Cabenuva

What is Cabenuva?

Cabenuva, a combination injection that contains cabotegravir (as well as rilpivirine), is administered once a month to adults and children older than 12 years old who weigh more than 77 pounds. HIV-1 can cause acquired immune deficiency syndrome. Cabenuva, a prescription drug that can be used to treat HIV without the use of any other antiviral medicine, is available on prescription. This is not a cure or treatment for HIV/AIDS.

Warnings

People with hypersensitivity to cabotegravir, rilpivirine, or any inactive ingredient in the kit should not receive the injection. Inform your doctor of all the medications you are taking, including any new ones. Cabenuva can be affected by many drugs. Rilpivirine has been associated with serious injection reactions. If you feel severe pain, swelling, or redness around the injection site, tell your doctor. Cabotegravir injections can cause liver damage. Your doctor should monitor your liver tests. There have also been reports of depression. Inform your doctor of any changes you notice in your mood. It is important to start a new treatment regimen no later than one month after your last Cabenuva injection if there is a suspicion of virological failure or you have stopped taking Cabenuva.

How to take Cabenuva?

Your doctor will first need to confirm that you are able to tolerate the active ingredients, cabotegravir and rilpivirine. You will need to take cabotegravir in tablet form and rilpivirine once a day, with food, at least 28 days prior to your first injection. This "lead in dose" helps determine if you can safely take these medications together.

• You will receive the first injection of this medication on the day after you finish taking the tablets. Cabenuva injections are given into the gluteal muscle (buttocks) once a month. This medicine will be given to you by your healthcare provider as two separate injections, separated by 2cm, in the same muscle or one injection for each buttock.
• After each injection, you will be closely monitored for 10 minutes to ensure that there is no serious reaction.
• Your HIV treatment will be successful if you are able to time your injections correctly. To help you stay on track, your doctor can set a specific calendar date as "target treatment dates". You may need to receive an injection up to seven days earlier or later than your "target treatment date".
• It is important to remain under the supervision of a physician while you receive your injections. To get the best results, stick to your schedule. Missing doses increase your risk of HIV medication resistance.
• You will need to begin taking other HIV medications within one month if you decide to stop using Cabenuva. This is to avoid your condition becoming resistant. Contact your healthcare provider immediately to discuss treatment options.
• You may need to undergo frequent medical testing. Cabenuva may have long-lasting effects (up to twelve months after the last dose). After stopping the use of this medication, you may need to undergo medical tests.

Before you take this drug

Tell your doctor about any of the following to ensure that you are safe to use Cabenuva.

• A skin rash or allergic reaction may occur after taking a medicine that contains cabotegravir (or rilpivirine).
• Hepatitis B and C are liver diseases.
• Mental illness
• Long QT syndrome (in yourself or in a member of your family)

Inform your doctor if you are pregnant or planning to become pregnant.

Children

Cabenuva should not be used by those younger than 12 or who weigh less than 77 lbs (35 kilograms).

Pregnancy

Cabenuva is not recommended for use during pregnancy. Cabotegravir, rilpivirine, and other components can remain in the systemic circulation for up to 12 or more months after stopping injections. If you plan to get pregnant, talk to your doctor about the benefits and risks. HIV can be transmitted to the baby if it is not controlled. There is a registry for women who become pregnant by accident. This registry monitors the pregnancy outcomes of women exposed to cabotegravir and rilpivirine while they are pregnant. You can register with your healthcare provider by calling the Antiretroviral Pregnancy Registry at 1-800-258-4263.

Lactation

Breastfeeding is not recommended for women with HIV/AIDS. Even if the baby was born HIV-free, the virus can be transmitted to the infant through your breast milk.

What happens if I miss the dose?

If you are unable to attend your Cabenuva appointment, call your doctor. You may need to take the cabotegravir/rilpivirine tablet every day until you receive your next monthly injection if you miss more than seven days. Start taking the tablets around 1 month after your last injection. Daily tablets can be used to replace injections for up to two months consecutively, if needed. Cabenuva may be the right treatment for you if you missed an injection more than seven days ago and haven't started taking the medication in tablet form.

What happens if I overdose?

Call 1-800-222-1222 for poison help or seek immediate medical attention.

What should be avoided?

Cabenuva provides comprehensive HIV treatment. Other HIV medications should only be taken if your doctor has prescribed them. Share razors and toothbrushes with no one. Speak to your doctor about the best ways to prevent HIV from being transmitted during sex. Even healthy people should never share drugs or needles.

Side effects of Cabenuva

If you experience symptoms of an allergic reaction such as hives, fever, tiredness, or body aches, if your mouth is sore or blistered, red or puffy, or if your eyes are red or puffy, seek emergency medical attention. Several side effects can occur shortly after the injection. If you experience anxiety, warmth, lightheadedness, sweating, stomach pain, or numbness, tell your carer.

If you experience:

• Unusual changes in mood or behaviour
• Suicidal thoughts and actions
• Liver problems include: loss of appetite (especially on the upper right side), nausea, vomiting (upper-right side), stomach pain, itching, dark urine (clay-coloured stools), and jaundice.

Cabenuva can cause a variety of side effects.

• Injection site reactions include pain, redness or swelling, itching, and bruising.
• Dizziness
• Feeling tired
• Headache,
• Nausea
• Pain in your joints or muscles
• Rash
• Sleep problems are a common problem.

There may be other side effects. For medical advice on side effects, call your doctor. Contacting the FDA in regards to adverse side effects can be done at 1-800-FDA-1088.

Interaction with other drug

Cabenuva should not be used with any other HIV medications.

Other medications can have an effect on the way injections work. Examples include:

• Apalutamide
• Certain antibiotics, such as clarithromycin or erythromycin
• Dexamethasone
• Enzalutamide
• Droperidol and disopyramide are two medications that have a Torsade de Pointes risk.
• Methadone
• Seizure medications such as Carbamazepine (Oxcarbazepine), Phenobarbital and Primidone can all provide significant relief.
• John's Wort
• Viekira Pak is a combination of ombitasvir (dasabuvir), paritaprevir (paritaprevir), and ritonavir.

Medication that increases UGT 1A1 or CYP 3A4 activity could potentially decrease plasma concentrations of cabotegravir and rilpivirine. Cabenuva may stay in your body for up to 12 months. Follow your doctor's advice about taking any other medications during the first 12 months after your last dose. This list is incomplete. Other drugs, such as prescription and non-prescription medicines, vitamins, and herbal products, may also interact with atorvastatin. This medication guide does not list all potential interactions.