DOSAGE & ADMINISTRATION SECTION

Highlight: •

Before initiating TRIUMEQ or TRIUMEQ PD, screen for the HLA‑B*5701 allele because TRIUMEQ and TRIUMEQ PD contain abacavir. (2.1).

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Prior to or when initiating TRIUMEQ or TRIUMEQ PD, test patients for HBV infection. (2.2)

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Pregnancy Testing: Pregnancy testing is recommended before initiation of TRIUMEQ in adolescents and adults of childbearing potential. (2.2, 5.5, 8.1, 8.3)

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TRIUMEQ and TRIUMEQ PD may be taken with or without food. (2.4, 2.5)

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Adults: One tablet of TRIUMEQ daily. (2.4)

ABC = abacavir, DTG = dolutegravir, 3TC = lamivudine.
Pediatric Population Body Weight	Number of Tablets (once daily)	Recommended Daily Dose
	TRIUMEQ PD Tablets (6 kg to <25 kg)
6 kg to <10 kg	3	180 mg ABC, 15 mg DTG, and 90 mg 3TC
10 kg to <14 kg	4	240 mg ABC, 20 mg DTG, and 120 mg 3TC
14 kg to <20 kg	5	300 mg ABC, 25 mg DTG, and 150 mg 3TC
20 kg to <25 kg	6	360 mg ABC, 30 mg DTG, and 180 mg 3TC
	TRIUMEQ Tablets (≥25 kg)
≥25 kg	1	600 mg ABC, 50 mg DTG, and 300 mg 3TC

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Do not interchange TRIUMEQ and TRIUMEQ PD on a milligram-per-milligram basis. (2.3)

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If dosing with certain UGT1A or CYP3A inducers, then the recommended dolutegravir dosage regimen should be adjusted. See Table 2 for complete dosing recommendations. (2.6)

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Because TRIUMEQ and TRIUMEQ PD are fixed-dose tablets and cannot be dose adjusted, TRIUMEQ and TRIUMEQ PD are not recommended in patients with creatinine clearance <30 mL/min and pediatric patients with a similar degree of renal impairment based on age-appropriate assessment of renal function, or patients with hepatic impairment. (2.7, 4)

2 DOSAGE AND ADMINISTRATION

2.2 Testing prior to or When Initiating Treatment with TRIUMEQ

Prior to or when initiating TRIUMEQ or TRIUMEQ PD, test patients for HBV infection [see Warnings and Precautions (5.2)].

Pregnancy testing is recommended before initiation of TRIUMEQ in adolescents and adults of childbearing potential [see Warnings and Precautions (5.5), Use in Specific Populations (8.1, 8.3)].

2.3 Overview of TRIUMEQ Dosage Forms

TRIUMEQ is available in two dosage forms.Do not interchange TRIUMEQ tablets and TRIUMEQ PD tablets for oral suspension on a milligram-per-milligram basis due to differing pharmacokinetic profiles for the dolutegravir component [see Warnings and Precautions (5.8), Clinical Pharmacology (12.3)].

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 TRIUMEQ tablets: 600 mg of abacavir, 50 mg of dolutegravir, and 300 mg of lamivudine. TRIUMEQ is recommended in adults and pediatric patients weighing at least 25 kg [see Dosage and Administration (2.4, 2.5)].

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 TRIUMEQ PD tablets for oral suspension: 60 mg of abacavir, 5 mg of dolutegravir, and 30 mg of lamivudine. TRIUMEQ PD is recommended in pediatric patients weighing 6 kg to less than 25 kg. [see Dosage and Administration (2.5)].

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 Because TRIUMEQ PD is a fixed-dose tablet and the dosage of individual components cannot be adjusted, it may lead to a suboptimal dosing for patients weighing ≥25 kg. TRIUMEQ PD is not recommended in patients weighing 25 kg or more [see Dosage and Administration (2.4, 2.5)].

2.4 Recommended Dosage in Adults

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 is one tablet once daily orally with or without food. Do not use TRIUMEQ PD in adults.

2.5 Recommended Dosage and Administration Instructions for Pediatric

Patients Weighing at Least 6 kg

The dosage and dosage form recommended for pediatric patients varies by weight as shown in Table 1 below.

Table 1. Recommended Dosage of TRIUMEQ Tablets and TRIUMEQ PD Tablets for Oral Suspension in Pediatric Patients

a TRIUMEQ is a fixed-dose combination product containing 600 mg of abacavir, 50 mg of dolutegravir, and 300 mg of lamivudine.
b TRIUMEQ PD is a fixed-dose combination product containing 60 mg of abacavir, 5 mg of dolutegravir, and 30 mg of lamivudine.
Body Weight	TRIUMEQ Tabletsa	TRIUMEQ PDb Number of Tablets	Total Daily Dose
6 kg to <10 kg	Not recommended	3 tablets once daily	180 mg abacavir, 15 mg dolutegravir, and 90 mg lamivudine once daily
10 kg to <14 kg	Not recommended	4 tablets once daily	240 mg abacavir, 20 mg dolutegravir, and 120 mg lamivudine once daily
14 kg to <20 kg	Not recommended	5 tablets once daily	300 mg abacavir, 25 mg dolutegravir, and 150 mg lamivudine once daily
20 kg to <25 kg	Not recommended	6 tablets once daily	360 mg abacavir, 30 mg dolutegravir, and 180 mg lamivudine once daily
≥25 kg	1 tablet once daily	Not recommended	600 mg of abacavir, 50 mg of dolutegravir, and 300 mg of lamivudine

AdministerTRIUMEQ PD tablets for oral suspension with or without food. Instruct patients (or instruct caregivers) to fullydisperse the tablets for oral suspension in 20 mL of drinking water (if using 4, 5, or 6 tablets for oral suspension) or 15 mL (if using 3 tablets for oral suspension) in the supplied cup; swirl the suspension so that no lumps remain. After full dispersion, administer the oral suspension within 30 minutes of mixing [see Instructions for Use]. Do not swallow the tablets for oral suspension whole, and do not chew, cut, or crush the tablets.

For children unable to use the supplied cup, an appropriate-sized syringe may be used to administer the oral suspension.

Administer TRIUMEQ tablet with or without food. Do not chew, cut, or crush the tablet.

2.6 Dosage Recommendation with Certain Concomitant Medications

The dolutegravir dose in TRIUMEQ (50 mg) and TRIUMEQ PD (5 mg) is insufficient when coadministered with medications listed in Table 2 that may decrease dolutegravir concentrations; the following dolutegravir dosage regimen is recommended.

Table 2. Dosing Recommendations for TRIUMEQ and TRIUMEQ PD with Coadministered Medications

Coadministered Drug

Dosing Recommendation

Efavirenz, fosamprenavir/ritonavir, tipranavir/ritonavir, carbamazepine, or rifampin

In adults and in pediatric patientsweighing at least 25 kg, the recommended dolutegravir dosage regimen is 50 mg twice daily. Thus, an additional TIVICAY 50-mg tablet, separated by 12 hours from TRIUMEQ, should be taken.

In pediatric patientsweighing 10 kg to <25 kg, an additional weight-based dose of dolutegravir should be given separated by 12 hours from TRIUMEQ PD.

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 6 to <10 kg: administer an additional 15-mg dose of dolutegravir (3 TIVICAY PD tablets for oral suspension), 12 hours after TRIUMEQ PD.

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 10 to <14 kg: administer an additional 20-mg dose of dolutegravir (4 TIVICAY PD tablets for oral suspension), 12 hours after TRIUMEQ PD,

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 14 to <20 kg: administer an additional 25-mg dose of dolutegravir (5 TIVICAY PD tablets for oral suspension), 12 hours after TRIUMEQ PD,

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 20 to <25 kg: administer an additional 30-mg dose of dolutegravir (6 TIVICAY PD tablets for oral suspension), 12 hours after TRIUMEQ PD.

2.7 Not Recommended Due to Lack of Dosage Adjustment

Because TRIUMEQ and TRIUMEQ PD are fixed-dose tablets and cannot be dose adjusted, TRIUMEQ and TRIUMEQ PD are not recommended in:

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 patients with creatinine clearance <30 mL/min and pediatric patients with a similar degree of renal impairment based on age-appropriate renal function assessment. There are no data available on the use of lamivudine, a component of TRIUMEQ and TRIUMEQ PD, in pediatric patients with renal impairment [see Use in Specific Populations (8.4, 8.6)].

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 patients with mild hepatic impairment. TRIUMEQ and TRIUMEQ PD are contraindicated in patients with moderate or severe hepatic impairment [see Contraindications (4), Use in Specific Populations (8.7)].

CLINICAL STUDIES SECTION

14 CLINICAL STUDIES

14.1 Adult Subjects

The efficacy of TRIUMEQ is supported by data from a randomized, controlled trial (double-blind through 96 weeks and open-label phase from 96 to 144 weeks) in antiretroviral treatment-naive subjects, SINGLE (ING114467, NCT01263015) and other trials in treatment-naive subjects. See full prescribing information for TIVICAY. The efficacy of dolutegravir, in combination with at least two active background regimens in treatment- experienced, INSTI- naive subjects is supported by data from SAILING (ING111762, NCT01231516) (refer to the prescribing information for TIVICAY).

Treatment-Naive Subjects

In SINGLE, 833 subjects were randomized and received at least 1 dose of either TIVICAY 50 mg once daily with fixed-dose abacavir and lamivudine (EPZICOM) or fixed-dose efavirenz/emtricitabine/tenofovir disoproxil fumarate (ATRIPLA). At baseline, the median age of subjects was 35 years, 16% female, 32% non-white, 7% had hepatitis C co-infection (hepatitis B virus co-infection was excluded), 4% were CDC Class C (AIDS), 32% had HIV‑1 RNA >100,000 copies/mL, and 53% had CD4+ cell count <350 cells/mm3; these characteristics were similar between treatment groups.

Week 144 (open-label-phase analysis which followed the Week 96 double-blind phase) outcomes for SINGLE are provided in Table 12.

Table 12. Virologic Outcomes of Randomized Treatment in SINGLE at 144 Weeks (Snapshot Algorithm)

a Adjusted for pre-specified stratification factors. b Includes subjects who discontinued due to an adverse event or death at any time point if this resulted in no virologic data on treatment during the analysis window. c Other includes reasons such as withdrew consent, loss to follow-up, moved, and protocol deviation. d The primary endpoint was assessed at Week 48 and the virologic success rate was 88% in the group receiving TIVICAY and 81% in the ATRIPLA group, with a treatment difference of 7.4% and 95% CI of (2.5%, 12.3%).
	TIVICAY + EPZICOM Once Daily (n = 414)	ATRIPLA Once Daily (n = 419)
HIV‑1 RNA <50 copies/mL	71%	63%
Treatment differencea	8.3% (95% CI: 2.0%, 14.6%)d
Virologic nonresponse	10%	7%
Data in window not <50 copies/mL	4%	<1%
Discontinued for lack of efficacy	3%	3%
Discontinued for other reasons while not suppressed	3%	4%
No virologic data	18%	30%
Reasons
Discontinued study/study drug due to adverse event or deathb	4%	14%
Discontinued study/study drug for other reasonsc	12%	13%
Missing data during window but on study	2%	3%
Proportion (%) of Subjects with HIV‑1 RNA <50 copies/mL by Baseline Category
Plasma viral load (copies/mL)
≤100,000	73%	64%
≥100,000	69%	61%
Gender
Male	72%	66%
Female	69%	48%
Race
White	72%	71%
African American/African Heritage/Other	71%	47%

Treatment differences were maintained across baseline characteristics including baseline viral load, CD4+ cell count, age, gender, and race. The adjusted mean changes in CD4+ cell counts from baseline were 378 cells/mm3 in the group receiving TIVICAY + EPZICOM and 332 cells/mm3 for the ATRIPLA group at 144 weeks. The adjusted difference between treatment arms and 95% CI was 46.9 cells/mm3 (15.6 cells/mm3, 78.2 cells/mm3) (adjusted for pre-specified stratification factors: baseline HIV‑1 RNA, and baseline CD4+ cell count).

Treatment-Experienced

In SAILING, there were 715 subjects included in the efficacy and safety analyses (see full prescribing information for TIVICAY). At Week 48, 71% of subjects randomized to TIVICAY plus background regimen versus 64% of subjects randomized to raltegravir plus background regimen had HIV‑1 RNA <50 copies/mL (treatment difference and 95% CI: 7.4% [0.7%, 14.2%]).

14.2 Pediatric Subjects

The efficacy of TRIUMEQ, TRIUMEQ PD and/or their individual components for the treatment of HIV-1 infection was evaluated in pediatric patients enrolled in the IMPAACT 2019 trial (NCT03760458), ARROW trial (NCT02028676) and IMPAACT P1093 trial (NCT01302847), as summarized below.

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TRIUMEQ and TRIUMEQ PD were evaluated in treatment-naive or treatment-experienced, HIV-1–infected subjects younger than 12 years in an open-label, multicenter clinical trial (IMPAACT 2019). Subjects were stratified by weight band and enrolled in one of five groups. Fifty-seven subjects, with a median age of 6.4 years (range: 1 to 11.3) and median weight of 17 kg (range: 8.2 to 39.3), received the recommended dose (determined by weight) and formulation, and contributed to the efficacy analysis at Week 48. At this timepoint, 79% of subjects achieved HIV-1 RNA less than 50 copies/mL and 95% achieved HIV-1 RNA less than 200 copies/mL (Snapshot algorithm).

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Abacavir and lamivudine once daily, in combination with a third antiretroviral drug, were evaluated in a randomized, multicenter trial (ARROW) in treatment-naive pediatric subjects with HIV-1 infection. Subjects randomized to once-daily dosing (n = 336) and who weighed at least 25 kg received abacavir 600 mg and lamivudine 300 mg, as either the single entities or as EPZICOM. At Week 96, 67% of subjects receiving abacavir and lamivudine once-daily in combination with a third antiretroviral drug, had HIV-1 RNA <80 copies/mL.

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Dolutegravir (TIVICAY or TIVICAY PD), in combination with other antiretroviral drugs, was evaluated in treatment-naive or treatment-experienced, INSTI-naive, HIV-1–infected subjects aged at least 4 weeks to 18 years in an ongoing open-label, multicenter, dose-finding clinical trial, IMPAACT P1093. Subjects were stratified by age from 4 weeks to younger than 18 years and enrolled in one of five age cohorts. Thirty-six subjects weighing at least 6 kg who received the recommended dose (determined by weight and age) and formulation contributed to the efficacy analysis at Week 48. At this timepoint, 72% (26/36) of subjects weighing at least 6 kg achieved HIV‑1 RNA <50 copies/mL (Snapshot algorithm).

NONCLINICAL TOXICOLOGY SECTION

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity

Dolutegravir: Two-year carcinogenicity studies in mice and rats were conducted with dolutegravir. Mice were administered doses of up to 500 mg/kg, and rats were administered doses of up to 50 mg/kg. In mice, no significant increases in the incidence of drug-related neoplasms were observed at the highest doses tested, resulting in dolutegravir AUC exposures approximately 26-fold higher than those in humans at the recommended dose of 50 mg once daily. In rats, no increases in the incidence of drug-related neoplasms were observed at the highest dose tested, resulting in dolutegravir AUC exposures 17-fold and 30-fold higher in males and females, respectively, than those in humans at the recommended dose of 50 mg once daily.

Abacavir: Abacavir was administered orally at 3 dosage levels to separate groups of mice and rats in 2‑year carcinogenicity studies. Results showed an increase in the incidence of malignant and non‑malignant tumors. Malignant tumors occurred in the preputial gland of males and the clitoral gland of females of both species, and in the liver of female rats. In addition, non‑malignant tumors also occurred in the liver and thyroid gland of female rats. These observations were made at systemic exposures in the range of 7 to 28 times the human exposure at the recommended dose of 600 mg.

Lamivudine: Long‑term carcinogenicity studies with lamivudine in mice and rats showed no evidence of carcinogenic potential at exposures up to 12 times (mice) and 57 times (rats) the human exposures at the recommended dose of 300 mg.

Mutagenicity

Dolutegravir: Dolutegravir was not genotoxic in the bacterial reverse mutation assay, mouse lymphoma assay, or in the in vivo rodent micronucleus assay.

Abacavir: Abacavir induced chromosomal aberrations both in the presence and absence of metabolic activation in an in vitro cytogenetic study in human lymphocytes. Abacavir was mutagenic in the absence of metabolic activation, although it was not mutagenic in the presence of metabolic activation in an L5178Y mouse lymphoma assay. Abacavir was clastogenic in males and not clastogenic in females in an in vivo mouse bone marrow micronucleus assay. Abacavir was not mutagenic in bacterial mutagenicity assays in the presence and absence of metabolic activation.

Lamivudine: Lamivudine was mutagenic in an L5178Y mouse lymphoma assay and clastogenic in a cytogenetic assay using cultured human lymphocytes. Lamivudine was not mutagenic in a microbial mutagenicity assay, in an in vitro cell transformation assay, in a rat micronucleus test, in a rat bone marrow cytogenetic assay, and in an assay for unscheduled DNA synthesis in rat liver.

Impairment of Fertility

Dolutegravir, abacavir, or lamivudine did not affect male or female fertility in rats at doses associated with exposures approximately 44, 9, or 112 times (respectively) higher than the exposures in humans at the doses of 50 mg, 600 mg, and 300 mg (respectively).

13.2 Animal Toxicology and/or Pharmacology

Myocardial degeneration was found in mice and rats following administration of abacavir for 2 years. The systemic exposures were equivalent to 7 to 21 times the expected systemic exposure in humans at a dose of 600 mg. The clinical relevance of this finding has not been determined.

SPL MEDGUIDE SECTION

MEDICATION GUIDE
TRIUMEQ (TRI-u-meck) (abacavir, dolutegravir, and lamivudine) tablets	TRIUMEQ PD (TRI-u-meck Pe De) (abacavir, dolutegravir, and lamivudine) tablets for oral suspension
What is the most important information I should know about TRIUMEQ and TRIUMEQ PD? TRIUMEQ and TRIUMEQ PD can cause serious side effects, including: • Serious allergic reactions (hypersensitivity reaction) that can cause death have happened with TRIUMEQ or TRIUMEQ PD and other abacavir-containing products. Your risk of this allergic reaction to abacavir is much higher if you have a gene variation called HLA‑B5701. Your healthcare provider can determine with a blood test if you have this gene variation. If you get a symptom from 2 or more of the following groups while taking TRIUMEQ or TRIUMEQ PD, call your healthcare provider right away to find out if you should stop taking TRIUMEQ or TRIUMEQ PD.*

		Symptom(s)
	Group 1	Fever
	Group 2	Rash
	Group 3	Nausea, vomiting, diarrhea, abdominal (stomach area) pain
	Group 4	Generally ill feeling, extreme tiredness, or achiness
	Group 5	Shortness of breath, cough, sore throat
A list of these symptoms is on the Warning Card your pharmacist gives you. Carry this Warning Card with you at all times. If you stop TRIUMEQ or TRIUMEQ PD because of an allergic reaction, never take TRIUMEQ, TRIUMEQ PD (abacavir, dolutegravir and lamivudine), or any other medicine that contains abacavir or dolutegravir (DOVATO, EPZICOM, JULUCA, TIVICAY, TIVICAY PD, TRIZIVIR, or ZIAGEN) again. o `If you have an allergic reaction, dispose of any unused TRIUMEQ or TRIUMEQ PD. Ask your pharmacist how to properly dispose of medicines.` o `If you take TRIUMEQ, TRIUMEQ PD or any other abacavir‑containing medicine again after you have had an allergic reaction, within hours you may get life‑threatening symptoms that may include very low blood pressure or death.` o `If you stop TRIUMEQ or TRIUMEQ PD for any other reason, even for a few days, and you are not allergic to TRIUMEQ or TRIUMEQ PD, talk with your healthcare provider before taking it again. Taking TRIUMEQ or TRIUMEQ PD again can cause a serious allergic or life‑threatening reaction, even if you never had an allergic reaction to it before.` If your healthcare provider tells you that you can take TRIUMEQ or TRIUMEQ PD again, start taking it when you are around medical help or people who can call a healthcare provider if you need one.
• `Worsening of Hepatitis B virus (HBV) infection. Your healthcare provider will test you for HBV infection before you start treatment with TRIUMEQ or TRIUMEQ PD. If you have HBV infection and take TRIUMEQ or TRIUMEQ PD, your HBV may get worse (flare-up) if you stop taking TRIUMEQ or TRIUMEQ PD. A “flare-up” is when your HBV infection suddenly returns in a worse way than before.` o `Do not run out of TRIUMEQ or TRIUMEQ PD. Refill your prescription or talk to your healthcare provider before your TRIUMEQ or TRIUMEQ PD is all gone.` o `Do not stop TRIUMEQ or TRIUMEQ PD without first talking to your healthcare provider.` o `If you stop taking TRIUMEQ or TRIUMEQ PD, your healthcare provider will need to check your health often and do blood tests regularly for several months to check your liver function and monitor your HBV infection. It may be necessary to give you a medicine to treat hepatitis B. Tell your healthcare provider about any new or unusual symptoms you may have after you stop taking TRIUMEQ or TRIUMEQ PD.` • `Resistant HBV. If you have human immunodeficiency virus-1 (HIV-1) and HBV, the HBV can change (mutate) during your treatment with TRIUMEQ or TRIUMEQ PD and become harder to treat (resistant). Your healthcare provider may give you other medicines to treat HBV infection if you have HIV-1 and HBV infections and take TRIUMEQ or TRIUMEQ PD.` • `For more information about side effects, see “What are the possible side effects of TRIUMEQ or TRIUMEQ PD?”`
What is TRIUMEQ and TRIUMEQ PD? TRIUMEQ and TRIUMEQ PD are prescription medicines used to treat HIV-1 infection in adults and children who are at least 3 months of age and weigh at least 13.2 pounds (6 kg). HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS). TRIUMEQ and TRIUMEQ PD contain the prescription medicines abacavir, dolutegravir, and lamivudine. • `TRIUMEQ or TRIUMEQ PD should not be used by itself in people who have resistance to certain types of medicines.` It is not known if TRIUMEQ PD is safe and effective in children who are less than 3 months of age or weigh less than 13.2 pounds (6 kg).
Do not take TRIUMEQ or TRIUMEQ PD if you: • `have a certain type of gene variation called the HLA‑B*5701 allele. Your healthcare provider will test you for this before prescribing treatment with TRIUMEQ or TRIUMEQ PD.` • `are allergic to abacavir, dolutegravir, lamivudine, or any of the ingredients in TRIUMEQ or TRIUMEQ PD. See the end of this Medication Guide for a complete list of ingredients in TRIUMEQ and TRIUMEQ PD.` • `take dofetilide. Taking TRIUMEQ or TRIUMEQ PD and dofetilide can cause side effects that may be serious or life-threatening.` • `have certain liver problems.`
Before you take TRIUMEQ or TRIUMEQ PD, tell your healthcare provider about all of your medical conditions, including if you: • `have been tested and know whether or not you have a particular gene variation called HLA‑B5701.` • `have or have had liver problems, including hepatitis B or C virus infection.` • `have kidney problems.` • `have heart problems, smoke, or have diseases that increase your risk of heart disease such as high blood pressure, high cholesterol, or diabetes.` • `drink alcohol or take medicines that contain alcohol.` • `are pregnant or plan to become pregnant. One of the medicines in TRIUMEQ and TRIUMEQ PD called dolutegravir may harm your unborn baby.` o `Your healthcare provider may prescribe a different medicine than TRIUMEQ if you are planning to become pregnant or if pregnancy is confirmed during the first 12 weeks of pregnancy.` o `If you can become pregnant, your healthcare provider may perform a pregnancy test before you start treatment with TRIUMEQ.` o `If you can become pregnant, you and your healthcare provider should talk about the use of effective birth control (contraception) during treatment with TRIUMEQ.` o `Tell your healthcare provider right away if you are planning to become pregnant, you become pregnant, or think you may be pregnant during treatment with TRIUMEQ.` Pregnancy Registry.There is a pregnancy registry for individuals who take TRIUMEQ and TRIUMEQ PD during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk with your healthcare provider about how you can take part in this registry. • `are breastfeeding or plan to breastfeed.* Do not breastfeed if you take TRIUMEQ.` o `You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.` o `TRIUMEQ and TRIUMEQ PD pass to your baby in your breastmilk.` Tell your healthcare provider about all the medicines you take,including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines interact with TRIUMEQ or TRIUMEQ PD. Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine. • `You can ask your healthcare provider or pharmacist for a list of medicines that interact with TRIUMEQ or TRIUMEQ PD.` • `Do not start taking a new medicine without telling your healthcare provider.** Your healthcare provider can tell you if it is safe to take TRIUMEQ or TRIUMEQ PD with other medicines.`
How should I take TRIUMEQ or TRIUMEQ PD? Read the Instructions for Use at the end of this Medication Guide for detailed instructions on how to prepare a dose of TRIUMEQ PD tablets for oral suspension. • `Take TRIUMEQ or TRIUMEQ PD exactly as your healthcare provider tells you to take it.` • `Do not change your dose, switch medicines or stop taking TRIUMEQ or TRIUMEQ PD without talking with your healthcare provider first.` • `TRIUMEQ tablets are not the same as TRIUMEQ PD tablets for oral suspension and cannot be substituted for each other. Check to make sure you receive the correct dosage form each time you or your child’s prescription is filled to avoid using the wrong medicine.` • `Your child’s healthcare provider will prescribe TRIUMEQ or TRIUMEQ PD based on your child’s weight.` • `TRIUMEQ PD tablets for oral suspension should be dispersed in drinking water.` • `Donot chew, cut, or crush TRIUMEQ tablets or TRIUMEQ PD tablets for oral suspension. Do not swallow TRIUMEQ PD tablets for oral suspension whole.` • `TRIUMEQ or TRIUMEQ PD may be taken with or without food.` • `If you take antacids, laxatives, or other medicines that contain aluminum, magnesium, or buffered medicines, TRIUMEQ or TRIUMEQ PD 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, or multivitamin supplements that contain iron or calcium, by mouth during treatment with TRIUMEQ or TRIUMEQ PD:` o `If you take TRIUMEQ or TRIUMEQ PD with food, you may take these supplements at the same time that you take TRIUMEQ or TRIUMEQ PD.` o `If you do not take TRIUMEQ or TRIUMEQ PD with food, take TRIUMEQ or TRIUMEQ PD at least 2 hours before or 6 hours after you take these supplements.` • `If you miss a dose of TRIUMEQ or TRIUMEQ PD, 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 or TRIUMEQ PD.` • `Do not run out of TRIUMEQ or TRIUMEQ PD. 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 or TRIUMEQ PD, call your healthcare provider or go to the nearest hospital emergency room right away.`
What are the possible side effects of TRIUMEQ or TRIUMEQ PD? TRIUMEQ or TRIUMEQ PD can cause serious side effects, including: • `See “What is the most important information I should know about TRIUMEQ and TRIUMEQ PD?”` • Liver problems. People with a history of hepatitis B or C virus may have an increased risk of developing new or worsening changes in certain liver function tests during treatment with TRIUMEQ or TRIUMEQ PD. Liver problems including liver failure have also happened with TRIUMEQ or TRIUMEQ PD in people without a history of liver disease or other risk factors. Liver failure resulting in liver transplant has also been reported with TRIUMEQ. Your healthcare provider may do blood tests to check your liver.Call your healthcare provider right away if you develop any of the signs or symptoms of liver problems listed below.
	o `your skin or the white part of your eyes turns yellow (jaundice)` o `dark or “tea-colored” urine` o `light colored stools (bowel movements)`	o `loss of appetite` o `nausea or vomiting` o `pain, aching, or tenderness on the right side of your stomach area`
• `Too much lactic acid in your blood (lactic acidosis).Too much lactic acid is a serious medical emergency that can lead to death. Call your healthcare provider right away if you get any of the following symptoms that could be signs of lactic acidosis:`
	o `feel very weak or tired` o `unusual (not normal) muscle pain` o `trouble breathing` o `stomach pain with nausea and vomiting`	o `feel cold, especially in your arms and legs` o `feel dizzy or lightheaded` o `have a fast or irregular heartbeat`

• `Lactic acidosis can also lead to severe liver problems, which can lead to death. Your liver may become large (hepatomegaly), and you may develop fat in your liver (steatosis).Call your healthcare provider right away if you get any of the signs or symptoms of liver problems which are listed above under “Liver problems”.` • `You may be more likely to get lactic acidosis or severe liver problems if you are female or very overweight (obese).` • `Changes in your immune system (Immune Reconstitution Syndrome) can happen when you start taking HIV-1 medicines. Your immune system may get stronger and begin to fight infections that have been hidden in your body for a long time. Tell your healthcare provider right away if you start having new symptoms after you start taking TRIUMEQ or TRIUMEQ PD.` • `Heart attack. Some HIV-1 medicines including TRIUMEQ or TRIUMEQ PD may increase your risk of heart attack.` • `The most common side effects of TRIUMEQ include:`
	o `trouble sleeping`	o `headache`	o `tiredness`
These are not all the possible side effects of TRIUMEQ or TRIUMEQ PD. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1‑800‑FDA‑1088.
How should I store TRIUMEQ or TRIUMEQ PD? • `Store TRIUMEQ and TRIUMEQ PD at room temperature between 68°F to 77°F (20°C to 25°C) in the original bottle. Keep the bottle tightly closed and protect it from moisture.` • `The bottle of TRIUMEQ and TRIUMEQ PD contains a desiccant packet to help keep your medicine dry (protect it from moisture). Do not remove the desiccant packet from the bottle.` Keep TRIUMEQ, TRIUMEQ PD, and all medicines out of the reach of children.
General information about the safe and effective use of TRIUMEQ or TRIUMEQ PD. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use TRIUMEQ or TRIUMEQ PD for a condition for which it was not prescribed. Do not give TRIUMEQ or TRIUMEQ PD to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about TRIUMEQ or TRIUMEQ PD that is written for health professionals.
What are the ingredients in TRIUMEQ and TRIUMEQ PD? Active ingredients: abacavir, dolutegravir, and lamivudine Inactive ingredients: TRIUMEQ tablets: D-mannitol, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate. Tablet film‑coating contains: iron oxide black, iron oxide red, macrogol/PEG, polyvinyl alcohol–part hydrolyzed, talc, and titanium oxide. TRIUMEQ PD tablets for oral suspension: acesulfame potassium, crospovidone, mannitol, microcrystalline cellulose, povidone K29/32, silicified microcrystalline cellulose, sodium starch glycolate, sodium stearyl fumarate, strawberry cream flavor, and sucralose. Tablet film‑coating contains: ferric oxide yellow, macrogol/PEG, polyvinyl alcohol-part hydrolyzed, talc, and titanium dioxide.
Manufactured for: ViiV Healthcare Durham, NC 27701
DOVATO, EPZICOM, JULUCA, TIVICAY, TIVICAY PD, TRIUMEQ, TRIUMEQ PD, TRIZIVIR, and ZIAGEN are trademarks owned by or licensed to the ViiV Healthcare group of companies. ©2023 ViiV Healthcare group of companies or its licensor. TRM:16MG For more information go to www.TRIUMEQ.com or call 1-877-844-8872.
This Medication Guide has been approved by the U.S. Food and Drug Administration.	Revised: June 2023

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