How to use KIVEXA 600 MG/300 MG FILM-COATED TABLETS
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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
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Introduction
Package Leaflet: Information for the User
Kivexa 600 mg/300 mg film-coated tablets
abacavir/lamivudine
Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.
- 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.
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 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,Triumeqand Ziagen). Some people who take abacavir may develop a hypersensitivity reaction(a severe allergic reaction), which can be life-threatening if they continue to take medicines containing abacavir.
You must read the information on “Hypersensitivity reactions” in section 4 of this leaflet carefully.
Ask your doctorif you think any of these situations apply to you. Do not take Kivexa.
Be especially careful with Kivexa
Some people who take Kivexa or other combination treatments for HIV have a higher risk of serious side effects. You need to know that there is a higher risk:
- 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 it may get worse)
- if you are significantly overweight(especially if you are a woman)
- if you have kidney problems.
Ask your doctor before starting Kivexa if youhave any of these conditions.You may need to have extra checks, including blood tests, while taking this medicine. For more information, see section 4.
Hypersensitivity reactions to abacavir
Even patients who do not have the HLA-B*5701 gene can develop a hypersensitivity reaction(a severe allergic reaction).
Read the information on “Hypersensitivity reactions” in section 4 of this leaflet carefully.
Risk of cardiovascular events
It cannot be excluded that abacavir increases the risk of having a heart attack or stroke.
Tell your doctorif you have heart problems, if you smoke, or if you have other diseases that may increase your risk of heart disease, such as high blood pressure or diabetes. Do not stop taking Kivexa unless your doctor advises you to.
Be aware of important symptoms
Some people who take medicines for HIV infection develop other conditions that can be serious. You need to know what important signs and symptoms to look out for while you are taking Kivexa.
Read the information on “Other possible side 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 medicines,including those obtained without a prescription.
Remember to tell your doctor or pharmacist if you start taking any new medicines while you are taking Kivexa.
The following medicines must not be used with Kivexa:
- emtricitabine, to treat HIV infection
- other medicines that contain lamivudine, used to treat HIV infectionor hepatitis B
- high doses of co-trimoxazole(a combination of trimethoprim and sulfamethoxazole), an antibiotic
- cladribine, used to treat hairy cell leukaemia.
Tell your doctorif you are being treated with any of these medicines.
Some medicines interact with Kivexa
These include:
- phenytoin, used to treat epilepsy.
Tell your doctorif 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 removed from the body. If you are taking methadone, you will need to be checked for signs of methadone withdrawal. You may need to have your methadone dose changed.
Tellyour doctorif you are taking methadone.
- medicines (usually liquids) that contain sorbitol and other polyalcohols(such as xylitol, mannitol, lactitol or maltitol), if taken regularly.
Tell your doctor or pharmacistif you are being treated with any of these.
- Riociguat, used to treat high blood pressure in the blood vessels(arteries) that carry blood from the heart to the lungs. Your doctor may need to reduce your dose of riociguat, as abacavir can increase the levels of riociguat in your blood.
Pregnancy
Kivexa is not recommended during pregnancy. Kivexa and similar medicines may harm your unborn baby. If you have taken Kivexa during your pregnancy, your doctor may request that you have regular blood tests and other checks on your baby.
Breast-feeding
It is recommended that HIV-infected women do not breast-feedbecause HIV can be passed to the baby through breast milk. A small amount of the ingredients of Kivexa can also pass into breast milk.
If you are breast-feeding or thinking of breast-feeding, consult your doctor as soon as possible.
Driving and using machines
Kivexa can cause side effects that may affect your ability to drive or use machines.
Consult your doctorabout your ability to drive or use machines while taking Kivexa
Important information about some of the ingredients of Kivexa
Kivexa contains a colour called orange yellow (E110), which may cause allergic reactions in some people.
This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e., it is essentially “sodium-free”.
3. How to take Kivexa
Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.
The recommended dose of Kivexa for adults, adolescents and children weighing at least 25 kg or more is one tablet once a day.
Swallow the tablets whole, with a little water. Kivexa can be taken with or without food.
Keep in regular contact with your doctor
Kivexa helps to control your condition. You need to take it every day to control your HIV infection. You may still develop other infections and illnesses associated with HIV.
Stay in touch with your doctor and do not stop taking Kivexawithout talking to your doctor first.
If you take more Kivexa than youshould
If you accidentally take more Kivexa than you should, tell your doctor or pharmacist, or contact the nearest hospital emergency department for more information.
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 normal treatment schedule.
Do not take a double dose to make up for a forgotten dose.
It is important to take Kivexa regularly, as irregular intake of Kivexa can increase the risk of a hypersensitivity reaction.
If you have stopped taking Kivexa
If for any reason you have stopped taking Kivexa — especially because you think you have had side effects or because of another illness:
Consult your doctor before restarting treatment. Your doctor will check whether your symptoms were related to a hypersensitivity reaction. If your doctor thinks that they may have been related, you should never take Kivexa or any other medicine containing abacavir (e.g.Trizivir, Triumeqor Ziagen) again.It is important that you follow this advice.
If your doctor advises you to restart treatment with Kivexa, they may ask you to take the first doses in a place where you can easily get medical help if you need it.
4. Possible Adverse Effects
During HIV treatment, there may be an increase in weight and levels of glucose and lipids in the blood. This may be partly related to the recovery of health and lifestyle, and in the case of blood lipids, sometimes to HIV medications themselves. Your doctor will monitor these changes.
Like all medications, this medication can produce adverse effects, although not all people suffer from them.
When you are undergoing HIV treatment, it may be difficult to distinguish whether a symptom is an adverse effect of Kivexa or other medications you are taking, or if it is due to an effect of the disease caused by HIV. Therefore, it is very important that you inform your doctor about any change in your health.
Even patients who do not present the HLA-B*5701 gene can develop a hypersensitivity reaction(a severe allergic reaction), described in this prospectus in the section called “Hypersensitivity Reactions”.
It is very important that you read and understand the information about this severe reaction.
In addition to the adverse effects listed below for Kivexa, other disorders can develop during combined HIV treatment.
It is important that you read the information under the heading “Other Possible Adverse Effects of Combined HIV Treatment”.
Hypersensitivity Reactions
Kivexacontains abacavir(an active ingredient also present in Trizivir, Triumeq, and Ziagen).
Abacavir can produce a severe allergic reaction known as a hypersensitivity reaction. These hypersensitivity reactions have been observed more frequently in people taking medications containing abacavir.
Who suffers from these reactions?
Anyone taking Kivexa could develop a hypersensitivity reaction to abacavir, which could put their life at risk if they continue taking Kivexa.
You are more likely to develop this reaction if you have a gene called HLA-B*5701(but you can suffer from this reaction even if you do not have this gene). Before starting treatment with Kivexa, you should have undergone a test to detect this gene. If you know you have this gene, tell your doctor before taking Kivexa.
About 3 to 4 out of every 100 patients treated with abacavir in a clinical trial who did not present the HLA-B*5701 gene developed a hypersensitivity reaction.
What are the symptoms?
The most frequent symptoms are:
- fever (high temperature) and skin rash.
Other frequently observed signs are:
- nausea (discomfort), vomiting, diarrhea, abdominal pain (stomach), and excessive fatigue.
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 numbness or tingling of the hands or feet.
When do these reactions occur?
Hypersensitivity reactions can appear at any time during treatment with Kivexa, but they are more likely to occur in the first 6 weeks of treatment.
Contact your doctor immediately:
1if you have 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, diarrhea, or abdominal pain
- excessive fatigue or general discomfort.
Your doctor may advise you to stop taking Kivexa.
While taking Kivexa, always carry the 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 OR ANY OTHER MEDICATION CONTAINING ABACAVIR (e.g., Trizivir, Triumeq, or Ziagen) AGAIN. If you do, within hours, you may experience a drop in blood pressure that can be life-threatening or cause death.
If, for any reason, you have interrupted treatment with Kivexa — especially because you think you have adverse effects or due to another illness:
Consult your doctor before restarting treatment. Your doctor will check if your symptoms were related to a hypersensitivity reaction. If your doctor considers that there may have been a relationship, they will indicatethatyou should never take Kivexa or any other medication containing abacavir (e.g., Trizivir, Triumeq, or Ziagen) again. It is important that you follow this warning.
Occasionally, hypersensitivity reactions have developed in people who restart abacavir after having had only one symptom of those included in the Patient Information Card before stopping it.
Very rarely, reactions have developed in people who restart treatment with abacavir but did not have any symptoms of hypersensitivity before stopping it.
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 to be safely disposed of. Consult your doctor or pharmacist.
The Kivexa packaging includes a Patient Information Cardto remind you and healthcare personnel about hypersensitivity reactions. Separate the card from the packaging and always carry it with you.
Frequent Adverse Effects
May affect up to 1 in 10people:
- hypersensitivity reaction
- headache
- vomiting
- discomfort (nausea)
- diarrhea
- stomach pain
- loss of appetite
- fatigue, lack of energy
- fever (high temperature)
- general feeling of discomfort
- difficulty sleeping (insomnia)
- muscle pain and discomfort
- joint pain
- cough
- irritated or runny nose
- skin rash
- hair loss.
Uncommon Adverse Effects
May affect up to 1 in 100people and may be reflected in blood tests:
- low red blood cell count (anemia) or low white blood cell count (neutropenia)
- increase in liver enzyme levels
- a decrease in the number of cells involved in blood clotting (thrombocytopenia).
Rare Adverse Effects
May affect up to 1 in 1,000people:
- liver disorders, such as jaundice, liver enlargement, or fatty liver, inflammation (hepatitis)
- pancreas inflammation (pancreatitis)
- muscle tissue rupture.
Rare adverse effects that may appear in blood tests are:
- increase in an enzyme called amylase.
Very Rare Adverse Effects
May affect up to 1 in 10,000people:
- numbness, tingling sensation in the skin (pins and needles)
- weakness sensation in the limbs
- skin rash that can form blisters resembling small targets (dark central spot surrounded by a paler area, with a dark ring around the edge) (erythema multiforme)
- widespread rash with blisters and skin peeling, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), and a more severe form that causes 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 suffer from adverse effects
Tell your doctor or pharmacistif you consider that any of the adverse effects you are suffering from is serious or if you notice any adverse effect not mentioned in this prospectus.
Other Possible Adverse Effects of Combined HIV Treatment
Combined treatments, such as Kivexa, can 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 severe infections (opportunistic infections). Such infections may have been "latent" and not detected by the weakened immune system before starting treatment. After starting treatment, the immune system becomes stronger, so it begins to fight these infections, which can cause symptoms of infection or inflammation. The symptoms generally include fever, in addition to some of the following:
- headache
- stomach pain
- difficulty breathing.
In rare cases, as the immune system becomes stronger, it can also attack healthy tissues (autoimmune disorders). The symptoms of autoimmune disorders can appear many months after starting to take medications to treat HIV infection. The symptoms can include:
- palpitations (rapid or irregular heartbeats) or tremors
- hyperactivity (excessive restlessness and movement)
- weakness starting in the hands and feet and ascending towards the body trunk.
If you observe any symptom of infectionand inflammation or if you notice any of the above symptoms:
- Tell your doctor immediately. Do not take any other medication for the infection without your doctor's advice.
You may have bone problems
Some patients receiving combined HIV treatment develop a bone disease called osteonecrosis. With this disease, part of the bone tissue dies due to a reduction in blood supply to the bone. People are more likely to suffer from this disease:
- if they have been taking combined treatment for a long time
- if they also take anti-inflammatory medications called corticosteroids
- if they drink alcohol
- if their immune system is severely weakened
- if they are overweight.
The signs of osteonecrosis include:
- stiffness in the joints
- pain and discomfort (especially in the hip, knee, or shoulder)
- difficulty moving.
If you notice any of these symptoms:
Tell your doctor.
Reporting Adverse Effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.
5. Storage of Kivexa
Keep this medication out of sight and reach of children.
Do not use this medication after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.
Do not store above 30°C.
Medications should not be disposed of through wastewater or household waste. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.
6. Package Contents and Additional Information
Kivexa Composition
The active ingredients of each Kivexa film-coated tablet are 600 mg of abacavir (as sulfate) and 300 mg of lamivudine.
The other ingredients 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 yellow-orange FCF (E110).
Kivexa Appearance and Package Contents
The tablets are orange, film-coated, capsule-shaped, and engraved on one side with GS FC2. They are available in blister packs containing 30 tablets and multi-packs containing 90 (3x30) tablets.
Marketing Authorization Holder
ViiV Healthcare BV
Van Asch van Wijckstraat 55H
3811 LP Amersfoort
Netherlands.
Manufacturer
Glaxo Wellcome S.A., Avenida de Extremadura, 3, 09400 Aranda de Duero (Burgos), Spain.
You can request more information about this medication by contacting the local representative of the marketing authorization holder:
Belgium/Belgique/Belgien ViiV Healthcare srl/bv Tel: + 32 (0) 10 85 65 00 | Lithuania ViiV Healthcare BV Tel: + 370 80000334 |
Bulgaria ViiV Healthcare BV Tel: + 359 80018205 | Luxembourg/Luxemburg ViiV Healthcare srl/bv Belgium/Belgien 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 Tel: + 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 Tel: + 47 22 70 20 00 |
Greece GlaxoSmithKline Μονοπρόσωπη A.E.B.E. 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 Tel: + 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: + 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 | United Kingdom(Northern Ireland) ViiV Healthcare BV Tel: + 44 (0)800 221441 |
Date of the Last Revision of this Prospectus:
Detailed information about this medication is available on the European Medicines Agency website: http://www.ema.europa.eu.
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- Country of registration
- Dosage formTABLET, 600/300 mg/mg
- ATC codeJ05AR02
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to KIVEXA 600 MG/300 MG FILM-COATED TABLETSDosage form: TABLET, 600 mg / 300 mgActive substance: lamivudine and abacavirManufacturer: Aurovitas Spain, S.A.U.Prescription requiredDosage form: TABLET, 600 mg/300 mgActive substance: lamivudine and abacavirManufacturer: Reddy Pharma Iberia S.A.Prescription requiredDosage form: TABLET, 600 mg/300 mgActive substance: lamivudine and abacavirManufacturer: Glenmark Arzneimittel GmbhPrescription required
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Frequently Asked Questions
KIVEXA 600 MG/300 MG FILM-COATED TABLETS requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
The active ingredient in KIVEXA 600 MG/300 MG FILM-COATED TABLETS is lamivudine and abacavir. This information helps identify medicines with the same composition but different brand names.
KIVEXA 600 MG/300 MG FILM-COATED TABLETS is manufactured by Viiv Healthcare B.V.. Pharmacy brands and packaging may differ depending on the distributor.
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether KIVEXA 600 MG/300 MG FILM-COATED TABLETS is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
Spain has a well-developed healthcare infrastructure across major cities such as Madrid, Barcelona, Valencia, and Seville. Pharmacies are widely available and operate under strict regulations, ensuring access to prescribed medications.
You can buy KIVEXA 600 MG/300 MG FILM-COATED TABLETS in Madrid, Barcelona, Seville, or Valencia at any local pharmacy with a valid prescription.
To obtain a prescription, you can use Oladoctor:
Other medicines with the same active substance (lamivudine and abacavir) include ABACAVIR/LAMIVUDINE AUROVITAS 600 mg/300 mg FILM-COATED TABLETS, ABACAVIR/LAMIVUDINE Dr. Reddy's 600 mg/300 mg FILM-COATED TABLETS, ABACAVIR/LAMIVUDINE GLENMARK 600 mg/300 mg FILM-COATED TABLETS. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
