Lefno Adverse Reactions

Summary of the safety profile: Classification of expected frequencies: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000), not known (cannot be estimated from the available data).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Infections and infestations: Rare: severe infections, including sepsis which may be fatal.
Neoplasms benign, malignant and unspecified (incl. cysts and polyps): The risk of malignancy, particularly lymphoproliferative disorders, is increased with use of some immunosuppressive agents.
Blood and lymphatic system disorders: Common: leucopenia (leucocytes >2 G/L).
Uncommon: anaemia, mild thrombocytopenia (platelets <100 G/L).
Rare: pancytopenia (probably by antiproliferative mechanism), leucopenia (leucocytes <2 G/L), eosinophilia.
Very rare: agranulocytosis.
Recent, concomitant or consecutive use of potentially myelotoxic agents may be associated with a higher risk of haematological effects.
Immune system disorders: Common: mild allergic reactions.
Very rare: severe anaphylactic/anaphylactoid reactions, vasculitis, including cutaneous necrotizing vasculitis.
Metabolism and nutrition disorders: Common: CPK increased.
Uncommon: hypokalaemia, hyperlipidemia, hypophosphataemia.
Rare: LDH increased.
Not known: hypouricemia.
Psychiatric disorders: Uncommon: anxiety.
Nervous system disorders: Common: paraesthesia, headache, dizziness.
Very rare: peripheral neuropathy.
Cardiac disorders: Common: mild increase in blood pressure.
Rare: severe increase in blood pressure.
Respiratory, thoracic and mediastinal disorders: Rare: interstitial lung disease (including interstitial pneumonitis), which may be fatal.
Not known: pulmonary hypertension.
Hepatobiliary disorders: Common: elevation of liver parameters (transaminases [especially ALT], less often gamma-GT, alkaline phosphatase, bilirubin).
Rare: hepatitis, jaundice/cholestasis.
Very rare: severe liver injury such as hepatic failure and acute hepatic necrosis that may be fatal.
Skin and subcutaneous tissue disorders: Common: increased hair loss, eczema, rash (including maculopapular rash), pruritus, dry skin.
Uncommon: urticaria.
Very rare: toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme.
Not known: cutaneous lupus erythematosus, pustular psoriasis or worsening psoriasis, Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS).
Musculoskeletal and connective tissue disorders: Common: tenosynovitis.
Uncommon: tendon rupture.
Renal and urinary disorders: Not known: renal failure.
Reproductive system and breast disorders: Not known: marginal (reversible) decreases in sperm concentration, total sperm count and rapid progressive motility.
General disorders and administration site conditions: Common: anorexia, weight loss (usually insignificant), asthenia.