5 mg and 25 mg capsules, hard
Idarubicin hydrochloride
What Zavedos is and what it is used for
Zavedos is a cytostatic drug . In blood cancer, the cell’s maturation process is disrupted and various forms of unfit, immature blood cells are formed. Zavedos prevents cell division and destroys cells that are about to divide.
Zavedos is a cell-killing agent used to treat blood cancer.
Idarubicin hydrochloride contained in Zavedos may also be approved to treat other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Zavedos
Do not use Zavedos
- are allergic to idarubicin hydrochloride or any of the other ingredients of this medicine (listed in section 6).
- have severely impaired kidney function
- has significantly impaired heart function
- recently had a heart attack
- have irregular heartbeats
- have a residual effect on blood regeneration in the bone marrow from previous treatments or if you have previously received treatment with maximum doses of Zavedos or another similar substance ( anthracyclines or anthracenediones).
Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Zavedos if you have a history of heart disease, severe bone marrow suppression, severe liver or kidney disease, uncontrolled infection, previous treatment with anthracyclines, radiation therapy to the sternum, or a bone marrow transplant.
Tell your doctor if you are taking or have recently taken trastuzumab (a medicine used to treat certain types of cancer). It can take up to 7 months for trastuzumab to leave the body. Because trastuzumab can affect the heart, you should not use Zavedos earlier than 7 months after you stop taking trastuzumab. If Zavedos is used before this time, your heart function should be closely monitored.
The capsules must not be opened due to the risk of coming into contact with the powder in the capsule. It is therefore important that you store the capsule in its glass jar to minimize the risk of the capsule breaking. If a capsule breaks and the contents get on the skin, eyes, or mouth, rinse with water immediately. A doctor must then be contacted.
Zavedos may affect male fertility. Talk to your doctor about fertility preservation measures before starting treatment. Both men and women should use effective contraception (see section “Pregnancy, breastfeeding and fertility”).
If you wish to have a child after treatment with Zavedos, you should talk to your doctor about your options.
As the active substance is red and excreted in the urine, the urine may become red-colored for 1-2 days after the treatment.
Other medicines and Zavedos
Tell your doctor or pharmacist if you are using, have recently used, or might be using other medicines.
Certain vaccinations should be avoided if you are treated with Zavedos. Therefore, consult your doctor before receiving a vaccination.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy
Avoid becoming pregnant while you or your partner are being treated with Zavedos. Zavedos can harm the fetus. It is therefore important to tell your doctor if you think you are pregnant.
Contraceptives for women who may become pregnant
You must always use effective contraception while receiving Zavedos and for at least 6.5 months after the last dose. Talk to your doctor about which contraceptives are right for you and your partner.
Contraceptives for men
Men should always use effective contraception during treatment with Zavedos and for at least 3.5 months after the last dose.
Breast-feeding
Do not breastfeed while receiving Zavedos and wait at least 14 days after the last dose. Some of the medicine can pass into the breast milk and could harm your baby.
Fertility
Both men and women should seek advice on fertility preservation measures before starting treatment.
Driving ability and use of machinery
It is not known whether Zavedos affects the ability to drive or use machines. 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. A description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
How to use Zavedos
Always use this medicine as directed by your doctor. Ask your doctor or pharmacist if you are unsure.
The treatment takes place in rounds of medication for 3 days followed by a break so that the production of blood cells can recover. Usually, several rounds of treatment are needed before the effect can be evaluated.
First, check that the capsules are whole. The capsules should be swallowed whole with at least ½ glass of water. The capsules must not be split, bitten, sucked, or chewed.
If you use too much Zavedos
If you have ingested too much medicine or if, for example, a child has ingested the medicine by mistake, contact a doctor or hospital for an assessment of the risk and advice.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Treatment with Zavedos often causes side effects and many of these are serious. Therefore, a doctor must always be contacted if side effects occur.
Very common (may affect more than 1 in 10 users): Infections, decreased number of blood platelets ( thrombocytopenia ), decreased number of white blood cells ( leukopenia and neutropenia ), anemia, decreased appetite, nausea, vomiting, infection of the oral mucosa, diarrhea, pain or burning in the abdomen, hair loss, red coloring of the urine for 1-2 days after the treatment, fever, headache, and chills.
Common (may affect up to 1 in 10 users): Bone marrow suppression, heart failure, changes in heart rhythm, bleeding, inflammation or clot formation in superficial blood vessels, bleeding from the gastrointestinal tract, stomach pain, effect on liver function, skin rash, itching, hypersensitivity of irradiated skin.
Uncommon (may affect up to 1 in 100 users): Blood poisoning, leukemia due to the treatment, dehydration, increased level of uric acid in the blood, heart attack, ECG changes, shock, inflammation of the esophagus and intestine, hives, increased amount of pigment in the skin and nails, connective tissue inflammation, tissue death.
Rare (may affect up to 1 in 1,000 people): Bleeding in the brain.
Very rare (may affect up to 1 in 10,000 users): Serious hypersensitivity reaction, pericarditis, inflammation of the heart muscle, changes in the rhythm of the heart, blood clots, hot flushes, superficial stomach ulcers, skin flushing.
Has been reported (occurs in an unknown number of users): General lack of blood cells formed in the bone marrow (pancytopenia), the rapid disintegration of tumor cells (tumor lysis syndrome), chronic heart failure, increased amount of pigment in the oral mucosa, skin changes, nail exfoliation.
If you get side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects that are not mentioned in this information.
How to store Zavedos
Keep this medicine out of the sight and reach of children.
No special storage instructions.
Use before the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
Medicines must not be thrown into the drain or among the household waste. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.
Contents of the packaging and other information
Contents declaration
- The active substance is idarubicin hydrochloride 5 mg and 25 mg respectively.
- Other ingredients are microcrystalline cellulose, glyceryl palmitostearate, gelatin, titanium dioxide (dye E 171), and for capsules 5 mg red iron oxide (dye E 172).
- 5 mg capsule: The marking ink contains trace amounts of shellac, black iron oxide (dye E 172), propylene glycol, potassium hydroxide, and concentrated ammonia.
- 25 mg capsule: The marking ink contains trace amounts of shellac, black iron oxide (dye E 172), and propylene glycol, with or without potassium hydroxide and concentrated ammonia.
Appearance and package sizes of the medicine
Zavedo’s capsules are packaged in brown glass jars with child-proof screw caps.
Pfizer AB
191 90 Sollentuna
Email: eumedinfo@pfizer.com
Manufacturer
| 5 mgCorden Pharma Latina SpAVia del Murillo, 704013 Sermoneta (LT)Italy | 25 mgActavis Italy SpAViale Pasteur, 1020014 Nerviano (Milan)Italy |