Onivyde pegylated liposomal Overview

Onivyde is a cancer medicine that is used to treat a form of pancreatic cancer called metastatic adenocarcinoma of the pancreas. Metastatic means that the cancer has spread to other parts of the body. Onivyde is used together with 5-fluorouracil and leucovorin (two other cancer medicines) in adults whose cancer has got worse despite treatment containing the cancer medicine gemcitabine.

Pancreatic cancer is rare, and Onivyde was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 9 December 2011.

Onivyde can only be obtained with a prescription and treatment should only be prescribed and given by a doctor who has experience in the use of cancer medicines.

Onivyde is available as a concentrate to be made into a solution for infusion (drip) into a vein. The recommended dose is 70 mg per square metre of body surface given every 2 weeks together with 5‑fluorouracil and leucovorin. The dose may be adjusted by the doctor in patients who develop severe side effects and those with particular genetic characteristics that increase the risk of side effects. For more information about using Onivyde, see the package leaflet or contact your doctor or pharmacist.

The active substance in Onivyde, irinotecan, is a cancer medicine that belongs to the group ‘topoisomerase inhibitors’. It blocks an enzyme called topoisomerase I, which is involved in copying cell DNA, which is needed to make new cells. By blocking the enzyme, cancer cells are prevented from multiplying and they eventually die. In Europe, irinotecan has been authorised for a number of years for the treatment of colorectal cancer. In Onivyde, irinotecan is contained within tiny fat particles called ‘liposomes’. The liposomes are expected to accumulate within the tumour and release the medicine slowly over time, thereby decreasing the rate at which irinotecan is removed from the body and allowing it to act for longer.

Onivyde was investigated in one main study involving 417 patients with metastatic adenocarcinoma of the pancreas whose cancer got worse despite cancer treatment that contained gemcitabine. Patients were given Onivyde or 5-fluorouracil plus leucovorin, or the three medicines in combination. The main measure of effectiveness was overall survival (how long the patients lived). The study showed that the addition of Onivyde to the 5-fluorouracil plus leucovorin regimen prolonged patients’ lives: patients taking the three medicines together lived for around 6.1 months, compared with 4.2 months for patients taking 5-fluorouracil plus leucovorin, and 4.9 months for patients taking Onivyde alone.

The European Medicines Agency decided that Onivyde’s benefits are greater than its risks and recommended that it be approved for use in the EU. The Agency considered that the increase in survival seen when Onivyde was used together with 5-fluorouracil and leucovorin was meaningful in previously treated patients with metastatic adenocarcinoma of the pancreas, for whom limited treatment options are available; the safety profile of Onivyde is in line with that of standard irinotecan, and the side effects manageable.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Onivyde have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Onivyde are continuously monitored. Side effects reported with Onivyde are carefully evaluated and any necessary action taken to protect patients.

Onivyde received a marketing authorisation valid throughout the EU on 14 October 2016.

What are the risks associated with Onivyde pegylated liposomal?

The most common side effects with Onivyde (which may affect more than 1 in 5 people) are diarrhoea, nausea (feeling sick), vomiting, loss of appetite, neutropenia (low levels of neutrophils, a type of white blood cell), tiredness, weakness, anaemia (low red blood cell counts), stomatitis (inflammation of the lining of the mouth) and fever. The most common serious side effects (which may affect more than 1 in 50 people) included diarrhoea, nausea and vomiting, neutropenia and fever, infections of blood or lungs (sepsis, pneumonia), shock, dehydration, kidney failure and thrombocytopenia (low levels of blood platelets). For the full list of side effects of Onivyde.

Onivyde must not be given to patients who had a severe hypersensitivity (allergic) reaction to irinotecan in the past and to breastfeeding women. For the full list of restrictions.

Owner of copyright and other intellectual property rights to European Medicines Agency

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