1 mg / mL concentrate for infusion solution
arsenic trioxide
1. What Arsenic Trioxide Accord is and what it is used for
Arsenic trioxide Accord contains arsenic trioxide, which is a medicine against cancer. It is used in adult patients with newly diagnosed acute promyelocytic leukemia (APL) with low to intermediate risk, as well as in adult patients when the disease has not improved after other treatments. APL is a unique form of myeloid leukemia, a disease in which abnormal white blood cells are produced and abnormal bleeding and bruising occur.
2. What you need to know before using Arsenic Trioxide Accord
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Arsenic Trioxide Accord must be given under the supervision of a physician experienced in the management of acute leukemias.
Do not use Arsenic Trioxide Accord
If you are allergic to arsenic trioxide or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
You must talk to your doctor or nurse before using Arsenic Trioxide Accord
- you have impaired kidney function.
- you have some liver problems.
Your doctor will take the following precautions:
- Tests are performed to check the amount of potassium, magnesium, calcium, and creatinine in your blood before your first dose of Arsenic Trioxide Accord.
- The electrical activity of the heart ( electrocardiogram, ECG ) should be measured before receiving the first dose.
- Blood tests ( potassium, calcium, magnesium, and liver function) are then repeated during your treatment with Arsenic Trioxide Accord.
- In addition, an ECG is taken on you twice a week.
- If you are at risk for a certain type of abnormal heart rhythm (eg torsade de pointes or QTc prolongation), your heart will be monitored continuously.
- Your doctor may monitor your health during and after treatment, as arsenic trioxide, the active substance in Arsenic Trioxide Accord may cause other types of cancer. You should report any new and unusual symptoms and circumstances each time you see your doctor.
Children and young people
Arsenic trioxide Accord is not recommended for children and adolescents under 18 years of age.
Other medicines and Arsenic trioxide Accord
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
In particular, tell your doctor
– if you are taking any of the different types of medicines that could cause a change in heart rhythm. These include:
- certain types of antiarrhythmics (medicines used to correct irregular heartbeat eg quinidine, amiodarone, sotalol, and dofetilide)
- drugs for the treatment of psychosis (lost perception of reality, eg thioridazine)
- antidepressants (eg amitriptyline)
- certain types of medicines to treat bacterial infections (eg erythromycin and sparfloxacin)
- certain medicines for the treatment of allergies such as hay fever, so-called antihistamines (eg terfenadine and astemizole)
- all medicines that cause a decrease in the amount of magnesium or potassium in the blood (eg amphotericin B)
- cisapride (a medicine used to relieve certain stomach ailments).
The effect of these drugs on your heart rate may be exacerbated by Arsenic Trioxide Accord. Therefore, you must inform your doctor about all the medicines you are taking.
– if you are taking or have recently taken any medication that may affect your liver. Show the bottle or package to your doctor if you are unsure.
Arsenic trioxide Accord with food and drink
There are no restrictions on food and drink while you are receiving Arsenic Trioxide Accord.
Pregnancy and breastfeeding
Pregnancy
Ask your doctor or pharmacist for advice before taking any medicine.
Arsenic Trioxide Accord can harm the fetus when used by pregnant women.
If you can get pregnant, you must use an effective contraceptive during treatment with Arsenic Trioxide Accord.
If you are pregnant or become pregnant during treatment with Arsenic Trioxide Accord, you must consult your doctor.
Men must use an effective contraceptive during treatment with Arsenic Trioxide Accord.
Breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
The arsenic in Arsenic trioxide Accord passes into breast milk.
Because Arsenic Trioxide Accord may harm infants and breast-fed infants, you must not breast-feed while you are being treated with Arsenic Trioxide Accord.
Driving and using machines
Arsenic trioxide Accord is expected to have no or negligible effect on the ability to drive and use machines.
If you experience discomfort or feel unwell after an Arsenic Trioxide Accord‑ injection, wait until the symptoms disappear before driving or using machines.
Arsenic trioxide Accord contains sodium
Arsenic trioxide Accord contains less than 1 mmol (23 mg) sodium per dose, ie essentially ‘sodium-free’. is next to “sodium-free”.
How to use Arsenic Trioxide Accord
Treatment time and frequency of treatment
Patients with newly diagnosed acute promyelocytic leukemia
Your doctor will give you Arsenic Trioxide Accord once a day as an infusion. In your first round of treatment, you may receive treatment every day for up to a maximum of 60 days or until your doctor assesses that your illness has improved. If your disease is improved by Arsenic Trioxide Accord, you will receive an additional 4 cycles. Each cycle consists of 20 doses given 5 days a week (followed by a 2-day break) for 4 weeks, followed by a 4-week break. Your doctor will decide exactly how long you should continue to be treated with Arsenic Trioxide Accord.
Patients with acute promyelocytic leukemia who have not responded to other treatments
Your doctor will give you Arsenic Trioxide Accord once a day as an infusion. During your first treatment cycle, you may receive treatment every day for up to a maximum of 50 days or until your doctor assesses that your illness has improved. If your disease is improved by the Arsenic Trioxide Accord, you will receive an additional 25- dose treatment cycle given 5 days a week (followed by a 2-day break) for 5 weeks. Your doctor will decide exactly how long you should continue to be treated with Arsenic Trioxide Accord.
Method of administration and route of administration
Arsenic trioxide Accord must be diluted with a solution containing glucose or a solution containing sodium chloride.
Arsenic trioxide Accord is usually given by a doctor or nurse. It is given as a drip (an infusion ) into a vein for 1-2 hours, but it may take longer if side effects such as redness and dizziness occur.
Arsenic trioxide Accord should not be mixed with or passed through, the same tube along with other drugs.
If your doctor gives you more Arsenic Trioxide Accord than he/she should
You may experience cramps, muscle weakness, and confusion. If this happens, stop taking Arsenic Trioxide Accord immediately and your doctor will treat the overdose of arsenic.
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.
Tell your doctor or nurse immediately if you notice any of the following side effects, as they may be signs of a serious condition, called ‘differentiation’, which can be fatal:
- hard to breathe
- cough
- chest pain
- fever.
Tell your doctor or nurse immediately if you notice any of the following side effects, as they may be signs of an allergic reaction:
- hard to breathe
- fever
- sudden weight gain
- water accumulation
- fainting
- palpitation er (strong heartbeat that you can feel in the chest).
While you are being treated with Arsenic Trioxide Accord, you may experience some of the following reactions:
Very common (may affect more than 1 user in 10):
- lethargy (fatigue), pain, fever, headache.
- nausea, vomiting, diarrhea
- dizziness, muscle aches, numbness, or tingling
- rash or itching
- high blood sugar, edema (swelling due to excess fluid)
- shortness of breath, palpitations, abnormal ECG measurement
- decreased potassium or magnesium in the blood, abnormal liver function tests including excess bilirubin or gamma-glutamyltransferase in the blood.
Common (may affect up to 1 in 10 people):
- decreased number of blood cells ( platelets , red and / or white blood cells ), increased number of white blood cells
- chills, weight gain
- fever due to infection and low white blood cell count, herpes zoster infection
- chest pain, bleeding in the lungs, hypoxia (lack of oxygen), fluid accumulation around the heart or lungs, low blood pressure, abnormal heart rhythm
- cramps, joint or leg pain, inflammation of the blood vessels
- increased sodium or magnesium, ketones in the blood and urine ( ketoacidosis ), abnormal kidney function tests, kidney failure
- abdominal pain (abdominal pain)
- redness, swollen face, blurred vision.
Has been reported (occurs in an unknown number of users):
– infection of the lungs, infection of the blood
– pneumonia-causing chest pain and shortness of breath, heart failure
– dehydration, confusion.
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 Arsenic Trioxide 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 label and carton.
No special storage instructions.
After first opening: The medicine should be used immediately after opening.
Chemical and physical in-use stability has been demonstrated for 168 hours at 25 ° C and at 2 ° C to 8 ° C. From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 ° C ‑ 8 ° C, unless dilution has taken place under controlled and validated aseptic conditions.
Do not use this medicine if you notice that the solution contains foreign particles or if the solution is discolored.
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 arsenic trioxide. One ml of concentrate contains 1 mg of arsenic trioxide. One vial contains 10 mg arsenic trioxide.
- The other ingredients are sodium hydroxide, concentrated hydrochloric acid (for pH adjustment), and water for injections. See section 2 “Arsenic trioxide Accord contains sodium”.
What the medicine looks like and the contents of the pack
Arsenic trioxide Accord is a concentrate for solution for infusion. Arsenic trioxide Accord is supplied in glass vials in the form of a concentrated, clear, colorless aqueous solution.
Each carton contains 1, 5, or 10 vials.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder
Accord Healthcare SLU
World Trade Center, Moll de Barcelona s / n,
Estifici Est, 6a planta,
08039 Barcelona,
Spain
Manufacturer
Accord Healthcare Polska Sp.z oo,
ul. Lutomierska 50,
95-200 Pabianice,
Poland