Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.
Fat redistribution: Over time, this medication may change how fat is distributed in your body and may change your body shape. You may notice increased fat in the upper back and neck and breast and around the back, chest, and stomach area, or loss of fat from the legs, arms, and face. The long-term effects of this are not known.
Heart attack: This medication may increase your risk of heart attack. If you have heart problems, smoke, have high blood pressure or diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Hepatitis B: If you have hepatitis B, your condition may worsen or recur if you stop taking this medication. Do not stop taking this medication unless recommended by your doctor. If your doctor recommends that you stop taking this medication, your doctor will monitor you for several months after stopping treatment.
Hypersensitivity reactions: This medication can cause serious hypersensitivity reactions. If you experience any of the following sets of symptoms, stop taking this medication and contact your doctor immediately:
- nausea, vomiting, diarrhea, or abdominal pain
- severe tiredness, achiness, or generally feeling ill
- sore throat, shortness of breath, or cough
These reactions usually occur within 6 weeks of starting this medication, but may occur at any time. If you have previously had an allergic reaction to abacavir, dolutegravir, or a medication containing either abacavir or dolutegravir, you should not take this medication.
Immune reconstitution syndrome: This medication may cause immune reconstitution syndrome, where signs and symptoms of inflammation from previous infections appear. These symptoms occur soon after starting anti-HIV medication and can vary. They are thought to occur as a result of the immune system improving and being able to fight infections that have been present without symptoms (such as pneumonia, herpes, or tuberculosis). Report any new symptoms to your doctor as soon as possible.
Kidney function: Lamivudine is removed from the body by the kidneys. If you have reduced kidney function, these medications may build up in the body and cause side effects. This medication should not be used by people with end-stage kidney disease. If you have reduced kidney function, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.
Lactic acidosis and enlarged fatty liver: Lamivudine can cause a rare but serious condition called lactic acidosis (build-up of lactic acid in the blood) together with an enlarged liver. This tends to occur more often in women, especially if they are overweight. If you experience any of the following symptoms, call your doctor immediately:
- abdominal pain, swelling, or bloating
- feeling unwell
- shortness of breath
- weight loss
Your doctor will monitor your liver function periodically by ordering laboratory tests.
Liver function: Abacavir and dolutegravir are removed from the body by the liver. Liver disease or reduced liver function may cause this medication to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking this medication.
Pancreatitis: Abacavir - dolutegravir - lamivudine may cause or worsen pancreatitis (inflammation of the pancreas). If you have a history of or are at risk for developing pancreatitis, you should be closely monitored by your doctor while taking this medication. If you develop signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen), contact your doctor.
Red blood cells: Pure red cell aplasia is a rare bone marrow disorder characterized by a reduction in red blood cells produced by the bone marrow. Symptoms include pallor, weakness, shortness of breath, heart palpitations, and decreased blood pressure. If you experience any of these symptoms, contact your doctor immediately.
Zidovudine may also cause low levels of red blood cells without causing red cell aplasia. If you experience symptoms of reduced red blood cell count (anemia) such as shortness of breath, feeling unusually tired, or pale skin, contact your doctor as soon as possible.
Stopping the medication: If you stop taking this medication, your HIV infection could get worse. Take the medication exactly as prescribed by your doctor, and do not stop taking the medication without checking with your doctor first.
Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks. If you become pregnant while taking this medication, contact your doctor immediately.
Breast-feeding: Lamivudine passes into breast milk. It is not known if abacavir and dolutegravir pass into breast milk. Women who have HIV infection are cautioned against breast-feeding because of the risk of passing HIV to a baby who does not have the infection.
Children: The safety and effectiveness of using this medication have not been established for children.
Seniors: Seniors are at an increased risk of experiencing side effects of this medication. The safety and effectiveness of using this medication have not been established for people over 65 years of age.