XTAMPZA ER Dosage & Rx Info | Uses, Side Effects

Xtampza Er Generic Name & Formulations

Legal Class

CII

General Description

Oxycodone 9mg, 13.5mg, 18mg, 27mg, 36mg; ext-rel caps.

Pharmacological Class

Opioid agonist.

How Supplied

ER caps—100

Manufacturer

Collegium Pharmaceutical, Inc.

Generic Availability

Mechanism of Action

Oxycodone is a full opioid agonist and is relatively selective for the mu receptor, although it can bind to other opioid receptors at higher doses. The principal therapeutic action of oxycodone is analgesia. Although the precise mechanism of the analgesic action is unknown, specific CNS opioid receptors for endogenous compounds with opioid-like activity have been identified throughout the brain and spinal cord and are thought to play a role in the analgesic effects of this drug.

Xtampza Er Indications

Indications

Management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatments are inadequate.

Limitations of Use

Due to risks of addiction, abuse, and misuse with opioids (can occur at any dosage or duration); increased risks of overdose and death with extended-release/long-acting opioid formulations, reserve for use in patients for whom alternative treatment options (eg, non-opioid analgesics, immediate-release opioids) are ineffective, not tolerated, or inadequate to provide sufficient management of pain. Not indicated as an as-needed (prn) analgesic.

Xtampza Er Dosage and Administration

Adult

Use lowest effective dose for shortest duration. Take with food. Swallow whole or may sprinkle capsule contents on soft foods or into a cup. May also give through gastrostomy or NG feeding tube. Individualize. Usually given on a 12-hour schedule. ≥18yrs: Opioid-naive or opioid non-tolerant: initially 9mg every 12hrs. May adjust dose at 1–2 day intervals. Max dose 288mg/day. Hepatic impairment: initiate at ⅓ to ½ the usual starting dose and titrate slowly; use alternative analgesic if <9mg required. Use a single dose >36mg, or a total daily dose >72mg in opioid-tolerant patients only. Withdraw gradually (esp. if opioid-dependent), taper by ≤10–25% every 2–4 weeks. Conversion from other opioids: see full labeling. Concomitant use or discontinuation of CYP3A4 inhibitors or inducers: monitor closely and consider dose adjustments (see full labeling).

Children

<18yrs: not established.

Xtampza Er Contraindications

Contraindications

Significant respiratory depression. Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment. Known or suspected GI obstruction, including paralytic ileus.

Xtampza Er Boxed Warnings

Boxed Warning

Serious and life-threatening risks from use of Xtampza ER: Addiction, abuse, and misuse. Life-threatening respiratory depression. Accidental ingestion. Risks from concomitant use with benzodiazepines or other CNS depressants. Neonatal opioid withdrawal syndrome. Opioid analgesic risk evaluation and mitigation strategy (REMS). Cytochrome P450 3A4 interaction.

Xtampza Er Warnings/Precautions

Warnings/Precautions

Assess the potential need for access to naloxone when initiating and renewing therapy. Consider prescribing naloxone based on risk factors for overdose (eg, history of opioid use disorder, prior opioid overdose, household members or other close contacts at risk for accidental ingestion or overdose). Abuse potential (monitor). Life-threatening respiratory depression esp. during initiation or following dose increases. Accidental exposure may cause fatal overdose (esp. in children). Opioid-induced hyperalgesia (OIH) and allodynia; consider decreasing dose of current opioid or opioid rotation if OIH is suspected. Sleep-related breathing disorders (including central sleep apnea (CSA), sleep-related hypoxemia); consider dose reduction if CSA develops. COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression; monitor and consider non-opioid analgesics. Adrenal insufficiency. Monitor for signs of hypotension when initiating or titrating dose. Head injury. Increased intracranial pressure, brain tumors; monitor. Seizure disorders. CNS depression. Impaired consciousness, coma, shock; avoid. Biliary tract disease. Acute pancreatitis. Drug abusers. Renal or hepatic impairment. Reevaluate periodically. Avoid abrupt cessation. Elderly. Cachectic. Debilitated. Pregnancy; potential neonatal opioid withdrawal syndrome during prolonged use. Labor & delivery, nursing mothers: not recommended.

REMS

YES

Xtampza Er Pharmacokinetics

Distribution

Volume of distribution (steady-state): 2.6 L/kg. Plasma protein bound: ~45%.

Metabolism

N-demethylation (CYP3A), O-demethylation (CYP2D6), glucuronidation.

Elimination

Renal.

Xtampza Er Interactions

Interactions

Increased risk of hypotension, respiratory depression, sedation with benzodiazepines or other CNS depressants (eg, non-benzodiazepine sedatives/hypnotics, anxiolytics, general anesthetics, phenothiazines, tranquilizers, muscle relaxants, antipsychotics, alcohol, other opioids); reserve concomitant use in those for whom alternative options are inadequate; limit dosages/durations to minimum required; monitor closely; consider prescribing naloxone if concomitant use is warranted. During or within 14 days of MAOIs: not recommended. Risk of serotonin syndrome with serotonergic drugs (eg, SSRIs, SNRIs, TCAs, triptans, 5-HT₃ antagonists, mirtazapine, trazodone, tramadol, cyclobenzaprine, metaxalone, MAOIs, linezolid, IV methylene blue); monitor and discontinue if suspected. Avoid concomitant mixed agonist/antagonist opioids (eg, butorphanol, nalbuphine, pentazocine) or partial agonist (eg, buprenorphine); may reduce effects and/or precipitate withdrawal symptoms. Potentiated by CYP3A4 inhibitors (eg, macrolides, azole antifungals, protease inhibitors). Antagonized by CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin). May antagonize diuretics; monitor. Paralytic ileus may occur with anticholinergics. May increase serum amylase.

Xtampza Er Adverse Reactions

Adverse Reactions

Nausea, headache, constipation, somnolence, pruritus, vomiting, dizziness; respiratory depression, orthostatic hypotension, syncope, OIH and allodynia.

Xtampza Er Clinical Trials

See Literature

Xtampza Er Note

Not Applicable

Xtampza Er Patient Counseling