BELEODAQ is a histone deacetylase inhibitor indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). This indication is approved under accelerated approval based on tumor response rate and duration of response. An improvement in survival or disease-related symptoms has not been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.
Important Safety Information	Full Prescribing Information

Spectrum Pharmaceuticals, Inc. Website Privacy Policy

This Privacy Policy applies to our data collection and use practices relating to our website located at www. spectrumpharm.com. References in this Privacy Policy to “we,” “us” or “our” refer to Spectrum Pharmaceuticals, Inc. (“Spectrum”). By using our website, you agree to the terms of this Privacy Policy and any modifications made to this Privacy Policy.

Please be aware that this Privacy Policy will not necessarily apply to information you may have provided or will provide to us in settings other than by or through our website.

Collection of Information

When you use our website, we collect personal information that you choose to provide voluntarily to us. For example, you may provide personal information on a customer feedback page. In addition, when you visit our website, you will be assigned a permanent “cookie” (a small text file) to be stored on your computer’s hard drive. We may also collect certain technical information from your computer, including your Internet Protocol (IP) address, during your visit to our website. Some third party service providers may also use cookies on this website in connection with advertising or otherwise. We do not have access to or control over these third party cookies.

Use of Information

We use the information that we collect to communicate with you.

We may also use the personal information that we collect to provide you with details about promotions and services that we believe may be of interest to you, but we will only do so if you separately request, at the time of registration or at a later date, to receive these details. If you no longer wish to receive communications about such promotions and services, you may opt out at any time by notifying us at optout@sppirx.com.

We use the aggregate statistical data that we collect to better serve you. For example, we use aggregate statistical data to identify the effectiveness of our promotional activities; and provide special savings offers, such as free samples, coupons, rebates and other promotions, to you.

Sharing of Information with Third Parties

We will not sell your personal information to third parties.

We may share your personal information with our subsidiaries, affiliates, agents, representatives and business partners for the limited purpose of providing services or information to us or our customers at our direction. We may also provide to third parties certain personal information that is necessary to fulfill an order you have placed with us, such as providing your name and address to a shipping carrier for delivery. We expect our agents and business partners to follow our privacy policies when using customer information provided by us. We are not responsible for any additional information that you provide directly to these third parties.

We may also disclose the aggregate statistical data that we collect to third parties in order to allow them to measure the effectiveness of programs and advertisements aimed at our customers.

Disclosure Of Information In Response To A Court Order Or In An Emergency

We will disclose information when compelled by a subpoena or court order, or when we believe, in our reasonable discretion, that such disclosure is warranted to cooperate with inquiries by law enforcement agencies or in emergencies where physical safety is at risk.

Contacting Us About Your Online Privacy

You may always contact us to remove or update personally identifiable information from our database by sending an e-mail to us at optout@sppirx.com. If you have any questions or comments about the way your personally identifiable information collected in via our website is used and handled, please e-mail us at listusage@sppirx.com.

Security

We have put into place physical, electronic and managerial procedures to safeguard and secure the information we collect about you. For example, we operate secure data networks protected by industry standard “firewalls” and password protection systems that are intended to keep unauthorized persons from accessing your personal information. Nevertheless, we cannot guarantee that unauthorized access or disclosure of your personal information will never occur.

Third Party Websites

As a convenience to our website visitors, this website may contain links to third-party web sites. Third party websites are not covered by this Privacy Policy and Spectrum will have no control over the information you enter or the cookies your browser accepts while on a third party’s website. You should examine the terms of use and privacy policies of other website pages whenever you leave a Spectrum website. Spectrum is not responsible for the privacy practices or the content included on third party websites.

Amendment Or Modification Of This Privacy Statement

We reserve the right to amend this Privacy Policy at any time and only the current Privacy Policy, as set forth on our websites www.beleodaq.com, www.BELEODAQ.com and www.sppirx.com will be deemed effective.

Important Safety Information about BELEODAQ

Low Blood Cell Counts: Patients may experience low blood cell counts. Your doctor will do weekly blood tests to check your blood counts.
- Low Platelet Count: Lower platelets may cause unusual bleeding, such as nosebleeds, or abnormal bruising. Talk to your doctor right away if this happens.
- Low Red Blood Cell Count: Lower red blood cell counts may make you feel weak, feel tired, and/or get tired easily. You may appear pale and be short of breath. Contact your doctor if you experience any of these symptoms following treatment with BELEODAQ.
- Low White Blood Cell Count: Lower white blood cell counts can reduce the body’s defenses against infection. If you have any of the following signs or symptoms of infection (fever, chills, cough, shortness of breath, pain or burning on urination, muscle aches, or worsening skin problems), tell your doctor right away. Serious illness or death could result if such infections are not treated when white blood cell counts are very low.
Serious Infections: BELEODAQ may lower the ability of your immune system to fight infections. People receiving BELEODAQ may develop serious infections that can sometimes lead to death. You should not receive BELEODAQ if you have an ongoing active infection. You should tell your doctor if you have any signs or symptoms of an infection.
Liver Problems: BELEODAQ may cause liver problems which can lead to death. Your doctor will do blood tests during your treatment with BELEODAQ to check for liver problems. Tell your doctor right away if you have any of the following signs or symptoms of liver problems: yellowing of the skin or the white part of your eyes, dark urine, itching, or pain in the right upper stomach area.
Tumor Lysis Syndrome (TLS): BELEODAQ can cause the fast breakdown of certain types of cancer cells. This can lead to TLS. As tumor cells die, they break apart and release their contents into the blood causing a change in certain chemicals in the bloodstream, which may cause damage to organs, including the kidneys, heart, and liver. Your doctor may do blood tests to check you for TLS and treat you for TLS if needed.
Nausea, Vomiting, and Diarrhea: Nausea, vomiting, and diarrhea are common with BELEODAQ and can sometimes be serious. Medicines can be given that may help reduce these symptoms. If you experience any of these symptoms, tell your doctor.
Pregnancy and Nursing: Tell your doctor if you are pregnant or plan to become pregnant. BELEODAQ can harm your unborn baby. BELEODAQ has not been studied in pregnant women. Tell your doctor if you are breastfeeding or plan to breast-feed. It is not known if BELEODAQ will pass into your breast milk. You and your doctor should decide if you will receive BELEODAQ or breastfeed. You should not do both.
Other common side effects may include:
- Fatigue
- Fever
These are not all of the potential side effects of BELEODAQ. If you have any side effect that bothers you or that doesn’t go away, be sure to talk with your healthcare professional.
Tell your doctor about your medical conditions, including infection, chemotherapy treatment, liver and kidney problems, nausea, vomiting, or diarrhea.
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Some medicines may affect how BELEODAQ works, and BELEODAQ may affect how other medicines work. Especially tell your doctor if you are also taking medications such as Nexavar (sorafenib), Tarceva (erlotinib), Lopid (gemfibrozil), or ketoconazole. Ask your doctor or pharmacist if you are not sure if your medicine should be avoided while taking BELEODAQ. Know the medicines you take. Keep a list of them and show it to your doctor or pharmacist each time you start a new medicine.

Please click here to see patient information within the full Prescribing Information for BELEODAQ.

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.

ISI-0154-096100

For Healthcare Professionals