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FAQs

How can my patients find the closest pharmacy that carries ZOHYDRO® ER with BeadTek™?

Patients can call 1-844-676-9663 (Monday - Friday, 8 AM to 9 PM EST)
A Pharmacy Locator Specialist will determine which local pharmacies have Zohydro® ER (hydrocodone bitartrate) Extended-Release Capsules, CII, in stock and call the patient back.

Setting expectations for your patients

  • Before patients transition to Zohydro® ER with BeadTek™, ensure they are equipped with enough of their current treatment to cover the time period while the pharmacy orders and receives Zohydro® ER with BeadTek™. Pharmacy ordering and receiving can take 2 to 3 days, which is the case with many controlled substances
  • When providing a pain contract to your patients, include the name of a pharmacy that you know stocks Zohydro® ER with BeadTek™

How is Zohydro® ER with BeadTek™ different from the original formulation?

BeadTek™ consists of polyethylene oxide (PEO), a commonly used pharmaceutical excipient.1-3

  • Each Zohydro® ER (hydrocodone bitartrate) Extended-Release Capsules, CII, with BeadTek capsule contains an indistinguishable mix of active immediate- and extended-release hydrocodone beads, plus inactive PEO beads.3 When taken as directed, the PEO beads in Zohydro ER with BeadTek™ remain inert.1,3 However, when crushed and dissolved in liquids or solvents, the PEO is designed to immediately form a viscous gel3
  • With intravenous abuse, the inactive ingredients in Zohydro ER with BeadTek™ can result in death, local tissue necrosis, infection, pulmonary granulomas, and increased risk of endocarditis and valvular heart injury1

The clinical significance of BeadTek™ on abuse/misuse liability has not been established.

The PEO beads of BeadTek™ are inactive. These beads are designed so that as they transit through the body and come in contact with liquids, they swell and dissolve.3 The PEO beads dissolve independently of the active hydrocodone beads and are designed not to change the 12-hour release properties of the medication when taken as directed.1,3

References: 1. Zohydro ER [package insert]. Morristown, NJ: Pernix Therapeutics, LLC.; 2016. 2. Chemical Products Corporation. Generally recognized as safe (GRAS) determination notification for poloxamer fatty acid ester formulations [letter to the FDA]. April 20, 2012. 3. Data on file. Pernix Therapeutics, LLC.

Is Zohydro® ER with BeadTek™ a DEA Schedule II or Schedule III product?

Zohydro® ER with BeadTek™ is a DEA Schedule II drug.1

Reference: 1. Zohydro ER [package insert]. Morristown, NJ: Pernix Therapeutics, LLC.; 2016.

What are the dose strengths for Zohydro® ER with BeadTek™?

Zohydro® ER with BeadTek™ is available in doses of 10 mg, 15 mg, 20 mg, 30 mg, 40 mg, and 50 mg.1

Reference: 1. Zohydro ER [package insert]. Morristown, NJ: Pernix Therapeutics, LLC.; 2016.

Has a Risk Evaluation and Mitigation Strategy (REMS) program been
developed for Zohydro® ER with BeadTek™?

Pernix Therapeutics is adhering to the class-wide Risk Evaluation and Mitigation Strategy (REMS) requirements for preventing inappropriate prescribing, misuse, and abuse of extended-release opioids.

For more information about REMS, visit http://www.er-la-opioidrems.com/IwgUI/rems/home.action.

What is the payer coverage for Zohydro® ER with BeadTek™?

Zohydro® ER with BeadTek™ is available to 7 out of 10 people with commercial or Medicare coverage.1*

*Certain restrictions apply.

The formulary status of Zohydro® ER with BeadTek™ can vary by plan and pharmacy benefit design. As status often changes, be sure to find updated, plan-specific coverage.

Reference: 1. Managed Markets Insight and Technology (MMIT) data as reviewed January 2016.

INDICATION

Zohydro® ER (hydrocodone bitartrate) is an extended-release opioid agonist 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

IMPORTANT SAFETY INFORMATION

WARNING: ADDICTION, ABUSE AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTION WITH ALCOHOL; and CYTOCHROME P450 3A4 INTERACTION

Addiction, Abuse, and Misuse

ZOHYDRO 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 ZOHYDRO 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 ZOHYDRO ER. Monitor for respiratory depression, especially during initiation of ZOHYDRO ER or following a dose increase. Instruct patients to swallow ZOHYDRO ER capsules whole; crushing, chewing, or dissolving ZOHYDRO ER capsules can cause rapid release and absorption of a potentially fatal dose of hydrocodone.

Accidental Ingestion

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

Neonatal Opioid Withdrawal Syndrome

Prolonged use of ZOHYDRO 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.

Interaction with Alcohol

Instruct patients not to consume alcoholic beverages or use prescription or non-prescription products that contain alcohol while taking ZOHYDRO ER. The co-ingestion of alcohol with ZOHYDRO ER may result in increased plasma levels and a potentially fatal overdose of hydrocodone.

Cytochrome P450 3A4 Interaction

The concomitant use of ZOHYDRO ER with all cytochrome P450 3A4 inhibitors may result in an increase in hydrocodone 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 hydrocodone plasma concentration. Monitor patients receiving ZOHYDRO ER and any CYP3A4 inhibitor or inducer.

CONTRAINDICATIONS

Zohydro ER is contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma, known or suspected paralytic ileus, or hypersensitivity to hydrocodone bitartrate.

WARNINGS AND PRECAUTIONS

See Boxed WARNINGS

ADVERSE REACTIONS

DRUG INTERACTIONS

INDICATION

Zohydro® ER (hydrocodone bitartrate) is an extended-release opioid agonist 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 Zohydro ER for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
  • Zohydro ER is not indicated as an as-needed (prn) analgesic.

CONTRAINDICATIONS

Zohydro ER is contraindicated in patients with significant respiratory depression, acute or severe bronchial asthma, known or suspected paralytic ileus, or hypersensitivity to hydrocodone bitartrate.

WARNINGS AND PRECAUTIONS

See Boxed WARNINGS

  • Interactions with CNS Depressants: Concomitant use may cause profound sedation, respiratory depression, and death. If coadministration is required, consider dose reduction of one or both drugs.
  • Elderly, Cachectic, Debilitated Patients, and Those with Chronic Pulmonary Disease: Monitor closely because of increased risk for life-threatening respiratory depression
  • Hypotensive Effects: Monitor during dose initiation and titration.
  • Patients with Head Injury or Increased Intracranial Pressure: Monitor for sedation and respiratory depression. Avoid use of Zohydro ER in patients with impaired consciousness or coma susceptible to intracranial effects of CO2 retention.
  • Concomitant use of CYP3A4 may increase opioid effects.

ADVERSE REACTIONS

  • Potential serious adverse events caused by opioids include addiction, abuse, and misuse; life-threatening respiratory depression; neonatal opioid withdrawal syndrome; interactions with other CNS depressants; hypotensive effects; gastrointestinal conditions; and seizures.
  • Adverse reactions in ≥2% of patients in placebo-controlled trials include constipation, nausea, somnolence, fatigue, headache, dizziness, dry mouth, vomiting, pruritus, abdominal pain, peripheral edema, upper respiratory tract infection, muscle spasms, urinary tract infection, back pain, and tremor.
  • With intravenous abuse, the inactive ingredients in Zohydro ER can result in death, local tissue necrosis, infection, pulmonary granulomas, and increased risk of endocarditis and valvular heart injury. Parenteral drug abuse is commonly associated with transmission of infectious diseases such as hepatitis and HIV.

IMPORTANT SAFETY INFORMATION

WARNING: ADDICTION, ABUSE AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; INTERACTION WITH ALCOHOL; and CYTOCHROME P450 3A4 INTERACTION

Addiction, Abuse, and Misuse
ZOHYDRO 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 ZOHYDRO 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 ZOHYDRO ER. Monitor for respiratory depression, especially during initiation of ZOHYDRO ER or following a dose increase. Instruct patients to swallow ZOHYDRO ER capsules whole; crushing, chewing, or dissolving ZOHYDRO ER capsules can cause rapid release and absorption of a potentially fatal dose of hydrocodone.

Accidental Ingestion
Accidental ingestion of even one dose of ZOHYDRO ER, especially by children, can result in a fatal overdose of hydrocodone.

Neonatal Opioid Withdrawal Syndrome
Prolonged use of ZOHYDRO 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.

Interaction with Alcohol
Instruct patients not to consume alcoholic beverages or use prescription or non-prescription products that contain alcohol while taking ZOHYDRO ER. The co-ingestion of alcohol with ZOHYDRO ER may result in increased plasma levels and a potentially fatal overdose of hydrocodone.

Cytochrome P450 3A4 Interaction
The concomitant use of ZOHYDRO ER with all cytochrome P450 3A4 inhibitors may result in an increase in hydrocodone 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 hydrocodone plasma concentration. Monitor patients receiving ZOHYDRO ER and any CYP3A4 inhibitor or inducer.

DRUG INTERACTIONS

  • Mixed Agonists/Antagonists and Partial Agonist Analgesics: Avoid use with Zohydro ER because they may reduce analgesic effect of Zohydro ER or precipitate withdrawal symptoms.
  • The use of MAO inhibitors or tricyclic antidepressants with Zohydro ER may increase the effect of either the antidepressant or Zohydro ER.

You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please read full Prescribing Information for the full boxed warning, complete safety information, and medication guide.

Rx Only.
DEA order form required.

ZOHYDRO® ER with BeadTekTM is manufactured for Pernix Ireland Pain Limited and distributed by Pernix Therapeutics, LLC., Morristown, NJ 07960. US Patent Nos.: US 6,228,398 and US 6,902,742.

ZOHYDRO® ER is a registered trademark of Pernix Ireland Pain Limited. BeadTekTM is a trademark used by Pernix Ireland Pain Limited under license.