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Please see Program Terms, Conditions, and Eligibility Criteria, which include additional exclusions.
ROXYBOND™ (oxycodone hydrochloride) tablets, for oral use, CII, is a strong prescription pain medicine that contains an opioid (narcotic) that is used to manage pain severe enough to require an opioid pain medicine, when other pain treatments such as non-opioid pain medicines do not treat your pain well enough or you cannot tolerate them.
ROXYBOND is an opioid pain medicine that can put you at risk for overdose and death. Even if you take your dose correctly as prescribed you are at risk for opioid addiction, abuse, and misuse that can lead to death.
WARNING: ADDICTION, ABUSE, AND MISUSE; RISK EVALUATION AND MITIGATION STRATEGY (REMS); 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
ROXYBOND 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 ROXYBOND, and monitor all patients regularly for the development of these behaviors and conditions.Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)
To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to
Serious, life-threatening, or fatal respiratory depression may occur with use of ROXYBOND. Monitor for respiratory depression, especially during initiation of ROXYBOND or following a dose increase.Accidental Ingestion
Accidental ingestion of even one dose of ROXYBOND, especially by children, can result in a fatal overdose of oxycodone.Neonatal Opioid Withdrawal Syndrome
Prolonged use of ROXYBOND 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 ROXYBOND 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 ROXYBOND 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.
These are not all the possible side effects of ROXYBOND. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. For more information go to dailymed.nlm.nih.gov
Please see additional Important Safety Information, and full Prescribing Information, including BOXED WARNINGS and Medication Guide at ProtegaPharma.com prior to taking ROXYBOND. Speak with your healthcare provider if you have additional questions about ROXYBOND.