Ceenu Side Effects

Generic Name: lomustine

Please note - some side effects for Ceenu may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Ceenu - for the Consumer

CeeNU

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using CeeNU:

Loss of appetite; nausea; occasional hair loss; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blindness; chest pain; chills; confusion or disorientation; decreased amount of urine; dry cough; fever; shortness of breath; sore throat; sores on your mouth or lips; swelling of feet or lower legs; trouble speaking; trouble walking or keeping your balance; unusual bleeding or bruising; unusual fatigue or weakness; vision changes; yellowing of skin or eyes.

Ceenu Side Effects - for the Professional

CeeNU

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.

Side Effects by Body System

Hematologic

In one study of 17 patients receiving an average of 12 weekly 30 mg/m2 dosages, 6 patients (35%) developed thrombocytopenia and 3 patients (18%) developed neutropenia.

Hematologic side effects including myelosuppression have been reported. Delayed myelosuppression is the most frequent and serious toxicity associated with lomustine therapy. This effect most frequently occurs from 4 to 6 weeks after drug administration and is dose related. Thrombocytopenia occurs approximately 4 weeks after drug administration and persists for about 1 to 2 weeks. Leukopenia generally occurs approximately 5 to 6 weeks after drug administration and also lasts for about 1 to 2 weeks. In patients receiving dosages of 130 mg/m2, approximately 65% develop white blood counts below 5000 wbc/mm3, and 36% develop counts below 3,000 wbc/mm3. Thrombocytopenia is generally more severe than leukopenia. Both may be dose limiting.

Cumulative myelosuppression, manifested by more depressed indices or longer duration of suppression after repeated doses, have been reported. Acute leukemia and bone marrow dysplasias have been reported in patients following long term nitrourea therapy.

Anemia has been reported less frequently and is also cumulative.

Respiratory

The onset of respiratory toxicity has been reported to occur 6 months or longer from the start of therapy. Cumulative doses are usually greater than 1100 mg/m2. The drug should be discontinued after a cumulative dose of 1400 mg.

There is one case report of a fatality due to pulmonary toxicity at a cumulative dose of 600 mg. Delayed onset pulmonary fibrosis occurring up to 15 years after treatment has been reported in patients who received nitrosoureas in childhood and early adolescence combined with cranial radiotherapy for intercranial tumors.

Respiratory side effects including pulmonary infiltrates and/or fibrosis have been reported rarely.

Gastrointestinal

Gastrointestinal side effects including nausea and vomiting may occur 2 to 6 hours after an oral dose is ingested. This effect usually lasts less than 24 hours. Anorexia for 2 to 3 days duration has also been reported. Stomatitis has been reported infrequently. Mucositis has been reported rarely.

Prior administration of antiemetics is effective in decreasing and sometimes preventing nausea and vomiting. This side effect can also be reduced if the patient fasts prior to dosage administration. Due to rapid absorption, vomiting one to two hours after lomustine administration will not interfere with the effectiveness of lomustine.

Hepatic

Hepatic side effects including a reversible hepatic toxicity, manifested by increased transaminase, alkaline phosphatase and bilirubin levels, have been reported in a small percentage of patients.

Renal

Four case reports of nephrotoxicity involved cumulative doses of 3320 mg, 2300 mg, 3360 mg and 3530 mg. In animal testing, lomustine caused fatal chronic interstitial nephritis in monkeys.

Renal side effects including progressive azotemia, decrease in kidney size, and renal failure have been reported in patients who have received large cumulative doses after prolonged therapy. Renal damage has also occasionally been reported in patients receiving lower total dosages.

Nervous system

Nervous system side effects including disorientation, lethargy, ataxia and dysarthria have been reported rarely.

The relationship of the nervous system side effects to lomustine therapy is unclear.

Dermatologic

Dermatologic side effects including alopecia have been reported infrequently.

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