FOLOTYN is indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). The indication for FOLOTYN is based on overall response rate. Clinical benefit such as improvement in progression-free survival or overall survival has not been demonstrated.

Glossary

Biopsy
The surgical removal of tissue or a tumor sample for testing to determine the type and stage of cancer.

Cancer
A term for a group of diseases in which abnormal cells divide without control and can invade nearby tissues.

Chemotherapy
The treatment of cancer by drugs designed to kill cancer cells or stop them from growing.

Folic acid
Folic acid is one of the B vitamins. It is used by the body to help make new cells.

Intravenous (IV)
Within or through a vein. Chemotherapy is often given intravenously.

Lymph
The clear fluid that travels through the lymphatic system and carries cells that help fight infections and other diseases. Also called lymphatic fluid.

Lymphatic system
The tissues and organs that produce, store, and carry white blood cells that fight infections and other diseases. This system includes the bone marrow, spleen, thymus, lymph nodes, and lymphatic vessels (a network of thin tubes that carry lymph and white blood cells into all the tissues of the body).

Lymphoma
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.

Mucositis
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.

Peripheral T-cell lymphoma
One of a group of fast-growing non-Hodgkin’s lymphomas that begins in the T cells. Also called mature T-cell lymphoma.

Platelets
Cells necessary to help form a clot and stop a wound from bleeding.

Red blood cells
Cells that carry oxygen throughout the body.

Refractory
A term used to describe cancer that does not respond to treatment. The cancer may be resistant at the beginning of treatment or it may become resistant during treatment.

Relapse
The tumor cells start growing again after a period of improvement.

T cells
A group of white blood cells that are of key importance in fighting infection.

Tumor lysis syndrome (TLS)
Complication that results from the fast breakdown of certain types of cancer cells.

Vitamin B₁₂
Vitamin B₁₂ helps maintain healthy nerve cells and red blood cells.

White blood cells
Cells that help the body fight against infections and other diseases.

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