Adverse reactions : תופעות לוואי

4.8      Undesirable Effects
The majority of patients who receive Foscavir 24mg/ml are severely immuno- compromised and suffering from serious viral infections. Patients’ physical status, the severity of the underlying disease, other infections and concurrent therapies contribute to adverse events observed during use of Foscavir 24mg/ml.


The undesirable effects reported with Foscavir 24mg/ml during clinical trials and post- marketing surveillance are shown in the table below. They are listed by System- Organ Class (SOC) and in order 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); very rare (<1/10,000); not known (cannot be estimated from the available data).


Please note that in these clinical trials, hydration and attention to electrolyte balance was not consistently given; the frequency of some adverse events will be lower when current recommendations are followed (see sections 4.2 Posology and method of administration and 4.4 Special warnings and precautions for use).


Table 2 - Frequency of adverse events

SOC              Frequency                   Event
Blood and        Very Common                 Granulocytopenia, anaemia lymphatic system disorders        Common                      Leukopenia, Thrombocytopenia, Neutropenia
Uncommon                    Pancytopenia
Immune system    Common                      Sepsis disorders
Not known                   Hypersensitivity (including anaphylactic reactions),
anaphylactoid reactions
Endocrine        Unknown                     Diabetes insipidus disorders
Very Common   Decreased Appetite,
Hypokalaemia,
Hypomagnesaemia,
Hypocalcaemia
Metabolism and     Common        Hyperphosphataemia,
nutrition                        Hyponatraemia,
disorders                        Hypophosphataemia, Blood alkaline phosphatase increased,
Blood lactate dehydrogenase increased, hypercalcaemia,
dehydration
Uncommon      Acidosis
Not known     Hypernatraemia
Common        Aggression,Agitation,
Anxiety, Confusional state,
Psychiatric
Depression, Nervousness disorders
Very Common   Dizziness, Headache,
Paraesthesia
Common        Coordination abnormal,
Nervous system
Convulsion, Hypoaesthesia,
disorders
Muscle contractions involuntary,
Neuropathy peripheral, Tremor
Common        Palpitations, tachycardia
Cardiac disorders Not Known      Electrocardiogram QT prolonged, Ventricular arrhythmia, torsade de pointes
Vascular           Common        Hypertension,
disorders                        Hypotension,
Thrombophlebitisa
Very Common   Diarrhoea, Nausea, Vomiting
Common        Abdominal pain,
Constipation, Dyspepsia,
Gastrointestinal
Pancreatitis, gastrointestinal disorders haemorrhage
Not Known     Oesophageal ulceration
Common        Hepatic function abnormal
Hepato-biliary disorders
Very Common   Rash
Skin and subcutaneous       Common        Pruritus disorders
Uncommon      Urticaria, angioedema
Not known                Erythema multiforme, toxic epidermal necrolysis, Stevens
Johnson syndromeb
Common                   Myalgia
Musculoskeletal Unknown                     Muscular weakness, Myopathy, disorders and                               Myositis, Rhabdomyolysis connective tissue disorders
Common                   Renal impairment, Renal failure acute, Dysuria,
Renal and
Polyuria, proteinuria urinary disorders          Uncommon                 Glomerulonephritis, nephrotic syndrome
Not known                Renal pain, renal tubular acidosis, crystal nephropathy,
haematuria
Reproductive       Common                   Genital discomfort and system and                                  ulcerationc breast disorders
Very Common              Asthenia, Chills, Fatigue,
Pyrexia
General disorders and      Common                   Malaise, Oedema, chest paind, administration                              injection site pain, injection site site conditions                             inflammation
Not known                Extravasation
Very Common              Blood creatinine increased, Haemoglobin decreased
Common                   Creatinine renal clearance
Investigations                              decreased,
Electrocardiogram abnormal, gamma- glutamyltransferase increased, alanine aminotransferase increased, aspartate aminotransferase increased, lipase increased
Uncommon                 Amylase increased, blood creatine phosphokinase increased.
aThrombophlebitis in peripheral veins following infusion of undiluted foscarnet solution has been observed.
bCases of vesiculobullous eruptions including erythema multiforme, toxic epidermal necrolysis, and Stevens Johnson syndrome have been reported. In most cases, patients were taking other medications that have been associated with toxic epidermal necrolysis or Stevens Johnson syndrome.
c Foscarnet is excreted in high concentrations in the urine and may be associated with significant irritation and ulceration in the genital area, particularly after prolonged therapy.
d   Transient chest pain has been reported as part of infusion reactions to foscarnet.


Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il