Cabotegravir (Tablets) Instructions for Use

Marketing Authorization Holder

Promomed Rus LLC (Russia)

Manufactured By

Biokhimik, JSC (Russia)

ATC Code

J05AJ04 (Cabotegravir)

Active Substance

Cabotegravir (Rec.INN registered by WHO)

Dosage Form

Cabotegravir

Film-coated tablets 30 mg

Dosage Form, Packaging, and Composition

Film-coated tablets

10 pcs. – blister packs (3 pcs.) – cardboard packs (30 pcs.) – By prescription
30 pcs. – jars – cardboard packs (30 pcs.) – By prescription

Clinical-Pharmacological Group

Antiviral drug active against HIV

Pharmacotherapeutic Group

Systemic antiviral agents; direct-acting antiviral agents; integrase inhibitors

Pharmacological Action

Antiviral drug for the treatment of HIV infection, an integrase inhibitor. Reduces the viral load on the body and maintains it at a low level.

Cabotegravir is administered intramuscularly in combination with rilpivirine.

Indications

Treatment of HIV infection in adults aged 18 years and older.

ICD codes

Dosage Regimen

Administered intramuscularly in combination with rilpivirine.

For monthly administration: 1st injection at a dose of 600 mg, 2nd injection and thereafter every month – at a dose of 400 mg.

For administration every 2 months: 1st injection and after 1 month 2nd injection at a dose of 600 mg, 3rd injection and thereafter every 2 months 600 mg.

The duration of treatment is determined by the doctor individually.

Adverse Reactions

Allergic reactions infrequently (<1/100) – skin reaction (rash, urticaria), fever, fatigue, angioedema with difficulty breathing, muscle or joint pain.

Nervous system disorders very often (>1/10) – headache; often (<1/10) – insomnia, dizziness; infrequently (<1/100) – drowsiness, dizziness during or after injection (may lead to fainting).

Psychiatric disorders often (<1/10) – depression, anxiety, unusual dreams; infrequently (<1/100) – suicide attempt and suicidal thoughts (especially in patients who have previously had depression or mental health problems.

Gastrointestinal disorders often (<1/10) – nausea, vomiting, abdominal pain, flatulence, diarrhea; infrequently (<1/100) – liver damage (signs may include yellowing of the skin and whites of the eyes, loss of appetite, itching, abdominal tenderness, light-colored stools, or unusually dark urine) (hepatotoxicity), increased transaminase activity or increased bilirubin concentration, increased lipase activity, pancreatitis.

Metabolism and nutrition disorders very often (>1/10) – feeling of heat (pyrexia), which may occur within one week after injection; often (<1/10) – weight gain.

Infections and inflammatory processes the appearance of symptoms of infection and inflammation caused by one of the following reasons: exacerbation of old, latent infections that the body begins to fight;
A consequence of autoimmune disorders.

Local reactions very often (>1/10) – pain and discomfort, induration or swelling; often (<1/10) – redness, itching, swelling, feeling of warmth, bruising; infrequently (<1/100) – numbness, minor bleeding, abscess or inflammation of subcutaneous tissues.

Other very often (>1/10) – often (<1/10) – rash, myalgia, fatigue, asthenia, malaise.

Contraindications

Hypersensitivity to cabotegravir; simultaneous use with rifampicin, rifapentine, phenytoin, phenobarbital, carbamazepine or oxcarbazepine.

Use in Pregnancy and Lactation

Cabotegravir is not recommended for use during pregnancy. If use is necessary, the doctor should assess the expected benefit of therapy for the mother and the potential risk to the fetus. In case of pregnancy, the patient should not stop treatment on her own without consulting a doctor.

Women with HIV infection should not breastfeed their child, as HIV can be transmitted to the child through breast milk. It should be borne in mind that after the last injection of Cabotegravir, it may potentially pass into breast milk for up to 12 months.

Use in Hepatic Impairment

Use with caution in patients with impaired liver function.

Pediatric Use

Cabotegravir should not be used in children and adolescents under 18 years of age, because the safety of this drug for this category of patients has not been established.

Special Precautions

Use with caution in patients with a history of liver disease, including hepatitis B and/or C.

Liver function should be assessed before starting treatment.

During treatment, the patient’s condition should be monitored for the occurrence of symptoms of infection and symptoms of liver damage.

For treatment effectiveness, it is extremely important that the patient regularly receives injections, in accordance with the prescribed treatment regimen. The patient should not stop treatment on their own.

Cabotegravir is a long-acting drug. After the last injection, a small amount of cabotegravir may remain in the patient’s body for up to 12 months or longer. During this time, the concentration of cabotegravir in the body will be low and will not protect the patient from the virus, and the virus may develop resistance. Therefore, it is necessary to start another HIV therapy within one month after the last injection of cabotegravir (if the patient received injections every month) or within 2 months after the last injection of cabotegravir (if the patient received injections every 2 months).

HIV infection is transmitted through contact with infected people sexually or through contact with infected blood (for example, when several people share the same needle for injections).

Cabotegravir does not prevent the transmission of HIV infection to other people. The patient should discuss with the doctor the precautions that must be taken to prevent the transmission of HIV.

Use in pediatrics

Cabotegravir should not be used in children and adolescents under 18 years of age, because the safety of this drug for this category of patients has not been established.

Effect on ability to drive vehicles and operate machinery

Cabotegravir may cause dizziness and other adverse reactions that may negatively affect the ability to concentrate. This should be taken into account when used in patients who drive vehicles and engage in other potentially hazardous activities.

Drug Interactions

Some drugs may affect the effectiveness of cabotegravir or increase the likelihood of adverse reactions.

Cabotegravir may also affect the action of some other drugs.

Concomitant use of cabotegravir with the following drugs is contraindicated: rifampicin, rifapentine, phenytoin, phenobarbital, carbamazepine or oxcarbazepine.

Storage Conditions

Store at 2°C (36°F) to 30°C (86°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.