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Abacavir/dolutegravir/lamivudine

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What Is Abacavir/dolutegravir/lamivudine ?

Abacavir/dolutegravir/lamivudine(TRIUMEQ) is a combination of dolutegravir (integrase strand transfer inhibitor [INSTI]), abacavir, and

lamivudine (both nucleoside analogue reverse transcriptase inhibitors(NRTIs)).

Abacavir, dolutegravir and lamivudine.svg


What are the uses of this medicine?

This combination is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in adults and in pediatric patients weighing at least 40 kg.

How does this medicine work?

Abacavir and lamivudine are in a class of medications called nucleoside analogue reverse transcriptase inhibitors (NRTIs) and dolutegravir is in a class of medications called integrase strand transfer inhibitors (INSTIs). They work by decreasing the amount of HIV in your blood and increasing the number of immune cells that help fight infections in your body. Although abacavir, dolutegravir, and lamivudine will not cure HIV, these medications may decrease your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses such as serious infections or cancer.

Dolutegravir: Dolutegravir inhibits HIV integrase by binding to the integrase active site and blocking the strand transfer step of retroviral DNA integration which is essential for the HIV replication cycle.

Abacavir:

  • Abacavir is a carbocyclic synthetic nucleoside analogue.
  • Abacavir is converted by cellular enzymes to the active metabolite, carbovir triphosphate (CBV-TP), an analogue of deoxyguanosine-5′-triphosphate (dGTP).
  • CBV-TP inhibits the activity of HIV-1 reverse transcriptase (RT) both by competing with the natural substrate dGTP and by its incorporation into viral DNA.

Lamivudine:

  • Lamivudine is a synthetic nucleoside analogue.
  • Intracellularly lamivudine is phosphorylated to its active 5′-triphosphate metabolite, lamivudine triphosphate (3TC-TP).
  • The principal mode of action of 3TC-TP is inhibition of RT via DNA chain termination after incorporation of the nucleotide analogue.

Who Should Not Use this medicine ?

This medicine cannot be used in:

  • who have the HLA-B*5701 allele
  • with prior hypersensitivity reaction to abacavir, dolutegravir or lamivudine.
  • in patients receiving dofetilide
  • in patients with moderate or severe hepatic impairment

Because TRIUMEQ is a fixed-dose tablet and cannot be dose adjusted, TRIUMEQ is not recommended in:

  • patients with creatinine clearance less than 30 mL per minute
  • patients with mild hepatic impairment

Is this medicine FDA approved?

  • It was approved for use in the United States and in the European Union in 2014.

How should this medicine be used?

  • Screen for the HLA‑B*5701 allele prior to initiating therapy.
  • Pregnancy testing is recommended before initiation of TRIUMEQ in adolescents and adults of childbearing potential
  • TRIUMEQ is a fixed-dose combination product containing 600 mg of abacavir, 50 mg of dolutegravir, and 300 mg of lamivudine.
  • The recommended dosage regimen of TRIUMEQ in adults and in pediatric patients weighing at least 40 kg is one tablet once daily orally with or without food.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

  • Each film-coated tablet contains abacavir sulfate equivalent to 600 mg of abacavir, dolutegravir sodium equivalent to 50 mg of dolutegravir, and 300 mg of lamivudine.

What side effects can this medication cause?

Common possible side effects of this medicine include:

Possible serious side effects, may include:


What special precautions should I follow?

  • Do not change your dose or stop taking TRIUMEQ without talking with your healthcare provider.
  • TRIUMEQ may be taken with or without food.
  • If you take antacids, laxatives, or other medicines that contain aluminum, magnesium, or buffered medicines, TRIUMEQ should be taken at least 2 hours before or 6 hours after you take these medicines.
  • If you need to take iron or calcium supplements by mouth during treatment with TRIUMEQ:
  • If you take TRIUMEQ with food, you may take these supplements at the same time that you take TRIUMEQ.
  • If you do not take TRIUMEQ with food, take TRIUMEQ at least 2 hours before or 6 hours after you take these supplements.
  • If you miss a dose of TRIUMEQ, take it as soon as you remember. Do not take 2 doses at the same time or take more than your healthcare provider tells you to take.
  • Stay under the care of a healthcare provider during treatment with TRIUMEQ.
  • Do not run out of TRIUMEQ. The virus in your blood may increase and the virus may become harder to treat. When your supply starts to run low, get more from your healthcare provider or pharmacy.
  • If you take too much TRIUMEQ, call your healthcare provider or go to the nearest hospital emergency room right away.

What to do in case of emergency/overdose?

  • There is no known specific treatment for overdose with TRIUMEQ.
  • If overdose occurs, the patient should be monitored and standard supportive treatment applied as required.

Dolutegravir

  • As dolutegravir is highly bound to plasma proteins, it is unlikely that it will be significantly removed by dialysis.

Abacavir

Lamivudine Because a negligible amount of lamivudine was removed via (4-hour) hemodialysis, continuous ambulatory peritoneal dialysis, and automated peritoneal dialysis, it is not known if continuous hemodialysis would provide clinical benefit in a lamivudine overdose event.


Can this medicine be used in pregnancy?

  • There are insufficient human data on the use of TRIUMEQ during pregnancy to definitively assess a drug-associated risk for birth defects and miscarriage.
  • Assess the risks and benefits of TRIUMEQ and discuss with the patient to determine if an alternative treatment should be considered at the time of conception through the first trimester or if pregnancy is confirmed in the first trimester due to the risk of neural tube defects.

Can this medicine be used in children?

  • Not recommended for patients weighing less than 40 kg.
  • TRIUMEQ is a fixed-dose combination tablet which cannot be adjusted for patients weighing less than 40 kg.


What should I know about storage and disposal of this medication?

  • Store TRIUMEQ at room temperature between 68°F to 77°F (20°C to 25°C).
  • Store TRIUMEQ in the original bottle.
  • Keep the bottle of TRIUMEQ tightly closed and protect it from moisture.
  • The bottle of TRIUMEQ contains a desiccant packet to help keep your medicine dry (protect it from moisture). Do not remove the desiccant packet from the bottle.

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