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Vemlidy▼ (tenofovir alafenamide fumarate) - patient safety update

Vemlidy▼, for Hepatitis B and Hepatitis from Gilead

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:
  • hands
  • feet
  • area around the eyes
  • lips and tongue
  • genitals
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.

You can follow developments on Vemlidy by using our Medicines Tracker service which provides users with updates about the medicines they are interested in.

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.

Sources
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.
Accessed 12/07/19
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 system.

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.


Disclaimer: This site is designed to offer information for general educational purposes only. The health information furnished on this site and the interactive responses are not intended to be professional advice and are not intended to replace personal consultation with a qualified physician, pharmacist, or other healthcare professional. We cannot provide individual medical advice. You must always seek the advice of a professional for questions related to a disease, disease symptoms, and appropriate therapeutic treatments.


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