dolutegravir 50 mg-rilpivirine 25 mg tablet

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Medication name

Generic name:
Dolutegravir/rilpivirine - oral

Pronunciation
(DOE-loo-TEG-ra-vir/RIL-pi-VIR-een)

Brand name(s)
Juluca

Uses

Dolutegravir/rilpivirine is used to help control HIV infection. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life. Dolutegravir is an integrase inhibitor while rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI). Both drugs block the virus from growing and infecting more cells.

Dolutegravir/rilpivirine is not a cure for HIV infection. To decrease your risk of spreading HIV disease to others, do all of the following: (1) continue to take all HIV medications exactly as prescribed by your doctor, (2) always use an effective barrier method (latex or polyurethane condoms/dental dams) during all sexual activity, and (3) do not share personal items (such as needles/syringes, toothbrushes, and razors) that may have contacted blood or other body fluids. Consult your doctor or pharmacist for more details.

Other uses

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This product may also be used to reduce the risk of getting HIV infection after contact with the virus. Consult your doctor for more details.

How to use

Read the Patient Information Leaflet if available from your pharmacist before you start using dolutegravir/rilpivirine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth with a meal as directed by your doctor, usually once daily. The dosage may be based on other medications you are taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Medications which reduce or block stomach acid (such as proton pump inhibitors/PPIs, H2 blockers, antacids) may reduce the absorption of rilpivirine, making this product work less well. Do not take PPIs (such as omeprazole, lansoprazole) while using this medication. If you take antacids, take the antacids at least 6 hours before or at least 4 hours after this product. If you take H2 blockers (such as famotidine, ranitidine), take them at least 12 hours before or at least 4 hours after this product.

Sucralfate and products containing aluminum or magnesium (such as antacids, laxatives, buffered medications) may reduce the absorption of dolutegravir, making this product work less well. Take these products 6 hours before or 4 hours after this medication.

Calcium or iron supplements (including vitamins/minerals that contain calcium or iron) may also reduce the absorption of dolutegravir, making this product work less well. Take these products 6 hours before or 4 hours after this medication. Or you can take this medication and the calcium or iron supplements together at the same time with a meal.

It is very important to keep taking this medication exactly as prescribed by your doctor. Do not skip any doses.

For the best effect, take this medication at evenly spaced times. To help you remember, take this medication at the same time every day.

Do not take more or less of this drug than prescribed or stop taking it even for a short time unless directed to do so by your doctor. Doing so may cause the amount of virus to increase, make the infection more difficult to treat (resistant), or worsen side effects.

Side effects

Headache or diarrhea may occur. If either of these effects lasts or gets worse, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

As your immune system gets stronger, it can begin to fight off infections you already had, possibly causing disease symptoms to come back. You could also have symptoms if your immune system becomes overactive. This reaction may happen at any time (soon after starting HIV treatment or many months later). Get medical help right away if you have any serious symptoms, including:

  • unexplained weight loss
  • severe tiredness
  • muscle aches/weakness that doesn't go away
  • headaches that are severe or don't go away
  • joint pain
  • numbness/tingling of the hands/feet/arms/legs
  • vision changes
  • signs of infection (such as fever, chills, swollen lymph nodes, trouble breathing, cough, non-healing skin sores)
  • signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter)
  • signs of a certain nerve problem known as Guillain-Barre syndrome (such as trouble breathing/swallowing/moving your eyes, drooping face, paralysis, trouble speaking)
  • signs of liver disease (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine)

Tell your doctor right away if you have any serious side effects, including:

  • mental/mood changes (such as depression, thoughts of suicide)

Get medical help right away if you have any very serious side effects, including:

  • fast/irregular heartbeat
  • severe dizziness
  • fainting

Changes in body fat may occur while you are taking this medication (such as increased fat in the upper back and stomach areas, decreased fat in the arms and legs). The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of treatment with your doctor, as well as the possible use of exercise to reduce this side effect.

Rilpivirine can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Get medical help right away if you develop any rash.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

  • rash
  • itching/swelling (especially of the face/tongue/throat)
  • severe dizziness
  • trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before taking this product, tell your doctor or pharmacist if you are allergic to dolutegravir or rilpivirine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

  • kidney disease
  • liver disease (such as hepatitis B, hepatitis C)
  • mental/mood disorders (such as depression)

Rilpivirine may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using rilpivirine, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions:

  • certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG)
  • family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death)

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using rilpivirine safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).

Before using this medication, women of childbearing age should talk with their doctor(s) about the risks and benefits. Tell your doctor if you are pregnant or if you plan to become pregnant. Your doctor should direct you to get a pregnancy test before starting this medication. You should not become pregnant while using this product. Dolutegravir may harm an unborn baby, especially during the first few months of pregnancy. Ask about reliable forms of birth control while using this medication.

It is unknown if this medication passes into breast milk. Because breast milk can transmit HIV, do not breast-feed.

Drug interactions

See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are:

  • dofetilide
  • orlistat
  • proton pump inhibitors (PPIs such as esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole)

Do not take this medication with other products that treat HIV infection. Do not take this medication with other products that contain rilpivirine, unless you are also taking rifabutin.

Other medications can affect the removal of rilpivirine from your body, which may affect how rilpivirine works. Examples include dexamethasone, certain macrolide antibiotics (such as clarithromycin, erythromycin), rifamycins (such as rifampin, rifapentine), St. John's wort, certain drugs used to treat seizures (such as carbamazepine, oxcarbazepine, phenobarbital, phenytoin, primidone), a certain combination product used to treat chronic hepatitis C (ombitasvir/paritaprevir/ritonavir/dasabuvir), among others.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: fast/irregular heartbeat, severe dizziness, fainting.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as viral load, T-cell counts, liver function) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Missed dose

If you miss a dose, take it with a meal as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. Store this drug in its original bottle with the desiccant inside the bottle. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Important note

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Information last revised June 2019.

Selected from NATIONAL DRUG DATA FILE (NDDF) data included with permission and copyrighted by First Databank, Inc., 2019. This copyrighted material has been downloaded from a licensed data provider.

The above information is intended to supplement, not substitute for, the expertise and judgment of your health care professional. You should consult your health care professional before taking any drug, changing your diet, or commencing or discontinuing any course of treatment.