What is Jylamvo - Methotrexate used for?
Jylamvo is an anti-inflammatory and anticancer medicine used to treat the following diseases:
- active rheumatoid arthritis (a disease that causes inflammation of the joints) in adults;
- severe juvenile idiopathic arthritis (inflammation of the joints in children) in patients from 3 years of age when NSAIDs (non-steroidal anti-inflammatory drugs) have not proved sufficiently effective;
- severe debilitating psoriasis (a disease that causes red, scaly patches on the skin) in adults when other treatments have not proved sufficiently effective;
- severe psoriatic arthritis (inflammation of the joints that occurs in psoriasis patients) in adults;
- acute lymphoblastic leukemia (ALL), a cancer of white blood cells, in adults and children older than 3 years.
Jylamvo is a "hybrid" medicine. This means that it is similar to a "reference medicine" (in this case Methotrexat Lederle) which contains the same active ingredient (methotrexate). The difference between Jylamvo and Methotrexat Lederle is that, while the latter is an injectable solution, Jylamvo is available as a solution to be taken by mouth.
How is Jylamvo - Methotrexate used?
Jylamvo can only be obtained with a prescription and must be prescribed by physicians experienced in methotrexate treatment and its mechanism of action.
Jylamvo is available as an oral solution. If used for inflammatory conditions, it should be taken once a week, on the same day of each week. The dose depends on the condition being treated, from the patient's response to treatment and, in the case of children, from the body surface. In most cases, Jylamvo is used in long-term treatment.
If used for ALL, the dose of Jylamvo depends on the body surface (calculated using the height and weight of the patient). The frequency of methotrexate administration depends on the other medicines used in combination with it.
For more information on how to use Jylamvo, see the package leaflet.
How does Jylamvo - Methotrexate work?
The active ingredient in Jylamvo, methotrexate, prevents cells from growing by interfering with DNA production. This particularly affects rapidly growing cells such as cancer cells. The mechanism of action of methotrexate in patients with arthritis and psoriasis is not entirely known, however it is believed that the benefits of methotrexate are due to its ability to reduce inflammation and block an overactive immune system.
What benefit has Jylamvo - Methotrexate shown during the studies?
The company presented data from the scientific literature on the benefits and risks of methotrexate in approved uses.
As with any medicine, the company has made studies on the quality of Jylamvo available. The company also conducted studies that showed it to be "bioequivalent" to other methotrexate-containing medicines used in the treatment of inflammatory diseases and ALL (Methotrexat Lederle and Ebetrexat tablets). Two medicines are bioequivalent when they produce the same levels of active ingredient in the body, so they are expected to have the same effect.
What are the risks associated with Jylamvo - Methotrexate?
Because Jylamvo is a hybrid medicine and is bioequivalent to Methotrexat Lederle and Ebetrexat tablets, its benefits and risks are considered to be the same as those of these medicines.
Furthermore, there is a risk that patients may make mistakes in measuring the amount of solution they need and therefore the provision of educational material will be provided to avoid it.
Why has Jylamvo - Methotrexate been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Jylamvo has been shown to have comparable quality and to be bioequivalent to Methotrexat Lederle and Ebetrexat, medicines containing methotrexate. Therefore, the CHMP considered that the benefits outweigh the identified risks and recommended to approve the use of Jylamvo in the EU.
What measures are being taken to ensure the safe and effective use of Jylamvo - Methotrexate?
The company that markets Jylamvo will distribute a guide for healthcare professionals to help them prescribe the medicine correctly and to inform patients about the correct use of the medicine to avoid medication errors.
Recommendations and precautions to be followed by healthcare professionals and patients for Jylamvo to be used safely and effectively have also been included in the summary of product characteristics and the package leaflet.
More information on Jylamvo - Methotrexate
For the full version of EPAR and the summary of Jylamvo's risk management plan, consult the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about Jylamvo therapy, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
