Litak - cladribine

What is Litak?

Litak is a solution for injection that contains the active substance cladribine.

What is Litak used for?

Litak is used to treat adults with hairy cell leukemia, a blood cancer caused by hyper-production of B lymphocytes (a type of white blood cell). The term "hairy cells" refers to the protuberances, which resemble hair, which can be observed under the microscope on the surface of the lymphocytes.

Given the small number of patients with hairy cell leukemia, the disease is considered rare and on 18 September 2001 Litak was designated an "orphan medicine" (a medicine used for rare diseases).

The medicine can only be obtained with a prescription.

How is Litak used?

Treatment with Litak should be started by a doctor experienced in cancer treatment. Litak is given as an injection under the skin. The recommended dose is 0.14 mg per kilogram of body weight taken once a day for five days. The patient can inject alone after proper training. Litak should not be used in patients with moderate to severe problems with their liver or kidneys. In patients over 65 years of age should be used with caution, with frequent checks of the liver, kidneys and blood counts.

How does Litak work?

Cladribine, the active ingredient in Litak, is a cytotoxic, a medicine that can kill cells that divide, such as cancer cells, that belong to a class of anti-cancer medicines called "antimetabolites". Cladribine is an "analogue" of purine (a substance whose chemical structure is similar to that of purine). Purine is one of the fundamental chemicals that make up DNA. In the body, cladribine is converted into lymphocytes into a chemical substance, CdATP, which intervenes in the production of new DNA. This prevents cell division, slowing the progression of leukemia. CdATP can also have effects on other cells, in particular on other blood cells, with consequent possible side effects. Cladribine has been used in anticancer medicines since the 1980s and is available as an intravenous infusion (drip into a vein) in some Member States of the European Union (EU) since 1993.

What studies have been carried out on Litak?

Since cladribine has been in use for years, the company presented data already published in the medical literature. Litak has been studied in one main study involving 63 adults with hairy cell leukemia. In this study, Litak was not compared to other treatments. The main parameters of effectiveness were the number of patients in whom complete or partial remission occurred after treatment. Complete remission means the disappearance of any sign of disease, while partial remission means an improvement in blood counts and a reduction in the number of cancer cells.

What benefit has Litak shown during the studies?

In the main study, 97% of patients had complete or partial remission (60 out of 62) and 76% had complete remission (47 of 62). These results are similar to those found in other published studies on the use of cladribine intravenously and better than the results obtained with alternative treatments, such as interferon alfa and pentostatin.

What is the risk associated with Litak?

The most common side effects associated with Litak (seen in more than 1 patient in 10) are infection, pancytopenia or myelosuppression (low blood cell count), purpura (skin lesion), immunosuppression (weakening of the immune system), decreased appetite, headache, dizziness, abnormal breathing and thoracic sounds, cough, nausea, vomiting, constipation, diarrhea, rash, localized rash (skin rash), diaphoresis (excessive sweating), injection site reactions (pain and inflammation in the injection site), fever, fatigue, chills and asthenia (weakness). For the full list of all side effects reported with Litak, see the Package Leaflet.

Litak should not be used in patients who may be hypersensitive (allergic) to cladribine or any of the other ingredients. Litak should not be used during pregnancy or lactation, in patients under the age of 18, in patients with moderate to severe kidney or liver diseases or in combination with other medicines that reduce blood cell production .

Why has Litak been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Litak's benefits outweigh its risks in hairy cell leukemia therapy. The committee recommended that Litak be given marketing authorization.

More information on Litak

On 14 April 2004, the European Commission issued a marketing authorization for Litak to Lipomed GmbH, valid throughout the European Union. The marketing authorization was renewed on April 14, 2009.

For a summary of the opinion of the Committee for Orphan Medicinal Products on Litak, click here.

For the full EPAR for Litak, click here.

Last update of this summary: 04-2009.