Vocabria Tablets 30mg (Cabotegravir Sodium)

Adult dose

This medicine must be prescribed by a physician experienced in the treatment of HIV infection. This medicine is used to treat HIV-1 infection in combination with rilpivirine tablets; therefore, refer to the prescribing information for rilpivirine tablets for the recommended dosage. When taken at the same time as rilpivirine tablets, take with a meal. Before initiating treatment with this medicine, healthcare professionals should carefully select patients who agree to the injection schedule and advise them about the importance of keeping scheduled appointments to maintain viral suppression and reduce the risk of viral rebound and resistance. An oral lead-in regimen may be used before starting this medicine to assess tolerability (see Table 1; see Precautions for Use, “3. General Precautions, 1) Hypersensitivity”). 1. Oral lead-in regimen When using this medicine as an oral lead-in regimen, cabotegravir tablets and rilpivirine tablets should be taken for approximately 1 month (at least 28 days) to assess tolerability in virologically suppressed patients before starting cabotegravir injection therapy. Table 1. Oral lead-in regimen in adults Oral lead-in regimen Drug For 1 month (at least 28 days) before injection therapy Cabotegravir 30 mg once daily Rilpivirine 25 mg once daily 2. Oral therapy as a substitute for injections If cabotegravir and rilpivirine injection therapy is temporarily replaced with oral therapy, take cabotegravir tablets (30mg) and rilpivirine tablets (25mg) once daily; oral therapy may replace injections for up to 2 months. Alternatively, another fully suppressive oral antiretroviral regimen may be used until injections are resumed. The latest HIV treatment guidelines should be considered when selecting a regimen. For details, refer to the prescribing information for rilpivirine injection and cabotegravir injection. 3. Missed dose of this medicine If a dose of cabotegravir tablets is missed, the patient should take the missed dose as soon as possible. 4. Patients with renal impairment No dose adjustment of this medicine is required in patients with mild (60 ≤ CrCL < 90 mL/min), moderate (30 ≤ CrCL < 60 mL/min), or severe renal impairment (15 ≤ CrCL < 30 mL/min and not receiving dialysis). 5. Patients with hepatic impairment No dose adjustment of this medicine is required in patients with mild or moderate hepatic impairment (Child-Pugh score A or B). This medicine has not been studied in patients with severe hepatic impairment (Child-Pugh score C).

This medication should not be used in patients with allergic reactions to this drug or its components. This medication may lose its effectiveness when taken with certain anti-tuberculosis or anticonvulsant drugs, so it should not be taken in combination with these medications. This medication contains lactose, so patients with lactose intolerance or genetic lactose-related disorders should not take it. This medication is used to treat HIV infection and is taken in combination with other antiviral drugs, so it is essential to check the information of concomitant medications. During treatment, side effects such as headaches, fever, gastrointestinal disturbances, skin rashes, muscle pain may occur, and if symptoms appear, one should consult a physician. If hypersensitivity reactions occur, stop taking the medication immediately and inform healthcare personnel, as it can lead to liver dysfunction requiring regular liver tests and monitoring. This medication should be used with caution in patients with liver disease or those infected with hepatitis B or C, and liver function status should be continuously monitored. This medication may affect driving or operating machinery, so one should check their condition after taking it. Women who are pregnant or may become pregnant should be cautious about using this medication, and nursing mothers should take it after consulting a physician. The safety of this medication has not been sufficiently confirmed for children or adolescents under 18, so caution is needed for use. For the elderly, no separate dosage adjustment is necessary, but it should be administered carefully. In the case of overdose, there is no specific antidote, so appropriate treatment and monitoring are required based on symptoms. This medication should be kept out of reach of children and should not be transferred to another container.

• Hypersensitivity
• depression
• anxiety
• strange dreams
• insomnia
• suicide attempt
• suicidal thoughts
• headache
• dizziness
• drowsiness

This medication should be stored in a tightly sealed container to protect it from air and moisture, preferably in a cool place below 30 degrees Celsius. Avoiding direct sunlight and high temperatures will help maintain the effectiveness of the medication.

Appearance

White oval film-coated tablets

Package unit

30 tablets/bottle