What is Imnovid - pomalidomide and what is it used for?
Imnovid is an anticancer medicine that contains the active substance pomalidomide . It is used in combination with dexamethasone (an anti-inflammatory medicine) in the treatment of multiple myeloma (a cancer of the spinal cord). It is used in adults who have undergone at least two previous therapies, including both lenalidomide and bortezomib, and with demonstrated progression of the disease during the last therapy. Because the number of patients with multiple myeloma is low, the disease is considered 'rare' and Imnovid was designated an 'orphan medicine' (a medicine used in rare diseases) on 8 October 2009
How is Imnovid used - pomalidomide?
Imnovid therapy should be started and monitored under the supervision of a physician experienced in the treatment of multiple myeloma. The medicine can only be obtained with a prescription. Imnovid is available as capsules (1, 2, 3 and 4 mg) and should be taken in 4-week treatment cycles. The recommended starting dose is 4 mg once a day; the medicine should be taken at the same time every day for the first 3 weeks of the cycle, followed by a week of therapy suspension. The recommended dose of dexamethasone is 40 mg once a day taken on days 1, 8, 15 and 22 of each cycle.
It may be necessary to suspend or stop treatment with Imnovid, or reduce the dose, if the disease progressed or if the patient reported some side effects. For more information, see the package leaflet.
How does Imnovid - pomalidomide work?
The active substance in Imnovid, pomalidomide, is an immunomodulatory agent. This means that it affects the activity of the immune system (the body's natural defenses). Pomalidomide acts in different ways in multiple myeloma, similarly to other immunomodulatory agents such as lenalidomide and thalidomide: it blocks the development of cancer cells, prevents the growth of blood vessels in tumors and stimulates some specific cells of the immune system to attack cancer cells.
What benefit has Imnovid - pomalidomide shown during the studies?
Imnovid was examined in one main study involving 455 adults with multiple myeloma whose disease did not respond to treatment or recurred after previous therapies. The study compared Imnovid with a low dose of dexamethasone with a dexamethasone monotherapy in a high dose. The main measure of effectiveness was the time to progression of the disease. Imnovid associated with a low dose of dexamethasone was more effective than dexamethasone monotherapy in a high dose in delaying the progression of multiple myeloma: patients who took Imnovid associated with a low dose of dexamethasone spent an average of 16 weeks before any signs were observed of worsening of the disease compared to 8 weeks recorded in patients treated with a high dose of dexamethasone.
What is the risk associated with Imnovid - pomalidomide?
The most common side effects of Imnovid (which may affect more than 1 in 10 people), some of them serious, include anemia (decreased number of red blood cells in the blood), neutropenia (decrease in the number of white blood cells in the blood), fatigue, thrombocytopenia (decrease in the number of platelets), pyrexia (fever), peripheral edema (swelling, especially in the ankles and feet), peripheral neuropathy (injury to the nerves accompanied by tingling, pain and numbness in the hands and feet) and pneumonia ( lung infection). For the full list of all side effects reported with Imnovid, see the package leaflet. Pomalidomide is believed to be harmful to the fetus, which causes serious and life-threatening birth defects. Therefore Imnovid should not be taken during pregnancy. It must not be taken by women of childbearing age, unless all the necessary measures are taken to avoid pregnancy before and during the treatment and immediately after its conclusion. Since the medicine may be present in the seminal fluid, it should not be used in male patients who are unable to take the required contraceptive measures. For the full list of limitations, see the package leaflet.
Why has Imnovid - pomalidomide been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Imnovid's benefits are greater than its risks and recommended that it be approved for use in the EU. The committee concluded that Imnovid is effective in delaying the progression of multiple myeloma in patients whose disease has not responded to therapy or returns after previous therapy, who have extremely limited treatment options. The committee also noted that the safety profile of Imnovid was considered acceptable for these patients, with side effects similar to those of other medicines of this type.
What measures are being taken to ensure the safe and effective use of Imnovid - pomalidomide?
A risk management plan has been developed to ensure that Imnovid is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Imnovid, including the appropriate precautions to be followed by healthcare professionals and patients. In addition, the company that produces Imnovid will develop a pregnancy prevention program in each Member State. It will provide a letter and information package for healthcare professionals and patient leaflets to explain that the medicine is considered harmful to the fetus and to indicate what steps need to be taken to use the medicine safely. In addition, it will make special cards available for patients to ensure that each patient takes all the necessary safety measures. Each Member State should ensure that information material and patient records are provided to the physicians responsible for prescribing the drug and to patients. The company will also establish a registry of patients treated with Imnovid to monitor reported side effects and to check if the medicine is used for the approved indication and in accordance with the pregnancy prevention program. Packs containing Imnovid capsules will contain a warning about the risk of serious birth defects.
Other information on Imnovid - pomalidomide
On 5 August 2013, the European Commission issued a marketing authorization for Pomalidomide Celgene, valid throughout the European Union. On 27 August 2013, the name of the medicine was changed to Imnovid. For more information on Imnovid therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. The summary of the opinion of the Committee for Orphan Medicinal Products related to Imnovid is available on the Agency's website: ema.Europa.eu/Find medicine / Human medicines / Rare disease designation. Last update of this summary: 09-2013.
