Triumeq Safety Information & Boxed Warning | Sunny Pharma

triumeq safety information

Triumeq Safety Information

*Triumeq Boxed Warning: Hypersensitivity Reactions and Exacerbations of Hepatitis B Virus (HBV)

Hypersensitivity Reactions

Medications containing abacavir have reported serious and sometimes fatal hypersensitivity reactions involving multiple organs. Patients with the HLA-B✶5701 allele face a higher risk of experiencing a hypersensitivity reaction, but reactions can occur in those without the allele.

Contraindications:

Do not use TRIUMEQ or TRIUMEQ PD if the patient:

  • Possesses the HLA-B✶5701 allele
  • Previously experienced hypersensitivity reactions to abacavir, dolutegravir, or lamivudine
  • Takes dofetilide
  • Has moderate or severe hepatic impairment

Exacerbations of Hepatitis B

Before using TRIUMEQ or TRIUMEQ PD, it is essential to test all HIV-1 patients for HBV. In co-infected patients, additional HBV treatment may be required.

Severe acute exacerbations of HBV have occurred in co-infected patients who stopped taking lamivudine (a component of TRIUMEQ and TRIUMEQ PD). Therefore, close hepatic function monitoring is advisable in such cases.

Warnings and Precautions

Hypersensitivity Reactions

Dolutegravir has been associated with hypersensitivity reactions, including rash, constitutional findings, and organ dysfunction.

If hypersensitivity signs develop, discontinue TRIUMEQ or TRIUMEQ PD immediately.

Hepatotoxicity

Patients using dolutegravir-containing regimens have experienced cases of hepatic toxicity.

Close monitoring is recommended, especially in patients with underlying hepatitis B or C.

TRIUMEQ has been associated with drug-induced liver injury leading to transplantation.

Lactic Acidosis and Severe Hepatomegaly With Steatosis

Nucleoside analogs like abacavir and lamivudine have been linked to fatal cases of lactic acidosis and severe hepatomegaly with steatosis.

If clinical or laboratory findings suggest lactic acidosis or hepatotoxicity, discontinue TRIUMEQ or TRIUMEQ PD.

Embryo-Fetal Toxicity

Due to the potential risk of neural tube defects, it is necessary to evaluate the risks and benefits of using TRIUMEQ during conception through the first trimester of pregnancy.

Pregnancy testing and contraception counseling are recommended for women of childbearing potential.

Adverse Reactions

Common adverse reactions in treatment-naïve adults include insomnia, headache, and fatigue.

Drug Interactions

Co-administering TRIUMEQ or TRIUMEQ PD with other drugs may influence drug concentrations.

It is crucial to consider potential interactions before and during therapy.

Several drugs may interact with Triumeq, potentially affecting its efficacy or causing adverse effects. It’s crucial to inform your healthcare provider about all the medications, supplements, and over-the-counter drugs you are taking to ensure your safety.

Here are some drugs that should not be taken with Triumeq or require careful monitoring:

  1. Dofetilide: Do not use Triumeq if you are taking dofetilide, a medication used to treat irregular heart rhythms. Combining Triumeq with dofetilide can lead to serious heart-related side effects.
  2. Sorbitol: Avoid products containing sorbitol, a sugar substitute found in some liquid medications or supplements, while taking Triumeq. Sorbitol can cause stomach discomfort and diarrhea when combined with Triumeq.
  3. Antacids and Calcium Supplements: If you need to take antacids, calcium supplements, or products containing iron, it’s essential to take them at least 2 hours before or 6 hours after taking Triumeq. These substances can interfere with the absorption of Triumeq.
  4. Multivitamins: Certain multivitamin supplements containing high amounts of calcium or iron should also be taken separately from Triumeq to avoid interference with absorption.
  5. Rifampin: Rifampin is an antibiotic used to treat various bacterial infections, including tuberculosis. It may reduce the effectiveness of Triumeq, and an alternative HIV treatment should be considered if rifampin is required.
  6. Other Antiretroviral Drugs: Combining Triumeq with other antiretroviral medications without medical supervision can lead to drug interactions or unnecessary duplication of therapy. Always follow your healthcare provider’s guidance when using multiple HIV medications.
  7. Certain Seizure Medications: Some seizure medications, such as phenytoin and phenobarbital, may interact with Triumeq. Your healthcare provider will carefully monitor your condition if these medications are necessary.
  8. St. John’s Wort: St. John’s Wort, an herbal supplement used for mood disorders, can decrease the effectiveness of Triumeq and should be avoided.
  9. Methadone: If you are taking methadone for opioid addiction, your healthcare provider will monitor your methadone dose and may adjust it as needed when you start Triumeq.
  10. Warfarin: If you are taking warfarin, a blood thinner, your healthcare provider may need to monitor your blood clotting times more closely when you start or stop Triumeq.

Special Considerations

  • TRIUMEQ and TRIUMEQ PD are not interchangeable.
  • When prescribing abacavir, take into account the underlying risk of coronary heart disease.
  • Assess risk factors for MI and take steps to minimize modifiable risk factors.
  • For pregnancy, lactation, and specific populations, adhere to recommended guidelines for assessment and counseling.
  • Pediatric patients aged <3 months or weighing <6 kg should avoid TRIUMEQ and TRIUMEQ PD.
  • Use TRIUMEQ and TRIUMEQ PD with caution in patients with impaired renal or hepatic function.

For more information on Triumeq give us a call or Text to 858-952-1077.  You can also email Info@Sunnypharma.info

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