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dactinomycin (Rx)Brand and Other Names:Cosmegen

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

powder for injection

  • 500mcg/vial
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Wilms Tumor/Ewing Sarcoma

15 mcg/kg IV qDay for 5 days 

Locally Recurrent/Locoregional Solid Malignancies (Regional Perfusion Therapy)

Dosing schedule & technique varies

Pelvis/lower extremity: 50 mcg/kg IV 

Upper extremity: 35 mcg/kg IV

May need to reduce dose in obese patients or patients who received chemotherapy/radiation therapy

Trophoblastic Neoplasms

12 mcg/kg IV for 5 days 

Repeat course after 2 weeks

Testicular Cancer (Metastatic Nonseminomatous)

1000 mcg/m² IV on day 1 in combo with cyclophosphamide, bleomycin, vinblastine, & cisplatin 

Ewing Sarcoma (Orphan)

Orphan desigantion of ANA-conjugated dactunomycin nanoemulsion for treatment of Ewing sarcoma

Sponsor

  • NanoSmart Pharmaceuticals, Inc; 27071 Cabot Road, Suite 104; Laguna Hills, CA 92653

Administration

Not to exceed15 mcg/kg/day or 400-600 mcg/m²/day for 5 days per 2-week cycle

Dosage Forms & Strengths

powder for injection

  • 500mcg/vial
more...

Ewing Sarcoma

< 6 years: Safety and efficacy not established

≥6 years: 15 mcg/kg IV qDay for 5 days in various chemotherapy combinations and schedules 

Rhabdomyosarcoma

< 1 year: 25 mcg/kg IV q3weeks; weeks 0-45 in combination with vincristine, cyclophosphamide, and mesna; omit dose following radiation  

≥1 year: 45 mcg/kg IV q3weeks; weeks 0-45 in combination with vincristine, cyclophosphamide, and mesna; omit dose following radiation

Wilms Tumor

15 mcg/kg/day IV for 5 days; repeat q3-6 weeks if necessary; not to exceed 15 mcg/kg/day IV for 5 days per 2-week cycle  

DD-4A regimen: 45 mcg/kg on day 1 q6weeks for 54 weeks (in combination with vincristine and doxorubicin)

EE-4A regimen: 45 mcg/kg on day 2 q3weeks for 18 weeks (in combination with vincristine)

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Interactions

Interaction Checker

dactinomycin and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            Frequency Not Defined

            Fatigue

            Fever

            Diarrhea

            Malaise

            Chills

            Nausea

            Vomiting

            Stomatitis

            Mucositis

            Hypocalcemia

            Hyperpigmentation of previously radiated areas

            Acne

            Alopecia

            Erythema

            Rash

            Fertility impairment

            Aplastic anemia

            Febrile neutropenia

            Neutropenia

            Pancytopenia

            Thrombocytopenia

            Hepatotoxicity

            Liver failure

            Veno-occlusive disease of the liver

            Anaphylaxis

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            Warnings

            Black Box Warnings

            The drug should be administered under the supervision of an experienced cancer chemotherapy physician

            If extravasation occurs, it may cause severe soft tissue damage. Contracture of the arms has occurred (rare).

            Avoid inhalation of vapors or contact with skin mucous membrane or eyes

            Handle and dispose agent using appropriate precautions

            Avoid exposure during pregnancy

            Contraindications

            Hypersensitivity

            Active chickenpox or herpes zoster

            Cautions

            Vesicant

            Caution in hepatic/renal impairment, elderly

            May cause hepatic sinusoidal obstruction syndrome

            Toxic effects may take 1-2 weeks to reach maximum severity following treatment; discontinue treatment if severe diarrhea, myelosuppression, or stomatitis occur

            Avoid pregnancy

            Avoid use within 2 weeks of radiation treatment for right-sided tumor (may increase risk of hepatotoxicity)

            Avoid use of concomitant live virus vaccines

            Use in myelosuppressive patients not recommended

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            Pregnancy & Lactation

            Pregnancy Category: D

            Lactation: not known if excreted in breast milk, do not nurse

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Actinomycin antibiotic; intercalates into DNA base pairs preventing RNA , DNA, and protein synthesis

            Pharmacokinetics

            Half-Life: 36 hr (adults); 14-43 hr (children)

            Protein Bound: 5%

            Vd: 59-714 L (extensive extravascular distribution)

            Metabolism: Minimal hepatic

            Excretion: Urine (30%), feces

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            Administration

            IV Incompatibilities

            Y-site: filgrastim

            IV Compatibilities

            Solution: D5W, NS

            Y-site: allopurinol, amifostine, aztreonam, cefepime, etoposide PO4, fludarabine, gemcitabine, granisetron, melphalan, ondansetron, sargramostim, teniposide, thiotepa, vinorelbine

            IV Preparation

            Reconstitute with 1.1 mL of preservative-free SWI to yield a final concentration of 500 mcg/mL

            Do not use preservative diluent as precipitation may occur

            Solution is chemically stable or 24 hr at room temp

            Significant binding of drug occurs with micrometer nitrocellulose filter materials

            Standard dilution

            • IV push: dose/syringe (500 mcg/mL)
            • IVPB: dose/50 mL D5W or NS

            IV Administration

            Vesicant

            Infuse over 10-15 min

            Do not use in-line cellulose membrane filter

            Do not give IM or SC

            Extravasation Management

            Apply ice immediately for 30-60 min

            Then alternate off/on q15min for 1 day

            Storage

            Store intact vials at room temp

            Protect from light

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            Images

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            Formulary

            FormularyPatient Discounts

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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