What is this medication?
Antirheumatic; Disease Modifying
Leflunomide, Arava is ndicated for treatment of rheumatoid arthritis.
“ALERT: US Boxed Warning
Leflunomide is contraindicated in pregnant women because of the potential for fetal harm. Teratogenicity and embryolethality occurred in animals administered leflunomide at doses lower than the human exposure level. Exclude pregnancy before the start of treatment with leflunomide in females of reproductive potential. Advise females of reproductive potential to use effective contraception during leflunomide treatment and during an accelerated elimination procedure after leflunomide treatment. Stop leflunomide and use an accelerated drug elimination procedure if the patient becomes pregnant.
Severe liver injury, including fatal liver failure, has been reported in patients treated with leflunomide. Leflunomide is contraindicated in patients with severe hepatic impairment. Concomitant use of leflunomide with other potentially hepatotoxic drugs may increase the risk of liver injury. Patients with preexisting acute or chronic liver disease, or those with serum ALT >2 times ULN before initiating treatment, are at increased risk and should not be treated with leflunomide. Monitor ALT levels at least monthly for 6 months after starting leflunomide, and thereafter every 6 to 8 weeks. If leflunomide-induced liver injury is suspected, stop leflunomide treatment, start an accelerated drug elimination procedure, and monitor liver tests weekly until normalized.”
How does this medication work?
Leflunomide, Arava has antiproliferative and anti-inflammatory effects that inhibits pyrimidine synthesis, resulting in immunomodulation. Leflunomide is a prodrug; the active metabolite is responsible for activity.
How should I take this medication?
Oral: Optional loading dose of 100 mg once daily for 3 days followed by a maintenance dose of20 mg once daily but may reduce dose to 10 mg once daily if higher dose is not tolerated.
Note: Loading dose may be omitted given the higher likelihood of side effects (eg, diarrhea), and especially may be omitted in patients at increased risk of hepatic or hematologic toxicity (eg, recent concomitant methotrexate or other immunosuppressive agents).
How to Take: Follow instructions provided by physician/pharmacy label, take consistently at same times each day without regard to food, unless otherwise directed, store at room temperature.
You Need to Avoid: No clinical data is available on the efficacy and safety of vaccinations during leflunomide treatment so vaccination with live vaccines is not recommended.
What should I watch for while using this medication?
Before starting Leflunomide, Arava make sure your physician is aware of any allergies or medications you currently take, if you have hepatic impairment, renal impairment, immunodeficiency, a serious infection, severe hypoproteinemia, are pregnant, or breastfeeding. Leflunomide, Arava use has been associated with rare but serious adverse events such as dermatologic reactions, hepatotoxicity, hematologic toxicities, hypertension, infections, interstitial lung disease, malignancy, and peripheral neuropathy.
What if I miss a dose?
If you miss a dose of medication, try to take it as soon as possible. However, if it is almost time for your next dose, take only that scheduled dose. Do not take double or extra doses.
How should I store this medication?
Keep out of the reach of children at all times. Store at room temperature, 59 to 86° F (15 to 30° C). Protect from light. Keep the container tightly closed. Properly dispose of any unused medication after the expiration date.
What are the possible side effects of using this medication?
Headache, alopecia, skin rash, diarrhea, nausea, hypertension, dizziness, gastrointestinal pain, abdominal pain, abnormal hepatic function tests, back pain, weakness, bronchitis
Note this is not a complete list of side effects, only common ones.
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