What is Targretin?
Targretin is a medicine that contains the active substance bexarotene. It is available as white soft capsules (75 mg).
What is Targretin used for?
Targretin is used in the treatment of skin manifestations visible in patients with cutaneous T-cell lymphoma (CTCL). Cutaneous T-cell lymphoma is a rare type of lymphoma (cancer of the lymphatic tissue), which occurs when a particular type of white blood cell (T-cell) grows in the skin. Targretin is used in patients with advanced disease and who have not responded to at least one previous treatment.
The medicine can only be obtained with a prescription.
How is Targretin used?
Targretin therapy should only be initiated and continued by physicians experienced in the treatment of patients with cutaneous T-cell lymphoma. The dose of Targretin depends on the patient's body surface area measured in square meters (m2). The recommended starting dose is 300 mg / m2 / day. The dose can be adjusted according to the patient's response to treatment or side effects. Therapy should be continued as long as the patient benefits from it. For further details, please refer to the Summary of Product Characteristics, included in the EPAR.
Targretin capsules should be taken in a single daily dose, with a meal.
How does Targretin work?
The active substance in Targretin, bexarotene, is an anticancer agent belonging to the group of retinoids, substances derived from vitamin A. The exact mechanism of action of bexarotene in CTCL is not known.
How has Targretin been studied?
The efficacy of Targretin was examined in two studies involving a total of 193 patients with CTCL who had failed to respond to at least two previous treatments. The studies did not include a control group (ie Targretin was not compared to another medicine or placebo). 93 of these patients were at an advanced stage of the disease and were refractory to other treatments. 61 patients were treated with the starting dose of 300 mg / m2 / day. The main measure of effectiveness was response to treatment after 16 weeks, measured by the physician's evaluation of the EMEA 2007 improvement and by a score obtained on the basis of 5 clinical signs (affected skin area, redness, raised areas, scaly skin and staining).
What benefit has Targretin shown during the studies?
In the two studies, approximately half of the patients treated with 300 mg / m2 responded to treatment, according to the physician's assessment. respectively, the following percentages: 36% and 27%.
What is the risk associated with Targretin?
The most frequently observed side effects with Targretin (in more than 1 in 10 patients) are leukopenia (drop in the number of white blood cells), hypothyroidism (insufficient thyroid gland activity), hyperlipemia (high levels of fat in the blood), hypercholesterolemia (high blood cholesterol), exfoliative dermatitis (peeling of the skin), itching, erythema, pain, headache and asthenia (weakness) For the complete list of side effects reported with Targretin, see the package leaflet.
Targretin should not be used in patients who may be hypersensitive (allergic) to bexarotene or any of the other substances. Targretin should also not be given to:
- pregnant or breastfeeding women;
- women who could become pregnant;
- people who have suffered from pancreatitis (inflammation of the pancreas) in the past;
- people with uncontrolled hypercholesterolemia (high blood cholesterol);
- people with uncontrolled hypertriglyceridemia (high level of triglycerides [fats] in the blood);
- people with hypervitaminosis A (high levels of vitamin A in the body);
- people with uncontrolled thyroid disease;
- people with liver disease;
people with an ongoing infection.
Why has Targretin been approved?
The Committee for Medicinal Products for Human Use (CHMP) decided that Targretin's benefits are greater than its risks for the treatment of skin manifestations in patients with advanced cutaneous T-cell lymphoma refractory to at least one systemic treatment, and therefore recommended the issue of the "authorization for the marketing of the product.
Other information about Targretin:
On 29 March 2001, the European Commission issued a "Marketing Authorization" for Targretin, valid throughout the European Union. The "Marketing Authorization" was renewed on 29 March 2006. The Marketing Authorization Holder "placing on the market is the company Eisai Ltd.
For the full version of Targretin's EPAR click here.
Last update of this summary: 03-2007.
Information on Targretin - bexarotene published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
