Pralatrexate

Pralatrexate is a prescription medication used for the treatment of peripheral T-cell lymphoma.

• Pralatrexate is available under the following different brand names: Folotyn

Common side effects of Pralatrexate include:

• sores or white patches in or around your mouth,
• trouble swallowing or talking,  
• dry mouth,
• bad breath,
• altered sense of taste,
• easy bruising,
• unusual bleeding,
• purple or red spots under the skin,
• nausea, and
• tiredness

Serious side effects of Pralatrexate include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• fever,
• sore throat,
• burning eyes,
• skin pain,
• red or purple skin rash with blistering and peeling,
• loss of appetite,
• stomach pain (upper right side),
• tiredness,
• itching,
• dark urine,
• clay-colored stools,
• yellowing of the skin or eyes (jaundice),
• weakness,
• muscle cramps,
• nausea,
• vomiting,
• diarrhea,
• irregular, fast or slow heart rate,
• tingling in the hands and feet or around the mouth,
• skin sores,
• cough,
• pale skin,
• unusual tiredness,
• lightheadedness,
• shortness of breath,
• cold hands and feet,
• leg cramps,
• constipation,
• fluttering in your chest,
• increased thirst or urination,
• numbness or tingling,
• muscle weakness,
• limp feeling,
• increased thirst,
• feeling hot,
• inability to urinate,
• heavy sweating, and
• hot and dry skin

Rare side effects of Pralatrexate include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

IV solution

• 20 mg/mL
• 40 mg/2 mL

Peripheral T-Cell Lymphoma

Adult dosage

• 30 mg/m² IV every week  for 6 weeks in 7 week cycles

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Pralatrexate has severe interactions with no other drugs.
• Pralatrexate has serious interactions with the following drugs:
  • adenovirus types 4 and 7 live, oral
  • axicabtagene ciloleucel
  • brexucabtagene autoleucel
  • ciltacabtagene autoleucel
  • idecabtagene vicleucel
  • influenza virus vaccine quadrivalent, adjuvanted
  • influenza virus vaccine trivalent, adjuvanted
  • lisocabtagene maraleucel
  • palifermin
  • tisagenlecleucel
  • tofacitinib
• Pralatrexate has serious interactions with at least 44 other drugs.
• Pralatrexate has serious interactions with the following drugs:
  • maitake
  • taurine
  • vitamin A
  • vitamin E

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Pralatrexate?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Pralatrexate?”

Cautions

• Treatment can cause mucositis; administer vitamin B12 and instruct patients to take folic acid to reduce the risk of mucositis; monitor for mucositis weekly and omit and/or reduce dose for grade 2 or higher mucositis
• Treatment interruption or dose reduction to 20 mg/sq.meters may be required with severe mucositis, thrombocytopenia, or elevated liver function tests
• Caution with moderate-to-severe renal impairment (higher risk for toxicity); monitor for systemic toxicity and adjust dose accordingly
• Reports of severe dermatologic reactions including skin exfoliation, ulceration, and toxic epidermal necrolysis; reactions may be progressive and increase in severity with further treatment and may involve skin and subcutaneous sites of known lymphoma; monitor closely for dermatologic reactions (withhold or discontinue treatment)
• Treatment can cause tumor lysis syndrome (TLS); monitor patients who are at increased risk of TLS and treat them promptly
• Avoid breastfeeding
• Probenecid decreases renal elimination of pralatrexate
• Myelosuppression
  • Therapy can cause myelosuppression, manifested by thrombocytopenia, neutropenia, and/or anemia
  • Administer vitamin B12 and instruct patients to take folic acid to reduce the risk of treatment-related myelosuppression
  • Monitor complete blood counts and omit and/or reduce the dose based on ANC and platelet count before each dose
• Hepatotoxicity
  • Can cause hepatic toxicity and liver function test abnormalities; persistent liver function test abnormalities may be indicators of hepatic toxicity and require dose modification or discontinuation.
  • Monitor liver function tests. Omit dose until recovery, adjust or discontinue therapy based on the severity of the hepatic toxicity
• Renal Impairment
  • Patients with severe renal impairment (eGFR 15 to less than  30 mL/min/1.73 m2 based on MDRD) may be at greater risk for increased exposure and adverse reactions; reduce dosage in patients with severe renal impairment
  • Serious adverse reactions, including TEN and mucositis, are reported in patients receiving therapy with end-stage renal disease (ESRD) undergoing dialysis; avoid therapy in patients with ESRD with or without dialysis; If the potential benefit of administration justifies the potential risk, monitor renal function and reduce dose based on adverse reactions

Pregnancy and Lactation

• Based on findings from animal studies and mechanism of action therapy can cause fetal harm when administered to a pregnant woman; there are insufficient data on use in pregnant women to evaluate for a drug-associated risk; the drug was embryotoxic and fetotoxic in rats and rabbits when administered during organogenesis at doses about 1.2% (0.012 times) of clinical dose on an mg/m2 basis; advise pregnant women of the potential risk to a fetus
• Therapy can cause fetal harm when administered to a pregnant woman; verify pregnancy status in females of reproductive potential before initiation of therapy
• Contraception
  • Females: Advise females of reproductive potential to use effective contraception during treatment and for 6 months following the last dose
  • Males: Advise males with female partners of reproductive potential to use effective contraception during treatment and for 3 months following the last dose
• Lactation
  • There is no data on the presence in human milk or its effects on the breastfed child or milk production; because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment and for 1 week after the last dose