Cosmegen

Cosmegen is a prescription medication that is used in various types of cancer chemotherapy. Cosmegen belongs to a group of antibiotics called actinomycins. It is thought to work by binding to the DNA of cancer cells and inhibiting RNA synthesis, causing the cancer cells to die.  

This medication comes in liquid form and is infused into a vein (IV) by a healthcare provider at a hospital or other medical facility. How often you will receive Cosmegen depends upon the condition being treated.

Common side effects include hair loss, hives, and difficulty breathing. Cosmegen may lower blood cells involved in fight infection; therefore, you should avoid people with known infections.

Cosmegen is a prescription antibiotic that is only used in cancer chemotherapy. It is used alone, or in combination with other medications, surgery, and/or radiation therapy to treat various types of cancer including:

• Wilm's tumor (kidney cancer usually occurring in children)
• rhabdomyosarcoma (cancer of the connective tissues and muscle) in children
• testicular cancer
• Ewing's sarcoma (cancer in bones or soft tissues)
• gestational trophoblastic tumors (tumor that forms inside a woman's uterus while pregnant)
• solid tumors

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Ovation Pharmaceuticals, Inc.

• Recordati Rare Diseases, Inc.

Some Cosmegen side effects can be serious. Tell your doctor right away or seek emergency medical attention if you experience any of these side effects:

• hives
• difficult breathing
• swelling of your face, lips, tongue, or throat
• pain, swelling, burning, irritation, or skin changes where the injections 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, yellowing of the skin or eyes
• shortness of breath, need to urinate less

Less serious side effects may include:

• nausea
• vomiting
• stomach pain
• diarrhea
• hair loss

This is not a complete list of Cosmegen side effects. Ask your doctor or pharmacist for more information.

No Cosmegen drug interactions have been identified, however, you should tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Not all drug interactions are known or reported and new drug interactions are continually being reported.

Do not receive Cosmegen if you are allergic to it, or if you have recently had chickenpox or herpes zoster (shingles).

"Live" vaccines should be avoided while using Cosmegen. Talk to your doctor if you are planning to be vaccinated.

This medication may increase your risk of developing other types of cancer, including leukemia. Talk to your doctor about the risks of receiving Cosmegen.

Cosmegen is given by injection into a vein. If it leaks into surrounding tissue it can cause severe irritation or damage. The area where the medicine is injected will be monitored by your healthcare provider for this reaction. Symptoms to watch for include: pain, itching, redness, swelling, blisters, or sores in the area of the injection.

This medication may lower blood cells that are involved in fighting infection, therefore, you should avoid people with known infections. Tell your doctor if you develop signs of infection including: fever, chills and body aches.

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Cosmegen there are no specific foods that you must exclude from your diet.

Before receiving Cosmegen, tell your doctor about all of your medical conditions including if you:

• are allergic to Cosmegen or any other medicines
• have kidney or liver problems
• have blood disorders
• have previously, or are currently being treated with other cancer medicines or radiation therapy
• have recently had chickenpox or herpes zoster (shingles)
• are pregnant or breastfeeding

Talk to your doctor if you plan to receive vaccinations.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category D. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Cosmegen is excreted in human breast milk or if it will harm your nursing baby.

Cosmegen comes as a liquid to be infused into a vein (IV) by a healthcare provider in a hospital or other medical facility. In some cases, the medication must be injected directly into a specific part of the body or the organ where the tumor is located.

The length of treatment depends on a number of factors including:

• the type of cancer being treated
• other medications you are receiving
• your body's response to treatment
• side effects

Cosmegen treatment may be delayed or stopped if certain side effects occur.

The Cosmegen dose your doctor recommends will be determined by the type of cancer you have, your height and weight, other medicines and treatments you are receiving, as well as other factors.

Cosmegen is usually administered by a healthcare provider in a medical setting making it unlikely for an overdose to occur. However, if overdose is suspected, seek emergency medical attention.

• Store at 20-25°C (68-77°F).
• Protect from light and humidity.
• Keep this and all medications out of the reach of children.

WARNING

Cosmegen 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 Cosmegen (e.g., corrosivity, carcinogenicity, mutagenicity, teratogenicity), special handling procedures should be reviewed prior to handling and followed diligently. Cosmegen 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.