Once-Monthly CABENUVA Treatment Planner Schedule

Oral lead-in phase

Patients will need to take 2 tablets, once daily with a meal, for about a month before their first injection.1

Treatment Planner

Select a date below to start treatment.

Dates provided here are a guide and may need to be adjusted based on clinic hours of operation and other factors.

show
1_month_gaps
/content/dam/cf-viiv/cabenuvahcp-treatment-planner/en_US/globals/syringes.png
$tp__approval_id
IM=intramuscular.
en

When will your patient start injections?

Scheduling monthly injection appointments will be new to both you and your patients. That’s why we created a Treatment Planner to help with scheduling CABENUVA.

Helpful tips

  1. Before initiation of clinician-administered CABENUVA, ensure patients agree to the required monthly dosing schedule and counsel patients about the importance of adherence to scheduled dosing visits. Talk to your patients about their availability to attend regular injection visits. Plan ahead for possible conflicts (eg, planned vacations, travel, childcare).

    Initiation injections should be administered on the last day of current antiretroviral therapy.

    Initiation injections should be administered on the last day of oral lead-in.

  2. CABENUVA must be administered as 2 intramuscular injections by a healthcare professional. Adherence to the dosing schedule is strongly recommended.
  3. Aim to deliver injections on the same date each month. This date is called the Target Treatment Date.
    • It is recommended that the Target Treatment Date be between the 1st and 28th day of the month to help ensure consistency each month.
    • Patients may receive injections up to 7 days before or after the Target Treatment Date. The +/-7-day period is called the Dosing Window.
    • When the Dosing Window is used, patients should return to their original Target Treatment Date for subsequent injections.
    • Patients who miss a scheduled injection visit should be clinically reassessed to ensure resumption of therapy remains appropriate. See dosing recommendations after missed injections.
Has your patient completed the optional oral lead-in phase?

If not, please select a new date at least 28 days later than the current date for the patient to complete the optional oral lead-in phase.

[PAST]Has your patient completed the optional oral lead-in phase?

If not, please select a new date at least 28 days later than the current date for the patient to complete the optional oral lead-in phase.

Optional Oral Lead-In
Month Before Injections
Will the patient start with the optional oral lead-in?

Prescribe 2 tablets (1x30-mg cabotegravir and 1x25-mg rilpivirine) to be taken once daily with a meal for approximately 1 month (at least 28 days) to assess tolerability.

Initiation injections should be administered on the last day of oral lead-in.

Yes

No

Prior to initiating treatment with CABENUVA, prescribe cabotegravir 30-mg and rilpivirine 25-mg oral tablets, both taken once daily with a meal, for approximately 1 month (at least 28 days) to assess tolerability.​

Oral lead-in: Month 1 (at least 28 days)

From 

Patients will take 2 tablets (1 cabotegravir and 1 rilpivirine tablet) once daily with a meal for 1 month (at least 28 days).

Appointment date

Appointment date is the day the patient attends your clinic to receive their injections. You can amend the appointment date by clicking on the pencil.

Earliest appointment date 

Latest appointment date 

Target Treatment Date

Injection visit 1, Month 2 (Initiation Injections)

Injection visit 1, Month 1 (Initiation Injections)

On the last day of oral lead-in, patients will receive their initiation injections: cabotegravir 600 mg (3 mL) and rilpivirine 900 mg (3 mL). The initiation injections are administered as 2 intramuscular injections at separate gluteal sites (opposite sides or 2 cm apart) during the same visit.

Patients will receive their initiation injections: cabotegravir 600 mg (3 mL) and rilpivirine 900 mg (3 mL). The initiation injections are administered as 2 intramuscular injections at separate gluteal sites (opposite sides or 2 cm apart) during the same visit.

On the last day of oral lead-in, patients will receive their initiation injections. The initiation injections are administered as 2 intramuscular injections at separate gluteal sites (opposite sides or 2 cm apart) during same visit.

Injection visit 2, Month 3 (Continuation Injections)

Injection visit 2, Month 2 (Continuation Injections)

Starting in Month 3, after the initiation injections, patients will begin continuation injections: cabotegravir 400 mg (2 mL) and rilpivirine 600 mg (2 mL). Continuation injections are administered as 2 intramuscular injections at separate gluteal sites (opposite sides or 2 cm apart) during same visit. Repeat continuation injections every month for the duration of treatment.

Starting in Month 2, patients will begin continuation injections: cabotegravir 400 mg (2 mL) and rilpivirine 600 mg (2 mL). Continuation injections are administered as 2 intramuscular injections at separate gluteal sites (opposite sides or 2 cm apart) during same visit. Repeat continuation injections every month for the duration of treatment.

Injection visit 3, Month 4 (Continuation Injections)

Injection visit 3, Month 3 (Continuation Injections)

Continuation injections are administered as 2 intramuscular injections at separate gluteal sites (opposite sides or 2 cm apart) during same visit. Repeat continuation injections every month for duration of treatment.

Repeat continuation injections every month for duration of treatment.1

Injection visit 4, Month 5 (Continuation Injections)

Injection visit 4, Month 4 (Continuation Injections)

Injection visit 5, Month 6 (Continuation Injections)

Injection visit 5, Month 5 (Continuation Injections)

Continuation Injection visit 6 - Month 7

Injection visit 6, Month 6 (Continuation Injections)

Continuation Injection visit 7 - Month 8

Continuation Injection visit 8 - Month 9

Continuation Injection visit 9 - Month 10

Continuation Injection visit 10 - Month 11

Continuation Injection visit 11 - Month 12

Continuation Injection visit 12 - Month 13

Continuation injections are administered as 2 intramuscular injections at separate gluteal sites (opposite sides or 2 cm apart) during same visit. Repeat continuation injections every month for duration of treatment.

Repeat continuation injections every month for duration of treatment.1

View more dates

Remove

Print or save as a PDF

Edit Appointment Date

Keep in mind that when amending appointments, the Target Treatment Date should always be the goal. The Target Treatment Date is highlighted in green on the calendar.

If a patient is unable to receive treatment on this date, select an alternative date within the +/-7-day Dosing Window. The appointment date can be edited by selecting a date highlighted in yellow.

If the patient is unable to receive treatment within the Dosing Window, a fully suppressive oral antiretroviral regimen should be prescribed. If injections are missed or delayed by more than 7 days and oral therapy has not been taken in the interim, clinically reassess the patient to determine if resumption of injection dosing remains appropriate.

Date in green: Target Treatment Date

Dates in yellow: Dosing Window

Save changes 

Discard changes 

Edit Appointment Date

The date selected is outside the Dosing Window.

Aim to deliver injections on the patient’s Target Treatment Date.

 

If it is not possible, the patient may receive injections up to 7 days before or after the Target Treatment Date. The +/-7-day period is called the Dosing Window.

 

If a patient plans to miss a scheduled injection visit by more than 7 days, daily oral therapy with any fully suppressive antiretroviral regimen should be prescribed. If using oral cabotegravir 30 mg and rilpivirine 25 mg, the duration of therapy should be limited to 2 months to replace up to 2 scheduled injection visits. The first dose of oral therapy should be taken approximately 1 month after the last injection dose of CABENUVA and continued until the day injection dosing is restarted.

 

Choose another date

INDICATION

CABENUVA is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 35 kg to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Do not use CABENUVA in patients with previous hypersensitivity reaction to cabotegravir or rilpivirine

Do not use CABENUVA in patients receiving carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, systemic dexamethasone (>1 dose), and St John’s wort

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions:

Hypersensitivity reactions, including cases of drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported during postmarketing experience with rilpivirine-containing regimens. While some skin reactions were accompanied by constitutional symptoms such as fever, other skin reactions were associated with organ dysfunctions, including elevations in hepatic serum biochemistries 

Serious or severe hypersensitivity reactions have been reported in association with other integrase inhibitors and could occur with CABENUVA 

Please see additional Important Safety Information throughout. Please see full Prescribing Information for CABENUVA (cabotegravir; rilpivirine) at http://bit.ly/cabenuva_pi.

 

 

 

 

 

 

 

 

 

Discontinue CABENUVA immediately if signs or symptoms of hypersensitivity reactions develop. Clinical status, including liver transaminases, should be monitored and appropriate therapy initiated. Cabotegravir and rilpivirine oral lead-in may be used to help identify patients who may be at risk of a hypersensitivity reaction

Post-Injection Reactions:

Serious post-injection reactions (reported in less than 1% of subjects) were reported within minutes after the injection of rilpivirine, including dyspnea, bronchospasm, agitation, abdominal cramping, rash/urticaria, dizziness, flushing, sweating, oral numbness, changes in blood pressure, and pain (e.g., back and chest). These events may have been associated with accidental intravenous administration and began to resolve within a few minutes after the injection

Carefully follow the Instructions for Use when preparing and administering CABENUVA. The suspensions should be injected slowly via intramuscular injection and avoid accidental intravenous administration. Observe patients briefly (approximately 10 minutes) after the injection. If a post-injection reaction occurs, monitor and treat as clinically indicated

Hepatotoxicity: 

Hepatotoxicity has been reported in patients receiving cabotegravir or rilpivirine with or without known pre-existing hepatic disease or identifiable risk factors 

Patients with underlying liver disease or marked elevations in transaminases prior to treatment may be at increased risk for worsening or development of transaminase elevations

Monitoring of liver chemistries is recommended and treatment with CABENUVA should be discontinued if hepatotoxicity is suspected

Please see additional Important Safety Information throughout. Please see full Prescribing Information for CABENUVA (cabotegravir; rilpivirine) at http://bit.ly/cabenuva_pi.

 

 

 

 

 

Depressive Disorders: 

Depressive disorders (including depressed mood, depression, major depression, mood altered, mood swings, dysphoria, negative thoughts, suicidal ideation or attempt) have been reported with CABENUVA or the individual products 

Promptly evaluate patients with depressive symptoms

Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions:

The concomitant use of CABENUVA and other drugs may result in known or potentially significant drug interactions (see Contraindications and Drug Interactions) 

Rilpivirine doses 3 and 12 times higher than the recommended oral dosage can prolong the QTc interval

CABENUVA should be used with caution in combination with drugs with a known risk of Torsade de Pointes

Long-Acting Properties and Potential Associated Risks with CABENUVA: 

Residual concentrations of cabotegravir and rilpivirine may remain in the systemic circulation of patients for prolonged periods (up to 12 months or longer). Select appropriate patients who agree to the required monthly or every-2-month injection dosing schedule because non-adherence could lead to loss of virologic response and development of resistance

To minimize the potential risk of developing viral resistance, it is essential to initiate an alternative, fully suppressive antiretroviral regimen no later than 1 month after the final injection doses of CABENUVA when dosed monthly and no later than 2 months after the final injections of CABENUVA when dosed every 2 months. If virologic failure is suspected, switch the patient to an alternative regimen as soon as possible

Please see additional Important Safety Information throughout. Please see full Prescribing Information for CABENUVA (cabotegravir; rilpivirine) at http://bit.ly/cabenuva_pi.

 

 

 

 

 

 

ADVERSE REACTIONS

The most common adverse reactions in adults (incidence ≥2%, all grades) treated with CABENUVA were injection site reactions, pyrexia, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash

The safety of CABENUVA in adolescents is expected to be similar to adults

DRUG INTERACTIONS 

Refer to the applicable full Prescribing Information for important drug interactions with CABENUVA, VOCABRIA (cabotegravir), or EDURANT (rilpivirine)

Because CABENUVA is a complete regimen, coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended 

Drugs that are strong inducers of UGT1A1 or UGT1A9 are expected to decrease the plasma concentrations of cabotegravir. Drugs that induce or inhibit CYP3A may affect the plasma concentrations of rilpivirine 

CABENUVA should be used with caution in combination with drugs with a known risk of Torsade de Pointes

USE IN SPECIFIC POPULATIONS 

Pregnancy: There are insufficient human data on the use of CABENUVA during pregnancy to adequately assess a drug-associated risk for birth defects and miscarriage. Discuss the benefit-risk of using CABENUVA during pregnancy and conception and consider that cabotegravir and rilpivirine are detected in systemic circulation for up to 12 months or longer after discontinuing injections of CABENUVA. An Antiretroviral Pregnancy Registry has been established 

Please see additional Important Safety Information throughout. Please see full Prescribing Information for CABENUVA (cabotegravir; rilpivirine) at http://bit.ly/cabenuva_pi.

 

 

 

 

 

 

 

 

 

 

Lactation: The CDC recommends that HIV-1−infected mothers in the United States not breastfeed their infants to avoid risking postnatal transmission of HIV-1 infection. Breastfeeding is also not recommended due to the potential for developing viral resistance in HIV-positive infants, adverse reactions in a breastfed infant, and detectable cabotegravir and rilpivirine concentrations in systemic circulation for up to 12 months or longer after discontinuing injections of CABENUVA

Please see additional Important Safety Information throughout. Please see full Prescribing Information for CABENUVA (cabotegravir; rilpivirine) at http://bit.ly/cabenuva_pi.