Lenalidomide Krka d.d. Novo mesto is a medicine used for the treatment of certain cancers affecting blood cells, namely multiple myeloma and follicular lymphoma. In **multiple myeloma**, a cancer of a type of white blood cells called plasma cells, Lenalidomide Krka d.d. Novo mesto is used: - in adults with previously untreated (newly diagnosed) multiple myeloma, who have had an autologous stem cell transplant (a procedure where the patient’s bone marrow is cleared of cells and replaced with the patient’s own stem cells to form new bone marrow); - in adults with previously untreated multiple myeloma, who cannot have stem cell transplantation. It is used in combination with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone; - in adults whose disease has been treated at least once. It is used in combination with dexamethasone. In **follicular lymphoma**, a blood cancer that affects a type of white blood cell called B lymphocytes, Lenalidomide Krka d.d. Novo mesto. Lenalidomide Krka d.d. Novo mesto is used in adults whose disease has come back after treatment or does not improve with treatment. It is used in combination with rituximab. Lenalidomide Krka d.d. Novo mesto contains the active substance lenalidomide and is a ‘generic medicine’. This means that Lenalidomide Krka d.d. Novo mesto contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Revlimid. For more information on generic medicines, see the question-and-answer document below.
Therapeutic Indication
### Therapeutic indication **Multiple myeloma** Lenalidomide krka d.d. Novo mesto as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. Lenalidomide krka d.d. Novo mesto as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4.2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. Lenalidomide krka d.d. Novo mesto in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. **Follicular lymphoma** Lenalidomide krka d.d. Novo mesto in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a). **Multiple myeloma** Lenalidomide krka d.d. Novo mesto as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation. Lenalidomide krka d.d. Novo mesto as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4.2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant. Lenalidomide krka d.d. Novo mesto in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy. **Follicular lymphoma** Lenalidomide krka d.d. Novo mesto in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 – 3a).
Therapeutic Area (MeSH)
ATC Code
L04AX04
ATC Item
lenalidomide
Pharmacotherapeutic Group
Immunosuppressants
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| lenalidomide hydrochloride monohydrate | N/A | lenalidomide hydrochloride monohydrate |
EMA Name
Lenalidomide Krka d.d. Novo mesto (previously Lenalidomide Krka)
Medicine Name
Lenalidomide Krka d.d. Novo mesto (previously Lenalidomide Krka)
Aliases
N/ANo risk management plan link.
