Generic name: cabotegravir and rilpivirine [ KA-boe-TEG-ra-vir-and-RIL-pi-VIR-een ]
Dosage form: intramuscular suspension, extended release (200 mg-300 mg/mL)
Drug class: Antiviral combinations
What is Cabenuva?
The Cabenuva injection kit contains cabotegravir and rilpivirine is separate single-dose vials. Cabotegravir and rilpivirine are antiviral medicines that prevent human immunodeficiency virus (HIV) from multiplying in your body. HIV is the virus that can cause acquired immunodeficiency syndrome (AIDS) .
Cabenuva is a prescription medicine that is used without any other antiviral medicines to treat HIV. Cabenuva is not a cure for HIV or AIDS.
Cabenuva is used in people 12 years of age and older who weigh at least 77 pounds (35 kg) to replace their current anti-HIV medications when the doctor determines it is appropriate.
Tell your doctor about all your current medicines and any you start or stop using. Many drugs can interact, and some drugs should not be used together.
Before receiving this medicine
You should not use the Cabenuva injection kit if you are allergic to cabotegravir or rilpivirine.
Many drugs can interact and cause dangerous effects. Some drugs should not be used together with Cabenuva. Your doctor may change your treatment plan if you also use:
- dexamethasone (in more than 1 dose);
- methadone ;
- St. John’s wort ;
- certain antibiotics – azithromycin , clarithromycin , erythromycin , rifabutin, rifampin , rifapentine; or
- seizure medicine – carbamazepine , oxcarbazepine , phenobarbital , phenytoin .
Cabenuva can stay in your system for 12 months or longer. If you stop using Cabenuva, follow your doctor’s instructions about using any other medicines during the first year after your last dose.
To make sure the Cabenuva injection kit is safe for you, tell your doctor if you have ever had:
- a skin rash or an allergic reaction after taking medicine that contains cabotegravir or rilpivirine;
- liver disease , including hepatitis B or C (cabotegravir and rilpivirine can affect the results of your liver function tests );
- mental illness; or
- long QT syndrome (in you or a family member).
Tell your doctor if you are pregnant or plan to become pregnant. It is not known whether cabotegravir and rilpivirine will harm an unborn baby. However, HIV can be passed to your baby if the virus is not controlled during pregnancy. Your name may be listed on a registry to track any effects of cabotegravir and rilpivirine on the baby.
Women with HIV or AIDS should not breastfeed a baby. Even if your baby is born without HIV, the virus may be passed to the baby in your breast milk.
Cabenuva is not approved for use by anyone younger than 12 years old or weighing less than 77 pounds (35 kilograms).
How should I use the Cabenuva injection kit?
Use the Cabenuva injection kit exactly as prescribed by your doctor. Follow all directions on your prescription label. At least 28 days before your first injection, you will take cabotegravir and rilpivirine in tablet forms once per day with a meal. This “lead-in dose” will help determine that you can safely use these medicines together.
On the last day you take the tablets, you will receive your first injectable dose of this medicine. Cabenuva is injected into a muscle either one time every month or one time every 2 months. A healthcare provider will give you this medicine as 2 separate injections in opposite sides of your buttocks.
One month after your first injectable dose, you will begin regular monthly Cabenuva injections. You will be watched closely for about 10 minutes after each injection, to make sure you do not have a serious reaction.
The timing of your injections is very important to the success of your HIV treatment. Your doctor may set a calendar day as your “target treatment date” to help keep you on schedule. If needed, you may receive an injection early or late, up to 7 days before or 7 days after your target date.
You must remain under the care of a doctor while receiving Cabenuva injections. Stay on schedule to get the most benefit. Missing doses can increase your risk of HIV that is resistant to medication.
If you stop using Cabenuva, you will need to start using other HIV medicines within 1 month to prevent your condition from becoming resistant. Call your healthcare provider right away to discuss your treatment options.
You will need frequent medical tests. Cabenuva can have long lasting effects on your body (up to 12 months after your last dose). You may still need medical tests for a short time after you stop using this medicine.
Usual Adult Dose for HIV Infection:
-Cabotegravir: 600 mg IM once as a single dose
-Rilpivirine: 900 mg IM once as a single dose
Continuation Injections (Once a Month Dosing Schedule):
-Cabotegravir: 400 mg IM once a month
-Rilpivirine: 600 mg IM once a month
Continuation Injections (Once Every Two Months Dosing Schedule):
-Cabotegravir: 400 mg IM administered at Month 2, Month 3, and every 2 months thereafter.
-Rilpivirine: 600 mg IM administered at Month 2, Month 3, and every 2 months thereafter.
-Initiation injections of this drug should follow oral lead-in (a cabotegravir 30 mg tablet plus a rilpivirine 25 mg tablet once a day); oral lead-in should be used for about 1 month (at least 28 days) before initiation of this drug to assess tolerability of cabotegravir and rilpivirine.
-Initiation injections should be started on the final day of oral lead-in.
-Continuation injections should be started 1 month after the initiation injections.
-Cabotegravir and rilpivirine injections (initiation and continuation) should be administered at separate gluteal injection sites (on opposite sides or 2 cm apart) during the same visit.
-Patients may be given this drug up to 7 days before or after the date of the scheduled monthly injection dosing visit.
Use: As a complete regimen, for the treatment of HIV-1 infection to replace the current antiretroviral regimen in patients who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known/suspected resistance to either cabotegravir or rilpivirine
Detailed Cabenuva dosage information
What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment for your Cabenuva injection.
If you plan to miss an injection by more than 7 days, you may need to take cabotegravir and rilpivirine tablets each day until your next monthly injection is due. You should start taking the tablets about 1 month after your last injection was given. If needed, daily tablets can replace Cabenuva injections for up to 2 months in a row.
If you miss an injection by more that 7 days and you have not started taking the medicine in tablet form, your doctor may need to decide whether or not Cabenuva is the best treatment for you.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while using Cabenuva?
Cabenuva is a complete treatment for HIV. Do not use other HIV medications unless your doctor tells you to.
Using the Cabenuva injection kit may not prevent your disease from spreading. Do not have unprotected sex or share razors or toothbrushes. Talk with your doctor about safe ways to prevent HIV transmission during sex. Sharing drug or medicine needles is never safe, even for a healthy person.
Cabenuva side effects
Get emergency medical help if you have signs of an allergic reaction to Cabenuva: hives ; fever, tiredness, body aches, not feeling well; sores or blisters in your mouth; red or puffy eyes; difficult breathing; swelling of your face, lips, tongue, or throat.
Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.
Your Cabenuva injections may be permanently discontinued if you have an allergic reaction.
Some side effects may occur within a few minutes after an injection. Tell your caregiver if you feel anxious, warm, light-headed, sweaty, or have stomach pain, or numbness in your mouth.
Call your doctor at once if you have:
- unusual changes in mood or behavior;
- suicidal thoughts or actions; or
- liver problems – loss of appetite, nausea , vomiting , stomach pain (upper right side), itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Common Cabenuva side effects may include:
- pain, redness, swelling, itching, bruising, warmth, or a hard lump where an injection was given;
- pain in your bones, joints or muscles;
- feeling tired, sleep problems;
- headache , dizziness ; or
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Cabenuva side effects (more detail)
What other drugs will affect Cabenuva?
Do not use Cabenuva along with other medicines that are used to treat HIV.
Other medications can affect the elimination of cabotegravir and rilpivirine from your body, which may affect how Cabenuva works. Examples include:
- certain antibiotics – clarithromycin, erythromycin, rifampin, and others;
- St. John’s wort;
- seizures medicine– carbamazepine, oxcarbazepine, phenobarbital, phenytoin, primidone, and others; or
- Viekira Pak (dasabuvir, ombitasvir, paritaprevir, and ritonavir).
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