Folotyn Side Effects

Generic name: pralatrexate

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

Some side effects of Folotyn may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to pralatrexate: intravenous solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking pralatrexate (the active ingredient contained in Folotyn) hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• taste loss, mouth pain, redness or ulcers, or white-yellow mouth sores;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• fever, chills, body aches, flu symptoms, rapid heart rate, rapid and shallow breathing, fainting;

• pale skin, feeling light-headed or short of breath, trouble concentrating;

• weakness, decreased sweating, hot or dry skin;

• confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling; or

• severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Less serious side effects of pralatrexate may include:

• nausea, vomiting, loss of appetite;

• diarrhea, constipation;

• tired feeling;

• cough;

• swelling; or

• mild rash or itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to pralatrexate: intravenous solution

Gastrointestinal

Gastrointestinal side effects including mucositis (70%), nausea (40%), constipation (33%), vomiting (25%), diarrhea (21%), and anorexia (15%) have been reported.

Hematologic

Hematologic side effects including thrombocytopenia (41%), anemia (34%), neutropenia (24%), and leukopenia (11%) have been reported.

General

General side effects including fatigue (36%), pyrexia (32%), and asthenia (10%) have been reported.

Cardiovascular

Cardiovascular side effects including edema (30%) and tachycardia (10%) have been reported.

Respiratory

Respiratory side effects including cough (28%), epistaxis (26%), dyspnea (19%), and upper respiratory tract infection (10%) have been reported.

Metabolic

Metabolic side effects including hypokalemia (15%) have been reported.

Dermatologic

Dermatologic side effects including rash (15%), pruritus (14%), mucositis, skin exfoliation, ulceration, and toxic epidermal necrolysis have been reported.

Other

Other side effects including pharyngolaryngeal pain (14%), abdominal pain (12%), pain in extremity (12%), back pain (11%), and night sweats (11%) have been reported.

Hepatic

Hepatic side effects including abnormal liver function tests (13%) have been reported.

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