Selected Important Safety Information

What are the possible side effects of Folotyn?

FOLOTYN may cause serious side effects, including:

Low Blood Cell Counts: FOLOTYN can affect your bone marrow and cause you to have low blood cell counts. Your doctor will do blood tests as needed to check your blood cell counts.

Low Platelet Count (thrombocytopenia): Tell your doctor right away if you have any unusual bleeding, such as nosebleeds, or bruising under your skin.

Low White Blood Cell Count (neutropenia): A low white blood cell count can cause you to get infections, which may be serious. Serious illness or death can happen if an infection is not treated right away when white blood cell counts are very low.

Tell your doctor right away if you have any of the following signs or symptoms of an infection:

Low Red Blood Cell Count (anemia): Tell your doctor if you have any of these symptoms of anemia during treatment with FOLOTYN:

  • feeling weak, tired, or you get tired easily
  • you look pale
  • you feel short of breath

Redness and sores of the mucous membrane lining of the mouth, lips, throat, digestive tract, and genitals (mucositis). Discomfort or pain due to mucositis may happen as early as a few days after treatment with FOLOTYN. Your doctor should tell you about ways to reduce your risk of getting mucositis, and how to maintain nutrition and control the discomfort from mucositis.

Severe Skin Reactions. Severe skin reactions may happen after treatment with FOLOTYN, especially if you have lymphoma in or under your skin. If your skin reactions are severe, they may lead to serious illness or death.

Tell your doctor right away if you have any of the following skin reactions:

Tumor Lysis Syndrome (TLS).  FOLOTYN can cause the fast breakdown of certain types of cancer cells. This can lead to TLS. Your doctor may do blood tests to check you for TLS and treat you for TLS if needed.

Harm to an unborn baby. Females should avoid becoming pregnant while being treated with FOLOTYN. Talk to your doctor about how to avoid pregnancy while taking FOLOTYN.

Fever. Fever is often one of the most common and earliest signs of infection. Follow your doctor’s instructions about how often to take your temperature, especially during the days after treatment with FOLOTYN. 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.

Shortness of breath. Tell your doctor if this is a problem for you.

Common side effects of FOLOTYN include:

Tell your doctor about any side effect that bothers you or that does not go away.

These are not all the possible side effects of FOLOTYN. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You can report side effects to FDA at 1-800-FDA-1088.

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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