Medicinal Products

ARAVA 10 mg

Generic drug of the therapeutic class: Rheumatology
Active ingredients: Leflunomide
laboratory: Sanofi-Aventis Deutsch

Coated tablet
Case of 1 bottle of 30
All forms

Indication

Leflunomide is indicated in adults:

■ in active rheumatoid arthritis, as a background therapy,

■ in the treatment of active psoriatic arthritis.

Recent or concomitant treatment with another hepatotoxic or hematotoxic DMARD (eg methotrexate) may result in an increased risk of serious adverse events; therefore, initiation of leflunomide therapy should carefully evaluate this benefit / risk aspect.

In addition, replacement of leflunomide with another DMARD without following the washout procedure (see Warnings and Precautions ) may increase the possibility of additive risks of adverse effects, even long after stopping leflunomide.

Dosage ARAVA 10 mg Film-coated tablet Case of 1 bottle of 30

Treatment should only be initiated and followed by specialist physicians with good experience in the treatment of rheumatoid arthritis and psoriatic arthritis.

Alanine aminotransferase (ALT) or serum glutamopyruvate transferase (SGPT) and complete blood counts, including leukocyte count and count and platelet count, should be monitored at the same time and with the same regularity:

■ before starting treatment with leflunomide,

■ every 2 weeks during the first 6 months of treatment, and

■ then every 8 weeks (see section Warnings and precautions for use ).

Dosage

• In rheumatoid arthritis: treatment with leflunomide is usually started with a loading dose of 100 mg once daily for 3 days. Omission of the loading dose may reduce the risk of adverse effects (see section 5.1 ).

The recommended maintenance dose is 10 to 20 mg leflunomide once daily depending on the severity (activity) of the disease.

• In psoriatic arthritis: treatment with leflunomide is initiated with a loading dose of 100 mg once daily for 3 days.

The recommended maintenance dose is 20 mg leflunomide once daily (see section 5.1 Pharmacodynamic properties ).

The therapeutic effect usually begins after 4 to 6 weeks and may improve thereafter until 4-6 months of treatment.

No dosage adjustment is recommended in patients with mild renal impairment.

No dose adjustment is required in subjects over 65 years of age.

Pediatric population

Arava is not recommended in patients younger than 18 years of age, as its efficacy and safety in juvenile idiopathic arthropathy has not been demonstrated (see sections on Pharmacodynamic properties and Pharmacokinetic properties ).

Administration mode

Arava tablets should be swallowed whole with a sufficient amount of liquid. The absorption of leflunomide is not affected by the simultaneous ingestion of food.

Against indications

• Hypersensitivity to the active substance (including history of Stevens-Johnson syndrome, Lyell's syndrome or erythema multiforme) or to any of the excipients listed under Composition.

• Patients with hepatic impairment.

• Patients with severe immunodeficiency, such as AIDS patients.

• Patients with severe bone marrow dysfunction, or anemia, leukopenia, neutropenia, or deep thrombocytopenia other than rheumatoid arthritis or psoriatic arthritis.

• Patients with serious infections (see Warnings and Precautions section ).

• Patients with moderate to severe renal impairment due to insufficient clinical experience in this group of patients.

• Patients with severe hypoproteinemia, eg nephrotic syndrome.

• Pregnant or childbearing women not using a reliable method of contraception while taking leflunomide and as long as plasma levels of the active metabolite of leflunomide are greater than 0.02 mg / l. (see section on Pregnancy and breastfeeding ). The existence of a pregnancy should be excluded before starting treatment with leflunomide.

• Breastfeeding (see section on Pregnancy and breastfeeding ).

Arava side effects

Tolerance Profile Summary
The most common side effects reported with leflunomide are: moderate increase in blood pressure, leukopenia, paresthesia, headache, dizziness, diarrhea, nausea, vomiting, lesions of the oral mucosa (eg stomatitis or mouth ulcers), abdominal pain, increased natural hair loss, eczema, rash (including maculopapular rash), pruritus, cutaneous dryness, tenosynovitis, increased CPK, anorexia, weight loss (usually not significant), asthenia, moderate allergic reactions and elevated liver parameters [ transaminases (in particular ALAT), more rarely gamma-GT, alkaline phosphatase, bilirubin].

Classification of expected frequencies:

Very common (≥ 1/10) frequent (≥ 1/100, <1/10); uncommon (≥ 1/1000, <1/100); rare (≥ 1/10 000, <1/1000); very rare (<1 / 10, 000), not known (can not be estimated based on available data).

For each frequency group, adverse effects are presented in order of decreasing severity.

Infections and infestations

Rare:

Severe infections, including septic states that can be fatal.

Like other potentially immunosuppressive drugs, leflunomide may increase susceptibility to infections, including opportunistic infections (see also Warnings and Precautions ). Thus the overall incidence of infections may increase (including rhinitis, bronchitis and pneumonia).

Benign, malignant neoplasms (including cysts and polyps)

The risk of malignancies, particularly lymphoproliferative syndromes, is increased when certain immunosuppressive drugs are used

Blood and lymphatic system disorders

Frequent

leukopenia (with leukocytes> 2 G / l)

Uncommon:

anemia, moderate thrombocytopenia (platelets <100 G / l)

Rare:

pancytopenia (probably by anti-proliferative mechanism), leukopenia (with leukocytes <2 G / l), eosinophilia

Very rare:

agranulocytosis

Recent, concomitant or consecutive use of potentially myelotoxic products may be associated with an increased risk of haematological effects.

Immune system disorders

Frequent

moderate allergic reactions

Very rare:

severe anaphylactic / anaphylactoid reactions, vasculitis, including necrotizing cutaneous vasculitis

Metabolism and nutrition disorders

Frequent

CPK increase

Uncommon:

hypokalemia, hyperlipidemia, hypophosphatemia

Rare:

increase in LDH

Not known:

hypouricemia

Psychiatric disorders

Uncommon:

anxiety

Nervous system disorders

Frequent

headache, dizziness, paresthesia

peripheral neuropathy

Heart conditions

Frequent

moderate increase in blood pressure

Rare:

severe hypertension

Respiratory, thoracic and mediastinal disorders

Rare:

interstitial lung disease (including interstitial lung disease), which may be fatal.

Gastrointestinal disorders

Frequent

diarrhea, nausea, vomiting, lesions of the oral mucosa (eg stomatitis or mouth ulcers), abdominal pain

Uncommon:

taste disturbances

Very rare:

pancreatitis

Hepatobiliary disorders

Frequent

elevation of liver parameters [transaminases (in particular ALT), more rarely gamma-GT, alkaline phosphatase, or bilirubin]

Rare:

hepatitis, jaundice / cholestasis

Very rare:

severe hepatic impairment including acute liver failure and acute hepatic necrosis may be fatal

Skin and subcutaneous tissue disorders

Frequent

accentuation of natural hair loss, rash (including maculopapular rash), pruritus, eczema, dry skin

Uncommon:

urticaria

Very rare:

Stevens-Johnson syndrome, Lyell's syndrome, erythema multiforme

Not known: lupus erythematosus, pustular psoriasis or worsening of psoriasis
Musculoskeletal and connective tissue disorders

Frequent

tenosynovitis

Uncommon:

tendon rupture

Renal and urinary disorders

Not known frequency:

renal failure

Disorders of reproductive organs and breast

Not known frequency:

low and reversible decrease in sperm sperm count, number and motility of spermatozoa

General disorders and administration site conditions

Frequent

anorexia, weight loss (usually not significant), asthenia

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