drugs

Paxene - paclitaxel

PLEASE NOTE: MEDICINAL PRODUCT IS NO LONGER AUTHORIZED

What is Paxene?

Paxene is a concentrate for the preparation of a solution for infusion (drip into a vein). The medicine contains the active substance paclitaxel.

What is Paxene used for?

Paxene is an anticancer medicine. It is used to treat the following types of tumors:

  1. advanced Kaposi sarcoma associated with AIDS (a skin cancer found in AIDS patients), in case the treatment with anthracycline (another type of anticancer medicine) has not been successful;
  2. metastatic breast cancer, when other treatments have not been successful or cannot be used. The term "metastatic" indicates that the tumor has spread to other parts of the body;
  3. advanced ovarian cancer (when the cancer has spread outside the ovary), in combination with cisplatin (another anticancer medicine);
  4. metastatic ovarian cancer, after failure of other treatments such as platinum-containing combination therapy;
  5. non-small cell lung cancer, in combination with cisplatin, in the case of patients who cannot undergo surgery or radiation therapy.

The medicine can only be obtained with a prescription.

How is Paxene used?

Paxene should be administered by an oncologist (a doctor who specializes in treating cancer) in a specialized department for the treatment of tumors. To prevent the onset of severe allergic reactions, all patients must be treated first with corticosteroids to reduce inflammation, with antihistamines to reduce swelling and itching and with H2 antagonists to reduce stomach acid. Paxene is given as an infusion that lasts for three hours or occasionally for 24 hours. It is given every 2-3 weeks using an infusion pump. The dose of Paxene, the duration of treatment and the frequency of administration depend on the type of cancer being treated and which other anticancer drugs are given together with Paxene. For more information, see the package leaflet.

How does Paxene work?

The active substance in Paxene, paclitaxel, belongs to the group of anticancer medicines known as the taxanes. Paclitaxel blocks the cells' ability to split the "skeleton" which allows the cells to divide and multiply. In the presence of the skeleton the cell cannot divide and therefore dies. Paxene also acts on non-tumor cells, such as blood cells, causing unwanted effects.

What studies have been carried out on Paxene?

Because Paxene is very similar to another authorized drug containing paclitaxel called Taxol, studies supporting the use of Taxol have also been used to support the use of Paxene. The company has also used data published in scientific journals.

Paxene has been studied in 107 patients with Kaposi sarcoma, in 312 patients with metastatic breast cancer, in 120 patients with metastatic ovarian cancer, in over 900 patients with advanced ovarian cancer and in more than 1 000 patients with lung cancer. In the studies Paxene was used together with other anticancer drugs and compared with other treatments. The main measures of effectiveness were the number of patients with tumor response to treatment, the length of time the patients lived without the worsening of the disease and the survival time.

What benefit has Paxene shown during the studies?

Treatment with Paxene improved the response rates of different types of cancer. In some cases they have proved significantly better than standard cancer therapies. Paxene has also increased the survival time of patients for certain types of cancer. The results of these studies were used to make recommendations on how to use the drug.

What are the risks associated with Paxene?

The most common side effects with Paxene (seen in more than 1 patient in 10) are infection, severe neutropenia (very low levels of neutrophils, a type of white blood cell), severe leukopenia (very low white blood cell count), thrombocytopenia (low platelet count), anemia (low red blood cell count), myelosuppression (situation in which the bone marrow is unable to produce a sufficient number of blood cells), mild hypersensitive reactions (allergic reactions), loss of appetite, neuropathy (damage to the nervous system), paraesthesia (unusual sensations such as pins and needles), drowsiness, hypotension (low blood pressure), nausea, vomiting, diarrhea, inflammation of the mucous membranes (inflammation of the body's wet surfaces), constipation, stomatitis (inflammation of the mucous membrane) oral), abdominal pain, alopecia (hair loss), arthralgia (joint pain), myalgia (muscle pain), asthenia (weakness), pain and edema (swelling). For the full list of all side effects reported with Paxene, see the Package Leaflet.

Paxene should not be used in patients who may be hypersensitive (allergic) to paclitaxel or any of the other ingredients. Paxene should not be used in patients with severe liver disease, severe uncontrolled infections or low levels of neutrophils. It must not be used in women who are pregnant or breast-feeding.

Why has Paxene been approved?

The Committee for Medicinal Products for Human Use (CHMP) has determined that the benefits of Paxene outweigh its risks in the treatment of advanced AIDS-associated Kaposi sarcoma, metastatic breast cancer, and advanced ovarian cancer combined with cisplatin, of metastatic ovarian cancer with failure of platinum-containing combination therapy and non-small cell lung carcinoma. The committee recommended the granting of a marketing authorization for Paxene.

More information on Paxene

The European Commission granted a marketing authorization valid throughout the European Union for Paxene to Norton Healthcare Limited on 19 July 1999. The marketing authorization was renewed on 19 July 2004 and 19 July 2009.

For the full EPAR of Paxene, click here.

Last update of this summary: 07-2009.