Viral infections:

Indications for: APRETUDE

For pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in at-risk adults and adolescents.

Adult Dosage:

Prior to initiation (with or without an oral cabotegravir lead-in) and each subsequent inj, must have a negative HIV-1 test. Must be administered by a healthcare provider. Give each IM inj at gluteal inj sites. Do not administer by any other route or anatomical site. ≥12yrs (≥35kg): Initiate injections at 600mg once on Months 1 and 2; continue at 600mg every 2 months starting on Month 4 onwards (may be given up to 7 days before or after the scheduled date to receive injections). With oral lead-in (cabotegravir for at least 28 days): initiate injections (on the last day of oral lead-in or within 3 days thereafter) at 600mg once on Months 2 and 3; continue at 600mg every 2 months starting on Month 5 onwards (may be given up to 7 days before or after the scheduled date to receive injections). Concomitant rifabutin (started before or with the 1st inj): initiate injections at 600mg once, repeat dose 2 weeks later, and then monthly thereafter while on rifabutin; (started with 2nd inj or later): 600mg monthly while on rifabutin. Missed injections: see full labeling.

Children Dosage:

<12yrs or <35kg: not established.

APRETUDE Contraindications:

Unknown or positive HIV-1 status. Concomitant carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, rifapentine.

Boxed Warning:

Risk of drug resistance with use of Apretude for HIV-1 pre-exposure prophylaxis (PrEP) in undiagnosed HIV-1 infection.

APRETUDE Warnings/Precautions:

Provide comprehensive management to reduce the risk of HIV-1 acquisition. Counsel individuals on the use of other prevention measures (eg, condom use, knowledge of partner(s)’ HIV-1 status, regular testing for STIs). Potential risk of resistance: reassess for HIV-1 acquisition risk; test before each inj to confirm HIV-1 negative status. Discontinue immediately if hypersensitivity reactions occur. Monitor liver function; discontinue if hepatotoxicity is suspected. Promptly evaluate if depressive symptoms occur. Long-acting properties: residual drug concentrations may remain ≥12months. Severe hepatic impairment. Severe renal impairment or ESRD: monitor. Elderly. Pregnancy. Nursing mothers: assess benefit/risk to infant.

APRETUDE Classification:

HIV-1 integrase strand transfer inhibitor (INSTI).

APRETUDE Interactions:

See Contraindications. Antagonized by strong UGT1A1 or 1A9 inducers. Antagonized by rifabutin (see Adult dose). Concomitant methadone; monitor; may need dose adjustment.

Adverse Reactions:

Inj site reactions, diarrhea, headache, pyrexia, fatigue, sleep disorders, nausea, dizziness, flatulence, abdominal pain, vomiting, myalgia, rash, decreased appetite, somnolence, back pain, upper respiratory tract infection; hepatotoxicity, depressive disorders.

Generic Drug Availability:

NO

How Supplied:

Kit—1 (vial w. supplies)

Pricing for APRETUDE

3ml of 600mg/3ml kit (Qty: 3)
Appx. price $3656
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