ONSCREEN TEXT:

CABENUVA (cabotegravir 200 mg/mL; rilpivirine 300 mg/mL) extended-release injectable suspensions

 

ANNOUNCER and ONSCREEN TEXT:

 

Announcer:

CABENUVA is a complete prescription regimen used to treat HIV-1 infection in people 12 years and older who weigh at least 77 pounds. It is used as a replacement for their current HIV-1 medicines when their doctor determines it’s right for them.

 

IMPORTANT SAFETY INFORMATION

Do not receive CABENUVA if you are allergic to any of its ingredients, or if you are taking certain medicines.

Watch the complete video for more safety information.

 

Text Onscreen:

What is CABENUVA?

CABENUVA is a complete prescription regimen used to treat HIV-1 infection in people 12 years and older who weigh at least 77 lbs (35 kg), to replace their current HIV-1 medicines when their healthcare provider determines they meet certain requirements.

 

IMPORTANT SAFETY INFORMATION

Do not receive CABENUVA if you:

• have ever had an allergic reaction to cabotegravir or rilpivirine.
• are taking certain medicines: carbamazepine; oxcarbazepine; phenobarbital; phenytoin; rifabutin; rifampin; rifapentine; dexamethasone (more than a single-dose treatment); St John’s wort (Hypericum perforatum).

 

Watch the complete video for more safety information. Please see the full Prescribing Information, including Patient Information, at CABENUVA.com

 

MARK and ONSCREEN TEXT:

 

Mark:

My name is Mark. I stay undetectable with CABENUVA

 

Text Onscreen:

Mark on CABENUVA

Mark is living with HIV and taking CABENUVA at the time of filming.

Undetectable means the amount of HIV in the blood measures less than 50 copies per mL. Individual results may vary.

 

MARK and ONSCREEN TEXT:

 

Mark:

and with the help of my doctor and nurse.

 

Text Onscreen:

Dr. Cunningham

Mark’s HIV doctor

 

ONSCREEN TEXT:

Getting to know you

 

MARK:

When I first met Dr. Cunningham and Nurse Sue, I felt like I was in good hands.

 

SUE and ONSCREEN TEXT:

 

Sue:

He has just been so warm and so open.

 

Text Onscreen:

Nurse Sue

Gives Mark his injections

 

SUE:

When you’re with somebody, you develop a bond.

 

MARK and ONSCREEN TEXT:

 

Mark:

It’s really gotten to the point where I actually look forward to coming in for my CABENUVA treatment.

 

Text Onscreen:

Your doctor may have you take about a month of once-daily starter pills before beginning injections. Stay under the care of your doctor during treatment.

 

MARK:

It’s nice to see you guys, both.

 

ONSCREEN TEXT:

An ongoing connection

 

SUE:

A person is not just their HIV. It’s not just the physical. There’s the social, the mental. It’s all a package, and so we try to remember that.

 

MARK:

I'm always concerned about taking new medications. I spoke to Dr. Cunningham and Sue, and they were open to hearing about all that. They reassured me.

 

SUE:

We want to create that safe atmosphere that Mark can talk to us openly and not face any judgment.

 

MARK:

There is no stigma, I feel at all, in Sue’s office.

 

SUE:

I ask my patients how they’re doing, how’s the family. If they have something else going on in their life, Dr. Cunningham and I want to know about it because we’re looking for any side effects.

 

MARK:

If anyone’s going to know about my health and what’s going on with me right now, it’s the clinic.

 

SUE:

I think it’s important to be open because we can treat them better. Because you know what’s going on in their lives.

 

ONSCREEN TEXT:

A team built on trust

 

MARK:

I do know that there’s certain people that are a little more apprehensive when they approach their doctors or want to keep some things from their healthcare team, stuff that’s going on with them and I question that. It’s important to be open about everything in my health, including my HIV treatment. I always bring up any questions or concerns I have about treatment. And I would encourage others to do the same. They’re there to help you and better you, and if you’re there for a reason, let them take care of you.

 

SUE:

There’s a closeness that comes when you’re seeing somebody on a regular basis. And I think that instills trust and confidence.

 

MARK:

We can learn from each other. I’m there to learn from them and, ultimately, they’re there to learn from me. I would gladly tell my HIV-positive friends to talk to their doctors about CABENUVA.

 

ONSCREEN TEXT:

Ready to have an open conversation? Ask your doctor about CABENUVA.

 

ANNOUNCER and ONSCREEN TEXT:

 

Announcer:

CABENUVA may cause serious side effects, including allergic reactions. Call your healthcare provider right away if you develop a rash. Stop receiving CABENUVA and get medical help right away if, along with a rash, you have a fever, feel generally ill or tired, have muscle or joint aches, have trouble breathing, have blisters or blisters or sores in the mouth, have redness or swelling of the eyes, or have swelling of the mouth, face, lips, or tongue.

Post-injection reactions have happened within minutes after rilpivirine injection. Most symptoms resolved within minutes. Symptoms may include trouble breathing, narrowing of airways, stomach cramps, sweating, numbness of the mouth, pain in areas such as the back and chest, feeling anxious, feeling warm, rash, feeling lightheaded or faint, and blood pressure changes.

 

Text Onscreen:

IMPORTANT SAFETY INFORMATION (cont’d)

What are the possible side effects of CABENUVA?
CABENUVA may cause serious side effects, including:

• Allergic reactions. Call your healthcare provider right away if you develop a rash with CABENUVA. Stop receiving CABENUVA and get medical help right away if you develop a rash with any of the following signs or symptoms: fever; generally ill feeling; tiredness; muscle or joint aches; trouble breathing; blisters or sores in mouth; blisters; redness or swelling of the eyes; swelling of the mouth, face, lips, or tongue.
• Post-injection reactions have happened in some people within minutes after receiving their rilpivirine injection. Most symptoms resolved within minutes. Symptoms may include: trouble breathing; narrowing of airways; stomach cramps; sweating; numbness of the mouth; pain (eg, back and chest); feeling anxious; feeling warm; rash; feeling lightheaded or faint; blood pressure

 

ANNOUNCER and ONSCREEN TEXT:

 

Announcer:

During CABENUVA treatment, people who have a history of hepatitis B or C or have certain liver function test changes may be at increased risk of liver problems and new or worsening changes in certain liver tests. Liver problems have also happened in people with no history of liver problems or other risk factors. Call your healthcare provider right away if you develop signs or symptoms of liver problems, including the skin or the white part of the eyes turning yellow, dark or “tea-colored” urine, light-colored stools, nausea or vomiting, loss of appetite, pain, aching, or tenderness on the right side of the stomach area, and itching.

 

Text Onscreen:

IMPORTANT SAFETY INFORMATION (cont’d)

What are the possible side effects of CABENUVA? (cont’d)
CABENUVA may cause serious side effects, including: (cont’d)

• Liver problems. People with a history of hepatitis B or C virus or with certain liver function test changes may have an increased risk of developing new or worsening changes in certain liver tests during CABENUVA treatment. Liver problems have also happened in people without history of liver problems or other risk factors. Your healthcare provider may do blood tests to check your liver function. Call your healthcare provider right away if you develop any of the following signs or symptoms of liver problems: the skin or the white part of the eyes turns yellow (jaundice); dark or “tea-colored” urine; light-colored stools (bowel movements); nausea or vomiting; loss of appetite; pain, aching, or tenderness on the right side of the stomach area; itching.

 

ANNOUNCER and ONSCREEN TEXT:

 

Announcer:

Depression or mood changes may occur. Call your healthcare provider or get emergency medical help right away if you feel sad or hopeless, anxious or restless, or have thoughts of hurting yourself or have tried to hurt yourself. The most common side effects are injection site reactions, fever, tiredness, headache, muscle or bone pain, nausea, sleep problems, dizziness, and rash. Injection site reaction symptoms include pain, tenderness, and others listed here. These are not all the possible side effects of CABENUVA. Call your doctor for medical advice about side effects.

 

Text Onscreen:

IMPORTANT SAFETY INFORMATION (cont’d)

What are the possible side effects of CABENUVA? (cont’d)
CABENUVA may cause serious side effects, including: (cont’d)

• Depression or mood changes. Call your healthcare provider or get emergency medical help right away if you have any of the following symptoms: feeling sad or hopeless; feeling anxious or restless; have thoughts of hurting yourself (suicide) or have tried to hurt yourself.

The most common side effects of CABENUVA include:

• Pain, tenderness, hardened mass or lump, swelling, redness, itching, bruising, and warmth at the injection site; fever; tiredness; headache; muscle or bone pain; nausea; sleep problems; dizziness; rash.

These are not all the possible side effects of CABENUVA. Call your doctor for medical advice about side effects.

 

ANNOUNCER and ONSCREEN TEXT:

 

Announcer:

Before receiving CABENUVA, tell your healthcare provider about all your medical conditions, including if you have ever had a rash or allergic reaction to medicines containing cabotegravir or rilpivirine, liver problems including hepatitis B or C infection, or mental health concerns. Tell your healthcare provider if you are, or plan to become, pregnant. It is not known if CABENUVA will harm your unborn baby. CABENUVA can remain in your body for up to 12 months or longer after the last injection. Also tell your healthcare provider if you are breastfeeding or plan to breastfeed. Do not breastfeed if you take CABENUVA because it isn’t known if CABENUVA can pass to your baby in your breast milk. You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby.

 

Text Onscreen:

IMPORTANT SAFETY INFORMATION (cont’d)

Before receiving CABENUVA

Tell your healthcare provider about all your medical conditions, including if you:

• have ever had a skin rash or an allergic reaction to medicines that contain cabotegravir or rilpivirine.
• have ever had liver problems, including hepatitis B or C infection.
• have ever had mental health problems.
• are pregnant or plan to become pregnant. It is not known if CABENUVA will harm your unborn baby. CABENUVA can remain in your body for up to 12 months or longer after the last injection.
• are breastfeeding or plan to breastfeed. Do not breastfeed if you take CABENUVA. You should not breastfeed if you have HIV-1 because of the risk of passing HIV-1 to your baby. It is not known if CABENUVA can pass to your baby in your breast milk. Talk with your healthcare provider about the best way to feed your baby during treatment.

 

ANNOUNCER and ONSCREEN TEXT:

 

Announcer:

Tell your healthcare provider about all medicines, vitamins, and herbal supplements you take. Some medicines interact with CABENUVA. Keep a list of your medicines and show it to your healthcare provider and pharmacist. Do not start taking a new medicine without telling your healthcare provider.

 

Text Onscreen:

IMPORTANT SAFETY INFORMATION (cont’d)

Before receiving CABENUVA (cont’d)

Tell your healthcare provider about all the medicines you take, including prescription and over-the- counter medicines, vitamins, and herbal supplements.

• Some medicines interact with CABENUVA. Keep a list of your medicines and show it to your healthcare provider and pharmacist. Do not start taking a new medicine without telling your healthcare provider.

 

ANNOUNCER and ONSCREEN TEXT:

 

Announcer:

When receiving CABENUVA once a month or once every 2 months, a healthcare provider will inject CABENUVA as 2 injections, 1 into the muscle of each side of your buttocks. Before your first CABENUVA injections, your doctor may have you take 1 VOCABRIA tablet and 1 EDURANT tablet once a day for 1 month to assess how you tolerate these medicines. Stay under the care of a healthcare provider during CABENUVA treatment. It is important that you attend all planned injection appointments. If you miss or plan to miss a scheduled CABENUVA injection by more than 7 days, call your healthcare provider right away to discuss your treatment options. If you stop CABENUVA treatment, you will need to take other medicines to treat your HIV-1 infection and reduce the risk of developing viral resistance. Call your healthcare provider right away to discuss your treatment options.

 

Text Onscreen:

IMPORTANT SAFETY INFORMATION (cont’d)

How will I receive CABENUVA?

• Once a month or once every 2 months, a healthcare provider will inject CABENUVA as 2 injections (cabotegravir and rilpivirine), one into the muscle of each side of your buttocks.
• Before receiving your first CABENUVA injections, your healthcare provider may have you take 1 VOCABRIA (cabotegravir) tablet and 1 EDURANT (rilpivirine) tablet once a day for 1 month (at least 28 days) to assess how you tolerate these medicines.
• Stay under the care of a healthcare provider during CABENUVA treatment. It is important that you attend all planned injection appointments.
• If you miss or plan to miss a scheduled CABENUVA injection by more than 7 days, call your healthcare provider right away to discuss your treatment options.
• If you stop treatment with CABENUVA you will need to take other medicines to treat your HIV-1 infection and reduce the risk of developing viral resistance. Call your healthcare provider right away to discuss your treatment options.

 

ANNOUNCER and ONSCREEN TEXT:

 

Announcer:

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

 

Please read the Patient Information for CABENUVA and discuss it with your healthcare provider.

 

Text Onscreen:

IMPORTANT SAFETY INFORMATION (cont’d)

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

 

Please read the Patient Information for CABENUVA and discuss it with your healthcare provider.

 

ONSCREEN TEXT:

CABENUVA (cabotegravir 200 mg/mL; rilpivirine 300 mg/mL) extended-release injectable suspensions

ViiV HEALTHCARE LOGO

Trademarks are property of their respective owners.

©2022 ViiV Healthcare or licensor. CBRVID220010 June 2022 Produced in USA.