This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PLGB 13832/0077.
BEKEMV 300 mg concentrate for solution for infusion
▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.
1. What BEKEMV is and what it is used for
2. What you need to know before you use BEKEMV
3. How to use BEKEMV
4. Possible side effects
5. How to store BEKEMV
6. Contents of the pack and other information
BEKEMV contains the active substance eculizumab and it belongs to a class of medicines called monoclonal antibodies. Eculizumab binds to and inhibits a specific protein in the body that causes inflammation and so prevents your body’s systems from attacking and destroying vulnerable blood cells or kidneys.
Paroxysmal Nocturnal Haemoglobinuria
BEKEMV is used to treat adults and children with a certain type of disease affecting the blood system called Paroxysmal Nocturnal Haemoglobinuria (PNH). In patients with PNH, their red blood cells can be destroyed which can lead to low blood counts (anaemia), tiredness, difficulty in functioning, pain, dark urine, shortness of breath, and blood clots. Eculizumab can block the body’s inflammatory response, and its ability to attack and destroy its own vulnerable PNH blood cells.
Atypical Haemolytic Uraemic Syndrome
BEKEMV is also used to treat adults and children with a certain type of disease affecting the blood system and kidney called atypical Haemolytic Uraemic Syndrome (aHUS). In patients with aHUS, their kidney and blood cells, including platelets, can be inflamed which can lead to low blood counts (thrombocytopenia and anaemia), reduced or lost kidney function, blood clots, tiredness and difficulty in functioning. Eculizumab can block the body’s inflammatory response, and its ability to attack and destroy its own vulnerable blood and kidney cells.
Meningococcal and other Neisseria infections alert
BEKEMV treatment may reduce your natural resistance to infections, especially against certain organisms that cause meningococcal infection (severe infection of the linings of the brain and sepsis) and other Neisseria infections including disseminated gonorrhoea.
Consult your doctor before you take BEKEMV to be sure that you receive vaccination against Neisseria meningitidis, an organism that causes meningococcal infection, at least 2 weeks before beginning therapy, or that you take antibiotics to reduce the risk of infection until 2 weeks after you have been vaccinated.
Ensure that your current meningococcal vaccination is up to date. You should also be aware that vaccination may not prevent this type of infection. In accordance with national recommendations, your doctor might consider that you need supplementary measures to prevent infection.
If you are at risk of gonorrhoea, ask your doctor or pharmacist for advice before using this medicine.
Meningococcal infection symptoms
Because of the importance of rapidly identifying and treating certain types of infection in patients who receive BEKEMV, you will be provided a card to carry with you, listing specific trigger symptoms.
This card is named: “Patient Safety Card”.
If you experience any of the following symptoms, you should immediately inform your doctor:
Treatment for meningococcal infection while travelling
If you are travelling in a remote region where you are unable to contact your doctor or in which you find yourself temporarily unable to receive medical treatment, your doctor can make arrangements to issue, as a preventive measure, a prescription for an antibiotic to counter Neisseria meningitidis that you keep with you. If you experience any of the symptoms amongst those cited above, you should take the antibiotics as prescribed. You should bear in mind that you should see a doctor as soon as possible, even if you feel better after having taken the antibiotics.
Before starting BEKEMV, inform your doctor if you have any infections.
BEKEMV contains a protein and proteins can cause allergic reactions in some people.
Patients less than 18 years of age must be vaccinated against Haemophilus influenzae and pneumococcal infections.
There are no special precautions needed for the treatment of patients aged from 65 years and over.
Tell your doctor or pharmacist if you are using or have recently used or might use any other medicines.
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Women of childbearing potential
The use of effective contraception during treatment and up to 5 months after treatment should be considered in women who are able to get pregnant.
BEKEMV has no or negligible influence on the ability to drive and use machines.
This medicine contains 50 mg sorbitol in each mL.
Sorbitol is a source of fructose. If you (or your child) have hereditary fructose intolerance (HFI), a rare genetic disorder, you (or your child) must not receive this medicine. Patients with HFI cannot break down fructose, which may cause serious side effects.
You must tell your doctor before receiving this medicine if you (or your child) have HFI or if your child can no longer take sweet foods or drinks because they feel sick, vomit or get unpleasant effects such as bloating, stomach cramps or diarrhoea.
This medicine contains less than 1 mmol of sodium (23 mg) per dose, that is to say essentially “sodium free”.
At least 2 weeks before you start treatment with BEKEMV, your doctor will administer a vaccine against meningococcal infection if it was not previously administered or if your vaccination is outdated. If your child is below the age of vaccination or if you are not vaccinated at least 2 weeks before you start treatment with BEKEMV, your doctor will prescribe antibiotics to reduce the risk of infection until 2 weeks after you have been vaccinated.
Your doctor will administer a vaccine to your child aged less than 18 years against Haemophilus influenzae and pneumococcal infections according to the national vaccination recommendations for each age group.
The treatment will be given by your doctor or other health care provider by infusing a dilution of the BEKEMV vial from a drip bag through a tube directly into one of your veins. It is recommended that the beginning of your treatments, called the initial phase, will extend over 4 weeks, followed by a maintenance phase.
If you use this medicine to treat PNH
Every week for the first four weeks, your doctor will administer an intravenous infusion of diluted BEKEMV. Each infusion will consist of a dose of 600 mg (2 vials of 30 mL) and will take 25 - 45 minutes (35 minutes ± 10 minutes).
If you use this medicine to treat aHUS
Every week for the first four weeks, your doctor will administer an intravenous infusion of diluted BEKEMV. Each infusion will consist of a dose of 900 mg (3 vials of 30 mL) and will take 25 – 45 minutes (35 minutes ± 10 minutes).
For children and adolescents:
Children and adolescents with PNH or aHUS and who are 40 kg weight and over are treated with the adult dosing.
Children and adolescents with PNH or aHUS and who are under 40 kg weight require a lower dose based on how much they weigh. Your doctor will calculate this.
For children and adolescents with PNH or aHUS above 2 years of age and with body weight below 40 kg:
Patient body weight – 30 to < 40 kg
Initial phase – 600 mg weekly x 2
Maintenance phase – 900 mg at week 3; then 900 mg every 2 weeks
Patient body weight – 20 to < 30 kg
Initial phase – 600 mg weekly x 2
Maintenance phase – 600 mg at week 3; then 600 mg every 2 weeks
Patient body weight – 10 to < 20 kg
Initial phase – 600 mg weekly x 1
Maintenance phase – 300 mg at week 2; then 300 mg every 2 weeks
Patient body weight – 5 to < 10 kg
Initial phase – 300 mg weekly x 1
Maintenance phase – 300 mg at week 2; then 300 mg every 3 weeks
Subjects who undergo plasma exchange may receive additional doses of BEKEMV.
Following each infusion, you will be monitored for about one hour. Your doctor’s instructions should be carefully observed.
If you suspect that you have been accidentally administered a higher dose of BEKEMV than prescribed, please contact your doctor for advice.
If you forget an appointment, please contact your doctor immediately for advice and see section below “If you stop using BEKEMV”.
Interrupting or ending treatment with BEKEMV may cause your PNH symptoms to come back more severely soon. Your doctor will discuss the possible side effects with you and explain the risks. Your doctor will want to monitor you closely for at least 8 weeks.
The risks of stopping BEKEMV include an increase in the destruction of your red blood cells, which may cause:
If you have any of these symptoms, contact your doctor.
Interrupting or ending treatment with BEKEMV may cause your aHUS symptoms to come back. Your doctor will discuss the possible side effects with you and explain the risks. Your doctor will want to monitor you closely.
The risks of stopping BEKEMV include an increase in the inflammation of your platelets, which may cause:
If you have any of these symptoms, contact your doctor.
Like all medicines, this medicine can cause side effects, although not everybody gets them. Your doctor will discuss the possible side effects with you and explain the benefits and risks of BEKEMV with you prior to treatment.
The most serious side effect was meningococcal sepsis. If you experience any of the meningococcal infection symptoms (see section 2 Meningococcal and other Neisseria infections alert), you should immediately inform your doctor.
If you are not sure what the side effects below are, ask your doctor to explain them to you.
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare (may affect up to 1 in 1,000 people)
If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly (see details below). By reporting side effects you can help provide more information on the safety of this medicine.
Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store
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 after “EXP”. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C – 8°C). Do not freeze.
BEKEMV vials in the original package may be removed from refrigerated storage for only one single period of up to 7 days. At the end of this period the product can be put back in the refrigerator.
Store in the original package in order to protect from light. After dilution, the product should be used within 24 hours.
Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
BEKEMV is presented as a concentrate for solution for infusion (30 mL in a vial – pack size of 1).
BEKEMV is a clear to slightly opalescent, colourless to slightly yellow solution.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Tel: +44 (0)1223 420305
This leaflet was last revised in November 2023.