1 mg / ml solution for injection
idarubicin hydrochloride
1. What Idarubicin Accord is and what it is used for
Idarubicin Accord belongs to a group of medicines called anthracyclines and affects how the cells in the body grow and increase in number.
Idarubicin Accord is a medicine used to treat:
Adults
- Acute non- lymphatic leukemia in adults to induce remission (improvement) in untreated patients and to induce remission in patients with relapse or treatment-resistant patients (who do not respond to treatment).
- Acute lymphocytic leukemia as secondary treatment.
Children
- Acute non- lymphatic leukemia , in combination with cytarabine to induce remission (improvement) in untreated patients
- Acute lymphocytic leukemia as secondary treatment.
Idarubicin Accord can also be used in combination with other anticancer medicines.
Idarubicin hydrochloride contained in Idarubicin Accord may also be approved for the treatment of 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.
2. What you need to know before using Idarubicin Accord
Do not use Idarubicin Accord
- if you are allergic to idarubicin or any of the other ingredients of this medicine (listed in section 6)
- if you are allergic to other anthracyclines or anthracenediones
- if you have severe liver problems
- if you have severe kidney problems
- if you have heart problems
- if you have low production of blood cells and platelets
- if you have previously been treated with idarubicin and / or other anthracyclines or anthracenediones
- if you are breast-feeding.
Warnings and cautions
- If you have heart problems. Cardiac function must be assessed before initiating idarubicin therapy and monitored throughout treatment to minimize the risk of severe heart failure .
- If you have a decreased number of blood cells in the bone marrow and a decreased number of platelets .
- If you have a clear and persistent increase in abnormal white blood cells in your blood You may develop leukemia .
- If you have problems with the gastrointestinal tract.
- If you have liver problems.
- If you have kidney problems.
- This medicine may cause vomiting, inflammation of the oral mucosa or inflammation of the lining of the gastrointestinal tract.
- You may experience reactions at the injection site.
- If extravasation (leakage of drugs to surrounding tissue ) occurs during injection , you may feel pain. Extravasation can cause severe tissue damage. If extravasation occurs, injection of one of the drugs must be stopped immediately.
- As with other cytotoxic agents, inflammation of a vein wall can occur, with the formation of blood clots.
- If you have recently received a vaccine or are considering getting vaccinated.
- If you are a man, idarubicin can cause permanent infertility (infertility).
Idarubicin should only be given under the supervision of a physician experienced in cytotoxic chemotherapy.
This medicine may cause redness of the urine for one or two days after administration.
Before and during treatment with Idarubicin Accord, regular examinations of blood, liver, kidneys, and heart should be performed. Infants and children appear to be more sensitive to the effects of anthracyclines on the heart. Thus, in these patients, it is necessary for a long time to perform regular examinations of the heart.
Other medicines and Idarubicin Accord
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Idarubicin is mainly used with other medicines to treat cancer (cytotoxic drugs) and there is an increased risk of damage, especially to the bone marrow, blood, and gastrointestinal tract. The risk of damage to the heart may increase in patients who at the same time have received other drugs that affect the heart.
Because idarubicin is largely broken down by the liver, hepatic impairment caused by other medicines may affect the way idarubicin works.
Anthracyclines, including idarubicin, must not be given with other substances that can damage the heart unless the cardiac function is closely monitored.
In combination with oral anticoagulants (blood thinners) and chemotherapy, closer monitoring of INR (International Normalized Ratio) is recommended.
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 taking this medicine.
Men receiving idarubicin treatment must use effective contraception for up to 3 months after stopping treatment.
There are no adequate and controlled studies on pregnant women. Idarubicin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Breast-feeding
It is unknown whether idarubicin is excreted in human milk. Because many drugs do this, mothers must stop breastfeeding before starting treatment.
Driving and using machines
The effect of idarubicin on the ability to drive and use machines has not been evaluated.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened 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 Idarubicin Accord
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Dose one is normally calculated based on body surface area (mg / m 2 ). The drug is usually given intravenously.
Acute non- lymphatic leukemia
Adults: In acute non-lymphocytic leukemia, the recommended dose is 12 mg / m 2 intravenously daily for 3 days in combination with cytarabine. Alternatively, 8 mg / m 2 can be given intravenously daily for 5 days, as a single treatment or as a combination treatment.
Children: The recommended dose range is 10‑12 mg / m 2 intravenously daily for 3 days in combination with cytarabine.
Acute lymphocytic leukemia
Adults: As the sole drug for acute lymphocytic leukemia, the recommended dose is 12 mg / m 2 intravenously daily for 3 days.
Children: As the sole drug for acute lymphocytic leukemia, the recommended dose is 10 mg / m 2 intravenously daily for 3 days.
All of these dosing schedules must take into account the patient’s blood status and the doses of other cytotoxic agents during combination therapy.
If you use more Idarubicin Accord than you should
Very high doses of idarubicin can cause acute damage to the heart muscle during the first 24 hours and severe inhibition of bone marrow production within one or two weeks.
The occurrence of delayed heart failure during treatment with anthracyclines has been observed, up to several months after an overdose.
If you have ingested too much medicine or if e.g. If a child has accidentally ingested the medicine, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice.
If you forget to use Idarubicin Accord
Do not take a double dose to make up for a forgotten dose.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects are very common: infections; decreased number of red blood cells, white blood cells, and platelets in the blood; markedly reduced appetite or loss of appetite; nausea, vomiting, diarrhea, abdominal pain, burning in the abdomen, inflammation of the oral mucosa; hair loss; red urine 1-2 days after receiving the medicine; fever, headache, and chills.
The following side effects are common: increased or decreased heart rate, irregular heartbeat, decreased heart function; inflammation of the vein, inflammation of the vein associated with blood clots ( thrombosis ), bleeding; gastrointestinal bleeding, stomach pain; elevated levels of liver enzymes and bilirubin; skin rash, itching, hypersensitivity of radiation-damaged skin.
The following side effects are less common: general infection; secondary leukemia; increased concentration of uric acid in the blood; abnormal ECG; shock; inflammation of the esophagus (esophagus), inflammation of the colon ( colon ), brown spots ( hyperpigmentation ) on skin and nails, skin infection ( cellulite ) and dead tissue ( necrosis ).
The following side effects are rare: cerebral haemorrhage.
The following side effects are very rare: general severe allergic reaction; myocarditis and other heart diseases; blockage ( occlusion ) in a blood vessel, redness, stomach ulcers, skin redness, especially on the arms and legs.
Cases of pancytopenia (lack of all types of blood cells in the blood), tumor lysis syndrome (rapid degradation of cancer cells), and local reaction in the skin have also been reported.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store Idarubicin Accord
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label or carton after EXP. The expiration date is the last day of the specified month.
Store in a refrigerator (2 ° C to 8 ° C). Store in the original package. Sensitive to light.
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.
6. Contents of the packaging and other information
Content declaration
- The active substance is idarubicin hydrochloride.
- 1 ml solution contains 1 mg idarubicin hydrochloride.
- One vial of 5 ml contains 5 mg of idarubicin hydrochloride.
- A vial with 10 ml contains 10 mg idarubicin hydrochloride.
- One vial of 20 ml contains 20 mg of idarubicin hydrochloride.
- The other ingredients are glycerol , concentrated hydrochloric acid , sodium hydroxide (for pH adjustment) and water for injections.
What the medicine looks like and contents of the pack
Solution for injection
The clear, orange-red solution, free from visible particles. A vial of clear type I glass containing use solution with 5 mg, 10 mg, or 20 mg of idarubicin hydrochloride injection solution.
Vials with 5 ml, 10 ml, or 20 ml solution. Carton with 1 vial.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare BV
Winthontlaan 200
3526 KV Utrecht
Netherlands
Manufacturer
Accord Healthcare Limited
Sage House
319 Pinner Road
North Harrow
Middlesex HA1 4HF
UK
Accord Healthcare Polska Sp.z oo,
ul. Lutomierska 50,95-200 Pabianice, Poland