Selected Important Safety Information

Acrotech Biopharma, LLC Terms of Use

The information provided on this Acrotech Biopharma, LLC Website is for general informational and educational use only and is subject to the following terms and conditions. By accessing and using this website, you acknowledge and accept, without limitation or qualification, this Terms of Use Agreement. If you do not wish to be bound by this agreement, you may not access or use any materials on this website.

1. Scope of Use

Acrotech Biopharma, LLC (“Acrotech”) maintains this website for your personal information and education. The information, documents and related graphics are available for your personal use, provided that the materials are not modified in any way and all copyright and other proprietary notices contained on the provided materials are maintained. This website and all its contents are intended to comply with United States laws that it may be subject to and Acrotech makes no representation that the information is appropriate for use in locations outside of the United States. Other countries may have laws, regulatory requirements, and medical practices that differ from those in the U.S. Those who access this site from other locations do so on their own initiative and are responsible to comply with applicable local laws and regulations. Any offer, product, or service available through this website is void where prohibited.

2. Intellectual Property

Images and materials displayed on this website are subject to intellectual property laws. Nothing contained herein shall be construed as conferring by implication, estoppel or otherwise any license or right under any patent, trademark, or copyright owned by Acrotech or any third party. Except as expressly provided herein, no use of any Acrotech intellectual property rights may be made without prior written consent of Spectrum. In addition, Spectrum neither warrants nor represents that the use of images or materials from this website will not infringe the rights of third parties not owned by or affiliated with Acrotech.

3. Medical Information.

The information provided on the Site is for informational purposes or general guidance only, and does not constitute medical advice. Such information is neither a substitute nor intended to be a substitute for the advice provided by a doctor, pharmacist, or other qualified healthcare professional. You agree that you will not use or rely on the information contained herein for diagnosing a health problem or condition. YOU SHOULD CONSULT WITH A DOCTOR BEFORE USING ANY PRODUCT DISCUSSED ON THIS OR ANY OTHER WEBSITE. The receipt of any questions or feedback you submit to us does not create a professional relationship and does not create any privacy interests other than those described in our Privacy Policy.

4. Non-Confidential Information.

Any oral, written or electronic response or communication established with Acrotech by any user of this website shall be deemed as non-confidential. Acrotech shall not have any obligations of any kind with respect to such information and shall be free to use any ideas, concepts, know-how or techniques contained in such communication without restriction for any purpose whatsoever. The sender of such information is fully responsible for its content, including, without limitation, its accuracy and truthfulness and its non-infringement of another party’s proprietary rights.

5. Forward-Looking Statements.

This website may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and in reliance upon the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are based on the beliefs of Spectrum’s management as well as assumptions made by and information currently available to Acrotech’s management. Readers should not put undue reliance on these forward-looking statements. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Acrotech’s actual results may differ materially from the results projected in the forwardlooking statements. Factors that might cause such a difference include, but are not limited to, those discussed in the documents and reports filed by the Acrotech from time to time with the Securities and Exchange Commission, specifically the most recent Form 10-K and 10-Q.

6. Disclaimer of Warranties.

While Acrotech uses reasonable efforts to include accurate and up-to-date information in this site, we make no warranties or representations of any kind as to the accuracy, currency or completeness of the information provided. We assume neither responsibility for any errors or omissions in the content of this site nor any liability to update the information contained in this site. Acrotech provides this information “as is” and disclaims all warranties of any kind, both express and implied, including, but not limited to, merchantability, fitness for a particular purpose, or non-infringement. Please note that some jurisdictions do not allow the exclusion of implied warranties, so the above disclaimer may not apply to you.

7. Limitations of Liability.

Use of this site is at the user’s own risk. Neither Acrotech nor any other party involved in the creating, producing, or delivering the website is liable for any direct, incidental, consequential, indirect or punitive damages arising out of access to or use of this website and/or the information provided, regardless of whether Spectrum has been advised as the possibility of such damages.

8. Third Party Websites and Links.

This site may contain references or links to other websites maintained by third parties not under Acrotech’s control. Such references or links are provided merely for convenience and Acrotech makes no representations or warranties of any kind with respect to any third party site. The inclusion of the reference or link does not imply endorsement of the site and Acrotech is not liable for any damages or injuries of any kind arising from such content or information.

9. Governing Law.

This Terms of Use Agreement and your use of this website shall be governed by the laws of the United States and the State of California without regard to its conflicts of law provisions. Any legal action or proceeding arising from or relating to your access or use of this website shall be brought exclusively in a federal or state court of proper jurisdiction in the State of California.

10. Modifications.

Acrotech Biopharma reserves the right to revise the terms and conditions of this agreement at any time without notice and such changes will be deemed effective upon posting. Continued use of the website following posting of an amended Terms of Use will indicate acceptance of such changes and therefore, this agreement should be reviewed periodically.

© 2019 Acrotech Biopharma, LLC. All rights reserved.

FOLOTYN Important Safety Information

  • 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 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), 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.
    • Low Red Blood Cell Count: Lower red blood cell counts may make you feel weak, feel tired, and 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 FOLOTYN.

  • Mucositis: Patients may develop mucositis, which is redness and/or sores in the mucous membranes including the mouth, lips, throat, and other areas along the digestive tract and genitals. Discomfort or pain due to mucositis may occur as early as a few days after treatment with FOLOTYN. Talk with your doctor about ways to reduce your risk of developing mucositis, and/or ways to maintain nutrition and control the discomfort if you develop it. It is important to take folic acid and vitamin B12 during your treatment with FOLOTYN. Your doctor will give you specific instructions for vitamin supplementation.
  • Severe Skin Reactions: Severe skin reactions may happen after treatment with FOLOTYN, which can be fatal. Tell your doctor right away if you have any of the following skin reactions: rash, peeling and loss of skin, sores, or blisters.
  • Tumor Lysis Syndrome (TLS): FOLOTYN can cause the fast breakdown of certain types of cancer This can lead to TLS. Your doctor may do blood tests to check you for TLS and treat you for TLS if needed.
  • Liver Toxicity: Folotyn can cause liver toxicity. Your doctor will monitor your liver function and may adjust or discontinue treatment based on liver tests.
  • Increased risk of serious reactions in people with kidney problems. People with severe kidney problems may have a greater risk for increased serious reactions during treatment with FOLOTYN. Tell your doctor if you have kidney problems.
  • Pregnancy and Nursing: Tell your doctor if you are pregnant or plan to become pregnant. FOLOTYN can harm your unborn baby.
    • Women of reproductive potential should use effective contraception during treatment with FOLOTN and for six months after final dose.
    • Males with female partners of reproductive potential should use effective contraception during treatment with Folotyn and for at least three months after final dose.
    • You should not breastfeed during treat with Folotyn and for 1 week after final dose.
  • Fever: Fever is often one of the most common and earliest signs of infection. Follow your doctor’s instructions on taking you temperature.  If you have a fever, tell your doctor or nurse right away.
  • Loss of too much fluid from the body (dehydration): If you feel tired and weak this could be a sign of dehydration. Follow your doctor’s instructions for what to do to help prevent or treat dehydration.
  • Nausea, Vomiting, Diarrhea and Constipation: Patients may experience nausea, vomiting, abdominal pain, diarrhea, and/or constipation. Medicines can be given that may help reduce these symptoms. If you experience any of these symptoms, tell your doctor.
  • Other side effects may include:
    • Dizziness, lightheadedness, and fainting spells
    • Fatigue, weakness, and lethargy
    • Rash, itching or swelling
    • Loss of appetite and weight loss
    • Joint and muscle pain

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Some medicines may affect how FOLOTYN works, and FOLOTYN may affect how other medicines work. Especially tell your doctor if you take: sulfamethoxazole trimethoprim (Bactrim®, Septra®, Septra DS, Sulfatrim Pediatric, Sulfamethoprim, Sulfamethoprim-DS), non-steroidal anti-inflammatory drugs (NSAIDs), probenecid (Probalan, Col-Probenecid). Ask your doctor or pharmacist if you are not sure if your medicine is listed above.

These are not all of the potential side effects of FOLOTYN. If you have any side effect that bothers you or that doesn’t go away, be sure to talk with your healthcare professional.

You may report side effects to FDA at 1-800-FDA-1088.

Please see patient information within the full Prescribing Information for FOLOTYN.

ISI-FOL-0172

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