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How does this medication work? What will it do for me?

Dolutegravir-rilpivirine is a combination medication used to treat human immunodeficiency virus (HIV) infection and help prevent the human immunodeficiency virus (HIV) from reproducing.

HIV is the virus responsible for acquired immune deficiency syndrome (AIDS). HIV infection destroys CD4 (T) cells, which are important to the immune system. The immune system helps fight infections. Dolutegravir-rilpivirine reduces the amount of HIV in the blood and increases CD4 (T) cell counts.

Dolutegravir belongs to the class of medications called human immunodeficiency virus (HIV) integrase strand transfer inhibitors (INSTIs). Rilpivirine belongs to a class of medications known as non-nucleoside reverse transcriptase inhibitors (NNRTI). These medications block the action of two different enzymes (integrase and reverse transcriptase) needed by the virus to reproduce. In doing so, they reduce the amount of HIV in the blood.

This medication does not cure AIDS and does not reduce the risk of passing HIV to others through sexual contact or blood contamination. It is used to slow further growth or reproduction of HIV and seems to slow down the destruction of the immune system. This may help to delay the development of problems such as infections related to AIDS or HIV.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use this medication?

The recommended adult dose of dolutegravir-rilpivirine is one tablet containing 50 mg of dolutegravir and 25 mg of rilpivirine, taken by mouth once daily. It should be taken with a meal.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor.

If you miss a dose, take it with a meal, as soon as possible and continue with your regular schedule. If it is less than 12 hours until your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication in its original container at room temperature, protect it from light and moisture, and keep it out of the reach of children.

What form(s) does this medication come in?

Each pink, film-coated, oval, biconvex tablet, debossed with "SV J3T" on one side contains 50 mg of dolutegravir (as 52.6 mg of dolutegravir sodium) and 25 mg of rilpivirine (as 27.5 mg of rilpivirine hydrochloride). Nonmedicinal ingredients: croscarmellose sodium, D-mannitol, iron oxide red, iron oxide yellow, lactose monohydrate, macrogol/PEG, magnesium stearate, microcrystalline cellulose, polysorbate 20, polyvinyl alcohol-part hydrolyzed, povidone K29/32 and K30, silicified microcrystalline cellulose, sodium starch glycolate, sodium stearyl fumarate, talc, and titanium dioxide.

Who should NOT take this medication?

Do not take this medication if you:

  • are allergic to dolutegravir, rilpivirine, or any ingredients of the medication
  • are taking any of the following medications:
    • fampridine
    • carbamazepine, oxcarbazepine, phenobarbital, or phenytoin
    • rifampin, rifapentine
    • esomeprazole, lansoprazole, omeprazole, pantoprazole, or rabeprazole
    • dexamethasone
    • St. John's wort
What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • abnormal dreams
  • decreased appetite
  • diarrhea
  • dizziness
  • gas
  • headache
  • itching
  • nausea
  • stomach pain
  • trouble sleeping
  • vomiting
  • weight gain

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

  • signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
  • signs of liver problems (e.g., nausea, vomiting, diarrhea, loss of appetite, weight loss, yellowing of the skin or whites of the eyes, dark urine, pale stools)

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, swelling of the face and throat)
  • signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Depression: Anti-retroviral medications have been known to cause mood swings and symptoms of depression. If you have depression or a history of depression, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, decreased interest in activities, or notice them in a family member who is taking this medication, contact your doctor as soon as possible.

Hypersensitivity reactions: A severe allergic reaction has occurred for some people with the use of dolutegravir-rilpivirine. This reaction involves a number of organs in the body and may be fatal if not treated quickly. Stop taking the medication and get immediate medical attention if you have symptoms of a severe allergic reaction, including fever, facial swelling, swollen glands, yellowing of the skin or eyes, or flu-like symptoms with skin rash, peeling, or blistering.

Liver function: Rilpivirine, one of the ingredients in this medication, is largely removed from the body by the liver. If you have decreased liver function or liver disease, this medication may build up in the body, causing increased side effects. Dolutegravir-rilpivirine may also reduce liver function and can cause liver failure. If you have liver disease or decreased liver function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

If you experience symptoms of liver problems (e.g., abdominal pain, persistent vomiting, feeling unwell, fever, itching, yellowing of the skin and eyes, dark urine), contact your doctor immediately.

Reduced response: Over a period of time, you may become less responsive to dolutegravir-rilpivirine as a particular treatment for HIV. This can occur when the HIV virus changes and becomes resistant to rilpivirine. As a result, the medication is no longer effective in preventing the virus from reproducing. If you start to experience symptoms of HIV infection, talk to your doctor. Your doctor may want to recommend another medication.

Stopping the medication: If you stop taking this medication, your HIV infection could get worse. Take the medication exactly as prescribed by your doctor, and do not stop taking the medication without checking with your doctor first.

Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately. A reliable method of contraception should be used while taking this medication.

Breast-feeding: It is not known if dolutegravir-rilpivirine passes into breast milk. Women who have HIV infection are cautioned against breast-feeding because of the risk of passing HIV to a baby who does not have the infection.

Children: The safety and effectiveness of using this medication have not been established for children.

What other drugs could interact with this medication?

There may be an interaction between dolutegravir-rilpivirine and any of the following:

  • aluminum hydroxide
  • antacids (e.g., aluminum hydroxide, calcium carbonate, magnesium hydroxide)
  • antiarrhythmics (e.g., amiodarone, disopyramide, dronedarone, flecainide, procainamide, quinidine, sotalol)
  • apalutamide
  • "azole" antifungals (e.g., itraconazole, ketoconazole, voriconazole)
  • bosentan
  • calcium supplements (e.g., calcium carbonate, calcium citrate)
  • ceritinib
  • chlorpromazine
  • cobicistat
  • dabrafenib
  • dexamethasone
  • didanosine
  • enzalutamide
  • ergonovine
  • H2 antagonists (e.g., famotidine, nizatidine)
  • HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., darunavir, efavirenz, etravirine, nevirapine)
  • HIV protease inhibitors (atazanavir, darunavir, lopinavir, ritonavir)
  • idelalisib
  • iron supplements
  • isoniazid
  • lumacaftor and ivacaftor
  • macrolide antibiotics (e.g., azithromycin, clarithromycin, erythromycin)
  • magnesium supplements
  • metformin
  • methadone
  • mifepristone
  • mitotane
  • modafinil
  • multivitamin/mineral supplements
  • orlistat
  • proton pump inhibitors (e.g., lansoprazole, omeprazole)
  • quinine
  • rifabutin
  • rifampin
  • St. John's wort
  • sarilumab
  • seizure medications (e.g. carbamazepine, eslicarbazepine, oxcarbazepine, phenobarbital, phenytoin, primidone, valproic acid)
  • selenium
  • siltuximab
  • sucralfate
  • tocilizumab
  • zinc supplements
  • ziprasidone

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • stop taking one of the medications,
  • change one of the medications to another,
  • change how you are taking one or both of the medications, or
  • leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

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