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Cabotegravir / Rilpivirine Dosage

Medically reviewed by Drugs.com. Last updated on Feb 12, 2021.

Applies to the following strengths: 200 mg-300 mg/mL

Usual Adult Dose for HIV Infection

Initiation Injections:
-Cabotegravir: 600 mg IM once as a single dose
-Rilpivirine: 900 mg IM once as a single dose

Continuation Injections:
-Cabotegravir: 400 mg IM once a month
-Rilpivirine: 600 mg IM once a month

Comments:
-Initiation injections of this drug should follow oral lead-in (a cabotegravir 30 mg tablet plus a rilpivirine 25 mg tablet once a day); oral lead-in should be used for about 1 month (at least 28 days) before initiation of this drug to assess tolerability of cabotegravir and rilpivirine.
-Initiation injections should be started on the final day of oral lead-in.
-Continuation injections should be started 1 month after the initiation injections.
-Cabotegravir and rilpivirine injections (initiation and continuation) should be administered at separate gluteal injection sites (on opposite sides or 2 cm apart) during the same visit.
-Patients may be given this drug up to 7 days before or after the date of the scheduled monthly injection dosing visit.

Use: As a complete regimen, for the treatment of HIV-1 infection to replace the current antiretroviral regimen in patients who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and with no known/suspected resistance to either cabotegravir or rilpivirine

Renal Dose Adjustments

Mild to moderate renal dysfunction (CrCl 30 to less than 90 mL/min): No adjustment recommended.
Severe renal dysfunction (CrCl 15 to less than 30 mL/min) or ESRD (CrCl less than 15 mL/min): Increased monitoring for side effects recommended.

Comments:
-In patients with ESRD not on dialysis, effects on the pharmacokinetics of each component are unknown.

Liver Dose Adjustments

Mild or moderate liver dysfunction (Child-Pugh A or B): No adjustment recommended.
Severe liver dysfunction (Child-Pugh C): Data not available

Comments:
-The effect of severe liver dysfunction on the pharmacokinetics of each component is unknown.

Dose Adjustments

Adherence to monthly injection dosing schedule is strongly recommended.

MISSED INJECTIONS:
Planned Missed Injections (Oral Dosing to Replace Up to 2 Consecutive Monthly Injections):
-If a patient plans to miss a scheduled injection visit by more than 7 days, the patient should be started on oral therapy (1 tablet each of cabotegravir tablets and rilpivirine tablets, once a day) to replace up to 2 consecutive monthly injection visits.
-The first dose of oral therapy should be administered about 1 month after the last injection dose of this drug and continued until the day injection dosing is restarted.

Unplanned Missed Injections:
-If monthly injections are missed or delayed by more than 7 days and oral therapy has not been taken in the interim, the patient should be clinically reassessed to determine if resumption of injection dosing remains appropriate.
-If injection dosing will be continued, Injection Dosing Recommendations after Missed Injections should be consulted.

Injection Dosing Recommendations after Missed Injections:
-If up to 2 months since last injection: If clinically appropriate, cabotegravir (400 mg) and rilpivirine (600 mg) injections should be resumed as soon as possible; if patient was on oral therapy, injections should be resumed on the same day as the last day of oral therapy dosing.
-If more than 2 months since last injection: If clinically appropriate, patient should be reinitiated on cabotegravir (600 mg) and rilpivirine (900 mg), and then should continue to follow the monthly cabotegravir (400 mg) and rilpivirine (600 mg) injection schedule; if patient was on oral therapy, injections should be resumed on the same day as the last day of oral therapy dosing.

Precautions

CONTRAINDICATIONS:
-Previous hypersensitivity reaction to either active component
-Coadministration with drugs that significantly decrease cabotegravir and/or rilpivirine plasma levels due to UGT1A1 and/or CYP450 3A enzyme induction (which may lead to loss of virologic response), including carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, systemic dexamethasone (more than a single-dose therapy), St. John's wort

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Comments:
-Each component of this drug is highly bound to plasma proteins; significant removal via dialysis is unlikely.

Other Comments

Administration advice:
-For gluteal IM use only; do not administer by any other route or anatomical site.
-Injections must be administered by a healthcare professional.
-A complete dose requires 2 injections: 1 injection of cabotegravir and 1 injection of rilpivirine; consult the Instructions for Use for further guidance.
-Administer cabotegravir and rilpivirine injections at separate gluteal injection sites (on opposite sides or 2 cm apart) during the same visit; the ventrogluteal site is recommended.
-Consider patient's BMI to ensure the needle length is sufficient to reach the gluteus muscle; may need longer needle lengths (not included in dosing kit) for patients with higher BMI (e.g., greater than 30 kg/m2) to ensure injections are administered IM and not subcutaneously
-The order of administration of cabotegravir and rilpivirine injections is not important.
-Observe patients for about 10 minutes after the injection.
-Adherence to monthly injection dosing schedule strongly recommended.
---Clinically reassess patients who miss a scheduled injection visit to ensure resumption of therapy remains appropriate (e.g., evaluate patient commitment to comply with dosing schedule, consider HIV-1 RNA viral load retesting).

Storage requirements:
-Store in refrigerator at 2C to 8C (36F to 46F) in original carton until ready to use; do not freeze.

Reconstitution/preparation techniques:
-Do not mix with any other product or diluent.
-Before administration, vials should be brought to room temperature (not to exceed 25C [77F]). Vials may remain in carton at room temperature for up to 6 hours; if not used within 6 hours, they must be discarded.
-Each vial should be shaken vigorously, so the suspensions look uniform before injecting; small air bubble are expected and acceptable.
-Once the suspensions have been drawn into the respective syringes, the injections should be administered as soon as possible, but may remain in the syringe for up to 2 hours; if 2 hours are exceeded, the medications, syringes, and needles must be discarded.
-The manufacturer product information (Instructions for Use) should be consulted.

General:
-Before starting this drug, healthcare professionals should carefully select patients who agree to the required monthly injection dosing schedule and counsel patients about the importance of keeping scheduled dosing visits (to help maintain viral suppression and reduce risk of viral rebound and potential development of resistance with missed doses).
-This drug should not be used in patients with known/suspected resistance to cabotegravir or rilpivirine.
-Dosing for this drug consists of 3 distinct phases: an oral lead-in with cabotegravir tablets coadministered with rilpivirine tablets (month 1), initiation injections with this drug (month 2), and continuation injections with this drug (month 3 onwards).

Monitoring:
-Hepatic: Liver chemistries

Patient advice:
-Read the US FDA-approved patient labeling (Patient Information).
-Contact healthcare provider at once if rash develops; stop this drug immediately and seek medical care if rash develops with fever, generally ill feeling, extreme tiredness, muscle/joint aches, blisters, oral blisters/lesions, eye inflammation, facial swelling, swelling of the eyes/lips/tongue/mouth, difficulty breathing, and/or signs/symptoms of liver problems (e.g., yellowing of the skin/whites of the eyes, dark/tea-colored urine, pale-colored stools/bowel movements, nausea, vomiting, loss of appetite, pain/aching/sensitivity on the right side below the ribs).
-Seek medical evaluation at once if depressive symptoms develop.
-Continued medication adherence and scheduled visits are important to help maintain viral suppression and to reduce risk of loss of virologic response and development of resistance.

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