DOLUTEGRAVIR/RILPIVIRINE - ORAL

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DOLUTEGRAVIR/RILPIVIRINE - ORAL

PHONETIC PRONUNCIATION: (DOE-loo-TEG-ra-vir/RIL-pi-VIR-een)

COMMON BRAND NAME(S): Juluca

GENERIC NAME(S): dolutegravir sodium/rilpivirine HCl

Uses

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.


How to use DOLUTEGRAVIR/RILPIVIRINE - ORAL

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

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). Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as depression, thoughts of suicide), signs of liver problems (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine). 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

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.

Interactions

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

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.

Images

JULUCA 50-25 MG TABLET
JULUCA 50-25 MG TABLET
color
pink
shape
oblong
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SV J3T

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Faq for DOLUTEGRAVIR/RILPIVIRINE - ORAL

Dolutegravir/Rilpivirine is a combination medication used to treat HIV infection. It contains two different drugs: dolutegravir and rilpivirine. Dolutegravir belongs to a class of drugs called integrase inhibitors, while rilpivirine is a non-nucleoside reverse transcriptase inhibitor. Together, they work by blocking the replication of the HIV virus and reducing the amount of virus in the body.

Dolutegravir/Rilpivirine is used to treat HIV-1 infection in adults who have already been on stable antiretroviral therapy (ART) for at least six months, with undetectable viral loads and no history of treatment failure or resistance to either drug in the combination.

Dolutegravir/Rilpivirine comes in tablet form and is usually taken once a day, with a meal. It is important to take the medication exactly as prescribed by your doctor and to not miss any doses.

Common side effects of Dolutegravir/Rilpivirine include headache, trouble sleeping, dizziness, nausea, diarrhea, and abnormal dreams. These side effects are usually mild and go away on their own. However, if you experience severe or persistent side effects, it is important to contact your doctor.

Dolutegravir/Rilpivirine may interact with other medications, including certain antacids, antifungal drugs, seizure medications, rifampin, and St. John's wort. It is important to inform your doctor about all the medications you are taking, including over-the-counter drugs and herbal supplements, to avoid potential interactions.

Dolutegravir/Rilpivirine is not recommended for use during pregnancy unless the potential benefits outweigh the risks. It is also not recommended while breastfeeding as it may pass into breast milk and potentially harm the baby. It is important to discuss the potential risks and benefits with your doctor if you are pregnant or planning to become pregnant.

Dolutegravir/Rilpivirine is a lifelong treatment for HIV infection. It is important to continue taking the medication as prescribed by your doctor, even if you start feeling better. Stopping the medication or missing doses can lead to viral replication and treatment failure.

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Disclaimer

IMPORTANT: 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.