Dactinomycin

Dactinomycin is a chemotherapy drug approved to treat several cancers across both adults and children. Here is the full list of supported uses:

• Wilms tumor — in adults and children, as part of a multi-drug chemotherapy regimen
• Rhabdomyosarcoma (a soft-tissue cancer) — in adults and children, as part of a multi-drug chemotherapy regimen
• Ewing sarcoma (a bone and soft-tissue cancer) — in adults and children, as part of a multi-drug chemotherapy regimen
• Metastatic nonseminomatous testicular cancer — in adults and children, as part of a multi-drug chemotherapy regimen
• Gestational trophoblastic neoplasia (a tumor arising from pregnancy tissue) — in post-menarchal patients, as a single agent or combined with other drugs
• Locally recurrent or locoregional solid malignancies — in adult patients only, as a component of palliative or adjunctive regional perfusion; safety and effectiveness have not been established for this use in pediatric patients

Dactinomycin is a cytotoxic (cell-killing) drug that works by inserting itself directly into the DNA strand inside cancer cells. Once bound, it blocks an enzyme called RNA polymerase from reading the DNA — essentially jamming the cell's ability to make RNA and, in turn, the proteins it needs to survive and divide. Without this ability, cancer cells stop growing and die.

Dactinomycin is always given as an intravenous (IV) infusion — directly into a vein — in a clinical or hospital setting by trained healthcare professionals. It is never taken by mouth. Dosing schedules vary significantly depending on the condition being treated: some regimens involve daily infusions over five days, others are given once every two to six weeks, and some use a single-dose regional perfusion technique.

• Infusions are given over 10 to 15 minutes
• There are no food restrictions associated with the IV infusion itself
• Your oncology team will determine your specific schedule and adjust it based on how your body responds
• Never adjust or skip doses on your own — always contact your care team first

Like all chemotherapy drugs, dactinomycin can cause a range of side effects. Common ones include:

Serious reactions — including severe liver disease, dangerous infections due to low white blood cell counts, severe skin blistering (Stevens-Johnson syndrome or toxic epidermal necrolysis), kidney damage, and tissue injury from IV leakage — require prompt medical attention. Contact your care team immediately if any of these occur.

• Bone marrow suppression: Dactinomycin significantly lowers blood cell counts, increasing risk of infection, bleeding, and anemia. Blood counts are checked before every cycle, and treatment may be delayed if counts are too low.
• Hepatic veno-occlusive disease (VOD): This serious — sometimes fatal — blockage of blood flow through the liver can occur. Children under 4 and patients also receiving radiation are at highest risk. Watch for yellowing of the skin or eyes, rapid weight gain, abdominal swelling, or liver tenderness.
• Extravasation (IV leakage): If dactinomycin leaks out of the vein, it can cause severe blistering, ulcers, and tissue damage that may require surgery. Report any pain or swelling at the infusion site immediately.
• Severe skin reactions: Stevens-Johnson syndrome and toxic epidermal necrolysis (TEN) — serious conditions where skin blisters and peels — have been reported. Treatment must be stopped permanently if these occur.
• Secondary cancers: There is an increased long-term risk of developing a second cancer, including leukemia, after treatment with dactinomycin.
• Radiation interactions: Dactinomycin intensifies radiation side effects and can trigger radiation recall — a flare-up in previously irradiated areas — especially if given within two months of radiation therapy.
• Embryo-fetal toxicity: Dactinomycin can cause serious birth defects. Effective contraception is required during treatment and for a period afterward for both men and women.

Dactinomycin has important interactions that your oncology team will manage, but it's good to be aware of them:

• Radiation therapy (concurrent): Dactinomycin amplifies radiation's toxic effects on the gut, skin, and bone marrow — the dose is reduced by 50% when both are given together
• Prior radiation therapy: Receiving dactinomycin within two months of previous radiation can cause radiation recall — a painful inflammatory reaction in the previously treated area
• Live vaccines (e.g., MMR, varicella, yellow fever): Not recommended during or before treatment — the immune system is suppressed and a live vaccine could cause serious infection
• P-glycoprotein and OATP1B3 transporter substrates: Lab studies suggest dactinomycin may interact with drugs that use these same transport pathways in the body — your care team will review your full medication list

Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.

• Pregnancy: Dactinomycin can cause serious fetal malformations. A pregnancy test is required before starting treatment. Tell your doctor immediately if you become pregnant during therapy.
• Breastfeeding: Do not breastfeed during treatment or for at least 14 days after the final dose, due to potential serious harm to the infant.
• Contraception — females: Use effective birth control during treatment and for at least 6 months after the last dose.
• Contraception — males: Men with partners who could become pregnant must use effective contraception during treatment and for 3 months after the last dose.
• Young children (under 4): Children in this age group face a higher risk of hepatic veno-occlusive disease (VOD) and require especially close monitoring.
• Prior radiation: Let your team know about any past radiation therapy — the timing and location matter for safe dosing.
• Older adults (65+): There is not enough data to confirm whether older patients respond differently; discuss individual risks with your oncologist.
• Kidney or liver concerns: Dactinomycin can affect both kidney and liver function; these will be monitored closely throughout treatment.

The precise relationship between dactinomycin blood levels and its effects in the body — and exactly how quickly those effects develop — are not fully understood from current data.

After IV administration, dactinomycin concentrates in cells that have a nucleus (including cancer cells) but does not cross into the brain or spinal fluid. It is eliminated through both urine and feces — about 30% of a dose is recovered within one week. In children and adolescents, the drug tends to be cleared from the body more quickly in those with higher body weight. Lab studies suggest dactinomycin may use specific protein transporters (P-glycoprotein and OATP1B3) to move in and out of cells, which could affect how it interacts with other medications.

Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F). Protect from light and humidity. Store the reconstituted Dactinomycin for Injection, USP at room temperature for no more than 4 hours from reconstitution to completion of administration .