For Healthcare Providers

Terms of Use

Amphastar Web Site Terms and Conditions

Updated January 3, 2019

Your access to www.Amphastar.com or www.baqsimi.com (collectively, “Web Sites”) is subject to the following Terms and Conditions, which may be updated by Amphastar Pharmaceuticals, Inc., including its subsidiaries and its affiliates, (collectively, “Amphastar”) from time to time without notice to you. By accessing or using these Web Sites, you agree that you have read, understand, and agree to be bound by these Terms and Conditions, as they may be amended from time to time, as well as to the terms of our Privacy Policy, which is hereby incorporated into these Terms and Conditions by reference. You are responsible for periodically reviewing these Terms and Conditions for applicable changes. Your use of these Web Sites after we have posted changes to these Terms and Conditions constitutes your acceptance to those changes. If you disagree with these Terms and Conditions (as they may be amended from time to time), or are dissatisfied with these Web Sites, your sole and exclusive remedy is to discontinue using this site.

Disclaimers

You hereby acknowledge and agree that:

a. Although we strive to provide the latest developments relating to our products and services, and other information about our company on these Web Sites, we do not represent or warrant the accuracy, effectiveness and/or suitability of any information contained on these Web Sites. Each person assumes full responsibility and all risk arising from use of these Web Sites. The information is presented “AS IS” and may include technical inaccuracies or typographical errors. Amphastar reserves the right to make additions, deletions, or modifications to the information at any time without any prior notification.

b. AMPHASTAR MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND OR NATURE WITH RESPECT TO THE INFORMATION OR CONTENT POSTED ON THIS WEB SITE. AMPHASTAR HEREBY DISCLAIMS ALL REPRESENTATIONS AND WARRANTIES, WHETHER EXPRESS OR IMPLIED, CREATED BY LAW, CONTRACT OR OTHERWISE, INCLUDING WITHOUT LIMITATION, ANY WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE OR NONINFRINGEMENT. IN NO EVENT SHALL AMPHASTAR BE LIABLE FOR ANY DAMAGES OF ANY KIND OR NATURE, INCLUDING WITHOUT LIMITATION, DIRECT, INDIRECT, SPECIAL (INCLUDING LOSS OF PROFIT), CONSEQUENTIAL OR INCIDENTAL DAMAGES ARISING FROM OR IN CONNECTION WITH THE EXISTENCE OR USE OF THIS WEB SITE AND/OR THE INFORMATION OR CONTENT POSTED ON THIS WEB SITE REGARDLESS OF WHETHER AMPHASTAR HAS BEEN ADVISED AS TO THE POSSIBILITY OF SUCH DAMAGES.

c. Amphastar is not responsible, and provides no representation or warranty whatsoever, for the accuracy, effectiveness, timeliness and/or suitability of any information or content obtained from third parties, including any hyperlinks to or from third-party sites. Except as otherwise provided on these Web Sites, Amphastar will not edit, censor or otherwise control any content provided by third parties on any bulletin board, chat room or other similar forums posted on third party websites. Such information should, therefore, be considered as suspect and is not endorsed by Amphastar.

d. These Web Sites may contain forward-looking statements that reflect Amphastar’s current expectation regarding future events and business development. The forward- looking statements involve risk and uncertainties. Actual developments or results could differ materially from those projected and depend on a number of factors including, but not limited to, the success of current research programs, results of pending or future product trials, ongoing commercialization of our products, commercial relationships, and general economic conditions. Amphastar intends to update this site on a regular basis but assumes no obligation to update any of the content.

You understand, and hereby acknowledge and agree to the following:

a. By using these Web Sites, you agree not to disrupt or intercept our electronic information posted on these Web Sites or on any of our servers. You also agree not to attempt to circumvent any security features of these Web Sites, and to abide by all applicable local, state, federal and international laws, rules, regulations, codes and ordinances.

b. You hereby grant to Amphastar the right to use all content that you upload or otherwise transmit to these Web Sites, subject to these Terms and Conditions and Amphastar’s Privacy Policy in any manner Amphastar chooses, including, but not limited to, copying, displaying, performing or publishing it in any format whatsoever, modifying it, incorporating it into other material or making a derivative work based on such content.

c. Except as expressly stated and agreed upon in advance by Amphastar in writing, no confidential relationship shall be established in the event that any user of these Web Sites should make any oral, written or electronic communication to Amphastar (such as feedback, questions, comments, suggestions, ideas, etc.). If any Amphastar Web Site requires or requests that such information be provided, and that such information contains personal identifying information (e.g., name, address, phone number), Amphastar shall obtain, use and maintain it in a manner consistent with our Privacy Policy. Otherwise, such communication and any information submitted therewith shall be considered non-confidential, and Amphastar shall be free to reproduce, publish or otherwise use such information for any purposes whatsoever including, without limitation, the research, development, manufacture use or sale of any product incorporating such information. The sender of any information to Amphastar is fully responsible for its content, including its truthfulness and accuracy and its non-infringement of any other third party’s proprietary or privacy rights and shall indemnify Amphastar against any claims or losses related to such information and its content.

Product Labeling

Unless otherwise noted, product names, descriptions and labeling are of U.S. origin. Products may not be available in all countries or may be available under a different brand name, in different strengths, or for different indications. Some of the products listed hereunder are available only by prescription. Except as expressly stated and agreed upon in advance by Amphastar in writing, no director, employee, agent, or representative of Amphastar, its subsidiaries and affiliates are engaged in rendering medical advice, diagnosis, treatment or other medical services that in any way create a physician-patient relationship through these Web Sites.

Intellectual Property

The information, documents and related graphics published on these Web Sites (the “Information”) are the sole property of Amphastar or its licensors.

Privacy and Security

Amphastar understands the importance of privacy to our customers and visitors to our Web Sites. Our use of personally identifiable information is governed by our Privacy Policy and by accessing and using our Web Sites, you agree to be bound by that policy. You recognize and agree that when submitting your personally identifiable information to www.Amphastar.com, while Amphastar has safeguards in place to prevent unauthorized access or interception, there is no absolute guarantee of security. IN THE EVENT OF ANY INTERCEPTION OR UNAUTHORIZED ACCESS OF PERSONALLY IDENTIFIABLE INFORMATION OR OTHER INFORMATION, YOU AGREE THAT AMPHASTAR AND ITS AFFILIATES SHALL IN NO EVENT BE LIABLE FOR ANY DIRECT, INDIRECT, SPECIAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES (INCLUDING LOST PROFITS) SUFFERED BY A CUSTOMER OR USER, EVEN IF AMPHASTAR HAS PREVIOUSLY BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. AMPHASTAR DOES NOT REPRESENT OR WARRANT, EITHER EXPRESSLY OR IMPLIEDLY, THAT THE INFORMATION PROVIDED BY ANY CUSTOMER OR USER OF THIS WEB SITE SHALL BE FREE FROM INTERCEPTION OR UNAUTHORIZED ACCESS, AND DOES NOT PROVIDE ANY IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. EACH CUSTOMER AND USER OF THIS WEB SITE IS SOLELY RESPONSIBLE FOR MAINTAINING THE CONFIDENTIALITY OF HIS OR HER OWN PASSWORD.

Limitation of Liability

Amphastar does not assume any liability for the materials, information and opinions provided on, posted to, or otherwise available through, these Web Sites. Reliance on these materials, information and opinions is solely at your own risk. Amphastar disclaims any liability for injury or damages resulting from the use of these Web Sites, or content thereon. In no event shall Amphastar or any of its officers, directors, employees, agents or affiliates, be liable, directly or indirectly, to anyone for any claims, losses or damages, direct, indirect, special, incidental or consequential, including, without limitation, loss of profits, resulting from or occasioned by the creation, use or reliance of or on its Web Sites or any third party websites or the information, advertising, products, resources or material accessed through any such Web Sites or third party websites, regardless of the nature or cause of any such damages or losses and whether or not a claim thereof is based in contract, tort, negligence or otherwise.

Collection of Personal Information by Third Parties

Some links on our Web Sites may redirect you to third party websites that we do not operate. The privacy practices of these websites will be governed by their own policies. We make no representation or warranty as to the privacy policies of any third parties, including the providers of third party applications. If you are submitting information to any such third party through our Site, you should review and understand that party’s applicable policies, including their privacy policy, before providing your information to the third party.

Visitors that reside outside the United States

Amphastar provides its Web Sites for the purpose of serving interested parties within the United States. The laws governing the collection and use of information within the United States may be different from the laws of your country. If you decide to use our Web Sites, or share your personal information with Amphastar, you are agreeing to be governed by the laws of the United States as appropriate, and you are expressly consenting to the transfer of your data to the United States.

Governing Law

These Terms and Conditions are governed by the laws of the State of California, U.S.A. without giving effect to any principles of conflict of law.

Safety Summary

Warnings – Do not use BAQSIMI if:

  • you have a tumor in the gland on top of your kidneys (adrenal gland) called pheochromocytoma.
  • you have a tumor in your pancreas called insulinoma.
  • you are allergic to glucagon, or any other ingredient in BAQSIMI.

BAQSIMI may cause serious side effects, including:

High blood pressure. BAQSIMI can cause high blood pressure in certain people with tumors in their adrenal glands.

Low blood sugar. BAQSIMI can cause certain people with tumors in their pancreas to have low blood sugar.

Serious allergic reaction. Call your doctor or get medical help right away if you have a serious allergic reaction including:

  • rash
  • difficulty breathing
  • low blood pressure

Common side effects

The most common side effects of BAQSIMI include:

  • nausea
  • vomiting
  • headache
  • runny nose
  • discomfort in your nose
  • stuffy nose
  • redness in your eyes
  • itchy nose, throat, and eyes
  • watery eyes

These are not all the possible side effects of BAQSIMI. For more information, ask your doctor. Call your doctor for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Before using

Before getting BAQSIMI, tell your health care provider about all your medical conditions, including if you:

  • have a tumor in your pancreas.
  • have not had food or water for a long time (prolonged fasting or starvation).
  • are pregnant or plan to become pregnant.
  • are breastfeeding or plan to breastfeed. It is not known if BAQSIMI passes into your breast milk. You and your doctor should decide if you can use BAQSIMI while breastfeeding.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How to use

Read the detailed Instructions for Use that comes with BAQSIMI.

  • Use BAQSIMI exactly how your doctor tells you to use it.
  • Make sure your caregiver knows where you keep your BAQSIMI and how to use BAQSIMI the right way before you need their help.
  • Your doctor will tell you how and when to use BAQSIMI.
  • BAQSIMI contains only one dose of medicine and cannot be reused.
  • BAQSIMI should be given in one side of your nose (nostril) but does not need to be inhaled.
  • BAQSIMI will work even if you have a cold or are taking cold medicine.
  • After giving BAQSIMI, the caregiver should call for emergency medical help right away.
  • If the person does not respond after 15 minutes, another dose may be given, if available.
  • Tell your doctor each time you use BAQSIMI.
  • Store BAQSIMI at temperatures up to 86°F (30°C).
  • Keep BAQSIMI in the shrink-wrapped tube until you are ready to use it.

Keep BAQSIMI and all medicines out of the reach of children.

Learn more

BAQSIMI is a prescription medicine. For more information, call 1-800-423-4136.

This summary provides basic information about BAQSIMI but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about BAQSIMI and how to take it. Your doctor is the best person to help you decide if BAQSIMI is right for you.

BAQSIMI® is a registered trademark owned or licensed by Amphastar Pharmaceuticals, Inc., its subsidiaries, or affiliates.

Indication

BAQSIMI® (BAK-see-mee) is used to treat very low blood sugar (severe hypoglycemia) in people with diabetes ages 4 years and above.

It is not known if BAQSIMI is safe and effective in children under 4 years of age.

Warnings – Do not use BAQSIMI if:

  • you have a tumor in the gland on top of your kidneys (adrenal gland) called pheochromocytoma.
  • you have a tumor in your pancreas called insulinoma.
  • you are allergic to glucagon, or any other ingredient in BAQSIMI.

BAQSIMI may cause serious side effects, including:

High blood pressure. BAQSIMI can cause high blood pressure in certain people with tumors in their adrenal glands.

Low blood sugar. BAQSIMI can cause certain people with tumors in their pancreas to have low blood sugar.

Serious allergic reaction. Call your doctor or get medical help right away if you have a serious allergic reaction including:

  • rash
  • difficulty breathing
  • low blood pressure

Common side effects

The most common side effects of BAQSIMI include:

  • nausea
  • vomiting
  • headache
  • runny nose
  • discomfort in your nose
  • stuffy nose
  • redness in your eyes
  • itchy nose, throat, and eyes
  • watery eyes

These are not all the possible side effects of BAQSIMI. For more information, ask your doctor. Call your doctor for medical advice about side effects. You are encouraged to report side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Before using

Before getting BAQSIMI, tell your health care provider about all your medical conditions, including if you:

  • have a tumor in your pancreas.
  • have not had food or water for a long time (prolonged fasting or starvation).
  • are pregnant or plan to become pregnant.
  • are breastfeeding or plan to breastfeed. It is not known if BAQSIMI passes into your breast milk. You and your doctor should decide if you can use BAQSIMI while breastfeeding.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How to use

Read the detailed Instructions for Use that comes with BAQSIMI.

  • Use BAQSIMI exactly how your doctor tells you to use it.
  • Make sure your caregiver knows where you keep your BAQSIMI and how to use BAQSIMI the right way before you need their help.
  • Your doctor will tell you how and when to use BAQSIMI.
  • BAQSIMI contains only one dose of medicine and cannot be reused.
  • BAQSIMI should be given in one side of your nose (nostril) but does not need to be inhaled.
  • BAQSIMI will work even if you have a cold or are taking cold medicine.
  • After giving BAQSIMI, the caregiver should call for emergency medical help right away.
  • If the person does not respond after 15 minutes, another dose may be given, if available.
  • Tell your doctor each time you use BAQSIMI.
  • Store BAQSIMI at temperatures up to 86°F (30°C).
  • Keep BAQSIMI in the shrink-wrapped tube until you are ready to use it.

Keep BAQSIMI and all medicines out of the reach of children.

Learn more

BAQSIMI is a prescription medicine. For more information, call 1-800-423-4136.

This summary provides basic information about BAQSIMI but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your doctor. Be sure to talk to your doctor or other healthcare provider about BAQSIMI and how to take it. Your doctor is the best person to help you decide if BAQSIMI is right for you.

BAQSIMI® is a registered trademark owned or licensed by Amphastar Pharmaceuticals, Inc., its subsidiaries, or affiliates.

Indication

BAQSIMI® (BAK-see-mee) is used to treat very low blood sugar (severe hypoglycemia) in people with diabetes ages 4 years and above.

It is not known if BAQSIMI is safe and effective in children under 4 years of age.