Selected Important Safety Information

Acrotech Biopharma, LLC. Website Linking Policy

Acrotech Biopharma, LLC. (“Acrotech”) ordinarily does not prohibit links to this website, provided that any such link does not improperly connote an endorsement by or affiliation with Acrotech Biopharma, or otherwise adversely impact Acrotech, and pursuant to the terms below.

If you are interested in linking to this website or any other Acrotech owned websites, please notify Acrotech Biopharma by sending an e-mail to webmaster@AcrotechBiopharma.com. Include your name, your organization name, contact information (such as a phone number and/or e-mail address) as well as the URL of your site and a list of any URLs from which you intend to link to this site.

By linking to any page on the Acrotech Biopharma websites, you hereby agree to be bound by the terms and conditions as set forth below:

Links may be text-based using the words: “FOLOTYN®“, “FOLOTYN”, “Acrotech”, or “AcrotechBiopharma.com” the “Acrotech Marks”. You may not use the FOLOTYN®logo, Acrotech Biopharma™ logo or any Acrotech logo as a link. By linking, you acknowledge and agree that, other than as set forth herein, all rights to the Acrotech Marks, other Acrotech marks, the content appearing on the Acrotech website and the design of the Acrotech website belong to Acrotech Biopharma, LLC. 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 Biopharma, LLC.

You may not create frames around any of the pages of the Acrotech Biopharma™ websites or use other techniques that alter in any way the visual presentation or appearance of any of the Acrotech™ websites.

You must not misrepresent your relationship with any Acrotech Biopharma™ product or Acrotech Biopharma, LLC. (or any Acrotech-owned business entity, Acrotech subsidiary, or Acrotech-affiliated business entity) or present false or misleading impressions about any Acrotech™ product or Acrotech Biopharma, LLC. (or any Acrotech-owned business entity, Acrotech subsidiary, or Acrotech-affiliated business entity). No links to any Acrotech™ website may be used in a manner that implies or suggests that Acrotech approves or endorses you, your website or your goods and services (in all cases, except as Acrotech may have agreed separately with you in writing).

Acrotech Biopharma has no responsibility or liability for any content appearing on your website. You agree to indemnify and defend Acrotech against all claims arising out of or based upon your website.

No link(s) may appear on any page on your website or within any context containing content or materials that may be interpreted as libelous, obscene or criminal, or which infringes, otherwise violates, or advocates the infringement or other violation of, any third party rights.

Acrotech Biopharma may at any time, in its sole discretion, without cause, terminate your right to link to any web pages of any Acrotech™ website. In such event, upon request, you agree to immediately remove all links to any Acrotech™ website and to cease using the Acrotech Marks.

Acrotech Biopharma, LLC., reserves the right to change this linking policy at any time. Changes will be posted on this page.

© 2020 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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