Asembia Privacy Policy
Asembia shares a commitment with the prescribers utilizing Hyalgan™ ER website, who are HIPAA covered entities (collectively "Covered Entities"), to protect the privacy and confidentiality of Protected Health Information (PHI) in accordance with applicable HIPAA regulations. Asembia is also committed to protecting Personally Identifiable Information (PII) submitted by users of the HYALGAN website. This Policy is provided by Asembia to help you better understand how we disclose and protect PHI in accordance with the terms of the Business Associate (BA) Agreement and how we protect and use PII. PLEASE NOTE, YOUR USE AND CONTINUED USE OF THE HYALGAN WEBSITE CONSTITUTES YOUR UNDERSTANDING AND AGREEMENT WITH THIS PRIVACY POLICY.
SafeguardsAsembia's policy is to maintain the confidentiality of PHI received from or on behalf of clients who are HIPAA Covered Entities and with whom we have executed a BA Agreement in accordance with such Agreements and applicable law. Asembia has implemented appropriate administrative, technical and physical safeguards for protecting the privacy of PHI and PII.
Use and Disclosure of DataWe may use PII and PHI for our management, administration, data aggregation and legal obligations to the extent such use of PII and PHI is permitted or required by the BA Agreement and this Privacy Policy and would not violate HIPAA regulations. We may also share de-identified data and select PII with business partners or potential business partners. No PHI information is shared with business partners or potential business partners, except as otherwise permitted by applicable law and the BA Agreement. In the event that PII and PHI must be disclosed to a subcontractor or agent, we will ensure that the subcontractor or agent agrees to abide by the same restrictions and conditions that apply to us under the BA Agreement and this Privacy Policy with respect to PII and PHI, including the implementation of reasonable and appropriate safeguards. We may also use PII and PHI to report violations of law to appropriate federal and state authorities, as permitted by the BA Agreement and applicable law.
Indications and Important Safety Information
Indications: Hyalgan® and Hymovis® are indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and to simple analgesics (e.g. acetaminophen).
Important Safety Information: Hyalgan® and Hymovis® are contraindicated in patients with known hypersensitivity to hyaluronate preparations or gram positive bacterial proteins (Hymovis® only) or patients with infections/skin diseases in the area of the injection site/joint. The safety and effectiveness of Hymovis® has not been tested in pregnant women, nursing mothers or children. See package insert for full prescribing information including adverse events, warnings, precautions, and side effects at www.Hyalgan.com and www.Hymovis.com. Rx Only
Indication
HYALGAN® is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and to simple analgesics, eg, acetaminophen.
Important Safety Information
HYALGAN is contraindicated in patients with known hypersensitivity to hyaluronate preparations or in cases of present infections or skin diseases in the area of the injection site. Use caution when injecting HYALGAN into patients who are allergic to avian proteins, feathers, and egg products.
The safety and effectiveness of HYALGAN has not been established in children or in pregnant or lactating women, for use in other joints or for concomitant use with other injectables. It is unknown whether HYALGAN® is excreted in human milk. The effectiveness of a single treatment cycle of less than 3 injections has not been established.
Transient increases in inflammation in the injected knee following HYALGAN injection have been reported in some patients with inflammatory arthritis and should not be injected if objective signs of inflammation are present. Transient pain and/or swelling of the injected joint may occur after intra-articular injection of HYALGAN®. Anaphylactoid and allergic reactions have been reported with the use of this product.
In the US clinical trial, adverse events included injection-site pain, gastrointestinal complaints, headache, local ecchymosis (bruising) and rash, local joint pain and swelling, and local pruritus (itching). In other clinical studies, the frequency and severity of adverse events occurring during repeat treatment cycles did not increase over that reported for a treatment cycle.
RX Only.
See the package insert section of this website for full prescribing information.
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