RediTrex Side Effects Center

Last updated on RxList: 10/25/2022
RediTrex Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is RediTrex?

RediTrex (methotrexate) injection is a folate analog metabolic inhibitor indicated for the management of patients with severe, active rheumatoid arthritis (RA) and polyarticular juvenile idiopathic arthritis (pJIA), who are intolerant of or had an inadequate response to first-line therapy; and for symptomatic control of severe, recalcitrant, disabling psoriasis in adults who are not adequately responsive to other forms of therapy.

What Are Side Effects of RediTrex?

RediTrex may cause serious side effects including:

  • hives,
  • difficulty breathing,
  • swelling of your face, lips, tongue, or throat,
  • fever,
  • sore throat,
  • burning in your eyes,
  • skin pain,
  • red or purple skin rash that spreads and causes blistering and peeling,
  • sudden chest pain,
  • wheezing,
  • dry cough,
  • cough with mucus,
  • shortness of breath,
  • swollen lymph glands,
  • night sweats,
  • weight loss,
  • blisters or ulcers in your mouth,
  • red or swollen gums,
  • trouble swallowing,
  • blood in your urine or stools,
  • skin changes such as redness, warmth, swelling, or oozing,
  • fever,
  • chills,
  • easy bruising,
  • unusual bleeding,
  • pale skin,
  • cold hands and feet,
  • lightheadedness,
  • little or no urination,
  • swelling in your feet or ankles,
  • swelling around your midsection,
  • right-sided upper stomach pain,
  • nausea,
  • loss of appetite,
  • dark urine,
  • yellowing of the skin or eyes (jaundice),
  • confusion,
  • weakness,
  • drowsiness,
  • coordination problems,
  • irritableness,
  • headache,
  • neck stiffness,
  • vision problems,
  • loss of movement in any part of your body,
  • seizure,
  • tiredness,
  • muscle cramps,
  • vomiting,
  • diarrhea,
  • fast or slow heart rate, and
  • tingling in your hands and feet or around your mouth

Get medical help right away, if you have any of the symptoms listed above.

Common side effects of RediTrex include:

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

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
  • 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.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for RediTrex

The starting dose of RediTrex for rheumatoid arthritis (RA) is 7.5 mg once weekly, for polyarticular juvenile idiopathic arthritis (pJIA) the dose is 10 mg/m2 once weekly, and for psoriasis the dose is 10 to 25 mg once weekly of an oral, intramuscular, subcutaneous, or intravenous formulation.

RediTrex In Children

The safety and effectiveness of RediTrex have not been established in pediatric patients with psoriasis. The safety and effectiveness of RediTrex have not been established in pediatric patients with neoplastic diseases. The safety and effectiveness of RediTrex have been established in pediatric patients with polyarticular juvenile idiopathic arthritis.

What Drugs, Substances, or Supplements Interact with RediTrex?

RediTrex may interact with other medicines such as:

  • aspirin,
  • nonsteroidal anti-inflammatory drugs (NSAIDs),
  • steroids,
  • proton pump inhibitors (PPIs),
  • oral antibiotics,
  • other potential hepatotoxins (e.g., azathioprine, retinoids, and sulfasalazine),
  • theophylline,
  • folic acid or its derivatives,
  • trimethoprim/sulfamethoxazole,
  • mercaptopurine,
  • nitrous oxide anesthesia,
  • salicylates,
  • phenylbutazone,
  • phenytoin,
  • sulfonamides,
  • probenecid,
  • gold,
  • penicillamine,
  • hydroxychloroquine,
  • sulfasalazine, and
  • cytotoxic agents

Tell your doctor all medications you use.

RediTrex During Pregnancy and Breastfeeding

RediTrex is not recommended for use during pregnancy; it may harm a fetus. Females of reproductive potential are advised to use effective contraception during and for 6 months after the final dose of RediTrex. Males with female partners of reproductive potential are advised to use effective contraception during and for at least 3 months after the final dose of RediTrex. RediTrex passes into breast milk in small amounts. Because of the potential for serious adverse reactions in breastfed infants, women are advised not to breastfeed during RediTrex therapy and for one week after final dose. Consult your doctor before breastfeeding.

Additional Information

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

SLIDESHOW

What Is Rheumatoid Arthritis (RA)? Symptoms, Treatment, Diagnosis See Slideshow
RediTrex Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Methotrexate can cause serious or fatal side effects. Call your doctor at once if you have:

  • sudden chest pain, wheezing, dry cough, cough with mucus, feeling short of breath;
  • swollen lymph glands, night sweats, weight loss;
  • blisters or ulcers in your mouth, red or swollen gums, trouble swallowing;
  • vomiting, diarrhea, blood in your urine or stools;
  • skin changes such as redness, warmth, swelling, or oozing;
  • low blood cell counts--fever, chills, bruising or bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;
  • kidney problems--little or no urination, swelling in your feet or ankles;
  • liver problems--swelling around your midsection, right-sided upper stomach pain, nausea, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);
  • nerve problems--confusion, weakness, drowsiness, coordination problems, feeling irritable, headache, neck stiffness, vision problems, loss of movement in any part of your body, seizure; or
  • signs of tumor cell breakdown--tiredness, muscle cramps, nausea, vomiting, diarrhea, fast or slow heart rate, tingling in your hands and feet or around your mouth.

Common side effects may include:

  • fever, chills, tiredness, not feeling well;
  • low blood cell counts;
  • cough, chest tightness, trouble breathing;
  • mouth sores;
  • headache, dizziness;
  • nausea, vomiting, stomach pain, indigestion, diarrhea;
  • abnormal liver function tests;
  • runny or stuffy nose, sore throat;
  • rash, hair loss, burning skin lesions; or
  • being more sensitive to light.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

The term arthritis refers to stiffness in the joints. See Answer
RediTrex Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in more detail in other sections of the labeling.

  • Organ System Toxicity [see WARNINGS AND PRECAUTIONS]
  • Embryo-Fetal Toxicity [see WARNINGS AND PRECAUTIONS]
  • Effects on Reproduction [see WARNINGS AND PRECAUTIONS]
  • Malignant Lymphomas [see WARNINGS AND PRECAUTIONS]

The most frequently reported adverse reactions include ulcerative stomatitis, leukopenia, nausea, and abdominal distress. Other frequently reported adverse reactions are malaise, undue fatigue, chills and fever, dizziness and decreased resistance to infection.

Clinical Trials Experience

This section provides a summary of adverse reactions reported in subjects in clinical studies conducted with methotrexate injection and oral methotrexate.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug, and may not reflect the rates observed in practice.

Rheumatoid Arthritis

The approximate incidences of methotrexate-attributed (i.e. placebo rate subtracted) adverse reactions in 12 to 18 week double-blind studies of patients (n=128) with rheumatoid arthritis treated with low-dose oral (7.5 to 15 mg/week) pulse methotrexate, are listed below. Virtually all of these patients were on concomitant nonsteroidal anti-inflammatory drugs and some were also taking low dosages of corticosteroids. Hepatic histology was not examined in these short-term studies.

Incidence greater than 10%: Elevated liver function tests 15%, nausea/vomiting 10%.

Incidence 3% to 10%: Stomatitis, thrombocytopenia (platelet count less than 100,000/mm3).

Incidence 1% to 3%: Rash/pruritus/dermatitis, diarrhea, alopecia, leukopenia (WBC less than 3000/mm3), pancytopenia, dizziness.

Two other controlled trials of patients (n=680) with Rheumatoid Arthritis on 7.5 mg to 15 mg/wk oral doses showed an incidence of interstitial pneumonitis of 1%.

Other less common reactions included decreased hematocrit, headache, upper respiratory infection, anorexia, arthralgias, chest pain, coughing, dysuria, eye discomfort, epistaxis, fever, infection, sweating, tinnitus, and vaginal discharge.

Polyarticular Juvenile Idiopathic Arthritis

The approximate incidences of adverse reactions reported in pediatric patients with pJIA treated with oral, weekly doses of methotrexate (5 to 20 mg/m2/wk or 0.1 to 0.65 mg/kg/wk) were as follows (virtually all patients were receiving concomitant nonsteroidal anti-inflammatory drugs, and some also were taking low doses of corticosteroids): elevated liver function tests, 14%; gastrointestinal reactions (e.g., nausea, vomiting, diarrhea), 11%; stomatitis, 2%; leukopenia, 2%; headache, 1.2%; alopecia, 0.5%; dizziness, 0.2%; and rash, 0.2%. Although there is experience with dosing up to 30 mg/m2/wk in pJIA, the published data for doses above 20 mg/m2/wk are too limited to provide reliable estimates of adverse reaction rates.

Psoriasis

There are two literature reports (Roenigk, 1969, and Nyfors, 1978) describing large series (n=204, 248) of psoriasis patients treated with methotrexate. Dosages ranged up to 25 mg per week and treatment was administered for up to four years. With the exception of alopecia, photosensitivity, and “burning of skin lesions” (each 3% to 10%), the adverse reaction rates in these reports were very similar to those in the rheumatoid arthritis studies. Rarely, painful plaque erosions may appear (Pearce, HP and Wilson, BB: Am Acad Dermatol 35: 835838, 1996).

Other Adverse Reactions

Other adverse reactions that have been reported with methotrexate in oncology, RA, pJIA, and psoriasis patients are listed below by organ system.

Alimentary System: gingivitis, pharyngitis, stomatitis, anorexia, nausea, vomiting, diarrhea, hematemesis, melena, gastrointestinal ulceration and bleeding, enteritis, pancreatitis.

Blood and Lymphatic System Disorders: suppressed hematopoiesis, anemia, aplastic anemia, pancytopenia, leukopenia, neutropenia, thrombocytopenia, agranulocytosis, eosinophilia, lymphadenopathy and lymphoproliferative disorders (including reversible). Hypogammaglobulinemia has been reported rarely.

Cardiovascular: pericarditis, pericardial effusion, hypotension, and thromboembolic events (including arterial thrombosis, cerebral thrombosis, deep vein thrombosis, retinal vein thrombosis, thrombophlebitis, and pulmonary embolus).

Central Nervous System: headaches, drowsiness, blurred vision, transient blindness, speech impairment including dysarthria and aphasia, hemiparesis, paresis and convulsions have also occurred following administration of methotrexate. Following low doses, there have been occasional reports of transient subtle cognitive dysfunction, mood alteration or unusual cranial sensations, leukoencephalopathy, or encephalopathy.

Hepatobiliary Disorders: hepatotoxicity, acute hepatitis, chronic fibrosis and cirrhosis, hepatic failure, decrease in serum albumin, liver enzyme elevations.

Infection: There have been case reports of sometimes fatal opportunistic infections in patients receiving methotrexate therapy for neoplastic and non-neoplastic diseases. Pneumocystis jiroveci pneumonia was the most common opportunistic infection. There have also been reports of infections, pneumonia, cytomegalovirus infection, including cytomegaloviral pneumonia, sepsis, fatal sepsis, nocardiosis; histoplasmosis, cryptococcosis, Herpes zoster, Herpes simplex hepatitis, and disseminated Herpes simplex.

Musculoskeletal System: stress fracture.

Ophthalmic: conjunctivitis, serious visual changes of unknown etiology.

Pulmonary System: respiratory fibrosis, respiratory failure, alveolitis, interstitial pneumonitis deaths have been reported, and chronic interstitial obstructive pulmonary disease has occasionally occurred.

Skin: erythematous rashes, pruritus, urticaria, photosensitivity, pigmentary changes, alopecia, ecchymosis, telangiectasia, acne, furunculosis, erythema multiforme, toxic epidermal necrolysis, Stevens-Johnson syndrome, skin necrosis, skin ulceration and exfoliative dermatitis.

Urogenital System: severe nephropathy or renal failure, azotemia, cystitis, hematuria, proteinuria; defective oogenesis or spermatogenesis, transient oligospermia, menstrual dysfunction, vaginal discharge, and gynecomastia; infertility, abortion, fetal death, fetal defects.

Other rarer reactions related to or attributed to the use of methotrexate such as nodulosis, vasculitis, arthralgia/myalgia, loss of libido/impotence, diabetes, osteoporosis, sudden death, lymphoma, including reversible lymphomas, tumor lysis syndrome, soft tissue necrosis and osteonecrosis. Anaphylactoid reactions have been reported.

Read the entire FDA prescribing information for RediTrex (Methotrexate Injection)

© RediTrex Patient Information is supplied by Cerner Multum, Inc. and RediTrex Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

Health Solutions From Our Sponsors