Formulary Toolkit
Use these resources to help you assess how ZYNRELEF can impact patient care at your facility.
ZYNRELEF is indicated in adults for
soft tissue or periarticular instillation to produce postsurgical analgesia for up to
Limitations of Use: Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures.
Videos
Mechanism of Action
Total Knee Arthroplasty Administration
Bunionectomy Administration
Open Inguinal Herniorrhaphy Administration
For more administration videos and resources, visit the ZYNRELEF Resource Center.
Resources for Formulary Decision Makers
Product Monograph
Read key information about ZYNRELEF, including efficacy and safety data, clinical pharmacology information, dosage and administration, and more.
Formulary Presentation
Download slides that provide an overview of ZYNRELEF, including efficacy and safety data, mechanism of action, pricing and reimbursement, and more.
Reference Guide
View the list of peer-reviewed manuscripts and posters describing the science and clinical trials behind ZYNRELEF.
Dossier
This document discusses the clinical and economic aspects of ZYNRELEF, drawing from published data, FDA-approved product labeling, and information not included in the product labeling. Available by request only.
Cost Savings Calculator
Estimate the potential cost savings your facility could see with ZYNRELEF. Use inputs specific to your organization for a customized result.
Key Product Information
Prescribing Information
View the full Prescribing Information (PI) for ZYNRELEF, including Boxed Warning.
Instructions for Use
View important information including kit components, preparation steps, administration steps, and other product usage details.
Multimodal Analgesic Protocols
View guidelines for using ZYNRELEF as the foundation of a non-opioid multimodal analgesic regimen.
Published Literature
EPOCH 1 Bunionectomy Publication, 2019
HTX-011 reduced pain intensity and opioid consumption versus bupivacaine HCl in bunionectomy: Phase III results from the randomized EPOCH 1 study. Published in Regional Anesthesia & Pain Medicine.
EPOCH 2 Herniorrhaphy Publication, 2019
HTX-011 reduced pain intensity and opioid consumption versus bupivacaine HCl in herniorrhaphy: results from the Phase 3 EPOCH 2 study. Published in Hernia.
EPOCH TKA Publication, 2020
HTX-011 reduced pain and opioid use after primary total knee arthroplasty: results of a randomized Phase 2b trial. Published in the Journal of Arthroplasty.
EPOCH 1 Single-Arma
Follow-On Publication, 2021
Opioid-free recovery from bunionectomy with HTX-011, a dual-acting local anesthetic combining bupivacaine and meloxicam, as the foundation of non-opioid multimodal analgesia. Published in Journal of the American Podiatric Medical Association.
EPOCH 2 Single-Arma
Follow-On Publication, 2020
Opioid-free recovery after herniorrhaphy with HTX-011 as the foundation of a multimodal analgesic regimen. Published in Surgery.
EPOCH TKA Single-Arma
Follow-On Publication, 2022
HTX-011 in combination with multimodal analgesic regimen minimized severe pain and opioid use after total knee arthroplasty in an open-label study. Published in The Journal of Knee Surgery.
The HOPE Project Publication, 2021
Opioid-free recovery after hernia repair with HTX-011 as the foundation of a non-opioid, multimodal analgesia regimen in a real-world setting: a randomized, open-label study. Published in Pain and Therapy.
ZYNRELEF MOA Publication, 2019
Mechanism of action of HTX-011: a novel, extended-release, dual-acting local anesthetic formulation for postoperative pain. Published in Regional Anesthesia & Pain Medicine.
ZYNRELEF in Elderly Populations, 2021
HTX-011 effectively reduced postoperative pain intensity and opioid use in the elderly. Published in Pain Management.
Distribution and Reimbursement Information
Ordering and Pricing Information
Get key details related to ordering ZYNRELEF, including pricing, NDCs, kit contents, and replacement part numbers.
Distribution Reference Guide
Find out which full-line wholesalers and specialty distributors can supply you with ZYNRELEF.
Heron Connect® Services Guide
Learn about Heron Connect support services for ZYNRELEF billing and coding questions.
Reimbursement Overview
Learn how ZYNRELEF is reimbursed across settings of care at a glance.
Reimbursement and Billing Guide
View comprehensive information on coding and reimbursement for ZYNRELEF, including sample claim forms.
Heron Connect Website
Learn about Heron Connect support services for all Heron products.
Indication
ZYNRELEF is indicated in adults for soft tissue or periarticular instillation to produce
postsurgical analgesia for up to
Limitations of Use: Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures.
Important Safety Information
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
- Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.
- ZYNRELEF is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
- NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.
Contraindications
ZYNRELEF is contraindicated in patients with a known hypersensitivity (eg, anaphylactic reactions and serious skin reactions) to any amide local anesthetic, NSAIDs, or other components of ZYNRELEF; with history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs (severe, sometimes fatal, anaphylactic reactions to NSAIDS have been reported in such patients); undergoing obstetrical paracervical block anesthesia; or undergoing CABG.
Warnings and Precautions
Dose-Related Toxicity: Monitor cardiovascular and respiratory vital signs and
patient’s state of consciousness after application of ZYNRELEF. When using ZYNRELEF
with other local anesthetics, overall local anesthetic exposure must be considered through
Hepatotoxicity: If abnormal liver tests persist or worsen, perform a clinical evaluation of the patient.
Hypertension: Patients taking some antihypertensive medication may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure.
Heart Failure and Edema: Avoid use of ZYNRELEF in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure.
Renal Toxicity: Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of ZYNRELEF in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal failure.
Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs.
Chondrolysis: Limit exposure to articular cartilage due to the potential risk of chondrolysis.
Methemoglobinemia: Cases have been reported with local anesthetic use.
Serious Skin Reactions: NSAIDs, including meloxicam, can cause serious skin adverse reactions. If symptoms present, evaluate clinically.
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): If symptoms are present, evaluate clinically.
Fetal Toxicity: Due to the risk of oligohydramnios/fetal renal dysfunction and premature closure of the ductus arteriosus with NSAIDS, limit use of ZYNRELEF between about 20 to 30 weeks gestation, and avoid use after about 30 weeks.
Hematologic Toxicity: Monitor hemoglobin and hematocrit in patients with any signs or symptoms of anemia.
Drug Interactions
Drugs That Interfere with Hemostasis: Monitor patients for bleeding who are using ZYNRELEF with drugs that interfere with hemostasis (eg, warfarin, aspirin, SSRIs/SNRIs).
ACE Inhibitors, Angiotensin Receptor Blockers (ARBs), or Beta-Blockers: Use with ZYNRELEF may diminish the antihypertensive effect of these drugs. Monitor blood pressure.
ACE Inhibitors and ARBs: Use with ZYNRELEF in elderly, volume-depleted, or those with renal impairment may result in deterioration of renal function. In such high-risk patients, monitor for signs of worsening renal function.
Diuretics: NSAIDs can reduce natriuretic effect of furosemide and thiazide diuretics. Monitor patients to assure diuretic efficacy including antihypertensive effects.
Use in Specific Populations
Infertility: NSAIDs are associated with reversible infertility. Consider avoidance of ZYNRELEF in women who have difficulties conceiving.
Severe Hepatic Impairment: Only use if benefits are expected to outweigh risks; monitor for signs of worsening liver function.
Severe Renal Impairment: Not recommended.
Adverse Reactions
Most common adverse reactions (incidence ≥10%) in controlled clinical trials with ZYNRELEF are constipation, vomiting, and headache.
Report side effects to Heron at 1-844-437-6611 or to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing Information, including Boxed Warning.
aSingle-arm, open-label, uncontrolled study. ZYNRELEF was given with a scheduled non-opioid MMA regimen.
References: 1. ZYNRELEF [package insert]. San Diego, CA: Heron Therapeutics Inc; 2021.
Important Safety Information and Indication
WARNING: RISK OF SERIOUS CARDIOVASCULAR AND GASTROINTESTINAL EVENTS
- Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use.
- ZYNRELEF is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.
- NSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious GI events.
Contraindications
ZYNRELEF is contraindicated in patients with a known hypersensitivity (eg, anaphylactic reactions and serious skin reactions) to any amide local anesthetic, NSAIDs, or other components of ZYNRELEF; with history of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs (severe, sometimes fatal, anaphylactic reactions to NSAIDS have been reported in such patients); undergoing obstetrical paracervical block anesthesia; or undergoing CABG.
Warnings and Precautions
Dose-Related Toxicity: Monitor cardiovascular and respiratory vital signs and
patient’s state of consciousness after application of ZYNRELEF. When using
ZYNRELEF with other local anesthetics, overall local anesthetic exposure must be
considered through
Hepatotoxicity: If abnormal liver tests persist or worsen, perform a clinical evaluation of the patient.
Hypertension: Patients taking some antihypertensive medication may have impaired response to these therapies when taking NSAIDs. Monitor blood pressure.
Heart Failure and Edema: Avoid use of ZYNRELEF in patients with severe heart failure unless benefits are expected to outweigh risk of worsening heart failure.
Renal Toxicity: Monitor renal function in patients with renal or hepatic impairment, heart failure, dehydration, or hypovolemia. Avoid use of ZYNRELEF in patients with advanced renal disease unless benefits are expected to outweigh risk of worsening renal failure.
Anaphylactic Reactions: Seek emergency help if an anaphylactic reaction occurs.
Chondrolysis: Limit exposure to articular cartilage due to the potential risk of chondrolysis.
Methemoglobinemia: Cases have been reported with local anesthetic use.
Serious Skin Reactions: NSAIDs, including meloxicam, can cause serious skin adverse reactions. If symptoms present, evaluate clinically.
Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS): If symptoms are present, evaluate clinically.
Fetal Toxicity: Due to the risk of oligohydramnios/fetal renal dysfunction and premature closure of the ductus arteriosus with NSAIDS, limit use of ZYNRELEF between about 20 to 30 weeks gestation, and avoid use after about 30 weeks.
Hematologic Toxicity: Monitor hemoglobin and hematocrit in patients with any signs or symptoms of anemia.
Drug Interactions
Drugs That Interfere with Hemostasis: Monitor patients for bleeding who are using ZYNRELEF with drugs that interfere with hemostasis (eg, warfarin, aspirin, SSRIs/SNRIs).
ACE Inhibitors, Angiotensin Receptor Blockers (ARBs), or Beta-Blockers: Use with ZYNRELEF may diminish the antihypertensive effect of these drugs. Monitor blood pressure.
ACE Inhibitors and ARBs: Use with ZYNRELEF in elderly, volume-depleted, or those with renal impairment may result in deterioration of renal function. In such high-risk patients, monitor for signs of worsening renal function.
Diuretics: NSAIDs can reduce natriuretic effect of furosemide and thiazide diuretics. Monitor patients to assure diuretic efficacy including antihypertensive effects.
Use in Specific Populations
Infertility: NSAIDs are associated with reversible infertility. Consider avoidance of ZYNRELEF in women who have difficulties conceiving.
Severe Hepatic Impairment: Only use if benefits are expected to outweigh risks; monitor for signs of worsening liver function.
Severe Renal Impairment: Not recommended.
Adverse Reactions
Most common adverse reactions (incidence ≥10%) in controlled clinical trials with ZYNRELEF are constipation, vomiting, and headache.
Report side effects to Heron at 1-844-437-6611 or to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Indication
ZYNRELEF is indicated in adults for soft tissue or periarticular instillation to
produce postsurgical analgesia for up to
Limitations of Use: Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures.
Please see full Prescribing Information, including Boxed Warning.
Thank you!
For general information:
844-HERON11 (844-437-6611)
Investors and Media
For all other inquiries, please visit the Heron Therapeutics corporate website.
Cost Savings Calculator
The Cost Savings Calculator is intended for use by population-based decision makers in US healthcare organizations. Please complete the form below, then check your email for a link to access this resource. All fields are required. If you have any questions, please contact your Heron representative.