Patient Medication Information: uses, side effects, how to take - Bekemv
Serious Warnings and Precautions
Bekemv increases the risk of serious infections including meningococcal infections. There have been reports of serious meningococcal infections including death, in patients treated with eculizumab. Meningococcal infections can quickly cause death, deafness, brain damage and/or loss of limbs, especially if not recognized and treated early.
- You must be vaccinated with meningococcal vaccines prior to, or at the time of, initiating Bekemv, unless the risks of delaying Bekemv therapy outweigh the risks of developing a meningococcal infection; you may be revaccinated according to current medical guidelines for vaccine use.
- You must be monitored for early signs of meningococcal infections, evaluated immediately if infection is suspected, and treated with antibiotics, if necessary.
- Vaccination may not prevent all meningococcal infections.
If you experience any of the following symptoms, you should immediately inform your doctor:
- headache with nausea or vomiting
- headache and a fever
- headache with a stiff neck or stiff back
- fever
- fever and a rash
- confusion
- muscle aches with flu-like symptoms
- eyes sensitive to light
What is Bekemv used for?
Bekemv is used to treat patients with:
- Chronic atypical Hemolytic Uremic Syndrome (atypical HUS), a very rare disease that affects the blood system, kidney and sometimes other body organs
How does Bekemv work?
The active substance in Bekemv, eculizumab, is a monoclonal antibody that blocks part of your immune system called the C5 complement protein.
In patients with atypical HUS, the complement proteins are over-active and damage the patients’ own blood cells. Bekemv works by preventing complement proteins from damaging blood cells.
Bekemv also lowers the ability of your immune system to fight infection.
What are the ingredients in Bekemv?
Medicinal ingredients: eculizumab
Non-medicinal ingredients: acetic acid (glacial), disodium edetate (EDTA), polysorbate 80, sodium hydroxide (may be used to adjust pH), sorbitol, Water for Injection.
Bekemv comes in the following dosage forms:
Bekemv is supplied as 300 mg single-use vials each containing 30 mL of 10 mg / mL sterile, preservative-free eculizumab solution.
Do not use Bekemv if:
- You have any allergies to this drug or its ingredients
- Your doctor confirms a serious infection, such as an active Neisseria meningitidis infection (in the brain, spinal cord or blood)
- You have not received a meningococcal vaccine prior to or at the time of initiating treatment
Your baby or child is below 2 years of age, who may not yet be diagnosed with hereditary fructose intolerance (HFI), and medicines containing sorbitol/fructose given intravenously can be life-threatening. Therefore, Bekemv must not be used in children younger than 2 years of age.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take Bekemv. Talk about any health conditions or problems you may have, including if you or your child:
- Have a disease that alters your immune system (such as HIV/AIDS) or take medication that alters your immune system (such as prednisone)
- Have hereditary fructose intolerance (HFI), a rare genetic disorder. Sorbitol is a source of fructose. Patients with HFI cannot break down fructose in this medicine, which may cause serious or life-threatening side effects. You must tell your healthcare professional if you or your child can no longer take sweet foods or drinks because you or your child feel sick, vomit or get unpleasant effects such as bloating, stomach cramps or diarrhea. Patients with HFI must not receive Bekemv unless strictly necessary.
Other warnings you should know about:
Fungal infections caused by Aspergillus have occurred in immunocompromised patients with abnormally low white blood cells. Inform your doctor before you take Bekemv if you have any infections.
Allergic Reactions:
Serious allergic reactions can happen during your Bekemv infusion. Tell your doctor or nurse immediately if you get any of these symptoms during your Bekemv infusion:
- Chest pain
- Trouble breathing or shortness of breath
- Swelling of your face, tongue or throat
- Feel faint or pass out
Pregnancy and Nursing:
Data in pregnant women treated with eculizumab from clinical trials and post-marketing setting, including the atypical HUS registry, indicate eculizumab is unlikely to increase the risk of harm to the fetus. Bekemv may be considered during pregnancy, if clinically needed. Tell your doctor if you are pregnant or nursing.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
How to take Bekemv:
Bekemv is given through a vein [“I.V.” or “intravenously”], usually over 35 minutes, and must be administered by a healthcare professional.
Usual dose:
The usual dose of Bekemv for adult patients with atypical HUS is:
- 900 mg of Bekemv weekly for the first 4 weeks, followed by
- 1200 mg of Bekemv for the fifth dose 1 week later, then
- 1200 mg of Bekemv every 2 weeks thereafter
If you are less than 18 years of age, the usual dose of Bekemv for atypical HUS will be based on your body weight according to the following schedule:
| Patient Body Weight | Induction | Maintenance |
|---|---|---|
| 40 kg and over | 900 mg weekly x 4 doses | 1200 mg at week 5; then 1200 mg every 2 weeks |
| 30 kg to less than 40 kg | 600 mg weekly x 2 doses | 900 mg at week 3; then 900 mg every 2 weeks |
| 20 kg to less than 30 kg | 600 mg weekly x 2 doses | 600 mg at week 3; then 600 mg every 2 weeks |
| 10 kg to less than 20 kg | 600 mg weekly x 1 dose | 300 mg at week 2; then 300 mg every 2 weeks |
| 5 kg to less than 10 kg | 300 mg weekly x 1 dose | 300 mg at week 2; then 300 mg every 3 weeks |
Bekemv should be administered at the recommended dates or within 48 hours of the recommended date. Your doctor should know by blood tests if Bekemv is working.
Overdose:
Bekemv should be given by a healthcare professional. This minimizes the chance of an overdose. No cases of overdose were seen in clinical studies.
If you think you, or a person you are caring for, have taken too much Bekemv, contact a healthcare professional, hospital emergency department, or regional poison control centre immediately, even if there are no symptoms.
Missed Dose or Stopping Treatment:
Tell your doctor right away if you have missed a dose or if you are considering stopping treatment. Stopping treatment with Bekemv may cause side effects.
If you have atypical HUS and miss a dose of Bekemv, your blood clotting may be abnormal, causing symptoms including:
- Stroke
- Confusion
- Seizure
- Chest pain
- Trouble breathing
- Kidney problems
- Swelling in arms or legs
- A drop in your platelet count which may cause easy bleeding and easy bruising
If you have atypical HUS, your doctor will need to monitor you closely during treatment and for at least 12 weeks after stopping Bekemv for signs of worsening atypical HUS symptoms or problems related to abnormal clotting.
What are possible side effects from using Bekemv?
These are not all the possible side effects you may have when taking Bekemv. If you experience any side effects not listed here, tell your healthcare professional.
In all clinical studies, including atypical HUS clinical trials, the most serious side effect was meningococcal sepsis, which is a common presentation of meningococcal infections in patients treated with eculizumab.
- You must be vaccinated with meningococcal vaccines prior to, or at the time of, initiating Bekemv, unless the risks of delaying Bekemv therapy outweigh the risks of developing a meningococcal infection; you may be revaccinated according to current medical guidelines for vaccine use.
- You must be monitored for early signs of meningococcal infections, evaluated immediately if infection is suspected, and treated with antibiotics, if necessary.
- Vaccination may not prevent all meningococcal infections.
- You must carry your Patient Safety Card at all times. If you experience any symptoms listed in your patient safety card, immediately seek medical care.
The most common side effects in people with atypical HUS treated with eculizumab include high blood pressure, diarrhea, headache, nausea, vomiting, low white blood cell count, bladder infection, hair loss, cold sore, low lymphocyte count, cough, joint pain, weakness, and viral infection.
The most common side effects in children with atypical HUS treated with eculizumab include common viral cold, and rash.
Serious side effects and what to do about them
| Serious side effects and what to do about them | |||
|---|---|---|---|
| Serious side effects and what to do about them | |||
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| Only if severe | In all cases | ||
| VERY COMMON | |||
| Headache | X | ||
| Flu-like illness | X | ||
| COMMON | |||
| High blood pressure | X | ||
| Low white blood cell count | X | ||
| Infection of the lung (pneumonia) | X | ||
| Respiratory tract infection | X | ||
| Infection of the urinary system (urinary tract infection) | X | ||
| Rash | X | ||
| Abdominal discomfort or pain | X | ||
| Agitation | X | ||
| Anemia | X | ||
| Chills | X | ||
| Deafness | X | ||
| Diarrhea | X | ||
| Fever | X | ||
| Light-headedness (dizziness) | X | ||
| Low blood pressure | X | ||
| Infection | X | ||
| UNCOMMON | |||
| Meningococcal infection including Meningococcal sepsis | X | X | |
| Fungal infection | X | ||
| Serious allergic reaction which causes difficulty in breathing or dizziness (anaphylactic reaction) | X | ||
| Hypersensitivity | X | ||
| Breathing difficulty | X | ||
| Inflammation of the peritoneum (the tissue that lines most of the organs of the abdomen) | X | ||
| Increase of liver enzymes | X | ||
| Relatively few platelets in blood (thrombocytopenia) | X | ||
| Kidney disorder | X | ||
| Muscle aches | X | ||
| Neck pain | X | ||
| Pain in extremity | X | ||
| Swelling (Face or Leg) | X | ||
| RARE | |||
| Jaundice | X | ||
| Disease with thyroid overactivity (Basedow’s disease) | X | ||
| Menstrual disorder | X | ||
| Infusion related reaction | X | ||
| Blood in urine | X | ||
| Blood clot in vein | X | ||
| Bone marrow disorder | X | ||
| Bacterial sexual transmitted disease | X | ||
| Skin tumour (melanoma) | X | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
- Visiting the Web page on Adverse Reaction Reporting (https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html) for information on how to report online, by mail or by fax; or
- Calling toll-free at 1-866-234-2345.
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.
Storage:
Store in original carton in a refrigerator (2°C - 8°C).
Protect from light.
Vial in original carton can stay at room temperature (not more than 30°C) for only one single period up to 7 days.
Do not use past the expiry date stamped on the carton.
DO NOT FREEZE. DO NOT SHAKE.
Keep out of reach and sight of children.
If you want more information about Bekemv:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website, www.amgen.ca; or by calling toll-free,1-866-502-6436.