Arthritis/rheumatic disorders:
Indications for: REDITREX
Management of adults with severe, active rheumatoid arthritis (RA) or children with active polyarticular juvenile idiopathic arthritis (pJIA), who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of first-line therapy including full dose NSAIDs.
Limitations of Use:
Not for treating neoplastic diseases.
Adult Dosage:
Administer by SC inj in abdomen or thigh. Initially 7.5mg once weekly; adjust dose gradually. Switching from oral to RediTrex SC inj: consider differences in bioavailability. Use alternative MTX form in patients requiring oral, IM, IV, intra-arterial, or intrathecal dosing, doses <7.5mg/wk or >25mg/wk, high-dose regimens, or dose adjustments <2.5mg increments.
Children Dosage:
<2yrs: not established. Administer by SC inj in abdomen or thigh. ≥2yrs: initially 10mg/m2 once weekly; adjust dose gradually. Switching from oral to RediTrex SC inj: consider differences in bioavailability. Use alternative MTX form in patients requiring oral, IM, IV, intra-arterial, or intrathecal dosing, doses <7.5mg/wk or >25mg/wk, high-dose regimens, or dose adjustments <2.5mg increments.
REDITREX Contraindications:
Alcoholism. Chronic liver disease. Immunodeficiency syndromes. Preexisting blood dyscrasias. Pregnancy.
Boxed Warning:
Severe toxic reactions, including embryo-fetal toxicity and death.
REDITREX Warnings/Precautions:
Be fully experienced in the use of antimetabolite therapy. Increased risk of severe toxic reactions. Discontinue if malignant lymphomas occur. Obtain baseline and monitor CBCs with differential, platelet counts, chest X-ray, and hepatic, renal and pulmonary function. During therapy monitor hematology monthly, renal and hepatic function, every 1–2 months, more often if increasing dose or predisposed to toxicity (eg, dehydration). Preexisting hematopoietic impairment. Discontinue immediately if blood counts drop significantly. Preexisting liver damage. Obtain liver biopsy prior to treatment if history of alcoholism, persistently abnormal LFTs, or chronic HBV/HCV infection; discontinue if persistently abnormal LFTs develop or liver biopsy shows moderate to severe changes. Interrupt therapy if vomiting, diarrhea, stomatitis, or pulmonary symptoms occur. Peptic ulcer. Ulcerative colitis. Active infection. Renal impairment, ascites, pleural effusions: monitor for toxicity and reduce dose or discontinue if needed. Obesity, diabetes, hepatic fibrosis, steatohepatitis; increased risk for hepatic injury. Maintain adequate hydration. Folate deficiency. Elderly. Debilitated. Embryo-fetal toxicity. Exclude pregnancy status prior to initiation. Advise to use effective contraception during and for 6 months (females of reproductive potential) and for ≥3 months (males w. female partners) after the last dose. Nursing mothers: not recommended (during and for 1 week after the last dose).
REDITREX Classification:
Folic acid antagonist.
REDITREX Interactions:
Avoid concomitant live virus vaccines, nitrous oxide. Toxicity increased by NSAIDs, salicylates, low-dose steroids, PPIs (eg, omeprazole, esomeprazole, pantoprazole), phenylbutazone, phenytoin, sulfonamides, probenecid, penicillins (monitor), folic acid antagonists. May be antagonized by oral antibiotics (eg, tetracycline, chloramphenicol, nonabsorbable broad spectrum antibiotics), folic acid. Increased hepatotoxicity with concomitant other hepatotoxins (eg, azathioprine, retinoids, sulfasalazine); monitor. Impaired response to immunization. May potentiate theophylline, mercaptopurine; monitor. Increased risk of soft tissue necrosis and osteonecrosis with radiotherapy. Recall reactions after UV radiation.
Adverse Reactions:
Nausea, abdominal pain, dyspepsia, stomatitis/mouth sores, rash, nasopharyngitis, diarrhea, liver function test abnormalities, vomiting, headache, bronchitis, thrombocytopenia, alopecia, leucopenia, pancytopenia, dizziness, photosensitivity, “burning of skin lesions”; myelosuppression, hepatotoxicity, nephrotoxicity, CNS toxicity, interstitial pneumonitis, tumor lysis syndrome, fatal skin reactions.
How Supplied:
Single-dose prefilled syringe—4
Psoriasis:
Indications for: REDITREX
Symptomatic control of severe, recalcitrant, disabling psoriasis in adults with inadequate response to other forms of therapy, but only with an established diagnosis as by biopsy and/or dermatologic consultation.
Limitations of Use:
Not for treating neoplastic diseases.
Adult Dosage:
Administer by SC inj in abdomen or thigh. 10–25mg once weekly using an oral, IM, SC, or IV formulation; max 30mg/wk. Adjust dose gradually. Switching from oral to RediTrex SC inj: consider differences in bioavailability. Use alternative MTX form in patients requiring oral, IM, IV, intra-arterial, or intrathecal dosing, doses <7.5mg/wk or >25mg/wk, high-dose regimens, or dose adjustments <2.5mg increments.
Children Dosage:
Not established.
REDITREX Contraindications:
Alcoholism. Chronic liver disease. Immunodeficiency syndromes. Preexisting blood dyscrasias. Pregnancy.
Boxed Warning:
Severe toxic reactions, including embryo-fetal toxicity and death.
REDITREX Warnings/Precautions:
Be fully experienced in the use of antimetabolite therapy. Increased risk of severe toxic reactions. Discontinue if malignant lymphomas occur. Obtain baseline and monitor CBCs with differential, platelet counts, chest X-ray, and hepatic, renal and pulmonary function. During therapy monitor hematology monthly, renal and hepatic function, every 1–2 months, more often if increasing dose or predisposed to toxicity (eg, dehydration). Preexisting hematopoietic impairment. Discontinue immediately if blood counts drop significantly. Preexisting liver damage. Obtain liver biopsy prior to treatment if history of alcoholism, persistently abnormal LFTs, or chronic HBV/HCV infection; discontinue if persistently abnormal LFTs develop or liver biopsy shows moderate to severe changes. Interrupt therapy if vomiting, diarrhea, stomatitis, or pulmonary symptoms occur. Peptic ulcer. Ulcerative colitis. Active infection. Renal impairment, ascites, pleural effusions: monitor for toxicity and reduce dose or discontinue if needed. Obesity, diabetes, hepatic fibrosis, steatohepatitis; increased risk for hepatic injury. Maintain adequate hydration. Folate deficiency. Elderly. Debilitated. Embryo-fetal toxicity. Exclude pregnancy status prior to initiation. Advise to use effective contraception during and for 6 months (females of reproductive potential) and for ≥3 months (males w. female partners) after the last dose. Nursing mothers: not recommended (during and for 1 week after the last dose).
REDITREX Classification:
Folic acid antagonist.
REDITREX Interactions:
Avoid concomitant live virus vaccines, nitrous oxide. Toxicity increased by NSAIDs, salicylates, low-dose steroids, PPIs (eg, omeprazole, esomeprazole, pantoprazole), phenylbutazone, phenytoin, sulfonamides, probenecid, penicillins (monitor), folic acid antagonists. May be antagonized by oral antibiotics (eg, tetracycline, chloramphenicol, nonabsorbable broad spectrum antibiotics), folic acid. Increased hepatotoxicity with concomitant other hepatotoxins (eg, azathioprine, retinoids, sulfasalazine); monitor. Impaired response to immunization. May potentiate theophylline, mercaptopurine; monitor. Increased risk of soft tissue necrosis and osteonecrosis with radiotherapy. Recall reactions after UV radiation.
Adverse Reactions:
Nausea, abdominal pain, dyspepsia, stomatitis/mouth sores, rash, nasopharyngitis, diarrhea, liver function test abnormalities, vomiting, headache, bronchitis, thrombocytopenia, alopecia, leucopenia, pancytopenia, dizziness, photosensitivity, “burning of skin lesions”; myelosuppression, hepatotoxicity, nephrotoxicity, CNS toxicity, interstitial pneumonitis, tumor lysis syndrome, fatal skin reactions.
How Supplied:
Single-dose prefilled syringe—4
