Generic name: Pralatrexate

Folotyn^® is the trade for the generic chemotherapy drug Pralatrexate. In some cases, health care professionals may use the generic name pralatrexate when referring to the trade name Folotyn^®.

Drug type: Folotyn^® is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. This medication is classified as an "antimetabolite." - (For more detail, see "How this drug works," below.)

What Folotyn Is Used For:

• For the treatment of peripheral T-cell lymphoma (PTCL).

Note: If a drug has been approved for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful.

How Folotyn Is Given:

• Folotyn^® is given through a vein by intravenous (IV) injection.
• Folic acid and vitamin B12 supplements are also prescribed during treatment with Folotyn^® to reduce the risk of possible side effects. Take as prescribed.
• The amount of Folotyn^® that you will receive depends on many factors, your general health or other health problems, and the type of cancer or condition being treated. Your doctor will determine your dose and schedule.

Side Effects:

Important things to remember about the side effects of Folotyn^®:

• Most people do not experience all of the side effects listed.
• Side effects are often predictable in terms of their onset and duration.
• Side effects are almost always reversible and will go away after treatment is complete.
• There are many options to help minimize or prevent side effects.
• There is no relationship between the presence or severity of side effects and the effectiveness of the medication.

The following side effects are common (occurring in greater than 30%) for patients taking Folotyn^®:

• Mouth Sores
• Low Platelet Count
• Nausea
• Fatigue
• Anemia
• Constipation
• Fever
• Swelling

These side effects are less common side effects (occurring in about 10-29%) of patients receiving Folotyn^®:

• Cough
• Nose Bleeds
• Vomiting
• Decreased white blood cell count
• Diarrhea
• Shortness of breath
• Rash
• Low Potassium
• Lack of appetite
• Itching
• Sore throat
• Elevated Liver Enzymes
• Abdominal Pain
• Limb pain
• Back Pain
• Night sweats
• Weakness
• Increased Heart Rate
• Upper respiratory tract infection

Not all side effects are listed above. Some that are rare (occurring in less than 10% of patients) are not listed here. However, you should always inform your health care provider if you experience any unusual symptoms.

When to contact your doctor or health care provider:

Contact your health care provider immediately, day or night, if you should experience any of the following symptoms:

• Fever of 100.4° F (38°C or higher, chills)

Always inform your health care provider if you experience any unusual symptoms.

The following symptoms require medical attention, but are not an emergency. Contact your health care provider within 24 hours of noticing any of the following:

• Diarrhea (4-6 episodes in a 24-hour period).
• Nausea (interferes with ability to eat and unrelieved with prescribed medication).
• Vomiting (vomiting more than 4-5 times in a 24 hour period).
• Unable to eat or drink for 24 hours or have signs of dehydration: tiredness, thirst, dry mouth, dark and decrease amount of urine, or dizziness.
• Shortness of breath, accompanied by cough and/or fever.

• Skin or the whites of your eyes turn yellow
• Urine turns dark or brown (tea color)
• Decreased appetite
• Pain on the right side of your stomach
• Bleed or bruise more easily than normal
• Itching or rash

Always inform your health care provider if you experience any unusual symptoms.

Precautions:

• Before starting Folotyn^® treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.). Do not take aspirin, or products containing aspirin unless your doctor specifically permits this.
• Take the folic acid and vitamin B12 supplements as prescribed.
• Do not receive any kind of immunization or vaccination without your doctor's approval while taking Folotyn^®.
• Inform your health care professional if you are pregnant or may be pregnant prior to starting this treatment. Pregnancy category D (Folotyn^® may be hazardous to the fetus. Women who are pregnant or become pregnant must be advised of the potential hazard to the fetus.)
• For both men and women: Do not conceive a child (get pregnant) while taking Folotyn^®. Barrier methods of contraception, such as condoms, are recommended. Discuss with your doctor when you may safely become pregnant or conceive a child after therapy.
• Do not breast feed while taking this medication.

Self-Care Tips:

• Drink at least two to three quarts of fluid every 24 hours, unless you are instructed otherwise.
• You may be at risk of infection so try to avoid crowds or people with colds, and report fever or any other signs of infection immediately to your health care provider.
• Wash your hands often.
• To help treat/prevent mouth sores, use a soft toothbrush, and rinse three times a day with 1 teaspoon of baking soda mixed with 8 ounces of water.
• Use an electric razor and a soft toothbrush to minimize bleeding.
• If you should experience nausea, take anti-nausea medications as prescribed by your doctor, and eat small frequent meals. Sucking on lozenges and chewing gum may also help.
• Avoid sun exposure. Wear SPF 15 (or higher) sun block and protective clothing.
• In general, drinking alcoholic beverages should be kept to a minimum or avoided completely. You should discuss this with your doctor.
• Get plenty of rest.
• Maintain good nutrition.
• If you experience symptoms or side effects, be sure to discuss them with your health care team. They can prescribe medications and/or offer other suggestions that are effective in managing such problems.

Monitoring and Testing:

Lab work to check blood counts and liver/kidney functions will be checked regularly by your health care professional while you are taking Folotyn ^®, to monitor side effects and check your response to therapy.

How Folotyn Works:

Cancerous tumors are characterized by cell division, which is no longer controlled as it is in normal tissue. "Normal" cells stop dividing when they come into contact with like cells, a mechanism known as contact inhibition. Cancerous cells lose this ability. Cancer cells no longer have the normal checks and balances in place that control and limit cell division. The process of cell division, whether normal or cancerous cells, is through the cell cycle. The cell cycle goes from the resting phase, through active growing phases, and then to mitosis (division).

The ability of chemotherapy to kill cancer cells depends on its ability to halt cell division. Usually, the drugs work by damaging the RNA or DNA that tells the cell how to copy itself in division. If the cells are unable to divide, they die. The faster the cells are dividing, the more likely it is that chemotherapy will kill the cells, causing the tumor to shrink. They also induce cell suicide (self-death or apoptosis).

Chemotherapy drugs that affect cells only when they are dividing are called cell-cycle specific. Chemotherapy drugs that affect cells when they are at rest are called cell-cycle non-specific. The scheduling of chemotherapy is set based on the type of cells, rate at which they divide, and the time at which a given drug is likely to be effective. This is why chemotherapy is typically given in cycles.

Chemotherapy is most effective at killing cells that are rapidly dividing. Unfortunately, chemotherapy does not know the difference between the cancerous cells and the normal cells. The "normal" cells will grow back and be healthy but in the meantime, side effects occur. The "normal" cells most commonly affected by chemotherapy are the blood cells, the cells in the mouth, stomach and bowel, and the hair follicles; resulting in low blood counts, mouth sores, nausea, diarrhea, and/or hair loss. Different drugs may affect different parts of the body.

Folotyn^® belongs to the class of chemotherapy drugs called antimetabolites. Antimetabolites are very similar to normal substances within the cell. When the cells incorporate these substances into the cellular metabolism, they are unable to divide. Antimetabolites are cell-cycle specific. They attack cells at very specific phases in the cycle. Antimetabolites are classified according to the substances with which they interfere:

Folic acid antagonist: Pralatrexate, Methotrexate, Folotyn^®.

Pyrimidine antagonist: 5-Fluorouracil, Foxuridine, Cytarabine, Capecitabine, and Gemcitabine.

Purine antagonist: 6-Mercaptopurine and 6-Thioguanine.

Adenosine deaminase inhibitor: Cladribine, Fludarabine and Pentostatin.

Folotyn^® exerts its chemotherapeutic effect by being able to counteract and compete with folic acid in cancer cells resulting in folic acid deficiency in the cells and causing their death.

Note: We strongly encourage you to talk with your health care professional about your specific medical condition and treatments. The information contained in this website is meant to be helpful and educational, but is not a substitute for medical advice.

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