Warnings:

In some people, the abacavir in this product has caused a serious (sometimes fatal) allergic reaction. Your doctor should order a blood test to measure your risk before you start this medication or take it again. If the blood test shows you are at greater risk, you should not take this medication and your doctor should discuss other treatment choices with you. Symptoms of an allergic reaction may include any of the following: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, fever, extreme tiredness, nausea, vomiting, diarrhea, stomach pain, muscle aches/pain, joint pain, sore throat, mouth sores, blisters, eye redness/swelling, or cough. Get medical help right away if you experience any of these symptoms. If you have stopped taking abacavir because of an allergic reaction, you must never take any form of abacavir again, or death could result. Tell all of your doctors and pharmacists if you have stopped taking abacavir due to an allergic reaction. Also, properly throw away any unused medications containing abacavir. Read the warning card provided with this medication for more details.

You should be tested for hepatitis B infection before starting this medication. If you have hepatitis B infection and HIV, you may need additional drugs to treat the hepatitis B infection. You may also have a serious worsening of hepatitis symptoms if you stop taking lamivudine. Talk with your doctor before stopping this medication. Your doctor will monitor liver tests for several months after you stop lamivudine. Get medical help right away if you develop symptoms of worsening liver problems.

How to use Abacavir-Dolutegravir-Lamivud Tablet

Read the Medication Guide and Warning Card provided by your pharmacist before you start taking this medication and each time you get a refill. Carry the Warning Card with you at all times. If you have any questions, ask your doctor or pharmacist.

Do not change dosage forms of this medication without checking with your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once daily. Do not chew, cut, or crush the tablets. If you are taking certain other medications, your doctor may direct you to take additional dolutegravir. Carefully follow your doctor's directions.

Take this medication at least 2 hours before or 6 hours after taking sucralfate and products containing aluminum or magnesium (such as antacids, laxatives, buffered medications). These products bind with dolutegravir, decreasing its effectiveness.

If you are also taking calcium or iron supplements (including vitamins/minerals that contain calcium or iron), take this medication at least 2 hours before or 6 hours after these products. Or if you take this medication with food, you can take the supplements at the same time.

If you stop taking any medication containing abacavir even for a short time and then restart the drug, you have an increased chance of developing a very serious (possibly fatal) allergic reaction. Refill your medication before you run out. Do not stop treatment unless directed by your doctor. Before restarting any medication containing abacavir, consult your doctor or pharmacist, and be sure you have easy access to medical care.

It is very important to keep taking this medication (and other HIV medications) 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 (or other HIV medicines) 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

See also Warning and How to Use sections.

Remember that this medication has been prescribed because your doctor 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 unsteadiness, loss of coordination, trouble swallowing/speaking/chewing, trouble moving your eyes).

Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as depression, anxiety), easy bruising/bleeding, signs of anemia (such as unusual tiredness, fast breathing, pale skin, fast heartbeat), signs of kidney problems (such as change in the amount of urine).

Get medical help right away if you have any very serious side effects, including: signs of pancreatitis (such as nausea, vomiting, stomach/abdominal/back pain, fever).

Rarely, this medication has caused severe (sometimes fatal) liver problems and a buildup of lactic acid in the blood (lactic acidosis). These serious side effects may occur more often in women and obese patients. Get medical help right away if you have any of the following serious symptoms, including: symptoms of liver problems (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine), symptoms of lactic acidosis (such as deep/rapid breathing, drowsiness, nausea/vomiting).

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 medication, tell your doctor or pharmacist if you are allergic to abacavir, dolutegravir, or lamivudine; 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 problems, liver problems (such as hepatitis B or C, cirrhosis), disease of the pancreas (pancreatitis), alcohol use.

Abacavir may increase your risk of a heart attack. Discuss the risks and benefits of treatment with your doctor and ways to lower your risk of heart disease. Tell your doctor if you have heart problems, if you smoke, or if you have other conditions that increase your risk of heart disease, such as high blood pressure, diabetes, or high cholesterol levels.

Limit alcoholic beverages, because they can increase the risk of liver problems and pancreatitis.

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

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. During pregnancy, this medication should be used only when clearly needed. It is not recommended for use during the first trimester of pregnancy due to possible harm to the unborn baby. Ask about reliable forms of birth control while using this medication.

This medication passes into breast milk. Because breast milk may transmit HIV, consult your doctor before breastfeeding.

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 include: dofetilide, orlistat, sorbitol.

Do not take this medication with other products (including those that treat HIV infection) that contain abacavir, lamivudine, or emtricitabine.

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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.

Notes Notes

Do not share this medication with others.

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

Missed Dose Missed Dose

If you miss a dose, take it as soon as you remember. If it is less than 4 hours before the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Storage Storage

Store in the original bottle at room temperature away from light and moisture. Keep the bottle tightly closed. Each bottle should contain a drying agent (desiccant) that helps keep moisture in the air from damaging the drug. Do not remove the desiccant from the bottle. Do not swallow the desiccant. 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.

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.