How is Xtampza ER different from other long-acting pain medications?

Xtampza ER can be taken in multiple ways that do not involve swallowing pills or capsules

  • According to an FDA publication, up to 40% of Americans may experience difficulties swallowing tablets and capsules
  • Many patients with chronic pain also experience issues with swallowing

In a survey of US adults.

If you have difficulty swallowing Xtampza ER capsules, talk to your doctor. Xtampza ER can be taken 4 ways, including several not previously available in other ER opioid medications:

  • Oral capsule

  • Sprinkled on soft foods

  • Sprinkled in a cup and then directly into mouth

  • Taken through feeding tubes

Xtampza ER MUST be taken with food.

It's important that you take your medication exactly as prescribed

Unlike other ER opioid medications, Xtampza ER is designed with DETERx® technology

DETERx technology can help prevent problems such as misuse or abuse

  • Misuse is when a medicine is used incorrectly (this can be on purpose or not)
  • Abuse is when a medicine is used for a nonmedical purpose, such as “getting high”

Store Xtampza ER away from children and in a safe place to prevent stealing or abuse.

Although Xtampza ER is formulated to make manipulation more difficult, it cannot entirely prevent abuse; abuse of Xtampza ER by injection and via the oral and nasal routes is still possible

INDICATIONS AND USAGE

Xtampza® ER (oxycodone) is indicated for the management of pain severe enough to require daily, around-the-clock, long-term 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, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve Xtampza ER for use in patients for whom alternative treatment options (eg, non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain
  • Xtampza ER is not indicated as an as-needed (prn) analgesic

IMPORTANT SAFETY INFORMATION

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

Addiction, Abuse, and Misuse

Xtampza ER 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 Xtampza ER and monitor all patients regularly for the development of these behaviors or conditions.

Life-threatening Respiratory Depression

Serious, life-threatening, or fatal respiratory depression may occur with use of Xtampza ER. Monitor for respiratory depression, especially during initiation of Xtampza ER or following a dose increase.

Accidental Ingestion

Accidental ingestion of even one dose of Xtampza ER, especially by children, can result in a fatal overdose of oxycodone.

Neonatal Opioid Withdrawal Syndrome

Prolonged use of Xtampza ER during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, 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.

Cytochrome P450 3A4 Interaction

The concomitant use of Xtampza ER with all cytochrome P450 3A4 inhibitors may result in an increase in oxycodone plasma concentrations, which could increase or prolong adverse drug effects 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 Xtampza ER and any CYP3A4 inhibitor or inducer.

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 Xtampza ER 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

CONTRAINDICATIONS:

WARNINGS AND PRECAUTIONS:

Addiction, Abuse, and Misuse

Life-threatening Respiratory Depression

Neonatal Opioid Withdrawal Syndrome

Risks of Concomitant Use or Discontinuation of Cytochrome P450 3A4 Inhibitors and Inducers

Risks From Concomitant Use With Benzodiazepines or Other CNS Depressants

Risk of Life-threatening Respiratory Depression in Patients With Chronic Pulmonary Disease or in Elderly, Cachectic, or Debilitated Patients

The use of Xtampza ER in patients with acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment is contraindicated.

Patients With Chronic Pulmonary Disease:

Xtampza ER -treated patients with significant chronic obstructive pulmonary disease or cor pulmonale, and those with a substantially decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression are at increased risk of decreased respiratory drive including apnea, even at recommended dosages of Xtampza ER.

Elderly, Cachectic, or Debilitated Patients:

Life-threatening respiratory depression is more likely to occur in elderly, cachectic, or debilitated patients as they may have altered pharmacokinetics or altered clearance compared to younger, healthier patients.

Monitor such patients closely, particularly when initiating and titrating Xtampza ER and when Xtampza ER is given concomitantly with other drugs that depress respiration.

Alternatively, consider the use of non-opioid analgesics in these patients. Use an alternative analgesic for patients who require a dose of Xtampza ER less than 9 mg.

Adrenal Insufficiency

Severe Hypotension

Risks of Use in Patients With Increased Intracranial Pressure, Brain Tumors, Head Injury, or Impaired Consciousness

Risks of Use in Patients With Gastrointestinal Conditions

Risk of Use in Patients With Seizure Disorders

Withdrawal

Risks of Driving and Operating Machinery

Laboratory Monitoring

ADMINISTRATION WITH FOOD:

ADVERSE REACTIONS:

Please see full Prescribing Information, including Boxed Warning and Medication Guide.