Proleukin (aldesleukin)

The frequency and severity of adverse effects of aldesleukin generally are dose related. Administration of doses in excess of the recommended dose has been associated with a more rapid onset of anticipated dose-limiting toxicities. Adverse effects of aldesleukin that persist following discontinuance of the drug should be monitored and managed with supportive treatment. Life-threatening toxicities of aldesleukin may be ameliorated by IV administration of dexamethasone, which also may reduce the therapeutic effect of aldesleukin.

Dosage of aldesleukin should be adjusted carefully according to patient tolerance and response. Potency of aldesleukin usually is expressed in international units (IU); because other units also have been reported (e.g., Cetus Units (CU), Roche Units (RU), Biologic Response Modifiers Program Units (BRMPU)) and are not equivalent (e.g., 1 RU = 3 IU, 1 CU = 6 IU), care should be exercised in interpreting published dosages and concentrations. In the dosage section, international units are stated as units rather than as IU in order to minimize medication errors that could have resulted from misinterpretation of written orders employing IU.

When a vial labeled as containing 22 million units of the drug is reconstituted by adding 1.2 mL of sterile water for injection, each mL contains 18 million units of aldesleukin, which is equivalent to 1.1 mg of the drug.

Toxicities requiring dosage modification should involve withholding or interrupting a dose rather than reducing the individual dose to be given. Most adverse effects are self-limiting and usually reversible after discontinuance of aldesleukin, but adverse effects that persist should be managed with supportive treatment. While glucocorticoids (e.g., IV dexamethasone) have been shown to ameliorate adverse effects of aldesleukin, including fever, renal insufficiency, hyperbilirubinemia, confusion, and dyspnea, concomitant use may reduce the therapeutic effect of aldesleukin and should be avoided except under life-threatening circumstances.

No dosing information is available for this tab.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

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.

Although there are no adequate and controlled studies to date in humans, aldesleukin has been shown to have embryolethal effects in rats when given in doses 27 to 36 times the usual human dose. Significant maternal toxicity was observed in pregnant rats receiving aldesleukin by IV injection during a critical period of organogenesis at doses 2.1 to 36 times higher than the usual human dose; no evidence of teratogenicity was observed other than that attributed to maternal toxicity. Aldesleukin should be used during pregnancy only when the potential benefits justify the possible risks to the fetus.

It is not known whether aldesleukin is distributed into human milk. Because of the potential for serious adverse effects in nursing infants if the drug were distributed into milk, a decision should be make whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.

No enhanced messaging available.