cabotegravir ER 400 mg/2 mL-rilpivirine ER 600 mg/2mL IM suspension,ER

Generic name:
Cabotegravir/rilpivirine extended-release - injection

Pronunciation
(KA-boe-TEG-ra-vir/RIL-pi-VIR-een)

Brand name(s)
Cabenuva

This product is used to help control HIV infection. It contains 2 medications: cabotegravir and rilpivirine. It helps to decrease the amount of HIV in your body so your immune system can work better. This lowers your chance of getting HIV complications (such as new infections, cancer) and improves your quality of life. Cabotegravir is an integrase inhibitor while rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI). Both drugs block the virus from growing and infecting more cells.

Cabotegravir/rilpivirine is not a cure for HIV infection. To decrease your risk of spreading HIV disease to others, continue to take all HIV medications exactly as prescribed by your doctor. Use an effective barrier method (latex or polyurethane condoms/dental dams) during sexual activity as directed by your doctor. Do not share personal items (such as needles/syringes, toothbrushes, and razors) that may have contacted blood or other body fluids. Consult your doctor or pharmacist for more details.

Read the Patient Information Leaflet if available from your pharmacist before you start using cabotegravir/rilpivirine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Before starting treatment with this product, your health care professional may have you take the forms of cabotegravir and rilpivirine taken by mouth for one month (at least 28 days). This is to see how well you can take these medications.

This product is given by injection into a muscle as directed by your doctor, usually once every month or once every 2 months. It is given by 2 injections, usually one on each side of your buttocks by a health care professional. The dosage is based on your medical condition and response to treatment.

It is very important to keep using these medications exactly as prescribed by your doctor. To help you remember, mark your calendar with a reminder. If you miss or will miss a planned monthly injection, tell your health care professional right away so that you may be given directions for your continued HIV treatment.

Injection site pain/discomfort, swelling, redness, itching, bruising, or a hardened mass or lump may occur. Headache, tiredness, nausea, or trouble sleeping may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Rarely, temporary symptoms such as sweating, shortness of breath, stomach cramps, dizziness/lightheadedness, or mouth numbness have happened after receiving the injections. Most symptoms stopped within a few minutes after the injection. Tell your health care professional right away if you have any of these symptoms soon after receiving an injection.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

As your immune system gets stronger, it can begin to fight off infections you already had, possibly causing disease symptoms to come back. You could also have symptoms if your immune system becomes overactive. This reaction may happen at any time (soon after starting HIV treatment or many months later). Get medical help right away if you have any serious symptoms, including:

• unexplained weight loss
• severe tiredness
• muscle aches/weakness that doesn't go away
• headaches that are severe or don't go away
• joint pain
• numbness/tingling of the hands/feet/arms/legs
• vision changes
• signs of infection (such as fever, chills, swollen lymph nodes, trouble breathing, cough, non-healing skin sores)
• signs of an overactive thyroid (such as irritability, nervousness, heat intolerance, fast/pounding/irregular heartbeat, bulging eyes, unusual growth in the neck/thyroid known as a goiter)
• signs of a certain nerve problem known as Guillain-Barre syndrome (such as unsteadiness, loss of coordination, trouble swallowing/speaking/chewing, trouble moving your eyes)
• signs of liver disease (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine)

Tell your doctor right away if you have any serious side effects, including:

• mental/mood changes (such as depression, thoughts of suicide)

Changes in body fat may occur while you are taking this medication (such as increased fat in the upper back and stomach areas, decreased fat in the arms and legs). The cause and long-term effects of these changes are unknown. Discuss the risks and benefits of treatment with your doctor, as well as the possible use of exercise to reduce this side effect.

Rilpivirine can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Get medical help right away if you develop any rash.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using this product, tell your doctor or pharmacist if you are allergic to cabotegravir or rilpivirine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• kidney disease
• liver disease (such as hepatitis B, hepatitis C)
• mental/mood disorders (such as depression)

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Treatment can lower the risk of passing HIV infection to your baby, and cabotegravir/rilpivirine may be part of that treatment. Discuss the risks and benefits with your doctor.

It is unknown if cabotegravir passes into breast milk. Rilpivirine passes into breast milk. Because breast milk may transmit HIV, consult your doctor before breastfeeding.

See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Do not use this medication with other products that treat HIV infection. Do not use this medication with other products that contain cabotegravir or rilpivirine.

Other medications can affect the removal of cabotegravir/rilpivirine from your body, which may affect how this product works. Examples include apalutamide, dexamethasone, enzalutamide, certain macrolide antibiotics (such as clarithromycin, erythromycin), rifamycins (such as rifampin, rifapentine), St. John's wort, certain drugs used to treat seizures (such as carbamazepine, oxcarbazepine, phenobarbital, phenytoin, primidone), a certain combination product used to treat chronic hepatitis C (ombitasvir/paritaprevir/ritonavir/dasabuvir), among others.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: fast/irregular heartbeat, severe dizziness, fainting.

Lab and/or medical tests (such as viral load, T-cell counts, liver function) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Not applicable. This product is given in a hospital or clinic or doctor's office and will not be stored at home.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.