Juluca (Dolutegravir and Rilpivirine) - Oral

What Is Juluca?

Juluca (dolutegravir and rilpivirine) is a medicine used to treat human immunodeficiency virus (HIV), the virus that causes acquired immunodeficiency syndrome (AIDS).

Juluca is one product that contains two drugs: dolutegravir and rilpivirine. It falls into the broad category of antiretroviral drugs. Dolutegravir is an HIV-1 integrase strand transfer inhibitor (INSTI). Rilpivirine is an HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI). Both of these drugs target stages of the virus’ life cycle, preventing it from making copies of itself. Without the ability to replicate itself, HIV can be suppressed to undetectable levels, which keeps the immune system functioning and also reduces the risk of transmitting the virus to others.

Juluca comes as a tablet taken by mouth. It is a prescription product, so you can’t purchase it over the counter. You’ll receive a prescription from your healthcare provider and get the medication from your pharmacy.

What Is Juluca Used For?

The Food and Drug Administration (FDA) approved Juluca to treat HIV in people who have already achieved viral suppression, meaning a lab test will detect less than 50 copies of the virus per milliliter of blood. This will include individuals who have been on a previous antiretroviral drug regimen for at least six months that successfully treated their HIV.

How to Take Juluca

Take Juluca at the same time every day with a meal. Taking Juluca with a meal that contains some fat is important because it will ensure that you absorb enough of the drug and receive the full dose. You can take it with whichever meal is most convenient for you, as long as you get enough calories. Around 600 calories should be the minimum, with about 200 calories coming from fat.

Storing Juluca

Store Juluca at room temperature (between 68 and 77 degrees Fahrenheit) in the original container with the lid on, out of reach of children and pets. Avoid storing your pill bottle in an area with a lot of heat and moisture, like the bathroom.

If you’re traveling by plane, you’ll want to keep Juluca in your carry-on luggage so that you aren’t separated from it if your checked baggage goes missing. If you’re traveling by car, take care not to leave your pill bottle in especially hot or cold temperatures for long periods, like overnight in the car.

What Are the Side Effects of Juluca?

This is not a complete list of side effects and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or a healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 1-800-FDA-1088.

Common Side Effects

Some common side effects that you may experience while taking Juluca include headache and diarrhea.

Severe Side Effects

Potential side effects of Juluca that were rarer in clinical trials but potentially more severe include:

• Severe skin and hypersensitivity reactions, including drug reaction cases with eosinophilia and systemic symptoms (DRESS): This is a serious reaction that can happen even weeks after beginning a drug and may include symptoms like fever, redness and blistering, and abnormal liver lab tests.
• Liver toxicity: Let your healthcare provider know if you also have hepatitis B or C or any other liver conditions, as these conditions are at an increased risk of worsening when taking Juluca.
• Psychiatric disorders, such as depression, especially in individuals with a history of psychiatric illness

Call your healthcare provider right away if you feel like you are experiencing serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency.

Long-Term Side Effects

No specific side effects apart from the ones listed above are associated with long-term use of Juluca.

Dosage: How Much Juluca Should I Take?

Modifications

You may need to take precautions while using or administering this medication in certain cases.

Pregnancy

It is unknown whether taking Juluca while pregnant increases the risk of birth defects or miscarriage. There is an online pregnancy exposure registry that reports outcomes in people exposed to antiretrovirals while pregnant. The overall risk does not seem to be higher in pregnant women exposed to the medicines that Juluca contains. However, there is not enough data here to make any definite conclusions.

Breastfeeding

It is not known whether Juluca is present in human breast milk. However, due to the risk of transmitting HIV through breast milk, the Centers for Disease Control and Prevention (CDC) recommends against breastfeeding if you have HIV.

Children

Juluca has not been established as safe or effective for children.

Older Adults

There have not been specific studies to determine whether older adults (above age 65) respond differently to Juluca than younger adults. In general, Juluca should be used cautiously in older adults, keeping in mind any decreased liver or kidney function and other medications that may interact with Juluca.

Missed Dose

If you forget to take a dose of Juluca, you can take it as soon as you remember. Just remember to take it with a meal.

If you are closer to your next dose than the dose you missed, go ahead and skip the missed dose and wait for your next scheduled one. For example, if you usually take Juluca at 8 am, and you remember at 9 pm that you forgot your morning dose, wait and take your next dose the following day at 8 am. Do not double up doses to make up for missed ones.

It is especially important to remember to refill your prescription when your supply gets too low. If you stop taking Juluca, the virus in your blood can increase and return to high levels, making it difficult to treat.

Overdose: What Happens If I Take Too Much Juluca?

As long as you take Juluca once daily as prescribed, you don’t need to be too concerned about overdosing. Treatment for an overdose would most likely consist of monitoring your vital signs, heart rhythm, and general condition.

Precautions

What Are Reasons I Shouldn't Take Juluca?

You should not take Juluca if you:

• Have had a previous hypersensitivity (allergic) reaction to Juluca. This includes an allergy to either of the drugs in Juluca (dolutegravir or rilpivirine).
• Also have hepatitis B or C that is not well controlled and has caused your liver function tests to be elevated. Make sure your healthcare provider is aware if you also have hepatitis or another liver disease, as Juluca may worsen these conditions.
• Also take a drug that interacts significantly with Juluca, such as the ones listed below.
  

What Other Medications Interact With Juluca?

Make sure the healthcare provider prescribing Juluca for you is aware of all other medicines and supplements you take. The following can have important interactions with Juluca:

• Tikosyn (dofetilide) is a drug that treats heart arrhythmias (abnormal heart rates). Taking Juluca at the same time can elevate the amount of Tikosyn in your system, which can worsen heart arrhythmias to the point of being severe or life-threatening.

The following drugs may cause less Juluca to be absorbed into your system. This can lead to the drug not working well enough to suppress your HIV, meaning your virus may become detectable again, and symptoms may return.

• Anti-seizure drugs including Tegretol (carbamazepine), Trileptal (oxcarbazepine), Luminal (phenobarbital), Dilantin (phenytoin)
• Rifampin
• Rifapentine
• Decadron (dexamethasone)
• St John’s Wort, a herbal supplement
• Proton pump inhibitors including Prilosec (omeprazole), Protonix (pantoprazole), Nexium (esomeprazole), Prevacid (lansoprazole)

What Medications Are Similar?

Dozens of drugs across different classes and mechanisms of action exist to treat HIV. It is necessary to use more than one drug class to effectively treat HIV and prevent it from replicating, which is why drugs from different classes are combined into one combination product. This provides the convenience of getting multiple drugs with only one pill.

These medications may be used at various stages of treatment, like right after you are diagnosed with HIV or after you have achieved undetectable virus levels. Many other combination products exist besides Juluca. A few of them are:

• Dovato (dolutegravir/lamivudine)
• Cabenuva (cabotegravir/rilpivirine)
• Triumeq (abacavir/dolutegravir/lamivudine)
• Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir)
• Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir)

Genvoya and Stribild have the same components but differ slightly. Genvoya contains tenofovir alafenamide, whereas Stribild contains tenofovir disoproxil fumarate. This is especially important because Genvoya causes less kidney or bone damage than Stribild but is a more expensive option.

This is NOT a list of drugs recommended to take with Juluca. You should not take these drugs together. Ask your pharmacist or a healthcare provider if you have questions.

How Can I Stay Healthy While Taking Juluca?

Finding out you are HIV positive can be overwhelming. The good news is that HIV treatments have advanced rapidly in the last couple of decades, and life expectancy is close to the same as an uninfected person. People diagnosed with HIV can live normal lives if they begin treatment promptly and remain adherent.

The goal of treatment with antiretroviral medication is always to keep the HIV virus undetectable in your blood. Undetectable means that a test run with a sample of your blood can only pick up an extremely small number of the virus, or none at all. Being in this status drastically reduces your chances of transmitting HIV to others and developing infections.

Learn everything you can about HIV and the treatment you are receiving, as this can make treatment more approachable and help you understand it. When living with a condition like HIV, it’s also essential to prioritize your mental health. Exercising, joining support groups, or seeking counseling if it feels necessary can improve or maintain your mental wellbeing.