Medically reviewed by Drugs.com. Last updated on Feb 12, 2021.
Applies to the following strengths: 30 mg
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for HIV Infection
30 mg orally once a day
-To be taken with rilpivirine tablets (25 mg orally once a day)
-Oral lead-in should be used for about 1 month (at least 28 days) to assess tolerability of cabotegravir before the initiation of cabotegravir-rilpivirine IM.
-The last oral dose should be administered on the same day injections with cabotegravir-rilpivirine IM are started.
-If a patient plans to miss a scheduled cabotegravir-rilpivirine IM injection by more than 7 days, this drug may be used with 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 cabotegravir-rilpivirine IM and continued until the day injection dosing is restarted.
---The manufacturer product information for cabotegravir-rilpivirine IM should be consulted regarding resumption of monthly injection dosing.
Uses: In combination with rilpivirine tablets, for short-term treatment of HIV-1 infection 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, as:
-Oral lead-in to assess tolerability of this drug before starting cabotegravir-rilpivirine IM
-Oral therapy for patients who will miss planned injection dosing with cabotegravir-rilpivirine IM
Renal Dose Adjustments
Mild to moderate renal dysfunction (CrCl 30 to less than 90 mL/min) or severe renal dysfunction (CrCl less than 30 mL/min): No adjustment recommended.
ESRD (CrCl less than 15 mL/min) not on dialysis: Data not available
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
-This drug has not been studied in patients with severe liver dysfunction.
-Previous hypersensitivity reaction to the active component
-Coadministration with drugs that significantly decrease cabotegravir plasma levels due to UGT1A1 enzyme induction (which may lead to loss of virologic response), including carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, rifapentine
-Contraindications to rilpivirine
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Data not available
-This drug is highly bound to plasma proteins; significant removal via dialysis is unlikely.
-Consult the manufacturer product information for cabotegravir-rilpivirine IM before starting this drug to ensure treatment with cabotegravir-rilpivirine IM is appropriate.
-Administer this drug with oral rilpivirine at about the same time each day with a meal.
-Consult the manufacturer product information regarding missed doses.
-Store below 30C (86F).
-Before starting this drug, healthcare professionals should be aware that use of cabotegravir-rilpivirine IM with rifabutin is contraindicated.
-This drug should not be used in patients with known/suspected resistance to cabotegravir or rilpivirine.
-Dosing for cabotegravir-rilpivirine regimen consists of 3 distinct phases: an oral lead-in with this drug coadministered with rilpivirine tablets (month 1), initiation injections of cabotegravir-rilpivirine IM (month 2), and continuation injections with cabotegravir-rilpivirine IM (month 3 onwards).
-The manufacturer product information for rilpivirine tablets should be consulted.
-Hepatic: Liver chemistries
-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).
-It is important to take this drug on a regular dosing schedule with a meal at the same time as oral rilpivirine; avoid missing doses as this can lead to development of resistance.
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