Version May 2024
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 of age: 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 neoplasia: 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 of age: 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 of age: 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 of age: 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 of age: 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).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling; however, based on the amount of urinary excretion, dosage adjustments may not be necessary (Kintzel 1995).
There are no dosage adjustments provided in manufacturer's labeling.
The following adjustments have also been recommended: Any transaminase increase: Reduce dose by 50%; may increase by monitoring toxicities (Floyd 2006).
ASCO Guidelines for appropriate chemotherapy dosing in adults with cancer with a BMI ≥30 kg/m2 : Utilize patient's actual body weight for calculation of BSA- or weight-based dosing; manage regimen-related toxicities in the same manner as for patients with a BMI <30 kg/m2; if a dose reduction is utilized due to toxicity, may consider resumption of full, weight-based dosing (or previously tolerated dose level) with subsequent cycles only if dose escalations are allowed in the prescribing information, if contributing underlying factors (eg, hepatic or kidney impairment) are sufficiently resolved, AND if performance status has markedly improved or is considered adequate (ASCO [Griggs 2021]). Note: The manufacturer's labeling recommends using ideal body weight to calculate the dose for patients with obesity or who are edematous.
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.
Refer to adult dosing.
(For additional information see "Dactinomycin: Pediatric drug information")
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. Antiemetics are recommended to prevent nausea and vomiting; dactinomycin is associated with a moderate or high emetic potential (depending on dose) in pediatrics (POGO [Paw Cho Sing 2019]).
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)
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling; however, based on the amount of urinary excretion, dosage adjustments may not be necessary.
There are no dosage adjustments provided in the manufacturer's labeling; however, the following adjustments have been recommended: Children and Adolescents: Any transaminase increase: Consider dose reduction by 50%; may increase by monitoring toxicities (Floyd 2006).
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
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
There are no contraindications listed in the manufacturer's labeling.
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.
• 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.
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.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Solution Reconstituted, Intravenous:
Cosmegen: 0.5 mg (1 ea [DSC])
Generic: 0.5 mg (1 ea)
Solution Reconstituted, Intravenous [preservative free]:
Generic: 0.5 mg (1 ea)
Yes
Solution (reconstituted) (Cosmegen Intravenous)
0.5 mg (per each): $3,250.25
Solution (reconstituted) (DACTINomycin Intravenous)
0.5 mg (per each): $921.88 - $1,822.59
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Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution Reconstituted, Intravenous:
Cosmegen: 0.5 mg (1 ea)
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 (ESMO/EONS [Pérez Fidalgo 2012]).
Parenteral: May administer undiluted into the side-port of a free flowing IV infusion by slow IVP over a few minutes; or may further dilute and administer as IV infusion over 10 to 15 minutes; consider a D5W or NS flush before and after a dactinomycin dose to ensure venous patency. Cellulose ester membrane filters may partially remove dactinomycin from solution and should not be used during administration. Avoid extravasation; do not give IM or SubQ.
Antiemetics are recommended to prevent nausea and vomiting; dactinomycin is associated with a moderate or high emetic potential (depending on dose) in pediatrics (POGO [Paw Cho Sing 2019]).
Vesicant; ensure proper needle or catheter placement prior to and during infusion; avoid extravasation. 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).
Hazardous agent (NIOSH 2016 [group 1]).
Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2016; USP-NF 2020).
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)
Ovarian germ cell tumors (malignant)
DACTINomycin may be confused with dacarbazine, Dacogen, DAPTOmycin, DAUNOrubicin
Actinomycin may be confused with achromycin
This medication is in a class the Institute for Safe Medication Practices (ISMP) includes among its list of drug classes which have a heightened risk of causing significant patient harm when used in error.
Substrate of OATP1B1/1B3 (SLCO1B1/1B3), P-glycoprotein/ABCB1 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
5-Aminosalicylic Acid Derivatives: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy
Abrocitinib: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination
Antithymocyte Globulin (Equine): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of cytotoxic chemotherapy is reduced. Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor therapy
Baricitinib: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Baricitinib. Risk X: Avoid combination
BCG (Intravesical): Myelosuppressive Agents may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination
BCG Products: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination
Brincidofovir: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Brincidofovir. Risk C: Monitor therapy
Brivudine: May enhance the adverse/toxic effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination
Chikungunya Vaccine (Live): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Chikungunya Vaccine (Live). Risk X: Avoid combination
Chloramphenicol (Ophthalmic): May enhance the adverse/toxic effect of Myelosuppressive Agents. Risk C: Monitor therapy
Chloramphenicol (Systemic): Myelosuppressive Agents may enhance the myelosuppressive effect of Chloramphenicol (Systemic). Risk X: Avoid combination
Cladribine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk X: Avoid combination
Cladribine: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Cladribine. Risk X: Avoid combination
CloZAPine: Myelosuppressive Agents may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor therapy
Coccidioides immitis Skin Test: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the diagnostic effect of Coccidioides immitis Skin Test. Management: Consider discontinuing cytotoxic chemotherapy several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider therapy modification
COVID-19 Vaccine (Adenovirus Vector): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of COVID-19 Vaccine (Adenovirus Vector). Management: Administer a 2nd dose using an mRNA COVID-19 vaccine (at least 4 weeks after the primary vaccine dose) and a bivalent booster dose (at least 2 months after the additional mRNA dose or any other boosters). Risk D: Consider therapy modification
COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor therapy
COVID-19 Vaccine (mRNA): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider therapy modification
COVID-19 Vaccine (Subunit): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of COVID-19 Vaccine (Subunit). Risk C: Monitor therapy
COVID-19 Vaccine (Virus-like Particles): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of COVID-19 Vaccine (Virus-like Particles). Risk C: 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. Risk D: Consider therapy modification
Dengue Tetravalent Vaccine (Live): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Dengue Tetravalent Vaccine (Live). Risk X: Avoid combination
Denosumab: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and cytotoxic chemotherapy. If combined, monitor patients for signs/symptoms of serious infections. Risk D: Consider therapy modification
Deucravacitinib: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination
Dipyrone: May enhance the adverse/toxic effect of Myelosuppressive Agents. Specifically, the risk for agranulocytosis and pancytopenia may be increased Risk X: Avoid combination
Etrasimod: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination
Fexinidazole: Myelosuppressive Agents may enhance the myelosuppressive effect of Fexinidazole. Risk X: Avoid combination
Filgotinib: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination
Inebilizumab: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Inebilizumab. Risk C: Monitor therapy
Influenza Virus Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating chemotherapy if possible. If vaccination occurs less than 2 weeks prior to or during chemotherapy, revaccinate at least 3 months after therapy discontinued if immune competence restored. Risk D: Consider therapy modification
Leflunomide: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents, such as cytotoxic chemotherapy. Risk D: 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. Risk D: 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. Risk D: Consider therapy modification
Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination
Nadofaragene Firadenovec: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid combination
Natalizumab: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Natalizumab. Risk X: Avoid combination
Ocrelizumab: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Ocrelizumab. Risk C: Monitor therapy
Ofatumumab: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Ofatumumab. Risk C: Monitor therapy
Olaparib: Myelosuppressive Agents may enhance the myelosuppressive effect of Olaparib. Risk C: 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. Risk D: Consider therapy modification
Pidotimod: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Pidotimod. Risk C: Monitor therapy
Pimecrolimus: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination
Pneumococcal Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Pneumococcal Vaccines. Risk C: Monitor therapy
Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Risk X: Avoid combination
Polymethylmethacrylate: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the potential for allergic or hypersensitivity reactions to Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider therapy modification
Promazine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy
Rabies Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider therapy modification
Ritlecitinib: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Ritlecitinib. Risk X: Avoid combination
Ropeginterferon Alfa-2b: Myelosuppressive Agents may enhance the myelosuppressive effect of Ropeginterferon Alfa-2b. Management: Avoid coadministration of ropeginterferon alfa-2b and other myelosuppressive agents. If this combination cannot be avoided, monitor patients for excessive myelosuppressive effects. Risk D: Consider therapy modification
Ruxolitinib (Topical): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Ruxolitinib (Topical). Risk X: Avoid combination
Sipuleucel-T: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants, such as cytotoxic chemotherapy, prior to initiating sipuleucel-T therapy. Risk D: Consider therapy modification
Sphingosine 1-Phosphate (S1P) Receptor Modulator: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk C: Monitor therapy
Tacrolimus (Topical): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Tacrolimus (Topical). Risk X: Avoid combination
Talimogene Laherparepvec: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid combination
Tertomotide: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Tertomotide. Risk X: Avoid combination
Tofacitinib: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Tofacitinib. Risk X: Avoid combination
Typhoid Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Typhoid Vaccine. Risk X: Avoid combination
Ublituximab: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Ublituximab. Risk C: Monitor therapy
Upadacitinib: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Upadacitinib. Risk X: Avoid combination
Vaccines (Inactivated/Non-Replicating): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of chemotherapy when possible. Patients vaccinated less than 14 days before initiating or during chemotherapy should be revaccinated at least 3 months after therapy is complete. Risk D: Consider therapy modification
Vaccines (Live): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Vaccines (Live) may diminish the therapeutic effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination
Yellow Fever Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Yellow Fever Vaccine. Risk X: Avoid combination
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.
Based on data from animal reproduction studies and its mechanism of action, dactinomycin may cause fetal harm if administered to a pregnant female.
When used for gestational trophoblastic neoplasm, unfavorable outcomes have been reported when subsequent pregnancies occur within 6 months of treatment (Matsui 2004; Seckl 2013).
It is not known if dactinomycin is present in breast milk. Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended by the manufacturer during therapy and (based on limited data) for 14 days after the last dactinomycin dose.
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.
The American Society of Clinical Oncology hepatitis B virus (HBV) screening and management provisional clinical opinion (ASCO [Hwang 2020]) recommends HBV screening with hepatitis B surface antigen, hepatitis B core antibody, total Ig or IgG, and antibody to hepatitis B surface antigen prior to beginning (or at the beginning of) systemic anticancer therapy; do not delay treatment for screening/results. Detection of chronic or past HBV infection requires a risk assessment to determine antiviral prophylaxis requirements, monitoring, and follow-up.
Dactinomycin binds to the guanine portion of DNA intercalating between guanine and cytosine base pairs inhibiting DNA and RNA synthesis and protein synthesis
Distribution: Children: Extensive extravascular distribution (59 to 714 L) (Veal 2005); does not penetrate blood-brain barrier
Metabolism: Minimally hepatic (Perry 2012)
Half-life elimination: 30 to 40 hours (Perry 2012); Children: Range: 14 to 43 hours (Veal 2005)
Excretion: ~30% in urine and feces within 1 week
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