Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following adverse reactions are discussed in other sections of the labeling: • Serious and sometimes fatal hypersensitivity reaction [see Boxed Warning , Warnings and Precautions ( 5.1 )] .
• Exacerbations of hepatitis B [see Boxed Warning , Warnings and Precautions ( 5.3 )] .
• Hepatotoxicity [see Warnings and Precautions ( 5.3 )] .
• Lactic acidosis and severe hepatomegaly with steatosis [see Warnings and Precautions ( 5.4 )] .
• Immune reconstitution syndrome [see Warnings and Precautions ( 5.6 )] .
• Myocardial infarction [see Warnings and Precautions ( 5.8 )] .
The most commonly reported adverse reactions of at least moderate intensity and incidence at least 2% (in those receiving TRIUMEQ) were insomnia, headache, and fatigue.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact ViiV Healthcare at 1-877-844-8872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Clinical Trials in Adults Serious and Fatal Abacavir-Associated Hypersensitivity Reactions: In clinical trials, serious and sometimes fatal hypersensitivity reactions have occurred with abacavir, a component of TRIUMEQ and TRIUMEQ PD [see Boxed Warning , Warnings and Precautions ( 5.1 )].
5 WARNINGS AND PRECAUTIONS • Hepatotoxicity has been reported in patients receiving a dolutegravir-containing regimen.
Monitoring for hepatotoxicity is recommended.
( 5.3 ) • Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogues.
( 5.4 ) • Immune reconstitution syndrome has been reported in patients treated with combination antiretroviral therapy.
( 5.6 ) • TRIUMEQ tablets and TRIUMEQ PD tablets for oral suspension are not substitutable.
Like all medications, Triumeq can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: