Medicinal Products

ARAVA 20 mg

Generic drug of the therapeutic class: Rheumatology
Active ingredients: Leflunomide
laboratory: Pharma Lab

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 20 mg film-coated tablet 1 vial of 30

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.

Against indications

• Hypersensitivity (including history of Stevens-Johnson syndrome, Lyell's syndrome or erythema multiforme) to the active substance, the main active metabolite teriflunomide 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 and unspecified tumors (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:

cutaneous lupus erythematosus, pustular psoriasis or worsening of psoriasis, DRESS syndrome (drug hypersensitivity syndrome with eosinophilia and systemic symptoms).

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

Reporting of suspected adverse reactions
The reporting of suspected adverse reactions after authorization of the drug is important. It allows continuous monitoring of the benefit / risk ratio of the drug. Health professionals report any suspected adverse reactions via the national reporting system - see Annex 5.

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