Xartemis XR

XARTEMIS XR- oxycodone hydrochloride and acetaminophen tablet, coated
PD-Rx Pharmaceuticals, Inc.

WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING
RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID
WITHDRAWAL SYNDROME; CYTOCHROME P450 3A4 INTERACTION; HEPATOTOXICITY; and RISKS FROM CONCOMITANT USE WITH BENZODIAZEPINES OR OTHER CNS DEPRESSANTS

Addiction, Abuse, and Misuse
XARTEMIS XR 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 XARTEMIS XR, and monitor all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions ( 5.1)].

Life-Threatening Respiratory Depression
Serious, life-threatening, or fatal respiratory depression may occur with use of XARTEMIS XR. Monitor for respiratory depression, especially during initiation of XARTEMIS XR or following a dose increase. Instruct patients to swallow XARTEMIS XR tablets whole; crushing, chewing, or dissolving XARTEMIS XR can cause rapid release and absorption of a potentially fatal dose of oxycodone [see Warnings and Precautions ( 5.2)].

Accidental Ingestion
Accidental ingestion of XARTEMIS XR, especially by children, can result in a fatal overdose of oxycodone [see Warnings and Precautions ( 5.2)].

Neonatal Opioid Withdrawal Syndrome
Prolonged use of XARTEMIS XR during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and requires management according to protocols developed by neonatology experts. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available [see Warnings and Precautions ( 5.3)].

Cytochrome P450 3A4 Interaction
The concomitant use of XARTEMIS XR with all cytochrome P450 3A4 inhibitors may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in oxycodone plasma concentration. Monitor patients receiving XARTEMIS XR and any CYP3A4 inhibitor or inducer [see Warnings and Precautions ( 5.4), Drug Interactions ( 7), Clinical Pharmacology ( 12.3)].

Hepatotoxicity
XARTEMIS XR contains acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4,000 milligrams per day, and often involve more than one acetaminophen-containing product [see Warnings and Precautions ( 5.5, 5.12)].

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 [see Warnings and Precautions ( 5.6), Drug Interactions ( 7)].

  • Reserve concomitant prescribing of XARTEMIS XR and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.
  • Limit dosages and durations to the minimum required.
  • Follow patients for signs and symptoms of respiratory depression and sedation.

1 INDICATIONS AND USAGE

XARTEMIS XR is indicated for the management of acute pain severe enough to require opioid treatment and for which alternative treatment options are inadequate.

Limitations of Use

Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses [see Warnings and Precautions ( 5.1)] , reserve XARTEMIS XR for use in patients for whom alternative treatment options (e.g., non-opioid analgesics):

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

2 DOSAGE AND ADMINISTRATION

2.1 Important Dosage and Administration Instructions

XARTEMIS XR is not interchangeable with other oxycodone/acetaminophen products because of differing pharmacokinetic profiles that affect the frequency of administration.

  • Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals [see Warnings and Precautions ( 5)] .
  • Initiate the dosing regimen for each patient individually, taking into account the patient’s severity of pain, patient response, 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 and following dosage increases with XARTEMIS XR and adjust the dosage accordingly [see Warnings and Precautions ( 5.2)] .

XARTEMIS XR is given orally. Instruct patients to swallow XARTEMIS XR tablets whole, one tablet at a time, with enough water to ensure complete swallowing immediately after placing in mouth [see Patient Counseling Information ( 17)] . Do not break, chew, crush, cut, dissolve or split the tablets. Breaking, chewing, crushing, cutting, dissolving or splitting XARTEMIS XR tablets will result in uncontrolled delivery of oxycodone and can lead to overdose or death [see Warnings and Precautions ( 5.1)] .

The total daily dose of acetaminophen from all drug products should not exceed 4,000 milligrams.

2.2 Initial Dosage

Use of XARTEMIS XR as the First Opioid Analgesic

The recommended dosage of XARTEMIS XR is 2 tablets every 12 hours administered with or without food. The second dose of 2 tablets may be administered as early as 8 hours after the initial dose if patients require analgesia at that time. Subsequent doses are to be administered 2 tablets every 12 hours.

2.3 Dosage Modifications in Patients with Hepatic Impairment

In patients with hepatic impairment start with one tablet and adjust dosage as needed. Monitor closely for respiratory depression, sedation, and hypotension [see Use in Specific Populations ( 8.6), Clinical Pharmacology ( 12.3)] .

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