Patient Medication Information: uses, side effects, how to take - Cabenuva
What VOCABRIA is used for:
VOCABRIA is taken together with EDURANT (rilpivirine) to treat HIV (human immunodeficiency virus) infection in patients who are at least 12 years of age and weigh at least 35 kg:
- in the month before you begin your treatment on CABENUVA to test how well you tolerate these medicines (cabotegravir and rilpivirine) and
- as a replacement for CABENUVA injections if you need to miss your next scheduled injection (e.g. vacation).
What CABENUVA is used for:
- CABENUVA is used to treat HIV infection in patients who are at least 12 years of age and weigh at least 35 kg.
- CABENUVA replaces your current HIV treatment.
Your doctor may prescribe VOCABRIA prior to starting CABENUVA. However, you and your doctor may decide to start with CABENUVA directly.
How VOCABRIA and CABENUVA works:
VOCABRIA tablets contain a medicine, cabotegravir, that is used to treat HIV infection when taken together with the medicine rilpivirine tablets (EDURANT).
CABENUVA kits contain long-acting injections of the medicines cabotegravir and rilpivirine.
These medicines work together to keep the amount of virus in your body at a low level. This helps maintain the number of CD4+ cell count in your blood. CD4+ cells are a type of white blood cells that are important in helping your body to fight infection. VOCABRIA and CABENUVA do not cure HIV infection.
The ingredients in VOCABRIA are:
Medicinal ingredients: 30 mg cabotegravir (as cabotegravir sodium)
Non-medicinal ingredients: hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium starch glycolate, and titanium dioxide
The ingredients in CABENUVA are:
Cabotegravir Injections (2 mL or 3 mL):
Medicinal ingredients: 400 mg / 2 mL or 600 mg / 3 mL cabotegravir
Non-medicinal ingredients: mannitol, polysorbate 20, polyethylene glycol (PEG) 3350, water for injection.
Rilpivirine Injections (2 mL or 3 mL):
Medicinal ingredients: 600 mg / 2 mL or 900 mg / 3 mL rilpivirine
Non-medicinal ingredients: citric acid monohydrate, glucose monohydrate, poloxamer 338, sodium dihydrogen phosphate monohydrate, sodium hydroxide, water for injection
VOCABRIA comes in the following dosage forms:
30 mg cabotegravir tablets.
CABENUVA comes in the following dosage forms:
2 mL Dosing Kit: 400 mg / 2 mL cabotegravir injection + 600 mg / 2 mL rilpivirine injection.
3 mL Dosing Kit: 600 mg / 3 mL cabotegravir injection + 900 mg / 3 mL rilpivirine injection.
Do not use VOCABRIA or CABENUVA if:
- You are allergic (hypersensitive) to cabotegravir or rilpivirine or to any of the other ingredients of VOCABRIA or CABENUVA. See “The ingredients in VOCABRIA/ CABENUVA are”.
Do not use VOCABRIA if:
You are taking any of these medicines:
- carbamazepine, oxcarbazepine, phenobarbital, or phenytoin (also known as anticonvulsants used to treat epilepsy and prevent seizures).
- Rifampin or rifapentine (to treat some bacterial infections such as tuberculosis).
When taking VOCABRIA with EDURANT, please read the EDURANT Patient Medication Information for any additional medicines that should not be taken with rilpivirine.
Do not use CABENUVA if:
You are taking any of these medicines:
- carbamazepine, oxcarbazepine, phenobarbital, or phenytoin (also known as anticonvulsants used to treat epilepsy and prevent seizures).
- Rifampin, rifapentine or rifabutin (to treat some bacterial infections such as tuberculosis).
- Dexamethasone – more than one dose (a corticosteriod used in a variety of conditions such as inflammation and allergic reactions).
- products that contain St John’s wort (Hypericum perforatum) (a herbal product used to treat depression).
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take VOCABRIA or CABENUVA. Talk about any health conditions or problems you may have, including if you:
- have had a mental health problem.
- have had liver problems, including hepatitis B or C infection.
- have had a severe skin rash or an allergic reaction to cabotegravir or rilpivirine (JULUCA, COMPLERA, EDURANT, or ODEFSEY).
Other warnings you should know about:
Depression or Mood Changes
Depression and mood changes, including having thoughts of hurting yourself (suicidal ideation) or trying to hurt yourself (suicide attempt), have been reported in people taking CABENUVA. You may be more likely to experience suicidal ideation and/or a suicide attempt if you have a history of depression or a mental health illness. See the Serious Side effects and what to do about them table, below, for more information on these and other serious side effects.
Pregnancy
Talk to your doctor if you are pregnant or plan to become pregnant. Your doctor will consider the benefit to you and the risk to your baby when taking VOCABRIA or CABENUVA while you are pregnant. .
It is not known if VOCABRIA or CABENUVA will harm your unborn baby. There is a registry for women who take antiretroviral medicines during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare professional about how you can take part in this registry.
Breastfeeding Do not breastfeed if you are taking VOCABRIA and CABENUVA. There is a risk of passing HIV-1 to your baby if you breastfeed. It is not known whether the ingredients of VOCABRIA can pass into breast milk and harm your baby. CABENUVA may pass into breastmilk for 12 months or longer after the last injection of CABENUVA. Talk with your healthcare provider about the best way to feed your baby.
More Information about Long-Acting Medications
CABENUVA is a long acting medication, so if you stop treatment CABENUVA may remain in your system for up to a year or more after your last injection. It is important that you attend your planned appointments to receive CABENUVA injections. It is important for you to talk to your healthcare professional if you are thinking about stopping treatment. You will need to take other medicines to treat HIV infection and to reduce the risk of developing viral resistance.
Reactions to Injections
Post-injection reaction symptoms have happened within minutes in some people after receiving their rilpivirine injection. Most symptoms resolved within a few minutes after the injection. Symptoms of post-injection reactions may include: difficulty breathing, stomach cramps, sweating, numbness of your mouth, feeling anxious, feeling warm, feeling lightheaded or feeling like you are going to pass out (faint), and blood pressure changes. Tell your healthcare professional if you experience these symptoms after you receive your injections.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with VOCABRIA:
medicines called antacids to treat indigestion and heartburn or laxatives, or other products that contain aluminum and/or calcium carbonate, magnesium or buffered medicines.
- Taking antacids can stop VOCABRIA from being absorbed into your body and not make it work as well.
- Antacids should be taken at least 2 hours before or 4 hours after you take VOCABRIA.
As VOCABRIA is to be taken together with EDURANT, please read the EDURANT Patient Medication Information for any additional interactions that may occur with rilpivirine.
The following may interact with CABENUVA:
- clarithromycin, erythromycin, antibiotics used to treat bacterial infections.
- methadone, a medicine used to treat narcotic withdrawal and dependence.
Talk to your healthcare professional for further advice if you are taking any of these medicines.
How to take VOCABRIA (and EDURANT):
If you are prescribed VOCABRIA (and EDURANT) as an Oral lead-in:
- Take VOCABRIA with EDURANT every day exactly as your doctor has told you to, for as long as your doctor has told you to.
- When starting to take VOCABRIA for the first time, it should be taken for at least 28 days. See schedule for monthly and every 2 month dosing below.
VOCABRIA and EDURANT must be taken with a meal to help get the right amount of the medicine rilpivirine in your body. A protein drink alone does not replace a meal.
- Check with your healthcare professional if you are not sure or if you have questions.
Usual dose of VOCABRIA:
The usual dose of VOCABRIA is one tablet (30 mg cabotegravir) taken once a day with one tablet of EDURANT (25 mg rilpivirine).
How to take CABENUVA:
If you and your doctor decide to start with CABENUVA directly, see schedule for monthly and every 2 month dosing without taking VOCABRIA and EDURANT as an oral lead-in.
CABENUVA will be administered by your healthcare professional.
Usual dose of CABENUVA:
CABENUVA is given by your healthcare professional as two injections into the muscle of your buttocks (one each for cabotegravir and rilpivirine). CABENUVA may be administered either as a once a month dosing schedule or a once every two months dosing schedule. Your healthcare professional will determine the best dosing schedule for you. Do not change your dosing schedule without discussing with your healthcare professional.
Schedule for Monthly Dosing when taking VOCABRIA and EDURANT as an Oral Lead-in:
| ORAL LEAD-IN | INITIATION INJECTIONS | CONTINUATION INJECTIONS |
|---|---|---|
| Month Prior to Starting Injections* | Month 1 | Month 2 onwards |
VOCABRIA cabotegravir tablet once daily | CABENUVA | CABENUVA |
| 3 mL cabotegravir injection | 2 mL cabotegravir injection | |
EDURANT rilpivirine tablet once daily | 3 mL rilpivirine injection | 2 mL rilpivirine injection |
*It is important to take your oral lead-in tablets, with a meal, for at least 28-days, including on the day you start your first injections.
Schedule for Monthly dosing when starting CABENUVA directly:
| First monthly injection | Next monthly Injections |
|---|---|
| Month 1 | Month 2 onwards |
| CABENUVA | CABENUVA |
| 3 mL cabotegravir injection | 2 mL cabotegravir injection |
| 3 mL rilpivirine injection | 2 mL rilpivirine injection |
Schedule for Every 2 Months Dosing when taking VOCABRIA and EDURANT as an Oral Lead-in:
| ORAL LEAD-IN | INITIATION INJECTIONS | CONTINUATION INJECTIONS |
|---|---|---|
| Month Prior to Starting Injections* | Month 1 and Month 2 | Month 4 onwards |
VOCABRIA cabotegravir tablet once daily | CABENUVA | CABENUVA |
| 3 mL cabotegravir injection | 3 mL cabotegravir injection | |
EDURANT rilpivirine tablet once daily | 3 mL rilpivirine injection | 3 mL rilpivirine injection |
*It is important to take your oral lead-in tablets, with a meal, for at least 28-days, including on the day you start your first injections.
Schedule for Every 2 Months Dosing when starting with CABENUVA directly
| INITIATION INJECTIONS | CONTINUATION INJECTIONS |
|---|---|
| Month 1 and Month 2* | Month 4* onwards |
| CABENUVA | CABENUVA |
| 3 mL cabotegravir injection | 3 mL cabotegravir injection |
| 3 mL rilpivirine injection | 3 mL rilpivirine injection |
*First and second injections one month apart, third injection onwards, every two months
Overdose:
| If you think you, or a person you are caring for, have taken too much VOCABRIA, contact a healthcare professional, hospital emergency department, regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no signs or symptoms. |
|---|
Missed Dose:
If you miss a tablet, take VOCABRIA soon as you remember. If your next dose is due within 12 hours, skip the dose you missed and take the next one at the usual time. Then continue your treatment as before. Don't take a double dose to make up for a missed dose.
Missed Injections:
It is important to not miss any of your planned appointments. If you are going to miss, or have missed, an injection of CABENUVA, talk to your doctor or healthcare professional as soon as possible. Your doctor may recommend you take VOCABRIA together with EDURANT tablets until you are able to take CABENUVA injections again.
Possible side effects from using VOCABRIA and CABENUVA:
These are not all the possible side effects you may feel when taking VOCABRIA or CABENUVA. If you experience any side effects not listed here, tell your healthcare professional.
The most common side effects of CABENUVA are:
- Injection site reactions; such as pain and discomfort, a hardened mass or lump, swelling, redness, itching, bruising (which may include discolouration or a collection of blood under the skin), and warmth at the site of the injection. Tell your doctor or pharmacist if the symptoms you experience at the injection site becomes severe or troublesome.
The most common side effects of CABENUVA and VOCABRIA are:
- Fever / feeling hot (which may occur within one week after injections)
- Feeling tired or weak, lack of energy
- Headache
- Muscle pain
- Feeling sick (nausea)
- Sleep problems (difficulty falling asleep or staying asleep)
- Dizziness
- Rash (mild)
- Diarrhea
Additional side effects that may occur with both CABENUVA and VOCABRIA include: intestinal gas (wind/flatulence), being sick (vomiting), stomach pain, abnormal dreams, weight gain, feeling sleepy, malaise (feeling unwell), and at the injection site, numbness, minor bleeding, cellulitis (skin infection) or an abscess (collection of pus). During or after an injection of CABENUVA you may feel lightheaded which could lead to fainting.
Tell your doctor if you have any side effect that bothers you or that does not go away. For more information, ask your healthcare professional.
Serious side effects and what to do about them
| Frequency/Side Effect/Symptom | Talk to your healthcare professional | Stop taking this drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| Uncommon | |||
Depression or mood changes:
| ✓ ✓ ✓ ✓ ✓ | ||
Hypersensitivity (allergic reactions) and severe skin rash:
| ✓ | ||
Liver problems and blood test results:
| ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ ✓ | ||
| Very Rare | |||
Stevens-Johnson syndrome (SJS) and Toxic epidermal necrolysis (TEN) (severe skin reactions):
| ✓ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your healthcare professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
Store VOCABRIA at up to 30°C.
Store CABENUVA in the refrigerator at 2° to 8°C in the original carton until ready to use. Do not freeze.
Keep out of reach and sight of children.
If you want more information about VOCABRIA or CABENUVA:
- Talk to your healthcare professional.
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada Drug Product Database website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website www.viivhealthcare.ca, or by calling 1-877-393-8448.
Date of Authorization: 2025-06-30
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