(doe″ loo teg′ ra vir)(ril″ pi vir′ een)

Brand Name(s): Juluca^®

WHY is this medicine prescribed?

Dolutegravir and rilpivirine is used alone to treat human immunodeficiency virus (HIV) infection in certain people who have been able to maintain a suppressed viral load (viral load less than 50 copies/mL) on a stable HIV medication regimen for 6 months or longer with no history of treatment failure or known resistance to dolutegravir or rilpivirine. Dolutegravir is in a class of medications called HIV integrase inhibitors. It works by decreasing the amount of HIV in your blood and increasing the number of immune cells that help fight infections in your body. Rilpivirine is in a class of medications called non-nucleoside reverse transcriptase inhibitors (NNRTIs). It works by decreasing the amount of HIV in the blood. Although dolutegravir and rilpivirine does not cure HIV, it may decrease your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses such as serious infections or cancer. Taking these medications along with practicing safer sex and making other lifestyle changes may decrease the risk of transmitting (spreading) the HIV virus to other people.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

Dolutegravir and rilpivirine comes as a tablet to take by mouth. It is usually taken with food once a day. Take dolutegravir and rilpivirine at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take dolutegravir and rilpivirine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Dolutegravir and rilpivirine controls HIV but does not cure it. Continue to take dolutegravir and rilpivirine even if you feel well. Do not stop taking dolutegravir and rilpivirine without talking to your doctor.

What SPECIAL PRECAUTIONS should I follow?

Before taking dolutegravir and rilpivirine,

• tell your doctor and pharmacist if you are allergic to dolutegravir, rilpivirine, any other medications, or any of the ingredients in dolutegravir and rilpivirine tablets. Ask your pharmacist or check the Medication Guide for a list of the ingredients.

• some medications should not be taken with dolutegravir and rilpivirine. Other medications may cause dosing changes or extra monitoring when taken with dolutegravir and rilpivirine. Make sure you have discussed any medications you are currently taking or plan to take before starting dolutegravir and rilpivirine with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking dolutegravir and rilpivirine, please get the advice of your doctor or pharmacist.

• if you are taking vitamins or supplements or antacids such as calcium, magnesium, or aluminum (Maalox, Mylanta, Tums, others) or sucralfate or buffered medications, take them at least 4 hours before or 6 hours after dolutegravir and rilpivirine.

• if you are taking a medication for indigestion, heartburn, or ulcers such as cimetidine (Tagamet), famotidine (Pepcid), nizatidine (Axid), or ranitidine (Zantac), take it at least 12 hours before or at least 4 hours after dolutegravir and rilpivirine.

• the following nonprescription or herbal products may interact with dolutegravir and rilpivirine: St John's Wort. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking dolutegravir and rilpivirine. Do not start any of these medications while taking dolutegravir and rilpivirine without discussing with your healthcare provider.

• tell your doctor if you have or have ever had depression or other mental illness, liver disease, including hepatitis B or C, or kidney disease.

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking dolutegravir and rilpivirine, call your doctor.

What SPECIAL DIETARY instructions should I follow?

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medication.

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Dolutegravir and rilpivirine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• diarrhea
• headache

Some side effects can be serious. If you experience any of these symptoms, stop taking dolutegravir and rilpivirine and call your doctor immediately or get emergency medical treatment:

• fever, tiredness, muscle or joint pain, sores in the mouth, blistering or peeling of the skin, redness or swelling of the eyes, swelling of the mouth, lips, face or tongue, difficulty breathing
• yellowing of the skin or whites of the eyes, dark urine, light-colored stools, nausea or vomiting, loss of appetite, pain in the lower right side of your stomach
• feeling sad or hopeless, feeling anxious or restless, having thoughts of hurting yourself or others

Dolutegravir and rilpivirine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not remove the desiccant package.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (https://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to dolutegravir and rilpivirine.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: August 20, 2024.