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abacavir - dolutegravir - lamivudine
How does this medication work? What will it do for me?
This combination product contains 3 medications: abacavir, dolutegravir, and lamivudine.
Abacavir and lamivudine belong to a class of medications known as nucleoside reverse transcriptase inhibitors. Reverse transcriptase is a part of HIV required to infect cells and make more virus. These two medications prevent reverse transcriptase from working properly.
Dolutegravir belongs to the class of medications called human immunodeficiency virus (HIV) integrase strand transfer inhibitors. Dolutegravir works by blocking an enzyme called integrase that is necessary for the HIV virus to reproduce. In doing so, it reduces the amount of HIV in the blood.
The combination of these medications into a single product creates a simpler alternative to taking these medications individually.
Abacavir – dolutegravir – lamivudine is used in combination to help prevent the human immunodeficiency virus (HIV) from reproducing. HIV is the virus responsible for acquired immune deficiency syndrome (AIDS). HIV infection destroys CD4 (T) cells, which are important to the immune system. The immune system helps fight infections.
This medication does not cure AIDS and does not prevent it from being spread to others. It is used to slow further growth or reproduction of HIV and seems to slow down the destruction of the immune system. This may help to delay the development of problems such as infections related to AIDS or HIV disease.
What form(s) does this medication come in?
Each purple, biconvex, oval, film-coated tablet debossed with "572 Trı" on one side contains dolutegravir sodium equivalent to 50 mg of dolutegravir, abacavir sulfate equivalent to 600 mg of abacavir, and 300 mg of lamivudine. Nonmedicinal ingredients: D-mannitol, magnesium stearate, microcrystalline cellulose, povidone K29/32, and sodium starch glycolate; film-coating:(OPADRY II Purple 85F90057) iron oxide black, iron oxide red, macrogol/PEG, polyvinyl alcohol – part hydrolyzed, talc, and titanium dioxide.
How should I use this medication?
The usual recommended dose of abacavir – dolutegravir – lamivudine for adults and adolescents weighing at least 40 kg, is one tablet (600 mg of abacavir, 50 mg of dolutegravir, and 300 mg of lamivudine), taken by mouth, once daily.
This medication may be taken with or without food. It should be swallowed whole with a glass of water.
Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.
It is important to take this medication exactly as prescribed by your doctor.
If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is 4 hours or less until the time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.
Store this medication in its original package, at room temperature, protect it from light and moisture, and keep it out of the reach of children. Do not remove the silica gel desiccant from the container.
Who should NOT take this medication?
Do not take this medication if you:
- are allergic to abacavir, dolutegravir, lamivudine, or any ingredients of the medication
- are positive for the HLA-B*5701 allele
- are taking dofetilide
What side effects are possible with this medication?
- abnormal dreams
- diarrhea (without other symptoms)
- difficulty sleeping
- fever (without other symptoms)
- hair loss
- headache (without other symptoms)
- lack of energy
- loss of appetite
- joint and muscle pain (without other symptoms)
- nausea (without other symptoms)
- skin rash (without other symptoms)
- trouble sleeping
- upper abdominal pain and bloating (without other symptoms)
- vomiting (without other symptoms)
- weight gain
Although most of the side effects listed below don’t happen very often, they could lead to serious problems if you do not seek medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
- signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don’t stop bleeding)
- signs of lactic acidosis (e.g., nausea, vomiting, increased breathing rate, abdominal pain, unusual tiredness, dizziness, rapid heart rate)
- signs of depression (e.g., poor concentration, changes in weight, changes in sleep, decreased interest in activities, thoughts of suicide)
- signs of infection (e.g., fever or chills, sore throat, cough)
- signs of liver problems (e.g., dark urine, diarrhea, loss of appetite, nausea, pale stools, vomiting, weight loss, yellowing of the skin or whites of the eyes)
- symptoms of anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath, fatigue)
- symptoms of immune reconstitution inflammatory syndrome (e.g., fever, redness, rash or swelling, fatigue, joint or muscle pain, numbness or weakness in the extremities, pounding heartbeat, chest pain)
- symptoms of lactic acidosis (weight loss, fatigue, generally feeling ill, abdominal pain, shortness of breath) along with an enlarged liver and symptoms of liver problems (nausea, vomiting, abdominal pain, weakness, diarrhea)
Seek immediate medical attention if any of the following occur:
- signs of heart attack (e.g., sudden chest pain or pain radiating to back, down arm, jaw; sensation of fullness of the chest; nausea; vomiting; sweating; anxiety)
- signs of pancreatitis (e.g., abdominal pain on the upper left side, back pain, nausea, fever, chills, rapid heartbeat, swollen abdomen)
- signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, swelling of the face and throat)
- signs of severe infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
- signs of a severe skin reaction (e.g., blistering, peeling, rash combined with fever or discomfort, rash covering a large area of the body, rash that spreads quickly)
- symptoms of a hypersensitivity reaction (fever, rash, nausea, vomiting, diarrhea, or abdominal pain; severe tiredness, aches, or generally feeling ill; sore throat, shortness of breath, or cough)
- thoughts of self-harm or suicide
Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.
Are there any other precautions or warnings for this medication?
HEALTH CANADA ADVISORY
Blood sugar: Abacavir – dolutegravir – lamivudine may cause an increase in blood sugar levels and glucose tolerance may change. People with diabetes may find it necessary to monitor their blood sugar more frequently while using this medication.
Cholesterol levels: This medication may cause an increase in the amount of cholesterol in the blood. If you have high cholesterol your doctor may want to monitor your cholesterol levels more closely while you are taking this medication.
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 inflammatory 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. Women tend to experience this more often, 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.
This medication 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. This medication may cause harm to the developing baby. There have been reports of defects to the brain and spinal cord called neural tube defects. If you become pregnant while taking this medication, contact your doctor immediately. A reliable method of contraception must be used while taking this medication.
Breast-feeding: Lamivudine and abacavir pass into breast milk. It is not known if dolutegravir passes 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 under the age of 12 years and weighing less than 40 kg.
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.
What other drugs could interact with this medication?
There may be an interaction between abacavir-dolutegravir-lamivudine and any of the following:
- aluminum hydroxide
- calcium supplements (e.g., calcium carbonate, calcium citrate)
- HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., efavirenz, etravirine, nevirapine)
- HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
- HIV nucleoside reverse transcriptase inhibitors (NRTIs; e.g., abacavir, didanosine, emtricitabine, lamivudine, tenofovir, zidovudine)
- iron salts (e.g., ferrous fumarate, ferrous gluconate, ferrous sulfate)
- magnesium salts (e.g., magnesium hydroxide, magnesium oxide)
- multivitamins including vitamins A and E with or without minerals
- St. John’s wort
- seizure medications (e.g., carbamazepine, oxcarbazepine, phenobarbital, phenytoin, primidone, valproate)
- stop taking one of the medications,
- change one of the medications to another,
- change how you are taking one or both of the medications, or
- leave everything as is.
Medications other than those listed above may interact with this medication. Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.
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