The patient must remain under the care of their doctor while taking Genvoya.
They can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy. Discuss with a doctor, the precautions needed to avoid infecting other people. This medicine is not a cure for HIV infection. While taking Genvoya they may still develop infections or other illnesses associated with HIV infection.
Talk to a doctor before taking Genvoya. If the patient has liver problems or a history of 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 the patient has hepatitis B infection, the doctor will carefully consider the best treatment regimen for them.
If they have hepatitis B infection, liver problems may become worse after they stop taking Genvoya. It is important not to stop taking Genvoya without talking to the doctor (see Precautions).
If patient is intolerant to lactose (see Precautions).
While patient is taking Genvoya:
Once they start taking Genvoya, look out for: Signs of inflammation or infection.
Joint pain, stiffness or bone problems.
If patient has noticed any of these symptoms, tell the doctor immediately.
Children and adolescents:
Do not give this medicine to children aged 11 years or under, or weighing less than 35 kg. The use of Genvoya in children aged 11 years or under has not yet been studied.
During HIV therapy 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. The doctor will test for these changes.
Like all medicines, this medicine can cause side effects, although not everybody gets them. When treating HIV infection, it is not always possible to tell whether some of the unwanted effects are caused by Genvoya or by other medicines that the patient is taking at the same time, or by the HIV disease itself.
Possible serious side effects:
Tell a doctor immediately.
Any signs of inflammation or infection. In some patients with advanced HIV infection (AIDS) and a history of opportunistic infections (infections that occur in people with a weak immune system), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment 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.
Autoimmune disorders, when the immune system attacks healthy body tissue, may also occur after the patient start taking medicines for HIV infection. 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.
If the patient notices the side effects described above, tell the doctor immediately.
Very common side effects (may affect more than 1 in 10 people):
feeling sick (nausea).
Common side effects (may affect up to 1 in 10 people):
abnormal dreams, headache, dizziness, diarrhoea, vomiting, stomach pain, wind (flatulence), rash, tiredness (fatigue).
Uncommon side effects (may affect up to 1 in 100 people):
low red blood cell count (anaemia), depression, problems with digestion resulting in discomfort after meals (dyspepsia), swelling of the face, lips, tongue or throat (angioedema), itching (pruritus).
If any of the side effects get serious, tell the doctor.
Other effects that may be seen during HIV treatment:
The frequency of the following side effects is not known (frequency cannot be estimated from the available data).
Bone problems. Some patients taking combination antiretroviral medicines such as Genvoya 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 the patient notices any of these symptoms tell the doctor.
Reporting of side effects:
If the patient gets any side effects, talk to the doctor or pharmacist. This includes any possible side effects not listed in this leaflet. They can also report side effects directly via the national reporting system or via the Marketing Authorisation Holder (Telephone number: 02-257-3500).