IMPORTANT SAFETY INFORMATION

Dilaudid^® (HYDROmorphone HCl) Injection, USP

IMPORTANT SAFETY INFORMATION

WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF DILAUDID INJECTION

Addiction, Abuse, and Misuse

Because the use of DILAUDID INJECTION exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient's risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions.

Life-Threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of DILAUDID INJECTION, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of DILAUDID INJECTION are essential.

Risks From Concomitant Use With Benzodiazepines Or Other CNS Depressants

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 of DILAUDID INJECTION and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.

Neonatal Opioid Withdrawal Syndrome (NOWS)

Advise pregnant women using opioids for an extended period of time 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.

INDICATIONS AND USAGE

DILAUDID INJECTION (hydromorphone hydrochloride) for intravenous, intramuscular, or subcutaneous use, is an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternate treatments are inadequate.

Limitations of Use: Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration, and persist over the course of therapy, reserve opioid analgesics, including DILAUDID INJECTION for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.

Do not rapidly reduce or abruptly discontinue DILAUDID INJECTION in patients who may be physically dependent on opioids.

CONTRAINDICATIONS

DILAUDID INJECTION is contraindicated in patients with:

Significant respiratory depression.
Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment.
Known or suspected gastrointestinal obstruction, including paralytic ileus.
Known hypersensitivity to hydromorphone, hydromorphone salts, sulfite-containing medications, or any other components of the product.

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.
Life-Threatening Respiratory Depression in Patients with Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients: Monitor closely, particularly during initiation and titration.
Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid.
Severe Hypotension: Monitor during dosage initiation and titration. Avoid use of DILAUDID INJECTION in patients with circulatory shock.
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 DILAUDID INJECTION in patients with impaired consciousness or coma.
DILAUDID INJECTION contains sodium metabisulfite: There is a risk of anaphylactic symptoms and life-threatening asthmatic episodes in susceptible people.

ADVERSE REACTIONS

Serious adverse reactions associated with DILAUDID INJECTION include respiratory depression and apnea and, to a lesser degree, circulatory depression, respiratory arrest, shock, and cardiac arrest.

The most common adverse reactions are lightheadedness, dizziness, sedation, nausea, vomiting, sweating, flushing, dysphoria, euphoria, dry mouth, and pruritus.

Opioid-induced esophageal dysfunction (OIED): Cases of OIED have been reported in patients taking opioids and may occur more frequently in patients taking higher doses of opioids, and/or in patients taking opioids longer term

To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Serotonergic Drugs: Concomitant use may result in serotonin syndrome. Discontinue DILAUDID INJECTION if serotonin syndrome is suspected.
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.
Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics: Avoid use with DILAUDID INJECTION because they may reduce analgesic effect of DILAUDID INJECTION or precipitate withdrawal symptoms.

USE IN SPECIFIC POPULATIONS

Pregnancy: May cause fetal harm.

OVERDOSAGE

Acute overdose with hydromorphone can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and, in some cases, pulmonary edema, bradycardia, hypotension, hypoglycemia, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis, rather than miosis, may be seen with hypoxia in overdose situations. Toxic leukoencephalopathy has been reported after opioid overdose and can present hours, days, or weeks after apparent recovery from the initial intoxication.

In case of overdose, priorities are the reestablishment of a patent airway and protected airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures (including oxygen and vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life-support measures. For clinically significant respiratory or circulatory depression secondary to hydromorphone overdose, administer an opioid overdose reversal agent such as naloxone or nalmefene. Because the duration of opioid reversal is expected to be less than the duration of hydromorphone in DILAUDID INJECTION, carefully monitor the patient until spontaneous respiration is reliably reestablished.

This important safety information does not include all the information needed to use DILAUDID INJECTION safely and effectively. Please see full prescribing information, including BOXED WARNING, for Dilaudid Injection.

Significant risks and stressors exist at the point of drug preparation and administration.

Simplist^® ready-to-administer (RTA) prefilled syringes simplify the process and reduce the opportunity for error.¹

Ready-to-administer
Manufacturer-prepared
18–, 24–, or 36–month shelf life
Single unit dosing
Tamper-evident packaging

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Simplist is associated with a 4x lower error rate^* compared to traditional practice, including a cartridge-based systems¹

10.4

2.5

4x

lower error rate

A prospective, multisite, observational study of IV push medication preparation and administration compared the error rates between ready-to-administer products and traditional practice, including a cartridge-based syringe system and vial and syringe.

Simplist was the only RTA delivery system used in the study
Study limitations include only a select number of sites (3) and steps observed

Ready-to-administer delivery system benefits²

Medication Safety

Fewer steps and manipulations, minimizing contamination and limiting the opportunities for medication errors^2,3
Optimizing product presentations with single unit doses may reduce waste and financial burden⁴
Adherence to safety guidelines²
Labeled and barcoded to help verification of proper drug and dose prior to administration, promoting safe medication delivery²

Operational Efficiency

No dilution required
Time savings and improved workflow for nurses²
Improved nurse satisfaction²
Reduced training requirements for medication administration²
Less variability in administration practices² ³
Improved standardization^2,3

RTA medication systems are recommended by leading independent medication safety associations and professional organizations.^4,5,6,7

The Joint Commission

Whenever possible, have medications available in ready-to-administer form.⁴

CMS State Operations Manual

Whenever possible, medications shall be available for inpatient use in single-unit packages and in a ready-to-administer form. Manipulation of medications before administration by final users should be minimized.⁵

American Society of Health-System Pharmacists

Whenever possible, medications are dispensed in the most ready to administer form available from the manufacturer.⁶

Institute for Safe Medication Practices

To the greatest extent possible, provide adult IV push medications in a ready-to-administer form (to minimize the need for manipulation outside of the pharmacy sterile compounding area). Do not withdraw IV push medications from commercially available, cartridge-type syringes into another syringe for administration.⁷

MicroVault^® packaging supports secure dispensing of controlled substances

Simplist prefilled syringes in MicroVault tamper-evident packaging provides options that may help enable product size optimization in a consistent drug delivery system across our portfolio.

Omnicell^® Controlled Substance Dispenser (CSD) accommodates Simplist MicroVault prefilled syringes

The Controlled Substance Dispenser provides additional levels of security for single dose dispensing of high-risk, high-value medications.

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Blister packaging with clear, easy-to-read labels may help ensure delivery of the right medication at the right dose

Each Simplist prefilled syringe and blister are color coded and identically prelabeled with the drug name, strength, expiration date, and barcode to assist with drug identification.

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Simplist MicroVault instructions for use video

Simplist MicroVault Instructions for Use Training Video

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