"Sabahaddin Akman, owner of the Istanbul, Turkey, firm Ozay Pharmaceuticals, has pleaded guilty to charges of smuggling misbranded and adulterated cancer treatment drugs into the United States.
Akman pleaded guilty in the U.S. District Court"...
Cosmegen® for Injection
(dactinomycin) for Injection (Actinomycin D)
COSMEGEN® (dactinomycin for injection) should be administered only under the supervision of a physician who is experienced in the use of cancer chemotherapeutic agents.
This drug is HIGHLY TOXIC and both powder and solution must be handled and administered with care. Inhalation of dust or vapors and contact with skin or mucous membranes, especially those of the eyes, must be avoided. Avoid exposure during pregnancy. Due to the toxic properties of dactinomycin (e.g., corrosivity, carcinogenicity, mutagenicity, teratogenicity), special handling procedures should be reviewed prior to handling and followed diligently. Dactinomycin is extremely corrosive to soft tissue. If extravasation occurs during intravenous use, severe damage to soft tissues will occur. In at least one instance, this has led to contracture of the arms.
Dactinomycin is one of the actinomycins, a group of antibiotics produced by various species of Streptomyces. Dactinomycin is the principal component of the mixture of actinomycins produced by Streptomyces parvullus. Unlike other species of Streptomyces, this organism yields an essentially pure substance that contains only traces of similar compounds differing in the amino acid content of the peptide side chains. The empirical formula is C62H86N12O16 and the structural formula is:
COSMEGEN is a sterile, yellow to orange lyophilized powder for injection by the intravenous route or by regional perfusion after reconstitution. Each vial contains 0.5 mg (500 mcg) of dactinomycin and 20.0 mg of mannitol.
What are the possible side effects of dactinomycin (Cosmegen)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- pain, swelling, burning, irritation, or skin changes where the injection was given;
- fever, chills, body aches, diarrhea, flu symptoms, sores in your mouth and throat;
- swelling or tenderness in your upper stomach, weight gain, dark urine, jaundice (yellowing of the skin or eyes);
- feeling short of breath, urinating less...
What are the precautions when taking dactinomycin for injection (Cosmegen)?
Before using dactinomycin, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: current infection with chickenpox or herpes zoster (shingles).
Tell your doctor your medical history, especially of: certain virus illnesses (herpes, chickenpox), liver problems, kidney problems, blood disorders (e.g., anemia, clotting problems), previous chemotherapy/radiation treatment.
Do not have immunizations/vaccinations without the consent of your...
Last reviewed on RxList: 9/18/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Cosmegen Information
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