Myleran – Busulfan uses, dose and side effects


2 mg film-coated tablets

What Myleran is and what it is used for

Myleran contains the active substance busulfan which belongs to a group of medicines called cytostatics. Busulfan reduces the number of new blood cells that bone marrow produces, which reduces the symptoms of the disease.

Myleran is used in the treatment of:

Some serious blood vessel diseases such as chronic myelocytic leukemia.

What you need to know before you take Myleran

Do not take Myleran

  • if you are allergic to busulfan or any of the other ingredients of this medicine (listed in section 6)
  • if you have taken Myleran before and it did not work.

Warnings and cautions

The use of Myleran may increase the risk of other tumor diseases (type of cancer).

Talk to your doctor before taking Myleran if:

  • you are a man and planning to have children, see section Pregnancy, breastfeeding and fertility
  • if you are undergoing or have recently undergone radiation therapy or any other chemotherapy , or if you have ever had a stem cell transplant . Because you have a higher risk of developing severe liver problems (venous occlusive liver disease)
  • you have excess uric acid in your blood or gout , which can cause joint pain
  • you have problems with your liver, kidneys or lungs.

Other drugs and Myleran

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

The following medicines may affect or be affected by Myleran:

  • Other cytostatics
  • Phenytoin ( antiepileptic medicine )
  • Vaccines that contain living organisms (eg oral polio, measles, mumps and rubella)
    – Myleran may make your body less likely to fight infection .
  • Itraconazole (medicine used to treat fungal infections)
  • Metronidazole (medicine for bacterial infections)
  • Cyclophosphamide (used for certain types of blood disorders)
  • Paracetamol (painkiller and antipyretic)
  • Deferasirox (a drug that removes excess iron from the body).

Also, tell your doctor if you are going to be vaccinated as vaccination with live vaccines should be avoided when the immune system is weakened.

Pregnancy, breastfeeding and fertility

Myleran can cause menstruation to stop and can damage sperm, egg cells, and/or the fetus. Reliable contraceptives MUST therefore be used to avoid pregnancy while you or your partner are being treated with Myleran.

Breast-feeding should be discontinued during treatment with Myleran.

Myleran can cause sterility in both men and women. Before treatment, talk to your doctor about preserving sperm.

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.

Driving and using machines

There is no data on the effect of Myleran on 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 sharpened vigilance. 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. If you are not sure, talk to your doctor or pharmacist.

Myleran contains excipients

Myleran contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

How to take Myleran

Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.

Myleran should only be given by a specialist doctor who has experience in the treatment of cancer.

The dose is determined by your doctor, who will tailor it for you.

Your doctor will regularly check your blood counts (the number of blood cells in your blood) during treatment. Depending on the test result, your doctor may change your dose during treatment.

Chronic myeloid leukemia


At the beginning of treatment, the dose is one up to 4 mg, depending on how much you weigh.
A course of treatment normally lasts 12-20 weeks. After treatment, your doctor will continue to check your blood levels. If necessary, you will receive another round of treatment with Myleran.

You can also get Myleran as maintenance treatment. This means that you get a lower dose that is given for a long time. The usual maintenance dose is between 0.5 mg and 2 mg per day. If your dose is less than 2 mg every day, your doctor may ask you to only take the tablets on certain days.

The tablet should not be divided.

If you take more Myleran than you should

If you have ingested too much Myleran or if e.g. a child ingested the medicine by mistake, contact a doctor, hospital, or the Poison Information Center for risk assessment and advice. Take the medicine pack with you, even if there are no tablets left.

If you forget to take Myleran

Tell your doctor about this. DO NOT take a double dose to make up for a forgotten dose.

If you stop taking Myleran

Do not stop taking Myleran without talking to your doctor.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you get any of the following symptoms, consult a doctor or go directly to the hospital:

  • fever or signs of infection such as sore throat, sore mouth or difficulty urinating. This may be because you have a decrease in the number of white blood cells ( leukopenia ) in your blood, which is a very common side effect of treatment with Myleran. White blood cells fight infection , and when there are too few white blood cells , infection can occur.
  • unexpected bruising or bleeding. This may be because you have a decrease in the number of platelets ( platelets ) in your blood, which is a very common side effect of treatment with Myleran. Platelets help the blood to coagulate and when there are too few platelets , bruising and bleeding can be easier.
  • Fatigue, fainting, dizziness, paleness and shortness of breath. This may be because you have a decrease in red blood cell count ( anemia ), which is a rare side effect of treatment with Myleran. Red blood cells carry oxygen around your body.

Other side effects that may occur:

Very common (may affect more than 1 user in 10)

  • in boys and men, sperm production may be delayed, reduced or stopped and the testicles may decrease in size
  • in girls, the onset of puberty may be delayed or prevented
  • inflammation of the lungs without signs of infection – this is called idiopathic pneumonia syndrome
  • reduction in the number of blood cells and platelets

Common (may affect up to 1 in 10 people)

  • leukemia (blood cancer)
  • your heart may not be able to beat properly – especially if you have an inherited blood disease called thalassemia
  • patchy darker skin
  • inflammation of the lungs that causes shortness of breath, cough and fever
  • signs of blood in the urine and pain when urinating ( inflammation of the bladder) – at the same time as you are taking a medicine called cyclophosphamide

Uncommon (may affect up to 1 in 100 people)

  • in women, menstruation may cease, fertility may be affected and menopause may begin early.

Rare (may affect up to 1 in 1,000 people)

  • connective tissue in the lungs ( pulmonary fibrosis ) that can cause shortness of breath and dry cough
  • cataracts and other eye problems
  • yellowing of the whites of the eyes or the skin (jaundice)
  • hair loss
  • nausea, vomiting, diarrhea, cold sores
  • seizures
  • dry mouth
  • abnormal development of certain types of cells (dysplasia)
  • problems with skin and mucous membranes such as dryness, itching , rash or inability to sweat normally (anhidrosis)
  • radiation skin damage in patients receiving radiation therapy

Very rare (may affect up to 1 in 10,000 people)

  • muscle weakness that can cause drooping eyelids, speech difficulties or difficulty using the arms and legs – ( myasthenia gravis )
  • connective tissue in the heart (endocardial fibrosis )
  • enlarged breasts in men

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

  • incomplete tooth development

How to store Myleran

  • 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 carton. The expiration date is the last day of the specified month.
  • 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.

Contents of the pack and other information

Content declaration

What Myleran contains

  • The active substance is busulfan. One tablet contains 2 mg busulfan.
  • The other ingredients are lactose (anhydrous) 92.5 mg, magnesium stearate, pregelatinized starch , hypromellose, titanium dioxide (dye E171), triacetin.

What the medicine looks like and contents of the pack

Myleran film-coated tablets are white, round, cupped tablets, 6.5 mm in diameter, marked with

GX EF3 on one side and M on the other.

The tablets are supplied in a brown glass jar with a child-resistant lid containing 100 tablets.

Marketing Authorization Holder and Manufacturer

Aspen Pharma Trading Limited

3016 Lake Drive,

Citywest Business Campus

Dublin 24, Ireland


Excella GmbH & Co. KG

Nürnberger Strasse 12

90537, Feucht, Germany

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