Patient Medication Information: uses, side effects, how to take - Cosmegen
Serious warnings and precautions box
COSMEGEN should only be given under the care of a doctor who is experienced in the use of cancer drugs.
COSMEGEN is highly toxic. Taking COSMEGEN may cause the following serious side effects:
- a decrease in the production of blood cells
- severe skin damage, including redness and blistering. This can be life-threatening.
What COSMEGEN is used for:
COSMEGEN is used in adults:
alone or as part of a combination cancer therapy to treat:
- gestational trophoblastic neoplasia
as part of a combination cancer therapy to treat:
- Wilms’ tumor
- Childhood rhabdomyosarcoma
- Ewing’s sarcoma
How COSMEGEN works:
COSMEGEN is a chemotherapy drug often used in combinations with other drugs to kill cancer cells. It works by preventing the reproduction of cells, especially abnormal cells which are associated with some types of cancer. This action can affect normal cells as well.
The ingredients in COSMEGEN are:
Medicinal ingredient: Dactinomycin
Non-medicinal Ingredients: Mannitol
COSMEGEN comes in the following dosage forms:
Powder for solution: 0.5 mg/vial
Do not use COSMEGEN if:
- you are allergic to dactinomycin or to any ingredient in COSMEGEN or component of the container.
- you have the chickenpox or herpes zoster (shingles) because of the risk of severe generalized disease which may result in death.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take COSMEGEN. Talk about any health conditions or problems you may have, including if you:
- receive live vaccines
- have radiation therapy
- plan to have surgery
Other warnings you should know about:
Second cancers: Taking cancer medications such as COSMEGEN may result in developing a second cancer, including leukemia.
Fertility: It is not known whether COSMEGEN can cause infertility. A decrease in fertility has been reported with other cancer medications.
Female patients:
Pregnancy and birth control:
- Speak to your healthcare professional if you are pregnant, plan on becoming pregnant, or become pregnant while taking COSMEGEN.
If you are able to get pregnant:
- Taking COSMEGEN may harm your unborn baby.
- Use effective birth control while taking COSMEGEN. Continue to use birth control for at least seven months after your last dose. Speak to your healthcare professional about birth control that is right for you.
- Breastfeeding: It is not known if COSMEGEN passes into breast milk. You should stop breast-feeding once you start treatment with COSMEGEN. Speak to your healthcare professional about what options are available.
Male patients: Use effective birth control while taking COSMEGEN if you have a female partner who can become pregnant. Continue to use birth control for four months after your last dose. Speak to your healthcare professional about birth control that is right for you.
Driving and using machines: COSMEGEN may cause side effects that impact your ability to drive and use machinery. Before you do tasks which may require special attention, wait until you know how you respond to COSMEGEN.
Monitoring and tests: Your healthcare professional will monitor your kidney, liver and blood cell count frequently by completing blood tests.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with COSMEGEN:
- Halogenated inhalation anesthetics (e.g. enflurane, halothane).
- Live vaccines
- radiation therapy
How to take COSMEGEN:
- You will be given COSMEGEN by a healthcare professional in a healthcare setting. The duration of your treatment will be determined by your healthcare professional.
- COSMEGEN is administered through a vein in your body (“intravenously”).
Usual dose:
Your dose of COSMEGEN will be determined by your healthcare professional. It will depend on:
- your weight
- your condition
- your response to COSEMEGEN
- if you experience any side effects
- if you are having other treatments at the same time
Overdose:
If you are given too large a dose of COSMEGEN, you could develop the following serious problems:
- sores in the mouth and gastrointestinal tract
- a serious bacterial infection in the bloodstream or body tissues (sepsis, including neutropenic sepsis) which can lead to death
- critically low blood counts
- blockage of veins in the liver
- kidney failure
- death
If you think that you or a person you are caring for have taken too much COSMEGEN, contact your healthcare professional, hospital emergency department, regional poison control centre or Health Canada's toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms.
Possible side effects from using COSMEGEN:
These are not all the possible side effects you may have when taking COSMEGEN. If you experience any side effects not listed here, tell your healthcare professional.
- Diarrhea
- Constipation
- Hair loss
- Nausea and vomiting
- tiredness
COSMEGEN can cause abnormal blood test results. Your healthcare professional will decide when to perform the tests and interpret the results.
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
|---|---|---|---|
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Very common | |||
| Anemia (decreased number of red blood cells): fatigue, loss of energy, looking pale, shortness of breath, weakness | √ | ||
| Myelosuppression (a large decrease in the production of blood cells and platelets by the bone marrow): bleeding, bruising, chills, fatigue, fever, infections, weakness, shortness of breath or other signs of infection | √ | ||
| Common | |||
| Infection: fever, chills or sweating, sore throat, coughing, redness or swelling around a cut, wound or catheter site | √ | ||
| Injection site reaction: pain, redness, or swelling at site of injection | √ | ||
| Infertility (trouble getting pregnant or fathering a child): pelvic or abdominal pain, irregular vaginal bleeding, irregular periods or no periods, issues with ejaculation | √ | ||
| Uncommon | |||
| Liver problems, including hepatitis and liver failure, that may lead to death: yellowing of your skin and | √ | ||
| eyes (jaundice), right upper stomach area pain or swelling, nausea or vomiting, unusual dark urine, unusual tiredness, unexplained loss of appetite | |||
| Rare | |||
| Toxic Epidermal Necrolysis (TEN) (severe skin reaction): redness, blistering and/or peeling of large areas of the skin | √ | ||
| Stevens Johnson Syndrome (SJS) (severe skin rash): redness, blistering and/or peeling of the skin and/or inside of the lips, eyes, mouth, nasal passages or genitals, accompanied by fever, chills, headache, cough, body aches or swollen glands | √ | ||
| Allergic reaction: difficulty swallowing or breathing, wheezing, feeling sick to your stomach and throwing up, hives or rash, swelling of the face, lips, tongue or throat. | √ | ||
| Sepsis, which may lead to death (infection of the blood): fever or dizziness, chills, high or very low body temperature, little or no urine, low blood pressure, palpitations, rapid breathing, rapid heartbeat | √ | ||
| Kidney problems: nausea, vomiting, swelling of extremities, fatigue, thirst, dry skin, irritability, dark urine, increased or decreased urine output, blood in the urine, rash, weight gain (from retaining fluid), loss of appetite, abnormal blood test results, mental status changes, pain in the lower back or side. | √ | ||
| Very rare | |||
| Disseminated intravascular coagulation (blood clotting disorder): severe bruising or | √ | ||
| unusual bleeding from the skin or other areas, confusion, fever, difficulty breathing. | |||
| Optic neuropathy (Eye nerve damage): vision loss, eye pain, loss of colour vision, seeing flashing lights | √ | ||
| Hepatic encephalopathy (Brain dysfunction caused by liver failure): trouble focusing or paying attention, not knowing where you are, sleepiness during the day or trouble sleeping at night, memory loss or confusion, flapping tremor in the limbs, personality or mood changes, slurred speech or movement, falling into a coma | √ | ||
| Pleural effusion (fluid in lungs): chest pain, difficult or painful breathing, cough | √ | ||
| Peripheral neuropathy (nerve disorder of the hands and feet): numbness, prickling, or tingling in your feet or hands, sharp, jabbing, throbbing or burning pain, extreme sensitivity to touch, muscle weakness | √ | ||
| Thrombophlebitis (vein inflammation caused by blood clots): swelling and redness along a vein which is extremely tender or painful when touched | √ | ||
| Hemorrhage (loss of blood from a damaged blood vessel): severe headache, sudden weakness or numbness, vision changes, nausea, vomiting, and loss of consciousness | √ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting side effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.htmlcanada.ca/drug-device-reporting) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
COSMEGEN should be stored in a dry place between 15○C -30○C. Protect from light and humidity.
If you want more information about COSMEGEN:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website (www.recordatirarediseases.com/ca), or by calling 1-888-926-3073.
Date of Authorization: 2025-11-10