Dolutegravir & Abacavir & Lamivudine

Dolutegravir/abacavir/lamivudine is a prescription medication used to treat human immunodeficiency virus (HIV). It is a single tablet containing 3 medications, dolutegravir, abacavir, and lamivudine.

Dolutegravir is an integrase strand transfer inhibitor (INSTI). These help to increase the number of immune cells that help fight infections in your body.

Abacavir and lamivudine belong to a group of drugs called nucleoside reverse transcriptase inhibitors (NRTIs). Together these medications help to increase the number of immune cells that help fight infections in your body and decrease the amount of HIV in the blood.

This medication comes in tablet form and is taken typically once a day.

Common side effects of dolutegravir/abacavir/lamivudine include insomnia (trouble sleeping), headache, and fatigue (tiredness).

Dolutegravir/abacavir/lamivudine can cause fatigue (tiredness). Do not drive or operate heavy machinery until you know how dolutegravir/abacavir/lamivudine affects you.

Dolutegravir/abacavir/lamivudine is a prescription medication used to treat HIV infection.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

The recommended dose of dolutegravir/abacavir/lamivudine in adults and children weighing at least 88 lbs (40 kg) is one tablet by mouth once a day with or without food.

BOXED WARNING: RISK OF HYPERSENSITIVITY REACTIONS, LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY, AND EXACERBATIONS OF HEPATITIS B

Serious and sometimes fatal hypersensitivity reactions have been associated with abacavir-containing products.

• Hypersensitivity to abacavir is a multi-organ clinical syndrome.
• Patients who carry the HLA‑B*5701 allele are at high risk for experiencing a hypersensitivity reaction to abacavir.
• Discontinue dolutegravir/abacavir/lamivudine as soon as a hypersensitivity reaction is suspected. Regardless of HLA-B*5701 status, permanently discontinue dolutegravir/abacavir/lamivudine if hypersensitivity cannot be ruled out, even when other diagnoses are possible.
• Following a hypersensitivity reaction to abacavir, NEVER restart dolutegravir/abacavir/lamivudine or any other abacavir‑containing product.
• Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues.
• Severe acute exacerbations of hepatitis B have been reported in patients who are co‑infected with Hepatitis B Virus (HBV) and Human Immunodeficiency Virus (HIV) ‑1 and have discontinued lamivudine, a component of dolutegravir/abacavir/lamivudine. Monitor hepatic function closely in these patients and, if appropriate, initiate anti-hepatitis B treatment.

Serious side effects have been reported with dolutegravir/abacavir/lamivudine including the following:

• serious allergic reactions. Serious allergic reactions have occurred with dolutegravir/abacavir/lamivudine and other abacavir-containing products. Your risk of this allergic reaction is much higher if you have a gene variation called HLA-B*5701, which can be determined by a blood test from your doctor. If you experience symptoms from 2 or more of the following groups while taking dolutegravir/abacavir/lamivudine, then call your healthcare provider immediately: Group 1 fever; Group 2 rash; Group 3 nausea, vomiting, diarrhea, stomach pain; Group 4 feeling ill, extreme tiredness, achiness; Group 5 shortness of breath, cough, sore throat. Always carry the Warning Card with you listing these symptoms that is provided by your pharmacist.
• lactic acidosis (build-up of acid in your blood). Lactic acidosis is a serious medical emergency that can cause death. Call your healthcare provider right away if you experience any of the following symptoms: feeling very weak or tired, unusual muscle pain, trouble breathing, stomach pain with nausea and vomiting, feeling cold (especially in arms and legs), feeling dizzy or lightheaded, fast or irregular heartbeat.
• serious liver problems. Serious liver problems can sometimes cause death. Your liver may become large (hepatomegaly) and you may develop fat in your liver (steatosis). Call your healthcare provider immediately if you experience any of the following symptoms: skin or white part of eyes turns yellow, dark or "tea-colored" urine, light colored stools, loss of appetite for several days or longer, nausea, and pain, aching, or tenderness on the right side of your stomach area.
• worsening of hepatitis B virus (HBV) in people who have HIV-1 infection. If you have HIV-1 and HBV infection, your HBV may get worse if you stop taking dolutegravir/abacavir/lamivudine. Do not run out of dolutegravir/abacavir/lamivudine. Refill your prescription or talk to your healthcare provider before your dolutegravir/abacavir/lamivudine is all gone. Do not stop taking dolutegravir/abacavir/lamivudine without talking to your healthcare provider. If you stop taking dolutegravir/abacavir/lamivudine, then your healthcare provider will need to check your health often and do blood tests regularly for several months to check your liver.
• resistant HBV. If you have HIV-1 and HBV, the HBV can change (mutate) during your treatment with dolutegravir/abacavir/lamivudine and become harder to treat.
• worsening liver disease in people infected with both HIV-1 and hepatitis C. Worsening of liver disease that has caused death has occurred in people taking antiretroviral medicines and also being treated for hepatitis C with interferon with or without ribavirin. If you are taking dolutegravir/abacavir/lamivudine and interferon with or without ribavirin, tell your healthcare provider if you have any new symptoms.
• drug interactions may cause more dolutegravir/abacavir/lamivudine side effects or make your HIV harder to treat. Dolutegravir/abacavir/lamivudine may interact with other medications causing dolutegravir/abacavir/lamivudine to not work as well and possible development of resistance. In addition, medications may interact with dolutegravir/abacavir/lamivudine causing more side effects. Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Do not start new medications without first talking to your doctor or pharmacist.

Do not take dolutegravir/abacavir/lamivudine if you:

• are allergic to dolutegravir/abacavir/lamivudine or to any of its ingredients
• have a certain type of gene variation called the HLA-B*5701 allele
• take dofetilide (Tikosyn). Taking dolutegravir/abacavir/lamivudine and Tikosyn can cause life-threatening side effects.
• have liver problems

Serious side effects have been reported with dolutegravir/abacavir/lamivudine. See the “Dolutegravir/abacavir/lamivudine Precautions” section.

Common side effects of dolutegravir/abacavir/lamivudine include the following:

• insomnia (trouble sleeping)
• headache
• fatigue (tiredness)

This is not a complete list of dolutegravir/abacavir/lamivudine side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• antacids, laxatives, or other medicines that contain aluminum, magnesium, sucralfate (Carafate), or buffered medicines. Dolutegravir/abacavir/lamivudine should be taken at least 2 hours before or 6 hours after you take these medicines.
• anti-seizure medicines: oxcarbazepine (Trileptal), phenytoin (Dilantin, Dilantin-125, Phenytek), phenobarbital, carbamazepine (Carbatrol, Equetro, Tegretol, Tegretol XR, Teril, Epitol)
• any other HIV medication
• iron or calcium supplements taken by mouth. Supplements containing calcium or iron may be taken at the same time with dolutegravir/abacavir/lamivudine if taken with food. Otherwise, dolutegravir/abacavir/lamivudine should be taken at least 2 hours before or 6 hours after you take these medicines.
• medicines used to treat hepatitis virus infections, such as interferon or ribavirin
• medicines containing metformin
• methadone
• rifampin (Rifater, Rifamate, Rimactane, Rifadin
• St. John's wort (Hypericum perforatum)

This is not a complete list of dolutegravir/abacavir/lamivudine drug interactions. Ask your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories-A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Dolutegravir/abacavir/lamivudine falls into category C. There are no well-controlled studies that have been done in pregnant women. Dolutegravir/abacavir/lamivudine should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

There is a pregnancy registry for women who take antiretroviral medicines during pregnancy. Talk to your healthcare provider about how you can take part in this registry.

Do not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.