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Submitted URL: https://tracking.managedhealthcareconnect.com/?ref=bkQAAEQ1TTHc0nkVvRfhtEgsc3mBNKkHAQAAAI6oTmTP4aynwtReegHUuW1OU1DehNWfQQARA6DQOhworK0NjVs-2Ot...
Effective URL: https://cabenuvahcp.com/?utm_source=N744860.471832FIRSTREPORTNOW.COM&utm_medium=banner&utm_campaign=CabenuvaNowApprovedU...
Submission: On September 03 via api from US
Effective URL: https://cabenuvahcp.com/?utm_source=N744860.471832FIRSTREPORTNOW.COM&utm_medium=banner&utm_campaign=CabenuvaNowApprovedU...
Submission: On September 03 via api from US
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<p style="font-size: 16px;"><span style="font-family: arial, helvetica, sans-serif;"><strong>Terms and Conditions<br></strong></span><span style="font-family: arial, helvetica, sans-serif; font-size: 14px;">By checking the "Sign up for email
updates" box, you are giving ViiV Healthcare, and companies working with ViiV Healthcare, permission to market or advertise to you across multiple channels, e.g., mail, websites, email, online advertising, applications, and services,
regarding professional information from ViiV Healthcare. ViiV Healthcare will not sell or share this information with third parties for their marketing purposes and will always provide you with the opportunity to change your advertising
preferences. For additional information regarding how ViiV Healthcare handles your information, please see our <span
style="color: #e67300;"><a href="https://privacy.viivhealthcare.com/en-us/?__hstc=113372760.a0025ee0e4d74ef465ba91c88f78a65f.1630686835199.1630686835199.1630686835199.1&__hssc=113372760.1.1630686835200&__hsfp=651832833" rel="nofollow noopener" target="_blank" style="color: #e67300;"><span style="text-decoration: underline;">privacy notice</span></a></span>,
which you are agreeing to by using this website.</span></p>
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</form>Text Content
This site is intended for US healthcare professionals only. CONTINUESwitch to
patient site
* Prescribing Info
* Clinical Trials
* Trial Design
* Efficacy
* Confirmed Virologic Failure
* Adverse Reactions
* Patient-reported Outcomes
* Risks & Side Effects
* Dosing & Drug Interactions
* Getting Started
* Readiness Assessment Tool
* Talking to Your Patients
* Patient Enrollment
* Ordering
* Reimbursement & Coding
* Patient Support
* Connect With Us
* Clinical Trials
* Trial Design
* Efficacy
* Confirmed Virologic Failure
* Adverse Reactions
* Patient-reported Outcomes
* Risks & Side Effects
* Dosing & Drug Interactions
* Injection Education
* Patient Experience
* Getting Started
* Readiness Assessment Tool
* Talking to Your Patients
* Patient Enrollment
* Ordering
* Reimbursement & Coding
* Patient Support
* Connect With Us
Speak to a CABENUVA Resource
Michael, living with HIV.
Individuals featured on this website have
been compensated by ViiV Healthcare.
CABENUVA is administered as 2 intramuscular injections by a healthcare
professional. Adherence to the monthly dosing schedule is strongly recommended.1
INDICATION
CABENUVA is indicated as a complete regimen for the treatment of human
immunodeficiency virus type 1 (HIV-1) infection in adults to replace the current
antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less
than 50 copies per mL) on a stable antiretroviral regimen with no history of
treatment failure and with no known or suspected resistance to either
cabotegravir or rilpivirine.
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.1
First and only once-monthly, complete treatment regimen for HIV-11†
More about Dosing
Proven as effective as continuing a daily oral regimen1‡
Primary endpoint: proportion of patients with HIV-1 RNA ≥50 copies/mL at Week 48
via FDA Snapshot Algorithm. Proportion of patients with HIV‑1 RNA ≥50 copies/mL
at Week 48 in pooled analysis was 2% for CABENUVA vs 2% for daily oral
comparator (non-inferior treatment difference: 0.2% [95% CI: -1.4, 1.7])
More about Efficacy
Preferred by 9 out of 10 patients in clinical trials2-4§
In an exploratory endpoint, at Week 48, 88% (523/591) of ITT-E population
preferred CABENUVA vs 2% (9/591) who preferred their previous oral regimen; data
not available for 59 patients. These results are descriptive in nature and
should not be used to infer clinical significance.
More about Patient Preference
*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.1
†HIV-1 RNA <50 copies/mL.1
‡Based on a pooled analysis from two Phase 3, international, randomized,
non-inferiority trials (ATLAS and FLAIR) in virologically suppressed (HIV-1 RNA
<50 copies/mL) adults ≥18 years with HIV-1.1-4 In ATLAS, 616
treatment-experienced, virologically suppressed (for ≥6 months) patients on 2
NRTIs + an INSTI, NNRTI, or PI were randomized 1:1 to receive either CABENUVA
(after a 4-week oral lead-in of cabotegravir 30 mg and rilpivirine 25 mg) or to
remain on their current therapy.1,3 In FLAIR, patients without previous ARV
exposure were given ABC/DTG/3TC (or DTG + 2 NRTIs if HLA-B*5701-positive) for 20
weeks to achieve suppression for 4 weeks and then randomized 1:1 (N=566) to
receive either CABENUVA (after a 4-week oral lead-in of cabotegravir 30 mg and
rilpivirine 25 mg) or to remain on their current regimen.1,4 At baseline, in
FLAIR and ATLAS, respectively, 24% and 31% of patients were nonwhite.1,2 In both
studies, 7% had CD4+ T-cell count <350 cells/mm3.1 In ATLAS, baseline
third-agents were: 50% NNRTIs, 33% INSTIs, or 17% PIs.1 Patients were excluded
if they were pregnant or breastfeeding, had moderate to severe hepatic
impairment, or evidence of HBV infection at screening.3,4 Non-inferiority of
CABENUVA would be shown if the upper bound of the 95% CI for the treatment
difference was <6% for the individual studies.2-4
§Patient preference data collected from clinical trial participants from ATLAS
and FLAIR randomized to long-acting arm, completing a single-item question
assessing their preference for CABENUVA compared to their previous oral
regimens.
3TC=lamivudine; ABC=abacavir; ARV=antiretroviral; CI=confidence interval;
DTG=dolutegravir; FDA=Food and Drug Administration; HBV=hepatitis B virus;
HLA-B=human leukocyte antigen complex B; INSTI=integrase strand transfer
inhibitor; ITT-E=intent-to-treat efficacy; NNRTI=non-nucleoside reverse
transcriptase inhibitor; NRTI=nucleoside reverse transcriptase inhibitor;
PI=protease inhibitor.
SPEAK TO A CABENUVA RESOURCE
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"With CABENUVA injections, I feel a sense of independence from not having
to take a pill at the same time every day and fearing that I missed it.
Instead of stressing about daily treatment, I can focus on treatment once a
month. Even though it's just a few seconds a day to take a pill, I now don't
have to remember to take my HIV treatment until my next appointment."
— Mark, clinical trial participant and patient ambassador
Patient experiences with CABENUVA after receiving 1 month of oral lead-in of
cabotegravir and rilpivirine. Individual patient experiences are not indicative
of all patient experiences or clinical trial results.
Learn More
YOU MAY ALSO BE INTERESTED IN
TALKING TO YOUR PATIENTS
Key points to discuss with your virologically suppressed HIV-1 adult patients
for a better understanding of CABENUVA
Learn More
PATIENT TESTIMONIALS
Hear what patients have to say about CABENUVA
Learn More
PATIENT SUPPORT
Patient support options are available for prescribed CABENUVA
Learn More
"Until I stopped taking the daily HIV pill, I didn't appreciate how much it
impacted my every day.
Now, I don't have to worry about taking treatment every day, instead, once a
month. Being liberated from taking HIV medication daily makes life different in
a way - you're not a different person, but it changes your day-to-day living
with the disease. I do have to plan for appointments around work, and that was a
change, but now I'm used to the process."
— Jayson, clinical trial participant and patient ambassador
Patient experiences with CABENUVA after receiving 1 month of oral lead-in of
cabotegravir and rilpivirine. Individual patient experiences are not indicative
of all patient experiences or clinical trial results.
Learn More
FOR YOUR PRACTICE
CLINICAL TRIALS
Learn about ATLAS and FLAIR: Phase 3 clinical trials in virologically
suppressed adult patients with HIV-1
Learn More
RISKS & SIDE EFFECTS
Review risks and side effects information, including safety and tolerability
data, for CABENUVA
Learn More
DOSING & DRUG INTERACTIONS
Get information on dosing and administering CABENUVA, as well as potential drug
interactions
Learn More
References:
1. CABENUVA [package insert]. Research Triangle Park, NC: ViiV Healthcare;
2021.
2. Rizzardini G, Overton ET, Orkin C, et al. Long-acting injectable
cabotegravir + rilpivirine for HIV maintenance therapy: week 48 pooled
analysis of phase 3 ATLAS and FLAIR trials. J Acquir Immune Defic Syndr.
2020;85(4):498-506.
3. Data on File, ViiV Healthcare.
4. Swindells S, Andrade-Villanueva JF, Richmond GJ, et al. Long-acting
cabotegravir and rilpivirine for maintenance of HIV-suppression. N Engl J
Med. 2020;382(12):1112-1123.
5. Orkin C, Arasteh K, Górgolas Hernández-Mora M, et al. Long-acting
cabotegravir and rilpivirine after oral induction for HIV‑1 infection. N
Engl J Med. 2020;382(12):1124-1135.
CBRWCNT210020
ARROW
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
ARROW
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
Discontinue CABENUVA immediately if signs or symptoms of hypersensitivity
reactions develop. Clinical status, including liver transaminases, should be
monitored and appropriate therapy initiated. Prescribe the oral lead-in prior to
administration of CABENUVA 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,
agitation, abdominal cramping, flushing, sweating, oral numbness, and changes in
blood pressure. These events may have been associated with inadvertent (partial)
intravenous administration and began to resolve within a few minutes after the
injection
Carefully follow the Instructions for Use when preparing and administering
CABENUVA to 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
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 injection
dosing schedule because non-adherence to monthly injections or missed doses
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. If virologic failure
is suspected, switch the patient to an alternative regimen as soon as possible
ADVERSE REACTIONS
The most common adverse reactions (incidence ≥2%, all grades) with CABENUVA were
injection site reactions, pyrexia, fatigue, headache, musculoskeletal pain,
nausea, sleep disorders, dizziness, and rash.
DRUG INTERACTIONS
Refer to the applicable full Prescribing Information for important drug
interactions with CABENUVA, VOCABRIA, or EDURANT
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 1A9 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
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
INDICATION
CABENUVA is indicated as a complete regimen for the treatment of human
immunodeficiency virus type 1 (HIV-1) infection in adults to replace the current
antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less
than 50 copies per mL) on a stable antiretroviral regimen with no history of
treatment failure and with no known or suspected resistance to either
cabotegravir or rilpivirine.
Please see full Prescribing Information for CABENUVA.
CBTWCNT190001
To report SUSPECTED ADVERSE REACTIONS, contact ViiV Healthcare at
1-877-844-8872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please see full Prescribing Information for CABENUVA.
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