Brand and Other Names:Cosmegen
- Classes: Antineoplastics, Antibiotic
Dosing & Uses
Dosage Forms & Strengths
powder for injection
Locally Recurrent/Locoregional Solid Malignancies (Regional Perfusion Therapy)
Dosing schedule & technique varies
Upper extremity: 35 mcg/kg IV
May need to reduce dose in obese patients or patients who received chemotherapy/radiation therapy
Testicular Cancer (Metastatic Nonseminomatous)
Ewing Sarcoma (Orphan)
Orphan desigantion of ANA-conjugated dactunomycin nanoemulsion for treatment of Ewing sarcoma
- NanoSmart Pharmaceuticals, Inc; 27071 Cabot Road, Suite 104; Laguna Hills, CA 92653
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
< 6 years: Safety and efficacy not established
≥1 year: 45 mcg/kg IV q3weeks; weeks 0-45 in combination with vincristine, cyclophosphamide, and mesna; omit dose following radiation
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)
Serious - Use Alternative
Significant - Monitor Closely
Frequency Not Defined
Hyperpigmentation of previously radiated areas
Veno-occlusive disease of the liver
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
Active chickenpox or herpes zoster
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 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
Pregnancy & Lactation
Pregnancy Category: D
Lactation: not known if excreted in breast milk, do not nurse
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.
Mechanism of Action
Actinomycin antibiotic; intercalates into DNA base pairs preventing RNA , DNA, and protein synthesis
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
Solution: D5W, NS
Y-site: allopurinol, amifostine, aztreonam, cefepime, etoposide PO4, fludarabine, gemcitabine, granisetron, melphalan, ondansetron, sargramostim, teniposide, thiotepa, vinorelbine
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
- IV push: dose/syringe (500 mcg/mL)
- IVPB: dose/50 mL D5W or NS
Infuse over 10-15 min
Do not use in-line cellulose membrane filter
Do not give IM or SC
Apply ice immediately for 30-60 min
Then alternate off/on q15min for 1 day
Store intact vials at room temp
Protect from light
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.
|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.|
Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
Select a box to add or remove a plan.
Select a class to view formulary status for similar drugs