1 mg / mL concentrate for infusion solution 
arsenic trioxide

Read all of this leaflet carefully before you are given this medicine.

  • It contains information that is important to you. Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • 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. See section 4.

In this leaflet you will find information about: 
1. What Arsenic trioxide Mylan is and what it is used for 
2. What you need to know before you get Arsenic trioxide Mylan 
3. How to use Arsenic trioxide Mylan 
4. Possible side effects 
5. How Arsenic trioxide Mylan to be stored 
6. Contents of the packaging and other information 

What Arsenic Trioxide Mylan is and what it is used for

Arsenic trioxide Mylan is used in adult patients with newly diagnosed acutepromyelotic 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.

What you need to know before you get Arsenic Trioxide Mylan

Arsenic trioxide Mylan must be given under the supervision of a doctor who has experience in treating acute leukemias.

You should not receive Arsenic trioxide Mylan

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 receiving Arsenic Trioxide Mylan

  • 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 Mylan.
  • The electrical activity of the heart ( electrocardiogram, ECG ) should be measured before receiving the first dose.
  • Blood tests ( potassium, magnesium, calcium, liver function) are then repeated during your treatment with Arsenic trioxide Mylan.
  • 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 Mylan may cause other types of cancer. You should report any new and unusual symptoms and circumstances each time you see your doctor.
  • Follow-up of your cognitive functions and your mobility if you are at risk for vitamin B1 deficiency.

Children and young people

Arsenic trioxide Mylan is not recommended for children and adolescents under 18 years of age.

Other medicines and Arsenic trioxide Mylan

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 Mylan. 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 Mylan with food and drink

There are no restrictions on food and drink while you are receiving Arsenic Trioxide Mylan.

Pregnancy and breastfeeding

Pregnancy

Ask your doctor or pharmacist for advice before taking any medicine.

Arsenic trioxide Mylan can harm the fetus when used by pregnant women.

If you could become pregnant, you must use an effective contraceptive during treatment with Arsenic Trioxide Mylan.

If you are pregnant or become pregnant during treatment with Arsenic trioxide Mylan, you must consult your doctor.

Men must use effective contraceptive during treatment with Arsenic Trioxide Mylan.

Breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

The arsenic in Arsenic trioxide Mylan passes into breast milk.

Because Arsenic Trioxide Mylan can harm breastfed infants, you must not breast-feed while you are being treated with Arsenic Trioxide Mylan.

Driving and using machines

Arsenic trioxide Mylan 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 Mylan‑ injection, you should wait until the symptoms disappear before driving or using machines.

Arsenic trioxide Mylan contains sodium

This medicine contains less than 1 mmol sodium (23 mg) per bottle, ie essentially ‘ sodium-free’. is largely “sodium-free”.

3. How to use Arsenic trioxide Mylan

Treatment time and frequency of treatment

Patients with newly diagnosed acute promyelocytic leukemia

Your doctor will give you Arsenic Trioxide Mylan 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 Mylan, you get 4 more 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 Mylan.

Patients with acute promyelocytic leukemia who have not responded to other treatments

Your doctor will give you Arsenic Trioxide Mylan once a day as an infusion. In your first round of treatment, 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 Arsenic trioxide Mylan, you will receive an additional treatment cycle of 25 doses 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 Mylan.

Method of administration and route of administration

Arsenic trioxide Mylan must be diluted with a solution containing glucose or a solution containing sodium chloride.

Arsenic trioxide Mylan 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 Mylan should not be mixed with or passed through, the same tube along with other drugs.

If your doctor or nurse gives you more Arsenic Trioxide Mylan than he or she should

You may experience cramps, muscle weakness, and confusion. If this happens, stop taking Arsenic trioxide Mylan 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, pharmacist, or nurse.

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 Mylan, you may experience some of the following reactions:

Very common (may affect more than 1 in 10 people):

  • 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.

No known frequency (frequency can not be calculated from available data):

  • infection of the lungs, infection of the blood
  • pneumonia-causing chest pain and shortness of breath, heart failure
  • dehydration, confusion
  • brain disease ( encephalopathy, Wernicke’s encephalopathy ) with various manifestations including difficulty using the arms and legs, speech disorders, and 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 Mylan

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 bottle label and carton.

Do not freeze.

If the solution is not used immediately after dilution, your doctor will be responsible for the storage times and conditions before use. Normally this time should not exceed 24 hours at 2‑8 ° C unless dilution has taken place in a sterile environment.

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. Each ml of concentrate contains 1 mg arsenic trioxide Each vial of 10 ml containing 10 mg of arsenic trioxide.
  • The other ingredients are sodium hydroxide, hydrochloric acid, and water for injections. See section 2 “Arsenic trioxide Mylan contains sodium”.

What the medicine looks like and the contents of the pack

Arsenic trioxide Mylan is a concentrate for solution for infusion (sterile concentrate). Arsenic trioxide Mylan is supplied in glass bottles in the form of a concentrated, clear, colorless aqueous solution. Each carton contains 1 or 10 disposable glass bottles.

Marketing Authorisation Holder

Mylan Ireland Limited

Unit 35/36 grange Parade

Baldoyle Industrial Estate

Dublin 13

Ireland

Manufacturer

Haupt Pharma Wolfratshausen GmbH

Pfaffenrieder Straße 5

82515 Wolfratshausen

Germany

Contact the representative of the marketing authorization holder to find out more about this medicine:

Muhammad Nadeem

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