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Hysingla ER: an ER opioid
with national TRICARE
formulary coverage* |
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| Dear Healthcare Professional: |
| Great news – Hysingla® ER (hydrocodone bitartrate) Extended-Release Tablets CII is covered on TRICARE National Formulary. |
| Inclusion on formulary does not imply superior clinical efficacy or safety. |
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| WARNING: ADDICTION, ABUSE, AND MISUSE; LIFE-THREATENING RESPIRATORY DEPRESSION; ACCIDENTAL INGESTION; NEONATAL OPIOID WITHDRAWAL SYNDROME; AND CYTOCHROME P450 3A4 INTERACTION |
| Addiction, Abuse, and Misuse |
| HYSINGLA 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 HYSINGLA ER, and monitor all patients regularly for the development of these behaviors or conditions [see Warnings and Precautions (5.1)]. |
| Life-Threatening Respiratory Depression |
| Serious, life-threatening, or fatal respiratory depression may occur with use of HYSINGLA ER. Monitor for respiratory depression, especially during initiation of HYSINGLA ER or following a dose increase. Instruct patients to swallow HYSINGLA ER tablets whole; crushing, chewing, or dissolving HYSINGLA ER tablets can cause rapid release and absorption of a potentially fatal dose of hydrocodone [see Warnings and Precautions (5.2)]. |
| Accidental Ingestion |
| Accidental ingestion of even one dose of HYSINGLA ER, especially by children, can result in a fatal overdose of hydrocodone [see Warnings and Precautions (5.2)]. |
| Neonatal Opioid Withdrawal Syndrome |
| Prolonged use of HYSINGLA 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 [see Warnings and Precautions (5.3)]. |
| Cytochrome P450 3A4 Interaction |
| The concomitant use of HYSINGLA 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 HYSINGLA ER and any CYP3A4 inhibitor or inducer [see Warnings and Precautions (5.11), Drug Interactions (7.1), and Clinical Pharmacology (12.3)]. |
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| National TRICARE formulary coverage |
| Hysingla ER has national TRICARE formulary coverage in the US from coast to coast, and in Alaska, Hawaii, and Puerto Rico.† |
| Click here to access formulary coverage in your area. |
| Inclusion on formulary does not imply superior clinical efficacy or safety. |
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Please click here to read the Full Prescribing Information,
including Boxed Warning. |
For more information about Hysingla ER, please visit
www.HysinglaER.com |
| To report adverse events, please click here. |
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Covered represents on formulary (on any tier, with or without restrictions) and may include quantity limits, prior authorizations, and/or step edit restrictions. |
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Source: Fingertip Formulary®–database represents 95%-98% of commercial, Medicare, and Medicaid covered lives in the U.S. (11/02/15). Please check with the health plan directly to confirm coverage for individual patients. Patient costs may vary among plans. |
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| ©2015 Purdue Pharma L.P. |
| One Stamford Forum, 201 Tresser Boulevard |
| Stamford, CT 06901-3431 |
| A10276 10/15 |
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