Can Triumeq be crushed or split?

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Official answer

by Drugs.com

To ensure you receive the entire dose of Triumeq, the manufacturer recommends that the tablet be swallowed whole. If you have trouble swallowing a whole tablet, crushing or splitting Triumeq tablets may be an acceptable alternative, if approved by your healthcare provider. Do not chew, cut, or crush the Triumeq PD tablets.

The manufacturer states that crushed or split tablets should be placed in a small amount of semi-solid food or liquid and consumed immediately.

Triumeq contains a fixed-dose combination of abacavir, dolutegravir, and lamivudine and is used in the treatment of HIV. It is a film-coated, non-scored and non-sustained release tablet.

Recommendations regarding crushing or splitting Triumeq tablets before administration are not included in the manufacturer’s product label; however, manufacturer's data on file and a pharmacokinetic study are available.

In March 2022, the FDA approved Triumeq PD, a pediatric-specific formulation of Triumeq. Do not switch between Triumeq and Triumeq PD, and do not chew, cut, or crush the Triumeq PD tablets. Learn more here.

Study

In a 3-period cross-over study in 22 adult HIV-negative volunteers, researchers evaluated the effects of crushing and suspending the dolutegravir/abacavir/lamivudine (Triumeq) tablet. Subjects took the crushed / suspended tablet either in the fed state (with 250 mL enteral nutrition orally), or fasted state (on an empty stomach), as compared to taking the tablet whole while fasting (the reference). There was a 7-day washout between treatments.

Predefined bioequivalence criteria (90% CI of the GMR in the acceptance range 80%–125%) of AUC0-∞ and Cmax were used.

Bioequivalence could not be demonstrated. The investigators found that crushing and suspending dolutegravir/abacavir/lamivudine (Triumeq) led to higher dolutegravir exposure (AUC0-∞: +26% and Cmax: +30%). Crushed and suspended Triumeq combined with enteral nutrition led to a decrease in abacavir Cmax (−17%). Lamivudine concentrations were not affected and were within the accepted range. However, these deviations were not considered clinically relevant.

No serious side effects were reported, but at least one side effect was reported in 77% of subjects, including headache, nausea and fatigue, dizziness, stomach pain and diarrhea.

The authors concluded that although both scenarios led to higher dolutegravir concentrations, these levels were not any higher than when Triumeq is taken with food or with twice-daily dosing. They concluded that Triumeq can be crushed for patients who are unconscious or have swallowing difficulties and can be given with enteral nutrition.

The effects of splitting Triumeq has not been studied. The manufacturer states that splitting film-coated, non-scored and non-sustained release tablets such as Triumeq should not alter the clinical effect.

Triumeq PD

In March 2022, the FDA approved Triumeq PD, a pediatric-specific formulation. Triumeq PD is recommended in pediatric patients weighing 10 kg (22 lbs) to less than 25 kg (55 lbs). It is available as tablets for oral suspension and contains 60 mg of abacavir, 5 mg of dolutegravir, and 30 mg of lamivudine.

The number of tablets for each dose is based on body weight. Triumeq PD is dispersed in drinking water and administered within 30 minutes of dispersing. The tablets for oral suspension can be given with or without food. Do not chew, cut, or crush the Triumeq PD tablets.

Do not switch between Triumeq tablets and Triumeq PD tablets for oral suspension on a milligram-per-milligram basis due to differing pharmacokinetic profiles for the dolutegravir component. If a patient switches from one formulation to the other, the dose must be adjusted.

This is not all the information you need to know about Triumeq (abacavir, dolutegravir, and lamivudine) for safe and effective use and does not take the place of talking to your doctor about your treatment. Review the full Triumeq information here, and discuss this information and any questions you have with your doctor or other health care provider.

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