6 mg / ml concentrate for solution for infusion solution 
busulfan

Read all of this leaflet carefully before you start using 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.

– If you get any side effects, talk to your doctor. This also applies to any side effectsnot mentioned in this information.

In this leaflet: 
1. What Busilvex is and what it is used for 
2. What you need to know before you use Busilvex 
3. How to use Busilvex 
4. Possible side effects 
5. How to store Busilvex 
6. Contents of the packaging and other information 

1. What Busilvex is and what it is used for

Busilvex contains the active substance busulfan, which belongs to a group of medicines called alkylating agents. Busilvex destroys the original bone marrow before transplantation.

Busilvex is used in adults, newborns, children, and adolescents as a pre-transplant treatment.

Busilvex is used in adults in combination with cyclophosphamide or fludarabine.

For newborns, infants, and young people, Busilvex is used in combination with cyclophosphamide or melphalan.

You will receive this preparatory medicine before receiving a transplant of either bone marrow or hematopoietic stem cells.

2. What you need to know before you use Busilvex

Do not use Busilvex

  • if you are allergic to busulfan or any of the other ingredients of this medicine (listed in section 6)
  • if you are pregnant or suspect you may be pregnant.

Warnings and cautions

Busilvex is a powerful antitumor drug that greatly reduces the number of blood cells. This is the desired effect at the recommended dose. Close monitoring and follow-up will therefore be done. It is possible that the use of Busilvex may increase the risk of another tumor disease in the future.

Tell your doctor:

  • if you have liver, kidney, heart, or lung problems
  • if you have had seizures before
  • if you are currently taking other medicines.

Blood clots can form in the small blood vessels after hematopoietic cell transplantation (HCT) if a high dose of your treatment is given with other medicines.

Other medicines and Busilvex

Tell your doctor if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription. Busilvex can affect or be affected by other medicines.

Take special care with itraconazole and metronidazole (used for certain types of infections ) or ketobemidone (used to treat pain) as these may increase the side effects.

Use of paracetamol within 72 hours before or during Busilvex treatment should be done.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using this medicine. Women must not be pregnant during treatment with Busilvex and for up to 6 months after treatment. Women must stop breast-feeding before starting treatment with Busilvex.

Appropriate contraception should be used when either partner is being treated with Busilvex.

There is a risk that you can no longer become pregnant after treatment with busulfan ( infertility ).

If you are worried about not being able to have children, you should discuss this with your doctor before treatment.

Busilvex can also cause menopausal-like symptoms and can prevent young girls from entering puberty.

Men treated with Busilvex are advised not to have children during and up to 6 months after treatment.

3. How to use Busilvex

Dosage and administration:

Dose a Busilvex will be calculated according to your body weight.

Adults:

Busilvex in combination with cyclophosphamide:

  • The recommended dose of Busilvex is 0.8 mg/kg
  • Each infusion will last for 2 hours
  • Busilvex will be given every 6 hours for 4 consecutive days before transplantation.

Busilvex in combination with fludarabine:

  • The recommended dose of Busilvex is 3.2 mg/kg
  • Each infusion will last for 3 hours
  • Busilvex will be given once daily for 2 to 3 consecutive days before transplantation.

Newborns, children, and adolescents (0-17 years):

The recommended dose of Busilvex in combination with cyclophosphamide or melphalan is calculated according to your body weight and varies between 0.8 and 1.2 mg/kg.

  • Each infusion will last for 2 hours.
  • Busilvex will be given every 6 hours for 4 consecutive days before transplantation.

Medications before you receive Busilvex:

Before you receive Busilvex you will receive

  • anticonvulsants to prevent seizures ( phenytoin or benzodiazepines) and
  • medicines to prevent vomiting.

4. Possible side effects

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

Serious side effects:

The most serious side effects of Busilvex treatment or transplantation are a decrease in the number of circulating blood cells (which is the intended effect of the medicine to prepare you for your transplant infusion), infection , liver disease including stoppage of a hepatic vein, transplant- versus-host-disease ( transplant et attacks your body) and lung complications. Your doctor will monitor your blood levels and liver enzymes regularly to detect and treat these side effects.

Other side effects that may occur:

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

Blood: reduction in the number of circulating blood cells (red and white) and platelets. Infection is. Nervous system: insomnia, anxiety, dizziness, and depression. Nutrition: loss of appetite, decreased magnesium, calcium, potassium , phosphate, albumin in the blood, and increased blood sugar. Heart: increased heart rate, increase or decrease in blood pressure , vasodilation (a condition of dilation of blood vessels), and blood clots. Lungs: shortness of breath, runny nose), sore throat, cough, hiccups, nosebleeds, abnormal breathing sounds. Gastrointestinal disorders: nausea, inflammation of the oral mucosa, vomiting, abdominal pain, diarrhea, constipation, heartburn, anal discomfort, fluid in the abdomen. Liver: enlarged liver, jaundice, blockage of a hepatic vein. Skin: rash, itching, hair loss. Muscles and bones: back, muscle, and joint pain. Kidneys: increased excretion of creatinine, discomfort when urinating, decreased amounts of urine, and blood in the urine. General: fever, headache, weakness, chills, pain, allergic reaction, edema, general pain inflammation at the injection site, chest pain, inflammation of the mucous membrane. Examinations: elevated liver enzymes and weight gain.

Common (may affect up to 1 in 10 people):

Nervous system: confusion, diseases of the nervous system. Nutrition: low sodium in the blood. Heart: altered and abnormal heart rhythm, fluid or inflammation around the heart, decreased flow from the heart. Lungs: increase in respiratory rhythm, respiratory failure, alveolar hemorrhage, asthma, collapse of small parts of the lung, fluid around the lung. Gastrointestinalinflammation of the esophageal mucosa, intestinal paralysis, vomiting of blood. Skin: changes in skin color, skin redness, peeling. Kidneys: increase in the number of nitrogen components in the blood, moderate renal impairment, kidney disease.

Uncommon (may affect up to 1 in 100 people):

Nervous system: delirium, nervousness, hallucinations, agitation, abnormal brain function, cerebral hemorrhage, and seizures. Heart: thrombosis of the femoral artery, extra heartbeat, decreased heart rate, diffuse leakage of fluid from the capillaries (small blood vessels). Lungs: decreased oxygen content in the blood. Gastrointestinal: bleeding in the stomach and/or intestines.

No known frequency (cannot be calculated from the available data)

Impaired function in the gonads.

Visual disturbances including cloudiness of the lens of the eye ( cataracts ) and blurred vision (thinning of the cornea of the eye ).

Symptoms such as menopause and infertility in women.

Brain abscess, dermatitis, the spread of infection.

Liver disease.

An increased amount of lactate dehydrogenase in the blood.

The increased amount of uric acid and urea in the blood.

Incomplete development of teeth.

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 Busilvex

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 and carton after EXP.

Unopened vial:

Store in a refrigerator (2 ° C – 8 ° C).

Diluted solution:

Chemical and physical in-use stability after dilution with 5% glucose or 9 mg/ml (0.9%) sodium chloride solution for injection has been demonstrated for 8 hours (including infusion time) after dilution when stored at 20 ° C ± 5 ° C or 12 hours after dilution when stored at 2 ° C – 8 ° C followed by 3 hours at 20 ° C ± 5 ° C (including infusion time).

Do not freeze.

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 busulfan. One ml of concentrate contains 6 mg of busulfan (60 mg in the vial). After dilution: One ml of solution contains about 0.5 mg of busulfan.
  • The other ingredients are dimethylacetamide and macrogol 400.

What the medicine looks like and the contents of the pack

Busilvex consists of an infusion concentrate and is supplied in colorless glass vials, each containing 60 mg of busulfan.

Busilvex is supplied in a multiple packs consisting of two cartons, each containing four vials.

After dilution, Busilvex is a clear, colorless solution.

Marketing Authorisation Holder:

Pierre Fabre Medicament

45, Place Abel Gance

F-92654 Boulogne-Billancourt Cedex

France

Manufacturer:

Pierre Fabre Medicament Production, Aquitaine Pharm International

Avenue du Béarn

F-64320 Idron

France

For further information on this medicine, please contact the Marketing Authorization Holder.

Muhammad Nadeem

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