the ADRs based on experience from clinical studies as well as adverse reactions, some with fatal outcome, reported from post-marketing experience. Within the organ system classes, adverse reactions are listed under headings of frequency using the following categories: 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.
Table 1
Undesirable effects in clinical studies and from post-marketing experienc
Infections and infestations
Very Common:
Common:
Viral infection (e.g. influenza, herpes virus infection).
Bacterial infections (e.g. sepsis, cellulitis, abscess).
Uncommon:
Rare:
Tuberculosis, fungal infections (e.g. candidiasis).
Meningitis, opportunistic infections (such as invasive fungal infections [pneumocystosis, histoplasmosis, aspergillosis, coccidioidomycosis, cryptococcosis, blastomycosis], bacterial infections [atypical mycobacterial, listeriosis, salmonellosis], and viral infections [cytomegalovirus]), parasitic infections, hepatitis B reactivation.
Neoplasms benign, malignant and unspecified (including cysts and polyps)
Rare:
Lymphoma, non-Hodgkins's lymphoma, Hodgkin's disease, leukaemia.
Not known:
Hepatosplenic T-cell lymphoma (primarily in adolescents and young adults with Crohn's disease and ulcerative colitis)
Blood and lymphatic system disorders
Common:
Uncommon:
Neutropenia, leucopenia, anaemia, lymphadenopathy.
Thrombocytopenia, lymphopenia, lymphocytosis.
Rare:
Agranulocytosis, thrombotic thrombocytopenic purpura, pancytopenia, haemolytic anaemia, idiopathic thrombocytopenic purpura.
Immune system disorders
Common:
Allergic respiratory symptom.
Uncommon:
Anaphylactic reaction, lupus-like syndrome, serum sickness or serum sickness-like reaction.
Rare:
Anaphylactic shock, vasculitis, sarcoid-like reaction.
Psychiatric disorders
Common:
Uncommon:
Rare:
Depression, insomnia.
Amnesia, agitation, confusion, somnolence, nervousness.
Apathy.
Nervous system disorders
Very common:
Common:
Headache.
Vertigo, dizziness, hypoaesthesia, paraesthesia.
Uncommon:
Seizure, neuropathy.
Rare:
Transverse myelitis, central nervous system demyelinating disorders (multiple sclerosis-like disease and optic neuritis), peripheral demyelinating disorders (such as Guillain-Barrẽ syndrome, chronic inflammatory demyelinating polyneuropathy and multifocal motor neuropathy).
Eye disorders
Common:
Uncommon:
Rare:
Conjunctivitis.
Keratitis, periorbital oedema, hordeolum.
Endophthalmitis.
Not known
Transient visual loss occurring during or within two hours of infusion.
Cardiac disorders
Common:
Uncommon:
Tachycardia, palpitation.
Cardiac failure (new onset or worsening), arrhythmia, syncope, bradycardia.
Rare:
Cyanosis, pericardial effusion.
Not known:
Myocardial ischaemia/myocardial infarction occurring during or within two hours of infusion.
Vascular disorders
Common:
Hypotension, hypertension, |
