How does this medication work? What will it do for me?

This combination product contains 2 medications: dolutegravir and lamivudine.

Lamivudine belongs 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.

Dolutegravir - lamivudine is used by adults and adolescents older than 12 years of age 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.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

What form(s) does this medication come in?

Each oval, biconvex, white, film-coated tablets, debossed with "SV 137" on one face, contains 50 mg of dolutegravir (as 52.6 mg of dolutegravir sodium) and 300 mg of lamivudine. Nonmedicinal ingredients: hypromellose, macrogol/PEG, magnesium stearate, mannitol (E421), microcrystalline cellulose, povidone (K29/32), sodium starch glycolate, sodium stearyl fumarate, and titanium dioxide.

How should I use this medication?

The usual recommended dose of dolutegravir - lamivudine for adults and adolescents 12 years of age and weighing at least 40 kg, is one tablet (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 before 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 container at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

Who should NOT take this medication?

Do not take this medication if you:

  • are allergic to dolutegravir, lamivudine, or any ingredients of the medication
  • are taking the medications dofetilide or fampridine (dalfampridine)

What side effects are possible with this medication?

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

  • abnormal dreams
  • diarrhea
  • difficulty sleeping
  • dizziness
  • drowsiness/sleepiness
  • fatigue
  • fever
  • gas
  • headache
  • itchiness
  • joint and muscle pain
  • nausea
  • upper abdominal pain and bloating
  • vomiting

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:

  • anxiety
  • signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding)
  • 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 kidney problems (e.g., change in the amount or colour of urine, increased urination at night, blood in the urine, swelling in the feet or legs)
  • 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 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)

Stop taking the medication and seek immediate medical attention if any of the following occur:

  • signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, swelling of the face and throat)
  • 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?

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.

Anemia: This medication may also cause low levels of red blood cells. If you experience symptoms of reduced red blood cell count such as shortness of breath, feeling unusually tired, or pale skin, contact your doctor as soon as possible.

Blood sugar: Dolutegravir - lamivudine may cause an increase in blood sugar levels and glucose tolerance may change. If you have diabetes or are at risk of developing 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. 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.

Hepatitis B: If you have hepatitis B, your condition may worsen or come back 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:

  • fever
  • headache
  • nausea, vomiting, diarrhea, or abdominal pain
  • rash
  • 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 dolutegravir, or a medication containing 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. 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.

People with severely reduced kidney function should not take this medication.

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
  • diarrhea
  • fatigue
  • feeling unwell
  • nausea
  • shortness of breath
  • vomiting
  • weakness
  • weight loss

Your doctor will monitor your liver function periodically by ordering laboratory tests.

Liver function: 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.

Dolutegravir - lamivudine may reduce liver function and can cause liver failure. If you experience symptoms of liver problems (e.g., abdominal pain, persistent vomiting, feeling unwell, fever, itching, yellowing of the skin and eyes, dark urine), contact your doctor immediately.

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: Dolutegravir – lamivudine has been linked to severe birth defects. It should not be taken by the mother while she is pregnant. Let your doctor know if you are or are planning to become pregnant. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: Lamivudine passes 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 who are under 12 years old and weigh less than 40 kg.

Seniors: Seniors may be at an increased risk of experiencing side effects of this medication.

What other drugs could interact with this medication?

There may be an interaction between dolutegravir - lamivudine and any of the following:

  • aluminum hydroxide
  • bromocriptine
  • calcium supplements (e.g., calcium carbonate, calcium citrate)
  • cladribine
  • diabetes medications (e.g., acarbose, canagliflozin, glyburide, insulin, linagliptin, lixisenatide, metformin)
  • fampridine
  • HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., efavirenz, etravirine, nevirapine)
  • iron supplements
  • isoniazid
  • magnesium-containing products (e.g., magnesium citrate, magnesium hydroxide)
  • multivitamin/mineral supplements
  • orlistat
  • protein kinase inhibitors (e.g., cabozantinib, erdafitinib)
  • rifabutin
  • rifampin
  • St. John's wort
  • selenium
  • seizure medications (e.g., carbamazepine, oxcarbazepine, phenobarbital, phenytoin, valproic acid)
  • sorbitol
  • sucralfate
  • trimethoprim
  • zinc supplements

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

  • 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.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

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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