. Avoid concomitant use in patients receiving MAOIs or within 14 days of stopping treatment with an MAOI. (7)
Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics: Avoid use with Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] because they may reduce analgesic effect of Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] or precipitate withdrawal symptoms. (7)

USE IN SPECIFIC POPULATIONS

Pregnancy: May cause fetal harm. (8.1)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 4/2024

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use HYDROMORPHONE HYDROCHLORIDE INJECTION [high potency formulation (HPF)] safely and effectively. See full prescribing information for HYDROMORPHONE HYDROCHLORIDE INJECTION [high potency formulation (HPF)].

HYDROMORPHONE HYDROCHLORIDE INJECTION [high potency formulation (HPF)], for intravenous, intramuscular, or subcutaneous use, CII

Initial U.S. Approval: January 1984

WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF HYDROMORPHONE HYDROCHLORIDE INJECTION [HIGH POTENCY FORMULATION (HPF)]

See full prescribing information for complete boxed warning.

Do not confuse Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] with standard parenteral formulations of Hydromorphone Hydrochloride Injection or other opioids, as overdose and death could result. (5.1)
Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient's risk before prescribing and reassess regularly for these behaviors and conditions. (5.2)
Serious, life-threatening, or fatal respiratory depression may occur, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] are essential. (5.3)
Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate. (5.4, 7)
If opioid use is required for an extended period of time in a pregnant woman, advise the patient of the risk of Neonatal Opioid Withdrawal Syndrome, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery. (5.5)

RECENT MAJOR CHANGES

Boxed Warning

Indications and Usage (1)

Dosage and Administration (2.1, 2.2, 2.5)

Warnings and Precautions (5.6)

12/2023

12/2023

12/2023

12/2023

INDICATIONS AND USAGE

Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] is an opioid agonist indicated for use in opioid-tolerant patients who require higher doses of opioids for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate.

Patients considered opioid tolerant are those who are taking, for one week or longer, around-the-clock medicine consisting of at least 60 mg of oral morphine per day, at least 25 mcg/hr of transdermal fentanyl per hour, at least 30 mg of oral oxycodone per day, at least 8 mg of oral hydromorphone per day, at least 25 mg oral oxymorphone per day, at least 60 mg oral hydrocodone per day, or an equianalgesic dose of another opioid daily for a week or longer. Patients must remain on around-the-clock opioids when administering Hydromorphone Hydrochloride Injection [high potency formulation (HPF)].

Limitations of Use: (1)

Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration (5.2), reserve Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products):

Have not been tolerated or are not expected to be tolerated,
Have not provided adequate analgesia or are not expected to provide adequate analgesia.

Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.

DOSAGE AND ADMINISTRATION

Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] should be prescribed only by healthcare professionals who are knowledgeable about the use of opioids and how to mitigate the associated risks. (2.1)
Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals. Reserve titration to higher doses of Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks. (2.1, 5)
Many acute pain conditions (e.g., the pain that occurs with a number of surgical procedures or acute musculoskeletal injuries) require no more than a few days of an opioid analgesic. Clinical guidelines on opioid prescribing for some acute pain conditions are available. (2.1)
Initiate the dosing regimen for each patient individually, taking into account the patient’s underlying cause and severity of pain, prior analgesic treatment and response, and risk factors for addiction, abuse, and misuse. (2.1, 5.2)
Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with Hydromorphone Hydrochloride Injection [high potency formulation (HPF)]. Consider this risk when selecting an initial dose and when making dose adjustments. (2.1, 5.3)
Initial Dosage:
o
Intramuscular or Subcutaneous Use: The usual starting dose is 1 mg to 2 mg every 2 to 3 hours as necessary. (2.2)
o
Intravenous Use: The usual starting dose is 0.2 mg to 1 mg every 2 to 3 hours. The injection should be given slowly, over at least 2 to 3 minutes. (2.2)
Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] is for opioid-tolerant patients only and should be used only if the amount of hydromorphone required can be delivered accurately with this formulation. (2.2)
Hepatic Impairment: Initiate treatment with one-fourth to one-half the usual starting dose, depending on degree of hepatic impairment. (2.3)
Renal Impairment: Initiate treatment with one-fourth to one-half the usual starting dose, depending on degree of renal impairment. (2.4)
Do not abruptly discontinue Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] in a physically-dependent patient. (2.6, 5.13)

DOSAGE FORMS AND STRENGTHS

Hydromorphone Hydrochloride Injection, USP [high potency formulation (HPF)], 10 mg/mL available in 1 mL, 5 mL or 50 mL vials. (3)

CONTRAINDICATIONS

Significant respiratory depression. (4)
Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment. (4)
Known or suspected gastrointestinal obstruction, including paralytic ileus. (4)
Known hypersensitivity to hydromorphone, hydromorphone salts, or any other components of the product. (4)
Hydromorphone Hydrochloride Injection [high potency formulation (HPF)]: Patients who are not opioid tolerant. (4)

WARNINGS AND PRECAUTIONS

Opioid-Induced Hyperalgesia and Allodynia: Opioid-Induced Hyperalgesia (OIH) occurs when an opioid analgesic paradoxically causes an increase in pain, or an increase in sensitivity to pain. If OIH is suspected, carefully consider appropriately decreasing the dose of the current opioid analgesic, or opioid rotation. (5.6)
Life-Threatening Respiratory Depression in Patients With Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: Monitor closely, particularly during initiation and titration. (5.7)
Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. (5.8)
Severe Hypotension: Monitor during dosage initiation and titration. Avoid use of Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] in patients with circulatory shock. (5.9)
Risks of Use in Patients With Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness: Monitor for sedation and respiratory depression. Avoid use of Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] in patients with impaired consciousness or coma. (5.10)

ADVERSE REACTIONS

Most common adverse reactions are lightheadedness, dizziness, sedation, nausea, vomiting, sweating, flushing, dysphoria, euphoria, dry mouth, and pruritus. (6)

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Serotonergic Drugs: Concomitant use may result in serotonin syndrome. Discontinue Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] if serotonin syndrome is suspected. (7)
Monoamine Oxidase Inhibitors (MAOIs): Can potentiate the effects of hydromorphone. Avoid concomitant use in patients receiving MAOIs or within 14 days of stopping treatment with an MAOI. (7)
Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics: Avoid use with Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] because they may reduce analgesic effect of Hydromorphone Hydrochloride Injection [high potency formulation (HPF)] or precipitate withdrawal symptoms. (7)

USE IN SPECIFIC POPULATIONS

Pregnancy: May cause fetal harm. (8.1)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 4/2024

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