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 COMMON | COMMON | |
|---|---|---|
| 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 disorders | Anaemia | Leukopenia, thrombocytopenia, granulocytopenia, febrile neutropenia |
| Metabolism and nutrition disorders | Anorexia | Dehydration, hypokalaemia, decreased appetite |
| Psychiatric disorders | Confusional state, depression, insomnia, anxiety | |
| Nervous system disorders | Headache, dizziness | Paraesthesia, hypoaesthesia, tremor, somnolence, lethargy |
| Eye disorders | Blurred vision | |
| Ear and labyrinth disorders | Vertigo, tinnitus, hearing loss | |
| Cardiac disorders | Tachycardia | Cyanosis, palpitations |
| Vascular disorders | Hypertension, hypotension | Phlebitis, flushing, pallor |
| Respiratory, thoracic and mediastinal disorder | Dyspnoea, tachypnoea, cough | Pleutal effusion, exacerbated dyspnoea, productive cough, haemoptysis, wheezing, epistaxis, exertional dyspnoea, sinus congestion, nasal congestion, pharyngolaryngeal pain |
| Gastrointestinal disorders | Vomiting, diarrhoea, constipation, abdominal pain, nausea | Upper abdominal pain, dyspepsia, abdominal distension, lower abdominal pain |
| Hepatobiliary disorders | Hepatic pain | |
| Skin and subcutaneous tissue disorders | Hyperhidrosis | Rash, pruitus, erythema, alopecia, dry skin |
| Musculoskeletal and connective tissue disorders | Myalgia, arthralgia, back pain in extremity | Muscle 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 conditions | Fever, chills, fatigue, hypothermia, pain, malaise, asthenia, chest pain | Peripheral 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.