Abacavir, dolutegravir, and lamivudine

Name: Abacavir, dolutegravir, and lamivudine

Abacavir, dolutegravir, and lamivudine dosing information

Usual Adult Dose for HIV Infection:

1 tablet orally once a day

Use: For the treatment of HIV-1 infection

Uses For abacavir, dolutegravir, and lamivudine

Abacavir, dolutegravir, and lamivudine combination is used for the treatment of the infection caused by human immunodeficiency virus (HIV). HIV is the virus that causes acquired immune deficiency syndrome (AIDS).

Abacavir, dolutegravir, and lamivudine combination will not cure or prevent HIV infection or AIDS; however, it helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay the development of problems that usually result from AIDS or HIV disease. Abacavir, dolutegravir, and lamivudine combination will not keep you from spreading HIV to other people. People who receive abacavir, dolutegravir, and lamivudine may continue to have some of the problems usually related to AIDS or HIV disease.

abacavir, dolutegravir, and lamivudine is available only with your doctor's prescription.

Proper Use of abacavir, dolutegravir, and lamivudine

Take abacavir, dolutegravir, and lamivudine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not change the dose or stop taking abacavir, dolutegravir, and lamivudine without checking first with your doctor. When your supply of abacavir, dolutegravir, and lamivudine is running low, contact your doctor or pharmacist ahead of time. Do not allow yourself to run out of abacavir, dolutegravir, and lamivudine.

abacavir, dolutegravir, and lamivudine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

Keep taking Triumeq® for the full time of treatment, even if you begin to feel better. It is also important to take abacavir, dolutegravir, and lamivudine together with other medicines for HIV. Be sure to take all of the medicines your doctor ordered, and to take them at the right times.

Abacavir, dolutegravir, and lamivudine combination contains a fixed amount of each medicine in the tablet.

Take Triumeq® at least 2 hours before or 6 hours after you take sucralfate, an antacid or laxative that contains aluminum, calcium, or magnesium, or a buffered medicine. You may take calcium or iron supplements together with abacavir, dolutegravir, and lamivudine if you take them with food. If not, take Triumeq® 2 hours before or 6 hours after you take these supplements.

Dosing

The dose of abacavir, dolutegravir, and lamivudine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of abacavir, dolutegravir, and lamivudine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For HIV infection:
      • Adults—600 milligrams (mg) of abacavir, 50 mg of dolutegravir, and 300 mg of lamivudine (equal to one tablet) once a day.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of abacavir, dolutegravir, and lamivudine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If it is less than 4 hours until your next dose, skip the missed dose and just take your regular dose at that time. Do not take extra medicine to make up for a missed dose.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Uses of Abacavir, Dolutegravir, and Lamivudine

  • It is used to treat HIV infection.

What are some other side effects of Abacavir, Dolutegravir, and Lamivudine?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Headache.
  • Not able to sleep.
  • Feeling tired or weak.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Brand Names U.S.

  • Triumeq

Use Labeled Indications

HIV infection: Treatment of human immunodeficiency virus type 1 (HIV-1) infection

Limitations of use: Not recommended for use in patients with current or past history of resistance to abacavir, dolutegravir, or lamivudine; not recommended in patients with resistance-associated integrase substitutions or clinically suspected integrase strand transfer inhibitor resistance because the dose of dolutegravir is insufficient in these subpopulations.

Dosing Renal Impairment

CrCl ≥50 mL/minute: No dosage adjustment necessary.

CrCl <50 mL/minute: Use is not recommended (use dose-adjusted individual component drugs).

Adverse Reactions

See individual agents as well as other combination products for additional information.

>10%:

Endocrine & metabolic: Hyperglycemia (≥126 mg/dL)

Gastrointestinal: Increased serum lipase (>1.5 x ULN)

Neuromuscular & skeletal: Increased creatine phosphokinase (≥6.0 x ULN)

1% to 10%:

Central nervous system: Drowsiness (<2%), lethargy (<2%), nightmares (<2%), sleep disorder (<2%), suicidal ideation (<2%), depression, fatigue, headache, insomnia

Dermatologic: Pruritus (<2%)

Endocrine & metabolic: Hypertriglyceridemia (<2%)

Gastrointestinal: Abdominal distention (<2%), abdominal distress (<2%), abdominal pain (<2%), anorexia (<2%), dyspepsia (<2%), flatulence (<2%), gastroesophageal reflux disease (<2%), upper abdominal pain (<2%), vomiting (<2%)

Hematologic & oncologic: Decreased neutrophils

Hepatic: Hepatitis (<2%), increased serum ALT (>2.5 x ULN), increased serum AST (>2.5 x ULN)

Neuromuscular & skeletal: Arthralgia (<2%), myositis (<2%)

Renal: Renal insufficiency (<2%)

Miscellaneous: Fever (<2%)

<1% (Limited to important or life-threatening): Abnormal dreams, diarrhea, dizziness, hypersensitivity reaction, immune reconstitution syndrome, nausea, skin rash

Monitoring Parameters

Baseline HLA-B*5701 allele screening, hypersensitivity reactions, liver aminotransferases, renal and hepatic function, hepatotoxicity, treatment-associated toxicities including hepatic decompensation, hepatitis exacerbation, or lamivudine resistance in coinfected patients

What side effects can this medication cause?

Some side effects can be serious. If you experience any of the symptoms listed in the IMPORTANT WARNING or SPECIAL PRECAUTIONS sections, call your doctor immediately or get emergency medical treatment.

Abacavir, dolutegravir, and lamivudine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Precautions

US BOXED WARNINGS:
-HYPERSENSITIVITY REACTIONS: Serious and sometimes fatal hypersensitivity reactions (with multiple organ involvement) reported with abacavir. Patients with the human leukocyte antigen subtype B*5701 (HLA-B*5701) allele are at higher risk of abacavir hypersensitivity reactions; however, such reactions have occurred in patients without the HLA-B*5701 allele. This drug is contraindicated in patients with prior hypersensitivity reaction to abacavir and in HLA-B*5701-positive patients. All patients should be screened for the HLA-B*5701 allele before starting or restarting treatment with this drug (unless HLA-B*5701 allele assessment previously documented). Regardless of HLA-B*5701 status, this drug should be discontinued without delay if hypersensitivity reaction is suspected, even if other diagnoses are possible. After hypersensitivity reaction to this drug, NEVER restart this or any other abacavir-containing product as more severe symptoms (including death) can occur within hours. Similar severe reactions also reported after restarting abacavir-containing products in patients with no history of abacavir hypersensitivity.
-LACTIC ACIDOSIS AND SEVERE HEPATOMEGALY WITH STEATOSIS: Lactic acidosis and severe hepatomegaly with steatosis (including fatalities) reported with use of nucleoside analogs alone or in combination (including abacavir, lamivudine, and other antiretrovirals). This drug should be discontinued if clinical or laboratory findings suggest lactic acidosis or pronounced hepatotoxicity.
-EXACERBATIONS OF HEPATITIS B: Severe acute exacerbations of hepatitis B reported in patients coinfected with HBV and HIV-1 after stopping lamivudine. Hepatic function of coinfected patients should be closely monitored with clinical and laboratory follow-up for at least several months after stopping this drug. If appropriate, initiation/resumption of antihepatitis B therapy may be necessary.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

(web3)