Comprehensive guidance on the use of cabotegravir/rilpivirine injection suspension

Cabotegravir/rilpivirine injection suspension (cabotegravir and rilpivirine) , as a long-acting injection regimen, is specially designed for adults and adolescents 12 years old and above HIV-1 virus infection. The drug consists of cabotegravir (HIV-1integrase strand transfer inhibitor, INSTI) and rilpivirine (HIV-1Non-nucleoside reverse transcriptase inhibitors, NNRTI) are carefully combined to provide comprehensive and convenient antiviral treatment.

Cabotegravir/Rilpivirine Injection Suspension has a unique mechanism of action. It effectively reduces the amount of virus in the blood by inhibiting the replication process of the HIV-1 virus. This helps patients maintain a virologically suppressed state and reduce the risk of acquired immunodeficiency syndrome (AIDS) and HIV related diseases. Its efficacy has been verified through multiple clinical trials. A randomized, multicenter, active-controlled, parallel-arm, open-label non-inferiority trial in both FLAIR and ATLAS during the 3-period randomized, multicenter, active-control trial In clinical trials, cabotegravir/rilpivirine injection suspension showed a therapeutic effect comparable to that of the control group, maintaining a low viral rebound rate whether in the monthly dosing schedule or the every 2 monthly dosing schedule.

Regarding usage and dosage, cabotegravir/ Rilpivirine injection suspension can be administered orally or directly injected. If oral introduction is chosen, the patient needs to take 30 mg of cabotegravir and 25 mg of rilpivirine orally with food every day for at least 28 consecutive days. Subsequently, for a monthly dosing schedule, patients will receive gluteal injections 1month after oral introduction, with an initial dose of cabotegravir 600mg and subsequent monthly doses of pan>400mg; the initial dose of rilpivirine is 900mg, with subsequent monthly doses of 600mg. For every 2monthly dosing schedule, the initial dose of cabotegravir and rilpivirine should be at least 28 days after oral introduction, respectively. span>1 month and 2 month, with subsequent doses starting at 4Starting every 2 months, the dose is the same as the initial dose.

However, attention should be paid to possible side effects when using cabotegravir/rilpivirine injection suspension. Common side effects include pain, tenderness, lump, swelling, redness, itching, bruising at the injection site, as well as fever, tiredness, headache, muscle or bone pain, nausea, sleep problems, dizziness, and rash. Serious side effects may include allergies, difficulty breathing, stomach cramps, sweating, numbness in the mouth, back or chest pain, anxiety, increased blood pressure, jaundice, dark or tea-colored urine, nausea and vomiting, loss of appetite, pain on the right side of the stomach, and depression or mood changes. Once these symptoms occur, patients should seek medical attention immediately.

In addition, the following points should be noted when using cabotegravir/Rilpivirine injection suspension: the drug may cause hypersensitivity reactions when combined with certain integrase inhibitors; severe injection site reactions may occur after injection; liver biochemical indicators need to be monitored to assess hepatotoxicity; depressive symptoms should be assessed promptly; if treatment fails, alternative antiretroviral agents should be initiated regimen; contraindicated for those with hypersensitivity reactions to cabotegravir or rilpivirine and pregnant women; prohibited from combined use with specific drugs to avoid lowering drug concentrations; caution is required for drug interactions, especially when co-administered with drugs that induce UGT1A1 or CYP3A4.

In terms of storage, cabotegravir/rilpivirine injection suspension should be placed in the original carton and stored in a refrigerator at 2-8℃ until just before use. Do not freeze and do not mix with other medications or diluents. Before administration, the vial should be kept at room temperature not exceeding 25°C. The vial can be kept in the carton for up to 6 hours. If not used within 6 hours, it must be discarded. Once the suspended medication is drawn into the syringe, the injection should be administered as soon as possible, but should only be retained in the syringe for up to 2 hours. If more than 2 hours have passed, the medication, syringe, and needle must be discarded.

In conclusion, cabotegravir/rilpivirine injection suspension provides a new and effective treatment option for adultsHIV infected. When using it, patients should follow the doctor's instructions and pay attention to the usage, dosage, side effects and precautions of the drug to ensure the safety and effectiveness of the treatment.

Reference link: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/212888s011lbl.pdf