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Indications

REMS

Contraind./Precautions

Contraindicated in:

Use Cautiously in:

Exercise Extreme Caution in:

Adv. Reactions/Side Effects

CV: chest pain, hypertension.

Derm: alopecia, rash, DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS (DRESS), dry skin, eczema, pruritus, STEVENS-JOHNSON SYNDROME (SJS), TOXIC EPIDERMAL NECROLYSIS (TEN).

EENT: pharyngitis, rhinitis, sinusitis.

F and E: hypokalemia.

GI: diarrhea, nausea, ↑ liver enzymes, abdominal pain, anorexia, dyspepsia, gastroenteritis, HEPATOTOXICITY, HEPATOTOXICITY, mouth ulcers, vomiting.

GU: urinary tract infection.

Metab: ↓ weight.

MS: arthralgia, back pain, joint disorder, leg cramps, synovitis, tenosynovitis.

Neuro: headache, dizziness, paresthesia, peripheral neuropathy, weakness.

Resp: bronchitis, cough, INTERSTITIAL LUNG DISEASE (ILD), pneumonia.

Misc: INFECTION (INCLUDING SEPSIS AND TUBERCULOSIS [TB] REACTIVATION).

Interactions

Drug-Drug:

Availability

(Generic available)

Route/Dosage

US Brand Names

Arava

Action

Therapeutic Effects:

Classifications

Therapeutic Classification: antirheumatics (DMARDs)

Pharmacologic Classification: immune response modifiers, pyrimidine synthesis inhibitors

Pharmacokinetics

Absorption: 80% absorbed following oral administration;.

Distribution: Crosses the placenta.

Protein Binding: 99%.

Metabolism/Excretion: Extensively metabolized in the liver to teriflunomide, which is responsible for pharmacologic activity; metabolites excreted in urine (43%) and feces (48%). Also undergoes biliary recycling.

Half-life: 14–18 days.

Time/Action Profile

(antirheumatic effect)

ROUTEONSETPEAKDURATION
PO1 mo3–6 mowk–mos†

†Due to persistence of active metabolite.

Patient/Family Teaching

Pronunciation

le-FLU-noe-mide audio

Code

NDC Code*