Folotyn (pralatrexate) is used to treat adults with a blood cancer called peripheral T-cell lymphoma (PTCL). It’s a chemotherapy medication known as an antimetabolite. This medication is given as an injection into the vein (also called an intravenous or IV). It’s given by a trained healthcare professional at a clinic or cancer center. You need vitamin B12 and folic acid supplementation before and during treatment. This helps manage side effects such as low blood cells and mouth sores.
Folotyn (pralatrexate) is a type of chemotherapy called an antimetabolite. It works by blocking dihydrofolate reductase. This is a protein in your body that’s important for helping cells make their DNA.
When this protein gets blocked, fast-growing cells, like cancer cells, can’t make the DNA that they need to survive. This helps slow the cancer from spreading and growing.
| Common Brands | Folotyn |
|---|---|
| Drug Class | Antimetabolite |
| Controlled Substance Classification | Not a controlled medication |
| Generic Status | No lower-cost generic available |
| Availability | Prescription only |
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Contact your healthcare provider immediately if you experience any of the following.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor or nurse immediately if any of the following side effects occur:
More common
Black, tarry stools
bleeding gums
blood in the urine or stools
body aches or pain
chills
convulsions
cracked lips
decreased urine
difficult or labored breathing
difficulty with swallowing
ear congestion
fast, pounding, or irregular heartbeat or pulse
headache
increased thirst
loss of appetite
loss of voice
lower back or side pain
mood changes
muscle pain or cramps
nausea or vomiting
numbness or tingling in the hands, feet, or lips
painful or difficult urination
pale skin
pinpoint red spots on the skin
shortness of breath
sores, ulcers, or white spots on the lips, tongue, or inside the mouth
swelling
tightness in the chest
troubled breathing with exertion
unusual bleeding or bruising
unusual tiredness or weakness
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Before you start Folotyn (pralatrexate):
While taking Folotyn (pralatrexate):
Folotyn (pralatrexate) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Folotyn (pralatrexate) can lower your blood cell counts. This can cause low platelets, which can lead to easy bleeding or bruising. It can also cause low white blood cells, making it easier for you to get sick. And having low red blood cells, or anemia, can make you feel very tired.
Before starting Folotyn (pralatrexate), you’ll need a vitamin B12 shot in the muscle within 10 weeks of your first dose. You’ll also take daily folic acid tablets starting 10 days before your first Folotyn (pralatrexate) injection. This helps lower the risk of low blood cell counts. Before your first injection, you’ll also need a blood test to check your blood counts and make sure it’s safe to start treatment.
While taking Folotyn (pralatrexate), keep taking folic acid tablets every day and get vitamin B12 shots every few months. Your care team will check your blood counts before each Folotyn (pralatrexate) injection. If your counts are too low, you might need a lower dose or you might need to skip a dose.
A common side effect of Folotyn (pralatrexate) is mouth sores, also called mucositis. This can look like swelling and irritation inside your mouth. It can cause painful sores in your mouth that make it hard to eat, drink, or talk.
To help prevent this, or keep it from becoming severe, you’ll take folic acid tablets and get vitamin B12 shots. You’ll get a vitamin B12 injection into the muscle before starting and then every few months after that. And you’ll start daily folic acid 10 days before your first Folotyn (pralatrexate) injection and keep taking it during treatment.
Tell your care team if you get mouth sores while taking Folotyn (pralatrexate). Your oncologist or hematologist might lower your dose or give you a special mouthwash to help with pain.
Folotyn (pralatrexate) can cause serious skin reactions, which can be life-threatening. It can include peeling skin, sores, and toxic epidermal necrolysis (TEN). These problems can get worse as you continue treatment.
Tell your care team right away if you have painful blisters, skin sores, peeling skin, or a fever while taking Folotyn (pralatrexate). These can be signs of a serious skin reaction that needs urgent care.
Folotyn (pralatrexate) can sometimes cause a reaction called tumor lysis syndrome (TLS). This happens when many cancer cells are destroyed quickly. It can cause high levels of potassium and uric acid in the blood, which can lead to serious heart or kidney problems.
Your cancer care team will monitor you closely for TLS while you’re taking Folotyn (pralatrexate). Watch for possible signs of TLS. These might include nausea, low appetite, tiredness, numbness, muscle cramps, or an uneven heartbeat. If you develop TLS, your cancer care team will help treat it.
Folotyn (pralatrexate) can cause higher liver enzyme levels on blood tests. This can be a sign of liver damage.
Your oncologist or hematologist will check your liver with blood tests during treatment. If your levels are too high, you might need to pause treatment until your liver gets better. Your oncologist or hematologist might also lower your dose when you restart.
People with severe kidney problems have a higher risk of side effects from Folotyn (pralatrexate). Your kidneys play a role in removing the medication from your body. When your kidneys don’t work as well, Folotyn (pralatrexate) can stay in your body longer and build up. This can raise your risk of having worse side effects, like severe skin reactions and mouth sores.
Before starting Folotyn (pralatrexate), tell your oncologist or hematologist if you have kidney problems. They can make sure it’s safe for you. They might prescribe a lower dose of the medication to lower your risk of side effects. But people with advanced kidney problems shouldn’t take Folotyn (pralatrexate).
Based on animal studies and how Folotyn (pralatrexate) works, the medication could harm an unborn baby. If you can become pregnant, you’ll likely need a pregnancy test before starting treatment to make sure you’re not pregnant.
If you can get pregnant, use effective birth control while taking Folotyn (pralatrexate) and for 6 months after your last dose. If you can father a child, also use birth control like condoms during treatment and for 3 months after stopping. If you or your partner gets pregnant during treatment, tell your care team right away.
Folotyn (pralatrexate) is given as an injection into a vein (IV) by a trained healthcare professional.
Your oncologist or hematologist will find the dose based on your body size or body surface area (BSA). This is calculated in m² and it takes your height and weight into account.
The usual dose is 30 mg/m² given IV once a week for 6 weeks. Then, you take 1 week off before starting a new treatment cycle. One cycle is 6 weeks of treatment, then by 1 week off.
If you have severe kidney problems, your dose might be lower (15 mg/m² per dose).
If needed, your oncologist or hematologist can adjust your dose to help manage side effects.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
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Yes, Folotyn is a type of traditional chemotherapy. More specifically, it’s called an antimetabolite. It works by blocking fast-growing cells in the body, like cancer cells, from making DNA. This helps stop them from growing and spreading.
Folic acid and vitamin B12 help lower the risk of common side effects from Folotyn. They are low blood cell counts and mouth sores. Folotyn can damage healthy cells like blood cells and those that make up the lining of your mouth, in addition to cancer cells. These vitamins help your body make healthy cells and can make these side effects less severe. You’ll take prescription folic acid every day and get vitamin B12 injections every few months. You'll start both before treatment and continue them during treatment. Keep taking daily folic acid for 30 days after your last Folotyn dose. Your cancer team will tell you when to start and how to take these supplements. Ask them if you have questions.
If you have kidney problems, tell your oncologist or hematologist before starting Folotyn. When your kidneys don’t work well, the medication can build up in your body and raise the risk of worse side effects. Some people severe kidney problems can still take Folotyn, but they’ll need a lower dose. This helps prevent more serious side effects. People with kidney failure usually should avoid Folotyn. If you take this medication and you have kidney problems, your cancer team might monitor you more closely for side effects like low blood cell counts.
Take Folotyn for as long as your oncologist or hematologist recommends. This depends on how well it’s working for you and if you have serious or bothersome side effects. To see how well the medication is working, your care team will check your lab tests and scans. They’ll also ask you about your symptoms. These follow-ups can also help your cancer team check for serious side effects. Tell your care team if you have side effects like mouth sores, nausea, or tiredness that make it hard to do your daily activities. If your cancer gets worse or side effects are severe, you might need to stop the medication. But don’t stop taking Folotyn without talking to your cancer team first.
Pralatrexate, which is the active ingredient of Folotyn, and methotrexate are both types of chemotherapy called antimetabolites. The main difference is how they’re used. Pralatrexate treats a rare blood cancer called peripheral T-cell lymphoma (PTCL). Methotrexate is used for many types of cancers and some autoimmune conditions like rheumatoid arthritis (RA). The medications are also given differently. Pralatrexate is an IV infusion, while methotrexate can be taken as pills by mouth or as an injection. Talk to a healthcare professional to compare in detail.
Don’t breastfeed while taking Folotyn and for 1 week after your last dose. We don't know if the medication can pass into breast milk and if it could harm your baby. But there’s a potential risk that it could cause side effects in your baby. Talk to your oncologist, hematologist, or a lactation expert for safer feeding options.
