Vemlidy

Tenofovir alafenamide.

Vemlidy contains the active substance tenofovir alafenamide. This is an antiviral medicine, known as a nucleotide reverse transcriptase inhibitor (NtRTI).
Excipients/Inactive ingredients: Lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, for tablet core; and polyvinyl alcohol, titanium dioxide, macrogol, talc, iron oxide yellow for film-coating.

Vemlidy is used to treat chronic (long term) hepatitis B in adults and adolescents 12 years of age and older, who weigh at least 35 kg. Hepatitis B is an infection affecting the liver, caused by the hepatitis B virus. In patients with hepatitis B, Vemlidy controls the infection by stopping the virus from multiplying.

Always take this medicine exactly as the doctor has told. Check with the doctor or pharmacist if unsure.
The recommended dose is one tablet once a day. Treatment should continue for as long as the doctor advises. Usually this is for at least 6 to 12 months and may be for many years.
Do not stop taking Vemlidy without the doctor's advice. Stopping treatment with Vemlidy may cause hepatitis B to get worse. In some patients with advanced liver disease or cirrhosis, this could be life threatening. If the patient stops taking Vemlidy, they will need regular health checks and blood tests for several months to check hepatitis B infection.
Talk to the doctor before stopping Vemlidy for any reason, particularly if the patient is experiencing any side effects or they have another illness.
Tell the doctor immediately about new or unusual symptoms after stopping treatment, particularly symptoms associated with hepatitis B infection.
Talk to the doctor before restarting taking Vemlidy tablets.
If there are any further questions on the use of this medicine, ask a doctor or pharmacist.
It is important not to miss a dose of Vemlidy. If a dose is missed, work out how long since they should have taken it.
If it is less than 18 hours after the patient usually take Vemlidy, take it as soon as they can, and then take the next dose at its regular time.
If it is more than 18 hours after the patient usually take Vemlidy, then do not take the missed dose. Wait and take the next dose at the regular time. Do not take a double dose to make up for a forgotten tablet.
If the patient becomes sick (vomit) less than 1 hour after taking Vemlidy, take another tablet. The patient do not need to take another tablet if the patient is sick (vomit) more than 1 hour after taking Vemlidy.

If the patient accidentally takes more than the recommended dose of Vemlidy they may be at an increased risk of experiencing possible side effects with this medicine.
Contact the doctor or nearest emergency department immediately for advice. Keep the tablet bottle so that they can easily describe what the patient have taken.

Do not take Vemlidy if the patient is allergic to tenofovir alafenamide or any of the other ingredients of this medicine.
Vemlidy contains lactose.
Tell the doctor if they are lactose intolerant or intolerant to other sugars. Vemlidy contains lactose monohydrate.

Tell the doctor if the patient has a history of liver disease. Patients with liver disease, who are treated for hepatitis B with antiviral medicines, have a higher risk of severe and potentially fatal liver complications. The doctor may need to carry out blood tests to monitor liver function.
Talk to a doctor or pharmacist if the patient have had kidney disease or if tests have shown problems with their kidneys. Before starting treatment and during treatment, the doctor may order blood tests to monitor how the kidneys work.
Talk to a doctor if the patient has hepatitis C or D. Vemlidy has not been tested on patients who have hepatitis C or D as well as hepatitis B.
Talk to a doctor if the patient has HIV. If they are not sure whether they have HIV, a doctor should offer HIV testing before starting Vemlidy for hepatitis B.
Effects on ability to drive and use machinery: Vemlidy can cause dizziness. If the patient feels dizzy when taking Vemlidy, do not drive and do not use any tools or machines.
Use in Children: Do not give this medicine to children who are under 12 years old or weigh less than 35 kg.
Vemlidy has not been tested in children aged less than 12 years old or weighing less than 35 kg.

If the patient is pregnant or breast feeding, thinks they may be pregnant or are planning to have a baby, ask the doctor for advice before taking this medicine.
Take steps to avoid getting pregnant during treatment with Vemlidy. The patient must use an effective method of contraception. Tell the doctor immediately if they become pregnant.
Do not breast feed during treatment with Vemlidy. It is recommended that the patient do not breast feed to avoid passing tenofovir alafenamide or tenofovir to the baby through breast milk.

Hypersensitivity reaction to tenofovir alafenamide or any of the other ingredients of this medicine.
Undesirable effects that require the patient to inform the doctor. Do not stop taking the medicine.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common side effects (may affect more than 1 in 10 people): Headache.
Common side effects (may affect up to 1 in 10 people): Diarrhoea, being sick (vomiting), feeling sick (nausea), dizziness, stomach pain, joint pain (arthralgia), rash, itchiness, feeling bloated, wind (flatulence), feeling tired.
Tests may also show: Increased level of a liver enzyme (ALT) in the blood.
If any of these side effects gets serious, tell the doctor.
Reporting of side effects: If the patient get any side effects, talk to the doctor or pharmacist. This includes any possible side effects not listed in this section. The patient can also report side effects directly via the national reporting system or via the Marketing Authorization Holder (Telephone number : 02-257-3500).

Tell the doctor or pharmacist if taking, have recently taken or might have taken any other medicines. Vemlidy may interact with other medicines. As a result, the amounts of Vemlidy or other medicines in the blood may change. This may stop the medicines from working properly, or may make any side effects worse.
Medicines used in treating hepatitis B infection: Do not take Vemlidy with other medicines containing: tenofovir alafenamide; tenofovir disoproxil fumarate; adefovir dipivoxil.
Other types of medicines: Talk to the doctor if taking: antibiotics used to treat bacterial infections including tuberculosis; antiviral medicines used to treat HIV; anticonvulsants used to treat epilepsy; antifungal medicines used to treat fungal infections.

Store in the original package in order to protect from moisture. Keep the bottle tightly closed.
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away medicines no longer used. These measures will help protect the environment.

Do not stop taking Vemlidy without your doctor's advice. Stopping treatment with Vemlidy may cause your hepatitis B to get worse.
Talk to your doctor before you stop taking Vemlidy for any reason, particularly if you are experiencing any side effects or you have another illness.
Take care not to pass on your hepatitis B to other people. You can still infect others when taking this medicine. Vemlidy does not reduce the risk of passing on hepatitis B to others through sexual contact or blood contamination. You must continue to take precautions to avoid this. Discuss with your doctor the precautions needed to avoid infecting others.

Antivirals

J05AF13 - tenofovir alafenamide ; Belongs to the class of nucleoside and nucleotide reverse transcriptase inhibitors. Used in the systemic treatment of viral infections.

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