Kivexa 600 mg/300 mg film-coated tablets
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Kivexa 600 mg/300 mg film-coated tablets
abacavir/lamivudine
Read the entire leaflet carefully before you start taking this medicine, as it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you only and must not be given to other people,
even if they have the same symptoms as you, as it may harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.
IMPORTANT — Hypersensitivity Reactions
Kivexa contains abacavir (which is also the active substance in medicines such as Trizivir, Triumeq and Ziagen). Some people taking abacavir may develop a hypersensitivity reaction (a severe allergic reaction), which can be life-threatening if treatment with abacavir-containing medicines is continued.
You must carefully read the information on “Hypersensitivity reactions” in section 4 of this leaflet.
The Kivexa package includes an Information Card to remind you and healthcare professionals about abacavir hypersensitivity. You must remove this card and always carry it with you.
Leaflet Contents
- What Kivexa is and what it is used for
- What you need to know before taking Kivexa
- How to take Kivexa
- Possible side effects
- How to store Kivexa
- Contents of the pack and other information
1. What Kivexa is and what it is used for
Kivexa is used to treat human immunodeficiency virus (HIV) infection in adults, adolescents, and children weighing at least 25 kg.
Kivexa contains two active substances used to treat HIV infection: abacavir and lamivudina. Both belong to a group of antiretroviral medicines known as nucleoside reverse transcriptase inhibitors (NRTIs).
Kivexa does not completely cure HIV infection; it reduces the amount of virus in the body and maintains it at a low level. It also increases the number of CD4 cells in the blood. CD4 cells are a type of white blood cell that play an important role in helping the body fight infection.
Not everyone responds to treatment with Kivexa in the same way. Your doctor will monitor how well your treatment is working.
2. What you need to know before taking Kivexa
Do not take Kivexa
- if you are allergic (hypersensitive) to abacavir (or to any other medicine containing abacavir — e.g. Trizivir, Triumeq or Ziagen), lamivudine, or to any of the other ingredients of this medicine (listed in section 6).
Read carefully all the information about hypersensitivity reactions in section 4 of this leaflet.
Consult your doctor if you think any of the following conditions apply to you. Do not take Kivexa.
Take special care with Kivexa
Some people taking Kivexa or other combination treatments for HIV are at higher risk of developing serious adverse effects. You need to be aware that the risk is greater:
- 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, do not stop taking Kivexa without your doctor's advice, as your condition may worsen)
- if you are significantly overweight (especially if you are female)
- if you have any kidney problems.
Consult your doctor before starting Kivexa if any of these conditions apply to you. You may need additional tests, including blood tests, while taking this medicine. For more information, see section 4.
Hypersensitivity reactions to abacavir
Even patients who do not carry the HLA-B*5701 gene can develop a hypersensitivity reaction (a serious allergic reaction).
Read carefully all the information about hypersensitivity reactions in section 4 of this leaflet.
Risk of cardiovascular events
It cannot be ruled out that abacavir may increase the risk of cardiovascular events.
Tell your doctor if you have cardiovascular problems, smoke, or have conditions that may increase your risk of cardiovascular disease, such as high blood pressure or diabetes. Do not stop taking Kivexa unless your doctor advises you to do so.
Be alert to important symptoms
Some people taking medicines for HIV infection develop other disorders, which may be serious. You need to know which important signs and symptoms to watch for while taking Kivexa.
Read the information on “Other possible adverse effects of combination therapy for HIV” in section 4 of this leaflet.
Other medicines and Kivexa
Tell your doctor or pharmacist if you are taking or have recently taken any other medicine, including herbal medicines and those obtained without a prescription.
Remember to inform your doctor or pharmacist if you start taking a new medicine while taking Kivexa.
The following medicines must not be used with Kivexa:
- emtricitabine, used to treat HIV infection
- other medicines containing lamivudine, used to treat HIV infection or hepatitis B
- high doses of cotrimoxazole (a combination of trimethoprim and sulfamethoxazole), an antibiotic
- cladribine, used to treat hairy cell leukemia.
Tell your doctor if you are being treated with any of these medicines.
Some medicines interact with Kivexa
These include:
- phenytoin, used to treat epilepsy.
Tell your doctor if you are taking phenytoin. Your doctor may need to monitor you while you are taking Kivexa.
- methadone, used as a heroin substitute. Abacavir increases the rate at which methadone is eliminated from the body. If you are taking methadone, you should be monitored for symptoms of withdrawal. Your methadone dose may need to be adjusted.
Tell your doctor if you are taking methadone.
- medicines (usually liquids) containing sorbitol and other polyols (such as xylitol, mannitol, lactitol or maltitol), if taken regularly.
Tell your doctor or pharmacist if you are being treated with any of these.
- riociguat, used to treat high blood pressure in the blood vessels (pulmonary arteries) carrying blood from the heart to the lungs. Your doctor may need to reduce your dose of riociguat, as abacavir may increase blood levels of riociguat.
Pregnancy
The use of Kivexa during pregnancy is not recommended. Kivexa and similar medicines may cause adverse effects in babies during pregnancy. If you have taken Kivexa during pregnancy, your doctor may request periodic blood tests and other diagnostic tests to monitor your child's development. In children whose mothers took NRTIs during pregnancy, the benefit of protection against HIV outweighed the risk of adverse effects occurring.
Breast-feeding
Breast-feeding is not recommended for women living with HIV because HIV infection can be transmitted to the baby through breast milk. A small amount of the components of Kivexa may also pass into breast milk.
If you are breast-feeding or considering breast-feeding, you should consult your doctor as soon as possible.
Driving and using machines
Kivexa may cause adverse effects that could affect your ability to drive or use machines.
Consult your doctor about your ability to drive or operate machinery while taking Kivexa.
Important information about some of the ingredients of Kivexa
Kivexa contains a colouring agent called orange-yellow (E110), which may cause allergic reactions in some people.
This medicine contains less than 1 mmol of sodium (23 mg) per dose unit; essentially “sodium-free”.
3. How to take Kivexa
Follow exactly the instructions given by your doctor for taking this medicine. If you are unsure, consult your doctor or pharmacist again.
The recommended dose of Kivexa for adults, adolescents, and children weighing at least 25 kg or more is one tablet once daily.
Swallow the tablets whole with a little water. Kivexa can be taken with or without food.
Maintain regular contact with your doctor
Kivexa helps control your condition. You will need to take it every day to prevent your disease from worsening. You may still develop other infections and illnesses associated with HIV infection.
Stay in contact with your doctor and do not stop taking Kivexa without first talking to your doctor.
If you take more Kivexa than you should
If you accidentally take more Kivexa than you should, inform your doctor or pharmacist, or contact the nearest hospital emergency department for advice.
If you forget to take Kivexa
If you forget to take a dose, take it as soon as you remember, and then continue with your regular treatment schedule.
Do not take a double dose to make up for a missed dose.
It is important to take Kivexa regularly, as irregular intake of Kivexa may increase the risk of experiencing a hypersensitivity reaction.
If you have stopped taking Kivexa
If for any reason you have stopped taking Kivexa—especially because you think you are experiencing side effects or due to another illness:
Consult your doctor before restarting treatment. Your doctor will assess whether your symptoms were related to a hypersensitivity reaction. If your doctor considers that there may have been a connection, you will be instructed never to take Kivexa or any other medicine containing abacavir again (e.g., Trizivir, Triumeq, or Ziagen). It is important that you follow this warning.
If your doctor advises restarting treatment with Kivexa, they may ask you to take the first doses in a place where you have easy access to medical assistance, if needed.
4. Possible adverse effects
During HIV treatment, there may be an increase in weight and in blood glucose and lipid levels. This may be partly related to the recovery of health and lifestyle, and in the case of blood lipids, sometimes to the anti-HIV medications themselves. Your doctor will monitor these changes.
Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.
When undergoing HIV treatment, it may be difficult to differentiate whether a symptom is an adverse effect of Kivexa or of other medicines you are taking, or is due to the HIV disease itself. Therefore, it is very important that you inform your doctor about any changes in your health.
Even patients who do not carry the HLA-B*5701 gene may develop a hypersensitivity reaction (a severe allergic reaction), described in this leaflet in the section called "Hypersensitivity reactions".
It is very important that you read and understand the information about this serious reaction.
In addition to the adverse effects listed below for Kivexa, other disorders may develop during combination antiretroviral treatment.
It is important that you read the information under the heading "Other possible adverse effects of combination HIV treatment".
Hypersensitivity reactions
Kivexa contains abacavir (the active substance also present in Trizivir, Triumeq, and Ziagen).
Abacavir may cause a serious allergic reaction known as a hypersensitivity reaction. These hypersensitivity reactions have been observed more frequently in people taking medications containing abacavir.
Who experiences these reactions?
Any person taking Kivexa could develop a hypersensitivity reaction to abacavir, which could be life-threatening if you continue taking Kivexa.
You are more likely to develop this reaction if you have a gene called HLA-B*5701 (but you may still experience this reaction even if you do not have this gene). Before starting treatment with Kivexa, you should have been tested for this gene. If you know you have this gene, tell your doctor before taking Kivexa.
Approximately 3 to 4 out of every 100 patients treated with abacavir in a clinical trial who did not carry the HLA-B*5701 gene developed a hypersensitivity reaction.
What are the symptoms?
The most common symptoms are:
- fever (high temperature) and skin rash.
Other commonly observed signs include:
- nausea (feeling unwell), vomiting, diarrhoea, abdominal pain (stomach), and excessive tiredness.
Other symptoms may include:
- joint or muscle pain, swelling of the neck, difficulty breathing, sore throat, cough, occasional headache, eye inflammation (conjunctivitis), mouth ulcers, low blood pressure, and tingling or numbness in the hands or feet.
When do these reactions occur?
Hypersensitivity reactions can occur at any time during treatment with Kivexa, but are most likely to occur within the first 6 weeks of treatment.
Contact your doctor immediately:
1if you develop a skin rash OR
2if you have symptoms included in at least 2 of the following groups:
- fever
- difficulty breathing, sore throat, or cough
- nausea or vomiting, diarrhoea, or abdominal pain
- excessive tiredness or general aches or discomfort.
Your doctor may advise you to stop taking Kivexa.
While taking Kivexa, always carry your Patient Information Card with you.
If you have stopped taking Kivexa
If you have stopped taking Kivexa due to a hypersensitivity reaction, NEVER take Kivexa again or any other medicine containing abacavir (e.g. Trizivir, Triumeq or Ziagen). If you do, within hours you may experience a drop in blood pressure that could be life-threatening or fatal.
If for any reason you have interrupted treatment with Kivexa — especially because you think you are experiencing adverse effects or due to another illness:
Consult your doctor before restarting treatment. Your doctor will assess whether your symptoms were related to a hypersensitivity reaction. If your doctor considers there may have been a link, you will be advised never to take Kivexa or any other medicine containing abacavir (e.g. Trizivir, Triumeq or Ziagen) again. It is important that you follow this warning.
Occasionally, hypersensitivity reactions have occurred in people who restarted abacavir after having experienced only one symptom listed on the Patient Information Card before stopping.
Very rarely, reactions have occurred in people restarting abacavir treatment who had no hypersensitivity symptoms before stopping.
If your doctor advises you to restart treatment with Kivexa, they may ask you to take the first doses in a place where you have easy access to medical assistance, if needed.
If you are hypersensitive to Kivexa, you must return all unused Kivexa tablets for safe disposal. Consult your doctor or pharmacist.
The Kivexa package includes a Patient Information Card to remind you and healthcare professionals about hypersensitivity reactions. Separate the card from the package and always carry it with you.
Frequent adverse effects
May affect up to 1 in 10 people:
- hypersensitivity reaction
- headache
- vomiting
- nausea
- diarrhoea
- stomach pain
- loss of appetite
- tiredness, lack of energy
- fever (high temperature)
- general feeling of discomfort
- difficulty sleeping (insomnia)
- muscle pain and discomfort
- joint pain
- cough
- irritated nose or excessive nasal discharge
- skin rash
- hair loss.
Uncommon adverse effects
May affect up to 1 in 100 people and may be detected in blood tests:
- low red blood cell count (anaemia) or low white blood cell count (neutropenia)
- increased levels of liver enzymes
- decreased number of cells involved in blood clotting (thrombocytopenia).
Rare adverse effects
May affect up to 1 in 1,000 people:
- liver problems, such as jaundice, enlarged liver, fatty liver, or inflammation (hepatitis)
- inflammation of the pancreas (pancreatitis)
- muscle tissue breakdown.
Rare adverse effects that may appear in blood tests include:
- increased levels of an enzyme called amylase.
Very rare adverse effects
May affect up to 1 in 10,000 people:
- numbness, skin tingling (pins and needles)
- feeling of weakness in the limbs
- skin rash that may blister and resemble small targets (a dark central spot surrounded by a paler area and a dark ring at the edge) (erythema multiforme)
- widespread blistering rash with peeling skin, especially around the mouth, nose, eyes, and genitals (Stevens–Johnson syndrome), and a more severe form causing skin peeling over more than 30% of the body surface (toxic epidermal necrolysis)
- lactic acidosis (excess lactic acid in the blood).
If you notice any of these symptoms, contact a doctor urgently.
A very rare adverse effect that may appear in blood tests is:
- failure of the bone marrow to produce new red blood cells (pure red cell aplasia).
If you experience adverse effects
Inform your doctor or pharmacist if you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not mentioned in this leaflet.
Other possible adverse effects of combination HIV treatment
Combination treatments, such as Kivexa, may cause other disorders to develop during HIV treatment.
Symptoms of infection and inflammation
Exacerbation of Old Infections
People with advanced HIV infection (AIDS) have a weakened immune system and are more likely to develop serious infections (opportunistic infections). These infections may have been "latent" and not detected by the weakened immune system before treatment was started. After beginning treatment, the immune system becomes stronger and starts to fight these infections, which may cause symptoms of infection or inflammation. Symptoms usually include fever, along with some of the following:
- headache
- stomach pain
- difficulty breathing
In rare cases, as the immune system becomes stronger, it may also attack healthy tissues (autoimmune disorders). Symptoms of autoimmune disorders may appear many months after starting HIV treatment. Symptoms may include:
- palpitations (rapid or irregular heartbeat) or tremor
- hyperactivity (excessive restlessness and movement)
- weakness beginning in the hands and feet and progressing upward toward the body trunk
If you notice any symptoms of infection and inflammation, or if you experience any of the symptoms listed above:
- Contact your doctor immediately. Do not take any other medication for the infection without first consulting your doctor.
You may have problems with your bones
Some patients receiving combination HIV treatment develop a bone disease called osteonecrosis. In this condition, part of the bone tissue dies due to reduced blood supply to the bone. The risk of developing this disease is higher in individuals who:
- have been receiving combination treatment for a long time
- also take anti-inflammatory medicines called corticosteroids
- drink alcohol
- have a severely weakened immune system
- are overweight
Signs of osteonecrosis include:
- joint stiffness
- pain and discomfort (especially in the hip, knee, or shoulder)
- difficulty moving
If you notice any of these symptoms:
Inform your doctor.
Reporting of Adverse Reactions
If you experience any type of adverse reaction, talk to your doctor or pharmacist, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse reactions, you can help provide more information on the safety of this medicine.
5. Storage of Kivexa
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.
Do not store above 30°C.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Kivexa
The active substances in each Kivexa film-coated tablet are 600 mg of abacavir (as sulfate) and 300 mg of lamivudine.
The other components are microcrystalline cellulose, sodium carboxymethyl starch, and magnesium stearate in the tablet core. The coating contains Opadry Orange YS-1-13065-A, which in turn contains hypromellose (E464), titanium dioxide, macrogol 400, polysorbate 80, and orange yellow FCF (E110).
Appearance of Kivexa and contents of the pack
The tablets are orange, film-coated, capsule-shaped, and marked on one side with GS FC2. They are supplied in blisters containing 30 tablets and in multi-pack blisters containing 90 tablets (3 x 30).
Marketing Authorization Holder
ViiV Healthcare BV
Van Asch van Wijckstraat 55H
3811 LP Amersfoort
The Netherlands
Manufacturer
Glaxo Wellcome S.A., Avenida de Extremadura, 3, 09400 Aranda de Duero (Burgos), Spain.
Further information on this medicinal product is available from the local representative of the Marketing Authorization Holder:
Belgium/Belgium/Belgium ViiV Healthcare srl/bv Tel/Tel: + 32 (0) 10 85 65 00 | Lithuania ViiV Healthcare BV Tel: + 370 80000334 |
| Luxembourg/Luxembourg ViiV Healthcare srl/bv Belgium/Belgium Tel/Tel: + 32 (0) 10 85 65 00 |
Czech Republic GlaxoSmithKline s.r.o. Tel: + 420 222 001 111 | Hungary ViiV Healthcare BV Tel.: + 36 80088309 |
Denmark GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00 | Malta ViiV Healthcare BV Tel: + 356 80065004 |
Germany ViiV Healthcare GmbH Tel.: + 49 (0)89 203 0038-10 | Netherlands ViiV Healthcare BV Tel: + 31 (0) 33 2081199 |
Estonia ViiV Healthcare BV Tel: + 372 8002640 | Norway GlaxoSmithKline AS Tlf: + 47 22 70 20 00 |
Greece GlaxoSmithKline Μονοπρόσωπη Ε.Ε. Tel: + 30 210 68 82 100 | Austria GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0 |
Spain Laboratorios ViiV Healthcare, S.L. Tel: + 34 900 923 501 | Poland GSK Services Sp. z o.o. Tel.: + 48 (0)22 576 9000 |
France ViiV Healthcare SAS Tél.: + 33 (0)1 39 17 6969 Croatia ViiV Healthcare BV Tel: + 385 800787089 | Portugal VIIVHIV HEALTHCARE, UNIPESSOAL, LDA Tel: + 351 21 094 08 01 Romania ViiV Healthcare BV Tel: + 40800672524 |
Ireland GlaxoSmithKline (Ireland) Limited Tel: + 353 (0)1 4955000 | Slovenia ViiV Healthcare BV Tel: + 386 0688869 |
Iceland Vistor hf. Tel: +354 535 7000 | Slovakia ViiV Healthcare BV Tel: + 421 800500589 |
Italy ViiV Healthcare S.r.l Tel: + 39 (0)45 7741600 | Finland GlaxoSmithKline Oy Tel/Tel: + 358 (0)10 30 30 30 |
Cyprus ViiV Healthcare BV Tel: + 357 80070017 | Sweden GlaxoSmithKline AB Tel: + 46 (0)8 638 93 00 |
Latvia ViiV Healthcare BV Tel: + 371 80205045 | |
Date of the most recent review of this leaflet:
Detailed information on this medicine is available on the website of the European Medicines Agency: http://www.ema.europa.eu.