Mitoxantrone (mitoxantrone HCl)

Dosage of mitoxantrone hydrochloride is expressed in terms of the base.

Prior to each course of mitoxantrone therapy, a complete blood cell count, including platelets, and liver function tests should be performed.

The effect of renal and/or hepatic impairment on the disposition of mitoxantrone has not been fully determined.

Renal excretion of mitoxantrone is limited, accounting for only up to approximately 10% of the total clearance of the drug. Therefore, reduction of mitoxantrone dosage in patients with impaired renal function does not appear to be necessary.

Mitoxantrone appears to be eliminated principally by the hepatobiliary system, and the manufacturer states that the safety of the drug in patients with hepatic insufficiency is not established. The clearance of mitoxantrone is reduced in patients with severe hepatic impairment (i.e., serum total bilirubin concentration exceeding 3.4 mg/dL). Decreased clearance of mitoxantrone also may occur in patients with abnormalities of the third space (e.g., edema, ascites, pleural effusion) because of the extensive tissue penetration and protein-binding of the drug. Patients with cancer who have hepatic impairment should be treated with caution, and reduction of mitoxantrone dosage may be required. Patients with multiple sclerosis who have hepatic impairment generally should not be treated with mitoxantrone.

No dosing information is available for this tab.

No dosing information is available for this tab.

No dosing information is available for this tab.

Formal drug interaction studies have not been performed to date. There have been no reports of marked drug interactions in patients receiving mitoxantrone for cancer. Limited information is available on drug interactions in patients receiving mitoxantrone for multiple sclerosis.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

There is no enhanced messaging for this drug.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

There is no enhanced messaging for this drug.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

No enhanced messaging available.

Mitoxantrone can cause fetal toxicity when administered to pregnant women, but potential benefits may be acceptable in certain conditions despite the possible risks to the fetus.

Mitoxantrone is considered a potential human teratogen because of its mechanism of action and the adverse developmental effects observed with similar agents. Fetal growth retardation was observed in reproduction studies of rats receiving mitoxantrone doses of 0.1 mg/kg daily (0.01 times the recommended human dose on a mg/m2 basis) or greater during the organogenesis period of gestation. An increased incidence of premature delivery was observed in reproduction studies of rabbits receiving mitoxantrone doses of 0.1 mg/kg daily (0.01 times the recommended human dose on a mg/m2 basis) or greater during the organogenesis period of gestation. No teratogenic effects were observed in these animal studies, but the maximum doses administered were well below the recommended human dose for mitoxantrone.

There are no adequate and well-controlled studies to date using mitoxantrone in pregnant women. Women with multiple sclerosis who are capable of becoming pregnant should receive a pregnancy test prior to each dose of mitoxantrone and the results of the test should be known before the drug is administered. Mitoxantrone should be used during pregnancy only in life-threatening situations or for severe disease for which safer drugs cannot be used or are ineffective. When mitoxantrone is used during pregnancy or if the patient becomes pregnant while receiving the drug, the patient should be informed of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant during therapy with mitoxantrone.

Mitoxantrone is distributed into milk. Because of the potential for serious adverse reactions from mitoxantrone in nursing infants, breast feeding should be discontinued before initiation of therapy with the drug.

No enhanced messaging available.