Dactinomycin Side Effects

Some side effects of dactinomycin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to dactinomycin: intravenous powder for injection

Get emergency medical help if you have any of these signs of an allergic reaction while taking dactinomycin: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• pain, swelling, burning, irritation, or skin changes where the injection was given;

• fever, chills, body aches, diarrhea, flu symptoms, sores in your mouth and throat;

• swelling or tenderness in your upper stomach, weight gain, dark urine, jaundice (yellowing of the skin or eyes);

• feeling short of breath, urinating less than usual or not at all;

• chest pain, dry cough, wheezing;

• pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating;

• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

• any wound that will not heal; or

• redness or your skin or the inside of your mouth and throat (if you are also receiving radiation treatment).

Common side effects may include:

• nausea, vomiting, stomach pain, loss of appetite;

• tired feeling, muscle pain;

• rectal pain or bleeding;

• numbness or tingly feeling around your mouth, fast or slow heart rate, muscle tightness or contraction, overactive reflexes;

• hair loss;

• dry or cracked skin, chapped lips; or

• acne, mild skin rash.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to dactinomycin: intravenous powder for injection

Gastrointestinal

Gastrointestinal side effects have been reported in 75% of patients and are usually mild to moderate in severity. Nausea and vomiting may present within hours of administration, may be dose-limiting, may be most intense two to four days after the end of a five-day course, typically require and respond to antiemetic therapy, and may persist for as long as a week after therapy is stopped. Intravenously administered ondansetron is compatible with dactinomycin for up to four hours. Other serious gastrointestinal problems include cheilitis (inflammation of the lip), dysphagia, esophagitis, ulcerative stomatitis, and pharyngitis. Anorexia, abdominal pain, diarrhea, proctitis and gastrointestinal ulceration have also been reported.

Radiation-recall enteritis has been reported after the use of dactinomycin and doxorubicin therapy.

Hepatic

Hepatic side effects have been serious, ranging from elevated liver function tests in approximately 17% of patients to rare cases of hepatitis, hepatomegaly, ascites, hepatic failure, hepatic veno-occlusive disease which may be associated with intravascular clotting disorder and multi-organ failure, and death. Dactinomycin-induced hepatotoxicity may be more likely in the presence of x-radiation therapy to an hepatic port (not uncommon during treatment of right-sided Wilms' tumors) or after higher single doses. There appears to be a causal relationship between dactinomycin and the development of veno-occlusive disease of the liver.

X-radiation therapy (XRT) to the liver apparently produces a vascular lesion affecting primarily the small hepatic veins leading to vascular obstruction and hyperemia. The contribution of dactinomycin towards the development of veno-occlusive disease of the liver is unknown. Some experts have suggested a two-month interval between XRT to the liver and dactinomycin therapy.

A rare case of portal hypertension that necessitated mesocaval shunting because of life-threatening esophageal variceal hemorrhaging has been associated with the use of dactinomycin and x-radiation therapy in a girl who had been treated for a right-sided Wilms' tumor.

Hematologic

Myelosuppression can be dose-limiting or life-threatening.

Experts recommend DAILY complete blood cell counts to detect severe hematopoietic depression and withholding therapy if any cell line becomes markedly depressed. Bone marrow recovery typically takes three weeks.

Elderly patients may be associated with an increased risk of myelosuppression compared to younger patients.

Hematologic side effects have presented as myelosuppression in approximately 20% to 50% of patients. Leukopenia and thrombocytopenia have typically been observed at one to two weeks after doses are started, but nadirs can be delayed until three weeks. Anemia, even aplastic anemia, agranulocytosis, pancytopenia, reticulopenia, neutropenia, febrile neutropenia,
and rare cases of immune thrombocytopenia have also been reported.

Dermatologic

Dermatologic side effects have been common, and included alopecia, skin eruptions (including bullous pemphigoid and folliculitis), acne, and exacerbations of erythema or increased pigmentation associated with previous disease or x-radiation therapy. Alopecia has typically developed within one to four weeks, and resolved within two to three months.

Dactinomycin-induced RNA damage precludes growing cells (in vitro) from repairing sublethal radiation damage. The pathogenesis of "radiation recall" is otherwise poorly understood. Theories include primary cytologic damage to neurons, glia and myelin; an allergic reactive phenomenon; and damage to neural tissue secondary to vascular injury. Factors related to the intensity of "radiation recall" appear to include individual patient variation, the total dose of radiation administered, and the intensity of the radiation. Incidentally, patients who experience radiation recall are more likely to also experience gastrointestinal and bone marrow toxicity.

Some severe cases of acne associated with the use of dactinomycin have also been associated with elevated levels of androgenous serum hormones.

Local

Local side effects have included IV site extravasation which should be rigorously avoided as dactinomycin is extremely toxic and corrosive. Extravascular infiltrates should be aspirated and treated locally with hydrocortisone and/or sodium thiosulfate. Extravasation has resulted in severe soft tissue damage, including necrosis and contracture of extremities.

General

General side effects including malaise, fatigue, lethargy, muscle aches, and fever have been reported.

Metabolic

Metabolic side effects have been associated with overdoses of dactinomycin, including hyponatremia, hypokalemia, hypocalcemia, and hypomagnesemia. Excessive urinary magnesium loss has been documented in such rare cases. Hypocalcemia may be observed after usual therapeutic doses.

Musculoskeletal

Musculoskeletal side effects have generally been limited to myalgias. The pediatric literature describes radiographic findings of transverse lines of long bones associated with the use of dactinomycin.

Hypersensitivity

Hypersensitivity side effects, including frank anaphylaxis reactions, have been reported, but have been rare.

Endocrine

Endocrinologic side effects have been rare. Gynecomastia without elevated serum beta-HCG levels has been associated with dactinomycin therapy in males with testicular cancer. Thymic enlargement has rarely been associated with the use of dactinomycin (with later generation computerized axial tomograms [CT scans] the thymus is demonstrable in all patients less than 30 years old).

Cardiovascular

Cardiovascular side effects have been rare. A single case of portal hypertension has been reported. Rare cases of pericarditis have been associated with the use of dactinomycin in combination with other antineoplastic agents, such as cyclophosphamide, vinblastine, bleomycin, and cisplatin.

Oncologic

Oncologic side effects have consisted of animal data which have reported that dactinomycin is a carcinogen. In vivo animal data have revealed sarcomas and mesenchymal tumors after regular subcutaneous or intraperitoneal injections. In vitro and in vivo human data have shown dactinomycin to be mutagenic in a number of test systems, including human fibroblasts, leukocytes and HELA cells.

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