Juluca

Juluca is a prescription medication used to treat human immunodeficiency virus (HIV) in certain adult patients.

It is a single product containing 2 medications: rilpivirine and dolutegravir.

Juluca belongs to a group of drugs called antiretrovirals. These work by decreasing the amount of HIV in your blood and increasing the number of immune cells that help fight infections in your body. 

This medication comes in tablet form and is taken once a day, with a meal.

Common side effects of Juluca include diarrhea and headache.

Juluca is a prescription medication used to treat human immunodeficiency virus type 1 (HIV-1) in certain adult patients. Juluca replaces antiretroviral therapy in adults who are suppressed or have an amount of HIV in their blood (called the "viral load") that is less than 50 copies/mL. Patients must have been on previous antiretroviral therapy for at least 6 months and no treatment failure

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Juluca. See the “Juluca Precautions” section.

Common side effects of Juluca include the following:

• diarrhea
• headache

This is not a complete list of Juluca side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effects that bother you or that do not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• other medications for HIV including efavirenz (Sustiva, in Atripla), etravirine (Intelence), fosamprenavir (Lexiva) taken with ritonavir (Norvir), nevirapine (Viramune), and tipranavir (Aptivus) taken with ritonavir (Norvir)
• metformin (Fortomet, Glumetza, Glucophage, Riomet)
• dofetilide (Tikosyn)
• rifabutin (Mycobutin)
• antacids or laxatives that contain aluminum, magnesium or calcium, sucralfate (Carafate), iron or calcium supplements, including multivitamins containing calcium or iron, or buffered medicines. Juluca should be taken at least 2 hours before or 6 hours after you take these medicines.
• a histamine-2 blocker medicine, including famotidine (Pepcid), cimetidine (Tagamet), nizatidine (Axid), or ranitidine hydrochloride (Zantac). Take these medicines at least 12 hours before or at least 4 hours after you take Juluca.
• the antibiotic medicines clarithromycin (Biaxin), erythromycin (E-Mycin, Eryc, Ery-Tab, PCE, Pediazole, Iloson), telithromycin (Ketek) and troleandomycin (TAO)
• methadone (Dolophine)

Do not take rilpivirine if you also take these medicines:

• the anti-seizure medications carbamazepine (Carbatrol, Equetro, Tegretol, Tegretol- XR, Teril, Epitol), oxcarbazepine (Trileptal), phenobarbital (Luminal), phenytoin (Dilantin, Dilantin-125, Phenytek)
• the anti-tuberculosis medications rifabutin (Mycobutin), rifampin (Rifater, Rifamate, Rimactane, Rifadin) and rifapentine (Priftin)
• a proton pump inhibitor medication used for certain stomach or intestinal problems, including esomeprazole (Nexium, Vimovo), lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole sodium (Protonix), rabeprazole (Aciphex)
• more than one dose of the steroid medicine dexamethasone or dexamethasone
• St. John's wort (Hypericum perforatum)

This is not a complete list of Juluca drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Juluca including the following:

• hypersensitivity (severe allergic reaction). Tell your healthcare provider about any signs or symptoms of hypersensitivity, including rash, chest pain, difficulty breathing or swallowing, or swelling of the face, eyes, lips, tongue, arms, or legs.
• a decline in liver function. Tell your healthcare provider about any signs or symptoms of liver damage, including loss of appetite, weight loss, nausea, vomiting, feeling tired, stomach pain, dark urine, light-colored stools, fever, rash, or yellowing of the skin or whites of the eyes.
• depression or mood changes. Tell your doctor right away if you have any of the following symptoms:
  • feeling sad or hopeless
  • feeling anxious or restless
  • have thoughts of hurting yourself (suicide) or have tried to hurt yourself

Do not take Juluca if you:

• are allergic to Juluca, dolutegravir, rilpivirine, or to any of its ingredients
• are taking dofetilide
• are taking certain anticonvulsants including carbamazepine, oxcarbazepine, phenobarbital, and phenytoin
• are taking rifampin or rifapentine
• are taking dexamethasone for more than one dose
• are taking St. John's wort
• are taking proton pump inhibitors including esomeprazole, lansoprazole, omeprazole, pantoprazole, and rabeprazole

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Juluca, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Juluca, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Juluca or to any of its ingredients
• have any mental health problems
• have liver problems
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

There are no well-done studies that have been done in humans with the medications in Juluca. In animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Juluca crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, it is not recommended to breastfeed while taking Juluca. Human immunodeficiency virus (HIV) can be passed on through the breast milk.a

• Juluca comes in tablet form and is taken once a day.
• Stay under the care of your doctor during treatment with Juluca.
• Take Juluca every day exactly as prescribed by your doctor.
• Always take Juluca with a meal. Taking Juluca with a meal is important to help get the right amount of medicine in your body. A protein drink alone does not replace a meal.
• Do not change your dose or stop taking Juluca without first talking with your doctor. See your doctor regularly while taking Juluca.
• When your supply of Juluca starts to run low, get more from your doctor or pharmacy. It is important not to run out of Juluca. The amount of HIV in your blood may increase if the medicine is stopped even for a short time.
• If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Juluca at the same time.
• Juluca should be taken at least 2 hours before or 6 hours after you take antacids or laxatives that contain aluminum, magnesium or calcium, sucralfate (Carafate), iron or calcium supplements, or buffered medicines.

Avoid doing things that can spread HIV infection to others.

• Do not share or re-use needles or other injection equipment.
• Do not share personal items that can have blood or body fluids on them, like toothbrushes and razor blades.
• Do not have any kind of sex without protection. Always practice safe sex by using a latex or polyurethane condom to lower the chance of sexual contact with any body fluids such as semen, vaginal secretions, or blood.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The recommended dose of Juluca for the treatment of human immunodeficiency virus (HIV) is 50 mg of dolutegravir and 25 mg of rilpivirine once daily.

If you take too much Juluca, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Juluca at room temperature between 68^oF to 77^oF (20^oC to 25^o​​​​​​C)
• Store Juluca tablets in the original bottle to protect from light and moisture.
• Keep this and all medicines out of the reach of children.