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Human medicines European public assessment report (EPAR): Bortezomib Accord, bortezomib, Date of authorisation: 20/07/2015, Revision: 14, Status: Authorised

Bortezomib Accord can only be obtained with a prescription and treatment should only be started and given under the supervision of a doctor who has experience in the use of cancer chemotherapy.

Bortezomib Accord is available as a 1 mg injection to be given into a vein or a 3.5 mg injection to be injected into a vein or under the skin. Bortezomib Accord must not be given in any other way.

The dose of Bortezomib Accord is calculated using the patient’s height and weight. When given into a vein, it is injected through a catheter (a thin sterile tube) over 3 to 5 seconds. At least 72 hours must pass between two doses of Bortezomib Accord. When injected under the skin, it is given in the thigh or abdomen (belly).

Doses of Bortezomib Accord are given with rest periods between doses, in treatment cycles of 3 to 6 weeks depending on whether Bortezomib Accord is given alone or in combination with other medicines. If a patient develops severe side effects, the treatment must be stopped, delayed or the dose adjusted.

For more information about using Bortezomib Accord, see the package leaflet or contact a doctor or pharmacist.