Pronunciation:

doe-loo-TEG-ra-vir, ril-pi-VIR-een

Brand Names:

• Juluca

Dosage Forms:

• Tablet

Classifications:

Therapeutic—

Antiretroviral Agent

Pharmacologic—

Integrase Inhibitor

Uses of This Medicine:

Dolutegravir and rilpivirine combination is used to treat human immunodeficiency virus (HIV) infection. HIV is the virus that causes acquired immune deficiency syndrome (AIDS). It is given to patients to replace their current anti-HIV medicines when their healthcare provider determines that they meet certain requirements.

This medicine will not cure HIV infection or AIDS. It works by lowering the amount of HIV in the blood and it will also help your immune system. This may help delay some of the medical conditions that usually result from AIDS or HIV disease. It will not keep you from spreading HIV to other people.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of combination in dolutegravir and rilpivirine combination in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of dolutegravir and rilpivirine combination in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution in the dose for patients receiving this medicine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Carbamazepine
• Cisapride
• Dexamethasone
• Dexlansoprazole
• Dofetilide
• Esomeprazole
• Fosphenytoin
• Lansoprazole
• Omeprazole
• Oxcarbazepine
• Pantoprazole
• Phenobarbital
• Phenytoin
• Primidone
• Rabeprazole
• Rifampin
• Rifapentine
• Saquinavir
• St John's Wort
• Vonoprazan

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abametapir
• Aluminum
• Aluminum Carbonate, Basic
• Aluminum Hydroxide
• Aluminum Phosphate
• Amprenavir
• Anagrelide
• Aripiprazole
• Arsenic Trioxide
• Buserelin
• Cabotegravir
• Calcium
• Calcium Carbonate
• Carbamazepine
• Ceritinib
• Cimetidine
• Crizotinib
• Dabrafenib
• Dalfampridine
• Dasabuvir
• Degarelix
• Delamanid
• Delavirdine
• Deslorelin
• Dihydroxyaluminum Aminoacetate
• Dihydroxyaluminum Sodium Carbonate
• Domperidone
• Donepezil
• Drospirenone
• Efavirenz
• Eslicarbazepine Acetate
• Ethinyl Estradiol
• Etravirine
• Famotidine
• Fedratinib
• Fexinidazole
• Fosamprenavir
• Fosphenytoin
• Gonadorelin
• Goserelin
• Histrelin
• Hydroxychloroquine
• Iron
• Itraconazole
• Levofloxacin
• Magaldrate
• Magnesium
• Magnesium Carbonate
• Magnesium Hydroxide
• Magnesium Oxide
• Magnesium Trisilicate
• Mavacamten
• Metformin
• Moxifloxacin
• Nafarelin
• Nevirapine
• Nizatidine
• Norethindrone
• Norgestimate
• Omaveloxolone
• Ombitasvir
• Ondansetron
• Orlistat
• Oxcarbazepine
• Panobinostat
• Paritaprevir
• Pasireotide
• Pazopanib
• Phenobarbital
• Phenytoin
• Primidone
• Ranitidine
• Rifabutin
• Rifampin
• Sevoflurane
• Sodium Bicarbonate
• St John's Wort
• Sucralfate
• Tipranavir
• Triptorelin
• Vandetanib
• Zinc

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Boceprevir

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Depression or
• Hepatitis B or C infection, history of or
• Mental illness, history of—Use with caution. May make these conditions worse.

• Kidney disease, severe or end-stage—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Keep using this medicine for the full time of treatment, even if you begin to feel better. Do not stop using it without checking first with your doctor. When your supply of the medicine is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of the medicine.

It is best to take this medicine with food.

Take this medicine at least 4 hours before or 6 hours after you take antacids, laxatives, or other products that contain aluminum, calcium, magnesium, or sucralfate.

Take this medicine at least 4 hours before or 12 hours after you take a stomach medicine for heartburn or ulcers (eg, cimetidine, famotidine, nizatidine, Axid®, Pepcid®, or Tagamet®).

If you take iron or calcium supplements, you may take these supplements at the same time that you take this medicine with food or at least 4 hours before or 6 hours after you take this medicine.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):
  • For treatment of HIV infection:
    • Adults—1 tablet once a day with food. For patients who are also taking this medicine together with rifabutin, take an additional 25 milligrams (mg) tablet of rilpivirine (Edurant®) once a day.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Store the medicine in the original bottle. Keep it tightly closed.

Precautions While Using This Medicine:

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

It is important to tell your doctor if you are pregnant or planning to become pregnant before using this medicine. Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Do not use this medicine during the first part of your pregnancy unless your doctor tells you to. Use an effective form of birth control to keep from getting pregnant.

This medicine should not be used together with dexamethasone (Decadron®), dofetilide (Tikosyn®), certain seizure medicines (eg, carbamazepine, oxcarbazepine, phenobarbital, phenytoin, Dilantin®, Tegretol®, Trileptal®), medicine for tuberculosis (eg, rifampin, rifapentine, Priftin®, Rifadin®, Rimactane®), certain stomach medicines (eg, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole, Aciphex®, Nexium®, Prevacid®, Prilosec®) or St. John's wort.

This medicine may cause serious allergic reactions including anaphylaxis and drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have black, tarry stools, chest pain, chills, cough, fever, painful or difficult urination, rash, itching, hoarseness, lightheadedness or dizziness, sore throat, sores, ulcers, or white spots on the lips or in the mouth, swollen glands, trouble breathing, trouble swallowing, unusual bleeding or bruising, unusual tiredness or weakness, or any swelling of your hands, face, or mouth with this medicine.

This medicine may cause serious liver problems. This may occur in patients with hepatitis B or C infection. Check with your doctor right away if you or your child have clay-colored stools, dark urine, a decreased appetite, fever, headache, itching, nausea and vomiting, skin rash, stomach pain or tenderness, swelling of the feet or lower legs, unusual tiredness or weakness, or yellow eyes or skin.

Tell your doctor right away if you start to feel depressed and have thoughts about hurting yourself. Report any unusual thoughts or behavior that troubles you, especially if they are new or get worse quickly.

This medicine will not keep you from giving HIV to your partner during sex. Make sure you understand this and practice safe sex, even if your partner also has HIV, by using a latex condom or other barrier method. This medicine will also not keep you from giving HIV to other people if they are exposed to your blood. Do not re-use or share needles with anyone.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Less common

Abnormal dreams

anxiety

cloudy or bloody urine

dark urine

decreased frequency or amount of urine

depressed mood

gaseous stomach pain

increased blood pressure

increased thirst

indigestion

light-colored stools

loss of appetite

lower back or side pain

nausea

recurrent fever

severe nausea or vomiting

stomach fullness or pain

swelling of the face, fingers, feet, or lower legs

thoughts or attempts at killing oneself

trouble sleeping

trouble breathing

unusual tiredness or weakness

upper right abdominal or stomach pain

vomiting

weight gain

yellow eyes or skin

Incidence not known

Black, tarry stools

chest pain

chills

cough

decreased appetite

difficulty swallowing

fast heartbeat

fever

headache

painful or difficult urination

skin itching, rash, or redness

sore throat

sores, ulcers, or white spots on the lips or in the mouth

stomach tenderness

stomach pain, continuing

swelling of the face, throat, or tongue

swollen glands

unusual bleeding or bruising

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

Bloated feeling

diarrhea

dizziness

excess air or gas in the stomach or bowels

feeling of fullness

muscle pain

passing gas

sleepiness or unusual drowsiness

Incidence not known

Difficulty in moving

joint pain or swelling

muscle ache, cramp, or stiffness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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