Leflunomide 10mg

Leflunomide, Arava
Description: Antirheumatic; Disease Modifying

“ALERT: US Boxed Warning

​Embryofetal toxicity:
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.

Hepatotoxicity:
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.”

CSA NA – FDA Approved – REMS (N) – Can Ship

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.

Rheumatoid Arthritis

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.

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.

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

1. What do I do if side effects are intolerable?
   If side effects are causing a lot of distress speak to your physician as soon as possible to discuss options.