Pronunciation:

ka-boe-TEG-ra-vir

Dosage Forms:

• Suspension, Extended Release

Warnings:

Warning: Risk of Drug Resistance with Use of Apretude for HIV-1 Pre-Exposure Prophylaxis (PrEP) in Undiagnosed HIV-1 InfectionIndividuals must be tested for HIV-1 infection prior to initiating injectable cabotegravir suspension or oral cabotegravir, and with each subsequent injection of cabotegravir suspension, using a test approved or cleared by the FDA for the diagnosis of acute or primary HIV-1 infection. Drug-resistant HIV-1 variants have been identified with use of injectable cabotegravir suspension by individuals with undiagnosed HIV-1 infection. Do not initiate injectable cabotegravir suspension for HIV-1 PrEP unless negative infection status is confirmed. Individuals who become infected with HIV-1 while receiving injectable cabotegravir suspension for PrEP must transition to a complete HIV-1 treatment regimen .

Classifications:

Pharmacologic—

Integrase Inhibitor

Uses of This Medicine:

Cabotegravir injection is used for pre-exposure prophylaxis (PrEP) to reduce the risk of human immunodeficiency virus type 1 (HIV-1) infection. HIV is the virus that causes acquired immune deficiency syndrome (AIDS). Your doctor may do tests to make sure you are negative from HIV-1 infection before receiving this medicine for HIV-1 PrEP.

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 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 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.

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
• Oxcarbazepine
• Phenobarbital
• Phenytoin
• Rifampin
• Rifapentine

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
• Aluminum Carbonate, Basic
• Aluminum Hydroxide
• Aluminum Phosphate
• Amprenavir
• Atazanavir
• Calcium Carbonate
• Darunavir
• Delavirdine
• Didanosine
• Dihydroxyaluminum Aminoacetate
• Dihydroxyaluminum Sodium Carbonate
• Dolutegravir
• Doravirine
• Efavirenz
• Elvitegravir
• Emtricitabine
• Enfuvirtide
• Etravirine
• Fosamprenavir
• Fostemsavir
• Ibalizumab-uiyk
• Indinavir
• Lamivudine
• Lopinavir
• Magaldrate
• Magnesium Carbonate
• Magnesium Hydroxide
• Magnesium Oxide
• Magnesium Trisilicate
• Maraviroc
• Nelfinavir
• Nevirapine
• Raltegravir
• Ritonavir
• Saquinavir
• Sodium Bicarbonate
• Stavudine
• Tenofovir
• Tipranavir
• Zalcitabine
• Zidovudine

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.

• HIV-1 infection, positive or unknown status—Should not be used in patients with this condition.

• 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 your buttocks. It is usually given once a month for the first 2 months, then 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 tell you to take 1 tablet of cabotegravir once a day for at least 28 days before receiving your first injection. This will allow your doctor to see how well you will tolerate this medicine.

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 a seizure medicine (eg, carbamazepine, oxcarbazepine, phenobarbital, phenytoin, Dilantin®, Tegretol®, Trileptal®) or medicine to treat tuberculosis (eg, rifampin, rifapentine, Priftin®, Rifadin®, Rimactane®). Using these medicines together may make cabotegravir less effective.

This medicine may cause serious allergic reactions, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have a rash, fever, general feeling of discomfort or illness, muscle or joint aches, redness or swelling of the eyes, sores or blisters in the mouth, swelling of the mouth, face, lips, or tongue, trouble breathing, or unusual tiredness or weakness.

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 (including suicidal thoughts), 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

Changes in behavior

dark urine

discouragement

feeling sad or empty

loss of appetite

loss of interest or pleasure

nausea or vomiting

stomach pain, severe

thoughts of hurting oneself

trouble concentrating

trouble sleeping

unusual tiredness or weakness

yellow eyes or skin

Rare

Rash

Incidence not known

Black, tarry stools

chest pain

chills

cough

large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

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

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

Less common

Bloated

body aches or pain

diarrhea

difficulty in moving

dizziness

ear congestion

excess air or gas in the stomach or intestines

fever

full feeling

headache

increased weight

joint pain

loss of voice

muscle aches, cramps, pains, or stiffness

passing gas

sleepiness or unusual drowsiness

sneezing

stuffy or runny nose

swollen joints

unusual tiredness or weakness

vomiting

Incidence not known

Burning, dry, or itching eyes

discharge, excessive tearing

redness, pain, swelling of the eye, eyelid, or inner lining of eyelid

swelling or puffiness of the face

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.