Aldesleukin

IL-2 Interleukin-2 precursor T-cell growth factor (TCGF)

Interactions

Active ingredient Aldesleukin interacts in the following cases:

Glucocorticoids may decrease the activity of aldesleukin

Concomitantly administered glucocorticoids may decrease the activity of aldesleukin and therefore should be avoided. However, patients who develop life-threatening signs or symptoms may be treated with dexamethasone until toxicity resolves to an acceptable level. 2

Beta-blockers may potentiate the hypotension seen with aldesleukin

Antihypertensive agents, such as beta-blockers, may potentiate the hypotension seen with aldesleukin and therefore blood pressure should be monitored. 2

Beta-blockers

Antihypertensive agents, such as beta-blockers, may potentiate the hypotension seen with aldesleukin and therefore blood pressure should be monitored.

Aldesleukin may alter patient response to psychotropic medicinal products

Aldesleukin may affect central nervous function. Therefore, interactions could occur following concomitant administration of centrally acting medicinal products. Aldesleukin may alter patient response to psychotropic medicinal products and therefore patients should be monitored. 2

Psychotropic medicinal products

Aldesleukin may affect central nervous function. Therefore, interactions could occur following concomitant administration of centrally acting medicinal products. Aldesleukin may alter patient response to psychotropic medicinal products and therefore patients should be monitored.

Contrast media after aldesleukin administration may recall the toxicity observed during aldesleukin administration

Use of contrast media after aldesleukin administration may result in a recall of the toxicity observed during aldesleukin administration. Most events were reported to occur within 2 weeks after the last dose of aldesleukin, but some occurred months later. Therefore it is recommended not to use contrast media within 2 weeks after treatment with aldesleukin. 2

Dacarbazine, cis-platinum, tamoxifen, interferon-alpha

Hypersensitivity reactions have been reported in patients receiving combination regimens containing sequential high dose aldesleukin and antineoplastic agents, specifically, dacarbazine, cis-platinum, tamoxifen and interferon-alpha. These reactions consisted of erythema, pruritus, and hypotension and occurred within hours of administration of chemotherapy. These events required medical intervention in some patients.

Concomitant administration of aldesleukin and interferon-alpha can cause myocardial damage

Severe rhabdomyolysis and myocardial injury, including myocardial infarction, myocarditis and ventricular hypokinesia appear to be increased in patients receiving aldesleukin (intravenously) and interferon-alpha concurrently.

There has also been exacerbation or the initial presentation of a number of autoimmune and inflammatory disorders observed following concurrent use of interferon-alpha and aldesleukin, including crescentic immunoglobulin A (IgA) glomerulonephritis, oculo-bulbar myasthenia gravis, inflammatory arthritis, thyroiditis, bullous pemphigoid, and Stevens-Johnson syndrome. It is recommended that patients with pre-existing auto-immune disease should not be treated with aldesleukin.

Pregnancy

There are no adequate data on the use of aldesleukin in pregnant women.

Experimental animal studies are insufficient to assess the safety with respect to reproduction, development of the embryo or foetus, the course of gestation and peri- and postnatal development. Aldesleukin has been shown to have embryolethal and maternal toxic effects in rats.

The potential risk for humans is unknown.

Aldesleukin should not be used during pregnancy unless the potential benefit to the patient justifies the potential risk to the foetus.

Nursing Mothers

It is not known whether this drug is excreted in human milk.

Because the potential for serious adverse reactions in nursing infants is unknown, mothers should not breast feed their infants during treatment.

Carcinogenesis, Mutagenesis and Fertility

Women of child-bearing potential and contraception in males and females

Both sexually active men and women should use effective methods of contraception during treatment.

Effects on Ability to Drive and Use Machines

Aldesleukin may affect central nervous system function. Hallucination, somnolence, syncope, convulsions may occur during treatment with aldesleukin and may affect the patient’s ability to drive and operate machines.

Patients should not drive or operate machines until they have recovered from the adverse drug reactions.