KIVEXA contains both abacavir and lamivudine. KIVEXA belongs to a group of antiretroviral medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs) and is used in combination with other antiretrovirals to treat Human Immunodeficiency Virus (HIV) infection in adults and adolescents from 12 years of age, weighing at least 40 kg. KIVEXA reduces HIV viral load and keeps it at a low level. Response to treatment with KIVEXA varies between patients. Your doctor will be monitoring the effectiveness of your treatment.
1. WHAT KIVEXA IS AND WHAT IT IS USED FOR:
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE KIVEXA:
Do not take KIVEXA:
- if you are allergic to the active substances abacavir, lamivudine or any of the other ingredients in KIVEXA.
- if you have serious liver disease, KIVEXA may not be suitable for you
- if you are pregnant, intend to become pregnant or if you are breastfeeding your baby.
If you are not sure whether you should be taking KIVEXA, please discuss with your doctor before taking this medicine.
Warnings and precautions:
Take special care with KIVEXA: Hypersensitivity reaction (serious allergic reaction): KIVEXA contains abacavir. Abacavir can cause a serious allergic reaction known as a hypersensitivity reaction, which can be life-threatening if treatment with abacavir containing products is not stopped. Who gets these reactions? Anyone taking KIVEXA could develop a hypersensitivity reaction to abacavir, which could be life-threatening if they continue to take KIVEXA. Research has found that people with a gene called HLA-B (type 5701) are more likely to have a hypersensitivity reaction to abacavir. However, even if you do not have this gene type it is still possible for you to get this reaction. If you know you have this gene type, be sure to tell your doctor before you take abacavir.
What are the symptoms?
The most common symptoms of this reaction are:
- high temperature (fever) and a skin rash.
Other frequently observed signs or symptoms include:
- nausea (feeling sick), vomiting (being sick), diarrhoea, abdominal (stomach) pain, shortness of breath, cough, headache and severe tiredness.
Other symptoms may include:
- joint or muscle pain, discomfort, swelling of the neck, serious breathing problems and sore throat. Occasionally inflammation of the eye (conjunctivitis), ulcers in the mouth, low blood pressure or tingling or numbness of the hands or feet may occur.
When do these reactions happen?
The symptoms of this allergic reaction can occur at any time during treatment with KIVEXA. However, they usually occur in the first six weeks of treatment and get worse with continued treatment.
3. HOW TO TAKE KIVEXA:
Do not share medicines prescribed for you with any other person. Always take KIVEXA exactly as your doctor has instructed. You should check with your doctor or pharmacist if you are unsure. Take KIVEXA for as long as your doctor recommends. Don’t stop unless your doctor advises you to. Take great care not to miss any doses if at all possible. Swallow the tablet whole with water. The usual dose in adults and adolescents from 12 years of age, who weigh at least 40 kg, is one tablet daily.
If you take more KIVEXA than you should: In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison control centre.
If you forget to take KIVEXA: It is important to take KIVEXA as prescribed to ensure you get maximum benefit. If you forget to take a dose, take it as soon as you remember and then continue as before. Do not take a double dose to make up for forgotten individual doses. It is important to take KIVEXA regularly because irregular intake may increase the risk of hypersensitivity reactions.
If you stop taking KIVEXA: If you have stopped taking KIVEXA for any reason, particularly because you think you are having side effects or for other illness, it is important that you contact your doctor before restarting. In some cases, your doctor will ask you to restart KIVEXA under direct medical supervision. If your doctor thinks that there is a possibility that your symptoms were related to a hypersensitivity reaction, you may be told never to take KIVEXA or any other medicine containing abacavir again.
4. POSSIBLE SIDE EFFECTS:
KIVEXA can have side effects. Not all side effects reported for KIVEXA are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking this medicine, please consult your doctor, pharmacist or other health care professional for advice.
Conditions you need to look out for: KIVEXA may cause other conditions to develop during HIV treatment. Hypersensitivity reaction: KIVEXA can cause a serious allergic reaction known as a hypersensitivity reaction, see ‘Hypersensitivity reaction’ in ‘Take special care with KIVEXA’. It is important that you read and understand the information about this serious reaction.
Symptoms of infection and inflammation: Symptoms of infection and inflammation may develop and include:
- muscle weakness and/or muscle pain
- joint pain or swelling
- weakness beginning in the hands and feet and moving up towards the trunk of the body
- palpitations or tremor
- hyperactivity (excessive restlessness and movement).
If you get any symptoms of infection while you’re taking KIVEXA: Tell your doctor immediately. Don’t take other medicines for the infection without your doctor’s advice.
Your body shape may change: People taking combination therapy for HIV may find that their body shape changes, because of changes in fat distribution:
- fat may be lost from the legs, arms or face.
- extra fat may build up around the stomach, or on the breasts or internal organs.
- fatty lumps (sometimes called buffalo hump) may appear on the back of the neck.
If you notice changes in your body shape, tell your doctor.
Lactic acidosis is serious side effect: Some people taking KIVEXA or other medicines like it (NRTIs), develop a condition called lactic acidosis, together with an enlarged liver. Signs of lactic acidosis include:
- deep, rapid, difficult breathing
- drowsiness
- numbness or weakness in the limbs
- feeling sick (nausea), being sick (vomiting)
- stomach pain.
During your treatment, your doctor will monitor you for signs of lactic acidosis. If you have any of the symptoms listed above or any other symptoms that worry you: See your doctor as soon as possible.
5. HOW TO STORE KIVEXA:
Do not store above 30 °C. Protect from light. Keep the blisters in the carton until required for use. Do not take the medicine after the expiry date stated on the bottle or blister and carton. Store all medicines out of the reach of children. Return all unused medicine to your pharmacist. Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).