Thalidomide Celgene

What is Thalidomide Celgene?

Thalidomide Celgene is a medicine that contains the active substance thalidomide and is available as capsules (50 mg).

What is Thalidomide Celgene used for?

Thalidomide Celgene is used to treat multiple myeloma (a cancer of the bone marrow) in combination with melphalan and prednisone (anticancer medicines) in patients who have never been treated for this disease and are over 65 years of age; in younger patients it is used when they are not treatable with high-dose chemotherapy (anticancer therapy).
Thalidomide Celgene is prescribed and dispensed according to a special schedule to avoid exposure of the fetus to the medicine.
Because the number of patients with multiple myeloma is low, the disease is considered 'rare', and Thalidomide Celgene was designated an 'orphan medicine' (a medicine used in rare diseases) on 20 November 2001.
The medicine can only be obtained with a prescription.

How is Thalidomide Celgene used?

Therapy with Thalidomide Celgene should be initiated and monitored under the supervision of a physician who specializes in the use of drugs that regulate the immune system or anticancer drugs. The physician must also be aware of the risks associated with thalidomide and how their use should be controlled. of the medicine.
The recommended dose of Thalidomide Celgene is four capsules a day, taken at the same time, preferably at bedtime. The capsules can be taken on a full stomach or on an empty stomach. Thalidomide Celgene can be used for up to 12 treatment cycles, each lasting six weeks. Your doctor may delay, reduce, or stop doses if certain side effects occur, including blood clots, neurological lesions, rash, lowered heart rate, fainting or sleepiness. Each patient should also be given an anticoagulant. (drug that prevents the formation of blood clots) at least for the first five months of treatment, after a "careful assessment of individual risk.
Patients with severe liver or kidney problems should be carefully observed for any side effects. Thalidomide Celgene is not recommended for use in patients below 18 years of age due to a lack of information on safety and efficacy for this age group.

How does Thalidomide Celgene work?

The active substance in Thalidomide Celgene, thalidomide, is thought to work by blocking the proliferation of cancer cells and by stimulating some specialized cells of the immune system (the body's defense system) to attack cancer cells. This can help to attack cancer cells. slow the progression of multiple myeloma.

How has Thalidomide Celgene been studied?

The effects of Thalidomide Celgene were first tested in experimental models before being studied in humans.
The efficacy of Thalidomide Celgene was the subject of one main study involving 447 patients with multiple myeloma. The patients consisted of subjects over 65 years of age as well as of younger subjects untreatable with high-dose chemotherapy. compared the effect of melphalan and prednisone, taken with or without Thalidomide Celgene, on survival times.
The applicant also presented the results of a study on the combination of Thalidomide Celgene and dexamethasone as an 'induction' therapy for multiple myeloma to be used prior to high-dose chemotherapy. However, the applicant withdrew the application during the evaluation of the medicinal product. .

What benefit has Thalidomide Celgene shown during the studies?

Survival times were longer in patients treated with Thalidomide Celgene in addition to melphalan and prednisone. Patients treated with melphalan and prednisone had a median survival of 33.2 months from study initiation compared with 51.6 months when adding Thalidomide Celgene.

What is the risk associated with Thalidomide Celgene?

Undesirable effects occur in most patients taking thalidomide. The most common side effects (seen in more than 1 in 10 patients) are neutropenia (low levels of neutrophils, a type of white blood cell), leukopenia (low levels of leukocytes, another type of white blood cell), anemia (low levels of red blood cells), lymphopenia (low levels of lymphocytes, another type of white blood cell), thrombocytopenia (low levels of platelets in the blood), peripheral neuropathy (neurological lesions that cause tingling, pain and numbness in the hands and feet), tremor, dizziness , paraesthesia (abnormal stinging sensations), dysesthesia (decreased sensitivity to touch), sleepiness, constipation and peripheral edema (swelling, usually of the legs). For the full list of side effects reported with Thalidomide Celgene, see the package leaflet.
Thalidomide is a potent "teratogenic" agent in humans, that is, it has harmful effects on the fetus and induces severe birth-threatening malformations. The severe conditions required to avoid the establishment of a pregnancy and the exposure of the fetus to thalidomide must be observed by all patients, men and women, who take this medicine.
Thalidomide Celgene should never be used in the following patient groups:

1. pregnant women;
2. women of childbearing potential, unless they take all necessary measures to exclude the existence of a pregnancy at the beginning of therapy and to avoid the establishment of a pregnancy during therapy or shortly after its termination;
3. patients who are unable to follow or use the required methods of contraception.

Thalidomide Celgene should also not be used in patients who may be hypersensitive (allergic) to thalidomide or any of the other ingredients. For the complete list of restrictions on use, see the package leaflet.

Why has Thalidomide Celgene been approved?

The Committee for Medicinal Products for Human Use (CHMP) concluded that Thalidomide Celgene's benefits are greater than its risks, in combination with melphalan and prednisone, in first-line therapy of previously untreated patients with multiple myeloma of at least the age. age 65 or unsuitable for high dose chemotherapy provided that strict measures are in place to avoid fetal exposure to thalidomide. The Committee recommended that Thalidomide Celgene be given marketing authorization.

What measures are being taken to ensure the safe use of Thalidomide Celgene?

The pharmaceutical company that makes Thalidomide Celgene has committed to establishing a pregnancy prevention program in each Member State. It includes a letter and information packs for healthcare professionals and brochures for patients, detailing the steps to be taken for safe use of the medicine. Provision is also made for providing patients with a "special card to ensure that they take all appropriate safety measures. Each Member State will also ensure that doctors and patients receive the appropriate information materials and patient cards."
Finally, the pharmaceutical company will collect data on the possible use of the medicine outside the authorized indication. On boxes containing Thalidomide Celgene capsules there will be a "warning indicating the danger of thalidomide to the fetus.

More information about Thalidomide Celgene

On April 16, 2008, the European Commission issued a "Marketing Authorization" for Thalidomide Pharmion, valid throughout the European Union. The holder of the Marketing Authorization is Celgene Europe Ltd. On October 22, 2008 the name of the medicine was changed to Thalidomide Celgene.
For the summary of the opinion of the Committee for Orphan Medicinal Products for Thalidomide Celgene, click here.
For the full version of the Thalidomide Celgene EPAR, click here.

Last update of this summary: 01-2009.

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