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APRETUDE is administered as an intramuscular injection by a healthcare professional every 2 months after 2 initiation injections administered 1 month apart.¹

APRETUDE Information

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A zero is removed if a 10-digit NDC is needed. 600-mg/3-mL cabotegravir: 49702-264-23.¹

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List price to wholesalers and warehousing chains, not including prompt pay, stocking, or distribution allowances, or other discounts, rebates, or chargebacks. List price may not represent prices charged to other customers, including specialty distributors.

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Modifier 33 does not guarantee coverage or zero cost-sharing. Actual reimbursement and patient cost-sharing is subject to the payer’s coverage policy. Reference payer instructions to help ensure accurate billing.

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Do not use APRETUDE in individuals:

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Use APRETUDE as part of a comprehensive prevention strategy, including adherence to the administration schedule and safer sex practices, including condoms, to reduce the risk of sexually transmitted infections (STIs). APRETUDE is not always effective in preventing HIV-1 acquisition. Risk for HIV-1 acquisition includes, but is not limited to, condomless sex, past or current STIs, self-identified HIV risk, having sexual partners of unknown HIV-1 viremic status, or sexual activity in a high prevalence area or network. Inform, counsel, and support individuals on the use of other prevention measures (e.g., consistent and correct condom use; knowledge of partner(s) HIV-1 status, including viral suppression status; regular testing for STIs)

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Use APRETUDE only in individuals confirmed to be HIV-1 negative. HIV-1 resistance substitutions may emerge in individuals with undiagnosed HIV-1 infection who are taking only APRETUDE, because APRETUDE alone does not constitute a complete regimen for HIV-1 treatment. Prior to initiating APRETUDE, ask seronegative individuals about recent (in past month) potential exposure events and evaluate for current or recent signs or symptoms consistent with acute HIV-1 infection (e.g., fever, fatigue, myalgia, skin rash). If recent (<1 month) exposures to HIV-1 are suspected or clinical symptoms consistent with acute HIV-1 infection are present, use a test approved or cleared by the FDA as an aid in the diagnosis of acute HIV-1 infection

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When using APRETUDE, HIV-1 testing should be repeated prior to each injection and upon diagnosis of any other STIs

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If an HIV-1 test indicates possible HIV-1 infection, or if symptoms consistent with acute HIV-1 infection develop following an exposure event, additional HIV testing to determine HIV status is needed. If HIV-1 infection is confirmed, then transition the individual to a complete HIV-1 treatment

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Counsel HIV-1 uninfected individuals to strictly adhere to the recommended dosing and testing schedule for APRETUDE

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There is a potential risk of developing resistance to APRETUDE if an individual acquires HIV-1 either before, while taking, or following discontinuation of APRETUDE. To minimize this risk, it is essential to clinically reassess individuals for risk of HIV-1 acquisition and to test before each injection to confirm HIV-1–negative status. Individuals who are confirmed to have HIV-1 infection must transition to a complete HIV-1 treatment. Alternative forms of PrEP should be considered following discontinuation of APRETUDE for those individuals at continuing risk of HIV-1 acquisition and initiated within 2 months of the final injection of APRETUDE

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Residual concentrations of cabotegravir may remain in the systemic circulation of individuals for prolonged periods (up to 12 months or longer). Take the prolonged-release characteristics of cabotegravir into consideration and carefully select individuals who agree to the required every-2-month injection dosing schedule because non-adherence to every-2-month injections or missed doses could lead to HIV-1 acquisition and development of resistance

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

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Discontinue APRETUDE immediately if signs or symptoms of hypersensitivity reactions develop. Clinical status, including liver transaminases, should be monitored and appropriate therapy initiated

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Hepatotoxicity has been reported in a limited number of individuals receiving cabotegravir with or without known pre-existing hepatic disease or identifiable risk factors

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Clinical and laboratory monitoring should be considered and APRETUDE should be discontinued if hepatotoxicity is suspected and individuals managed as clinically indicated

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Depressive disorders (including depression, depressed mood, major depression, persistent depressive disorder, suicidal ideation or attempt) have been reported with APRETUDE

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Promptly evaluate patients with depressive symptoms

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The concomitant use of APRETUDE and other drugs may result in reduced drug concentration of APRETUDE

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Refer to the full Prescribing Information for steps to prevent or manage these possible and known significant drug interactions, including dosing recommendations. Consider the potential for drug interactions prior to and during use of, and after discontinuation of APRETUDE; review concomitant medications during use of APRETUDE

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Refer to the full Prescribing Information for important drug interactions with APRETUDE

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Drugs that induce UGT1A1 may significantly decrease the plasma concentrations of cabotegravir

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Lactation: Assess the benefit-risk of using APRETUDE to the infant while breastfeeding due to the potential for adverse reactions and residual concentrations in the systemic circulation for up to 12 months or longer after discontinuation

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Pediatrics: Not recommended in individuals weighing less than 35 kg

Please see full Prescribing Information, including Boxed Warning, for APRETUDE.

CPT=Current Procedural Terminology; HCPCS=Healthcare Common Procedure Coding System; ICD-10-CM=International Classification of Diseases, Tenth Revision, Clinical Modification.

©2022 ViiV Healthcare or licensor.
CBTEML220050 ‌ ‌May 2022
Produced in USA.