Lomustine capsules

Name: Lomustine capsules

About lomustine capsules

Type of medicineAn alkylating chemotherapy medicine
Used forCancer
Available asCapsules

Lomustine is used to treat some cancers. It is given in particular to treat Hodgkin's disease when other treatments have not proved effective. It is also prescribed for some brain, lung and skin cancers. Lomustine can be given alongside other medicines or treatments for cancer.

In cancer, certain cells in the body grow and multiply too fast. Chemotherapy medicines like lomustine work by preventing the growth and division of cells. This reduces the number of cancer cells that your body makes.

Getting the most from your treatment

  • You must try to keep your regular appointments with your doctor or hospital. This is so your doctor can check on your progress. You will need to have regular blood tests and check-ups during your treatment with lomustine.
  • It is important that you do not get pregnant or father a child while you are taking lomustine. Make sure you have discussed with your doctor which types of contraception are suitable for you and your partner. You should continue to use contraception for six months after your treatment has finished. If you would like to have children in the future, you should ask your doctor for advice about family planning before you begin taking lomustine. This is particularly important if you are a man, as there is a risk of reduced male fertility or sterility with lomustine treatment.
  • While you are taking lomustine and for six months after you have stopped the treatment, do not have any immunisations (vaccinations) without talking to your specialist doctor first. Lomustine lowers your body's resistance and there is a risk that you will get an infection from some vaccines.

Can lomustine cause problems?

Medicines used to treat cancer can have a number of side-effects, some of which can be delayed for several days or weeks after taking the medicine. Most chemotherapy medicines can lower the number of white cells in your blood, which increases the risk of you getting an infection. The risk of this is commonly highest 4-6 weeks after taking lomustine. You should take precautions to reduce the risk of getting an infection - you can do this by avoiding being with people who you know have an infection. If you think you are getting a sore throat or if you have a high temperature, please let your doctor know as soon as possible so that you can get some treatment straightaway.

Your doctor will discuss with you the possibility of unwanted side-effects from your treatment with lomustine, although not everyone experiences these. The table below contains some of the side-effects associated with lomustine. You will find a full list in the manufacturer's information leaflet supplied with your medicine. Please let your doctor know if you experience any of the following:

Lomustine side-effectsWhat can I do if I experience this?
A high temperature, or symptoms of an infectionLet your doctor know about this straightaway
Feeling or being sick, loss of appetiteStick to simple foods. Let your doctor know about this, as an anti-sickness medicine may help
Mouth ulcers, sore mouthBrushing your teeth 2-3 times a day with a soft toothbrush and regularly using a mouth rinse may help to prevent this. If mouth ulcers become a problem, speak with your doctor
Feeling disorientated, confused or tired; loss of hair (occurs rarely)If troublesome, let your doctor know
Changes to some blood testsYour doctor will check for these

If you experience any other symptoms which you think may be due to the capsules, speak with your doctor or pharmacist for further advice.

Side effects

Hematologic Toxicity

The most frequent and most serious toxicity of CeeNU is delayed myelosuppression. It usually occurs 4 to 6 weeks after drug administration and is dose related. Thrombocytopenia occurs at about 4 weeks postadministration and persists for 1 to 2 weeks. Leukopenia occurs at 5 to 6 weeks after a dose of CeeNU and persists for 1 to 2 weeks. Approximately 65% of patients receiving 130 mg/m² develop white blood counts below 5000 wbc/mm³. Thirty-six percent developed white blood counts below 3000 wbc/mm³. Thrombocytopenia is generally more severe than leukopenia. However, both may be dose-limiting toxicities.

CeeNU may produce cumulative myelosuppression, manifested by more depressed indices or longer duration of suppression after repeated doses.

The occurrence of acute leukemia and bone marrow dysplasias have been reported in patients following long-term nitrosourea therapy.

Anemia also occurs, but is less frequent and less severe than thrombocytopenia or leukopenia.

Pulmonary Toxicity

Pulmonary toxicity characterized by pulmonary infiltrates and/or fibrosis has been reported rarely with CeeNU. Onset of toxicity has occurred after an interval of 6 months or longer from the start of therapy with cumulative doses of CeeNU usually greater than 1100 mg/m². There is 1 report of pulmonary toxicity at a cumulative dose of only 600 mg.

Delayed onset pulmonary fibrosis occurring up to 17 years after treatment has been reported in patients who received related nitrosoureas in childhood and early adolescence (1-16 years) combined with cranial radiotherapy for intracranial tumors. There appeared to be some late reduction of pulmonary function of all long-term survivors. This form of lung fibrosis may be slowly progressive and has resulted in death in some cases. In this long-term study of carmustine, all those initially treated at less than 5 years of age died of delayed pulmonary fibrosis.

Gastrointestinal Toxicity

Nausea and vomiting may occur 3 to 6 hours after an oral dose and usually last less than 24 hours. Prior administration of antiemetics is effective in diminishing and sometimes preventing this side effect. Nausea and vomiting can also be reduced if CeeNU is administered to fasting patients.

Hepatotoxicity

A reversible type of hepatic toxicity, manifested by increased transaminase, alkaline phosphatase, and bilirubin levels, has been reported in a small percentage of patients receiving CeeNU.

Nephrotoxicity

Renal abnormalities consisting of progressive azotemia, decrease in kidney size, and renal failure have been reported in patients who received large cumulative doses after prolonged therapy with CeeNU. Kidney damage has also been reported occasionally in patients receiving lower total doses.

Other Toxicities

Stomatitis, alopecia, optic atrophy, and visual disturbances, such as blindness, have been reported infrequently.

Neurological reactions, such as disorientation, lethargy, ataxia, and dysarthria have been noted in some patients receiving CeeNU. However, the relationship to medication in these patients is unclear.

Description

Gleostine (lomustine) is an alkylating drug for oral administration. The chemical name for lomustine is 1-(2chloro-ethyl)-3-cyclohexyl-1-nitrosourea and the molecular formula is C9H16ClN3O2. The molecular weight is 233.71. Lomustine is a yellow powder, which is soluble in 10% ethanol (0.05 mg per mL) and in absolute alcohol (70 mg per mL). Lomustine is insoluble in water ( < 0.05 mg per mL). The chemical structure is:

Gleostine is supplied as 5 mg, 10 mg, 40 mg, and 100 mg capsules and contains the following inactive ingredients: magnesium stearate NF and mannitol USP. The capsule shells are composed of gelatin and coloring pigments, depending on the strength: titanium dioxide, and/or yellow iron oxide, and/or Indigotine – FD&C Blue2.

Warnings

Included as part of the PRECAUTIONS section.

What is the most important information i should know about lomustine (ceenu)?

Do not use lomustine if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

You should not use this medication if you are allergic to lomustine.

Before taking lomustine, tell your doctor if you have bone marrow suppression, liver or kidney disease, or a history of lung or breathing problems.

Lomustine is usually taken once every 6 weeks. To get the correct dose, you may need to take 2 or more capsules that are different types and colors. Follow your doctor's dosing instructions very carefully.

Lomustine can cause nausea and vomiting or loss of appetite. Taking lomustine on an empty stomach may reduce nausea and vomiting. Call your doctor if you vomit right after taking a lomustine capsule.

To be sure this medication is not causing harmful effects, your blood will need to be tested weekly for at least 6 weeks after you take lomustine. Your kidneys, liver, and lung function may also need to be tested. Do not miss any follow-up visits to your doctor.

Wear disposable rubber gloves when you handle a lomustine capsule. Throw the gloves away after one use.

Do not use a lomustine capsule that has been accidentally opened or broken. The medicine from inside the capsule can be dangerous if it gets on your skin. If skin contact occurs, wash the area with soap and water.

What happens if i miss a dose (ceenu)?

Call your doctor if you forget to take your scheduled lomustine dose.

What should i avoid while taking lomustine (ceenu)?

Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while you are being treated with lomustine, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), oral polio, chickenpox (varicella), BCG (Bacillus Calmette and Guérin), and nasal flu vaccine.

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