Description
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.
This product is available in the following dosage forms:
- Suspension, Extended Release
Before Using
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.
Pediatric
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.
Geriatric
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 for patients receiving this medicine.
Breastfeeding
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.
Drug Interactions
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.
- Bepridil
- Carbamazepine
- Cisapride
- Dexamethasone
- Dexlansoprazole
- Dronedarone
- Esomeprazole
- Fluconazole
- Fosphenytoin
- Ketoconazole
- Lansoprazole
- Mesoridazine
- Omeprazole
- Oxcarbazepine
- Pantoprazole
- Phenobarbital
- Phenytoin
- Pimozide
- Piperaquine
- Posaconazole
- Primidone
- Rabeprazole
- Rifabutin
- Rifampin
- Rifapentine
- Saquinavir
- Sparfloxacin
- St John's Wort
- Terfenadine
- Thioridazine
- Vonoprazan
- Ziprasidone
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
- Adagrasib
- Alfuzosin
- Aluminum Carbonate, Basic
- Aluminum Hydroxide
- Aluminum Phosphate
- Amiodarone
- Amisulpride
- Amitriptyline
- Amprenavir
- Anagrelide
- Apomorphine
- Aripiprazole
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Asenapine
- Astemizole
- Atazanavir
- Atidarsagene Autotemcel
- Avacopan
- Azithromycin
- Bedaquiline
- Buprenorphine
- Buserelin
- Calcium Carbonate
- Calcium Silicate
- Ceritinib
- Chloroquine
- Chlorpromazine
- Cimetidine
- Ciprofloxacin
- Citalopram
- Clarithromycin
- Clofazimine
- Clomipramine
- Clozapine
- Crizotinib
- Cyclobenzaprine
- Dabrafenib
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
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 and instructions for use. 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
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 Cabenuva 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
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 hurting 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.
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