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Resources for health care providers

HELP YOUR PATIENTS FIND ZOHYDRO® ER WITH BEADTEK™ IN A LOCAL PHARMACY

Patients can call 1-844-676-9663, Monday to 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, with BeadTek™ in stock and call the patient back.

INSTANT SAVINGS PROGRAM

Eligible patients may pay as little as $15 for each prescription*

Instant savings for patients are available in 2 ways:

zohydro-card

*Instant Savings Program Details:
Insured or insured/not covered patients can use the copay card to reduce out-of-pocket expenses on eligible prescriptions of Zohydro ER with BeadTek™. Patients can present the copay card to the pharmacist along with a valid Zohydro ER with BeadTek™ prescription. Insured patients will pay as little as a $15 copay on each prescription. Maximum benefits apply. Good for up to 24 uses. Offer not valid for cash paying patients. Patients are not eligible if their prescriptions are paid in part or in full by any state or federally funded programs, including but not limited to, Medicare or Medicaid, Medigap, VA, DOD, or Tricare and where prohibited by law. Offer good only in the USA and cannot be redeemed at government-subsidized clinics. Pernix Therapeutics reserves the right to rescind, revoke, or amend this offer without notice. By redeeming this offer, the patient agrees to comply with the terms and conditions as set forth above.

Support for treating chronic pain

American Academy of Pain Management (AAPM): An academy whose mission is to advance a person-centered, integrative model of pain care through evidence-guided education, credentialing, and advocacy.

American Pain Society (APS): A multidisciplinary community (scientists, clinicians, and other professionals) whose mission is to increase the knowledge of pain and transform public policy and clinical practice to reduce pain-related suffering.

Center for Lawful Access and Abuse Deterrence (CLAAD): A not-for-profit organization that coordinates a national effort to prevent prescription drug fraud, diversion, misuse, and abuse while advancing consumer access to high-quality health care.

PainEDU.org: A website dedicated to improving pain treatment through education and providing free educational tools.

Practical Pain Management: A trusted source for information for patients about chronic pain conditions and pain management treatments.

Please call 1-800-793-2145 with questions or for more information.

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Education and support for patients

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 up to 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™

RESOURCES FOR PATIENTS

TheACPA.org: The American Chronic Pain Association (ACPA) website offers support and education to people living with chronic pain, as well as their families, so that they may live more fulfilling lives in spite of their pain.

LOCKMED.com: A website that offers a variety of safes and storage containers to protect patients' medications.

LockYourMeds.org: A website dedicated to raising awareness to help patients understand how important it is to take responsibility for keeping their medication safe.

PainACTION.com: A website providing a variety of downloadable resources for patients learning how to live and cope with pain.

Painpathways.org: Access to PainPathways magazine, dedicated to providing information and inspiration to people living with pain.

Project Lazarus: A secular, non-profit organization that provides technical assistance to empower communities and individuals to prevent drug overdoses and meet the needs of those living with chronic pain.

SaferLockrx.com: Safer Lock™ website sells locking bottles and caps, designed to keep patients' medication safe.

USPainFoundation.org: US Pain Foundation (USPF) website provides support and advocacy with the goal of helping to educate, empower, and inspire people living with pain.

Please call 1-800-793-2145 with questions or for more information.

Lock Your Meds® is a registered trademark of National Family Partnership.

Safer Lock™ is a trademark of Cap-N-Lock LLC.

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Product benefits

A UNIQUE OPTION FOR PATIENTS IN NEED OF TRANSITION FROM IR HYDROCODONE OR ROTATION FROM OTHER OPIOIDS

  • Demonstrated pain control and tolerability with no pattern of end-of-dose failure1-3
  • Measurable hydrocodone levels within a half hour of first dose2
  • No acetaminophen1
  • BeadTek™ technology designed to immediately form a viscous gel when crushed and dissolved in liquid2*
  • A variety of support services

Available to 7 out of 10 people with commercial or Medicare coverage2†

IR=immediate release.

*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 injury.1

Certain restrictions apply.

ZOHYDRO® ER WITH BEADTEK™ CAPSULES ARE SUPPLIED IN 60-COUNT BOTTLES WITH A CHILD-RESISTANT CLOSURE AS FOLLOWS1:

Strength NDC Number

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.