Reydin Side Effects

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Answer the side-effect intent for reydin without diagnosing; distinguish common from serious reactions and give safe next-step/reporting guidance.

What is Reydin?

Reydin contains the active ingredient Lamivudine. Tenofovir disoproxil. Dolutegravir.

• Active ingredient — Lamivudine. Tenofovir disoproxil. Dolutegravir
• Registration number — 52/20.2.8/0451
• Registration holder — Cipla Medpro (Pty) Ltd

It is approved for:

• REYDIN is an antiviral medicine
• REYDIN tablets are used to treat human immunodeficiency virus-1 (HIV-1) infected adults over 18 years of age
• WARNING TOO MUCH ACID IN THE BODY DUE TO LACTIC ACID AND SERIOUS ENLARGED, FATTY LIVER, INCLUDING CASES RESULTING IN DEATH, HAVE BEEN REPORTED WITH THE USE OF NUCLEOSIDE ANALOGUES (MEDICINES USED FOR THE TREATMENT OF HIV) ALONE OR IN COMBINATION WITH OTHER ANTIRETROVIRALS
• REYDIN IS NOT INDICATED FOR TREATMENT OF CHRONIC HEPATITIS B VIRUS (HBV) INFECTION

Common side effects of Reydin

Not everyone gets side effects. The effects below are those listed in the South African approved leaflet, grouped using the leaflet’s own frequency wording.

Frequent side effects

• Hypophosphataemia (electrolyte disorder in which there is a low level of phosphate in the blood, with symptoms that may include weakness, trouble breathing and loss of appetite)
• Insomnia (difficulty sleeping), abnormal dreams, depression, anxiety
• Headache, dizziness
• Cough, nasal discharge and congestion
• Nausea, diarrhoea, vomiting, flatulence, stomach pain or discomfort
• Skin rash, hair loss, severe itching of the skin
• Fatigue, general feeling of being unwell, fever
• Increased liver enzyme levels. S.G

Less frequent side effects

• Anaemia (not having enough healthy red blood cells), neutropenia (changes in the white blood cell counts), thrombocytopenia (low platelet count in your blood which is required for blood to clot) and pure red cell aplasia (type of anaemia which affects red blood cells)
• Peripheral neuropathy (damage to nerves outside the spinal cord, affecting the normal functioning of the body’s organs and movement and/or feeling of sensation in the extremities, including your arms and legs)
• Dyspnoea (difficulty breathing)
• Increased digestive enzyme (amylase) levels
• Joint pain, muscle pain
• Kidney problems including kidney failure
• Abnormal physical weakness or lack of energy
• Redistribution of fat around your body
• Decreased bone density, bone fractures. Side effects with unknown frequency:
• Hypokalaemia (low blood potassium levels)
• Fatty liver disease (symptoms include weight loss, fatigue and abdominal pain)
• Bone pain, muscle weakness, experiencing a decrease in height, stooped posture, and easily fractured bone (loss of bone mass)
• Inflammation of the kidney, diabetes insipidus (frequent urination and S.G often feeling thirsty)
• Immune reconstitution syndrome (condition in which the immune system begins to recover but then responds to a previously acquired opportunistic infection with an overwhelming inflammatory response making the symptoms of infection worse)

Serious side effects and warning signs

This leaflet does not set out a separate list of serious side effects. The general warning signs below apply to any medicine.

General warning signs that apply to any medicine

How long can side effects last?

How long a side effect lasts depends on the effect, the product, how long it has been used, and the person. Some effects ease within days as the body adjusts. Others continue for as long as the product is used. A few can persist after stopping, and some need review rather than waiting.

• Settling effects — mild effects that ease over the first days or weeks of use
• Ongoing effects — effects that continue while the product is being used and improve after stopping
• Persistent effects — effects that continue after stopping and need medical review
• Delayed effects — effects that appear after weeks or months rather than immediately

Which of these applies to a particular effect is a clinical question. If a side effect is not settling, is getting worse, or is affecting your daily life, that is worth a conversation with a pharmacist or doctor regardless of how long it has been going on.

Factors that may affect side effects

The approved leaflet identifies the following cautions and factors.

Do not use it at all if

• If you are hypersensitive (allergic) to dolutegravir, lamivudine or tenofovir disoproxil fumarate, or any of the ingredients of REYDIN (listed in section 6)
• If you have kidney failure
• If you have liver disease
• If you are pregnant or breastfeeding your baby
• If you plan on becoming pregnant
• If you are a woman of childbearing age and not using effective contraceptives to prevent falling pregnant
• If you are also taking heart medication for irregular heartbeat containing dofetilide and pilsicainide
• If you are taking metformin, for the treatment of type 2 diabetes
• If you are taking chronic medication for hepatitis B infection, containing adefovir dipivoxil
• If you are taking other anti-retroviral medicines containing didanosine
• If you are younger than 18 years of age

Use with care, and tell your doctor, if

• If you develop a rash, or show any general signs of allergy (rash, accompanied by fever, general feeling of being ill, tiredness, muscle or joint S.G aches, sores, oral scrapes, eye infection, facial swelling, a serious liver infection or swelling of the skin)
• If you develop changes in body fat, as changes have been seen in some patients taking REYDIN and other anti-HIV medicines. These changes may include increased amount of fat in the upper back and neck (“buffalo hump”), breast, and around the main part of your body (trunk). Loss of fat from the legs, arms and face may also happen. The cause and long-term health effect of these conditions are not known at this time
• If you show any symptoms of infection while you are taking REYDIN. People with advanced HIV infection (AIDS) have weak immune systems and are more likely to develop serious infections (opportunistic infections). When these people start with the treatment, they may find that old hidden infections (such as tuberculosis) flare up, causing signs and symptoms of inflammation (such as localised swelling, area appears red and hot, painful). These symptoms are probably caused by the body’s immune system becoming stronger, so that the body starts to fight these infections
• If you have abnormal metabolic processes, such as, increased cholesterol, glucose or lactate in the blood or are resistant to insulin. Your healthcare professional may perform regular blood tests to confirm normal metabolic processes
• If you have liver problems including hepatitis B virus (HBV) infection
• If you show signs of liver injury
• If you show symptoms such as nausea, vomiting, abdominal pain, non- specific general feeling of being ill, loss of appetite, weight loss, rapid and/or deep breathing, or muscle weakness. S.G
• If you are female, very overweight (obese), or have been using medicines for the treatment of HIV for a long time as you may be more likely to get lactic acidosis (build-up of lactic acid in the body)
• If you suffer from kidney disease
• If you experience pain in the stomach, as this can be a symptom of pancreatitis (swelling of the pancreas)
• If you suffer from liver disease including hepatitis B or C, as the use of antiviral medicine can cause fatal unfavourable liver symptoms. Your doctor will monitor your live enzymes as REYDIN can cause liver toxicity
• If your child experiences symptoms of poor growth, loss of muscle coordination, muscle weakness, visual problems, hearing problems, learning disabilities, heart disease, liver disease, kidney disease, gastrointestinal disorders, respiratory disorders, nervous system problems (brain, spine and nerves), loss of voluntary body functions (such as breathing, bladder function, heartbeat and digestive processes) and dementia (loss of memory) can be a sign of mitochondrial (part of the cell that creates energy) disorder. These findings should be considered for any child exposed to treatment, before being born
• If you have had bone problems in the past, your healthcare provider may need to do tests to check your bone mineral density or may prescribe medicines to help your bone mineral density
• If you experience joint aches and pain, joint stiffness or difficulty in movement, you may suffer from osteonecrosis
• If you are elderly and suffer from kidney or liver damage or failure. S.G
• If you have a history of depression or mental illness as REYDIN may cause depression and suicidal thoughts. REYDIN should be used with caution in the elderly (65 years and over), due to decreased liver and kidney function. REYDIN should not be taken with other medicines containing any of the active ingredients, namely: dolutegravir, lamivudine or tenofovir disoproxil fumarate. REYDIN does not reduce the risk of passing HIV to others through sexual contact or blood contamination. Therefore, it is important to continue to take appropriate precautions to prevent passing HIV to others. Even if you are receiving treatment for HIV, you are still at risk of contracting other infections and other complications of the HIV infection. Therefore, you should remain under close observation by your doctor

Pregnancy and breastfeeding

• REYDIN is contraindicated in pregnancy and breastfeeding
• If you are a woman who is able to have children, you should be counselled about the potential risk of neural tube defects with dolutegravir
• S.G A pregnancy test should be performed before you start taking REYDIN, if you are able to bear children, to exclude the unintentional use of REYDIN during the first trimester of pregnancy
• If you plan on becoming pregnant, your doctor will need to discuss the risks and benefits of starting or continuing treatment with REYDIN versus another medicine regimen
• It should be noted that the use of dolutegravir, as contained in REYDIN, was associated with a small increase in the likelihood of neural tube defects (birth defects) compared to non-dolutegravir regimens
• Most neural tube defects occur within the first 4 weeks of pregnancy which is approximately 6 weeks after your last menstrual cycle (period)

Interactions and medicines to check

The approved leaflet names these interactions.

• Other products that contain dolutegravir, lamivudine or tenofovir, either alone or as combined formulations. REYDIN should not be used with S.G these medicines because they contain the same or similar active ingredients as REYDIN
• Rifampicin, used for treatment of tuberculosis, can decrease blood concentrations of REYDIN
• REYDIN can increase blood concentrations of metformin (for the treatment of type 2 diabetes), when used simultaneously
• Other medicines used for the treatment of HIV infections that decrease REYDIN levels include efavirenz, nevirapine, ritonavir, tipranavir
• REYDIN can increase levels of the following heart medicine for the treatment of irregular heartbeat – dofetilide and pilsicainide
• REYDIN can increase blood concentration levels of isoniazid used for treatment of tuberculosis
• Certain antacids can also decrease REYDIN levels, that contain for example magnesium, aluminium or calcium
• REYDIN must be taken 2 hours before or 6 hours after taking products containing magnesium, calcium, iron or aluminium
• REYDIN may hinder the breakdown of zalcitabine, also used in the treatment of HIV infections
• Taking REYDIN in combination with high doses of co-trimoxazole or trimethoprim (used for the treatment of bacterial infections) must be avoided if you have a kidney condition or disease
• The use of REYDIN with etravirine for HIV infections is not recommended. S.G
• Medicines that can cause toxicity in the kidneys, for example antibiotics e.g., vancomycin, aminoglycosides (gentamycin, amikacin, tobramycin, neomycin), antifungals, e.g., amphotericin B, antivirals, e.g., foscarnet, ganciclovir, antimicrobials, e.g., pentamidine
• REYDIN increases the levels of atazanavir (also used for the treatment of HIV infection) and may need to be adjusted
• Phenobarbitone, phenytoin, oxcarbazepine, carbamazepine and St. John’s Wort decrease levels of REYDIN
• REYDIN increases levels of abacavir used in the treatment of HIV and may need to be adjusted
• REYDIN is not affected and does not influence the levels of emtricitabine, lopinavir and ritonavir used in the treatment of HIV
• REYDIN is not affected and does not change levels of methadone, used in the treatment of opioid abuse
• Combination medicines for treatment of HIV containing fosamprenavir and ritonavir or darunavir and ritonavir decrease levels of REYDIN
• Medicines containing ribavirin used in the treatment of hepatitis B, is not affected and does not alter the levels of REYDIN

What to do if you experience side effects

If you think you are having a side effect, the response depends on how severe it is. Use the warning signs above first — if any of those apply, treat it as urgent.

If the symptom is severe or frightening

Get medical help immediately. Call 10177 for an ambulance, or 112 from a mobile phone, or go to the nearest emergency department. Take the product and its packaging with you if you can.

If the symptom is mild but bothering you

• Write down what the symptom is, when it started, and how it relates to when you take the product
• Check the leaflet that came with the product to see whether the symptom is listed
• Speak to your pharmacist — for many questions this is the fastest route to a useful answer
• Contact the prescriber if the symptom is affecting your daily life or is not settling

You can also report a suspected side effect in South Africa. Reporting does not replace getting medical advice, and you do not need to be certain the product was the cause.

When to seek urgent medical help

Some symptoms need medical attention straight away rather than an appointment in a few days. Do not wait to see whether they settle.

Get same-day medical advice if you have

• A high fever, or a rash together with feeling generally unwell
• Yellowing of the eyes or skin, or unusually dark urine
• Unusual bruising or bleeding that you cannot explain
• Severe or persistent vomiting or diarrhoea, especially if you cannot keep fluids down
• A sudden change in mood, or thoughts of harming yourself
• Any symptom that is rapidly getting worse

How to report a suspected side effect in South Africa

South Africa has an official system for reporting suspected side effects, run by the South African Health Products Regulatory Authority (SAHPRA). Reports from the public and from healthcare professionals are how safety signals get detected after a product is already in use.

Who can report

Anyone can report — you do not have to be a healthcare professional, and you do not need to prove that the product caused the problem. A suspicion is enough. Patients, caregivers and family members can all submit a report.

What to have ready

• The name of the product, its strength and form, and the batch number if you have it
• Why it was being used, and when it was started and stopped
• What the suspected reaction was, when it began, and how long it lasted
• Any other medicines, supplements or remedies being used at the same time
• Basic details about the person affected — age and sex are usually enough

How to report

SAHPRA accepts adverse reaction reports through its e-Services reporting system and through the Med Safety mobile app. Healthcare professionals can also report through the same routes. Current forms and access points are published on the SAHPRA site.

• SAHPRA Health Products Vigilance — the main vigilance and reporting hub
• SAHPRA e-Services — current adverse reaction reporting access

For a fuller walkthrough see how to report an adverse drug reaction.

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