Lomustine capsules

Some medicines are not suitable for people with certain conditions, and sometimes a medicine may only be used if extra care is taken. For these reasons, before you start taking lomustine it is important that your doctor knows:

• If you are pregnant or breast-feeding.
• If you have any problems with the way your kidneys work.
• If you have an infection or feel unwell.
• If you have coeliac disease or wheat allergy.
• If you have a rare inherited blood condition called porphyria.
• If you have ever had an allergic reaction to a medicine.
• If you are taking any other medicines. This includes any medicines you are taking which are available to buy without a prescription, such as herbal and complementary medicines.

• Before you start this treatment, read any printed information you have been given by your doctor and the printed manufacturer's leaflet from inside your pack of capsules. These will give you more information about lomustine and will provide you with a full list of the side-effects which you may experience from taking it.
• Lomustine will be prescribed for you by a specialist doctor who is experienced in treating your condition. Your doctor will calculate what dose is right for you and will tell you how many capsules to take. You will also be told on which day you should take them - it is important that you take lomustine exactly as your doctor tells you to. It is usually taken on just one day every 6-8 weeks (occasionally the dose can be split over three days instead). Your dose will be printed on the label of the pack to remind you about what the doctor said to you but if you are unsure about how to take the capsules, or if you have any other concerns, you should contact your doctor or hospital clinic for advice.
• If you are sick shortly after taking a dose, please speak with your doctor or clinic for advice on what to do.

Accidental overdose with lomustine has been reported, including fatal cases. Accidental overdose has been associated with bone marrow suppression, abdominal pain, diarrhea, vomiting, anorexia, lethargy, dizziness, abnormal hepatic function, cough, and shortness of breath.

No proven antidotes have been established for CeeNU overdosage. In case of overdose, appropriate supportive measures should be taken.

Although it is generally agreed that CeeNU alkylates DNA and RNA, it is not cross resistant with other alkylators. As with other nitrosoureas, it may also inhibit several key enzymatic processes by carbamoylation of amino acids in proteins.

CeeNU may be given orally. Following oral administration of radioactive CeeNU at doses ranging from 30 mg/m² to 100 mg/m², about half of the radioactivity given was excreted in the urine in the form of degradation products within 24 hours.

The serum half-life of the metabolites ranges from 16 hours to 2 days. Tissue levels are comparable to plasma levels at 15 minutes after intravenous administration.

Because of the high lipid solubility and the relative lack of ionization at physiological pH, CeeNU crosses the blood-brain barrier quite effectively. Levels of radioactivity in the CSF are 50% or greater than those measured concurrently in plasma.

Brain Tumors

Gleostine is indicated for the treatment of patients with primary and metastatic brain tumors following appropriate surgical and/or radiotherapeutic procedures.

Hodgkin's Lymphoma

Gleostine is indicated as a component of combination chemotherapy for the treatment of patients with Hodgkin's lymphoma whose disease has progressed following initial chemotherapy.

Dosage Forms And Strengths

Gleostine capsules are available in four strengths, distinguishable by the color of the capsules:

• 100 mg capsules (green/green)
• 40 mg capsules (white/green)
• 10 mg capsules (white/white)
• 5 mg capsules (yellow/yellow)

Gleostine is available in four strengths, distinguishable by the color of the capsules, in individual bottles of 5 capsules each:

Storage And Handling

Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Avoid temperatures over 40°C (104°F).

Gleostine is a cytotoxic drug. Follow applicable special handling and disposal procedures.1

To minimize the risk of dermal exposure, always wear impervious gloves when handling bottles containing Gleostine capsules. Do not break Gleostine capsules; avoid exposure to broken capsules. If dermal contact occurs, wash areas of skin contact immediately and thoroughly.

REFERENCES

OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html.

Manufactured by Corden Pharma Latina S.p.A., Sermoneta (LT), Italy for: NextSource Biotechnology, LLC Miami, FL 33155 USA. Revised: Jan 2016

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

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

• bone marrow suppression;
• liver disease;
• kidney disease; or
• a history of lung or breathing problems.

FDA pregnancy category D. 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.

It is not known whether lomustine passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

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.

Read the entire FDA prescribing information for Ceenu (Lomustine Capsules)

• Brain Tumor (Symptoms, Signs, Types, Causes, Survival Rates)
• Cancer
• Hodgkin's Disease