Ivemend - fosaprepitant
What is Ivemend?
Ivemend is a powder that is made up into a solution for infusion (drip into a vein). 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 chemotherapy induced nausea and vomiting (medicines given to treat cancer) in adults. Ivemend is effective in chemotherapies with cisplatin (with high emetogenic potential, i.e. capable of inducing nausea and vomiting) and in moderately emetogenic chemotherapies (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 an infusion lasting 15 minutes and 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 to three days after Ivemend administration.
How does Ivemend work?
The active substance in Ivemend, fosaprepitant, is a "prodrug" of aprepitant: that is, it converts to aprepitant in the body. Apripitant is a neurokinin 1 (NK1) receptor antagonist, which prevents a chemical in the body from called "substance P", to bind to NK1 receptors. When substance P binds to these receptors, nausea and vomiting occur. By blocking the receptors, Ivemend can prevent nausea and vomiting that often occur during and after chemotherapy. Openspitant has been authorized in the European Union (EU) under the name of Emend since 2003.
How has Ivemend been studied?
The company presented information supporting the use of Ivemend to show that a 115 mg infusion of Ivemend produces in the body an amount of aprepitant similar to that of a 125 mg Emend capsule, as well as information from studies in which Emend 125 mg capsules 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 measure 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 125 mg capsules and Ivemend produce equivalent levels of aprepitant in the body, the observed benefits for Emend given on the first day of chemotherapy can be transposed to Ivemend.
The studies showed that adding Emend to the standard combination was more effective than the standard combination alone. When combined with the results of the two cisplatin studies, 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 feel sick or vomit (220 out of 433) ), compared with 43% of patients not taking the medicine (180 out of 424).
What is the risk associated with Ivemend?
The most common side effects seen with Ivemend (seen in 1 to 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 site. For the full list of side effects reported with Ivemend, see the package leaflet.
Ivemend must not be used in people who may be hypersensitive (allergic) to fosaprepitant, aprepitant, polysorbate 80 or any of the other ingredients. It must not be administered concomitantly with the following medicinal products:
- 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 certain stomach problems).
Why has Ivemend been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Ivemend's benefits are greater than its risks in the prevention of acute and delayed nausea and vomiting associated with a highly emetogenic cisplatin-based anticancer chemotherapy regimen, as well as in the prevention of nausea and vomiting associated with a moderately emetogenic anticancer chemotherapy regimen. The committee therefore recommended the granting of a marketing authorization for Ivemend.
Other information about Ivemend:
On 11 January 2008, the European Commission granted Merck Sharp & Dohme Ltd a "Marketing Authorization" for Ivemend, valid throughout the European Union.
For the full version of Ivemend's EPAR click here.
Last update of this summary: 07-2009.
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