TM Owner ViiV Healthcare
Juluca 50mg + 25mg Tablet
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Indications & Clinical Uses
- Juluca 50 mg/25 mg film-coated tablets combine dolutegravir, an HIV-1 integrase strand transfer inhibitor, with rilpivirine, a non-nucleoside reverse transcriptase inhibitor.
- It is a complete TWO-DRUG maintenance regimen for HIV-1 infection in adults, used only to REPLACE a current antiretroviral regimen in people who are already virologically suppressed (HIV-1 RNA below 50 copies/mL) on stable therapy for at least 6 months, with no history of treatment failure and no known resistance substitutions to either component.
- It is not a starting regimen for newly diagnosed or untreated HIV, and it is not combined with other antiretrovirals.
- One tablet is taken once daily WITH A MEAL, because food is required for rilpivirine to be absorbed properly; a protein drink on its own is not enough.
- Juluca does not cure HIV and does not stop you passing the virus to others.
- It is authorised in both the United States and the European Union and is marketed by ViiV Healthcare.
Side Effects
- The most commonly reported side effects of Juluca, each in about 2 in 100 people, are diarrhoea and headache.
- Nausea, dizziness, abnormal dreams, difficulty sleeping, tiredness, rash and rises in blood cholesterol, triglycerides and liver enzymes are also seen.
- Juluca has NO boxed warning.
- Get medical help straight away for a rash with fever, blistering, mouth sores, swelling of the face, difficulty breathing, or muscle and joint aches, which may mean a severe hypersensitivity reaction - Juluca must then be stopped at once and never restarted.
- Report yellowing of the eyes or skin, dark urine, pale stools, severe tiredness or pain under the right ribs, which can signal liver injury.
- Tell your healthcare provider about new or worsening low mood, depression or thoughts of self-harm, reported with both ingredients.
- In the first weeks old infections can flare as the immune system recovers.
Precautions & Warnings
- Juluca is only for adults who are already virologically suppressed; your viral load and CD4 count are monitored regularly, and treatment is changed if the virus becomes detectable.
- Liver enzymes are monitored, particularly if you have hepatitis B or hepatitis C, because hepatotoxicity has been reported; do not stop hepatitis B treatment without advice, as this can trigger a serious flare.
- Tell your healthcare provider about any history of depression or other mental health problems.
- Juluca is contraindicated in anyone with previous hypersensitivity to dolutegravir or rilpivirine and in anyone taking dofetilide.
- Take it with a proper meal at roughly the same time each day; if you vomit within 4 hours of a dose, take another tablet with food.
- Discuss pregnancy planning - current surveillance no longer shows an increased rate of neural tube defects with dolutegravir, but your regimen should be reviewed.
- Juluca does not prevent HIV transmission.
Avoid Interactions
- Tell your healthcare provider about every medicine, herbal product and supplement you take.
- Juluca is CONTRAINDICATED with drugs that cut rilpivirine levels and cause treatment failure and resistance: rifampicin, rifapentine, carbamazepine, oxcarbazepine, phenobarbital, phenytoin, St John's wort, systemic dexamethasone beyond a single dose, and all proton pump inhibitors such as omeprazole, esomeprazole, lansoprazole and pantoprazole.
- Dofetilide is contraindicated because dolutegravir raises its level and can cause dangerous heart rhythms.
- Antacids and supplements containing magnesium, aluminium, calcium or iron must be separated from the tablet - take them at least 6 hours before or 4 hours after Juluca.
- H2-blockers such as famotidine must be taken at least 12 hours before or 4 hours after.
- Rifabutin requires an extra 25 mg rilpivirine tablet daily.
- Metformin exposure rises sharply, so its dose may need reducing.
- Avoid other QT-prolonging medicines unless your prescriber advises otherwise.
References
Frequently Asked Questions
Juluca (dolutegravir and rilpivirine) is a complete two-drug tablet for HIV-1 in adults. It replaces a current regimen in people already virologically suppressed below 50 copies/mL for at least 6 months, with no past treatment failure or resistance. It is not used to start HIV treatment.
Take one Juluca tablet once daily with a meal, at about the same time each day. Food is essential because rilpivirine is poorly absorbed without it, and a protein drink alone does not count. If you vomit within 4 hours of a dose, take another tablet with food.
The commonest Juluca side effects are diarrhoea and headache, each in about 2 in 100 people. Nausea, dizziness, abnormal dreams, insomnia and raised cholesterol or liver enzymes also occur. Get urgent help for rash with fever, blistering, mouth sores or facial swelling, and report yellow eyes or dark urine.
Never take Juluca with a proton pump inhibitor such as omeprazole, or with rifampicin, rifapentine, carbamazepine, phenytoin, phenobarbital, oxcarbazepine, St John's wort or dofetilide. Separate antacids and calcium, magnesium or iron supplements by 6 hours before or 4 hours after. H2-blockers need a 12-hour gap beforehand.
Take the missed Juluca (dolutegravir and rilpivirine) dose with food as soon as you remember, if it is within 12 hours of the usual time. If more than 12 hours have passed, skip it and take the next dose with a meal as normal. Never take two tablets at once.
No, Juluca (dolutegravir and rilpivirine) carries no boxed warning. Its key safety points are stopping it immediately for severe rash or hypersensitivity, liver monitoring if you have hepatitis B or C, watching for new depression or low mood, and always taking the tablet with a meal.
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