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Arava (leflunomide)

BOXED WARNING

Exclude pregnancy before start of treatment. Avoid pregnancy during treatment or prior to completion of drug elimination procedure after treatment. Severe liver injury, including fatal liver failure, reported; not for use with preexisting acute or chronic liver disease, or those with serum ALT >2X ULN before initiating treatment. Caution with other potentially hepatotoxic drugs. Monitor ALT levels at least monthly for 6 months after starting therapy, and thereafter every 6-8 weeks. Interrupt therapy if ALT elevation >3X ULN occurs; if likely leflunomide-induced, start cholestyramine washout and monitor liver tests weekly until normalized. If leflunomide-induced liver injury is unlikely, may consider resumption of therapy.

THERAPEUTIC CLASS

Pyrimidine synthesis inhibitor

DEA CLASS

RX

INDICATIONS

Treatment of active rheumatoid arthritis in adults to reduce signs/symptoms, to inhibit structural damage as evidenced by x-ray erosions and joint space narrowing, and to improve physical function.

ADULT DOSAGE

Rheumatoid Arthritis

LD: 100mg qd for 3 days
Maint: 20mg qd; if not well tolerated, may reduce to 10mg qd
Max: 20mg qd

DOSING CONSIDERATIONS

Hepatic Impairment
Not recommended

ADMINISTRATION

Oral route

HOW SUPPLIED

Tab: 10mg, 20mg, 100mg

CONTRAINDICATIONS

Women who are or may become pregnant.

WARNINGS/PRECAUTIONS

Not recommended with severe immunodeficiency, bone marrow dysplasia, or severe, uncontrolled infections; interruption of therapy and administration of cholestyramine or charcoal may be necessary if a serious infection occurs. May cause immunosuppression, increased susceptibility to infections, including opportunistic infections, especially Pneumocystis jiroveci pneumonia, tuberculosis (TB), and aspergillosis, or increase risk of malignancy. Pancytopenia, agranulocytosis, and thrombocytopenia reported (rare). D/C therapy with evidence of bone marrow suppression. Monitor for hematologic toxicity if switching to another antirheumatic agent with a known potential for hematologic suppression. Serious toxicity (eg, hypersensitivity), peripheral neuropathy, rare cases of Stevens-Johnson syndrome and toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms reported; d/c therapy, and a drug elimination procedure is recommended if any of these occur. Age >60 yrs and diabetes may increase risk for peripheral neuropathy. Interstitial lung disease (ILD) reported. New onset or worsening of pulmonary symptoms (eg, cough, dyspnea), with or without associated fever, may be a reason for discontinuation of therapy; consider initiation of washout procedures if discontinuation is necessary. Screen for latent TB infection with a tuberculin skin test prior to initiating therapy. Caution with renal impairment. Has uricosuric effect and a separate effect of hypophosphaturia seen in some patients. Men wishing to father a child should consider discontinuing use and taking cholestyramine 8g tid for 11 days.

ADVERSE REACTIONS

Severe liver injury, diarrhea, upper respiratory infection, abnormal liver enzymes, alopecia, headache, N/V, rash, HTN, joint disorder, bronchitis, abdominal/back/GI pain, asthenia.

DRUG INTERACTIONS

See Boxed Warning. Coadministration with teriflunomide is not recommended. Vaccination with live vaccines is not recommended; consider long T1/2 when contemplating administration of live vaccine after stopping therapy. Decreased plasma levels of M1 with cholestyramine or activated charcoal. Multiple doses of rifampin may increase levels; use with caution. May increase levels of diclofenac, ibuprofen, or tolbutamide. May increase risk of hepatotoxicity with methotrexate or peripheral neuropathy with neurotoxic medications. Increased INR with warfarin (rare). Concomitant immunosuppressant therapy may increase susceptibility to infections.

PREGNANCY AND LACTATION

Category X, not for use in nursing.

MECHANISM OF ACTION

Pyrimidine synthesis inhibitor; isoxazole immunomodulatory agent. Inhibits dihydroorotate dehydrogenase and has antiproliferative activity. Has demonstrated an anti-inflammatory effect.

PHARMACOKINETICS

Absorption: Administration of various doses led to different parameters. Distribution: (M1) Vd=0.13L/kg, plasma protein binding (>99.3%). Metabolism: A77 1726 (M1) (active metabolite). Elimination: Urine (43%), feces (48%); T1/2 varies based on dosing; refer to PI for further information.

ASSESSMENT

Assess for hypersensitivity to drug or to teriflunomide, severe immunodeficiency, bone marrow dysplasia, severe uncontrolled infections, hepatic/renal impairment, comorbid illnesses, latent TB infection, any other conditions where treatment is cautioned or contraindicated, pregnancy/nursing status, and possible drug interactions. Obtain baseline BP, platelet, WBC count, Hgb or Hct, and ALT levels.

MONITORING

Monitor for signs/symptoms of immunosuppression and opportunistic infections, sepsis, pancytopenia, agranulocytosis, thrombocytopenia, severe liver injury, skin/hypersensitivity reactions, ILD, malignancy, and other adverse reactions. Monitor BP periodically. Monitor platelets, WBC count, Hgb/Hct, and ALT levels monthly for 6 months following initiation of therapy and every 6-8 weeks thereafter. Monitor carefully after dose reduction. Monitor for hematologic toxicity when switching to another antirheumatic agent with known potential for hematologic suppression. Monitor for bone marrow suppression monthly if used concomitantly with immunosuppressants.

PATIENT COUNSELING

Advise women of childbearing potential of the increased risk of birth defects if used during pregnancy, if they become pregnant while on therapy, or do not wait to become pregnant until they have stopped taking the drug and followed the drug elimination procedure; instruct to use reliable form of contraception while on therapy. Advise of the possibility of rare, serious skin reactions; instruct to inform physician promptly if skin rash or mucous membrane lesions develop. Advise of the potential hepatotoxic effects and of the need for monitoring liver enzymes; instruct to notify physician if symptoms such as unusual tiredness, abdominal pain, or jaundice develop. Advise that lowering of blood counts may develop; instruct to have frequent hematologic monitoring, particularly in patients who are receiving other concurrent immunosuppressive therapy, or who have had a history of significant hematologic abnormality, and to notify physician if symptoms of pancytopenia (eg, easy bruising/bleeding, recurrent infections, fever, paleness, unusual tiredness) develop. Inform about the early warning signs of ILD and instruct to contact physician as soon as possible if these symptoms appear/worsen during therapy.

STORAGE

25°C (77°F); excursions permitted to 15-30°C (59-86°F). Protect from light.

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