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administer a vaccine against meningococcal infection if it was not previously administered or if your vaccination is outdated.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
For adults:
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).
- Maintenance phase:
- In the fifth week, your doctor will administer an intravenous infusion of diluted BEKEMV at a dose of 900 mg (3 vials of 30 mL) over a 25 – 45 minute (35 minutes ± 10 minutes) period.
- After the fifth week, your doctor will administer 900 mg of diluted BEKEMV every two weeks as a long-term treatment.
If you use this medicine to treat aHUS
For adults:
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).
- Maintenance phase:
- In the fifth week, your doctor will administer an intravenous infusion of diluted BEKEMV at a dose of 1,200 mg (4 vials of 30 mL) over a 25 – 45 minute (35 minutes ± 10 minutes) period.
- After the fifth week, your doctor will administer 1,200 mg of diluted BEKEMV every two weeks as a long-term treatment.
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.
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