多替阿巴拉米片最新版说明书

The latest version of the manual

Product name: Suimeikai

All names: Trimeq, Docetabalamid, TRIUMEQ, Inbec

Ingredients: This product is a compound preparation, each tablet contains dolutegravir sodium (calculated as dolutegravir) 50 mg, abacavir sulfate (calculated as abacavir) 600 mg and lamivudine 300 mg.

Indications:

This product is suitable for the treatment of adults and adolescents over 12 years old (with a weight of at least 40 kg) infected with human immunodeficiency virus (HIV).

HIV-infected patients, regardless of race, should be screened for the HLA-B5701 allele before starting treatment with abacavir-containing products. If the patient is known to carry the HLA-B5701 allele, he should not take products containing abacavir.

Usage and dosage: This product should be taken under the guidance of a physician with experience in HIV infection.

dose

Adults and teenagers (weighing at least 40kg)

For adults and adolescents, the recommended dose is one tablet once daily.

Adults or adolescents whose body weight is less than 40 kg should not be given this product because this product is a fixed-dose tablet and the dose cannot be reduced.

This product is a fixed-dose tablet and should not be used in patients who require dose adjustments. If one of the active ingredients needs to be discontinued or a dose adjustment is required, separate formulations of dolutegravir, abacavir, or lamivudine may be used. In these cases, physicians should refer to the respective product information for these medicines.

Miss a dose

If the patient misses a dose of this product and there are more than 4 hours before the next dose, the patient should take this product as soon as possible. If the next dose is less than 4 hours away, patients should not take the missed dose and simply resume their usual dosing schedule.

elderly patients

There are limited data on the use of dolutegravir, abacavir, and lamivudine in patients aged ≥65 years, and there is no evidence that older patients require different doses than younger adults. Taking into account age-related changes, such as decreased renal function and changes in hematological parameters, special caution is recommended when administering the drug in this age group.

kidney damage

Patients whose creatinine clearance is less than 50mL/min are not recommended to take this product.

liver damage

Abacavir is primarily metabolized by the liver. There are no clinical data in patients with moderate or severe hepatic impairment; therefore, use of this product is not recommended unless deemed necessary. For patients with mild hepatic impairment (Child-Pugh score 5-6), close monitoring is required, including monitoring of abacavir plasma levels if feasible.

children crowd

The safety and effectiveness of this product in children under 12 years of age have not been established. No data yet.

Medication for the Elderly

There are limited data on the use of dolutegravir, abacavir, and lamivudine in patients 65 years and older. There is no evidence that older patients require different dosages than younger adult patients. Taking into account age-related changes, such as decreased renal function and changes in hematological parameters, special caution is recommended when administering the drug in this age group.

Dosing method

Oral

This product can be taken with or without food.

Things to note:

Spread HIV

Although effective viral suppression with antiretroviral therapy has been shown to significantly reduce the risk of sexual transmission, residual risks cannot be excluded. Precautions should be taken to prevent transmission in accordance with national guidance.

hypersensitivity reaction

Both abacavir and dolutegravir carry the risk of triggering a hypersensitivity reaction (HSR) and share some common characteristics, such as fever and/or rash and other symptoms indicating involvement of multiple organs. It is clinically impossible to determine whether abacavir or dolutegravir is responsible for a hypersensitivity reaction occurring with the use of this product. Hypersensitivity reactions have been observed to occur more commonly with abacavir, some of which can be life-threatening and, in rare cases, fatal if not managed appropriately. Patients who test positive for the HLA-B5701 allele are at higher risk of developing abacavir hypersensitivity reactions. However, abacavir hypersensitivity reactions are reported less frequently in patients who do not carry this allele.

Therefore, the following measures should be followed:

Before starting treatment, HLA-B5701 status must be confirmed.

Patients with a positive HLA-B5701 status, or patients with a negative HLA-B5701 status who have had suspected abacavir hypersensitivity reactions when previously receiving abacavir-containing treatment regimens, should not be treated with this product.

If a hypersensitivity reaction is suspected, this product should be discontinued without delay even if the HLA-B5701 allele is not present. After a hypersensitivity reaction occurs, if treatment with this product is not stopped immediately, a life-threatening reaction may occur immediately. Clinical status, including hepatic aminotransferases and bilirubin, should be monitored.

After discontinuation of this product due to suspected hypersensitivity reaction, this product or any other medicinal product containing abacavir or dolutegravir should never be reintroduced.

After a suspected hypersensitivity reaction to abacavir, symptoms may return within hours if abacavir-containing medicines are restarted. Relapses are generally more severe than the initial episode and may include life-threatening hypotension and death.

To avoid re-dosing abacavir and dolutegravir, patients with suspected hypersensitivity reactions should be instructed to discard remaining Abacavir tablets.

Clinical description of hypersensitivity reactions

In clinical studies, <1% of patients treated with dolutegravir reported hypersensitivity reactions, manifesting as rash, systemic symptoms, and sometimes organ dysfunction, including severe hepatic reactions.

Hypersensitivity reactions to abacavir have been well characterized during clinical studies and post-marketing surveillance. Symptoms generally occur within the first six weeks after starting abacavir treatment (median time to onset is 11 days), but these reactions may occur at any time during treatment.

Nearly all hypersensitivity reactions to abacavir include fever and/or rash. Other signs and symptoms observed as part of abacavir hypersensitivity reactions include respiratory and gastrointestinal symptoms. Importantly, these symptoms may lead to misdiagnosis of a hypersensitivity reaction as a respiratory illness (pneumonia, bronchitis, pharyngitis) or gastroenteritis. Continuing treatment can worsen symptoms associated with hypersensitivity reactions and may be life-threatening. These symptoms generally resolve after discontinuation of abacavir.

Rarely, life-threatening reactions may occur within hours of restarting abacavir in patients who have discontinued abacavir for reasons other than symptoms of a hypersensitivity reaction. In such patients, abacavir therapy must be restarted in an environment where immediate medical attention is available.

Body weight and metabolic parameters (lipids and blood glucose)

During antiretroviral therapy, weight gain and elevated blood lipid and blood glucose levels may occur. These changes may be related in part to disease control and lifestyle. In some cases, there is evidence of treatment effects on lipids, but there is no clear evidence that weight gain is associated with any particular treatment. Monitoring of lipids and blood glucose should refer to established HIV treatment guidelines. Dyslipidemia should be treated appropriately based on the clinical situation.

Liver disease

The safety and effectiveness of this product have not been established in patients with pre-existing severe liver disease. This product is not recommended for patients with moderate to severe liver damage.

Patients with pre-existing hepatic dysfunction, including those with chronic active hepatitis, develop hepatic dysfunction with increased frequency during combined antiretroviral therapy and should be monitored according to standard protocols. If in these patients there is evidence of worsening liver disease, withholding or discontinuing treatment should be considered.

Drug overdose:

After an acute overdose of dolutegravir, abacavir, or lamivudine, no specific symptoms or signs other than those listed as adverse reactions have been noted.

There is no specific treatment for overdose of this product. If overdose occurs, the patient should receive supportive care and appropriate monitoring if necessary. Because lamivudine is dialyzable, continuous hemodialysis may be used in the treatment of overdose, but this has not been studied. It is unknown whether abacavir is eliminated by peritoneal dialysis or hemodialysis. Dolutegravir is highly bound to plasma proteins, so it is unlikely to be significantly removed using dialysis.

Storage: sealed, stored below 30℃. Tablets should be stored in their original packaging to avoid moisture absorption. Seal the vial tightly and do not remove the desiccant.