Gilead,the manufacturers of hepatitis B treatment tenofovir alafenamide fumarate, brand name Vemlidy▼, have added angioedema and urticaria as adverse reactions. This follows a safety review conducted by Gilead, concluding the causal association of these two reactions with tenofovir alafenamide fumarate containing products.
Angioedema is swelling underneath the skin. It's usually a reaction to a trigger, such as a medication or something you're allergic to.
It isn't normally serious, but it can be a recurring problem for some people and can very occasionally be life-threatening if it affects breathing.
Symptoms of angioedema
The swelling most often affects the:
- area around the eyes
- lips and tongue
Many people also have a raised, itchy rash called urticaria (hives).
In more serious cases, angioedema can also cause breathing difficulties, tummy (abdominal) pain and dizziness.
Urticaria is also known as hives. Hives are rashes that can be different sizes and shapes, and appear anywhere on the body in both adults and children.
The rash is often itchy and sometimes feels like it's stinging or burning.
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About Vemlidy (source EMA)
Vemlidy is an antiviral medicine for treating chronic (long-term) hepatitis B, an infectious disease that affects the liver.
This medicine is used in patients aged 12 years and older weighing at least 35 kg. It contains the active substance tenofovir alafenamide.
The active substance in Vemlidy, tenofovir alafenamide, works by stopping the hepatitis B virus in the liver from multiplying. It is converted in the body into its active compound tenofovir, which blocks the activity of reverse transcriptase, an enzyme made by the hepatitis B virus that allows it to reproduce itself in the cells it has infected.
Vemlidy was first made available in the EU in 2017. It is manufactured by Gilead.
European Medicines Agency website page for Vemlidy
NHS website for angioedema and hives
Contains public sector information licensed under the Open Government Licence v3.0.
Links available in full article
EMA product information about Vemlidy
New medicines and vaccines that are under additional monitoring have an inverted black triangle symbol (▼) displayed in their package leaflet and summary of product characteristics, together with a short sentence explaining what the triangle means – it does not mean the medicine is unsafe. You should report all suspected adverse drug reactions (ADRs) for these products. ADRs can be reported by your doctor, pharmacist or online via the Yellow Card
Reporting of suspected adverse reactions
Reporting suspected adverse reactions (side effects) after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals or patients are asked to report any suspected adverse reactions via the Yellow Card Scheme at yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store.
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About Hepatitis B