Dolutegravir and rilpivirine

• Antiretroviral, Integrase Inhibitor (Anti-HIV)
• Antiretroviral, Reverse Transcriptase Inhibitor, Non-nucleoside (Anti-HIV)

HIV-1 infection, treatment: Treatment of HIV-1 infection in adults virologically suppressed on a stable antiretroviral regimen for ≥6 months with no history of treatment failure and no known resistance to the individual components

Hypersensitivity to dolutegravir, rilpivirine, or any component of the formulation; concurrent use with dofetilide, carbamazepine, systemic dexamethasone (>1 dose), oxcarbazepine, phenobarbital, phenytoin, proton pump inhibitors (PPIs) (eg, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole), rifampin, rifapentine, and/or St John's wort.

HIV-1 infection, treatment: Oral: One tablet (dolutegravir 50 mg/rilpivirine 25 mg) once daily. Note: Prior to switching to dolutegravir/rilpivirine, patients must be virologically suppressed on a stable antiretroviral regimen for ≥6 months with no history of treatment failure and no known resistance to dolutegravir or rilpivirine.

Dose adjustment for concomitant therapy with rifabutin: One tablet (dolutegravir 50 mg/rilpivirine 25 mg) once daily, with an additional rilpivirine 25 mg tablet once daily for the duration of rifabutin coadministration.

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Keep in original container; protect from moisture and do not remove desiccant.

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience headache or diarrhea. Have patient report immediately to prescriber signs of depression (suicidal ideation, anxiety, emotional instability, or confusion), agitation, muscle pain, joint pain, shortness of breath, severe loss of strength and energy, difficulty swallowing, signs of infection, signs of severe skin problems (red, swollen, blistered, or peeling skin [with or without fever]; red or irritated eyes; or sores in mouth, throat, nose, or eyes) or signs of liver problems (dark urine, fatigue, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or jaundice) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with a meal.
• Do not use a protein drink in place of a meal.
• Keep taking dolutegravir and rilpivirine as you have been told by your doctor or other health care provider, even if you feel well.
• It is important that you do not miss or skip a dose of this medicine during treatment.
• If you take products that have iron, aluminum, calcium, or magnesium in them (like some antacids or vitamins), you may need to take them at some other time than dolutegravir and rilpivirine. Talk with your doctor or pharmacist.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it, with a meal.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.
• If you are not sure what to do if you miss a dose, call your doctor.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of low mood (depression), thoughts of killing yourself, nervousness, emotional ups and downs, thinking that is not normal, anxiety, or lack of interest in life.
• Restlessness.
• Muscle or joint pain.
• Shortness of breath.
• Feeling very tired or weak.
• This medicine may help the immune system work. If you have an infection that you did not know you had, it may show up when you take this medicine. Tell your doctor right away if you notice any signs of infection like fever, sore throat, weakness, cough, or shortness of breath after you start dolutegravir and rilpivirine.
• Very bad skin and allergic reactions have happened with this medicine. Skin reactions have happened along with fever or problems in body organs like the liver. Call your doctor right away if you have red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; sores in your mouth, throat, nose, or eyes; trouble swallowing; or signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Loose stools (diarrhea).

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• Store at room temperature.
• Store in the original container. Do not take out the antimoisture cube or packet.
• Keep lid tightly closed.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Some medicines can make dolutegravir and rilpivirine less effective when taken at the same time. If you take any of the following medicines, take your dolutegravir and rilpivirine dose at least 4 hours before or 6 hours after you take the other medicine.

• antacids or laxatives that contain calcium, magnesium, or aluminum (such as Maalox, Milk of Magnesia, Mylanta, Rolaids, Tums, and others), or the ulcer medicine sucralfate (Carafate);

• buffered medicine; or

• vitamin or mineral supplements that contain calcium or iron (but if you take dolutegravir and rilpivirine with food, you can take these supplements at the same time).

Many drugs can interact with dolutegravir and rilpivirine, and some drugs should not be used together. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all your current medicines and any medicine you start or stop using.