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Akynzeo is a brand name for Netupitant. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Akynzeo is indicated in adults for the: - Prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based cancer chemotherapy. - Prevention of acute and delayed nausea and vomiting associated with moderately emetogenic cancer chemotherapy.
Verbatim from this product's EMA label. Tap a section to expand.
5 mg capsule should be administered approximately one hour prior to the start of each chemotherapy cycle. 1). Special populations Elderly people No dose adjustment is necessary for elderly patients. Caution should be exercised when using this medicinal product in patients over 75 years, due to the long half-life of the active substances and the limited experience in this population.
Renal impairment 3 Dose adjustment is not considered necessary in patients with mild to severe renal impairment. Renal excretion for netupitant is negligible. Mild to moderate renal impairment does not significantly affect palonosetron pharmacokinetic parameters.
Total systemic exposure to intravenous palonosetron increased by approximately 28% in severe renal impairment relative to healthy subjects. The pharmacokinetics of palonosetron or netupitant has not been studied in subjects with end-stage renal disease requiring hemodialysis and no data on the effectiveness or safety of netupitant/palonosetron capsules in these patients are available.
Therefore, use in these patients should be avoided. Hepatic impairment No dose adjustment is necessary for patients with mild or moderate hepatic impairment (Child-Pugh score 5-8). Limited data exist in patients with severe hepatic impairment (Child Pugh score ≥ 9).
2). Paediatric population The safety and efficacy of Akynzeo capsules in the paediatric population have not been established. No data are available. Method of administration For oral use. The hard capsule should be swallowed whole and not opened as it contains 4 single pharmaceutical components that should be administered at the same time.
It can be taken with or without food.
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). 8 Table1: Adverse reactions System organ class Common Uncommon Rare Infections and infestations Cystitis Blood and lymphatic system disorders Neutropenia Leukopenia Leucocytosis Lymphocytosis Metabolism and nutrition disorders Decreased appetite Hypokalaemia Psychiatric disorders Insomnia Acute psychosis Mood altered Sleep disorder Nervous system disorders Headache Dizziness Hypoaesthesia Somnolence Eye disorders Conjunctivitis Vision blurred Ear and labyrinth disorders Vertigo Tinnitus Cardiac disorders Atrioventricular block first degree Arrhythmia Cardiomyopathy Atrioventricular block second degree Conduction disorder Bundle branch block left Tachycardia Bundle branch block right Mitral valve incompetence Myocardial ischaemia Ventricular extrasystoles Vascular disorders Hypertension Flushing Hypotension Respiratory, thoracic and mediastinal disorders Hiccups Gastrointestinal disorders Constipation Abdominal distension Dry mouth Abdominal pain Dysphagia Diarrhoea Eructation Dyspepsia Haemorrhoids Flatulence Tongue coated Nausea Vomiting Skin and subcutaneous tissue disorders Alopecia Erythema Urticaria Pruritus Rash Musculoskeletal and connective tissue disorders Back pain Pain in extremities General disorders and administration site conditions Fatigue Asthenia Feeling hot Non-cardiac chest pain Product taste abnormal Investigations Liver transaminases increased Blood bilirubin increased Blood alkaline phosphatase increased Blood creatine phosphokinase increased Blood creatinine Blood creatine phosphokinase 9 increased MB increased Electrocardiogram QT prolonged Blood urea increased Electrocardiogram ST segment depression Electrocardiogram ST-T segment abnormal Myoglobin blood increased Neutrophil count increased Troponin increased Post-marketing data indicates that the adverse reactions profile is generally similar to that seen in clinical trials.
8). Serotonin syndrome There have been reports of serotonin syndrome with the use of 5-HT3 antagonists either alone or in combination with other serotonergic medicinal products (including selective serotonin reuptake inhibitors (SSRIs) and serotonin noradrenaline reuptake inhibitors (SNRIs).
8). 5 mg, respectively. 5 mg palonosetron). Upper 95% confidence limit of the point estimates of placebo 4 and baseline corrected QTcI was constantly within 10 ms at all time points over 2 days after study substance administration. However, since netupitant/palonosetron capsules contains a 5-HT3 receptor antagonist, caution should be exercised in concomitant use with medicinal products that increase the QT interval or in patients who have or are likely to develop prolongation of the QT interval.
These conditions include patients with a personal or family history of QT prolongation, electrolyte abnormalities, congestive heart failure, bradyarrhythmia, conduction disturbances and in patients taking anti-arrhythmic medicinal products or other medicinal products that lead to QT prolongation or electrolyte abnormalities.
Hypokalaemia and hypomagnesaemia should be corrected prior to administration. Caution should be exercised in patients with severe hepatic impairment since limited data are available in these patients. 5). g. 5). Therefore, patients should be monitored for increased toxicity of chemotherapeutic agents that are substrates for CYP3A4, including irinotecan.
Furthermore, netupitant may also affect the efficacy of chemotherapeutic agents that need activation by CYP3A4 metabolism. Excipients This medicinal product contains 7 mg of sorbitol (E420) in each hard capsule. The additive effect of concomitantly administered medicinal products containing sorbitol (E 420) (or fructose) and dietary intake of sorbitol (E 420) (or fructose) should be taken into account.
The content of sorbitol (E 420) in medicinal products for oral use may affect the bioavailability of other medicinal products for oral use administered concomitantly. This medicinal product also contains 20 mg of sucrose in each capsule.
1. 6).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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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.
Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicinal product. This medicinal product contains less than 1 mmol sodium per (23 mg) per hard capsule, that is to say essentially ‘sodium-free’.
It may also contain a trace of lecithin derived from soya. 8).