Tolerability

The safety of Liposomal Mifamurtide has been assessed in more that 700 patients with various kinds and stages of cancer and in 21 healthy adult subjects.1

Mifamurtide was studied as a single agent in 248 patients with mostly advanced malignancies during the early, single-arm Phase I and Phase II clinical studies. The most frequent adverse reactions, occurring in >50% of patients, were chills, pyrexia, fatigue, nausea, tachycardia and headache.



Many of the most frequently reported undesirable effects as shown in the following summary table are thought to be related to the mechanism of action of mifamurtide. The majority of these events were reported as either mild or moderate. This profile is consistent whether summarising all early studies (n=248) or only those studies in osteosarcoma (n=51). It is likely that undesirable effects also occurred in the large randomised study, but they were not recorded because only serious and life threatening adverse reactions were collected in that study.1

 VERY COMMONCOMMON
Infections and infestations Sepsis, cellulitis, nasopharyngitis, catheter site infection, upper respiratory tract infection, urinary tract infection, pharyngitis, herpes simplex infection
Neoplasms benign, malignant and unspecified (inc. cysts and polyps) Cancer pain
Blood and lymphatic system disordersAnaemiaLeukopenia, thrombocytopenia, granulocytopenia, febrile neutropenia
Metabolism and nutrition disordersAnorexiaDehydration, hypokalaemia, decreased appetite
Psychiatric disorders Confusional state, depression, insomnia, anxiety
Nervous system disordersHeadache, dizzinessParaesthesia, hypoaesthesia, tremor, somnolence, lethargy
Eye disorders Blurred vision
Ear and labyrinth disorders Vertigo, tinnitus, hearing loss
Cardiac disordersTachycardiaCyanosis, palpitations
Vascular disordersHypertension, hypotensionPhlebitis, flushing, pallor
Respiratory, thoracic and mediastinal disorderDyspnoea, tachypnoea, coughPleutal effusion, exacerbated dyspnoea, productive cough, haemoptysis, wheezing, epistaxis, exertional dyspnoea, sinus congestion, nasal congestion, pharyngolaryngeal pain
Gastrointestinal disordersVomiting, diarrhoea, constipation, abdominal pain, nauseaUpper abdominal pain, dyspepsia, abdominal distension, lower abdominal pain
Hepatobiliary disorders Hepatic pain
Skin and subcutaneous tissue disordersHyperhidrosisRash, pruitus, erythema, alopecia, dry skin
Musculoskeletal and connective tissue disordersMyalgia, arthralgia, back pain in extremityMuscle spasms, neck pain, groin pain, bone pain, shoulder pain, chest wall pain, musculoskeletal stiffness
Renal and urinary disorders Haematuria, dysuria, pollakiuria
Reproductive system and breast disorders Dysmenorrhoea
General disorders and administration site conditionsFever, chills, fatigue, hypothermia, pain, malaise, asthenia, chest painPeripheral oedema, oedema, mucosal inflammation, infusion site erythema, infusion site reaction, catheter site pain, chest discomfort, feeling cold
Investigations Weight decreased
Surgical and medical procedures Post-procedural pain

Contraindications1

Hypersensitivity to the active substance or to any of the excipients. Concurrent use with ciclosporin or other calcineurin inhibitors. Concurrent use with high dose non-steroidal anti-inflammatory drugs (NSAIDs, cyclooxygenase inhibitors).

Undesirable effects1

Adverse reactions are classified according to system organ class and frequency. Frequency groupings are defined according to the following convention: Very common (1/10), common (1/100 to <1/10). Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.1

General disorders and administration site conditions1

The majority of patients experience chills (89%), fever (85%) and fatigue (53%). These are typically mild to moderate, transient in nature and generally respond to palliative treatment (e.g. paracetamol for fever). Other generalised symptoms that were typically mild to moderate and very common included hypothermia (23%), malaise (13%), pain (15%), asthenia (13%) and chest pain (11%). Oedema, chest discomfort, local infusion or catheter site reactions and 'feeling cold' were less frequently reported in these patients, mostly with late stage malignant disease.1



Please refer to the summary of product characteristics for details of the full side effect profile of Mepact.