• Wilms tumor (in combination with other chemotherapy drugs).
• Rhabdomyosarcoma (in combination with other chemotherapy drugs).
• Ewing sarcoma (in combination with other chemotherapy drugs).
• Metastatic nonseminomatous testicular cancer (in combination with other chemotherapy drugs).
• Gestational trophoblastic neoplasia (as monotherapy or in combination with other chemotherapy drugs).
• As a component of regional perfusion for treatment of locally recurrent and locoregional solid malignancies.

Contraindicated in:

• Hypersensitivity
• Patients with concurrent or recent chickenpox or herpes zoster infection
• OB: Pregnancy (may cause fetal harm)
• Lactation: Lactation

Use Cautiously in:

• Active infections
• Immunosuppressed patients
• Concurrent radiation therapy (↑ risk of veno-occlusive disease)
• Hepatic impairment
• Rep: Women of reproductive potential and men with female partners of reproductive potential
• Pedi: Children <4 yr (↑ risk of hepatic veno-occlusive disease).

Derm: acne, alopecia, erythema (especially of previously irradiated skin), hyperpigmentation (especially of previously irradiated skin), skin eruptions, photosensitivity, rash.

EENT: pharyngitis.

F and E: hypocalcemia.

GI: HEPATIC VENO-OCCLUSIVE DISEASE, anorexia, nausea, stomatitis, vomiting, abdominal pain, ascites, diarrhea, dysphagia, esophagitis, hepatotoxicity, ulceration.

Hemat: anemia, leukopenia, thrombocytopenia, febrile neutropenia, neutropenia.

Local: phlebitis at IV site, tissue injury (due to extravasation).

MS: myalgia.

Neuro: lethargy, malaise.

Resp: pneumonitis.

Misc: fever.

Drug-Drug:

• ↑bone marrow depression with other antineoplastics or radiation therapy.
• May ↓ antibody response to live-virus vaccines and ↑ risk of adverse reactions (avoid concurrent use).

(Generic available)

• Powder for injection: 500 mcg/vial;

Wilms Tumor

• IV (Adults and Children): 45 mcg/kg every 3–6 wk for up to 26 wk.

Rhabdomyosarcoma

• IV (Adults and Children): 15 mcg/kg once daily for 5 days every 3–9 wk for up to 112 wk.

Ewing Sarcoma

• IV (Adults): 1250 mcg/m² every 3 wk for 51 wk.

Metastatic Nonseminomatous Testicular Cancer

• IV (Adults): 1000 mcg/m² every 3 wk for 12 wk.

Gestational Trophoblastic Neoplasms

• IV (Adults): Nonmetastatic or low-risk metastatic disease (as monotherapy) — 12 mcg/kg once daily for 5 days; High-risk metastatic disease (in combination with other chemotherapy drugs) — 500 mcg once daily on Days 1 and 2 given every 2 wk for a total of 8 wk.

Regional Perfusion in Locally Recurrent Solid Malignancies

• Regional perfusion (Adults): Lower extremity/pelvis (in combination with melphalan) — 50 mcg/kg as single dose; Upper extremity (in combination with melphalan) — 35 mcg/kg as single dose.

Cosmegen

• Inhibits RNA synthesis by forming a complex with DNA (cell-cycle phase–nonspecific).

• Death of rapidly replicating cells, particularly malignant ones.
• Also has immunosuppressive properties.

Therapeutic Classification: antineoplastics

Pharmacologic Classification: antitumor antibiotics

Absorption: IV administration results in complete bioavailability.

Distribution: Widely distributed, with extensive tissue binding; does not cross the blood-brain barrier. Crosses the placenta.

Metabolism/Excretion: Excreted in bile (50%) and feces (14%) as unchanged drug; small amounts excreted unchanged by the kidneys (10%).

Half-life: 36 hr.

(effects on blood counts)

• Explain purpose of dactinomycin to patient and family.
• Instruct patient to notify health care professional if fever; chills; sore throat; signs of infection; bleeding gums; bruising; petechiae; or blood in urine, stool, or emesis occurs. Caution patient to avoid crowds and persons with known infections. Instruct patient to use soft toothbrush and electric razor. Caution patient not to drink alcoholic beverages or take products containing aspirin or NSAIDs; may increase GI irritation.
• Instruct patient to inspect oral mucosa for erythema and ulceration. Notify health care professional for new skin lesions, mouth sores or oropharyngeal lesions. If ulceration occurs, advise patient to use sponge brush and rinse mouth with water after eating and drinking. Stomatitis may require treatment with opioid analgesics.
• Discuss with patient the possibility of hair loss, which usually occurs 7–10 days after administration. Explore coping strategies.
• Instruct patient not to receive any vaccinations without advice of health care professional.
• Rep: May be teratogenic. Advise females of reproductive potential to use effective contraception during and for at least 6 mo after last dose and to avoid breastfeeding during and for 14 days after final dose. Advise males with female partners of reproductive potential to use effective contraception during and for 3 mo after last dose.
• Emphasize the need for periodic lab tests to monitor for side effects.

dak-ti-noe-MYE-sin

NDC Code^*

• 39822- X-GEN Pharmaceuticals, Inc.
  • 39822-2100- dactinomycin
    • 39822-2100-2- 1 VIAL, SINGLE-DOSE in 1 CARTON (39822-2100-2) > 1 mL in 1 VIAL, SINGLE-DOSE (39822-2100-1)

• 55292- RECORDATI RARE DISEASES, INC.
  • 55292-811- Cosmegen
    • 55292-811-55- 12 VIAL, SINGLE-DOSE in 1 CARTON (55292-811-55) > 1 mL in 1 VIAL, SINGLE-DOSE

• 66993- Prasco Laboratories
  • 66993-489- Dactinomycin
    • 66993-489-35- 12 CARTON in 1 CARTON (66993-489-35) > 1 VIAL, SINGLE-DOSE in 1 CARTON (66993-489-83) > 1 mL in 1 VIAL, SINGLE-DOSE

• 67457- Mylan Institutional LLC
  • 67457-513- Dactinomycin
    • 67457-513-05- 1 VIAL, SINGLE-DOSE in 1 CARTON (67457-513-05) > 1 mL in 1 VIAL, SINGLE-DOSE

• 67457- Mylan Institutional LLC
  • 67457-513- Dactinomycin
    • 67457-513-99- 12 VIAL, SINGLE-DOSE in 1 CARTON (67457-513-99) > 1 mL in 1 VIAL, SINGLE-DOSE

• 67457- Mylan Institutional LLC
  • 67457-928- Dactinomycin
    • 67457-928-02- 1 VIAL, SINGLE-DOSE in 1 CARTON (67457-928-02) > 1 mL in 1 VIAL, SINGLE-DOSE