Folotyn Side Effects

Generic Name: pralatrexate

Note: This page contains information about the side effects of pralatrexate. Some of the dosage forms included on this document may not apply to the brand name Folotyn.

Not all side effects for Folotyn may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to pralatrexate: intravenous solution

In addition to its needed effects, some unwanted effects may be caused by pralatrexate (the active ingredient contained in Folotyn). In the event that any of these side effects do occur, they may require medical attention.

If any of the following side effects occur while taking pralatrexate, check with your doctor or nurse immediately:

More common
  • Black, tarry stools
  • bleeding gums
  • blood in the urine or stools
  • body aches or pain
  • chills
  • convulsions
  • cough
  • cracked lips
  • decreased urine
  • diarrhea
  • difficult or labored breathing
  • difficulty with swallowing
  • dry mouth
  • ear congestion
  • fast, pounding, or irregular heartbeat or pulse
  • fever
  • headache
  • increased thirst
  • loss of appetite
  • loss of voice
  • lower back or side pain
  • mood changes
  • muscle pain or cramps
  • nasal congestion
  • nausea or vomiting
  • numbness or tingling in the hands, feet, or lips
  • painful or difficult urination
  • pale skin
  • pinpoint red spots on the skin
  • runny nose
  • shortness of breath
  • sneezing
  • sore throat
  • 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 of the side effects that can occur with pralatrexate may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Abdominal or stomach pain
  • back pain
  • bloody nose
  • constipation
  • itching skin
  • lack or loss of strength
  • night sweats
  • pain in the arms or legs
  • rash
  • weight loss

For Healthcare Professionals

Applies to pralatrexate: intravenous solution

Gastrointestinal

Very common (10% or more): Mucositis (70%), nausea (40%), constipation (33%), vomiting (25%), diarrhea (21%), anorexia (15%)[Ref]

Hematologic

Very common (10% or more): Thrombocytopenia (41%), anemia (34%), neutropenia (24%), leukopenia (11%)
Common (1% to 10%): Febrile neutropenia, pancytopenia[Ref]

General

The most common side effects observed in patients with peripheral T-cell lymphoma (PTCL) were mucositis, thrombocytopenia, nausea, and fatigue.[Ref]

Cardiovascular

Very common (10% or more): Edema (30%), tachycardia (10%)
Uncommon (0.1% to 1%): Cardiopulmonary arrest[Ref]

Respiratory

Very common (10% or more): Cough (28%), epistaxis (26%), dyspnea (19%), upper respiratory tract infection (10%)

Metabolic

Very common (10% or more): Hypokalemia (15%)
Common (1% to 10%): Dehydration

Dermatologic

Very common (10% or more): Rash (15%), pruritus (14%)
Frequency not reported: Skin exfoliation, ulceration, toxic epidermal necrolysis

Other

Very common (10% or more): Fatigue (36%), pyrexia (32%), pharyngolaryngeal pain (14%), abdominal pain (12%), pain in extremity (12%), back pain (11%), night sweats (11%), asthenia (10%)

Hepatic

Very common (10% or more): Abnormal liver function tests (13%)

Immunologic

Common (1% to 10%): Sepsis

References

1. "Product Information. Folotyn (pralatrexate)." Allos Therapeutics, Westminster, CO.

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