Privacy

Asembia Privacy Policy

Asembia shares a commitment with the prescribers utilizing AUVI-Q direct delivery service 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 AUVI-Q direct delivery service 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 AUVI-Q DIRECT DELIVERY SERVICE WEBSITE CONSTITUTES YOUR UNDERSTANDING AND AGREEMENT WITH THIS PRIVACY POLICY.

Safeguards
Asembia'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 Data
We 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.

Indication

AUVI-Q^® (epinephrine injection, USP) is indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to allergens, idiopathic and exercise-induced anaphylaxis. AUVI-Q is intended for patients with a history of anaphylactic reactions or who are at increased risk for anaphylaxis.

Important Safety Information

AUVI-Q is intended for immediate self-administration as emergency supportive therapy only and is not a substitute for immediate medical care. In conjunction with the administration of epinephrine, the patient should seek immediate medical or hospital care. Each AUVI-Q contains a single dose of epinephrine for single-use injection. More than two sequential doses of epinephrine should only be administered under direct medical supervision. Since the doses of epinephrine delivered from AUVI-Q are fixed, consider using other forms of injectable epinephrine if doses lower than 0.1 mg are deemed necessary.

AUVI-Q should ONLY be injected into the anterolateral aspect of the thigh. Do not inject intravenously, or into buttock, digits, hands, or feet. Instruct caregivers to hold the leg of young children and infants firmly in place and limit movement prior to and during injection to minimize the risk of injection-related injury.

Rare cases of serious skin and soft tissue infections have been reported following epinephrine injection. Advise patients to seek medical care if they develop any of the following symptoms at an injection site: redness that does not go away, swelling, tenderness, or the area feels warm to the touch.

Epinephrine should be administered with caution to patients with certain heart diseases, and in patients who are on medications that may sensitize the heart to arrhythmias, because it may precipitate or aggravate angina pectoris and produce ventricular arrhythmias. Arrhythmias, including fatal ventricular fibrillation, have been reported in patients with underlying cardiac disease or taking cardiac glycosides or diuretics. Patients with certain medical conditions or who take certain medications for allergies, depression, thyroid disorders, diabetes, and hypertension, may be at greater risk for adverse reactions. Common adverse reactions to epinephrine include anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache, and/or respiratory difficulties.

Please see the full Prescribing Information and Patient Information at www.auvi-q.com.

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.