Otrexup PFS

Last reviewed on RxList: 1/6/2020
Otrexup PFS Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 1/6/2020

What Is Otrexup PFS?

Otrexup PFS (methotrexate) 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. The brand name Otrexup PFS had been discontinued. Generic versions of methotrexate are available.

What Are Side Effects of Otrexup PFS?

Common side effects of Otrexup PFS include:

Dosage for Otrexup PFS

Otrexup PFS is for once weekly subcutaneous use only. The starting dose of methotrexate to treat RA is 7.5 mg once weekly; to treat pJIA: 10 mg/m2 once weekly; and to treat psoriasis: 10 to 25 mg once weekly.

What Drugs, Substances, or Supplements Interact with Otrexup PFS?

Otrexup PFS may interact with salicylates such as aspirin, nonsteroidal anti-inflammatory drugs (NSAIDs), steroids, proton pump inhibitors (PPIs), oral antibiotics, azathioprine, retinoids, sulfasalazine, theophylline, folic acid or its derivatives, mercaptopurine, nitrous oxide, salicylates, phenylbutazone, phenytoin, and sulfonamides. Tell your doctor all medications and supplements you use.

Otrexup PFS During Pregnancy and Breastfeeding

Otrexup PFS is not recommended for use during pregnancy; it may harm a fetus. Because of the potential for serious adverse reactions from in breast fed infants, breastfeeding is not recommended while using Otrexup PFS.

Additional Information

Our Otrexup PFS (methotrexate) injection prefilled syringe, for Subcutaneous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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
Otrexup PFS 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.

Read the entire detailed patient monograph for Otrexup PFS (Methotrexate Injection)

SLIDESHOW

What Is Rheumatoid Arthritis (RA)? Symptoms, Treatment, Diagnosis See Slideshow
Otrexup PFS Professional Information

SIDE EFFECTS

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

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 Otrexup PFS as well as 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/pruritis/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: 835-838, 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 Otrexup PFS (Methotrexate Injection)

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

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