Juluca

(Dolutegravir/Rilpivirine)

The active ingredients in Juluca are dolutegravir sodium (DTG) and rilpivirine hydrochloride (RPV). Both of these are antiretroviral medications, meaning that they inhibit the HIV virus so that it cannot grow and cause disease. Dolutegravir belongs to a specific class known as integrase strand transfer inhibitors (INSTIs). These medications prevent DNA replication so that the virus cannot add its DNA to the patient’s DNA, preventing the virus from spreading. Rilpivirine belongs to a class known as non-nucleoside reverse transcriptase inhibitors (NNRTIs). Other medications in this class include efavirenz and doravirine. These medications work by preventing the virus from making more copies of its DNA. This combination of medications allows Juluca to be an effective maintenance treatment of HIV.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Juluca. However, the following is a synopsis of the general guidelines for the use of Juluca:

• Juluca should be used exactly as prescribed. Because it is considered a complete regimen, it should not be used with other antivirals used in the treatment of HIV.
• It is typically taken once a day with a meal. Your dose will be decided by your healthcare provider. It is important that you discuss with them before making any changes.
• Certain medications can affect how well Juluca works:
• If you take an H2 receptor antagonist, take Juluca 4 hours before or 12 hours after taking these medications.
• If you take antacids, laxatives, or any other medications with aluminum, calcium, or buffered products, take Juluca 4 hours before or 6 hours after taking these medications.
• If you take iron or calcium supplements, you may take them at the same time as your Juluca dose. If you do not take them at the same time, then take Juluca 4 hours before or 6 hours after these supplements.
• If you miss a dose, take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take 2 doses at the same time to make up for a missed one. Missing doses will make it harder to suppress the HIV infection. It is very important that you be consistent about taking the medication every day.

Some mild or common side effects of Juluca seen in clinical trials include:

• Diarrhea.
• Nausea.
• Headache.

Some individuals may experience serious side effects while using Juluca. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Signs of a severe skin rash, especially if it starts to spread, blister, peel, or is painful. Other signs could include a fever, unusual fatigue, muscle or joint pain, blisters or sores in the mouth, and difficulty breathing.
• Signs of a hypersensitivity or allergic reaction, such as hives, difficulty breathing, or swelling of the face, lips, eyes, or tongue.
• Signs of liver problems such as nausea, vomiting, right-sided stomach pain, loss of appetite, dark urine, pale stools, or yellowing of the skin and eyes (jaundice).
• Mood changes that are not typical for you. Tell your healthcare provider right away if you experience depression or if you have thoughts of suicide.

These are not all of the possible side effects of Juluca. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the U.S. Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Juluca, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• A history of severe skin rash or allergic reaction while on dolutegravir or rilpivirine
• Liver problems, including hepatitis B or C
• Mental health problems
• Are pregnant or plan to become pregnant
• Are breastfeeding or plan to breastfeed

Do not take Juluca if you have:

• An allergy to dolutegravir, rilpivirine, or any of the other ingredients in Juluca
• Are taking certain medications

Juluca begins to work right after the first dose and must be taken consistently to ensure suppression of viral load in those with HIV.

When Juluca is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Antiretrovirals
• Dofetilide
• Dalfampridine
• Metformin
• Antacids or laxatives with aluminum, calcium, and magnesium
• Carbamazepine
• Oxcarbazepine
• Phenobarbital
• Phenytoin
• Rifampin
• Rifapentine
• Rifabutin
• Dexamethasone
• H2 receptor antagonists such as famotidine, cimetidine, nizatidine, and ranitidine
• Herbal products such as St John’s Wort
• Clarithromycin
• Erythromycin
• Telithromycin
• Sucralfate
• Methadone
• Calcium or iron supplements
• Proton pump inhibitors such as esomeprazole, lansoprazole, omeprazole, pantoprazole, and rabeprazole

Juluca tablets each contain 50 mg of dolutegravir and 25 mg of rilpivirine.

Juluca should be stored in its original packaging with the desiccant at room temperature, away from light and moisture, and out of reach of children.

Juluca is manufactured by the pharmaceutical company ViiV Healthcare.

Currently, there is no generic available for the brand-name Juluca.

Consult your doctor or pharmacist before starting, stopping, or changing medications while taking Juluca.

Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

One of the medications in Juluca can pass into the breast milk. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.