Cabotegravir/rilpivirine

What is Cabotegravir/rilpivirine?

• Cabotegravir/rilpivirine (CABENUVA), a 2-drug co-packaged product of cabotegravir, a human immunodeficiency virus type-1 (HIV-1) integrase strand transfer inhibitor (INSTI), and rilpivirine, an HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI).

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What are the uses of this medicine?

This medicine is used without other Human Immunodeficiency Virus-1 (HIV-1) medicines to treat HIV-1 infection in adults to replace their current HIV-1 medicines when their healthcare provider determines that they meet certain requirements. HIV-1 is the virus that causes Acquired Immune Deficiency Syndrome (AIDS).

CABENUVA contains 2 different medicines:

• cabotegravir
• rilpivirine

How does this medicine work?

CABENUVA contains 2 long-acting HIV-1 antiretroviral drugs, cabotegravir and rilpivirine.

Cabotegravir

• Cabotegravir inhibits HIV integrase by binding to the integrase active site and blocking the strand transfer step of retroviral deoxyribonucleic acid (DNA) integration which is essential for the HIV replication cycle.

Rilpivirine

• Rilpivirine is a diarylpyrimidine NNRTI of HIV-1 and inhibits HIV-1 replication by non-competitive inhibition of HIV-1 reverse transcriptase (RT). Rilpivirine does not inhibit the human cellular DNA polymerases α, β, and γ.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• with previous hypersensitivity reaction to cabotegravir or rilpivirine

Coadministration with fallowing drugs which significantly decreases the cabotegravir and/or rilpivirine plasma concentrations . which may result in loss of virologic response.

• Anticonvulsants: Carbamazepine, oxcarbazepine, phenobarbital, phenytoin
• Antimycobacterials: Rifabutin, rifampin, rifapentine
• Glucocorticoid (systemic): Dexamethasone (more than a single-dose treatment)
• Herbal product: St John’s wort (Hypericum perforatum)

What drug interactions can this medicine cause?

• Avoid Coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended.
• Avoid Coadministration with drugs that induce uridine diphosphate glucuronosyltransferase (UGT)1A1 or cytochrome P450 (CYP)3A4 may decrease the plasma concentrations of the components of CABENUVA.
• CABENUVA should be used with caution in combination with drugs with a known risk of Torsade de Pointes.

Is this medicine FDA approved?

• It was approved for use in the United States in 2021.

How should this medicine be used?

• Prior to initiating treatment with CABENUVA, oral lead-in dosing should be used for approximately 1 month to assess the tolerability of cabotegravir and rilpivirine.
• The recommended oral lead-in daily dose is one 30-mg tablet of VOCABRIA (cabotegravir) and one 25-mg tablet of EDURANT (rilpivirine).

Recommended Dosage

• Initiate injections of CABENUVA (600 mg of cabotegravir and 900 mg of rilpivirine) on the last day of oral lead-in and continue with injections of CABENUVA (400 mg of cabotegravir and 600 mg of rilpivirine) every month thereafter.

Administration

• Your healthcare provider will inject CABENUVA into the muscle of each side of your buttocks.
• You will receive CABENUVA as 2 injections (cabotegravir and rilpivirine), one time every month.
• Before receiving your first injection doses of CABENUVA, your healthcare provider will have you take 1 VOCABRIA (cabotegravir) tablet and 1 EDURANT (rilpivirine) tablet one time a day for one month (at least 28 days). This will allow your healthcare provider to assess how well you tolerate these medicines.
• CABENUVA is a long-acting medicine and may stay in your system for 12 months or longer after your last injection.
• Stay under the care of a healthcare provider during treatment with CABENUVA. It is important that you attend your planned appointments to receive your injection doses of CABENUVA.
• If you miss or plan to miss a scheduled monthly injection of CABENUVA by more than 7 days, call your healthcare provider right away to discuss your treatment options.
• If you stop treatment with CABENUVA you will need to take other medicines to treat your HIV-1 infection and reduce the risk of developing viral resistance. Call your healthcare provider right away to discuss your treatment options.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form: Cabotegravir extended-release injectable suspension and rilpivirine extended-release injectable suspension, co-packaged as follows: CABENUVA 400-mg/600-mg Kit:

• single-dose vial of 400 mg/2 mL (200 mg/mL) cabotegravir
• single-dose vial of 600 mg/2 mL (300 mg/mL) rilpivirine

CABENUVA 600-mg/900-mg Kit:

• single-dose vial of 600 mg/3 mL (200 mg/mL) cabotegravir
• single-dose vial of 900 mg/3 mL (300 mg/mL) rilpivirine

This medicine is available in fallowing brand namesː

• CABENUVA

What side effects can this medication cause?

The most common side effects of this medicine include:

• Pain, tenderness, hardened mass or lump, swelling, redness, itching, bruising, and warmth at the injection site
• fever
• tiredness
• headache
• muscle or bone pain
• nausea
• sleep problems
• dizziness
• rash

CABENUVA may cause serious side effects including:

• Allergic reactions
• Post-injection reactions
• Liver problems
• Depression or mood changes

What special precautions should I follow?

• Hypersensitivity reactions have been reported. Discontinue CABENUVA immediately if signs or symptoms of hypersensitivity reactions develop.
• Serious post-injection reactions with rilpivirine were reported. Monitor and treat as clinically indicated.
• Hepatotoxicity has been reported in patients receiving cabotegravir or rilpivirine. Monitoring of liver chemistries is recommended. Discontinue CABENUVA if hepatotoxicity is suspected.
• Depressive disorders have been reported with CABENUVA. Immediate medical evaluation is recommended for depressive symptoms.
• Residual concentrations of cabotegravir and rilpivirine may remain in the systemic circulation of patients up to 12 months or longer. It is essential to initiate an alternative, fully suppressive antiretroviral regimen no later than 1 month after the final injection doses of CABENUVA.

What to do in case of emergency/overdose?

• There is no known specific treatment for overdose with cabotegravir or rilpivirine.
• If overdose occurs, monitor the patient and apply standard supportive treatment as required, including monitoring of vital signs and ECG (QT interval) as well as observation of the clinical status of the patient.
• As both cabotegravir and rilpivirine are highly bound to plasma proteins, it is unlikely that either would be significantly removed by dialysis.

Can this medicine be used in pregnancy?

• There are insufficient human data on the use of CABENUVA during pregnancy to adequately assess a drug-associated risk of birth defects and miscarriage.
• There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to CABENUVA during pregnancy.
• Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) at 1-800-258-4263.

Can this medicine be used in children?

• Safety and effectiveness of VERQUVO have not been established in pediatric patients.

What should I know about storage and disposal of this medication?

• Store CABENUVA in the refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton until ready to use.
• Do not freeze.
• Do not mix with any other product or diluent.
• Prior to administration, vials should be brought to room temperature (not to exceed 25°C [77°F]).
• Vials may remain in the carton at room temperature for up to 6 hours.
• If not used within 6 hours, they must be discarded.
• Once the suspensions have been drawn into the respective syringes, the injections should be administered as soon as possible, but may remain in the syringe for up to 2 hours.
• If 2 hours are exceeded, the medication, syringes, and needles must be discarded.

• Dailymed label info on Cabotegravir/rilpivirine
• FDA Cabotegravir/rilpivirine

Cabotegravir/rilpivirine Resources
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