What is it and how is it used?
What ISENTRESS is
ISENTRESS works against the Human Immunodeficiency Virus (HIV). This is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).
How ISENTRESS works
The virus produces an enzyme called HIV integrase. This helps the virus to multiply in the cells in your body. ISENTRESS stops this enzyme working. When used with other medicines, ISENTRESS may reduce the amount of HIV in your blood (this is called your "viral load") and increase your CD4-cell count (a type of white blood cells that plays an important role in maintaining a healthy immune system to help fight infection). Reducing the amount of HIV in the blood may improve the functioning of your immune system. This means your body may fight infection better.
ISENTRESS may not have these effects in all patients.
ISENTRESS is not a cure for HIV infection.
When ISENTRESS should be used
ISENTRESS is used to treat adults who are infected by HIV. Your doctor has prescribed ISENTRESS to help control your HIV infection.
What do you have to consider before using it?
Do not take ISENTRESS
Take special care with ISENTRESS
Remember that ISENTRESS is not a cure for HIV infection. This means that you may keep getting infections or other illnesses associated with HIV. You should keep seeing your doctor regularly while taking ISENTRESS.
ISENTRESS is not for use in children and adolescents.
Some patients taking combination anti-retroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone). The length of combination anti-retroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease. Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement. If you notice any of these symptoms please inform your doctor.
Tell your doctor if you have had problems with your liver before, including hepatitis B or C. Your doctor may eva luate how severe your liver disease is before deciding if you can take ISENTRESS.
HIV infection is spread by contact with blood or sexual contact with a person with HIV. Taking ISENTRESS has not been shown to reduce the risk of giving HIV to others through sexual contact or contact with blood.
Tell your doctor immediately if you notice any symptoms of infection. In some patients with advanced HIV infection and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started. It is believed 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.
Contact your doctor promptly if you experience unexplained muscle pain, tenderness, or weakness while taking ISENTRESS.
In patients taking ISENTRESS and darunavir, rashes (generally mild or moderate) may occur more frequently than in patients taking either drug separately.
Taking other medicines
ISENTRESS might interact with other medicines. Raltegravir is not known to have an important effect on blood levels of other agents used to treat HIV. Also, blood levels of raltegravir are not known to be affected to an important extent by other agents used to treat HIV. However, further information is expected to become available as experience with the use of raltegravir increases.
Please tell your doctor or pharmacist if you are now or have recently taken:
Taking ISENTRESS with food and drink
You can take ISENTRESS with or without food or drink.
Pregnancy and breast-feeding
Talk to your doctor before taking ISENTRESS if you are pregnant, might become pregnant or are breastfeeding. If you become pregnant, tell your doctor straight away.
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or breast-feeding.
Driving and using machines
Do not operate machines or drive if you feel dizzy after taking ISENTRESS.
Important information about some of the ingredients of ISENTRESS
ISENTRESS contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking this medicine.
How is it used?
Always take ISENTRESS exactly as your doctor has told you. You should check with your doctor if you are not sure. ISENTRESS must be used in combination with other medicines for HIV.
How much to take
If you take more ISENTRESS than you should
Do not take more tablets than the doctor recommends. If you do take too many tablets, contact your doctor.
If you forget to take ISENTRESS
If you stop taking ISENTRESS
It is important that you take ISENTRESS exactly as your doctor has instructed. Do not stop taking it because:
If you have any further questions on the use of ISENTRESS, ask your doctor or pharmacist.
What are possible side effects?
Like all medicines, ISENTRESS can cause side effects, although not everybody gets them.
Common side effects (affects 1 to 10 users in 100):
Uncommon side effects (affects 1 to 10 users in 1,000):
During post-marketing experience the following side effects have been reported (frequency = uncommon):
There have been reports of muscle pain, tenderness, or weakness during treatment with ISENTRESS.
In clinical studies, cancers were observed in patients receiving ISENTRESS at a rate similar to that observed in the patients receiving other HIV medicines.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
How should it be stored?
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
