2 mg / ml concentrate for solution for infusion solution
Doxorubicin hydrochloride
1. What Doxorubicin Accord is and what it is used for
The medicine is called Doxorubicin Accord 2 mg/ml concentrate for solution for infusion, but in the rest of the package leaflet, it is called Doxorubicin Accord.
Doxorubicin belongs to a group of medicines called anthracyclines. These medicines are also called medicines for cancer, chemotherapy, or chemotherapy. They are used to treat various types of cancer by slowing down or stopping the growth of cancer cells. A combination of different types of anti-cancer drugs is often used to achieve better results and minimize side effects.
Doxorubicin Accord is used to treat the following types of cancer:
- Breast cancer
- Cancer of connective tissue, ligaments, bones, muscles ( sarcoma )
- Cancer that develops in the stomach or colon
- Lung cancer
- Lymphoma, cancer that affects the immune system
- Leukemia, cancer that causes abnormal blood cell production
- Cancer of the thyroid gland
- Advanced ovarian cancer and cancer of the uterine lining or uterus
- Bladder cancer
- Advanced neuroblastoma (a cancer of the nerve cells that is common in children)
- Malignant renal tumor in children (Wilms tumor )
- Myeloma ( bone marrow cancer )
Doxorubicin hydrochloride contained in Doxorubicin 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 Doxorubicin Accord
Do not use Doxorubicin Accord
- if you are allergic to doxorubicin hydrochloride or any of the other ingredients of this medicine (listed in Section 6) or another anthracycline you
- if you have been informed that you have thin blood (ie that your bone marrow is not working properly)
- if you have previously been treated with doxorubicin or similar chemotherapy drugs such as idarubicin, epirubicin, or daunorubicin, as previous treatment with such similar medicines may increase the risk of side effects of Doxorubicin Accord
- if you start to bleed easily
- if you have any type of infection
- if you have cold sores
- if your liver is not working properly
- if you have cystitis (if you are given medicines that are administered directly into the bladder)
- if you have blood in your urine
- if you have had a heart attack
- if your heart is not working properly
- if you have a severe abnormal heartbeat ( arrhythmia ).
You should not take the medicine through a catheter (a thin flexible tube) directly into the bladder if you have:
- a tumor that has grown through the bladder wall
- urinary tract infection
- inflammation of the bladder
- have problems inserting a catheter.
Warnings and cautions
Talk to your doctor or pharmacist if you have or have had any of the following illnesses or problems:
- Poor blood cell production in the bone marrow a
- Heart problems
- Hepatic impairment
- Kidney problems
Also, tell your doctor about:
- you have previously received doxorubicin or similar anticancer medicines ( anthracyclines )
- you have received radiation treatment aimed at the upper body.
Before starting treatment and during treatment with Doxorubicin Accord, your doctor will perform the following tests:
- Blood values
- Functional tests of the heart, liver, and kidneys
Doxorubicin severely reduces blood cell production in the bone marrow. It can make you more prone to infection or bleeding. It is important that serious infections and/or bleeding can be treated effectively without delay.
Tell a doctor immediately:
- if you feel a burning or burning sensation at the injection site. Such pain can occur if the drug leaks out of the vein.
Your doctor will monitor your heart function closely during treatment because:
- doxorubicin can damage the heart muscle
- treatment with doxorubicin may lead to heart failure after a certain cumulative dose (aggregation of single doses )
- there is a greater risk of damage to the heart muscle if you have previously received drugs that can damage the heart or if you have received radiation treatment aimed at the upper body.
During treatment, the level of uric acid (which indicates that cancer cells are being destroyed) in the blood may be high. Your doctor will tell you if you need to take any medicine for this.
- If you have an infection, it should be treated before treatment with Doxorubicin Accord.
- The drug is not normally recommended in combination with live, attenuated vaccines. The patient should avoid contact with people who have recently been vaccinated against polio.
- Doxorubicin Accord is normally excreted through the liver and bile and the excretion may decrease in patients with hepatic impairment or impaired bile flow, which may lead to serious secondary side effects.
Doxorubicin Accord may make the urine red. It is not a sign of illness or medical condition.
Other medicines and Doxorubicin Accord
Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines.
The following medicines may affect or be affected by Doxorubicin Accord 2 mg/ml concentrate for solution for infusion :
- Other cytostatics (anticancer medicines) such as trastuzumab, anthracyclines(daunorubicin, epirubicin, idarubicin,), cisplatin, cyclophosphamide, ciclosporin, cytarabine, dacarbazine, dactinomycin, fluorouracil, mitomycin C, taxane (eg pacacre), streptozocin
- Cardiac active drugs (drugs for heart disease) e.g. calcium channel blockers, verapamil, and digoxin
- Drugs that lower uric acid levels in the blood
- Cytochrome P450 inhibitors (medicines that cause the substance cytochrome P450, which is important for cleansing the body of toxins, do not work properly) e.g. cimetidine, cytochrome P450 inducer (eg rifampicin and barbiturates as phenobarbital)
- Medicines for epilepsy (eg carbamazepine, phenytoin, and valproate )
- Antipsychotics: Clozapine (medicine for schizophrenia)
- Heparin (prevents blood clots)
- Antiretroviral drugs (drugs against specific types of viruses ).
- Chloramphenicol and sulfonamide (medicines for bacteria)
- Progesterone (eg at risk of miscarriage)
- Amphotericin B (a medicine used to treat fungal diseases)
- Live vaccines (eg polio ( myelitis ) and malaria )
Note! This may also apply to recently used medicines.
Pregnancy, breastfeeding, and fertility
Pregnancy
Animal studies show that doxorubicin crosses the placenta and damages the fetus. Your doctor will only prescribe doxorubicin to pregnant women if the benefits of the treatment outweigh the risks to the fetus. Tell your doctor immediately if you are, or think you may be, pregnant.
Breast-feeding
Do not breast-feed while you are being treated with Doxorubicin Accord. The drug can be transmitted to the baby through breast milk.
Fertility
Women treated with doxorubicin should not become pregnant during and up to 6 months after treatment. Men undergoing doxorubicin treatment should ensure that their partner does not become pregnant during and up to 6 months after treatment. Doxorubicin can cause permanent infertility and men should therefore seek advice on storing (or freezing) semen before treatment.
If you are considering having children after treatment, you should discuss it with your doctor.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Due to frequent nausea and vomiting, you are advised not to drive or use machines.
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.
Doxorubicin Accord contains sodium
This medicine contains 0.15 mmol (3.5 mg) sodium per ml. Patients on a low-salt diet should take this into account.
3. How to use Doxorubicin Accord
Methods of administration and routes of administration
Doxorubicin Accord should only be given under the supervision of a physician experienced in the treatment of cancer.
Dosage: Your doctor will decide what dose you should receive.
Do not take the medicine yourself. You will be given the drug by intravenous infusion into a blood vessel under the supervision of specialists. You are monitored regularly, both during and after treatment. If you have superficial bladder cancer, the medicine may be administered directly into the bladder (intravesically).
Dosage
Dose one is usually calculated based on body surface area. In monotherapy, 60–75 mg per m 2 of body surface area can be given every three weeks. If the drug is given in combination with other anti-cancer drugs, the dose may need to be reduced to 30–60 mg per m 2 of body surface area. Your doctor will tell you how many doses you need. If you receive this medicine every week, the recommended dose is 15-20 mg / m 2 body surface area. Your doctor will tell you how many doses you need.
Patients with hepatic and renal impairment
Dose one should be reduced for patients with hepatic or renal impairment. Your doctor will tell you how many doses you need.
Children / elderly or patients who have received radiotherapy
The dose may need to be reduced for children, the elderly, or patients who have received radiation therapy. Your doctor will tell you how many doses you need.
Patients with bone marrow inhibition
Dose one may need to be reduced for patients with bone marrow suppression. Your doctor will tell you how many doses you need.
Obese patients
Obese patients may need a lower starting dose or longer intervals between treatment cycles. Your doctor will tell you how many doses you need and how often you should be given the medicine.
If you use more Doxorubicin Accord then you should
You are monitored during and after treatment by doctors and other healthcare professionals. The symptoms of an overdose are that the side effects of the drug become more prolonged. This is especially true of changes in the blood and problems with the gastrointestinal tract and heart. Heart problems can even occur six months after the overdose.
Your doctor will take appropriate action if you have an overdose, such as blood transfusion and/or treatment with antibiotics.
Tell your doctor if you experience any of these symptoms.
If you forget to take Doxorubicin Accord
Your doctor will decide how long you should be treated with Doxorubicin Accord. If the treatment is stopped before the planned treatment cycles have been completed, the treatment may have a worse effect. Ask your doctor if you want to stop treatment.
If you stop using Doxorubicin Accord
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.
Contact a doctor or healthcare professional immediately if you notice any of the following side effects.
- Dizziness, fever, shortness of breath with chest and throat pain, or itchy rash. This type of allergic reaction can be very serious.
- Anemia (low red blood cell count ) can make you feel tired and apathetic.
- You may also have a decrease in the number of white blood cells (which fight infection ), which increases the risk of infection and fever.
- Platelets (cells that help the blood to clot) can be affected, which can make it easier for you to get bruises or bleed. If this happens, it is important to consult a doctor. Your doctor should check your blood cell count during treatment.
- Doxorubicin may impair bone marrow function. Your doctor should check your blood cell count during treatment.
| Usual(may affect up to 1 in 10 users) | Cardiomyopathy (heart muscle disease)Changes in ECG ( electrocardiogram )Bone marrow suppression (anemia that causes infection and bleeding)Changes in blood cell count ( leukopenia, neutropenia )NauseaVomitingMucositis ( inflammation of the lining of the gastrointestinal tract)Stomatitis ( inflammation of the oral mucosa)Anorexia (eating disorder)Diarrhea that can cause dehydration chemicals cystitis ( cystitis ), sometimes hemorrhagic (blood in the urine) after administration of the drug in the bladderAlopecia (hair loss) which is usually reversible (reversible)Sepsis (bacterial infection)Septicemia (bacterial infection in the blood) |
|---|---|
| Uncommon:(may affect up to 1 in 100 people) | Ulceration and necrosis (cell/tissue death) in the colon ( colon ) in combination with cytarabinePhlebitis ( inflammation in a friend)Bleeding in the stomach and intestinesAbdominal painLocal allergic reaction in the radiation areaDehydration |
| Rare:(may affect up to 1 in 1000 users) | Secondary acute myeloid leukemia (blood cancer that occurs after treatment of another cancer) when doxorubicin is used in combination with antineoplastic drugs that damage the genome tumor light syndrome (complications caused by chemotherapy)Conjunctivitis ( inflammation of the outer membrane of the eye)Urticaria ( hives )Exanthema (a type of rash)Erythema (skin redness) along the injection veinHyperpigmentation (darker areas) of skin and nailsOnycholysis (nail removal)Anaphylactic reactions (severe allergic reactions with or without shock that cause skin rash and itching )OverindulgeFeverDizziness |
| Has been reported: (occurs in an unknown number of users) | Acute lymphocytic leukemia (disease with uncontrolled growth of immature white blood cells , so-called lymphoblasts , in the blood and bone marrow )Acute myelogenous leukemia (disease with too much immature blood cell-producing cells in blood and bone marrow )Thrombophlebitis ( inflammation of a superficial vein)Thromboembolism (when a clot forms in a blood vessel)Reduced amount of a coagulation factor ( platelets )ShockOverindulgeInflammation of the esophagus ( esophagitis )Inflammation of the colon ( colitis )Arrhythmia (irregular heartbeat)Heart failure (impaired heart function)Hyperuricemia (elevated levels of uric acid in the blood)Bronchospasm (cough or difficulty breathing due to sudden narrowing of the trachea)Pneumonitis ( inflammation of lung tissue)Amenorrhea (missed period)Oligozoospermia (low amount of semen in the semen)Acute renal failure (decreased or no urine output)Keratitis ( inflammation of the cornea)Increased tear flow ( lacrimation )Acral erythema (swelling and numbness in hands and feet)Plantar-palmar dysesthesia (hand-foot syndrome, a clearly noticeable and relatively common skin reaction)Too high pigmentation of the oral mucosaExtreme heat sensation (hot flashes)Azoospermia (no sperm in the semen)Anemia (a decrease in the number of red blood cells )A stinging or burning sensation in the injection site during extravasation. Extravasation can cause local cell death in tissue, which may require surgery liver toxicityTransient increase in liver enzymesAsthenia (loss of or lack of body strength, weakness, weakness)Photosensitivity (increased sensitivity of the skin to the sun) |
Other side effects: Doxorubicin Accord may cause red urine for 1-2 days after administration. This is normal and does not pose a health risk.
5. How to store Doxorubicin 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 vial after EXP and the outer carton after EXP. dat. The expiration date is the last day of the specified month.
Store in a refrigerator (2-8 ° C). Keep the vial in the outer carton. Sensitive to light.
Do not use this medicine unless it is clear, red, and free from particles.
For single use only.
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.
Unopened vials: 18 months
Opened vials: The product should be used immediately after opening.
Chemical and physical stability after formulation has 0.9% sodium chloride and 5% dextrose injection for up to 28 days at 2-8 ° C for up to 7 days at 25 ° C when prepared in a glass container protected from light.
From a microbiological perspective, the product should be used immediately. If not used immediately, in-use storage times and conditions before use is the responsibility of the user. Normally the product should not be stored for longer than 24 hours at 2-8 °, unless dilution has taken place under controlled and validated antiseptic conditions.
6. Contents of the packaging and other information
Content declaration
The active substance in Doxorubicin Accord is doxorubicin hydrochloride.
1 ml contains 2 mg doxorubicin hydrochloride
Each 5 ml vial contains 10 mg doxorubicin hydrochloride.
Each 10 ml vial contains 20 mg of doxorubicin hydrochloride.
Each 25 ml vial contains 50 mg of doxorubicin hydrochloride.
Each 50 ml vial contains 100 mg of doxorubicin hydrochloride.
Each 100 ml vial contains 200 mg of doxorubicin hydrochloride.
The other ingredients are sodium chloride, hydrochloric acid (for pH adjustment), and water for injections.
What the medicine looks like and the contents of the pack
Doxorubicin Concentrate for solution for infusion is a clear, red liquid that is substantially free of particulate matter.
Pack sizes:
1 x 5 ml vial
1 x 10 ml vial
1 x 25 ml vial
1 x 50 ml vial
1 x 100 ml vial
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Accord Healthcare BV
Winthontlaan 200
3526 VK 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