For doctors

What is it?

Emend is a medicine containing the active substance aprepitant. It is available as capsules (white and yellow: 40 mg; white: 80 mg; white and pink: 125 mg).

What is it used for?

Emend is an anti-emetic (a medicine that prevents nausea [feeling sick] and vomiting). Emend 80 mg and 125 mg capsules are used with other medicines to prevent nausea and vomiting caused by chemotherapy (medicines used to treat cancer) in adults. Emend works with chemotherapy containing cisplatin (a strong trigger of nausea and vomiting) and with chemotherapy that is a moderate trigger of nausea and vomiting (such as cyclophosphamide, doxorubicin or epirubicin). Emend makes chemotherapy more tolerable for the patient.
Emend 40 mg capsules are used to prevent postoperative nausea and vomiting (PONV) in adults. This is nausea and vomiting that a patient can experience after surgery.
The medicine can only be obtained with a prescription.

How is it used?

In chemotherapy, the usual dose of Emend is one 125 mg capsule by mouth one hour before the start of chemotherapy. After chemotherapy, one 80 mg capsule is taken each day for the next two days. It must be given with other medicines that also prevent nausea and vomiting, including a corticosteroid (such as dexamethasone) and a ‘5HT antagonist’ (such as ondansetron).
In PONV, the usual dose is one 40 mg capsule given within the three hours before the patient is anaesthetised (‘put to sleep’).
Emend capsules should be swallowed whole, with or without food.

How does it work?

Emend is a neurokinin 1 (NK1) receptor antagonist. It stops a chemical in the body (substance P) from binding to the NK1 receptors. When substance P attaches to these receptors, it causes nausea and vomiting. By blocking the receptors, Emend can prevent nausea and vomiting, which often happens after chemotherapy or as a complication of surgery.

How has it been studied?

In chemotherapy, three main studies have been carried out. The first two studies involved a total of 1,094 adults receiving chemotherapy including cisplatin, and the third involved 866 patients with breast cancer who were receiving cyclophosphamide, with or without doxorubicin or epirubicin. All three studies compared the effectiveness of Emend, taken in combination with dexamethasone and ondansetron, with that of the standard combination of dexamethasone and ondansetron. The main measure of effectiveness was the number of patients who had nausea and vomiting in the five days after receiving chemotherapy.
In PONV, two studies were carried out in a total of 1,727 patients, most of whom were women undergoing gynaecological operations. Two doses of Emend (40 and 125 mg) were compared with ondansetron given as an injection. The studies measured how many patients had a ‘complete response’, which was defined as no vomiting and no need for any other medication to control nausea and vomiting in the 24 hours after the operation.

What benefits has it shown during the studies?

In the chemotherapy studies, adding Emend to the standard combination was more effective than the standard combination alone. Looking at the results of the two cisplatin studies taken together, 68% of the patients taking Emend had no nausea or vomiting over five days (352 out of 520), compared with 48% of the patients who did not take it (250 out of 523). The effectiveness of Emend was also seen during a further five cycles of chemotherapy. In the study of chemotherapy that is a moderate trigger of nausea and vomiting, 51% of the patients taking Emend had no nausea or vomiting (220 out of 433), compared with 43% of the patients who did not take it (180 out of 424).
In PONV, Emend was as effective as ondansetron. Looking at the results of both studies together, 55% of the patients taking Emend at a dose of 40 mg were ‘complete responders’ (298 out of 541), compared with 49% of the patients who received ondansetron (258 out of 526).

What is the risk associated?

The most common side effect of Emend at all doses (seen in between 1 and 10 patients in 100) is increased liver enzymes. At 80 mg and 125 mg, the other side effects seen in between 1 and 10 patients in 100 are headache, dizziness, hiccups, constipation, diarrhoea, dyspepsia (indigestion), eructation (burping), anorexia (loss of appetite), and asthenia (weakness) or fatigue (tiredness). For the full list of all side effects reported with Emend, see the Package Leaflet.
Emend should not be used in people who may be hypersensitive (allergic) to aprepitant or any of the other ingredients. Emend 80 mg and 125 mg must not be taken with the following medicines:

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Emend’s benefits are greater than its risks for the prevention of PONV in adults, and of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based cancer chemotherapy and moderately emetogenic cancer chemotherapy in adults. The Committee recommended that Emend be given marketing authorisation.

Further information

The European Commission granted a marketing authorisation valid throughout the European Union for Emend to Merck Sharp & Dohme Ltd on 11 November 2003. The marketing authorisation was renewed on 11 November 2008.

Name

EMEND 40 mg hard capsules

Composition

Each capsule contains 40 mg of aprepitant.

Excipient: 40 mg sucrose.

For a full list of excipients, see section 6.1.

Pharmaceutical Form

Hard capsule

Capsules are opaque with a white body and mustard yellow cap with “464” and “40 mg” printed radially in black ink on the body.