What is Ivemend?
Ivemend is a powder for the preparation of a solution for infusion (drip into a vein). It contains the active substance fosaprepitant (115 mg).
What is Ivemend used for?
Ivemend is an antiemetic (a medicine used to prevent nausea and vomiting). Ivemend is used together with other medicines to prevent nausea and vomiting caused by chemotherapy (medicines used to treat cancer) in adults. Ivemend is effective in chemotherapy with cisplatin (with high emetogenic potential, ie capable of inducing nausea and vomiting) and in moderately emetogenic chemotherapy (based on cyclophosphamide, doxorubicin or epirubicin). Ivemend makes chemotherapy more tolerable for the patient.
The medicine can only be obtained with a prescription.
How is Ivemend used?
Ivemend is given as a 15-minute infusion half an hour before the start of chemotherapy on the first day of chemotherapy. The medicine should always be given in combination with other medicines that prevent nausea and vomiting, including a corticosteroid (such as dexamethasone) and a "5HT3 antagonist" (such as ondansetron). The patient should continue to receive treatment to prevent nausea and vomiting by mouth for another two or three days after receiving Ivemend.
How does Ivemend work?
The active ingredient contained in Ivemend, fosaprepitant, is a "prodrug" of aprepitant: in other words, it converts into aprepitant in the body. Aprepitant is a neurokinin 1 receptor antagonist (NK1), which prevents a chemical in the body called "substance P" from binding to NK1 receptors. When substance P binds to these receptors, nausea and vomiting occur. By blocking receptors, Ivemend can prevent nausea and vomiting that often occurs during and after chemotherapy. Aprepitant has been authorized in the European Union (EU) as Emend since 2003.
How has Ivemend been studied?
The pharmaceutical company presented information to support the use of Ivemend to show that a 115 mg Ivemend infusion produces an amount of aprepitant in the body similar to that of a 125 mg Emend caspula, as well as information from studies in which 125 mg Emend caspules were administered on the first day of chemotherapy. Two studies involved a total of 1, 094 adults treated with chemotherapy that included cisplatin, while another study involved 866 breast cancer patients treated with cyclophosphamide, with or without doxorubicin or epirubicin. The three studies compared Emend, taken in combination with dexamethasone and ondansetron, with the standard combination of dexamethasone and ondansetron. The main indicator of effectiveness was the percentage of patients who suffered from nausea and vomiting in the five days following the chemotherapy treatment.
What benefit has Ivemend shown during the studies?
Since Emend in 125 mg capsules and Ivemend produce equivalent levels of aprepitant in the body, the benefits observed for Emend administered on the first day of chemotherapy can be transposed to Ivemend.
Studies have shown that adding Emend to the standard combination was more effective than the standard combination alone. Considering the results of the two cisplatin-related studies together, 68% of patients taking Emend had no symptoms of nausea or vomiting for five days (352 out of 520), compared with 48% of patients not taking the medicine (250 out of 523). ). In the study with chemotherapy with moderate emetic effects, 51% of patients taking Emend did not experience nausea or vomiting (220 out of 433), compared to 43% of patients who did not take the medicine (180 out of 424).
What is the risk associated with Ivemend?
The most common side effects with Ivemend (seen in between 1 and 10 patients in 100) are: increased liver enzymes, headache, dizziness, hiccups, constipation, diarrhea, dyspepsia (heartburn), belching, loss of appetite, asthenia or fatigue (weakness and tiredness), hardening and pain of the infusion point. For the full list of all side effects reported with Ivemend, see the Package Leaflet.
Ivemend should not be used in people who may be hypersensitive (allergic) to fosaprepitant, aprepitant, polysorbate 80 or any of the other components. It must not be administered concomitantly with the following medicines:
- pimozide (used to treat mental illness);
- terfenadine, astemizole (usually used to treat allergy symptoms; these medicines can be obtained without a prescription);
- cisapride (used to relieve some stomach problems).
Why has Ivemend been approved?
The Committee for Medicinal Products for Human Use (CHMP) has determined that the benefits of Ivemend outweigh its risks in the prevention of acute and delayed nausea and vomiting associated with a highly emetogenic anti-cancer chemotherapy regimen based on cisplatin, as well as in the prevention of nausea and vomiting associated with a moderately emetogenic anti-cancer chemotherapy regimen. The Committee therefore recommended that Ivemend be given marketing authorization.
More information on Ivemend:
On 11 January 2008, the European Commission issued a marketing authorization valid for Ivemend, valid throughout the European Union, to Merck Sharp & Dohme Ltd.
The full EPEM for Ivemend can be found here.
Last update of this summary: 07-2009.
