Lumivo 300 mg/50 mg Film-Coated Tablets

LUMIVO is used to treat HIV (‘human immunodeficiency virus’) infection. It belongs to a group of medicines called ‘antiretroviral medicines’. LUMIVO contains the active substances: lamivudine, tenofovir and dolutegravir sodium. LUMIVO is used in the treatment of human immunodeficiency virus (HIV) infection in adults and adolescents over 18 years of age.

Do not take LUMIVO:

• If you are hypersensitive (allergic) to lamivudine, tenofovir, dolutegravir or any of the other ingredients of LUMIVO (listed in section 6.1).
• If you have moderate or severe liver problems.
• If you have kidney problems (see Take special care with LUMIVO).
• If you are planning to become pregnant.
• If you are pregnant or breastfeeding your baby (see Pregnancy, breastfeeding and fertility).
• If you are a woman of childbearing age and are not using highly effective contraception.
• If you are currently taking adefovir dipivoxil (used to treat hepatitis B infection), dofetilide or pilsicainide (used to treat heart conditions), didanosine (used to treat HIV infection) or metformin (used to treat high sugar levels) (see Other medicines and LUMIVO).
• If you or your child is younger than 18 years old.

Warnings and precautions

Take special care with LUMIVO:

• If you experience any of the following signs or symptoms of a hypersensitivity (allergic) reaction: severe rash, fever, general feeling of discomfort, unusual weakness or tiredness, muscle or joint pain, blisters, mouth sores (oral lesions), pink eye (conjunctivitis), swelling of your face, swelling in other parts of your body due to fluid build-up (oedema), blood disorder (eosinophilia) or urticaria (hives), stop taking LUMIVO tablets and consult your doctor immediately.
• If you have lipodystrophy (a problem with the way your body uses and stores fat). This condition is characterised by being overweight (obesity), build-up of fat on the back of the neck between the shoulders (buffalo hump), loss of fat under the skin (making the face look thin), breast enlargement and high levels of fat and glucose (sugar) in the blood.
• If you have advanced HIV infection, your immune system is weak, and you are more likely to develop serious infections (opportunistic infections).
• In rare cases, as your immune system becomes stronger, it can also attack healthy body tissue (autoimmune disorders).
• Talk to your doctor or healthcare provider if you have a history of liver disease, including hepatitis.
• If you have a condition called osteonecrosis (where parts of the bone tissue die, because of reduced blood supply to the bone).
• Tell your doctor if you notice any of these symptoms of osteonecrosis: joint aches and pain, joint stiffness or difficulty in movement.
• Bone problems (sometimes resulting in fractures) may also occur due to damage to the kidney cells.
• If you are taking other medicine (prescription and non-prescription).
• If you develop opportunistic infections and other complications of HIV infection.
• HIV infection is spread by sexual contact with someone who has the infection, or by transfer of infected blood.
• Look out for possible signs and symptoms of lactic acidosis (excess of lactic acid in your blood) once you start taking LUMIVO tablets.
• LUMIVO may affect your kidneys.
• LUMIVO may cause pancreatitis (inflammation of the pancreas).
• You will need to take LUMIVO tablets every day.
• Do not take LUMIVO if you are already taking medicines that contain lamivudine, tenofovir and emtricitabine.

Do not share medicines prescribed for you with any other person. LUMIVO therapy should be initiated by a healthcare provider experienced in the management of HIV infection. Always take LUMIVO exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Adults and adolescents (aged 18 years and older)

The usual dose of LUMIVO is one (1) tablet taken orally, once daily with or without food.

Paediatrics

LUMIVO is not recommended for use if you or your child is younger than 18 years of age.

Your doctor will tell you how long your treatment with LUMIVO will last. Do not stop treatment early because it may worsen your condition and make your body resistant to LUMIVO. Your doctor will prescribe a dose according to your condition.

If you have the impression that the effect of LUMIVO is too strong or too weak, talk to your doctor or pharmacist.

If you take more LUMIVO than you should

In the event of overdosage, consult your doctor or pharmacist. If neither is available, contact the nearest hospital or poison centre. Take the tablet container with you so that the doctor can see what you have taken.

If you forget to take LUMIVO

It is important that you do not miss a dose. If you do miss a dose, take it as soon as possible unless it is nearly time for your next dose. Do not take a double dose to make up for forgotten individual doses.

If you throw up the tablet (just after taking your LUMIVO tablet) you should take another tablet. Do not wait until your next dose is due.

If you stop taking LUMIVO

Do not stop taking treatment unless your doctor tells you to. This is very important because the virus may become resistant to LUMIVO which may worsen your condition and make it more difficult to treat. If LUMIVO tablets are stopped, speak to your doctor before you restart taking LUMIVO tablets.

Your doctor may consider giving you the components of LUMIVO tablets separately if you are having problems or need your dose adjusted.

LUMIVO can have side effects. Not all side effects reported for LUMIVO are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking LUMIVO, please consult your healthcare provider for advice.

If any of the following happens, stop taking LUMIVO and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Skin rash accompanied by a high temperature (fever), lack of energy (fatigue) swelling of the face or mouth which may cause difficulty in swallowing or breathing, muscle or joint pain.
• Swelling with a red coloured rash (itchy or not itchy) beneath the surface of the skin, in area on or near the feet, hands, eyes, or lips; swollen throat, hoarseness, and difficulty breathing; abdominal cramps.
• Deep rapid breathing; drowsiness, feeling sick (nausea), being sick (vomiting) and stomach pain; a general feeling of discomfort and unusual sleepiness, tiredness, or weakness.

These are all very serious side effects. If you have them, you may have had a serious reaction to LUMIVO. You may need urgent medical attention or hospitalisation.

Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:

• Severe upper stomach pain, often with nausea and vomiting.
• Suicidal thoughts (especially if you have had depression or mental problems before), suicide attempt.
• Kidney problems, including kidney failure.

These are all serious side effects. You may need urgent medical attention.

Tell your doctor, pharmacist or other healthcare provider if you are pregnant; think you may be pregnant or if you are planning to have a baby as LUMIVO may cause abnormalities to the unborn baby (see Pregnancy, breastfeeding and fertility).

Tell your doctor if you notice any of the following:

• Frequent side effects:
• Sleeping problems (insomnia).
• Headache, dizziness, abnormal dreams.
• Anorexia (an eating disorder).
• Feeling of dizziness or spinning (vertigo).
• Nausea (feeling sick), diarrhoea, vomiting, flatulence (wind), pain in the upper stomach area.
• Unusual weakness or tiredness, fever.
• Coughing, nasal symptoms.
• Hair loss (temporary).
• Rash, itching (pruritis).

Less frequent side effects:

• Blood disorders (bleeding or bruising more easily than normal).
• Appearance of symptoms of infection as part of the “immune reconstitution inflammatory syndrome”.
• Anxiety depression, paranoia.
• Stomach pain, stomach discomfort, gastritis.
• Hepatitis (yellowing of the skin and eyes, also called jaundice).
• Hepatomegaly (enlarged liver, characterised by jaundice (yellowing of skin), abnormal liver function test results, blood in stools).
• Severe skin rash (erythema multiforme, Stevens-Johnson syndrome).
• Muscle breakdown (rhabdomyolysis), muscle spasms.
• Osteonecrosis (a bone disease that may cause pain or limit physical activity).
• Increase in amount of fat and sugar in the blood.
• Increase in enzymes (chemical that speed up chemical reactions in the body) produced by the pancreas (amylase), produced by muscles (creatine phosphokinase), produced by the liver (AST, ALT, gamma-GT).
• Test may show abnormal results for cholesterol, fat, enzyme creatine phosphokinase, white blood cells, blood and sugar (glucose) in the urine.
• Difficulty in breathing (dyspnoea), pneumonia (serious lung infection with fever, chills, shortness of breath, cough, phlegm.
• Changes in body shape due to changes in fat distribution.
• Anorexia (an eating disorder characterised by a loss of appetite and a decrease in body mass).
• Abnormal behaviour.
• Nerve injury causing weakness and sensations of tingling, prickling, or numbness of the skin, especially in the feet and hands (peripheral neuropathy).
• Seizures (convulsions).
• Disorders of the nervous system, e.g. the brain, spinal cord or nerves (which may develop at a later stage in children, who were exposed to LUMIVO while still developing in the womb).
• Breast enlargements in males (gynaecomastia).
• Inflammation of the kidney (nephritis), passing a lot of urine and feeling thirsty (nephrogenic diabetes insipidus).

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Reporting of side effects

If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of LUMIVO.

• Store all medicines out of reach of children.

• Store at or below 30 °C.

• Keep the container tightly closed.

• Keep in the original container until required for use.

• Protect from light and moisture.

• Do not store in a bathroom.

• Do not use after the expiry date stated on the label / bottle.

• Return all unused medicine to your pharmacist.

• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).