Tasonermin interacts in the following cases:
Tasonermin has been co-administered with interferon-gamma in the ILP setting but no added value has been demonstrated. The addition of interferon-gamma to the tasonermin perfusate seems not to be associated with significant increases in endogenous production of tasonermin or other inflammatory cytokines as shown in patients with severe trauma. Clinical data however indicate that the overall incidence of adverse events is increased if patients are simultaneously exposed to tasonermin and interferon-gamma.
Cases of compartment syndrome characterised by pain, swelling and neurological symptoms, as well as muscle damage affecting the perfused limb have been observed in isolated patients treated with tasonermin. Therefore patients should be monitored during the first three days after the ILP.
In case the clinical diagnosis of compartment syndrome is made the following treatment should be considered:
There are no adequate data from the use of tasonermin in pregnant women. Animal studies are insufficient with respect to effects on pregnancy, embryonal development and postnatal development. The potential risk for humans is unknown. Tasonermin is contraindicated in pregnancy.
It is not known whether tasonermin is excreted in human milk. Because of the unknown risk to the infant, breast-feeding is contraindicated within 7 days of ILP.
No data on the possible effect of this medicinal product on male and female fertility are available.
Not relevant.
Undesirable effects may be related to tasonermin, to melphalan, or to the ILP procedure and associated measures, or to a combination of these factors.
The most frequent adverse reactions reported in clinical trials were fever, nausea, vomiting, fatigue, arrhythmia, chills, pain, wound infection and skin reaction. Adverse reactions are either local, affecting the limb treated with ILP, or systemic. Systemic adverse reactions include mild constitutional reactions and toxic effects on different organ systems.
Adverse reactions have been ranked under headings of frequency using the following convention: 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).
Common: Infection, wound infection
Uncommon: Sepsis
Common: Leukopenia, thrombocytopenia
Common: Hypersensitivity reaction
Common: Nerve injury, peripheral neurotoxicity, altered state of consciouness, headache
Very common: Arrhythmia
Common: Cardiac failure
Common: Venous thrombosis, arterial thrombosis, shock, hypotension
Uncommon: Peripheral arterial occlusive disease
Common: Adult respiratory distress syndrome
Uncommon: Pulmonary oedema
Very common: Nausea, vomiting
Common: Diarrhoea, constipation
Uncommon: Abdominal pain upper, gastritis erosive
Very common: Hepatotoxicity
Very common: Skin reaction
Common: Skin necrosis, oedema peripheral
Uncommon: Onychomadesis (loss of nails)
Common: Compartment syndrome, myalgia
Common: Proteinuria
Uncommon: Renal failure acute
Very common: Fever, chills, pain, fatigue
Common: Night sweats
Uncommon: Blood creatinine increased
Common: Extremity necrosis, severe enough to warrant amputation
Extremity necrosis and compartment syndrome might be severe enough to warrant amputation.
Late onset of peripheral arterial occlusive disease (PAOD) of the lower limbs has been reported in patients several years after ILP, predominantly in patients presenting with established cardiovascular risk factors, or who had undergone additional irradiation therapy of the concerned limb.
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