Cabotegravir (Intramuscular)

Cabotegravir injection is used for pre-exposure prophylaxis (PrEP) to lower the chance of getting human immunodeficiency virus type 1 (HIV-1) infection. HIV is the virus that leads to acquired immune deficiency syndrome (AIDS). Your doctor may perform tests to confirm that you do not have HIV-1 infection before you receive this medicine for HIV-1 PrEP.

This medicine should only be given by your doctor or someone directly supervised by your doctor.

Your doctor will monitor your progress closely while you are taking this medicine to ensure it is working properly. Blood tests may be needed to check for side effects.

You should not take this medicine with seizure medications (for example, carbamazepine, oxcarbazepine, phenobarbital, phenytoin, Dilantin®, Tegretol®, Trileptal®) or medications for tuberculosis (for example, rifampin, rifapentine, Priftin®, Rifadin®, Rimactane®). Using these medications together may make cabotegravir less effective.

This medicine may cause serious allergic reactions, which can be life-threatening and require immediate medical help. Contact your doctor right away if you have a rash, fever, a 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.

Contact your doctor right away if you notice dark urine, clay-colored stools, stomach pain, or yellowing of your eyes or skin. These may be signs of a serious liver issue.

Inform your doctor immediately if you begin to feel depressed. Report any unusual thoughts or behaviors that concern you (including suicidal thoughts), particularly if they are new or worsen quickly.

This medicine does not reduce the risk of spreading HIV infection to others through sexual contact or through blood. HIV can be transmitted through infected body fluids, such as blood, vaginal fluid, or semen. If you are infected, it is best to avoid any sexual activity that involves exchanging body fluids with others. If you do have sex, always use (or have your partner use) a condom. Only use condoms made from latex or polyurethane and use them every time you come into 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, consult your doctor.

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or over-the-counter (OTC) medicines and herbal or vitamin supplements.

In deciding to use a medicine, you and your doctor must consider the risks versus the benefits. Here are important points for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies have not been conducted on the effects of cabotegravir injection in children younger than 12 years or weighing less than 35 kilograms (kg). Safety and effectiveness have not been determined.

Geriatric

Studies to date have not shown specific problems in elderly patients that would limit the use of cabotegravir injection. However, older adults are more likely to have age-related kidney, liver, or heart issues, which may require caution when using this medicine.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while in other cases, two different medicines may be used together even if an interaction might happen. If you are taking this medicine, it is particularly important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions are based on their potential significance and may not include all possible interactions.

Using this medicine with any of the following medicines is not recommended. Your doctor may choose not to treat you with this medication or adjust 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 necessary in some cases. If both medicines are prescribed, your doctor may change the dose or frequency of one or both 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

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating food or specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may impact the use of this medicine. Make sure to inform your doctor if you have any other medical conditions, especially:

• Depression or
• Liver disease—Use with caution. It may worsen these conditions.

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

• Severe or end-stage kidney disease—Use with caution. The effects may be stronger because the medicine is removed from the body more slowly.

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

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

Less frequent

• 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 fatigue or weakness
• yellow eyes or skin

Rare

• Rash

Incidence not known

• Black, tarry stools
• chest pain
• chills
• cough
• significant, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• sore 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 adverse effects may occur that usually do not need medical attention. These side effects may go away during therapy as your body adjusts to the medicine. Also, your health care professional may be able to inform you about ways to prevent or reduce some of these side effects. Verify 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 frequent

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

Less frequent

• 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 sleepiness
• sneezing
• stuffy or runny nose
• swollen joints
• unusual fatigue 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 clinician for medical guidance about adverse effects. You may report side effects to the FDA at 1-800-FDA-1088.

Available Dosage Forms:

• Suspension, Extended Release

Pharmacologic Class: Integrase Inhibitor

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. 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.