OXAYDO

2 DOSAGE AND ADMINISTRATION OXAYDO should be prescribed only by healthcare professionals who are knowledgeable about the use of opioids and how to mitigate the associated risks. ( 2.1 ) Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals. Reserve titration to higher doses of OXAYDO for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks. ( 2.1 , 5 ) Many acute pain conditions (e.g., the pain that occurs with a number of surgical procedures or acute musculoskeletal injuries) require no more than a few days of an opioid analgesic. Clinical guidelines on opioid prescribing for some acute pain conditions are available. ( 2.1 ) Initiate the dosing regimen for each patient individually, taking into account the patient’s underlying cause and severity of pain, prior analgesic treatment and response, and risk factors for addiction, abuse, and misuse. ( 2.1 , 5.1 ) Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with OXAYDO. Consider this risk when selecting an initial dose and when making dose adjustments. ( 2.1 , 5.2 ) Discuss opioid overdose reversal agents and options for acquiring them with the patient and/or caregiver, both when initiating and renewing treatment with OXAYDO, especially if the patient has additional risk factors for overdose, or close contacts at risk for exposure and overdose. ( 2.2 , 5.1 , 5.2 , 5.3 ) For opioid naïve patients, initiate treatment with 5 mg to 15 mg every 4 to 6 hours as needed for pain, and at the lowest dose necessary to achieve adequate analgesia. Titrate the dose based upon the individual patient’s response to their initial dose of OXAYDO. ( 2.2 , 2.4 ) Must be swallowed whole and is not amenable to crushing and dissolution. Do not use OXAYDO for administration via nasogastric, gastric, or other feeding tubes as it may cause obstruction of feeding tubes ( 2.1 , 17 ) Must take tablets one at a time, with enough water to ensure complete swallowing immediately after placing in mouth. ( 2.1 ) Periodically reassess patients receiving OXAYDO to evaluate the continued need for opioid analgesics to maintain pain control, for the signs or symptoms of adverse reactions, and for the development of addiction, abuse, or misuse. ( 2.4 ) Do not rapidly reduce or abruptly discontinue OXAYDO in a physically-dependent patient because rapid reduction or abrupt discontinuation of opioid analgesics has resulted in serious withdrawal symptoms, uncontrolled pain, and suicide. ( 2.4 , 5.14 ) 2.1 Important Dosage and Administration Instructions OXAYDO should be prescribed only by healthcare professionals who are knowledgeable about the use of opioids and how to mitigate the associated risks. Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals [see Warnings and Precautions ( 5 )]. Because the risk of overdose increases as opioid doses increase, reserve titration to higher doses of OXAYDO for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks. Many acute pain conditions (e.g., the pain that occurs with a number of surgical procedures or acute musculoskeletal injuries) require no more than a few days of an opioid analgesic. Clinical guidelines on opioid prescribing for some acute pain conditions are available. There is variability in the opioid analgesic dose and duration needed to adequately manage pain due both to the cause of pain and to individual patient factors. Initiate the dosing regimen for each patient individually, taking into account the patient’s underlying cause and severity of pain, prior analgesic treatment and response, and risk factors for addiction, abuse, and misuse [see Warnings and Precautions ( 5.1 )]. Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with OXAYDO. Consider this risk when selecting an initial dose and when making dose adjustments [see Warnings and Precautions ( 5.2 )]. OXAYDO must be swallowed whole. Take each tablet with enough water to ensure complete swallowing immediately after placing in the mouth. OXAYDO is not amenable to crushing and dissolution. Do not administer OXAYDO via nasogastric, gastric or other feeding tubes as it may cause obstruction of feeding tubes. 2.2 Patient Access to an Opioid Overdose Reversal Agent for the Emergency Treatment of Opioid Overdose Inform patients and caregivers about opioid overdose reversal agents (e.g., naloxone, nalmefene). Discuss the importance of having access to an opioid overdose reversal agent, especially if the patient has risk factors for overdose (e.g., concomitant use of CNS depressants, a history of opioid use disorder, or prior opioid overdose) or if there are household members (including children) or other close contacts at risk for accidental ingestion or opioid overdose. The presence of risk factors for overdose should not prevent the management of pain in any patient [ see Warnings and Precautions ( 5.1 , 5.2 , 5.3 ) ]. Discuss the options for obtaining an opioid overdose reversal agent (e.g., prescription, over-the-counter, or as part of a community-based program) [ see Warnings and Precautions ( 5.2 ) ]. There are important differences among the opioid overdose reversal agents, such as route of administration, product strength, approved patient age range, and pharmacokinetics. Be familiar with these differences, as outlined in the approved labeling for those products, prior to recommending or prescribing such an agent. 2.3 Initial Dosage Although it is not possible to list every condition that is important to the selection of the initial dose of OXAYDO, attention must be given to: the daily dose, potency and characteristics of a full agonist or mixed agonist/antagonist the patient has been taking previously the reliability of the relative potency estimate to calculate the dose of oxycodone HCl needed the degree of opioid tolerance the general condition and medical status of the patient, including the patient’s weight and age the balance between pain management and adverse reactions the type and severity of the patient’s pain risk factors for abuse or addiction, including a prior history of abuse or addiction Use of OXAYDO as the First Opioid Analgesic Initiate treatment with OXAYDO in a dosing range of 5 mg to 15 mg every 4 to 6 hours as needed for pain, and at the lowest dose necessary to achieve adequate analgesia. Titrate the dose based upon the individual patient’s response to their initial dose of OXAYDO . Conversion from Other Opioids to OXAYDO There is inter-patient variability in the potency of opioid drugs and opioid formulations. Therefore, a conservative approach is advised when determining the total daily dosage of OXAYDO. It is safer to underestimate a patient’s 24-hour OXAYDO dosage than to overestimate the 24-hour OXAYDO dosage and manage an adverse reaction due to overdose. If a patient has been receiving opioid-containing medications prior to taking OXAYDO , the potency of the prior opioid relative to oxycodone should be factored into the selection of the total daily dose (TDD) of oxycodone. In converting patients from other opioids to Oxycodone Hydrochloride Capsules, close observation and adjustment of dosage based upon the patient’s response to OXAYDO is imperative. Administration of supplemental analgesia for breakthrough or incident pain and titration of the total daily dose of OXAYDO may be necessary, especially in patients who have disease states that are changing rapidly. Conversion from Fixed-Ratio Oral Opioid/Non-Opioid Combinations When converting patients from fixed-ratio opioid/non-opioid drug regimens to OXAYDO, determine whether or not to continue the non-opioid analgesic. Titrate the dose of OXAYDO in response to the level of analgesia and adverse reactions afforded by the dosing regimen regardless of whether the non-opioid is continued. Conversion from Other Oral Opioid Therapy to OXAYDO If a patient has been receiving opioid-containing medications prior to taking OXAYDO, factor the potency of the prior opioid relative to oxycodone into the selection of the total daily dose of oxycodone. In converting patients from other opioids to OXAYDO, close observation and adjustment of dosage based upon the patient's response to OXAYDO is imperative. Conversion from OXAYDO to Extended-Release Oxycodone The relative bioavailability of OXAYDO compared to extended-release oxycodone is unknown, so conversion to extended-release tablets may lead to increased risk of excessive sedation and respiratory depression. 2.4 Titration and Maintenance of Therapy Individually titrate OXAYDO to a dose that provides adequate analgesia and minimizes adverse reactions. Continually reevaluate patients receiving OXAYDO to assess the maintenance of pain control, signs and symptoms of opioid withdrawal, and other adverse reactions, as well as to reassess for the development of addiction, abuse, or misuse [ see Warnings and Precautions ( 5.1 , 5.14 ) ]. Frequent communication is important among the prescriber, other members of the healthcare team, the patient, and the caregiver/family during periods of changing analgesic requirements, including initial titration. If the level of pain increases after dosage stabilization, attempt to identify the source of increased pain before increasing the dosage of OXAYDO. If after increasing the dosage, unacceptable opioid-related adverse reactions are observed (including an increase in pain after a dosage increase), consider reducing the dosage [ see Warnings and Precautions ( 5 ) ]. Adjust the dosage to obtain an appropriate balance between management of pain and opioid-related adverse reactions. 2.5 Safe Reduction or Discontinuation of OXAYDO Do not rapidly reduce or abruptly discontinue OXAYDO in patients who may be physically dependent on opioids. Rapid reduction or abrupt discontinuation of opioid analgesics in patients who are physically dependent on opioids has resulted in serious withdrawal symptoms, uncontrolled pain, and suicide. Rapid reduction or abrupt discontinuation has also been associated with attempts to find other sources of opioid analgesics, which may be confused with drug-seeking for abuse. Patients may also attempt to treat their pain or withdrawal symptoms with illicit opioids, such as heroin, and other substances. When a decision has been made to decrease the dose or discontinue therapy in an opioid-dependent patient taking OXAYDO, there are a variety of factors that should be considered, including the total daily dose of opioid (including OXAYDO) the patient has been taking, the duration of treatment, the type of pain being treated, and the physical and psychological attributes of the patient. It is important to ensure ongoing care of the patient and to agree on an appropriate tapering schedule and follow-up plan so that patient and provider goals and expectations are clear and realistic. When opioid analgesics are being discontinued due to a suspected substance use disorder, evaluate and treat the patient, or refer for evaluation and treatment of the substance use disorder. Treatment should include evidence-based approaches, such as medication assisted treatment of opioid use disorder. Complex patients with comorbid pain and substance use disorders may benefit from referral to a specialist. There are no standard opioid tapering schedules that are suitable for all patients. Good clinical practice dictates a patient-specific plan to taper the dose of the opioid gradually. For patients on OXAYDO who are physically opioid-dependent, initiate the taper by a small enough increment (e.g., no greater than 10% to 25% of the total daily dose) to avoid withdrawal symptoms, and proceed with dose-lowering at an interval of every 2 to 4 weeks. Patients who have been taking opioids for briefer periods of time may tolerate a more rapid taper. It may be necessary to provide the patient with lower dosage strengths to accomplish a successful taper. Reassess the patient frequently to manage pain and withdrawal symptoms, should they emerge. Common withdrawal symptoms include restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other signs and symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate. If withdrawal symptoms arise, it may be necessary to pause the taper for a period of time or raise the dose of the opioid analgesic to the previous dose and then proceed with a slower taper. In addition, evaluate patients for any changes in mood, emergence of suicidal thoughts, or use of other substances. When managing patients taking opioid analgesics, particularly those who have been treated for an extended period of time and/or with high doses for chronic pain, ensure a multimodal approach to pain management, including mental health support (if needed), is in place prior to initiating an opioid analgesic taper. A multimodal approach to pain management may optimize the treatment of chronic pain, as well as assist with the successful tapering of the opioid analgesic [ see Warnings and Precautions ( 5.14 ), Drug Abuse and Dependence ( 9.3 ) ].

See official label

1 INDICATIONS AND USAGE OXAYDO is indicated for the management of acute and chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.