Cabotegravir and rilpivirine injections are used in combination for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in certain adults and children 12 years of age or older weighing at least 77 pounds (35 kg). Cabotegravir is in a class of medications called HIV integrase inhibitors. Rilpivirine is in a class of medications called non-nucleoside reverse transcriptase inhibitors (NNRTIs). These medications work by decreasing the amount of HIV in the blood. Although cabotegravir and rilpivirine do not cure HIV, they may decrease your chance of developing acquired immunodeficiency syndrome (AIDS) and HIV-related illnesses such as serious infections or cancer. Receiving these medications along with practicing safer sex and making other life-style changes may decrease the risk of transmitting (spreading) the HIV virus to other people.

Cabotegravir and rilpivirine extended-release (long-acting) injections come as suspensions (liquids) to be injected into a muscle by a healthcare provider. You will receive cabotegravir and rilpivirine injections once every month or two months given as an injection of each medication into your buttocks.

Before receiving your first cabotegravir and rilpivirine extended-release injections, you may take cabotegravir (Vocabria) and rilpivirine (Edurant) tablets orally (by mouth) once daily for one month (at least 28 days) to see if you can tolerate these medications.

Rilpivirine extended-release injection may cause serious adverse reactions soon after receiving the injection. A doctor or nurse will monitor you during this time to be sure you are not having a serious reaction to the medication. Tell your doctor or nurse immediately if you experience any of the following symptoms during or shortly after your injection: difficulty breathing, stomach cramps, sweating, mouth numbness, anxiety, flushing, lightheadedness, or dizziness.

Cabotegravir and rilpivirine extended-release injections help to control HIV, but they do no not cure it. Keep all appointments to receive cabotegravir and rilpivirine extended-release injections even if you feel well. If you miss appointments to receive cabotegravir and rilpivirine extended-release injections, your condition may become more difficult to treat.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Before receiving cabotegravir and rilpivirine injections,

• tell your doctor and pharmacist if you are allergic to cabotegravir, rilpivirine, any other medications, or any of the ingredients in cabotegravir and rilpivirine injections. Ask your pharmacist for a list of the ingredients.
• tell your doctor if you are taking carbamazepine (Epitol, Equetro, Tegretol), dexamethasone (Decadron), oxcarbazepine (Trileptal), phenobarbital, phenytoin (Dilantin, Phenytek), rifabutin (Mycobutin), rifampin (Rifadin, Rimactane, in Rifamate, in Rifater), rifapentine (Priftin), or St. John's wort. Your doctor will probably tell you not to receive cabotegravir and rilpivirine injections if you are taking one or more of these medications.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: amiodarone (Nexterone, Pacerone); anagrelide (Agrylin); azithromycin (Zithromax); chloroquine; chlorpromazine; cilostazol; ciprofloxacin (Cipro); citalopram (Celexa); clarithromycin (Biaxin); dofetilide (Tikosyn); donepezil (Aricept); erythromycin (E-Mycin, Eryc, Ery-Tab, PCE); flecainide (Tambocor); fluconazole (Diflucan); haloperidol (Haldol); other medications to treat HIV/AIDS; ibutilide (Corvert); levofloxacin; methadone (Dolophine); moxifloxacin (Velox); ondansetron (Zuplenz, Zofran); other NNRTIs medications to treat HIV/AIDS; pentamidine (NebuPent, Pentam); pimozide (Orap); procainamide; quinidine (in Nuedexta); sotalol (Betapace, Sorine, Sotylize); and thioridazine. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with cabotegravir and rilpivirine, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.
• tell your doctor if you have or have ever had depression or other mental illness, or liver disease, including hepatitis B or C infection.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while receiving cabotegravir and rilpivirine injections, call your doctor. You should not breastfeed if you are infected with HIV or if you are receiving cabotegravir and rilpivirine injections.
• you should know that cabotegravir and rilpivirine injections may cause changes in your thoughts, behavior, or mental health. Call your doctor immediately if you develop any of the following symptoms while you are receiving and rilpivirine injections: new or worsening depression; or thinking about killing yourself or planning or trying to do so. Be sure your family knows which symptoms may be serious so that they can call your doctor if you are unable to seek treatment on your own.

If you miss a cabotegravir and rilpivirine injections appointment by more than 7 days, call your doctor right away to discuss your treatment options.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Unless your doctor tells you otherwise, continue your normal diet.

Cabotegravir and rilpivirine injections may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• pain, tenderness, swelling, redness, itching, bruising, or warmth at injection site
• fever
• tiredness
• headache
• muscle, bone, or back pain
• nausea
• difficulty falling asleep or staying asleep
• dizziness
• weight gain

Some side effects can be serious. If you experience any of these symptoms or those listed in the HOW or SPECIAL PRECAUTIONS sections, call your doctor immediately or get emergency medical treatment:

• rash with or without: fever; tiredness; muscle or joint pain; swelling of the face, lips, mouth, tongue, or throat; skin blisters; difficulty breathing or swallowing; mouth sores; redness or swelling of eyes; pain on right side of the stomach; pale stools; nausea; vomiting; or dark colored urine
• yellow eyes or skin; right upper abdominal pain; bruising; bleeding; loss of appetite; confusion; yellow or brown-colored urine; or pale stools
• altered mood, mood swings, negative thoughts, thoughts or attempts of harming yourself

Cabotegravir and rilpivirine injections may cause other side effects. Call your doctor if you have any unusual problems while receiving these medications.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to cabotegravir and rilpivirine injections.

Ask your pharmacist any questions you have about cabotegravir and rilpivirine injections.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Cabenuva®