Leitlinien & Arzneimittelsicherheit

HOS-097737 · has-adverse-reaction-information · PDF-Seite 5

Summary of the safety profile In clinical studies in adults at a dose of 250 micrograms (total 633 patients) the most frequently observed adverse reactions, at least possibly related to palonosetron, were headache (9 %) and constipation (5 %). Tabulated list of adverse reactions In the clinical studies the following adverse drug reactions (ADRs) were observed as possibly or probably related to palonosetron. These were classified as common (≥1/100 to <1/10) or uncommon (≥1/1,000 to <1/100). Very rare (<1/10,000) ADRs were reported post-marketing. Within each frequency grouping, adverse reactions are presented below in order of decreasing seriousness. System organ class Common ADRs Uncommon ADRs Very rare ADRs (≥1/100 to<1/10) (≥1/1,000 to <1/100) (<1/10,000) Immune system Hypersensitivity, disorders anaphylaxis, anaphylactic/ anaphylactoid reactions and shock Metabolism and Hyperkalaemia, nutrition disorders metabolic disorders, hypocalcaemia, hypokalaemia, anorexia, hyperglycaemia, appetite decreased Psychiatric disorders Anxiety, euphoric mood Nervous system Headache, Dizziness Somnolence, insomnia, disorders paraesthesia, hypersomnia, peripheral sensory neuropathy Eye disorders Eye irritation, amblyopia Ear and labyrinth Motion sickness, tinnitus disorders Cardiac disorders Tachycardia,

Auszug; vollständigen Abschnitt im Original lesen.

HOS-097733 · has-contraindication-information · PDF-Seite 3

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

HOS-097732 · has-indication-information · PDF-Seite 2

Palonosetron Accord is indicated in adults for: • the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy, • the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy. Palonosetron Accord is indicated in paediatric patients 1 month of age and older for. • the prevention of acute nausea and vomiting associated with highly emetogenic cancer chemotherapy and prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy.

HOS-097735 · has-interaction-information · PDF-Seite 4

Palonosetron is mainly metabolised by CYP2D6, with minor contribution by CYP3A4 and CYP1A2 isoenzymes. Based on in vitro studies, palonosetron does not inhibit or induce cytochrome P450 isoenzyme at clinically relevant concentrations. Chemotherapeutic agents In preclinical studies, palonosetron did not inhibit the antitumour activity of the five chemotherapeutic agents tested (cisplatin, cyclophosphamide, cytarabine, doxorubicin and mitomycin C). Metoclopramide In a clinical study, no significant pharmacokinetic interaction was shown between a single intravenous dose of palonosetron and steady state concentration of oral metoclopramide, which is a CYP2D6 inhibitor. CYP2D6 inducers and inhibitors In a population pharmacokinetic analysis, it has been shown that there was no significant effect on palonosetron clearance when co-administered with CYP2D6 inducers (dexamethasone and rifampicin) and inhibitors (including amiodarone, celecoxib, chlorpromazine, cimetidine, doxorubicin, fluoxetine, haloperidol, paroxetine, quinidine, ranitidine, ritonavir, sertraline or terbinafine). Corticosteroids Palonosetron has been administered safely with corticosteroids. Serotonergic Drugs (e.g. SSRIs and SNRIs) There have been reports of serotonin syndrome following concomitant use of 5-HT3 antagonists and other serotonergic drugs (including SSRIs and SNRIs). Other medicinal products Palonosetron has been administered safely with analgesics, antiemetic/antinauseants, antispasmodics and anticholinergic medicinal products.

HOS-097736 · has-pregnancy-information · PDF-Seite 4

Pregnancy For palonosetron no clinical data on exposed pregnancies are available. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. Only limited data from animal studies are available regarding the placental transfer (see section 5.3). There is no experience of palonosetron in human pregnancy. Therefore, palonosetron should not be used in pregnant women unless it is considered essential by the physician. Breast-feeding As there are no data concerning palonosetron excretion in breast milk, breast-feeding should be discontinued during therapy. Fertility 4 There are no data concerning the effect of palonosetron on fertility.

HOS-097734 · has-warning-information · PDF-Seite 3

QT prolongation At all dose levels tested, palonosetron did not induce clinically relevant prolongation of the QTc interval. A specific thorough QT/QTc study was conducted in healthy volunteers for definitive data demonstrating the effect of palonosetron on QT/QTc (see section 5.1). However, as for other 5-HT3 antagonists, caution should be exercised in the use of palonosetron 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, bradyarrhythmias, conduction disturbances and in patients taking anti-arrhythmic agents or other medicinal products that lead to QT prolongation or electrolyte abnormalities. Hypokalemia and hypomagnesemia should be corrected prior to 5-HT3-antagonist administration. Interference with serotonergic medicinal products There have been reports of serotonin syndrome with the use of 5-HT3 antagonists either alone or in combination with other serotonergic drugs (including selective serotonin reuptake inhibitors (SSRI) and serotonin noradrenaline reuptake inhibitors (SNRIs). Appropriate observation of patients for serotonin syndrome-like symptoms is advised. Other As palonosetron may increase large bowel transit time, patients with a history of constipation or signs of subacute intestinal obstruction should be monitored following administration. Two cases of constipation with faecal impaction requiring hospitalisation have been reported in association with palonosetron 750 micrograms. Palonosetron Accord should not be used to prevent or treat nausea and vomiting in the days following chemotherapy if not associated with another chemotherapy administration. Excipients This medicinal product contains less than 1 mmol sodium (23 mg) per vial that is to say essentially ‘sodium- free’. 3