20 mg powder for infusion solution
Daunorubicin
1. What Cerubidin is and what it is used for
Cerubidin is a medicine used to treat leukemia (cancer of the blood). Drugs used to treat cancer are often called chemotherapy drugs and Cerubidin belongs to a group of chemotherapy drugs called anthracyclines. These work by disrupting the growth of cancer cells.
Leukemia is a collective name for a number of different diseases that affect the white blood cells so that they increase in number in an abnormal and uncontrollable way.
The drug is used in the treatment of:
- rapidly progressing leukemia in adults
- in the treatment of certain types of rapidly progressing leukemia in children (as part of combination therapy of different drugs).
2. What you need to know before you use Cerubidin
Do not use Cerubidin
- if you are allergic to daunorubicin or any of the other ingredients of this medicine (listed in section 6)
- if you know you are allergic to anthracycline you
- if your bone marrow is affected with disturbed/impaired blood cell production
- if you have a serious infection
- if you have severe hepatic or renal impairment
- if you have heart failure
- if you have recently had a heart attack
- if you have severe heart rhythm problems
- if you are breast-feeding
Warnings and cautions
Talk to your doctor before taking Cerubidin:
- if you have previously received radiotherapy as there may be an increased risk of local reactions in the same area during treatment with Cerubidin.
- if you are older
- if you have/have had heart disease or high blood pressure
- If you have heart failure or if you have recently had a heart attack, do not use Cerubidin
- if you are also taking medicines that can inhibit the contractions of the heart or medicines that can be harmful to the heart, such as trastuzumab
- if you have kidney problems
- if you have liver problems
- if you are deficient in certain types of blood cells
- if you have an infection ( infection should be treated before starting treatment with Cerubidin)
- if you have previously taken Cerubidin or another similar medicine as it may increase the risk of serious heart problems.
- if you are going to undergo a vaccination
Vaccination with live vaccines should be avoided. Killed or inactivated vaccines can be given, but it is not certain that you will get the full effect.
Cerubidin provides a reduced activity in the bone marrow and to avoid complications associated with it, your doctor will monitor your blood levels closely to be able to take any action quickly. One usually recovers 2-3 weeks after the last injection one.
This type of drug affects the body’s production of immune cells. This can make you more susceptible to serious infections.
Cerubidin may cause nausea and vomiting which may lead to dehydration. Consult a doctor if you are bothered by this.
Intestinal inflammation ( colitis ) has been reported with the use of daunorubicin. See section 4, Possible side effects.
Your doctor will also monitor your heart function before, during, and after treatment with Cerubidin. This is to be able to identify the risk of heart complications that may occur.
The treating physician considers the pros and cons and decides in each case which treatment to give and the physician will take blood samples to check your blood levels.
A neurological disorder called PRES has been reported when treatment with daunorubicin has been used in combination with other cancer treatments. PRES can cause symptoms such as headaches, seizures, lethargy, confusion, and visual disturbances. If you experience any of these symptoms, consult your doctor.
Other medicines and Cerubidin
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Cerubidin may affect or be affected by other medicines, which may increase the risk of side effects. These other drugs are mainly:
- cardiac drugs (eg calcium channel blockers). Concomitant use with Cerubidin may affect the heart.
- other drugs that can affect the bone marrow, such as cytarabine and cyclophosphamide (medicines for cancer), sulfonamides and chloramphenicol (medicines for bacterial infections), diphenylhydantoin (medicines for epilepsy ), amidopyrine derivatives (medicines for pain and fever), and certain medicines for viruses.
- drugs that can affect the liver (eg methotrexate, which is used against cancer, among other things).
- sulfonamides and certain diuretics. Concomitant use with Cerubidin may lead to an increase in the amount of uric acid in the blood (hyperuricemia).
- anticoagulants (eg acetylsalicylic acid ). May lead to an increased tendency to bleed if you have reduced platelet counts.
It is important to know that the intake and uptake/effect of other medicines can be affected by mucositis that can occur in the mouth and in the gastrointestinal tract during treatment with Cerubidin.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
You should not use Cerubidin during pregnancy unless you and your doctor decide that the benefit to you outweighs the potential risk to you and your unborn baby.
If you are a woman of childbearing potential, you should use effective contraception.
Breast-feeding
Cerubidin should not be used during breastfeeding as there is no information on whether Cerubidin passes into breast milk.
Fertility
Cerubidin may affect male and female fertility.
Cerubidin can cause chromosomal damage in sperm. If you are a man, you should get advice on freezing sperm before starting Cerubidin treatment.
Men undergoing treatment must use effective contraception during and up to 6 months after stopping treatment.
If you are a woman of childbearing potential, you must use an effective method of contraception during treatment with Cerubidin.
If you want to get pregnant after stopping Cerubidine treatment, you should get genetic counseling before starting Cerubidin treatment.
Driving and using machines
Cerubidin may affect your ability to drive or use machines due to possible side effects of the treatment such as nausea and vomiting.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
3. How to use Cerubidin
Treatment with Cerubidin takes place in a hospital and should be initiated by or in consultation with a physician with extensive experience in chemotherapy.
Cerubidine can be given alone or in combination with other medicines.
It is given as an infusion into one of your veins ( intravenously ).
Tell your doctor or nurse immediately if you feel a burning sensation around the area where Cerubidin is given. This may be because the medicine has ended up outside the infusion site and the infusion should then be stopped and other measures may need to be taken.
Dose one is individually adjusted to your body weight. Your doctor will decide how often you should receive treatment depending on how you respond to the medication.
Your health condition will be closely monitored during treatment with Cerubidin, which may include blood tests, urine tests, and monitoring of heart function ( ECG ).
Use for children and adolescents
Dosage of Cerubidin in children older than 2 years is usually based on body surface area and is adjusted for each individual patient. Normally the course is repeated after 3-6 weeks.
If you have any further questions on the use of this product, ask your doctor or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Stop taking Cerubidin and contact a doctor immediately or see the nearest emergency department if you experience the following symptoms:
- Fever, shortness of breath, or palpitations can be signs of a serious infection, which can sometimes be fatal (eg blood poisoning, septic shock, pneumonia ). (Very common – affects more than 1 user in 10).
- If you have heart problems with symptoms such as shortness of breath and swollen legs. (Common – affects more than 1 user in 100).
- Allergic reactions ( hypersensitivity reactions ). Symptoms of an allergic reaction may include swelling of the eyelids, face, or lips, low blood pressure, palpitations, sudden itchy rash (hives), sudden wheezing, chest tightness, shortness of breath, and dizziness. (Has been reported – occurs in an unknown number of users).
- Diarrhea, abdominal pain, mucus, or blood in the stool, may be a sign of intestinal inflammation ( colitis ). (Has been reported – occurs in an unknown number of users).
Other side effects:
Very common (affects more than 1 user in 10)
- Blood effects
- Bone marrow Effect – Reduced blood formation in the bone marrow one which can give rise to infection s
- Impact on the heart muscles
- Bleeding
- Diarrhea
- Inflammation of the esophagus
- Inflammation of the oral mucosa or mucous membranes of the esophagus
- Nausea/vomiting
- Skin effects (skin rash, redness )
- Hair loss
- Pain
- Laboratory values that are linked to liver function may be affected
Common (affects more than 1 user in 100)
- Abdominal pain
- Local inflammation in a friend
- When measuring heart activity with ECG (electrocardiography), abnormalities can be seen
Uncommon (affects less than 1 user in 100)
- Blood cancers (secondary leukemia ) including rapidly progressing blood cancers ( acute myeloid leukemia ) and affecting the white blood cells ( myelodysplastic syndrome ).
- Myocardial infarction
Has been reported (occurs in an unknown number of users)
- Dehydration
- Degradation of cancer cells ( Tumor light syndrome); acute elevated uric acid levels in the blood (with possible impairment of renal function)
- Angina pectoris
- Increase of the connective tissue in the heart muscle
- Myocarditis/myocarditis
- Irregular heartbeat
- Feeling of warmth
- Shock
- Lack of oxygen in tissue are
- Liver inflammation
- Liver failure
- Inflammation of the skin ( contact dermatitis )
- Skin itching
- Hypersensitivity to irradiated skin (“radiation recall reaction”)
- Hyperpigmentation of skin and nails
- Hives
- Red urine for 1-2 days after administration
- Absence of menstruation
- Reduced number of sperm ( azoospermia )
- Overindulge
- That infusion one ends up outside the vein (perivenous extravasation)
- Death
- Hardening of veins
- Inflammation and clot in a superficial vein ( thrombophlebitis )
- Thickening of the venous wall (phlebosclerosis)
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Cerubidin
Keep this medicine out of the sight and reach of children.
The solution must be protected from direct sunlight.
Do not use this medicine after the expiry date which is stated on the carton after EXP. That. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
Waste that has been in contact with Cerubidin must be handled in accordance with current procedures for hazardous waste. When disposing of any spills, use protective equipment as shown below. Contaminated surfaces are rinsed with copious amounts of water. Glass shards and drying materials are treated as hazardous waste. Residues of Cerubidin can be inactivated with sodium hypochlorite solution if necessary.
6. Contents of the packaging and other information
Content declaration
- The active substance is daunorubicin hydrochloride
- The other ingredients are mannitol
What the medicine looks like and the contents of the pack
A colorless vial containing 20 mg powder for solution for infusion.
Pack size: 10 x 20 mg
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Sanofi AB, Box 30052, 104 25 Stockholm
Manufacturer
Cenexi Laboratories Thissen
2-6, rue de la Papyrée 1420 Braine L´Alleud
Belgium