Do not take VEMLIDY
- if you are allergic to tenofovir alafenamide or any of the other ingredients of this medicine (listed in section 6).
- if you are on treatment with other medicines containing tenofovir or adefovir dipivoxil
If this applies to you, do not take VEMLIDY and tell your doctor immediately.
Warnings and precautions
• Too much lactic acid in your blood (lactic acidosis) is a serious but rare medical emergency that can lead to death. Tell your healthcare provider right away if you get these symptoms: weakness or being more tired than usual, unusual muscle pain, being short of breath or fast breathing, stomach pain with nausea and vomiting, cold or blue hands and feet, feel dizzy or lightheaded, or a fast or abnormal heartbeat.
• 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.
• Tell your doctor if you have 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. Your doctor may need to carry out blood tests to monitor your liver function.
• Talk to your doctor or pharmacist if you have had kidney disease or if tests have shown problems with your kidneys, before or during treatment. Before starting treatment and during treatment with VEMLIDY, your doctor may order blood or urine tests to monitor how your kidneys work.
• Talk to your doctor if you also have hepatitis C or D. VEMLIDY has not been tested on patients who have hepatitis C or D as well as hepatitis B.
• Talk to your doctor if you also have HIV. If you are not sure whether you have HIV, your doctor should offer you HIV testing before you start taking VEMLIDY for hepatitis B.
If any of these apply to you, talk to your doctor before taking VEMLIDY.
Children and adolescents
Do not give VEMLIDY to children who are under 6 years old, or weighing less than 25 kg. It has not been tested in children aged less than 6 years old or weighing less than 25 kg.
Bone problems. Loss of bone mass has been reported in some children who received VEMLIDY. The effects on long-term bone health and future fracture risk in children are uncertain. Your doctor will monitor this possible risk. Tell your doctor if any bone pain or fractures occur.
Other medicines and VEMLIDY
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicine. VEMLIDY may interact with other medicines. As a result, the amounts of VEMLIDY or other medicines in your blood may change. This may stop your medicines from working properly or may make any side effects worse.
Medicines used in treating hepatitis B infection
You should not take VEMLIDY with other medicines containing:
- tenofovir alafenamide
- tenofovir disoproxil
- adefovir dipivoxil
Other types of medicines
Talk to your doctor if you are taking:
- antibiotics used to treat bacterial infections including tuberculosis, containing:
- rifabutin, rifampicin or rifapentine
- antiviral medicines used to treat HIV, such as:
- ritonavir or cobicistat boosted darunavir, lopinavir or atazanavir
- anticonvulsants used to treat epilepsy, such as:
- carbamazepine, oxcarbazepine, phenobarbital or phenytoin
- herbal remedies used to treat depression and anxiety, containing:
- St. John’s wort (Hypericum perforatum)
- antifungal medicines used to treat fungal infections, containing:
- ketoconazole or itraconazole
Tell your doctor if you are taking these or any other medicines.
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 or pharmacist for advice before taking this medicine.
- Tell your doctor immediately if you become pregnant.
- Do not breast-feed your baby during treatment with VEMLIDY. It is recommended that you do not breast-feed to avoid passing tenofovir alafenamide or tenofovir to the baby through breast milk.
Driving and using machines
VEMLIDY has minor influence on the ability to drive and use machines. If you experience dizziness, you should not drive and use machines. VEMLIDY can cause fatigue, headache, nausea and dizziness.
Important information about some of the ingredients of VEMLIDY:
VEMLIDY contains lactose If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
VEMLIDY contains sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’.