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 (mucositisMucositis
Redness, swelling, pain and/or the development of sores in the mucous membranes of the body. This includes the tissue lining the mouth or throat and can include the genital area as well. Mucositis is sometimes a side effect of chemotherapy or radiation.
). 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 lymphomaLymphoma
Cancer that begins in the lymphatic system. There are two basic categories of lymphoma: Hodgkin’s lymphoma and non-Hodgkin’s lymphoma (NHL); NHL includes a large, diverse group of cancers.
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) Tumor Lysis Syndrome (TLS)
Complication that results from the fast breakdown of certain types of cancer cells.
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.

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