Do not take DESCOVY:
- If you are allergic to emtricitabine, tenofovir alafenamide or any of the other ingredients of this medicine (listed in section 6 of this leaflet).
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.
If you have hepatitis B infection, your doctor will carefully consider the best treatment regimen for you. If you have hepatitis B infection, liver problems may become worse after you stop taking DESCOVY. It is important not to stop taking DESCOVY without talking to your doctor. You must remain under the care of your doctor while taking DESCOVY.
You can still pass on HIV when taking DESCOVY. Discuss with your doctor the precautions needed to avoid infecting other people. DESCOVY is not a cure for HIV infection. While taking DESCOVY you may still develop infections or other illnesses associated with HIV infection.
During HIV therapy such as with DESCOVY there may be an increase in weight and in levels of blood lipids and glucose. This is partly linked to restored health and life style, and in the case of blood lipids sometimes to the HIV medicines themselves. Your doctor will test for these changes.
Autoimmune disorders (the immune system attacks healthy body tissue), may also occur after you start taking medicines for HIV infection such as DESCOVY. Autoimmune disorders may occur many months after the start of treatment. Look out for any symptoms of infection or other symptoms such as:
- muscle weakness
- weakness beginning in the hands and feet and moving up towards the trunk of the body
- palpitations, tremor or hyperactivity
Talk to your doctor before taking DESCOVY:
- If you have liver problems or have suffered liver disease, including hepatitis.
Patients with liver disease including chronic hepatitis B or C, who are treated with antiretrovirals, have a higher risk of severe and potentially fatal liver complications. If you have hepatitis B infection, your doctor will carefully consider the best treatment regimen for you.
If you have hepatitis B liver problems it may become worse after you stop taking DESCOVY. Do not stop taking DESCOVY without talking to your doctor: see section 3, Do not stop taking DESCOVY.
Your doctor may not prescribe DESCOVY to you if the virus has a K65R mutation.
While you are taking DESCOVY Once you start taking DESCOVY, look out for:
- Signs of inflammation or infection
- Any signs of inflammation or infection. In some patients with advanced HIV infection (AIDS) and who have had opportunistic infections in the past (infections that occur in people with a weak immune system), signs and symptoms of inflammation from previous infections may occur soon after antiretroviral treatment, such as with DESCOVY, is started. It is thought that these symptoms are due to an improvement in the body’s immune response, enabling the body to fight infections that may have been present with no obvious symptoms.
- Joint pain, stiffness or bone problems
- Bone problems. Some patients taking combination antiretroviral medicines such as Descovy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). Taking this type of medicine for a long time, taking corticosteroids, drinking alcohol, having a very weak immune system, and being overweight, may be some of the many risk factors for developing this disease. Signs of osteonecrosis are:
- joint stiffness
- joint aches and pains (especially of the hip, knee and shoulder)
- difficulty with movement
If you notice any of these symptoms, tell your doctor immediately. For more information see section 4, Possible side effects.
Although kidney problems have not been observed with DESCOVY, there is a possibility that you may experience kidney problems when taking DESCOVY over a long period of time.
Children and adolescents
Do not give this medicine to children under 12 years of age, or weighing less than 35 kg. The use of DESCOVY in children under 12 years of age has not been studied.
Other medicines and DESCOVY
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. DESCOVY may interact with other medicines. As a result, the amounts of DESCOVY or other medicines in your blood may change. This may stop your medicines from working properly, or may make any side effects worse. In some cases, your doctor may need to adjust your dose or check your blood levels.
Medicines used in treating hepatitis B infection: You should not take DESCOVY with medicines containing:
- tenofovir alafenamide
- tenofovir disoproxil
- lamivudine
- adefovir dipivoxil
Tell your doctor if you are taking any of these medicines.
Other types of medicine: Talk to your doctor if you are taking: antibiotics, used to treat bacterial infections including tuberculosis, containing: - rifabutin, rifampicin, and rifapentine antiviral medicines used to treat HIV: - emtricitabine and tipranavir anticonvulsants, used to treat epilepsy, such as: - carbamazepine, oxcarbazepine, phenobarbitone and phenytoin herbal remedies used to treat depression and anxiety containing: - St. John’s wort (Hypericum perforatum) Tell your doctor if you are taking these or any other medicines. Do not stop your treatment without contacting your doctor.
