Initiating therapy with twice-daily Xtampza ER

  • Initiation & Titration
  • Equivalent Dosage
  • Dosage Calculator

Xtampza ER initiation and titration

Advise patients to eat approximately the same amount of food with each dose to ensure consistent plasma levels1

Opioid-naïve and opioid non-tolerant starting dose1

  • Initiate treatment with one 9-mg capsule orally every 12 hours with food

Individually titrate to a dosage that provides adequate analgesia while minimizing adverse reactions1

  • The dosage may be adjusted every 1 to 2 days
  • Reduce the dosage if unacceptable adverse reactions are observed
  • As a guideline, the total daily oxycodone dosage usually can be increased by 25% to 50% each time an increase is clinically indicated
  • The maximum daily dosage is 288 mg (eight 36-mg capsules, equivalent to 320 mg oxycodone HCl)

Reference

1. Xtampza ER [prescribing information]. Canton, MA: Collegium Pharmaceutical, Inc; 2016.

Equivalent dosage from oxycodone HCl to Xtampza ER

Available in 5 different capsule strengths1

Capsules not actual size.

Xtampza ER is formulated with an oxycodone base that has a lower molecular weight than oxycodone HCl1,2

To convert from other oral oxycodone formulations, administer half the equivalent total daily oral oxycodone dose Q12 hr with food1

  • Example: A patient receiving a total daily dose of 80 mg of oxycodone IR would receive 36 mg of Xtampza ER Q12 hr with food
  • Example: A patient receiving 40 mg of oxycodone ER Q12 hr would receive 36 mg of Xtampza ER Q12 hr with food

References

1. Xtampza ER [prescribing information]. Canton, MA: Collegium Pharmaceutical, Inc; 2016. 2. OxyContin [prescribing information]. Stamford, CT: Purdue Pharma L.P.; 2015.

Calculate the starting dosage of Xtampza ER

Equivalent dosage from:

  • Other oxycodone formulations1
  • Other opioids2

Total daily dose:

mg
mg Q12 hr Xtampza ER
This is equivalent to mg of morphine.

This tool is provided for demonstration purposes only. Do not rely solely on this calculator when converting to Xtampza ER. Dosing recommendations on the calculator do not replace clinical evaluation and decision.

There are no established conversion ratios for conversion from other opioids to Xtampza ER defined by clinical trials. The conversion ratios used in this calculation were adapted from equianalgesic doses published in Mary Lynn McPherson’s Demystifying Opioid Conversion Calculations: A Guide for Effective Dosing (2010).

A 50% reduction is factored into the calculation to account for interpatient variability in relative potency of different opioids. Monitor patients for potential toxicity and adequate analgesia after converting to Xtampza ER.1,2

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References

1. Xtampza ER [prescribing information]. Canton, MA: Collegium Pharmaceutical, Inc; 2016. 2. McPherson ML. Demystifying Opioid Conversion Calculations: A Guide for Effective Dosing. Bethesda, MD: American Society of Health-System Pharmacists; 2010.

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.