2%). Tabulated list of adverse reactions Adverse reactions are listed below by MedDRA body system organ class and frequency.
The following convention has been used for classification of frequency:
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).
Table1:
Adverse reactions System organ class Common Uncommon Rare Infections and infestations Cystitis Neutropenia LeukopeniaBlood and lymphatic system disorders Leucocytosis Lymphocytosis Metabolism and nutrition disorders Decreased appetite Hypokalaemia Insomnia Acute psychosis Mood altered Psychiatric disorders Sleep disorder Headache Dizziness HypoaesthesiaNervous system disorders Somnolence Eye disorders Conjunctivitis Vision blurred Ear and labyrinth disorders Vertigo Tinnitus Atrioventricular block first degree ArrhythmiaCardiac disorders Cardiomyopathy Atrioventricular block second degree Conduction disorder Bundle branch block left Tachycardia Bundle branch block right Mitral valve incompetence Myocardial ischaemia Ventricular extrasystoles Hypertension FlushingVascular disorders Hypotension Respiratory, thoracic and mediastinal disorders Hiccups Constipation Abdominal distension Dry mouth Abdominal pain Dysphagia Diarrhoea Eructation Dyspepsia Haemorrhoids Flatulence Tongue coated Gastrointestinal disorders Nausea Vomiting Alopecia ErythemaSkin and subcutaneous tissue disorders Urticaria Pruritus Rash Back painMusculoskeletal and connective tissue disorders Pain in extremities Fatigue Asthenia Feeling hot Non-cardiac chest pain General disorders and administration site conditions Product taste abnormal Liver transaminases increased Blood bilirubin increased Blood alkaline phosphatase increased Blood creatine phosphokinase increased Blood creatinine increased Blood creatine phosphokinase MB increased Electrocardiogram QT prolonged Blood urea increased Electrocardiogram ST segment depression Electrocardiogram ST-T segment abnormal Myoglobin blood increased Neutrophil count increased Investigations Troponin increased Post-marketing data indicates that the adverse reactions profile is generally similar to that seen in clinical trials.
Description of selected adverse reactions Netupitant:
No common adverse reactions are attributable to netupitant, the new component of the fixed combination. 75 mg. In addition, eye swelling, dyspnoea and myalgia as adverse reactions have been reported with oral palonosetron but not observed during the development of this medicinal product.
All these reactions were uncommon. Very rare cases of anaphylaxis, anaphylactic/anaphylactoid reactions and shock have been reported from the post-marketing use of intravenous palonosetron. The signs may include hives, itch, angioedema, low blood pressure, throat tightness, chest tightness, dyspnoea, loss of consciousness.
There have also been reports of serotonin syndrome. The signs may include tremor, agitation, sweating, myoclonic movements, hypertonia and fever.
Netupitant and Palonosetron Combinate Capsule:
This medicinal product may contain a trace of lecithin derived from soya. Therefore, patients with known hypersensitivity to peanut or soya should be monitored closely for signs of an allergic reaction. The signs may include hives, skin rash, itching, difficulty breathing or swallowing, swollen mouth, face, lips, tongue or throat and sometimes a drop-in blood pressure.
Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.