Contraindications |
Pregnancy
Breast-feeding
Alcoholism/abuse
Chronic liver disease or excessive alcohol use
Immune deficiency syndromes
Blood dyscrasias (anemia, thrombocytopenia, leukopenia, bone marrow hypoplasia)
Known hypersensitivity to methotrexate
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Pregnancy or intention to become pregnant ≤3 years after discontinuation
Ethanol consumption (women) for 2months after discontinuation
Blood donation within 3 years after discontinuation
Severely impaired liver or kidney function
Hypersensitivity to acitretin or other retinoids
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Baseline testing |
Physical exam and history: alcohol intake, exposure to hepatitis B and C, family history of liver disease
Screen for latent TB infection
CBC with differential and platelet count
Hepatic enzymes
Renal function tests
Chest radiograph, liver biopsy, HIV, pregnancy tests in selected high-risk patients
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History: possible exposure to TB, hepatitis Bor C, family history of renal disease
Screen for latent TB
Physical exam: document blood pressure, evaluate for presence of infection, tumors
Serum creatinine on 2 separate occasions
Other clinical laboratory tests: BUN, urinalysis, CBC, magnesium, potassium, uric acid, lipids, liver enzymes, bilirubin
Evaluate nephrotoxicity risk; obesity, age, diabetes
Ensure contraception
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Two separate negative pregnancy tests before initiating treatment
Laboratory testing includes lipid profile, LFTs, and renal function tests
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Physical exam and history: depression
No laboratory pre-screening is needed
In patients with renal disease, determine creatinine clearance >30mL/minute
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Ongoing monitoring |
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Every other week for first 3 months, then monthly thereafter: BP, BUN, creatinine, CBC, LFTs, lipids, magnesium, potassium, uric acid
Pregnancy tests
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Monthly negative pregnancy test before receiving prescription for drug
Every other week for first eight weeks, then every 6–12 weeks thereafter: lipid profile and LFTs
Every three months: CBC and renal function
Closely monitor blood sugar levels in diabetic patients
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Periodic physical exam
Monitor body weight
Be alert for depression, suicidal thoughts or changes in mood
No ongoing clinical laboratory monitoring is needed
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Patient education |
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Lifestyle/diet changes to manage potential hyperlipidemia
Caution when operating vehicle at night
Avoid sun lamps, high-dose vitamin A supplements
Pregnancy Category X
Do not use in women who intend to become pregnant within three years; following treatment discontinuation women must not become pregnant for at least 3 years
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Dosing schedule |
7.5–30mg, weekly, given in divided doses every 12 hours
Should not exceed 30mg/week
Folate (1–5mg/d except the day of methotrexate) can betaken daily while receiving methotrexate
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1.25–2.0mg/kg twice daily oral dose
Should not exceed 4.0 mg/kg/day
Do not use continuously >1 year
Best used as interventional treatment or part of an alternating/rotating therapy plan
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5-day oral dose titration during Week 1
30mg BID thereafter
In patients with severe renal impairment (creatinine clearance <30mL/minute), 30mg once daily
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Drug interactions |
PPIs, salicylates, NSAIDs, phenylbutazone, Phenytoin, sulfonamides, probenecid, cisplatin, mercaptopurine, oral antibiotics, other potential hepatotoxins, theophylline |
Antibiotics, NSAIDs, melphalan, amphotericin B, antifungals, calcium channel blockers, Cimetidine, ranitidine, tacrolimus, fibric acid derivatives, methotrexate, methylprednisone, allopurinol, amiodarone, bromocriptine, colchicine, anticonvulsants, bosentan, octreotide, orlistat, sulfinpyrazone, terbinafine, ticlopidine, St. John’s Wort, SSRIs, boceprevir, telaprevir |
Methotrexate, phenytoin, tetracyclines, oral retinoids, vitamin A supplements, microdose progestin minipill |
Strong CYP450 inducers: rifampin, phenobarbital, carbamazepine, phenytoin |
NSAID: Nonsteroidal anti-inflammatory drug; PPI: Proton pump inhibitor; CYP450: Cytochrome P450; CBC: Complete blood count; BP: Blood pressure; BUN: Blood urea nitrogen; TB: Tuberculosis; BID: Twice daily; LFT: Liver function test |