What is pomalidomide (Imnovid)?
Pomalidomide is an anticancer medicine that is used to treat myeloma in combination with dexamethasone (an anti-inflammatory medicine). It was approved by the European Medicines Agency (EMA) in 2013 for use in adults who have received at least two previous therapies, including both lenalidomide and bortezomib, and whose disease progressed after the last treatment. Pomalidomide is known as Pomalyst in the USA.
How does pomalidomide work?
Pomalidomide, is a type of biological therapy known as an immunomodulating agent. When it is taken with dexamethasone, it affects the activity of the body’s natural defences, the immune system, by blocking the development of tumour cells, preventing the growth of blood vessels within tumours, and stimulating some of the specialised cells of the immune system to attach the tumour cells. Other immunomodulating agents used in treating myeloma are lenalidomide and thalidomide.
What are the benefits of pomalidomide?
In an international study of 455 relapsed myeloma patients (the Phase III “MM-003” clinical trial), patients who were treated with pomalidomide and low-dose dexamethasone had significantly longer progression-free survival than patients treated with high-dose dexamethasone alone. Overall survival was also longer.
What are the side-effects?
The most common side-effects are:
- low red blood cell counts (anaemia)
- low white blood cell counts (neutropenia)
- low platelet counts (thrombocytopenia)
- swollen ankles and feet
- tingling, pain and numbness in the hands and feet
- chest infection
- loss of appetite
- shortness of breath
- constipation, diarrhoea or nausea, and
- muscle spasm, bone pain.
You should stop taking pomalidomide and see a doctor straight away if you have a fever, sore throat or cough; bleeding or bruising without a cause (including nosebleeds); chest pain; leg pain and swelling; shortness of breath; or any swelling of face, lips, tongue and throat which may cause difficulty breathing.
These side-effects can affect to your ability to drive so do not drive or operate tools or machinery if you feel tired, dizzy, faint, confused or less alert when taking pomalidomide.
Pomalidomide can cause severe birth defects. If you are planning to become pregnant consult your doctor. If you are a man you must also comply with the required contraceptive measures as pomalidomide can be found in semen of men taking this medicine.
How and when is pomalidomide given?
Pomalidomide is available as capsules in different strengths and is taken in four-week treatment cycles. The recommended starting dose is 4mg once a day, taken at the same time each day for the first three weeks of the cycle, followed by a week of no treatment. The recommended dose of dexamethasone is 40mg once a day on days 1, 8, 15 and 22 of each cycle.
You should talk to your doctor before taking pomalidomide:
- if you have ever had blood clots
- if you have ever had an allergic reaction while taking similar medicines (lenalidomide or thalidomide)
- if you have had a heart attack, have heart failure, have difficulty breathing, or if you smoke, have high blood pressure or high cholesterol levels
- if you have or have had neuropathy (nerve damage causing tingling or pain in your hands or feet), or
- if you have ever had hepatitis B infection.
- European Medicines Agency. Imnovid (pomalidomide) European public assessment report (EPAR) – lay summary October 2013 last updated 29/09/2016
- Manufacturer’s product information http://www.celgene.co.uk/medical-professionals/treatments/imnovid-pomalidomide/
- Patient information leaflet (PIL) http://www.medicines.org.uk/emc/medicine/28255/PIL/Imnovid/
- Miguel, JS et al. Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial. Lancet Oncol 2013; 14: 1055–66
- Leleu, X. New hope for relapsed and refractory multiple myeloma (Comment). Lancet Oncol S1470-2045(13)70399-1