Q: What is Cabenuva used for?

Cabenuva is used to treat HIV-1 infection .

Q: How does Cabenuva work?

Mechanism of Action Cabenuva contains two different types of drugs: cabotegravir and rilpivirine. These medications work by blocking specific enzymes that the human immunodeficiency virus (HIV) needs to replicate itself. How Cabotegravir Works Cabotegravir is an integrase strand transfer inhibitor (INSTI). It targets an enzyme called integrase, which HIV uses to insert its own genetic material into the DNA of healthy human cells. By blocking this enzyme, the medication prevents the virus from integrating into the host cell, which stops it from making new copies of itself. How Rilpivirine Works Rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI). It works by interfering with an enzyme called reverse transcriptase. HIV needs this enzyme to convert its genetic code (RNA) into a form (DNA) that can be used by human cells. When this process is blocked, the virus cannot complete its life cycle. Combined Effect By attacking the virus at two different stages, these medications help to: Reduce the amount of HIV in the blood (viral load). Prevent the virus from damaging the immune system. Maintain viral suppression in people who already have an undetectable viral load.

Q: What are the active ingredients in Cabenuva?

The active ingredients in Cabenuva are Cabotegravir and Rilpivirine .

Q: What are the side effects of Cabenuva?

Common side effects of Cabenuva may include: injection site reactions fever fatigue and others Always consult with a healthcare professional about potential side effects.

Q: What drug class is Cabenuva?

Cabenuva belongs to the antiretroviral combination drug class .

Q: What is the dosage of Cabenuva and how do I take it?

Administration and Schedule Cabenuva is administered as two separate intramuscular injections into the gluteal muscles of the buttocks during the same visit. These injections must be performed by a healthcare professional in a medical setting. The medication is typically given on a regular schedule, either once every month or once every two months, depending on the treatment plan determined by a healthcare provider. Before starting the injection series, a healthcare provider may suggest an oral lead-in period. During this time, daily oral tablets are taken for several weeks to ensure the medication is well-tolerated before transitioning to the long-acting injections. This lead-in phase is optional and should be discussed with a doctor. Missed Doses Consistency is vital for the effectiveness of this treatment. If an injection appointment is missed or delayed, contact a healthcare provider immediately to discuss rescheduling. If a scheduled injection will be missed by more than a few days, a doctor may prescribe daily oral tablets to be taken as a temporary bridge to maintain medication levels in the body until the next injection can be administered. Preparation The medication must be brought to room temperature before it is injected. A healthcare provider will handle the preparation and administration of the medicine to ensure it is given correctly.

Q: Is Cabenuva safe during pregnancy and breastfeeding?

Pregnancy There is currently limited data on the use of Cabenuva in pregnant individuals. Because Cabenuva is a long-acting injection, its active ingredients (cabotegravir and rilpivirine) can stay in the system for 12 months or longer after the final dose. This means a fetus could be exposed to the medication even if the injections are discontinued before conception. Healthcare providers typically discuss the benefits and risks of continuing HIV treatment during pregnancy. There is an Antiretroviral Pregnancy Registry that monitors health outcomes for individuals who take these medications while pregnant. Patients are encouraged to consult their medical team about pregnancy planning and the potential for long-term drug exposure. Breastfeeding The Centers for Disease Control and Prevention (CDC) and other health authorities generally recommend that individuals with HIV-1 do not breastfeed their infants. This recommendation is intended to prevent the transmission of HIV to the baby through breast milk. It is also not known if the components of Cabenuva pass into human breast milk, though animal studies suggest they may be present. Because of the risk of virus transmission and the unknown effects of the drug on a nursing infant, breastfeeding is not recommended while using this medication.

Q: What is the FDA approval status of Cabenuva?

FDA Approval History The U.S. Food and Drug Administration (FDA) first approved Cabenuva in January 2021. It was the first long-acting injectable treatment regimen approved for adults with HIV-1 infection. In 2022, the FDA expanded the approval to include adolescents 12 years of age and older who weigh at least 35 kg. Approved Indications Cabenuva is indicated as a complete regimen for the treatment of HIV-1 infection to replace a current stable antiretroviral regimen in individuals who meet specific criteria: They are virologically suppressed (HIV-1 RNA less than 50 copies per mL). They are on a stable antiretroviral regimen. They have no history of treatment failure. They have no known or suspected resistance to either cabotegravir or rilpivirine. Regulatory Status and Dosing The FDA initially approved Cabenuva for once-monthly administration. In February 2022, the agency approved an additional dosing schedule allowing the medication to be administered every two months. The FDA also updated the labeling to make the oral lead-in period optional, allowing patients to start injections without first taking oral versions of the medication. There are currently no Boxed Warnings or Risk Evaluation and Mitigation Strategies (REMS) required for Cabenuva.

Question 1

What is Cabenuva?

Accepted Answer

Cabenuva is a combination therapy that contains two different medications, cabotegravir and rilpivirine. These components work by inhibiting the ability of the human immunodeficiency virus (HIV) to replicate within the body. Cabotegravir is an integrase strand transfer inhibitor, while rilpivirine is a non-nucleoside reverse transcriptase inhibitor.

By targeting different stages of the viral life cycle, this combination helps to lower and maintain the amount of HIV in the blood. This approach is part of a broader category of treatments known as antiretroviral therapy, which aims to manage the virus and support immune system function.

Question 2

What is Cabenuva used for?

Accepted Answer

Cabenuva is used to treat HIV-1 infection.

Question 3

How does Cabenuva work?

Accepted Answer

Mechanism of Action

Cabenuva contains two different types of drugs: cabotegravir and rilpivirine. These medications work by blocking specific enzymes that the human immunodeficiency virus (HIV) needs to replicate itself.

How Cabotegravir Works

Cabotegravir is an integrase strand transfer inhibitor (INSTI). It targets an enzyme called integrase, which HIV uses to insert its own genetic material into the DNA of healthy human cells. By blocking this enzyme, the medication prevents the virus from integrating into the host cell, which stops it from making new copies of itself.

How Rilpivirine Works

Rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI). It works by interfering with an enzyme called reverse transcriptase. HIV needs this enzyme to convert its genetic code (RNA) into a form (DNA) that can be used by human cells. When this process is blocked, the virus cannot complete its life cycle.

Combined Effect

By attacking the virus at two different stages, these medications help to:

Reduce the amount of HIV in the blood (viral load).
Prevent the virus from damaging the immune system.
Maintain viral suppression in people who already have an undetectable viral load.

Question 4

What are the active ingredients in Cabenuva?

Accepted Answer

The active ingredients in Cabenuva are Cabotegravir and Rilpivirine.

Question 5

What are the side effects of Cabenuva?

Accepted Answer

Common side effects of Cabenuva may include:

injection site reactions
fever
fatigue
and others

Always consult with a healthcare professional about potential side effects.

Question 6

What drug class is Cabenuva?

Accepted Answer

Cabenuva belongs to the antiretroviral combination drug class.

Question 7

What is the dosage of Cabenuva and how do I take it?

Accepted Answer

Administration and Schedule

Cabenuva is administered as two separate intramuscular injections into the gluteal muscles of the buttocks during the same visit. These injections must be performed by a healthcare professional in a medical setting. The medication is typically given on a regular schedule, either once every month or once every two months, depending on the treatment plan determined by a healthcare provider.

Before starting the injection series, a healthcare provider may suggest an oral lead-in period. During this time, daily oral tablets are taken for several weeks to ensure the medication is well-tolerated before transitioning to the long-acting injections. This lead-in phase is optional and should be discussed with a doctor.

Missed Doses

Consistency is vital for the effectiveness of this treatment. If an injection appointment is missed or delayed, contact a healthcare provider immediately to discuss rescheduling. If a scheduled injection will be missed by more than a few days, a doctor may prescribe daily oral tablets to be taken as a temporary bridge to maintain medication levels in the body until the next injection can be administered.

Preparation

The medication must be brought to room temperature before it is injected. A healthcare provider will handle the preparation and administration of the medicine to ensure it is given correctly.

Question 8

Is Cabenuva safe during pregnancy and breastfeeding?

Accepted Answer

Pregnancy

There is currently limited data on the use of Cabenuva in pregnant individuals. Because Cabenuva is a long-acting injection, its active ingredients (cabotegravir and rilpivirine) can stay in the system for 12 months or longer after the final dose. This means a fetus could be exposed to the medication even if the injections are discontinued before conception.

Healthcare providers typically discuss the benefits and risks of continuing HIV treatment during pregnancy. There is an Antiretroviral Pregnancy Registry that monitors health outcomes for individuals who take these medications while pregnant. Patients are encouraged to consult their medical team about pregnancy planning and the potential for long-term drug exposure.

Breastfeeding

The Centers for Disease Control and Prevention (CDC) and other health authorities generally recommend that individuals with HIV-1 do not breastfeed their infants. This recommendation is intended to prevent the transmission of HIV to the baby through breast milk. It is also not known if the components of Cabenuva pass into human breast milk, though animal studies suggest they may be present. Because of the risk of virus transmission and the unknown effects of the drug on a nursing infant, breastfeeding is not recommended while using this medication.

Question 9

What forms and strengths does Cabenuva come in?

Accepted Answer

Cabenuva is supplied as a kit for intramuscular injection. The kit contains two separate medications in individual vials:

Cabotegravir extended-release injectable suspension
Rilpivirine extended-release injectable suspension

The kit includes the vials of medication along with the necessary syringes and needles for administration by a healthcare professional.

Question 10

What is the FDA approval status of Cabenuva?

Accepted Answer

FDA Approval History

The U.S. Food and Drug Administration (FDA) first approved Cabenuva in January 2021. It was the first long-acting injectable treatment regimen approved for adults with HIV-1 infection. In 2022, the FDA expanded the approval to include adolescents 12 years of age and older who weigh at least 35 kg.

Approved Indications

Cabenuva is indicated as a complete regimen for the treatment of HIV-1 infection to replace a current stable antiretroviral regimen in individuals who meet specific criteria:

They are virologically suppressed (HIV-1 RNA less than 50 copies per mL).
They are on a stable antiretroviral regimen.
They have no history of treatment failure.
They have no known or suspected resistance to either cabotegravir or rilpivirine.

Regulatory Status and Dosing

The FDA initially approved Cabenuva for once-monthly administration. In February 2022, the agency approved an additional dosing schedule allowing the medication to be administered every two months. The FDA also updated the labeling to make the oral lead-in period optional, allowing patients to start injections without first taking oral versions of the medication.

There are currently no Boxed Warnings or Risk Evaluation and Mitigation Strategies (REMS) required for Cabenuva.

Question 11

What should I know about Cabenuva and cost?

Accepted Answer

Factors Influencing Cost

The actual price you pay for Cabenuva can vary based on several elements:

Insurance Coverage: Your specific health insurance plan, including its formulary and tier system, determines your out-of-pocket costs.
Treatment Schedule: Cabenuva is administered as an injection either once a month or every two months, which may affect the total cost over time.
Administration Fees: Because Cabenuva must be administered by a healthcare professional, there may be additional costs associated with the office visit or the injection procedure itself.

Insurance and Government Programs

Most commercial insurance plans, Medicare, and Medicaid provide coverage for Cabenuva. However, some plans may require prior authorization, a process where your doctor must prove the medical necessity of the drug before the insurance company agrees to pay for it.

Financial Assistance

There are programs available to help reduce the cost of Cabenuva for eligible patients:

Copay Savings: The manufacturer offers a savings program for people with commercial insurance that can help lower monthly out-of-pocket costs.
Patient Assistance Programs: For those without insurance or with limited coverage, patient assistance programs may provide the medication at no cost to those who meet specific income and eligibility requirements.

Cabenuva

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How It Works

Uses

Active Ingredients

Common Side Effects

Warnings & Precautions

Dosage

Pregnancy & Breastfeeding

Frequently Asked Questions

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