Sandimmun/Sandimmun Neoral新山地明

Sandimmun/Sandimmun Neoral Adverse Reactions





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Adverse Reactions
Many adverse effects associated with ciclosporin treatment are dose-dependent.
For Sandimmun, the range of adverse effects is generally the same in all indications.
Anaphylactoid reactions have been observed following i.v. administration (see Precautions).
For Sandimmun Neoral, in the various indications, the overall spectrum of adverse effects is essentially the same; however, as a consequence of the higher initial doses and longer maintenance therapy required, adverse effects are more frequent and more severe in transplantation than in the other indications.
Infections: Patients receiving immunosuppressive therapies, including ciclosporin and regimens containing ciclosporin, are at increased risk of viral, bacterial, fungal and parasitic infection (see Precautions). Generalised and localised infections may occur and pre-existing infections may be aggravated. Reactivation of polyomavirus infections may lead to polyomavirus-associated nephropathy (PVAN) or JC-virus-associated progressive multifocal leucoencephalopathy (PML). Serious and/or fatal outcomes have been reported.
Benign, malignant and unspecified neoplasms (including cysts and polyps): Patients receiving immunosuppressive therapies, including ciclosporin and regimens containing ciclosporin, are at increased risk of developing lymphomas or lymphoproliferative disorders and other malignancies, particularly of the skin. The frequency of malignant tumours increases with the intensity and duration of therapy (see Precautions). Some malignancies may be fatal.
Adverse effects are listed according to their frequencies (starting with the most frequent), which are defined as: "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), including isolated reports.
Blood and lymphatic system disorders: Common: Leukopenia.
Uncommon: Anaemia, thrombocytopenia.
Rare: Thrombotic microangiopathy (including thrombotic thrombocytopenic purpura, haemolytic uraemic syndrome).
Metabolism and nutrition disorders: Very common: Hyperlipidaemia.
Common: Anorexia, hyperuricaemia, hyperkalaemia, hypomagnesaemia.
Rare: Hyperglycaemia.
Nervous system disorders: Very common: Tremor (10 to 20%), headache - including migraine (up to about 15%).
Common: Paraesthesia.
Uncommon: Signs of encephalopathy, incl. posterior reversible encephalopathy syndrome (PRES), such as convulsions, confusion, disorientation, decreased responsiveness, agitation, insomnia, visual disturbances, cortical blindness, coma, paresis, cerebellar ataxia.
Rare: Motor polyneuropathy.
Very rare: Papilloedema, with possible visual impairment, due to benign intracranial hypertension.
Vascular disorders: Very common: Hypertension (15 to 40%).
Gastrointestinal disorders: Very common: Nausea, vomiting, abdominal pain, diarrhoea, gingival hyperplasia.
Common: Peptic ulcer.
Rare: Pancreatitis.
Hepatobiliary disorders: Common: Liver injury (see Precautions).
Skin and subcutaneous tissue disorders: Very common: Hypertrichosis.
Common: Acne, rash.
Uncommon: Allergic skin reactions.
Musculoskeletal disorders: Common: Muscle cramps, myalgia.
Rare: Muscle weakness, myopathy, pain in the extremities.
Renal and urinary disorders: Very common: Renal dysfunction (see Renal and hepatic function under Precautions; incidence 10 to 50%, according to indication).
Reproductive system and breast disorders: Rare: Menstrual disturbances, gynaecomastia.
General disorders and administration site reactions: Common: Fatigue, pyrexia, oedema.
Uncommon: Weight increase.
Other adverse effects, based on post-marketing experience: There have been solicited and spontaneous post-marketing reports of hepatotoxicity and liver injury - including cholestasis, jaundice, hepatitis and hepatic failure - in patients treated with ciclosporin. Most reports included patients with significant comorbidities, underlying conditions and other confounding factors, including infectious complications and co-medications with hepatotoxic potential. In some cases, mainly in transplant patients, fatal outcomes have been reported (see Precautions).
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