绥美凯需要注意的事项有哪些？

It is mainly used to treat adults and adolescents over 12 years old (with a weight of at least 40kg) infected with human immunodeficiency virus (HIV). It can help patients prolong their survival time and improve their quality of life. Patients need to understand the precautions clearly while taking the medicine to prevent the medicines from interacting with each other and causing harm to the body. So, what should you pay attention to while taking Suimeikai?

Taboo overeating and overdrinking

During the diet, patients must avoid overeating and eat small meals frequently to avoid aggravating the burden on the gastrointestinal tract and causing other complications.

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 liver 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.

Patients with chronic hepatitis B or hepatitis C

Patients with chronic hepatitis B or hepatitis C who receive combination antiretroviral therapy are at increased risk for serious and potentially fatal hepatic adverse effects. If you are also taking antiviral treatment for hepatitis B or hepatitis C, please refer to the relevant product information for these medicines.

This product contains lamivudine, which is effective against hepatitis B. Abacavir and dolutegravir lack such effects. It is generally believed that lamivudine monotherapy is not an adequate treatment for hepatitis B because of the high risk of developing hepatitis B virus resistance. Therefore, if this product is used to treat patients co-infected with hepatitis B, another antiviral drug is generally required. Treatment guidelines should be consulted.

If patients co-infected with hepatitis B virus discontinue this product, regular monitoring of liver function and HBV replication markers is recommended, as discontinuation of lamivudine may lead to an acute exacerbation of hepatitis.

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. These results do not affect current national guidelines for the use of antiretrovirals in pregnant women to prevent vertical transmission of HIV.

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. When used, measures should be taken to minimize all modifiable risk factors (e.g., smoking, hypertension, and hyperlipidemia).