Indications:
Bortezomib Dr. Reddy's contains the active substance bortezomib, a so-called 'proteosomal inhibitor'. Proteosomes play an important role in controlling the function and growth of cells. By interfering with their function, bortezomib can kill cancer cells.

Bortezomib Dr. Reddy's is used to treat multiple myeloma (a type of bone marrow cancer) in patients over 18 years of age:
- administered alone or together with the medicines pegylated liposomal doxorubicin or dexamethasone in patients whose disease has worsened (progressively) after previous treatment and in whom blood stem cell transplantation has not worked or in patients who cannot be treated with bone marrow transplantation.
- in combination with the medicines melphalan and prednisone, in patients whose disease has not been previously treated and who are not eligible for high-dose chemotherapy, associated with blood stem cell transplantation.
- in combination with the medicine dexamethasone or in combination with dexamethasone together with thalidomide in previously untreated patients and before they are given high-dose chemotherapy and blood stem cell transplantation (as induction treatment).

Bortezomib Dr. Reddy's is used to treat mantle cell lymphoma (a type of cancer that affects the lymph nodes) in patients aged 18 years or older, in combination with the medicines rituximab, cyclophosphamide, doxorubicin and prednisone, in patients who have not been treated before for their disease and who are not eligible for a blood stem cell transplant.

Contraindications:
Do not use Bortezomib Dr. Reddy's:
- if you are allergic to bortezomib, boron, or any of the other ingredients of this medicine (listed in section 6).

Precautions:
Talk to your doctor or pharmacist before using Bortezomib Dr. Reddy's.

Pregnancy and breastfeeding:
You should not use Bortezomib Dr. Reddy's if you are pregnant unless absolutely necessary.

Both men and women must use effective contraception during treatment with Bortezomib Dr. Reddy's and for 3 months after stopping treatment. If, despite these measures, you become pregnant, inform your doctor immediately.
You should not breast-feed while taking Bortezomib Dr. Reddy's. If you want to restart breast-feeding after treatment has finished, you should discuss this with your doctor, who will tell you when it is safe to start again.

Thalidomide causes birth defects and fetal death. When bortezomib is administered with thalidomide, you should follow the pregnancy prevention program developed for thalidomide (see the package leaflet for thalidomide).

Driving and using machines:
Bortezomib Dr. Reddy's may cause tiredness, dizziness, fainting or blurred vision. Do not drive or use any tools or machines if you experience these side effects; even if you do not experience these side effects, you should still be careful.

Method of administration:
Your doctor will determine the dose of Bortezomib Dr. Reddy's based on your height and weight (body surface area). The usual starting dose of bortezomib is 1.3 mg/m2 body surface area, given twice a week. Your doctor may change the dose and the total number of treatment cycles, depending on your response to treatment, the occurrence of certain side effects and your pre-existing conditions (e.g. liver problems).

If you have any further questions on this medicine, ask your doctor, pharmacist or nurse.

Composition:
- The active substance is bortezomib. Each vial contains 3.5 mg of bortezomib (as mannitol boronic ester).
- The other ingredients are mannitol (Ph. Eur.) and nitrogen.
Reconstitution for intravenous administration:
After reconstitution, 1 ml of solution for intravenous injection contains 1 mg bortezomib.
Reconstitution for subcutaneous administration:
After reconstitution, 1 ml of solution for subcutaneous injection contains 2.5 mg bortezomib.

Presentation:
1 bottle

Warning:
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.