Kivexa
abacavir, lamivudine
abacavir/lamivudine
Keep this leaflet. You may need to read it again.
If you have any further questions ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
The Kivexa pack includes an Alert Card, to remind you and medical staff about abacavir hypersensitivity. Detach this card and keep it with you at all times.
What Kivexa is and what it is used for
What you need to know before you take Kivexa
How to take Kivexa
Possible side effects
How to store Kivexa
Contents of the pack and other information
Kivexa contains two active ingredients that are used to treat HIV infection: abacavir and lamivudine. These belong to a group of anti-retroviral medicines called nucleoside analogue reverse transcriptase inhibitors (NRTIs).
Kivexa does not completely cure HIV infection; it reduces the amount of virus in your body, and keeps it at a low level. It also increases the CD4 cell count in your blood. CD4 cells are a type of white blood cells that are important in helping your body to fight infection.
Not everyone responds to treatment with Kivexa in the same way. Your doctor will monitor the effectiveness of your treatment.
if you are allergic (hypersensitive) to abacavir (or any other medicine containing abacavir — (e.g. Trizivir, Triumeq or Ziagen), lamivudine or any of the other ingredients of this medicine (listed in Section 6)
Some people taking Kivexa or other combination treatments for HIV are more at risk of serious side effects. You need to be aware of the extra risks:
if you have moderate or severe liver disease
if you have ever had liver disease, including hepatitis B or C (if you have hepatitis B infection, do not stop Kivexa without your doctor’s advice, as your hepatitis may come back)
if you are seriously overweight (especially if you are a woman)
if you have a kidney problem
Abacavir hypersensitivity reactions
Even patients who don’t have the HLA-B*5701 gene may still develop a hypersensitivity reaction (a serious allergic reaction)
It cannot be excluded that abacavir may increase the risk of having a heart attack.
Some people taking medicines for HIV infection develop other conditions, which can be serious. You need to know about important signs and symptoms to look out for while you are taking Kivexa.
HIV infection is spread by sexual contact with someone who has the infection, or by transfer of infected blood (for example, by sharing injection needles). You can still pass on HIV when taking this medicine, although the risk is lowered by effective antiretroviral therapy. Discuss with your doctor the precautions needed to avoid infecting other people.
Remember to tell your doctor or pharmacist if you begin taking a new medicine while you are taking Kivexa.
Emtricitabine, to treat HIV infection
other medicinal products containing lamivudine, used to treat HIV infection or hepatitis B infection
high doses of trimethoprim/sulfamethoxazole, an antibiotic
cladribine, used to treat hairy cell leukaemia
These include:
medicines (usually liquids) containing sorbitol and other sugar alcohols (such as xylitol, mannitol, lactitol or maltitol), if taken regularly.
If you have taken Kivexa during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child. In children whose mothers took NRTIs during pregnancy, the benefit from the protection against HIV outweighed the risk of side effects.
If you are breast-feeding, or thinking about breast-feeding:
Kivexa may cause side effects which could affect your ability to drive or use machines.
Kivexa contains a colouring called sunset yellow (E110), this may cause allergic reactions in some people.
This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free’.
Swallow the tablets whole, with some water. Kivexa can be taken with or without food.
Kivexa helps to control your condition. You need to keep taking it every day to stop your illness getting worse. You may still develop other infections and illnesses linked to HIV infection.
If you accidentally take too much Kivexa, tell your doctor or your pharmacist, or contact your nearest hospital emergency department for further advice.
If you forget to take a dose, take it as soon as you remember. Then continue your treatment as before. Do not take a double dose to make up for a forgotten dose.
It is important to take Kivexa regularly, because if you take it at irregular intervals, you may be more likely to have a hypersensitivity reaction.
If you have stopped taking Kivexa for any reason — especially because you think you are having side effects, or because you have other illness:
symptoms were related to a hypersensitivity reaction. If the doctor thinks they may have been related, you will be told never again to take Kivexa, or any other medicine containing abacavir (e.g.Trizivir, Triumeq or Ziagen). It is important that you follow this advice.
If your doctor advises that you can start taking Kivexa again, you may be asked to take your first doses in a place where you will have ready access to medical care if you need it.
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. Your doctor will test for these changes.
Like all medicines, this medicine can cause side effects, although not everyone gets them.
When you are being treated for HIV, it can be hard to tell whether a symptom is a side effect of Kivexa or other medicines you are taking, or an effect of the HIV disease itself. So it is very important to talk to your doctor about any changes in your health.
Even patients who don’t have the HLA-B*5701 gene may still develop a hypersensitivity reaction (a serious allergic reaction), described in this leaflet in the panel headed ‘Hypersensitivity reactions’.
It is important to read the information later in this section under ‘Other possible side effects of combination therapy for HIV’.
Anyone taking Kivexa could develop a hypersensitivity reaction to abacavir, which could be life threatening if they continue to take Kivexa.
You are more likely to develop this reaction if you have a gene called HLA-B*5701 (but you can get a reaction even if you do not have this gene). You should have been tested for this gene before Kivexa was prescribed for you. If you know you have this gene, tell your doctor before you take Kivexa.
About 3 to 4 in every 100 patients treated with abacavir in a clinical trial who did not have the HLA- B*5701 gene developed a hypersensitivity reaction.
The most common symptoms are:
Other common symptoms are:
nausea (feeling sick), vomiting (being sick), diarrhoea, abdominal (stomach) pain, severe tiredness.
Other symptoms include:
Pains in the joints or muscles, swelling of the neck, shortness of breath, sore throat, cough, occasional headaches, inflammation of the eye (conjunctivitis), mouth ulcers, low blood pressure, tingling or numbness of the hands or feet.
Hypersensitivity reactions can start at any time during treatment with Kivexa, but are more likely during the first 6 weeks of treatment.
fever
shortness of breath, sore throat or cough
nausea or vomiting, diarrhoea or abdominal pain
severe tiredness or achiness, or generally feeling ill.
If you have stopped taking Kivexa because of a hypersensitivity reaction, you must NEVER AGAIN take Kivexa, or any other medicine containing abacavir (e.g. Trizivir, Triumeq or Ziagen). If you do, within hours, your blood pressure could fall dangerously low, which could result in death.
If you have stopped taking Kivexa for any reason — especially because you think you are having side effects, or because you have other illness:
Occasionally hypersensitivity reactions have developed in people who start taking abacavir containing products again, but who had only one symptom on the Alert Card before they stopped taking it.
Very rarely patients who have taken medicines containing abacavir in the past without any symptoms of hypersensitivity have developed a hypersensitivity reaction when they start taking these medicines again.
If your doctor advises that you can start taking Kivexa again, you may be asked to take your first doses in a place where you will have ready access to medical care if you need it.
The Kivexa pack includes an Alert Card, to remind you and medical staff about hypersensitivity reactions. Detach this card and keep it with you at all times.
These may affect up to 1 in 10 people:
hypersensitivity reaction
headache
being sick (vomiting)
feeling sick (nausea)
diarrhoea
stomach pains
loss of appetite
tiredness, lack of energy
fever (high temperature)
general feeling of being unwell
difficulty in sleeping (insomnia)
muscle pain and discomfort
joint pain
cough
irritated or runny nose
skin rash
hair loss
These may affect up to 1 in 100 people and may show up in blood tests:
a low red blood cell count (anaemia) or low white blood cell count (neutropenia)
an increase in the level of liver enzymes
a decrease in the number of cells involved in blood clotting (thrombocytopenia).
These may affect up to 1 in 1000 people:
liver disorders, such as jaundice, enlarged liver or fatty liver, inflammation (hepatitis)
inflammation of the pancreas (pancreatitis)
breakdown of muscle tissue.
Rare side effects that may show up in blood tests are:
increase in an enzyme called amylase.
These may affect up to 1 in 10,000 people:
numbness, tingly feelings in the skin (pins and needles)
sensation of weakness in the limbs
skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)
a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens–Johnson syndrome), and a more severe form causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis).
lactic acidosis (excess lactic acid in the blood)
Very rare side effects that may show up in blood tests are:
a failure of the bone marrow to produce new red blood cells (pure red cell aplasia).
Combination therapy such as Kivexa may cause other conditions to develop during HIV treatment.
People with advanced HIV infection (AIDS) have weak immune systems, and are more likely to develop serious infections (opportunistic infections). Such infections may have been “silent” and not detected by the weak immune system before treatment was started. After starting treatment, the immune system becomes stronger, and may attack the infections, which can cause symptoms of infection or inflammation. Symptoms usually include fever, plus some of the following:
headache
stomach ache
difficulty breathing
In rare cases, as the immune system becomes stronger, it can also attack healthy body tissue (autoimmune disorders). The symptoms of autoimmune disorders may develop many months after you start taking medicine to treat your HIV infection. Symptoms may include:
palpitations (rapid or irregular heartbeat) or tremor
hyperactivity (excessive restlessness and movement)
weakness beginning in the hands and feet and moving up towards the trunk of the body
Some people taking combination therapy for HIV develop a condition called osteonecrosis. With this condition, parts of the bone tissue die because of reduced blood supply to the bone. People may be more likely to get this condition:
if they have been taking combination therapy for a long time
if they are also taking anti-inflammatory medicines called corticosteroids
if they drink alcohol
if their immune systems are very weak
if they are overweight.
stiffness in the joints
aches and pains (especially in the hip, knee or shoulder)
difficulty moving.
If you notice any of these symptoms:
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not take this medicine after the expiry date shown on the carton. The expiry date refers to the last day of that month.
Do not store above 30C.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
The active substances in each Kivexa film-coated tablet are 600 mg of abacavir (as sulfate) and 300 mg of lamivudine.
The other ingredients are microcrystalline cellulose, sodium starch glycollate and magnesium stearate in the core of the tablet. The tablet coating contains Opadry Orange YS-1-13065-A containing hypromellose, titanium dioxide, macrogol 400, polysorbate 80 and sunset yellow FCF (E110).
Kivexa film-coated tablets are engraved with ‘GS FC2’ on one side. They are orange and capsule- shaped and are provided in blister packs containing 30 tablets and multipack blister packs containing 90(3 x 30) tablets.
ViiV Healthcare BV, Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands
Glaxo Wellcome S.A., Avenida de Extremadura 3, 09400 Aranda de Duero Burgos, Spain.
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
ViiV Healthcare BV Tel: + 370 80000334
ViiV Healthcare BV Teл.: + 359 80018205
Tél/Tel: + 32 (0) 10 85 65 00
GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00
ViiV Healthcare BV Tel: + 356 80065004
ViiV Healthcare GmbH
Tel.: + 49 (0)89 203 0038-10
viiv.med.info@viivhealthcare.com
ViiV Healthcare BV
Tel: + 31 (0) 33 2081199
ViiV Healthcare BV Tel: + 372 8002640
GlaxoSmithKline Μονοπρόσωπη A.E.B.E.
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GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0
Laboratorios ViiV Healthcare, S.L.
Tel: +34 900 923 501
GSK Services Sp. z o.o. Tel.: + 48 (0)22 576 9000
ViiV Healthcare SAS Tél.: + 33 (0)1 39 17 6969
ViiV Healthcare BV Tel: + 385 800787089
VIIVHIV HEALTHCARE, UNIPESSOAL, LDA
Tel: + 351 21 094 08 01
ViiV Healthcare BV Tel: + 40800672524
GlaxoSmithKline (Ireland) Limited Tel: + 353 (0)1 4955000
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Vistor hf.
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ViiV Healthcare S.r.l Tel: + 39 (0)45 7741600
ViiV Healthcare BV
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ViiV Healthcare BV Tel: + 371 80205045
ViiV Healthcare BV Tel: + 44 (0)800 221441