- Important Safety Information
- How We Use the Information We Collect
- Trademark Information
- Important Safety Information
- Links to Other Sites
- Limited License
- Use of this Website
- Forward-Looking Statements
- User-Provided Ideas
- Medical Advice
- Limitation of Liability
- Rights for California Residents
The Site Content is for your general education only and is not intended to provide advice or guidance or to be used for any commercial purpose. The Site Content may be out of date or include omissions or other errors. In particular, we may not update our website on a daily or other regular basis. We may update or otherwise change the Site Content at any time without notice. The identification or description of products or services of Heron Therapeutics, Inc. or third parties on the website is for informational purposes only and does not constitute a representation, warranty, guarantee, endorsement or recommendation of such products and services. All Site Content is provided “AS IS” and “AS AVAILABLE” without warranty of any kind. To the maximum extent permitted by law, Heron Therapeutics, Inc. and its affiliates and partners disclaim all warranties, express or implied, regarding the website and the Site Content therein, including the implied warranties of merchantability, fitness for a particular purpose, and non-infringement of third party rights.
We make no warranty that this website will meet your requirements; that this website will be uninterrupted, timely, secure, or error free; that messages or requests will be delivered; that defects will be corrected; or that this website is free of viruses or other harmful components. We make no warranty regarding any goods or services purchased or obtained through this website or any transactions entered into through this website. You assume the entire risk as to the results and performance of this website and any goods or services purchased therefrom.
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.
ZYNRELEF is contraindicated in patients with 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 coronary artery bypass graft (CABG) surgery.
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 72 hours.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.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.
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 effect.
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.
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 accompanying Full Prescribing Information, including BOXED WARNING or visit www.ZYNRELEF.com.
How We Use the Information We Collect
- Provide the services you or others request, including verifying, enrolling, and serving patients in the Heron Connect Copay Assistance Program or Heron Connect Patient Assistance Program, or enrolling and serving practices in the Heron Commitment Program;
- Complete the transactions you have requested, including processing copay reimbursements;
- Provide you with an account, and manage your account;
- Provide user or technical support, and respond to communications from you;
- Notify you about updates to our products, services, and websites, at your request;
- Measure and improve our products, business, products, services, and performance, including our programs and website layout and content;
- Perform analyses on the data we have collected, such as market analyses, trends, and other research for statistical purposes;
- Process, provide, and administer surveys and special events;
- Provide, administer, and utilize our social media pages and websites;
- Send updates or notices about our company and the products we offer that we think may be of interest to you;
- Send investor-related materials, either at your request, or in the ordinary course of business if you are an investor in our securities;
- Compare information and identification for accuracy and verify it, including for identification purposes;
- Anonymize or otherwise protect your data;
- Recruit and hire employees;
- Prevent potentially fraudulent, prohibited, or illegal activities, and enforce our Terms & Conditions; and
- Comply with legal requirements, or assert or defend a legal claim.
Heron Therapeutics will not sell your personal information to third parties. We may, at times, disclose personal information we collect to the following categories of third parties:
- With third parties to provide, maintain, and improve our services, including insurance companies and third party service providers who access information about you to perform services on our behalf, or help us execute services you have requested (for example, verification of insurance coverage), as well as financial institutions and payment processors in the case of business transactions;
- With third parties that assist with email campaigns, special offers, or other events or activities in connection with our products and services;
- With other persons with whom you have requested that we share information, in order to fulfill services you request (for example, with insurance companies, with your physician, if you are a patient, or with your colleagues or friends);
- If we believe that disclosure is reasonably necessary (a) to comply with any applicable law, regulation, legal process or governmental request, (b) to enforce or comply with our Terms & Conditions or other applicable agreements or policies, (c) to protect our rights or property, or the security or integrity of our services, or (d) to protect us, users of our services or the public from harm or potentially prohibited or illegal activities.
Our service providers generally are bound by contract to keep your personal information confidential, and to retain, use, or disclose it only to perform on our behalf the purposes laid out in the contract.
Heron Therapeutics, the Heron Therapeutics, Inc. logo, SUSTOL, CINVANTI, ZYNRELEF and Biochronomer (collectively, “Heron’s Marks”) are registered trademarks of Heron Therapeutics, Inc. Any use of Heron’s Marks except as permitted herein is prohibited and may be in violation of trademark law and other laws. Heron’s Marks and all other trademarks, logos, trade names, trade dress, service marks and products of Heron Therapeutics, Inc. (collectively with Heron’s Marks, “Marks”) displayed on our website are the property of Heron Therapeutics, Inc. or third parties, are protected in the United States and internationally and may not be used for advertising or publicity purposes, or to indicate any affiliation with or endorsement by Heron Therapeutics, Inc. These Marks may not be used in whole or in part without the prior written permission of such owners.
CINVANTI is a substance P/neurokinin-1 (NK1) receptor antagonist, indicated in adults, in combination with other antiemetic agents, for the prevention of: acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin as a single-dose regimen; delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC) as a single-dose regimen; and nausea and vomiting associated with initial and repeat courses of MEC as a 3-day regimen.
Limitations of Use: CINVANTI has not been studied for treatment of established nausea and vomiting.
Important Safety Information
CINVANTI is contraindicated in patients with hypersensitivity to any of the components of CINVANTI.
Concurrent use of pimozide with CINVANTI is contraindicated.
Warnings and Precautions
Clinically Significant CYP3A4 Drug Interactions
Aprepitant is a substrate, weak-to-moderate (dose-dependent) inhibitor, and an inducer of CYP3A4.
- Use with other drugs that are CYP3A4 substrates may result in increased plasma concentration of the concomitant drug.
- Use of CINVANTI with strong or moderate CYP3A4 inhibitors (e.g., ketoconazole, diltiazem) may increase plasma concentrations of aprepitant and result in an increased risk of adverse reactions related to CINVANTI.
- Use of CINVANTI with strong CYP3A4 inducers (e.g., rifampin) may result in a reduction in aprepitant plasma concentrations and decreased efficacy of aprepitant.
Serious hypersensitivity reactions, including anaphylaxis during or soon after administration of CINVANTI have occurred. Symptoms including dyspnea, eye swelling, flushing, pruritus, and wheezing have been reported. If hypersensitivity reactions occur, discontinue CINVANTI. Do not reinstate CINVANTI in patients who experience these symptoms with previous use.
Decrease in INR with Concomitant Warfarin
Co-administration of CINVANTI with warfarin, a CYP2C9 substrate, may result in a clinically significant decrease in the International Normalized Ratio (INR) of prothrombin time. Monitor the INR in patients on chronic warfarin therapy in the 2-week period, particularly at 7 to 10 days, following initiation of CINVANTI with each chemotherapy cycle.
Risk of Reduced Efficacy of Hormonal Contraceptives
The efficacy of hormonal contraceptives may be reduced during administration of and for 28 days following the last dose of CINVANTI. Advise patients to use effective alternative or back-up methods of non-hormonal contraception during treatment with CINVANTI and for 1 month following administration of CINVANTI or oral aprepitant, whichever is administered last.
Use in Specific Populations
Avoid use of CINVANTI in pregnant women as alcohol is an inactive ingredient for CINVANTI. There is no safe level of alcohol exposure in pregnancy.
The most common adverse reactions with the 3-day oral aprepitant regimen in conjunction with MEC (≥1% and greater than standard therapy) were fatigue and eructation.
The most common adverse reactions with the single-dose intravenous fosaprepitant regimen in conjunction with HEC were generally similar to that seen in prior HEC studies with oral aprepitant. In addition, infusion site reactions (3%) occurred.
The most common adverse reactions with single-dose CINVANTI (≥2%) were headache and fatigue. The safety profile of CINVANTI in healthy subjects who received a single 2-minute injection was similar to that seen with a 30-minute infusion.
Report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Report side effects to Heron at 1-844-437-6611.
Links to Other Sites
This website may provide links to other websites as a service to our visitors. These are websites we believe may have helpful information. However, Heron Therapeutics does not endorse and is not responsible for the content of third-party websites. Nor does Heron Therapeutics have any control over information you may choose to provide to those websites.
Use of this Website
You agree not to do any of the following while visiting or using this website or any services provided by or through this website:
- Impersonate or misrepresent your affiliation with any person or entity;
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- Access or use password protected, secure or non-public areas of this website without authorization; or
- Frame, repackage, or otherwise re-distribute any portion of this website.
This website contains forward-looking statements within the meaning of the federal securities laws, specifically the Securities Litigation Reform Act of 1995, including without limitation, statements related to: the degree of commercial success of SUSTOL, CINVANTI, ZYNRELEF, and any other product candidates that we commercialize; the scope, rate of progress, results and costs of preclinical testing and clinical trials; the timing and cost to manufacture our products; the number and characteristics of product development programs we pursue and the pace of each program, including the timing of clinical trials; the time, cost and outcome involved in seeking other regulatory approvals; scientific progress in our research and development programs; the magnitude and scope of our research and development programs; our ability to establish and maintain strategic collaborations or partnerships for research, development, clinical testing, manufacturing and marketing of our products and product candidates; the cost and timing of establishing sales, marketing and distribution capabilities if we commercialize products independently; the cost of establishing clinical and commercial supplies of our product candidates and any products that we may develop; general market conditions; the degree of commercial success of the continued development and clinical, therapeutic and commercial potential of, and opportunities, for ZYNRELEF; the timing of the commercial launch of ZYNRELEF; the potential market opportunity for ZYNRELEF in the US and Europe; the timing and results of studies for the HTX-034 and HTX-019 development programs; the full-year 2021 net product sales guidance for the oncology care franchise; the expected future balances of Heron’s cash, cash equivalents and short-term investments; the expected duration over which Heron’s cash, cash equivalents and short-term investments balances will fund its operations; the extent of the impact of the ongoing COVID-19 pandemic on our business; the continued development and clinical, therapeutic and commercial potential of, and opportunities, for Heron Therapeutics, Inc.’s partnered compounds and programs; future periods; future events; and future operating and financial plans and performance; and other risks and uncertainties identified in the Company’s filings with the U.S. Securities and Exchange Commission. Forward-looking statements reflect our analysis only on their stated date, and Heron takes no obligation to update or revise these statements except as may be required by law. Any statements contained in this website that are not statements of historical fact may be deemed to be forward-looking statements. Words such as “anticipates,” “believes,” “continue,” “demonstrate,” “estimates,” “expects,” “forecast,” “goal,” “intends,” “may,” “objective,” “outlook,” “plans,” “potential,” “should,” “will” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Heron Therapeutics, Inc.’s current plans, assumptions, beliefs and expectations. Forward-looking statements involve risks and uncertainties. Heron Therapeutics, Inc.’s actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. These and other risk factors are discussed under “Risk Factors” and elsewhere in Heron Therapeutics, Inc.’s periodic reports filed with the Securities and Exchange Commission (SEC), including Heron Therapeutics, Inc.’s most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q, and Heron Therapeutics, Inc.’s other filings with the SEC. Heron Therapeutics, Inc. expressly disclaims any duty, obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained in this website to reflect any change in Heron Therapeutics, Inc.’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
Heron Therapeutics, Inc. does not accept or consider unsolicited ideas submitted through or in connection with the website. Notwithstanding the foregoing, you agree that any feedback, information, suggestions, ideas or materials (e.g., text, photographs, caricatures, illustrations, designs, icons, articles, audio clips, and video clips, etc.) you submit through or in connection with this website (each, an “idea”) will not be subject to any use or disclosure restrictions and will be considered non-confidential by us. By providing ideas to us you agree that we shall have, at no charge, a non-exclusive, transferable, royalty free, perpetual, irrevocable, worldwide right and license to reproduce distribute, display, perform and create derivative works of such ideas and to use, make, offer for sale, sell and import products containing or based on such ideas. We shall be free to use and disseminate such ideas on an unrestricted basis for any purpose. In addition, we do not control ideas posted or otherwise transmitted via this website by others and we do not guarantee the accuracy, integrity, or quality of such ideas. Any communications you send to this website or otherwise to Heron Therapeutics, Inc. by electronic mail, with the exception of personally identifiable information as defined in the Internet Privacy Statement, shall be deemed to be non-confidential.
The Site Content is provided for informational purposes only and should not be construed as medical, legal, financial, investment, or other professional advice or opinion. We do not offer personalized medical advice or patient-specific treatment advice. Only your doctor or other healthcare professional can determine if a product described on this website is appropriate for you. Use of this website is not a substitute for a call or visit to, or consultation with, your physician or a healthcare professional. You should not rely on this website or any other service offered by or through this website for medical diagnosis or treatment. YOU SHOULD NEVER DISREGARD OR DELAY SEEKING MEDICAL ADVICE BECAUSE OF SOMETHING THAT YOU HAVE SEEN OR HEARD ON THIS WEBSITE. PLEASE CONSULT WITH YOUR DOCTOR, OR OTHER QUALIFIED HEALTHCARE PROFESSIONAL, BEFORE USING ANY PRODUCT DISCUSSED ON THIS WEBSITE.
Limitation of Liability
Heron Therapeutics, Inc. its directors, officers, employees, affiliates, agents, representatives, consultants and business partners shall not be liable for any direct, indirect, special, punitive, consequential or incidental damages (including without limitation those arising from lost profits, lost data or business interruption) arising from or related to use, inability to use, or the result of use of the website or the materials, information or hyperlinks contained therein, or on any other hyperlinked website, whether based on warranty, contact, tort or any other legal theory, even if Heron Therapeutics, Inc. its directors, officers, employees, affiliates, agents, representatives, consultants or business partners have been expressly advised of the possibility of such damages. You agree to hold Heron Therapeutics, Inc., its directors, officers, employees, affiliates, agents, representatives, consultants and business partners harmless from and against any claims or actions based upon or related to the use of our website or any hyperlinked website or based on any reliance upon the information contained therein. Applicable law may not allow the exclusion or limitation of incidental or consequential damages so the above limitation or exclusion may not apply to you.
Rights for California Residents
The California Consumer Privacy Act of 2018, California Civil Code Sections 1798.100 et seq. (CCPA), may additionally afford rights to our users and customers who are California residents. For example, California residents may have a right, following a verifiable request, to:
- access—twice in a 12-month period, free of charge—for the 12-month period prior to the request, the categories and specific pieces of personal information Heron Therapeutics has collected about the user, the categories of sources from which the personal information is collected, the business purpose for collecting the personal information, and the categories of third parties with whom Heron Therapeutics shares personal information; and
- delete personal information under certain circumstances.
Such requests may be made as described in the above Your Access and Control Over Information section above, or in the Contact section below. Heron Therapeutics does not discriminate against our users and customers on the basis of their exercising any of the rights afforded by the CCPA, which is further in accordance with California residents’ rights under that title.
In order to protect your information security, following any request, we will verify your identity using at least two data points you have previously provided to us. You may also authorize an agent to submit a request on your behalf, so long as you provide the authorized agent written permission to request on your behalf, and your authorized agent is able to verify their identity with us.