Patient leaflet - BYLVAY 200 MICROGRAMS HARD CAPSULE
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Bylvay contains the active substance odevixibat. Odevixibat is a medicine which increases the removal of substances called bile acids from the body. Bile acids are components of the digestive fluid called bile, which is produced by the Liver and secreted into the intestines. Odevixibat blocks the mechanism that normally reabsorbs them from the intestines after they have done their job. This allows them to pass out of the body in the stool.
Bylvay is used to treat progressive familial intrahepatic cholestasis (PFIC) in patients aged 6 months or older. PFIC is a Liver disease caused by build-up of bile acids (cholestasis) that gets worse over time and is often accompanied with severe itching.
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Do not take Bylvay
- if you are allergic to odevixibat or any of the other ingredients of this medicine (Listed in section 6)
Warnings and precautions
Talk to your doctor or pharmacist before taking Bylvay if you have:
- been diagnosed with a complete absence or Lack of function of bile salt export pump protein
- severely reduced Liver function
- reduced stomach or bowel motility, or reduced circulation of bile acids between Liver, bile and small intestine due to medicines, surgical procedures or diseases other than PFIC since these may reduce the effect of odevixibat
Talk to your doctor if you develop diarrhoea while taking Bylvay. Drinking sufficient Liquid is recommended in patients with diarrhoea to prevent dehydration.
Increased Levels in Liver function tests can occur in some patients receiving ByLvay. Assessment of Liver function is recommended for all patients prior to ByLvay treatment. Your doctor may recommend more frequent monitoring if you have elevated Liver function test results.
Your doctor may recommend assessment of Vitamin A, D and E blood Levels and the blood clotting value called INR prior to and during ByLvay treatment.
Children
ByLvay is not recommended for babies under 6 months because it is not known if the medicine is safe and effective in this age group.
Other medicines and Bylvay
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.
Treatment with odevixibat may affect the absorption of fat-soluble vitamins such as Vitamin A, D and E, and some medicines, including oral contraceptives.
Pregnancy and breast-feeding
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 taking this medicine.
Bylvay is not recommended during pregnancy and in women of childbearing potential not using contraception. Use of a barrier contraceptive method is recommended since the uptake of Lipophilic oral contraceptives may be affected by odevixibat.
It is not known if odevixibat can pass into breast milk and affect the baby. Your doctor will help you to decide whether to stop breast-feeding or avoid Bylvay treatment, considering the benefit of breast-feeding to the baby and Bylvay to the mother.
Driving and using machines
Bylvay has no or negligible influence on the ability to drive or capacity to use machinery.
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Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.
Treatment must be started and supervised by a doctor experienced in the management of progressive Liver disease with reduced bile flow.
The dose of Bylvay is based on your weight. Your doctor will work out the right number and strength of capsules for you to take.
The recommended dose is
- 40 micrograms odevixibat per kilogram body weight once daily
- If the medicine is not working well enough after 3 months, your doctor may increase the dose to 120 micrograms odevixibat per kilogram body weight (up to a maximum of 7 200 micrograms once daily).
No dose differences are recommended for adults.
Method of use
Take the capsules once daily in the morning with or without food.
ALL capsules can be either swallowed whole with a glass of water or opened and sprinkled on food.
The Larger 200 and 600 micrograms capsules are intended to be opened and sprinkled on food but may be swallowed whole.
The smaller 400 micrograms and 1 200 micrograms capsules are intended to be swallowed whole but may be opened and sprinkled on food.
Instructions to open capsules and sprinkle the contents on food:
- Place a small amount of soft food into a bowl (2 tablespoons/30 mL of yoghurt, apple sauce, banana or carrot puree, chocolate pudding, rice pudding or oatmeal porridge). Food should be at or below room temperature.
Hold the capsule horizontally at both ends, twist in opposite directions.
Pull apart to empty the contents into the bowl of soft food.
Gently tap the capsule to ensure that all pellets come out.
Repeat the previous step if the dose requires more than one capsule.
Gently mix the contents of the capsule into the soft food.
- Take the entire dose immediately after mixing. Do not store the mixture for future use.
- Drink a glass of water following the dose.
- Dispose of the empty capsule shells.
If the medicine does not improve your condition after 6 months of continuous daily treatment, your doctor will recommend an alternative treatment.
If you take more Bylvay than you should
Tell your doctor if you think you have taken too much Bylvay.
Possible overdose symptoms are diarrhoea, stomach and bowel problems.
If you forget to take Bylvay
Do not take a double dose to make up for a forgotten dose. Take the next dose at the usual time.
If you stop taking Bylvay
Do not stop taking Bylvay without first discussing with your doctor.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
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Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects may occur with the following frequencies: common (may affect up to 1 in 10 people)
- diarrhoea, including diarrhoea with bloody stool, soft stools
- abdominal (belly) pain
- enlarged Liver
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not Listed in this Leaflet. You can also report side effects directly via the Yellow Card Scheme at:. gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
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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 and bottle after EXP. The expiry date refers to the Last day of that month.
Store in the original package to protect from Light. This medicine does not require any special temperature storage conditions.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no Longer use. These measures will help protect the environment.
Contents of the pack and other information
What Bylvay contains
- The active substance is odevixibat.
Each Bylvay 200 micrograms hard capsule contains 200 micrograms odevixibat (as sesquihydrate).
Each Bylvay 400 micrograms hard capsule contains 400 micrograms odevixibat (as sesquihydrate).
Each Bylvay 600 micrograms hard capsule contains 600 micrograms odevixibat (as sesquihydrate).
Each Bylvay 1200 micrograms hard capsule contains 1200 micrograms odevixibat (as sesquihydrate).
- Other ingredients are:
Capsule content
Microcrystalline cellulose
Hypromellose
Capsule shell
Bylvay 200 micrograms and 600 micrograms hard capsules:
Hypromellose, Titanium dioxide (E171), Yellow iron oxide (E172)
Bylvay 400 micrograms and 1200 micrograms hard capsules: Hypromellose, Titanium dioxide (E171), Yellow iron oxide (E172), Red iron oxide (E172)
Printing ink
Shellac Propylene glycol
Black iron oxide (E172)
What Bylvay looks like and contents of the pack
Bylvay 200 micrograms hard capsules:
Size 0 capsules (21.7 mm x 7.64 mm) with ivory opaque cap and white opaque body; imprinted “A200” with black ink.
Bylvay 400 micrograms hard capsules:
Size 3 capsules (15.9 mm x 5.82 mm) with orange opaque cap and white opaque body; imprinted „A400“ with black ink.
Bylvay 600 micrograms hard capsules:
Size 0 capsules (21.7 mm x 7.64 mm) with ivory opaque cap and body; imprinted „A600“ with black ink.
Bylvay 1200 micrograms hard capsules:
Size 3 capsules (15.9 mm x 5.82 mm) with orange opaque cap and body; imprinted „A1200“ with black ink.
Bylvay hard capsules are packed in a plastic bottle with a tamper evident, child resistant polypropylene closure. Pack size: 30 capsules.
Marketing Authorisation Holder
ALbireo AB,
Albire^
Arvid Wallgrens backe 20
413 46 Goteborg
Sweden
e-mail:
Manufacturer
ALmac Pharma Services Limited,
Seagoe Industrial Estate
Portadown, Craigavon
County Armagh
BT63 5UA
United Kingdom (Northern Ireland)
This leaflet was last revised in 05/2021.
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