Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Intravenous:
Cosmegen: 0.5 mg (1 ea)
Generic: 0.5 mg (1 ea)
Solution Reconstituted, Intravenous [preservative free]:
Generic: 0.5 mg (1 ea)
Pharmacology
Mechanism of Action
Dactinomycin binds to the guanine portion of DNA intercalating between guanine and cytosine base pairs inhibiting DNA and RNA synthesis and protein synthesis
Pharmacokinetics/Pharmacodynamics
Distribution
Children: Extensive extravascular distribution (59 to 714 L) (Veal 2005); does not penetrate blood-brain barrier
Metabolism
Minimally hepatic (Perry 2012)
Excretion
~30% in urine and feces within 1 week
Half-Life Elimination
30 to 40 hours (Perry 2012); Children: Range: 14 to 43 hours (Veal 2005)
Use: Labeled Indications
Ewing sarcoma: Treatment of Ewing sarcoma (as part of a multi-phase, combination chemotherapy regimen)
Gestational trophoblastic neoplasia: Treatment of gestational trophoblastic neoplasia in post-menarchal patients (as a single agent or as part of a combination chemotherapy regimen)
Rhabdomyosarcoma: Treatment of rhabdomyosarcoma (as part of a multi-phase, combination chemotherapy regimen)
Solid tumors: Palliative and/or adjunctive treatment of locally recurrent or locoregional solid malignancies (as a component of regional perfusion) in adult patients
Wilms tumor: Treatment of Wilms tumor (as part of a multi-phase, combination chemotherapy regimen)
Use: Off Label
Ovarian germ cell tumors (malignant)b
Data from two phase II studies supports the use of dactinomycin (in combination with vincristine and cyclophosphamide) for the treatment of malignant ovarian germ cell cancers Gershenson 1985, Slayton 1985.
Contraindications
There are no contraindications listed in the manufacturer's labeling.
Dosage and Administration
Dosing: Adult
Note: Dactinomycin may be prescribed in MICROgrams (eg, 150 mcg), although many regimens list the dose in MILLIgrams (eg, mg/kg or mg/m2). Reduce the dactinomycin dose by 50% during concomitant radiation. Dactinomycin is associated with a high emetic potential; antiemetics are recommended to prevent nausea and vomiting (Basch 2011). Calculate the dose for obese or edematous patients based on ideal body weight (manufacturer's labeling).
Ewing sarcoma: IV:
VAIA regimen: Adults ≤35 years: 500 mcg/m2/dose for 3 days (dactinomycin alternates with doxorubicin) every 3 weeks for 14 cycles (in combination with vincristine, ifosfamide, and mesna) (Paulussen 2008)
VAC/IE regimen: Adults ≤30 years: 1,250 mcg/m2 on day 1 of each odd-numbered 21-day cycle (dactinomycin is substituted for doxorubicin after a maximum doxorubicin dose is reached; in combination with vincristine, cyclophosphamide, and mesna; alternating with IE [ifosfamide, mesna, and etoposide] on even-numbered cycles); continue through cycle 17 (Grier 2003)
Manufacturer's labeling: 1,250 mcg/m2 once every 3 weeks for 51 weeks (as part of a combination chemotherapy regimen)
Gestational trophoblastic neoplasm: IV:
Nonmetastatic or metastatic low-risk disease: 1.25 mg/m2 every 2 weeks as a single agent; continue until human chorionic gonadotropin (hCG) level normalizes (Osborne 2011) or (manufacturer's labeling) 12 mcg/kg/day for 5 days (as a single agent)
Metastatic high-risk disease (off-label dosing):
EMA-CO regimen: 500 mcg/dose on days 1 and 2 every 2 weeks (in combination with etoposide, methotrexate, leucovorin, cyclophosphamide, and vincristine); continue for at least 2 treatment cycles after a normal hCG level (Escobar 2003; Lurain 2006)
EMA-EP regimen: 500 mcg/dose on days 1 and 2 every 2 weeks (in combination with etoposide, methotrexate, leucovorin, and cisplatin); continue for 2 to 4 treatment cycles after a normal hCG level (Ghaemmaghami 2004)
EP-EMA regimen: EMA: 500 mcg/dose on day 1 every 2 weeks (in combination with etoposide, methotrexate, and leucovorin); alternating weekly with EP (etoposide and cisplatin) (Newlands 2000)
Manufacturer's labeling: 500 mcg/dose on days 1 and 2 every 2 weeks for up to 8 weeks
Ovarian germ cell tumors, malignant (off-label use): IV: VAC regimen: 500 mcg daily for 5 days every 4 weeks (in combination with vincristine and cyclophosphamide) for ~1 year (Gershenson 1985) or 300 mcg/m2/day for 5 days every 4 weeks (in combination with vincristine and cyclophosphamide) for at least 10 cycles (Slayton 1985)
Regional perfusion in solid tumors (dosages and techniques may vary by institution; in combination with melphalan): Manufacturer's labeling: Lower extremity or pelvis: 50 mcg/kg once; upper extremity: 35 mcg/kg once
Regional limb perfusion: Soft tissue sarcoma (locally advanced/unresectable): Isolated limb infusion protocol: 50 to 100 mcg/L of tissue in 400 mL warmed, heparinized NS (in combination with melphalan) over 20 to 30 minutes (Moncrieff 2008).
Rhabdomyosarcoma: IV:
VAC regimen: Patients <50 years: 45 mcg/kg (maximum dose: 2,500 mcg) every 3 weeks; duration of therapy depends on risk status (in combination with vincristine and cyclophosphamide, and mesna); dose omission required following radiation therapy (Raney 2011)
VA regimen: Patients <50 years: 45 mcg/kg (maximum dose: 2,500 mcg) every 3 weeks for ~1 year (in combination with vincristine); dose omission required following radiation therapy (Raney 2011)
Manufacturer's labeling: Dosing in the prescribing information may not reflect current clinical practice; 15 mcg/kg/day for 5 days every 3 to 9 weeks for up to 112 weeks (as part of a combination chemotherapy regimen).
Wilms tumor: IV:
VAD regimen (preoperative induction): Patients <30 years: IV: 45 mcg/kg/dose (maximum: 2,300 mcg/dose) on day 1 of weeks 1, 4, 7, and 10 (in combination with vincristine and doxorubicin) (Ehrlich 2017).
DD-4A regimen (postoperative): Patients <30 years: 45 mcg/kg/dose (maximum dose: 2,300 mcg/dose) on day 1 of weeks 1, 7, 13, 19, and 25 (in combination with vincristine, doxorubicin, and radiation). Note: The first dose of dactinomycin administered following whole lung or whole abdomen irradiation should be decreased by 50% (Ehrlich 2017).
EE-4A regimen (pre- or postoperative): Patients <30 years: 45 mcg/kg/dose (maximum dose: 2,300 mcg/dose) on day 1 of weeks 1, 4, 7, 10, 13, 16, and 19 (in combination with vincristine) (Ehrlich 2017).
Manufacturer's labeling: 45 mcg/kg once every 3 to 6 weeks for up to 26 weeks (as part of a combination chemotherapy regimen)
Dosing: Geriatric
Refer to adult dosing.
Dosing: Pediatric
Note: Medication orders for dactinomycin are commonly written in MICROgrams (eg, mcg/kg, mcg/m2) although many regimens list the dose in MILLIgrams (eg, mg/kg or mg/m2); use extra precaution. The dose intensity per 2-week cycle for adults and children should not exceed 15 mcg/kg/day for 5 days or 400 to 600 mcg/m2/day for 5 days. The manufacturer recommends calculation of the dosage for obese or edematous adult patients on the basis of body surface area in an effort to relate dosage to lean body mass.
Ewing sarcoma: Children and Adolescents: VAIA regimen: Limited data available: IV: 500 mcg/m2/dose for 3 days (dactinomycin alternating with doxorubicin) every 3 weeks for 14 cycles (in combination with vincristine, ifosfamide, and mesna) (Paulussen 2008)
Kaposi sarcoma: Limited data available: Children and Adolescents: IV: 420 mcg/m2/day for 5 days every 4 weeks (in various combination regimens) (Olweny 1974)
Rhabdomyosarcoma: VAC regimen: Limited data available:
Infants: IV: 25 mcg/kg every 3 weeks, weeks 0 to 45 (in combination with vincristine and cyclophosphamide, and mesna); dose omission required following radiation therapy (Raney 2011)
Children and Adolescents: IV: 45 mcg/kg (maximum dose: 2,500 mcg/dose) every 3 weeks, weeks 0 to 45 (in combination with vincristine and cyclophosphamide, and mesna); dose omission required following radiation therapy (Raney 2011)
Wilms tumor: Note: Regimen selection based on multiple factors including the extent of disease at diagnosis, response to induction chemotherapy, and extent of surgical resection.
EE-4A regimen: Note: If the radiation field includes the whole lung or whole abdomen, reduce dose 50% during irradiation therapy
Infants: IV: 23 mcg/kg/dose (maximum dose: 2,300 mcg/dose) over 1 to 5 minutes on day 1 of weeks 1, 4, 7, 10, 13, 16, and 19 (in combination with vincristine) (Ehrlich 2017)
Children and Adolescents: IV: 45 mcg/kg/dose (maximum dose: 2,300 mcg/dose) over 1 to 5 minutes on day 1 of weeks 1, 4, 7, 10, 13, 16, and 19 (in combination with vincristine) (Ehrlich 2017)
VAD regimen: Limited data available:
Infants: IV: 23 mcg/kg/dose (maximum dose: 2,300 mcg/dose) over 1 to 5 minutes on day 1 of weeks 1, 4, 7, and 10 (in combination with vincristine and doxorubicin) (Ehrlich 2017)
Children and Adolescents: IV: 45 mcg/kg/dose (maximum dose: 2,300 mcg/dose) over 1 to 5 minutes on day 1 of weeks 1, 4, 7, and 10 (in combination with vincristine and doxorubicin) (Ehrlich 2017)
Dosing: Adjustment for Toxicity
Mucocutaneous reaction, severe: Permanently discontinue dactinomycin.
Myelosuppression, severe: Consider treatment delay or dose reduction in patients with prolonged myelosuppression based on the reaction severity and the disease being treated.
Sinusoidal obstruction syndrome (SOS, also known as veno-occlusive disease): If SOS develops, consider delaying the next dactinomycin dose. Resume, reduce dose, or permanently discontinue dactinomycin based on the reaction severity and the disease being treated.
Concurrent radiation therapy: May require dactinomycin dose reduction (50%) or dose omission; refer to specific protocol.
Dosing: Obesity
Calculate the dose for obese or edematous patients based on ideal body weight (manufacturer's labeling).
ASCO Guidelines for appropriate chemotherapy dosing in obese adults with cancer: Utilize patient's actual body weight (full weight) for calculation of body surface area- or weight-based dosing, particularly when the intent of therapy is curative; manage regimen-related toxicities in the same manner as for nonobese patients; if a dose reduction is utilized due to toxicity, consider resumption of full weight-based dosing with subsequent cycles, especially if cause of toxicity (eg, hepatic or renal impairment) is resolved (Griggs 2012).
Reconstitution
Reconstitute initially with 1.1 mL of preservative-free SWFI to yield a concentration of 500 mcg/mL. Further dilute in D5W or NS to a recommended concentration of >10 mcg/mL. Cellulose ester membrane filters should not be used during preparation or administration.
Administration
Dactinomycin is associated with a high emetic potential; antiemetics are recommended to prevent nausea and vomiting (Basch 2011).
IV: Infuse over 10 to 15 minutes; may also be administered as a slow IV push (off-label rate) in some protocols. Do not filter with cellulose ester membrane filters.
Regional perfusion: Technique may vary by institution; consult protocol for details. Local reactions including epidermolysis, erythema, and edema have been reported (may be severe).
Vesicant; ensure proper needle or catheter placement prior to and during infusion; avoid extravasation.
Extravasation management: If extravasation occurs, stop infusion immediately and disconnect (leave cannula/needle in place); gently aspirate extravasated solution (do NOT flush the line); remove needle/cannula; elevate extremity. Apply dry cold compresses for 20 minutes 4 times a day for 1 to 2 days (Pérez Fidalgo 2012).
Storage
Store intact vials at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). Protect from light and humidity. According to the manufacturer's labeling, recommended final concentrations (>10 mcg/mL) in D5W or NS should be stored for no more than 4 hours from reconstitution to completion of infusion (due to the lack of preservative).
Drug Interactions
Baricitinib: Immunosuppressants may enhance the immunosuppressive effect of Baricitinib. Management: Use of baricitinib in combination with potent immunosuppressants such as azathioprine or cyclosporine is not recommended. Concurrent use with antirheumatic doses of methotrexate or nonbiologic disease modifying antirheumatic drugs (DMARDs) is permitted. Consider therapy modification
BCG (Intravesical): Immunosuppressants may diminish the therapeutic effect of BCG (Intravesical). Avoid combination
BCG (Intravesical): Myelosuppressive Agents may diminish the therapeutic effect of BCG (Intravesical). Avoid combination
Chloramphenicol (Ophthalmic): May enhance the adverse/toxic effect of Myelosuppressive Agents. Monitor therapy
Cladribine: May enhance the immunosuppressive effect of Immunosuppressants. Avoid combination
Cladribine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Avoid combination
CloZAPine: Myelosuppressive Agents may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk for neutropenia may be increased. Monitor therapy
Coccidioides immitis Skin Test: Immunosuppressants may diminish the diagnostic effect of Coccidioides immitis Skin Test. Monitor therapy
Deferiprone: Myelosuppressive Agents may enhance the neutropenic effect of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Consider therapy modification
Denosumab: May enhance the adverse/toxic effect of Immunosuppressants. Specifically, the risk for serious infections may be increased. Monitor therapy
Dipyrone: May enhance the adverse/toxic effect of Myelosuppressive Agents. Specifically, the risk for agranulocytosis and pancytopenia may be increased Avoid combination
Echinacea: May diminish the therapeutic effect of Immunosuppressants. Consider therapy modification
Fingolimod: Immunosuppressants may enhance the immunosuppressive effect of Fingolimod. Management: Avoid the concomitant use of fingolimod and other immunosuppressants when possible. If combined, monitor patients closely for additive immunosuppressant effects (eg, infections). Consider therapy modification
Leflunomide: Immunosuppressants may enhance the adverse/toxic effect of Leflunomide. Specifically, the risk for hematologic toxicity such as pancytopenia, agranulocytosis, and/or thrombocytopenia may be increased. Management: Consider not using a leflunomide loading dose in patients receiving other immunosuppressants. Patients receiving both leflunomide and another immunosuppressant should be monitored for bone marrow suppression at least monthly. Consider therapy modification
Lenograstim: Antineoplastic Agents may diminish the therapeutic effect of Lenograstim. Management: Avoid the use of lenograstim 24 hours before until 24 hours after the completion of myelosuppressive cytotoxic chemotherapy. Consider therapy modification
Lipegfilgrastim: Antineoplastic Agents may diminish the therapeutic effect of Lipegfilgrastim. Management: Avoid concomitant use of lipegfilgrastim and myelosuppressive cytotoxic chemotherapy. Lipegfilgrastim should be administered at least 24 hours after the completion of myelosuppressive cytotoxic chemotherapy. Consider therapy modification
Mesalamine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Monitor therapy
Natalizumab: Immunosuppressants may enhance the adverse/toxic effect of Natalizumab. Specifically, the risk of concurrent infection may be increased. Avoid combination
Nivolumab: Immunosuppressants may diminish the therapeutic effect of Nivolumab. Consider therapy modification
Ocrelizumab: May enhance the immunosuppressive effect of Immunosuppressants. Monitor therapy
Palifermin: May enhance the adverse/toxic effect of Antineoplastic Agents. Specifically, the duration and severity of oral mucositis may be increased. Management: Do not administer palifermin within 24 hours before, during infusion of, or within 24 hours after administration of myelotoxic chemotherapy. Consider therapy modification
Pidotimod: Immunosuppressants may diminish the therapeutic effect of Pidotimod. Monitor therapy
Pimecrolimus: May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination
Promazine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Monitor therapy
Roflumilast: May enhance the immunosuppressive effect of Immunosuppressants. Consider therapy modification
Siponimod: Immunosuppressants may enhance the immunosuppressive effect of Siponimod. Monitor therapy
Sipuleucel-T: Immunosuppressants may diminish the therapeutic effect of Sipuleucel-T. Management: Evaluate patients to see if it is medically appropriate to reduce or discontinue therapy with immunosuppressants prior to initiating sipuleucel-T therapy. Consider therapy modification
Smallpox and Monkeypox Vaccine (Live): Immunosuppressants may diminish the therapeutic effect of Smallpox and Monkeypox Vaccine (Live). Monitor therapy
Tacrolimus (Topical): May enhance the adverse/toxic effect of Immunosuppressants. Avoid combination
Tertomotide: Immunosuppressants may diminish the therapeutic effect of Tertomotide. Monitor therapy
Tofacitinib: Immunosuppressants may enhance the immunosuppressive effect of Tofacitinib. Management: Concurrent use with antirheumatic doses of methotrexate or nonbiologic disease modifying antirheumatic drugs (DMARDs) is permitted, and this warning seems particularly focused on more potent immunosuppressants. Consider therapy modification
Trastuzumab: May enhance the neutropenic effect of Immunosuppressants. Monitor therapy
Upadacitinib: Immunosuppressants may enhance the immunosuppressive effect of Upadacitinib. Avoid combination
Vaccines (Inactivated): Immunosuppressants may diminish the therapeutic effect of Vaccines (Inactivated). Management: Vaccine efficacy may be reduced. Complete all age-appropriate vaccinations at least 2 weeks prior to starting an immunosuppressant. If vaccinated during immunosuppressant therapy, revaccinate at least 3 months after immunosuppressant discontinuation. Consider therapy modification
Vaccines (Live): Immunosuppressants may enhance the adverse/toxic effect of Vaccines (Live). Immunosuppressants may diminish the therapeutic effect of Vaccines (Live). Management: Avoid use of live organism vaccines with immunosuppressants; live-attenuated vaccines should not be given for at least 3 months after immunosuppressants. Exceptions: Smallpox and Monkeypox Vaccine (Live). Avoid combination
Adverse Reactions
Frequency not defined:
Cardiovascular: Thrombophlebitis
Central nervous system: Fatigue, malaise, peripheral neuropathy
Dermatologic: Acne vulgaris, alopecia, cheilitis, dermatitis, erythema multiforme, skin rash, Stevens-Johnson syndrome, toxic epidermal necrolysis
Endocrine & metabolic: Growth suppression, hypocalcemia
Gastrointestinal: Abdominal pain, anorexia, aphthous stomatitis, constipation, diarrhea, dysphagia, esophagitis, gastrointestinal ulcer, mucositis, nausea, proctitis, vomiting
Hematologic & oncologic: Anemia, bone marrow depression, disseminated intravascular coagulation, febrile neutropenia, hemorrhage, leukopenia, neutropenia (nadir: 14 to 21 days), pancytopenia, reticulocytopenia, second primary malignant neoplasm (including leukemia), thrombocytopenia, tumor lysis syndrome
Hepatic: Abnormal hepatic function tests, ascites, hepatic failure, hepatic sinusoidal obstruction syndrome, hepatitis, hepatomegaly, hepatotoxicity, severe hepatic disease (hepatopathy-thrombocytopenia syndrome, Farruggia 2011)
Hypersensitivity: Hypersensitivity reaction
Infection: Infection, sepsis
Neuromuscular & skeletal: Myalgia
Ophthalmic: Optic neuropathy
Renal: Renal function abnormality, renal failure syndrome, renal insufficiency
Respiratory: Pneumonitis, pneumothorax
Miscellaneous: Fever, radiation recall phenomenon
Warnings/Precautions
Concerns related to adverse effects:
- Bone marrow suppression: Severe and fatal myelosuppression (neutropenia, thrombocytopenia, and anemia) may occur. The neutrophil nadir typically occurs 14 to 21 days after administration. Obtain complete blood counts prior to each cycle; delay the next dactinomycin dose if severe myelosuppression has not improved. Based on the severity of myelosuppression and disease state being treated, consider dose reduction in patients with prolonged myelosuppression.
- Dermatologic toxicity: Severe mucocutaneous toxicity, such as Stevens-Johnson syndrome and toxic epidermal necrolysis, may occur. Permanently discontinue dactinomycin if a severe mucocutaneous reaction occurs.
- Extravasation: Dactinomycin is a vesicant (Pérez Fidalgo 2012); ensure proper needle or catheter placement prior to and during infusion. Avoid extravasation. Severe local tissue damage (blistering, ulcerations, and persistent pain) requiring wide excision surgery followed by split-thickness skin grafting may occur. Immediately interrupt the infusion if signs/symptoms of extravasation occur. Apply dry, cold compresses to the site of extravasation for 20 minutes, 4 times per day for 1 to 2 days (Pérez Fidalgo 2012). Monitor closely; plastic surgery consultation may be necessary if extravasation occurs.
- Gastrointestinal toxicity: Antiemetics are recommended to prevent nausea and vomiting; dactinomycin is associated with a high emetic potential in adults and a moderate or high emetic potential (depending on dose) in pediatrics (Basch 2011; Paw Cho Sing 2019).
- Hepatotoxicity: Dactinomycin may cause hepatotoxicity; monitor AST, ALT, alkaline phosphatase, and bilirubin prior to and during dactinomycin therapy. May also cause severe and fatal hepatic sinusoidal obstruction syndrome (SOS; formerly called veno-occlusive liver disease); risk factors include age <4 years or concomitant radiotherapy. Use with caution in hepatobiliary dysfunction. Monitor for signs or symptoms of hepatic SOS, including bilirubin >1.4 mg/dL, unexplained weight gain, ascites, hepatomegaly, or unexplained right upper quadrant pain (Arndt 2004). If SOS develops, consider delaying the next dactinomycin dose. May require therapy interruption, dose reduction, or permanent discontinuation (based on the severity of the reaction and disease being treated).
- Nephrotoxicity: Renal function abnormalities may occur with dactinomycin; monitor creatinine and electrolytes frequently during treatment.
- Secondary malignancies: The risk of secondary malignancies (including leukemia) is increased with dactinomycin.
Concurrent drug therapy issues:
- Drug-drug interactions: Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.
Special populations:
- Radiation therapy recipients: Dactinomycin potentiates the effects of radiation therapy; use with caution in patients who have received radiation therapy. Reduce the dactinomycin dose by 50% in patients who are receiving dactinomycin and concomitant radiation therapy. Combination with radiation therapy may result in increased toxicity (eg, GI toxicity, myelosuppression, or erythema and vesiculation of the skin or buccal and pharyngeal mucosa). Erythema from prior radiation therapy may be reactivated by dactinomycin. Radiation recall risk appears to be highest when administered within 2 months of prior radiation, although the risk can still occur with distant radiation exposure.
Other warnings/precautions:
- Dosage expression: Dosage is usually expressed in MICROgrams. Calculate the dose for obese or edematous patients based on ideal body weight.
- Vaccines: Avoid administration of live vaccines prior to and during dactinomycin treatment.
Monitoring Parameters
CBC prior to each treatment cycle, liver function tests (eg, AST, ALT, total bilirubin, alkaline phosphatase), renal function tests, and electrolytes; verify pregnancy status in females of reproductive potential prior to therapy initiation. Monitor for signs/symptoms of hepatic sinusoidal obstruction syndrome, including unexplained weight gain, ascites, hepatomegaly, or unexplained right upper quadrant pain (Arndt 2004). Monitor for signs/symptoms of secondary malignancy, extravasation, mucocutaneous reactions, and radiation recall.
Pregnancy
Pregnancy Considerations
Based on data from animal reproduction studies and its mechanism of action, dactinomycin may cause fetal harm if administered to a pregnant female.
Verify pregnancy status of females of reproductive potential prior to initiating dactinomycin therapy; effective contraception should be used during therapy and for at least 6 months after the last dactinomycin dose. When used for gestational trophoblastic neoplasm, unfavorable outcomes have been reported when subsequent pregnancies occur within 6 months of treatment. It is recommended to use effective contraception for 6 months to 1 year after therapy (Matsui 2004; Seckl 2013).
Males with female partners of reproductive potential should use effective contraception during therapy and for 3 months after the last dactinomycin dose.
Patient Education
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Patient may experience nausea, vomiting, or hair loss. Have patient report immediately to prescriber severe injection site redness, burning, pain, edema, or irritation, signs of infection, signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin), signs of kidney problems (unable to pass urine, blood in the urine, change in amount of urine passed, or weight gain), bruising, bleeding, severe loss of strength and energy, diarrhea, mouth irritation, mouth sores, difficulty swallowing, or signs of Stevens-Johnson syndrome/toxic epidermal necrolysis (red, swollen, blistered, or peeling skin [with or without fever]; red or irritated eyes; or sores in mouth, throat, nose, or eyes) (HCAHPS).
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.
