What is Targretin?
Targretin is a medicine containing the active substance bexarotene. It is available in white soft capsules (75 mg).
What is Targretin used for?
Targretin is used to treat visible skin manifestations in patients with cutaneous T-cell lymphoma (CTCL). Cutaneous T-cell lymphoma is a rare type of lymphoma (tumor of the lymphatic tissue), which manifests itself with the growth of a particular type of white blood cells (T cells) at skin level. Targretin is used in patients at an advanced stage of the 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 started 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 depending on the patient's response to treatment or side effects. Therapy should be continued until the patient benefits. 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, during a meal.
How does Targretin work?
The active substance in Targretin, bexarotene, is an antitumor agent belonging to the group of retinoids, substances derived from vitamin A. The exact mechanism of action of bexarotene in the 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 not responded to at least two previous treatments. The studies did not include a control group (ie Targretin was not compared to another medicine or to placebo). 93 of these patients were at an advanced stage of the disease and were refractory to other treatments. 61 patients were treated with an initial dose of 300 mg / m2 / day. The main measure of effectiveness was the response to treatment at 16 weeks, measured by the evaluation of delEMEA 2007 improvement by the doctor and a score obtained based on 5 clinical signs (area of the skin affected, redness, raised areas), scaly skin and coloring).
What benefit has Targretin shown during the studies?
In the two studies, about half of the patients treated with 300 mg / m2 responded to the treatment, according to the doctor's evaluation. Regarding the response rate obtained based on the score of 5 clinical signs, the following percentages were collected, respectively: 36% and 27%.
What is the risk associated with Targretin?
The most common side effects seen with Targretin (in more than 1 patient in 10) are leukopenia (decrease in the number of white blood cells in the blood), hypothyroidism (insufficient activity of the thyroid gland), hyperlipemia (high levels of fat in the blood), hypercholesterolemia (high rate of cholesterol in the blood), exfoliative dermatitis (peeling of the epidermis), itching, erythema, pain, headache and asthenia (weakness). For the full list of all 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 nursing women;
- women who could become pregnant;
- people who have suffered from pancreatitis (inflammation of the pancreas) in the past;
- people with hypercholesterolemia (high cholesterol in the blood) not controlled;
- people with hypertriglyceridemia (high rate of triglycerides [fats] in the blood) not controlled;
- individuals 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 cutaneous manifestations in patients with advanced cutaneous T-cell lymphoma, refractory to at least one systemic treatment, and therefore recommended the granting of the marketing authorization for the product.
More information on 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 is Eisai Ltd.
The full EPAR for Targretin can be found here.
Last update of this summary: 03-2007.
