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Otrexup
methotrexate
Black Box Warnings .
Appropriate Use
admin. only under supervision of physician experienced w/ antimetabolite tx; use only for severe, recalcitrant, disabling psoriasis or RA not responsive to other tx; deaths reported w/ use in malignancy, psoriasis, and RA; closely monitor for bone marrow, liver, lung, skin, and kidney toxicities; inform pts of risks and monitor throughout therapy
Embryo-Fetal Toxicity and Death
may cause embryo-fetal toxicity and death; contraindicated in pregnant pts; verify pregnancy status before tx start; use effective contraception during tx and x6mo after D/C in female pts of reproductive potential and during tx and for at least 3mo after D/C in male pts
Impaired Drug Elimination
drug elimination reduced in renal impairment, ascites, or pleural effusions; closely monitor for toxicity, reduce dose or in some cases D/C tx
Concomitant NSAID Use
unexpectedly severe and sometimes fatal myelosuppression, aplastic anemia, and GI toxicity reported w/ methotrexate (usually high dose) in combo w/ some NSAIDs
Hepatotoxicity
hepatotoxicity, fibrosis and cirrhosis generally only after prolonged use; acute LFT elevation common, usually transient and asymptomatic, not predictive of later hepatic dz; abnormal LFTs or sx may not precede fibrosis or cirrhosis in psoriasis pts, periodic liver biopsies recommended if chronic tx; persistent abnormal LFTs may precede fibrosis or cirrhosis in RA pts
Pulmonary Toxicity
methotrexate-induced lung dz, incl. acute or chronic interstitial pneumonitis, may occur acutely or any time during tx; has occurred at low doses; not always reversible and fatalities reported; pulmonary sx, especially nonproductive dry cough, may require interruption of tx and careful investigation
GI Toxicity
diarrhea and ulcerative stomatitis require tx interruption, otherwise intestinal perforation may lead to hemorrhagic enteritis and death
Malignant Lymphoma
may occur w/ low-dose tx and may regress when D/C tx; if lymphoma does not regress when D/C tx, start appropriate cytotoxic tx
Tumor Lysis Syndrome
may occur in pts w/ rapidly growing tumors
Skin Rxns
severe, occasionally fatal; rxns may occur w/in days after single or multiple PO, IM, IV, or intrathecal doses; recovery may occur when tx D/C
Opportunistic Infections
potentially fatal; incl. PCP
Concomitant Radiotherapy
incr. risk of soft tissue necrosis and osteonecrosis
Adult Dosing .
Dosage forms: INJ (auto-injector): 10 mg, 12.5 mg, 15 mg, 17.5 mg, 20 mg, 22.5 mg, 25 mg
Dosage Forms Discontinued in US
- [7.5 mg injectable form not avail. as brand]
rheumatoid arthritis
- [7.5-20 mg SC qwk]
- Start: 7.5 mg SC qwk; Max: 25 mg/wk; Info: use lowest effective dose; give w/ folic acid 1 mg qd or leucovorin 5 mg qwk; consider lower doses in elderly pts
psoriasis, severe
- [10-25 mg SC qwk]
- Max: 30 mg/wk; Info: use lowest effective dose; give w/ folic acid 1 mg qd or leucovorin 5 mg qwk; consider lower doses in elderly pts
renal dosing
- [see below]
- CrCl 10-50: decr. usual dose by 50%; CrCl <10: avoid use
- HD: decr. usual dose by 50%, on dialysis days admin. after dialysis; no supplement; PD: avoid use
hepatic dosing
- [see below]
- hepatic impairment: not defined, caution advised; chronic hepatic dz: contraindicated
Peds Dosing .
- Dosage forms: INJ (auto-injector): 10 mg, 12.5 mg, 15 mg, 17.5 mg, 20 mg, 22.5 mg, 25 mg
Dosage Forms Discontinued in US
- [7.5 mg injectable form not avail. as brand]
juvenile idiopathic arthritis
- [2-16 yo]
- Dose: 10-20 mg/m^2/dose SC qwk; Start: 10 mg/m^2/dose SC qwk; Max: 25 mg/wk; Info: use lowest effective dose; give w/ folic acid 1 mg qd or leucovorin 5 mg qwk
renal dosing
- [adjust dose amount]
- CrCl 10-50: decr. usual dose by 50%; CrCl <10: decr. usual dose by 70%
- HD: decr. usual dose by 70%, on dialysis days admin. after dialysis; no supplement; PD: decr. usual dose by 70%; no supplement
hepatic dosing
- [see below]
- hepatic impairment: not defined, caution advised; chronic hepatic dz: contraindicated