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Drug overview for CABENUVA (cabotegravir/rilpivirine):
Generic name: cabotegravir/rilpivirine (KA-boe-TEG-ra-vir/RIL-pi-VIR-een)
Drug class: Antiviral-HIV (Antiretroviral) Nonnucleoside RT Inhibitor
Therapeutic class: Anti-Infective Agents
Cabotegravir, an HIV integrase strand transfer inhibitor (INSTI), and rilpivirine, an HIV non-nucleoside reverse transcriptase inhibitor (NNRTI), are used in combination as an antiretroviral agent.
No enhanced Uses information available for this drug.
Generic name: cabotegravir/rilpivirine (KA-boe-TEG-ra-vir/RIL-pi-VIR-een)
Drug class: Antiviral-HIV (Antiretroviral) Nonnucleoside RT Inhibitor
Therapeutic class: Anti-Infective Agents
Cabotegravir, an HIV integrase strand transfer inhibitor (INSTI), and rilpivirine, an HIV non-nucleoside reverse transcriptase inhibitor (NNRTI), are used in combination as an antiretroviral agent.
No enhanced Uses information available for this drug.
DRUG IMAGES
CABENUVA ER 600 MG-900 MG SUSP
CABENUVA ER 400 MG-600 MG SUSP
The following indications for CABENUVA (cabotegravir/rilpivirine) have been approved by the FDA:
Indications:
HIV infection
Professional Synonyms:
Human immunodeficiency virus disease
Human immunodeficiency virus infection
Indications:
HIV infection
Professional Synonyms:
Human immunodeficiency virus disease
Human immunodeficiency virus infection
The following dosing information is available for CABENUVA (cabotegravir/rilpivirine):
No enhanced Dosing information available for this drug.
Cabotegravir/rilpivirine is commercially available as cabotegravir extended-release injectable suspension in a single-dose vial and rilpivirine extended-release injectable suspension in a single-dose vial copackaged for coadministration by IM administration. The injections must be administered by a healthcare provider by gluteal IM injection only; administer the IM injections at separate gluteal sites (on opposite sides or at least 2 cm apart) during the same visit. The ventrogluteal site is recommended, but a dorsogluteal approach (upper outer quadrant) is acceptable, if preferred by the healthcare professional.
Do not administer by any other route or anatomical site. Consider the body mass index (BMI) of the patient to ensure that the needle length is sufficient to reach the gluteus muscle. Longer needle lengths (not included in the dosing kit) may be required for patients with higher BMI (e.g., >30 kg/m2) to ensure that injections are administered intramuscularly as opposed to subcutaneously.
The administration order of cabotegravir and rilpivirine extended-release injections is not important. Cabotegravir and rilpivirine combination therapy may be initiated with oral forms of the drugs (oral lead-in daily dose is cabotegravir 30 mg and rilpivirine 25 mg with a meal for approximately 1 month (at least 28 days)) prior to beginning the IM injections to assess tolerability or the combination therapy may be initiated directly with the injectable forms without an oral lead-in. Cabotegravir and rilpivirine extended-release suspensions can be injected monthly or every 2 months.
Discuss these 2 dosing options with the patient prior to starting treatment to determine which dosing frequency is more appropriate. Store the co-packaged cabotegravir/rilpivirine extended-release suspensions at 2-8degrees C in their original carton; do not freeze.
Do not administer by any other route or anatomical site. Consider the body mass index (BMI) of the patient to ensure that the needle length is sufficient to reach the gluteus muscle. Longer needle lengths (not included in the dosing kit) may be required for patients with higher BMI (e.g., >30 kg/m2) to ensure that injections are administered intramuscularly as opposed to subcutaneously.
The administration order of cabotegravir and rilpivirine extended-release injections is not important. Cabotegravir and rilpivirine combination therapy may be initiated with oral forms of the drugs (oral lead-in daily dose is cabotegravir 30 mg and rilpivirine 25 mg with a meal for approximately 1 month (at least 28 days)) prior to beginning the IM injections to assess tolerability or the combination therapy may be initiated directly with the injectable forms without an oral lead-in. Cabotegravir and rilpivirine extended-release suspensions can be injected monthly or every 2 months.
Discuss these 2 dosing options with the patient prior to starting treatment to determine which dosing frequency is more appropriate. Store the co-packaged cabotegravir/rilpivirine extended-release suspensions at 2-8degrees C in their original carton; do not freeze.
No dosing information available.
No generic dosing information available.
The following drug interaction information is available for CABENUVA (cabotegravir/rilpivirine):
There are 2 contraindications.
These drug combinations generally should not be dispensed or administered to the same patient. A manufacturer label warning that indicates the contraindication warrants inclusion of a drug combination in this category, regardless of clinical evidence or lack of clinical evidence to support the contraindication.
| Drug Interaction | Drug Names |
|---|---|
| Cobicistat-Elvitegravir/NNRTIs SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: Cobicistat inhibits CYP2D6, CYP3A4, BCRP, OATP1B1 and OATP1B3. Elvitegravir induces CYP2C9. Efavirenz may induce the metabolism of cobicistat via CYP3A4.(1) CLINICAL EFFECTS: Concurrent use of cobicistat-elvitegravir with non-nucleoside reverse transcriptase inhibitors (NNRTIs) may result in altered and/or suboptimal pharmacokinetics of cobicistat, elvitegravir, and/or the NNRTI.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: The combination product containing cobicistat-elvitegravir-emtricitabine-tenofovir should not be used with non-nucleoside reverse transcriptase inhibitors.(1) DISCUSSION: Concurrent use of cobicistat-elvitegravir with non-nucleoside reverse transcriptase inhibitors may result in altered and/or suboptimal pharmacokinetics of cobicistat, elvitegravir, and/or the NNRTI.(1) |
GENVOYA, STRIBILD |
| Cabotegravir-Rilpivirine/Strong CYP3A4 & UGT1A1 Inducers SEVERITY LEVEL: 1-Contraindicated Drug Combination: This drug combination is contraindicated and generally should not be dispensed or administered to the same patient. MECHANISM OF ACTION: Apalutamide, barbiturates, carbamazepine, dexamethasone, efavirenz, encorafenib, enzalutamide, eslicarbazepine, fosphenytoin, ivosidenib, lumacaftor, mitotane, natisedine, oxcarbazepine, phenobarbital, phenytoin, primidone, rifabutin, rifampin, rifapentine, ritonavir, or St. John's wort may induce the metabolism of cabotegravir-rilpivirine by CYP3A4 and uridine diphosphate (UDP)-glucuronosyl transferase 1A1 (UGT1A1).(1) CLINICAL EFFECTS: Concurrent or recent use of apalutamide, barbiturates, carbamazepine, dexamethasone, efavirenz, encorafenib, enzalutamide, eslicarbazepine, fosphenytoin, ivosidenib, lumacaftor, mitotane, natisedine, oxcarbazepine, phenobarbital, phenytoin, primidone, rifabutin, rifampin, rifapentine, ritonavir, or St. John's wort may result in decreased levels and effectiveness of cabotegravir-rilpivirine, as well as the development of resistance.(1) PREDISPOSING FACTORS: Induction effects may be more likely with regular use of the inducer for longer than 1-2 weeks. PATIENT MANAGEMENT: The US manufacturer of cabotegravir-rilpivirine states that concurrent use of CYP3A4 inducers and/or UGT1A1 inducers is contraindicated.(1) It may take several weeks after the discontinuation of an enzyme inducer for enzyme activity to return to normal.(1) DISCUSSION: In a study in 16 subjects, rifampin (600 mg daily) decreased the concentration maximum (Cmax), area-under-curve (AUC), and concentration minimum (Cmin) of rilpivirine (150 mg daily) by 69%, 80%, and 89%, respectively. There were no significant effects on the Cmax or AUC of rifampin or 25-desacetylrifampin.(1) In a study in 15 subjects, rifampin (600 mg daily) decreased the Cmax, AUC, and Cmin of cabotegravir by 6%, 59%, and 50%, respectively.(1) Strong CYP3A4 inducers linked include: apalutamide, barbiturates, carbamazepine, dexamethasone, encorafenib, enzalutamide, eslicarbazepine, fosphenytoin, ivosidenib, lumacaftor, mitotane, natisedine, oxcarbazepine, phenobarbital, phenytoin, primidone, rifabutin, rifampin, rifapentine, or St. John's wort.(1,2) UGT1A1 inducers linked include: carbamazepine, efavirenz, fosphenytoin, oxcarbazepine, phenobarbital, phenytoin, primidone, rifapentine, rifampin, and ritonavir.(1,2) |
APTIOM, ASA-BUTALB-CAFFEINE-CODEINE, ASCOMP WITH CODEINE, BRAFTOVI, BUPIVACAINE-DEXAMETH-EPINEPHRN, BUTALB-ACETAMINOPH-CAFF-CODEIN, BUTALBITAL, BUTALBITAL-ACETAMINOPHEN, BUTALBITAL-ACETAMINOPHEN-CAFFE, BUTALBITAL-ASPIRIN-CAFFEINE, CARBAMAZEPINE, CARBAMAZEPINE ER, CARBATROL, CEREBYX, DEXABLISS, DEXAMETHASONE, DEXAMETHASONE ACETATE, DEXAMETHASONE ACETATE MICRO, DEXAMETHASONE INTENSOL, DEXAMETHASONE ISONICOTINATE, DEXAMETHASONE MICRONIZED, DEXAMETHASONE SOD PHOS-WATER, DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE-0.9% NACL, DILANTIN, DILANTIN-125, DMT SUIK, DONNATAL, DOUBLEDEX, EFAVIRENZ, EFAVIRENZ-EMTRIC-TENOFOV DISOP, EFAVIRENZ-LAMIVU-TENOFOV DISOP, EPITOL, EQUETRO, ERLEADA, FIORICET, FIORICET WITH CODEINE, FOSPHENYTOIN SODIUM, HEMADY, KALETRA, LIDOCIDEX-I, LOPINAVIR-RITONAVIR, LYSODREN, MAS CARE-PAK, MITOTANE, MYSOLINE, NORVIR, ORKAMBI, OXCARBAZEPINE, OXCARBAZEPINE ER, OXTELLAR XR, PAXLOVID, PENTOBARBITAL SODIUM, PHENOBARBITAL, PHENOBARBITAL SODIUM, PHENOBARBITAL-BELLADONNA, PHENOBARBITAL-HYOSC-ATROP-SCOP, PHENOHYTRO, PHENYTEK, PHENYTOIN, PHENYTOIN SODIUM, PHENYTOIN SODIUM EXTENDED, PRIFTIN, PRIMIDONE, RIFABUTIN, RIFADIN, RIFAMPIN, RITONAVIR, SEZABY, SYMFI, SYMFI LO, TALICIA, TAPERDEX, TEGRETOL, TEGRETOL XR, TENCON, TIBSOVO, TRILEPTAL, XTANDI, ZCORT |
There are 4 severe interactions.
These drug interactions can produce serious consequences in most patients. Actions required for severe interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration scheduling, and providing additional patient monitoring. Review the full interaction monograph for more information.
| Drug Interaction | Drug Names |
|---|---|
| Betibeglogene Autotemcel/Anti-Retrovirals; Hydroxyurea SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Betibeglogene autotemcel is prepared from apheresed cells that are transduced with a replication defective, self-inactivating lentiviral vector. Antiretrovirals may interfere with the manufacturing of apheresed cells. Hydroxyurea may interfere with hematopoietic stem cell (HSC) mobilization of CD34+ cells.(1) CLINICAL EFFECTS: Use of hydroxyurea before mobilization may result in unsuccessful stem cell mobilization. Use of antiretrovirals before mobilization and apheresis may interfere with the production of betibeglogene autotemcel. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Discontinue antiretrovirals and hydroxyurea for at least one month prior to mobilization and until all cycles of apheresis are completed. If a patient requires antiretrovirals for HIV prophylaxis, then confirm a negative HIV test before beginning mobilization and apheresis of CD34+ cells. DISCUSSION: Antiretroviral medications and hydroxyurea may interfere with the manufacturing of betibeglogene autotemcel therapy.(1) |
ZYNTEGLO |
| Elivaldogene Autotemcel/Anti-Retrovirals SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Elivaldogene autotemcel is prepared from apheresed cells that are transduced with a replication defective, self-inactivating lentiviral vector. Antiretrovirals may interfere with the manufacturing of apheresed cells. CLINICAL EFFECTS: Use of antiretrovirals before mobilization and apheresis may interfere with the production of elivaldogene autotemcel. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Discontinue antiretrovirals for at least one month prior to mobilization and until all cycles of apheresis are completed. If a patient requires antiretrovirals for HIV prophylaxis, then confirm a negative HIV test before beginning mobilization and apheresis of CD34+ cells. DISCUSSION: Antiretroviral medications may interfere with the manufacturing of elivaldogene autotemcel therapy.(1) |
SKYSONA |
| Lovotibeglogene Autotemcel/Anti-Retrovirals SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Lovotibeglogene autotemcel is prepared from apheresed cells that are transduced with a replication defective, self-inactivating lentiviral vector. Antiretrovirals may interfere with the manufacturing of apheresed cells. CLINICAL EFFECTS: Use of antiretrovirals before mobilization and apheresis may interfere with the production of lovotibeglogene autotemcel.(1) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Discontinue antiretrovirals for at least one month prior to mobilization and until all cycles of apheresis are completed.(1) There are some long-acting antiretroviral medications that may require a longer duration of discontinuation for elimination of the medication. If a patient is taking anti-retrovirals for HIV prophylaxis, confirm a negative test for HIV before beginning mobilization and apheresis of CD34+ cells.(1) DISCUSSION: Antiretroviral medications may interfere with the manufacturing of lovotibeglogene autotemcel therapy.(1) |
LYFGENIA |
| Atidarsagene Autotemcel/Anti-Retrovirals SEVERITY LEVEL: 2-Severe Interaction: Action is required to reduce the risk of severe adverse interaction. MECHANISM OF ACTION: Atidarsagene autotemcel is prepared from apheresed cells that are transduced with a replication defective, self-inactivating lentiviral vector. Antiretrovirals may interfere with the manufacturing of apheresed cells. CLINICAL EFFECTS: Use of antiretrovirals before mobilization and apheresis may interfere with the production of atidarsagene autotemcel. PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Discontinue antiretrovirals for at least one month prior to mobilization (or the expected duration of time needed for elimination of the medication) until all cycles of apheresis are completed. If a patient requires antiretrovirals for HIV prophylaxis, then confirm a negative HIV test before beginning mobilization and apheresis of CD34+ cells. DISCUSSION: Antiretroviral medications may interfere with the manufacturing of atidarsagene autotemcel therapy.(1) |
LENMELDY |
There are 1 moderate interactions.
The clinician should assess the patient’s characteristics and take action as needed. Actions required for moderate interactions include, but are not limited to, discontinuing one or both agents, adjusting dosage, altering administration.
| Drug Interaction | Drug Names |
|---|---|
| Rilpivirine/Tecovirimat SEVERITY LEVEL: 3-Moderate Interaction: Assess the risk to the patient and take action as needed. MECHANISM OF ACTION: Tecovirimat may induce the metabolism of rilpivirine by CYP3A4.(1-4) CLINICAL EFFECTS: Concurrent or recent use of tecovirimat may result in decreased levels and effectiveness of rilpivirine, as well as the development of resistance.(1-4) PREDISPOSING FACTORS: None determined. PATIENT MANAGEMENT: Coadministration of rilpivirine with tecovirimat should be approached with caution. Consider increasing rilpivirine to 50 mg daily during treatment with tecovirimat and for approximately 2 weeks after the end of treatment.(1-4) DISCUSSION: In a study in 18 subjects, rifabutin (300 mg daily), a moderate CYP3A4 inducer, decreased the maximum concentration (Cmax), area-under-curve (AUC), and minimum concentration (Cmin) of rilpivirine (25 mg orally daily) by 31%, 42%, and 48%, respectively.(1) A study in 18 subjects compared rilpivirine administered alone (25 mg orally daily) to coadministration with rifabutin (300 mg daily) and rilpivirine (50 mg orally daily). A significant difference was not found with the Cmax (1.43), AUC (1.16), or Cmin (0.93) of rilpivirine.(1) In a pharmacokinetic study, tecovirimat decreased the Cmax and AUC of midazolam by 39% and 32%, respectively.(2-3) |
TPOXX (NATIONAL STOCKPILE) |
The following contraindication information is available for CABENUVA (cabotegravir/rilpivirine):
Drug contraindication overview.
*Previous hypersensitivity reaction to cabotegravir or rilpivirine. *Coadministration with drugs for which significant decreases in cabotegravir plasma concentrations may occur due to uridine diphosphate glucuronosyl transferase (UGT)1A1 enzyme induction and/or cytochrome P-450 (CYP) 3A enzyme induction, which may result in loss of virologic response (e.g., anticonvulsants (carbamazepine, oxcarbazepine, phenobarbital, phenytoin), antimycobacterials (rifampin, rifabutin, rifapentine), systemic glucocorticoids (dexamethasone; more than a single dose treatment), and herbal products (St John's wort)).
*Previous hypersensitivity reaction to cabotegravir or rilpivirine. *Coadministration with drugs for which significant decreases in cabotegravir plasma concentrations may occur due to uridine diphosphate glucuronosyl transferase (UGT)1A1 enzyme induction and/or cytochrome P-450 (CYP) 3A enzyme induction, which may result in loss of virologic response (e.g., anticonvulsants (carbamazepine, oxcarbazepine, phenobarbital, phenytoin), antimycobacterials (rifampin, rifabutin, rifapentine), systemic glucocorticoids (dexamethasone; more than a single dose treatment), and herbal products (St John's wort)).
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Lactation |
There are 3 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Depression |
| Disease of liver |
| Suicidal ideation |
There are 4 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min |
| Chronic kidney disease stage 5 (failure) GFr<15 ml/min |
| Disease of liver |
| Viral hepatitis |
The following adverse reaction information is available for CABENUVA (cabotegravir/rilpivirine):
Adverse reaction overview.
The most common adverse reactions observed in >=2% of subjects receiving cabotegravir/rilpivirine were injection site reactions, pyrexia, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash.
The most common adverse reactions observed in >=2% of subjects receiving cabotegravir/rilpivirine were injection site reactions, pyrexia, fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness, and rash.
There are 26 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. | None. |
| Rare/Very Rare |
|---|
|
Abnormal hepatic function tests Angioedema Autoimmune hepatitis Biliary calculus Blistering skin Bronchospastic pulmonary disease Cholecystitis Conjunctivitis DRESS syndrome Dyspnea Eosinophilia Facial edema Glomerulonephritis Graves' disease Guillain-barre syndrome Hypersensitivity drug reaction Increased alanine transaminase Increased aspartate transaminase Kidney stone Nephrotic syndrome Polymyositis Stevens-johnson syndrome Stomatitis Suicidal Suicidal ideation Toxic epidermal necrolysis |
There are 45 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Acute abdominal pain Back pain Diarrhea Dizziness Dream disorder Drowsy Fatigue Headache disorder Injection site sequelae Insomnia Musculoskeletal pain Nausea Skin rash Sleep disorder Symptoms of anxiety Upper respiratory infection |
Anorexia Diarrhea Dizziness Dream disorder Fatigue Fever Flatulence Nausea Pruritus of skin Vomiting |
| Rare/Very Rare |
|---|
|
Acute abdominal pain Agitation Allergic conjunctivitis Anorexia Depression Drowsy Drug fever Eosinophilia General weakness Hypercholesterolemia Hypertriglyceridemia Mood changes Myalgia Oral hypoesthesia Sleep disorder Stomatitis Symptoms of anxiety Urticaria Weight gain |
The following precautions are available for CABENUVA (cabotegravir/rilpivirine):
Safety and effectiveness of cabotegravir/rilpivirine have been established in pediatric patients 12 to younger than 18 years of age and weighing at least 35 kg. Efficacy and safety of cabotegravir/rilpivirine in HIV-1-infected patients as a complete regimen including oral lead-in therapy were established in 3 adult clinical studies (FLAIR, ATLAS, ATLAS-2M) and an adolescent clinical study (MOCHA). Safety, tolerability, and pharmacokinetics of oral and injectable cabotegravir and oral and injectable rilpivirine in adolescent patients are being assessed in an ongoing Phase 1/2, open-label, non-comparative study (MOCHA).
The primary objective of this study at week 16 was to confirm the use of the adult dose, through the evaluation of safety and pharmacokinetics, for oral and injectable cabotegravir and injectable rilpivirine in 23 HIV-1-infected virologically suppressed patients 12 to younger than 18 years of age and weighing at least 35 kg. Patients were assigned to 1 of 2 cohorts, 1C or 1R, based on their background antiretroviral regimen. In cohort 1C, 8 patients received cabotegravir 30 mg daily for 1 month, followed by monthly cabotegravir injections (Month 1: 600 mg injection, Months 2 and 3: 400 mg injection) for an additional 3 months, while continuing background antiretroviral therapy.
In cohort 1R, 15 patients received rilpivirine 25 mg daily for 1 month, followed by monthly rilpivirine injections (Month 1: 900 mg injection, Months 2 and 3: 600 mg injection) for an additional 3 months, while continuing background antiretroviral therapy. The safety of cabotegravir and rilpivirine injections in patients 12 to younger than 18 years of age and weighing at least 35 kg is expected to be similar to adults, as there was no clinically significant difference in drug exposure for the components of cabotegravir and rilpivirine extended-release injection. The efficacy of cabotegravir and rilpivirine injections in patients 12 to younger than 18 years of age and weighing at least 35 kg is extrapolated from adults with support from pharmacokinetic analyses showing similar drug exposure. The safety, efficacy, and pharmacokinetics of the combined regimen of cabotegravir and rilpivirine extended-release injection have not been established in pediatric patients <12 years of age or weighing <35 kg.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
The primary objective of this study at week 16 was to confirm the use of the adult dose, through the evaluation of safety and pharmacokinetics, for oral and injectable cabotegravir and injectable rilpivirine in 23 HIV-1-infected virologically suppressed patients 12 to younger than 18 years of age and weighing at least 35 kg. Patients were assigned to 1 of 2 cohorts, 1C or 1R, based on their background antiretroviral regimen. In cohort 1C, 8 patients received cabotegravir 30 mg daily for 1 month, followed by monthly cabotegravir injections (Month 1: 600 mg injection, Months 2 and 3: 400 mg injection) for an additional 3 months, while continuing background antiretroviral therapy.
In cohort 1R, 15 patients received rilpivirine 25 mg daily for 1 month, followed by monthly rilpivirine injections (Month 1: 900 mg injection, Months 2 and 3: 600 mg injection) for an additional 3 months, while continuing background antiretroviral therapy. The safety of cabotegravir and rilpivirine injections in patients 12 to younger than 18 years of age and weighing at least 35 kg is expected to be similar to adults, as there was no clinically significant difference in drug exposure for the components of cabotegravir and rilpivirine extended-release injection. The efficacy of cabotegravir and rilpivirine injections in patients 12 to younger than 18 years of age and weighing at least 35 kg is extrapolated from adults with support from pharmacokinetic analyses showing similar drug exposure. The safety, efficacy, and pharmacokinetics of the combined regimen of cabotegravir and rilpivirine extended-release injection have not been established in pediatric patients <12 years of age or weighing <35 kg.
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Antiretroviral Pregnancy Registry at 800-258-4263 or https://www.apregistry.com.
The manufacturer states that data are insufficient on the use of cabotegravir/rilpivirine during pregnancy to adequately assess a drug-associated risk of birth defects and miscarriage. Healthcare professionals should discuss the risks and benefits of using cabotegravir and rilpivirine extended-release injection with individuals of childbearing potential or during pregnancy. The Health and Human Services Panel on Treatment of Pregnant Women with HIV Infection and Prevention of Perinatal Transmission states that data are not available regarding use of cabotegravir for the treatment of HIV-1 infection during pregnancy and, therefore it is not recommended as a complete treatment regimen in pregnant females or females of reproductive potential trying to conceive.
The Panel recommends that pregnant individuals who present to care on this regimen should be switched to an appropriate 3-drug antiretroviral regimen recommended for use in pregnancy. Lower exposures with oral rilpivirine were observed during pregnancy. Viral load should be monitored closely if the patient remains on cabotegravir and rilpivirine extended-release injection during pregnancy. Cabotegravir and rilpivirine are detected in systemic circulation for up to >=12 months after discontinuing injections of cabotegravir and rilpivirine injection; therefore, consideration should be given to the potential for fetal exposure during pregnancy.
The manufacturer states that data are insufficient on the use of cabotegravir/rilpivirine during pregnancy to adequately assess a drug-associated risk of birth defects and miscarriage. Healthcare professionals should discuss the risks and benefits of using cabotegravir and rilpivirine extended-release injection with individuals of childbearing potential or during pregnancy. The Health and Human Services Panel on Treatment of Pregnant Women with HIV Infection and Prevention of Perinatal Transmission states that data are not available regarding use of cabotegravir for the treatment of HIV-1 infection during pregnancy and, therefore it is not recommended as a complete treatment regimen in pregnant females or females of reproductive potential trying to conceive.
The Panel recommends that pregnant individuals who present to care on this regimen should be switched to an appropriate 3-drug antiretroviral regimen recommended for use in pregnancy. Lower exposures with oral rilpivirine were observed during pregnancy. Viral load should be monitored closely if the patient remains on cabotegravir and rilpivirine extended-release injection during pregnancy. Cabotegravir and rilpivirine are detected in systemic circulation for up to >=12 months after discontinuing injections of cabotegravir and rilpivirine injection; therefore, consideration should be given to the potential for fetal exposure during pregnancy.
Rilpivirine is present in human milk. There are no data on the presence of cabotegravir in human milk; however, cabotegravir is present in animal milk. When a drug is present in animal milk, it is likely present in human milk.
If cabotegravir and/or rilpivirine are present in human milk, residual exposures may remain for >=12 months after the last injections have been administered. It is unknown if cabotegravir and rilpivirine affect milk production or have effects on the breastfed infant. The HHS perinatal HIV transmission guideline provides updated recommendations on infant feeding.
The guideline states that patients with HIV should receive evidence-based, patient-centered counseling to support shared decision making about infant feeding. During counseling, patients should be informed that feeding with appropriate formula or pasteurized donor human milk from a milk bank eliminates the risk of postnatal HIV transmission to the infant. Additionally, achieving and maintaining viral suppression with antiretroviral therapy during pregnancy and postpartum reduces the risk of breastfeeding HIV transmission to <1%, but does not completely eliminate the risk. Replacement feeding with formula or banked pasteurized donor milk is recommended when patients with HIV are not on antiretroviral therapy and/or do not have a suppressed viral load during pregnancy (at a minimum throughout the third trimester), as well as at delivery.
If cabotegravir and/or rilpivirine are present in human milk, residual exposures may remain for >=12 months after the last injections have been administered. It is unknown if cabotegravir and rilpivirine affect milk production or have effects on the breastfed infant. The HHS perinatal HIV transmission guideline provides updated recommendations on infant feeding.
The guideline states that patients with HIV should receive evidence-based, patient-centered counseling to support shared decision making about infant feeding. During counseling, patients should be informed that feeding with appropriate formula or pasteurized donor human milk from a milk bank eliminates the risk of postnatal HIV transmission to the infant. Additionally, achieving and maintaining viral suppression with antiretroviral therapy during pregnancy and postpartum reduces the risk of breastfeeding HIV transmission to <1%, but does not completely eliminate the risk. Replacement feeding with formula or banked pasteurized donor milk is recommended when patients with HIV are not on antiretroviral therapy and/or do not have a suppressed viral load during pregnancy (at a minimum throughout the third trimester), as well as at delivery.
Use caution when administering cabotegravir/rilpivirine in elderly patients. Experience in patients >=65 years of age is insufficient to determine whether they respond differently to cabotegravir/rilpivirine than younger adults. Cabotegravir/rilpivirine should be used with caution in geriatric patients because of age-related decreases in hepatic, renal, and/or cardiac function and potential for concomitant disease and drug therapy.
The following prioritized warning is available for CABENUVA (cabotegravir/rilpivirine):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for CABENUVA (cabotegravir/rilpivirine)'s list of indications:
| HIV infection | |
| B20 | Human immunodeficiency virus [HIv] disease |
| B97.35 | Human immunodeficiency virus, type 2 [HIV 2] as the cause of diseases classified elsewhere |
| O98.7 | Human immunodeficiency virus [HIv] disease complicating pregnancy, childbirth and the puerperium |
| O98.71 | Human immunodeficiency virus [HIv] disease complicating pregnancy |
| O98.711 | Human immunodeficiency virus [HIv] disease complicating pregnancy, first trimester |
| O98.712 | Human immunodeficiency virus [HIv] disease complicating pregnancy, second trimester |
| O98.713 | Human immunodeficiency virus [HIv] disease complicating pregnancy, third trimester |
| O98.719 | Human immunodeficiency virus [HIv] disease complicating pregnancy, unspecified trimester |
| O98.72 | Human immunodeficiency virus [HIv] disease complicating childbirth |
| O98.73 | Human immunodeficiency virus [HIv] disease complicating the puerperium |
| Z21 | Asymptomatic human immunodeficiency virus [HIv] infection status |
Formulary Reference Tool