Pronunciation:

ka-boe-TEG-ra-vir, ril-pi-VIR-een

Brand Names:

• Cabenuva

Dosage Forms:

• Suspension, Extended Release

Uses of This Medicine:

Cabotegravir and rilpivirine combination injection are used together for the treatment of the human immunodeficiency virus type 1 (HIV-1) infection. HIV is the virus that causes acquired immune deficiency syndrome (AIDS). This medicine is usually given to patients to replace their current anti-HIV medicines when their healthcare provider determines that they meet certain requirements.

Cabotegravir and rilpivirine combination injection will not cure or prevent HIV infection or AIDS. It helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay problems that are usually related to AIDS or HIV disease from occurring. This medicine will not keep you from spreading HIV to other people. People who receive this medicine may continue to have other problems usually related to AIDS or HIV disease.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of cabotegravir and rilpivirine combination injection in children younger than 12 years of age or weighing less than 35 kilograms (kg). Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of cabotegravir and rilpivirine combination injection in the elderly. However, elderly patients are more likely to have age-related kidney, liver, or heart problems, which may require caution or patients receiving this medicine.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Carbamazepine
• Cisapride
• Dexamethasone
• Dexlansoprazole
• Esomeprazole
• Fosphenytoin
• Lansoprazole
• Omeprazole
• Oxcarbazepine
• Pantoprazole
• Phenobarbital
• Phenytoin
• Primidone
• Rabeprazole
• Rifampin
• Rifapentine
• Saquinavir
• St John's Wort
• Vonoprazan

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abacavir
• Abametapir
• Aluminum Carbonate, Basic
• Aluminum Hydroxide
• Aluminum Phosphate
• Amprenavir
• Anagrelide
• Aripiprazole
• Arsenic Trioxide
• Atazanavir
• Buserelin
• Calcium Carbonate
• Ceritinib
• Cimetidine
• Crizotinib
• Dabrafenib
• Darunavir
• Dasabuvir
• Degarelix
• Delamanid
• Delavirdine
• Deslorelin
• Didanosine
• Dihydroxyaluminum Aminoacetate
• Dihydroxyaluminum Sodium Carbonate
• Dolutegravir
• Domperidone
• Donepezil
• Doravirine
• Drospirenone
• Efavirenz
• Elvitegravir
• Emtricitabine
• Enfuvirtide
• Ethinyl Estradiol
• Etravirine
• Famotidine
• Fedratinib
• Fexinidazole
• Fosamprenavir
• Fostemsavir
• Gonadorelin
• Goserelin
• Histrelin
• Hydroxychloroquine
• Ibalizumab-uiyk
• Indinavir
• Itraconazole
• Lamivudine
• Levofloxacin
• Lopinavir
• Magaldrate
• Magnesium Carbonate
• Magnesium Hydroxide
• Magnesium Oxide
• Magnesium Trisilicate
• Maraviroc
• Mavacamten
• Moxifloxacin
• Nafarelin
• Nelfinavir
• Nevirapine
• Nizatidine
• Norethindrone
• Norgestimate
• Omaveloxolone
• Ombitasvir
• Ondansetron
• Orlistat
• Panobinostat
• Paritaprevir
• Pasireotide
• Pazopanib
• Raltegravir
• Ranitidine
• Rifabutin
• Ritonavir
• Saquinavir
• Sevoflurane
• Sodium Bicarbonate
• Stavudine
• Tenofovir
• Tipranavir
• Triptorelin
• Vandetanib
• Zalcitabine
• Zidovudine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Boceprevir

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Depression or
• Liver disease—Use with caution. May make these conditions worse.

• Kidney disease, severe or end-stage—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. This medicine is given as a shot into a muscle, usually at each side of your buttocks. It is usually given once a month or once every 2 months.

This medicine comes with a patient information leaflet. Read and follow the instructions carefully. Read it again each time you receive the injection in case there is new information. Ask your doctor if you have any questions.

Your doctor may ask you to take 1 tablet of cabotegravir and 1 tablet of rilpivirine once a day for 1 month (at least 28 days) before receiving your first injection. This will allow your doctor to see how well you tolerate these medicines.

If you stop treatment with this medicine, you will need to take other medicines for HIV infection to reduce the risk of resistance to the virus. Call your doctor right away to discuss what other medicines to take.

Missed dose—

Call your doctor or pharmacist for instructions.

Precautions While Using This Medicine:

Your doctor will check your progress closely while you are receiving this medicine to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

You should not receive this medicine together with dexamethasone (Decadron®), St. John's wort, medicine to treat tuberculosis (eg, rifabutin, rifampin, rifapentine, Mycobutin®, Priftin®, Rifadin®, Rimactane®), seizure medicine (eg, carbamazepine, oxcarbazepine, phenobarbital, phenytoin, Dilantin®, Tegretol®, Trileptal®). Using these medicines together may make Cabuneva less effective.

This medicine may cause serious skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS). Check with your doctor right away if you have black, tarry stools, chest pain, cough, fever, painful or difficult urination, sore throat, sores, ulcers, or white spots on the lips or in the mouth, swollen glands, trouble breathing, unusual bleeding or bruising, or unusual tiredness or weakness.

Check with your doctor right away if you have anxiety, back pain, chest pain or tightness, dizziness, lightheadedness, fainting, feeling of warmth, hives, skin rash, numbness of your mouth, stomach cramps, sweating, trouble breathing, or pain, itching, redness, swelling, or tenderness at the injection site after you get the injection.

Check with your doctor right away if you have dark urine, clay-colored stools, stomach pain, or yellow eyes or skin. These may be symptoms of a serious liver problem.

Tell your doctor right away if you start to feel depressed. Report any unusual thoughts or behaviors that trouble you, especially if they are new or get worse quickly.

This medicine does not decrease the risk of transmitting HIV infection to others through sexual contact or by contamination through blood. HIV may be acquired from or spread to others through infected body fluids, including blood, vaginal fluid, or semen. If you are infected, it is best to avoid any sexual activity involving an exchange of body fluids with other people. If you do have sex, always wear (or have your partner wear) a condom. Only use condoms made of latex or polyurethane and use them every time you have contact with semen, vaginal secretions, or blood. Also, do not share needles or equipment with anyone or use dirty needles. If you have any questions about this, check with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Less common

Bone or muscle pain

changes in behavior

dark urine

discouragement

feeling sad or empty

headache

irritability

loss of appetite

loss of interest or pleasure

nausea or vomiting

sleepiness or unusual drowsiness

stomach pain

thoughts of killing oneself

trouble concentrating

trouble sleeping

unusual tiredness or weakness

yellow eyes or skin

Rare

Anxiety

back pain

chest pain or tightness

cough

diarrhea

dizziness, lightheadedness, fainting

feeling of warmth

hives, itching skin, rash

light-colored stools

noisy breathing

numbness of the mouth

redness of the face, neck, arms and occasionally, upper chest

redness of the skin

stomach cramps

sweating

trouble breathing

upper right stomach pain

Incidence not known

Black, tarry stools

chills

cloudy or blood urine

fever

high blood pressure

painful or difficult urination

sore throat

sores, ulcers, or white spots on the lips or in the mouth

swelling of the face, feet, or lower legs

swollen glands

unusual bleeding or bruising

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Bleeding, blistering, burning, coldness, discoloration of skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

small lumps under the skin

Less common

Bloated

collection of blood under skin

deep, dark purple bruise

difficulty in moving

excess air or gas in the stomach or intestines

full feeling

general feeling of discomfort or illness

increased weight

joint pain

lack or loss of strength

muscle aches, cramps, pains, or stiffness

passing gas

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.