多替阿巴拉米片详细说明书

Detailed instructions

Generic name: Doptabalamid tablets

Product name: Suimeikai

All names: Trimeq, Docetabalamid, TRIUMEQ, Inbec

Indications:

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

Usage and dosage of Dotiabalamid Tablets:

Dolutegra tablets 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 of Dolutegra is one tablet once daily.

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

Dolutegravir 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 SuimeiKai and there are more than 4 hours left before the next dose, he should take Doptabalamid tablets 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 50 mL/min are not recommended to take doptabalamid tablets.

liver damage

Abacavir is primarily metabolized by the liver. There are no clinical data in patients with moderate or severe hepatic impairment; therefore, the use of dolutea 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 dolutegra tablets have not been established in children under 12 years of age. No data yet.

Dosing method

Oral

Docetaxel can be taken with or without food.

Adverse reactions of doptabalamid tablets:

There are limited clinical data on dolutegravir and abacalamvir/lamivudine, and the most commonly reported adverse reactions that are possibly or probably related to dolutegravir and abacalongvir/lamivudine (pooled data from 679 antiretroviral-naïve subjects who received this combination in Phase IIb to IIIb clinical trials) are nausea (12%), insomnia (7%), dizziness (6%), and headache (6%).

Precautions for Dote Abalamid Tablets:

Spread HIV

Although 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.

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 dolutegravir have not been established in patients with pre-existing severe liver disease. Suimeikan 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.

immune reconstitution inflammatory syndrome

In severely immunodeficient HIV-infected patients when initiating combination antiretroviral therapy (CART), an inflammatory response to asymptomatic or residual opportunistic pathogens may occur, leading to severe clinical illness or symptom exacerbation. Such reactions are usually observed in the weeks or months before starting CART therapy. Relevant examples include cytomegalovirus retinitis, systemic and/or focal mycobacterial infections, and Pneumocystis jiroveci pneumonia. Symptoms of inflammation should be evaluated and treated if necessary. Autoimmune disorders (e.g., Graves' disease) have also been reported during immune reconstitution; however, the reported timing of onset is inconsistent and these events may occur many months after initiation of therapy.

In patients with co-infection with hepatitis B or hepatitis C virus, elevated liver chemistries consistent with immune reconstitution inflammatory syndrome have been observed upon initiation of dolutegravir therapy. In patients with hepatitis B and/or hepatitis C virus infection, monitoring of liver chemistry test values ​​is recommended.

Mitochondrial dysfunction following in utero exposure

Nucleosides and nucleoside analogs may affect mitochondrial function to varying degrees, with the effects being most significant when combined with stavudine, didanosine, and zidovudine. Mitochondrial dysfunction has been reported in HIV-negative infants exposed to nucleoside analogues in utero and/or postnatally, primarily in association with zidovudine-containing treatment regimens. The main adverse reactions reported were hematological disorders (anemia, neutropenia) and metabolic disorders (hyperlactemia, hyperlipidemia). These reactions are often short-lived. Some late-onset neurological disorders (hypertonia, convulsions, behavioral abnormalities) are rarely reported. It is unclear whether the neurological condition is temporary or permanent. These results should be considered in children exposed to nucleosides and nucleoside analogues in utero who have severe clinical symptoms of unknown etiology, especially neurological symptoms.

myocardial infarction

Observational studies have demonstrated an association between myocardial infarction and abacavir use. The patients participating in the study were mainly those who had received antiretroviral therapy. Clinical trial data show a limited number of myocardial infarctions and a small increase in risk cannot be ruled out. Overall, there are some inconsistencies between observational cohort data and randomized trial data, so a causal relationship between abacavir treatment and the risk of myocardial infarction cannot be confirmed or denied. To date, there is no precise biological mechanism to explain the possible increased risk. While using Trimax, steps should be taken to minimize all modifiable risk factors (such as smoking, hypertension, and hyperlipidemia).

osteonecrosis

Although the etiology is thought to be multifactorial (including use of corticosteroids, bisphosphonates, alcohol consumption, severe immunosuppression, and high body mass index), cases of osteonecrosis have been reported, particularly in patients with advanced HIV disease and/or long-term exposure to CART. Patients should be advised to seek medical attention if they experience joint pain, joint stiffness, or difficulty moving.

Opportunistic infections

Patients should be informed that dolutea or any other antiretroviral treatment does not cure HIV infection and that they may still develop opportunistic infections and other complications of HIV infection. Therefore, patients should be under close clinical observation by physicians experienced in treating HIV-related diseases.

Contraindications: Contraindicated in patients with known hypersensitivity to dolutegravir, abacavir, and lamivudine or any excipients. Concomitant use with dofetilide and pisicanide is prohibited.