Version May 2024
Individuals must be tested for HIV-1 infection prior to initiating IM or oral cabotegravir, and with each subsequent injection of cabotegravir, using a test approved or cleared by the FDA for the diagnosis of acute or primary HIV-1 infection. Drug-resistant HIV-1 variants have been identified with use of cabotegravir by individuals with undiagnosed HIV-1 infection. Do not initiate IM cabotegravir for HIV-1 preexposure prophylaxis (PrEP) unless negative infection status is confirmed. Individuals who become infected with HIV-1 while receiving IM cabotegravir for PrEP must transition to a complete HIV-1 treatment regimen.
HIV infection, preexposure prophylaxis:
Note: May initiate with cabotegravir oral lead-in therapy prior to IM injections or may precede directly to IM injections without oral lead-in.
Oral lead-in therapy: Oral: 30 mg once daily for ~1 month (≥28 days) (CDC 2021; Delany-Moretlwe 2022; Landovitz 2021). Administer IM initiation injection on the last day of oral lead-in, or within 3 days after.
Initiation injections: IM: 600 mg once monthly for 2 doses (CDC 2021; Delany-Moretlwe 2022; Landovitz 2021); if using oral lead-in, first IM initiation injection should be administered on the last day of oral lead-in, or within 3 days after. Note: Second initiation injection may be administered up to 7 days before or after the date the individual is scheduled to receive the injection.
Continuation injections: IM: 600 mg once every 2 months, starting 2 months after the last initiation injection (CDC 2021; Delany-Moretlwe 2022; Landovitz 2021). Note: Continuation injections may be administered up to 7 days before or after the date the individual is scheduled to receive the injection.
Missed doses:
Planned missed injections:
Oral bridging therapy: If a patient plans to miss a scheduled every-2-month continuation injection visit by >7 days, administer oral cabotegravir 30 mg once daily for up to 2 months to replace 1 missed scheduled every-2-month injection. The first dose of oral therapy should be administered ~2 months after the last injection dose; restart injections on the day oral dosing is stopped or within 3 days after. If oral cabotegravir is continued >2 months, an alternative oral PrEP regimen is recommended.
Unplanned missed injections: If a scheduled injection visit is missed or delayed by >7 days and oral therapy has not been administered in the interim, clinically reassess patient to determine appropriateness of resumption of injection dosing. If injection dosing will be continued, administer as follows:
Second injection missed:
≤2 months since first injection: Administer missed injection as soon as possible, then continue to follow the every-2-month injection dosing schedule.
>2 months since first injection: Restart with cabotegravir 600 mg IM, followed by a second 600 mg IM injection dose 1 month later. Then, continue to follow the every-2-month injection dosing schedule.
Third or subsequent injection missed:
≤3 months since last injection: Administer missed injection as soon as possible, then continue with every-2-month injection dosing schedule.
>3 months since last injection: Restart with cabotegravir 600 mg IM, followed by a second 600 mg IM injection dose 1 month later. Then, continue with the every-2-month injection dosing schedule.
HIV infection, treatment: Oral:
Oral lead-in therapy: Note: May initiate with cabotegravir and rilpivirine oral lead-in therapy prior to initiation of IM injections of cabotegravir and rilpivirine or may precede directly to IM injections without oral lead-in.
30 mg once daily, in combination with oral rilpivirine, for ~1 month (≥28 days) prior to initiation of cabotegravir and rilpivirine injections, to assess tolerability to cabotegravir. Final oral dose should be taken on the same day as initiation of injections.
Oral bridging therapy: 30 mg once daily, in combination with oral rilpivirine, in patients who plan to miss a scheduled cabotegravir and rilpivirine injection visit by >7 days. Note: First oral dose should be initiated at approximately the same time as the planned missed injection dose and continued until the day injection dosing is restarted. Oral therapy may be used for up to 2 months to replace missed injection(s).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
CrCl ≥15 mL/minute: No dosage adjustment necessary (Parasrampuria 2019).
End-stage renal disease not on dialysis: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Patients on dialysis: There are no dosage adjustments provided in the manufacturer's labeling; because of high protein binding, dialysis is not expected to alter cabotegravir exposure.
Mild to moderate impairment (Child-Pugh class A or B): No dosage adjustment necessary.
Severe impairment (Child-Pugh class C): There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
Refer to adult dosing.
(For additional information see "Cabotegravir: Pediatric drug information")
HIV-1 infection, preexposure prophylaxis (PrEP):
Note: HIV testing must be negative before initiation and each subsequent injection. Cabotegravir is available in 2 dosage forms which have unique indications and dosing: Immediate-release oral tablets (Vocabria) and extended-release IM injection (Apretude); use caution to ensure correct product selection and dosing. Prior to initiating injection therapy, oral lead-in therapy to assess tolerability is an option, but is not required.
Children ≥12 years and Adolescents, weighing ≥35 kg:
Oral: Immediate release (Vocabria):
Oral lead-in: Oral: 30 mg once daily for ~1 month (≥28 days). Initiate cabotegravir injection (Apretude) on the same day as the final oral dose, or within 3 days.
Oral bridging therapy: Patients who plan to miss a scheduled cabotegravir injection visit by >7 days: Oral: 30 mg once daily for up to 2 months to replace 1 missed scheduled injection. First oral dose should be initiated ~2 months after the last injection dose and continued until the day injection dosing is restarted; restart injection dosing within 3 days of last oral dose.
IM: Extended release (Apretude):
Initiation: IM: 600 mg once a month for 2 months, followed by continuation dosing. The second injection may be administered ≤7 days before or after the scheduled date. If oral lead-in is used, administer first injection within 3 days of the final oral dose.
Continuation: IM: 600 mg every 2 months, starting 2 months following completion of initiation dosing. Injections may be administered ≤7 days before or after the scheduled date.
HIV-1 infection, treatment: Note: Gene mutation and antiretroviral resistance patterns should be evaluated (refer to https://www.iasusa.org for more information) when necessary.
Combination treatment with oral rilpivirine: Note: Prior to initiating cabotegravir and rilpivirine injection therapy, oral lead-in therapy to assess tolerability is an option, but is not required.
Children ≥12 years and Adolescents, weighing ≥35 kg:
Oral lead-in therapy: Oral: 30 mg once daily for ~1 month (≥28 days) prior to initiation of cabotegravir and rilpivirine injections, to assess tolerability to cabotegravir. Final oral dose should be taken on the same day as initiation of injections.
Oral bridging therapy: Patients who plan to miss a scheduled cabotegravir and rilpivirine injection visit by >7 days: Oral: 30 mg once daily for up to 2 months to replace missed scheduled injection(s). First oral dose should be initiated at approximately the same time as the planned missed injection dose and continued until the day injection dosing is restarted.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Children ≥12 years and Adolescents, weighing ≥35 kg:
Mild to moderate kidney impairment: No dosage adjustment necessary.
Severe kidney impairment: There are no dosage adjustments provided in the manufacturer's labeling; increase monitoring for adverse effects.
Dialysis: There are no dosage adjustments provided in the manufacturer's labeling; because of high protein binding, dialysis is not expected to alter cabotegravir exposure.
Children ≥12 years and Adolescents, weighing ≥35 kg:
Mild to moderate impairment: No dosage adjustment necessary.
Severe impairment: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adults.
>10%:
Local: Induration at injection site (12% to 15%), injection-site nodule (14% to 15%), injection-site reaction (38% to 82%; severe: ≤3%), pain at injection site (≤98%), swelling at injection site (12% to 18%), tenderness at injection site (≤98%)
Nervous system: Headache (2% to 12%)
Neuromuscular & skeletal: Increased creatine phosphokinase in blood specimen (2% to 15%)
1% to 10%:
Dermatologic: Skin rash (≤2%)
Gastrointestinal: Abdominal distress (≤2%), abdominal pain (1% to 2%), decreased appetite (≤2%), diarrhea (2% to 4%), flatulence (≤1%), increased serum lipase (≤3%), nausea (3% to 4%), vomiting (≤2%)
Hepatic: Increased serum alanine aminotransferase (≤2%), increased serum aspartate aminotransferase (≤3%)
Local: Abscess at injection site (≤2%), bruising at injection site (1% to 4%), erythema at injection site (4% to 5%), injection-site numbness (1%), injection-site pruritus (3% to 6%), skin discoloration at injection site (≤1%), warm sensation at injection site (≤3%)
Nervous system: Anxiety (≤1%), asthenia (≤2%), dizziness (2% to 4%), drowsiness (≤2%), fatigue (1% to 4%), sleep disorder (1% to 3%, including abnormal dreams and insomnia)
Neuromuscular & skeletal: Back pain (≤1%), myalgia (≤2%)
Renal: Increased serum creatinine (3% to 5%)
Respiratory: Upper respiratory tract infection (2% to 4%)
Miscellaneous: Fever (≤4%)
<1%:
Cardiovascular: Presyncope, vasodepressor syncope
Dermatologic: Pruritus
Endocrine & metabolic: Weight gain
Hepatic: Hepatotoxicity
Nervous system: Depression, suicidal ideation, suicidal tendencies
Frequency not defined: Endocrine & metabolic: Change in LDL, decreased HDL cholesterol, hypercholesterolemia, increased serum triglycerides
Postmarketing:
Endocrine & metabolic: Diabetes mellitus (O’Halloran 2022), hyperglycemia (O’Halloran 2022)
Hypersensitivity: Hypersensitivity reaction (including angioedema)
Nervous system: Major depressive disorder, mood changes (including depressed mood and emotional lability)
Hypersensitivity to cabotegravir or any component of the formulation; concomitant use with uridine diphosphate-glucuronosyl transferase 1A1 enzyme inducers (antiseizure medications [eg, carbamazepine, oxcarbazepine, phenobarbital, phenytoin], antimycobacterials [eg, rifampin, rifapentine]); unknown or positive HIV-1 status (when used for HIV-1 preexposure prophylaxis).
Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
Concerns related to adverse effects:
• Depressive disorders: Depressive disorders, including altered or depressed mood, depression, mood swings, and suicidal ideation or attempt, have been reported. Evaluate patients with depressive symptoms to assess relation to cabotegravir use and risk/benefit of continued therapy.
• Hepatotoxicity: Hepatotoxicity has been reported in patients with or without known preexisting hepatic disease or other risk factors. Patients with underlying hepatic disease or marked elevations in transaminases prior to treatment may be at increased risk for worsening or development of transaminase elevations. Monitor liver chemistries and discontinue treatment if hepatoxicity is suspected.
• Hypersensitivity reactions: Serious or severe hypersensitivity reactions have been reported with other integrase inhibitors. Oral lead-in dosing was used in clinical trials to help identify individuals who may be at risk of a hypersensitivity reaction. Discontinue immediately if signs of hypersensitivity (eg, severe rash, rash with fever, malaise, fatigue, muscle/joint aches, blisters, oral blisters/lesions, conjunctivitis, facial edema, hepatitis, eosinophilia, angioedema, difficulty breathing) occur.
Other warnings/precautions:
• Comprehensive prevention strategy: Preexposure prophylaxis (PrEP) should be accompanied by a comprehensive HIV-1 prevention strategy (eg, counseling on use of other preventative measures, adherence to dosing schedule and safer sex practices). Time from initiation of therapy to maximal protection against HIV-1 infection is unknown. Prior to initiation for PrEP, ask seronegative individuals about potential exposure events in the past month and evaluate for current or recent signs/symptoms consistent with acute HIV-1 infection. If recent (<1 month) exposures to HIV-1 are suspected or clinical symptoms consistent with acute HIV-1 infection are present, use an FDA-approved/cleared test as an aid in the diagnosis of acute or primary HIV-1 infection. Repeat testing prior to each cabotegravir injection and upon diagnosis of any other sexually transmitted infections. If an HIV-1 test indicates possible infection, or if symptoms consistent with acute infection develop following an exposure event, additional testing is needed to determine HIV status. If HIV-1 infection is confirmed, transition therapy to a complete HIV-1 treatment regimen. If an antigen-/antibody-specific test is used with negative results, an RNA-specific assay should also be performed to confirm.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension Extended Release, Intramuscular [preservative free]:
Apretude: 600 mg/3 mL (3 mL) [contains polyethylene glycol (macrogol)]
Tablet, Oral, as sodium:
Vocabria: 30 mg
May be product dependent
Suspension Extended Release (Apretude Intramuscular)
600 mg/3 mL (per mL): $1,547.60
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Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral, as sodium:
Generic: 30 mg
Oral: Administer with a meal.
IM: For health care professional administration only. If refrigerated, allow vial to warm to room temperature prior to administration (not to exceed 30°C [86°F]). Shake vial vigorously for 10 seconds to achieve a uniform suspension; if not uniform, shake again; small air bubbles are expected and acceptable. Using provided vial adapter, withdraw appropriate volume of medication into syringe. Administer IM, preferably as a ventrogluteal injection; dorsogluteal (upper outer quadrant) injection is also acceptable; do not administer at any other site. Provided needle may not be a length sufficient to reach the gluteus muscle in individuals with higher BMI (eg, >30 kg/m2); longer length needles may be required. Administer within 2 hours of drawing into the syringe.
Oral: Administer with a meal at same time daily.
Parenteral: IM: For health care professional administration only. If stored in refrigerator, allow to come to room temperature prior to administration. Shake vial vigorously for 10 seconds to achieve a uniform suspension; if not uniform, shake again; small air bubbles are expected and acceptable. Using vial adapter, withdraw appropriate volume of medication into syringe. Administer IM, preferably as a ventrogluteal injection; dorsogluteal (upper outer quadrant) injection is also acceptable; do not administer at any other site. A needle is included in the dosing kit, but longer needles may be needed for individuals with higher BMI (eg, >30 kg/m2) to ensure IM (versus subcutaneous) injection. Administer within 2 hours of drawing into the syringe.
Missed IM doses:
Planned (to miss by >7 days): Take oral cabotegravir daily for ≤2 months to replace 1 missed scheduled injection; if treating >2 months, use an alternative oral regimen.
Unplanned (missed or delayed by >7 days): Reassess individual to determine if injection therapy is appropriate given importance of adherence. If decision is to continue, recommended action depends on injection number and time since the previous injection; see table.
|
Dose Missed |
Time Since Previous Dose |
Recommendation |
|---|---|---|
|
Second injection |
≤2 months |
Administer dose as soon as possible, then continue every-2-month schedule |
|
>2 months |
Restart initiation dosing (2 doses separated by 1 month), followed by every-2-month schedule | |
|
Third injection or after |
≤3 months |
Administer dose as soon as possible, then continue every-2-month schedule |
|
>3 months |
Restart initiation dosing (2 doses separated by 1 month), followed by every-2-month schedule |
HIV-1 infection:
Preexposure prophylaxis:
Injection: Preexposure prophylaxis (PrEP) in at-risk adults and adolescents weighing ≥35 kg to reduce the risk of sexually acquired HIV-1 infection. Individuals must have a negative HIV-1 test prior to initiating cabotegravir (with or without an oral lead-in with oral cabotegravir) for HIV-1 PrEP.
Oral: As oral lead-in to assess tolerability of cabotegravir prior to administration of IM cabotegravir or as oral bridging therapy for missed cabotegravir injections.
Treatment:
Oral: Short-term treatment of HIV-1 infection (in combination with rilpivirine) in adults and adolescents ≥12 years of age weighing ≥35 kg who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and no known or suspected resistance to cabotegravir or rilpivirine, as an oral lead-in to assess tolerability of cabotegravir prior to initiating IM cabotegravir and rilpivirine, or an oral bridging therapy for missed cabotegravir injections.
Substrate of BCRP/ABCG2, P-glycoprotein/ABCB1 (minor), UGT1A1, UGT1A9; Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Betibeglogene Autotemcel: Antiretroviral Agents may diminish the therapeutic effect of Betibeglogene Autotemcel. Risk X: Avoid combination
Elivaldogene Autotemcel: Antiretroviral Agents may diminish the therapeutic effect of Elivaldogene Autotemcel. Management: Avoid use of antiretroviral medications for at least one month, or for the amount of time required for elimination of the retroviral medication, prior to stem cell mobilization and until the all apheresis cycles are finished Risk X: Avoid combination
Lovotibeglogene Autotemcel: Antiretroviral Agents may diminish the therapeutic effect of Lovotibeglogene Autotemcel. Risk X: Avoid combination
Mitapivat: May decrease the serum concentration of UGT1A1 Substrates. Risk C: Monitor therapy
Orlistat: May decrease the serum concentration of Antiretroviral Agents. Risk C: Monitor therapy
OXcarbazepine: May decrease the serum concentration of Cabotegravir. Risk X: Avoid combination
Polyvalent Cation Containing Products: May decrease the serum concentration of Cabotegravir. Management: Administer polyvalent cation containing products at least 2 hours before or 4 hours after oral cabotegravir. Risk D: Consider therapy modification
Rifabutin: May decrease the serum concentration of Cabotegravir. Additionally, rifabutin may decrease rilpivirine concentrations, a drug often coadministered with IV cabotegravir. Management: Do not use long-acting injectable cabotegravir (Cabenuva) with rifabutin. Cabotegravir dose adjustments required if extended-release suspension (Apretude) is coadministered with rifabutin. No interaction expected with cabotegravir tablets. Risk D: Consider therapy modification
Rifapentine: May decrease the serum concentration of Cabotegravir. Risk X: Avoid combination
UGT1A1 Inducers: May decrease the serum concentration of Cabotegravir. Risk X: Avoid combination
Contraception is not required to initiate or continue antiretroviral therapy.
The Health and Human Services (HHS) perinatal HIV guidelines note data are insufficient to recommend cabotegravir (oral or IM) for the treatment of patients with HIV infection who are not yet pregnant but are trying to conceive. The long half-life of the injection should be considered in patients planning to conceive.
Maximum viral suppression sustained below the limits of detection prior to conception is recommended for all persons with HIV who are planning a pregnancy. Optimization of the health of the person who will become pregnant is recommended. Selection of or changes to a specific antiretroviral regimen prior to pregnancy should be done as part of a shared decision-making process. In most cases, recommendations from the HHS perinatal HIV guidelines (based on data obtained from cisgender women) can be applied to transgender and gender diverse people assigned female sex at birth.
Cabotegravir IM is recommended for preexposure prophylaxis in patients at risk for HIV infection; however, safety data if pregnancy occurs during treatment are limited. Pregnancy testing should be done at baseline, then as indicated. The optimal time to conceive following the last injection is not known.
Health care providers caring for couples planning a pregnancy when one or both partners are diagnosed with HIV may contact the National Perinatal HIV Hotline (1-888-448-8765) for clinical consultation (HHS [perinatal] 2023).
Based on a placental perfusion study, cabotegravir has a low level for potential transfer across the human placenta.
Data collected by the antiretroviral pregnancy registry are insufficient to evaluate human teratogenic risk. Maternal antiretroviral therapy (ART) may be associated with adverse pregnancy outcomes including preterm birth, low birth weight, and small for gestational age infants. Actual risks may be influenced by maternal factors such as disease severity, gestational age at initiation of therapy, and specific ART regimen, therefore close fetal monitoring is recommended. Because there is clear benefit to appropriate treatment, maternal ART should not be withheld due to concerns for adverse neonatal outcomes. Long-term follow-up is recommended for all infants exposed to antiretroviral medications; children not diagnosed with HIV but who were exposed to ART in utero or as a neonate and develop significant organ system abnormalities of unknown etiology (particularly of the CNS or heart) should be evaluated for potential metabolic dysfunction.
The Health and Human Services (HHS) perinatal HIV guidelines do not recommend cabotegravir (oral or IM) for the treatment of pregnant patients with HIV infection who are antiretroviral-naïve; data are insufficient to recommend treatment of patients who are pregnant who have had ART in the past but are restarting, or who require a new ART regimen (due to poor tolerance or poor virologic response of current regimen). Patients who become pregnant during therapy may continue with frequent monitoring if viral suppression is effective and the regimen is well tolerated or consider changing to a preferred or alternate regimen due to insufficient data for cabotegravir. When the decision to switch therapies is made, patients who become pregnant on the long-acting IM formulation should be changed to a recommended oral regimen within 4 weeks of the last injection.
Cabotegravir IM is recommended for preexposure prophylaxis (PrEP) in patients at risk for HIV infection; however, safety data if pregnancy occurs during treatment are limited. The initiation or continued use of cabotegravir IM for PrEp during pregnancy should be done as part of a shared decision-making process.
Pharmacokinetic studies of oral or IM cabotegravir are insufficient to make dosing recommendations for patients who are pregnant.
ART is recommended for all pregnant people with HIV to maximize their health, maintain the viral load below the limit of detection and reduce the risk of perinatal transmission. Selection of or changes to a specific antiretroviral regimen during pregnancy should be done as part of a shared decision-making process. Monitoring of patients who are pregnant is more frequent than in patients who are not pregnant. ART initiated during pregnancy can be modified after delivery. In most cases, recommendations from the HHS perinatal HIV guidelines (based on data obtained from cisgender women) can be applied to transgender and gender diverse people assigned female sex at birth.
Data collection to monitor pregnancy and infant outcomes following exposure to ART is ongoing. Health care providers should enroll all patients exposed to antiretroviral medications during pregnancy in the Antiretroviral Pregnancy Registry (1-800-258-4263). Enrollment should be done as early in pregnancy as possible.
Health care providers caring for pregnant patients with HIV and their infants may contact the National Perinatal HIV Hotline (1-888-448-8765) for clinical consultation (HHS [perinatal] 2023).
It is not known if cabotegravir is present in breast milk.
Maintaining maximum viral suppression during pregnancy and postpartum decreases but does not eliminate the risk of HIV transmission via breast milk. In addition, multiclass-resistant virus has been detected in breastfeeding infants who acquire HIV despite maternal therapy. In the United States, where formula is usually accessible, affordable, safe, and sustainable, and the risk of infant mortality due to diarrhea and respiratory infections is low, the Health and Human Services perinatal HIV guidelines do not recommend breastfeeding for patients with HIV when safer infant feeding options are available. Persons with HIV who maintain an undetectable viral load while taking antiretroviral therapy (ART) should evaluate infant feeding options (formula, banked donor milk, or breastfeeding) as part of a shared decision-making process (if breastfeeding is being considered, see guidelines for measures to reduce the risk of HIV transmission). When the HIV status at delivery is not known, breast milk may be expressed and stored until a negative test is available. If HIV infection is diagnosed after breastfeeding has been initiated, breastfeeding should be discontinued immediately. Breastfeeding is not recommended for persons with HIV who are not taking ART and/or who do not have sustained viral suppression.
Information is available for counseling and managing patients with HIV who are considering breastfeeding (1-888-448-8765). In most cases, recommendations from the HHS perinatal HIV guidelines (based on data obtained from cisgender women) can be applied to transgender and gender diverse people assigned female sex at birth (HHS [perinatal] 2023).
Take oral tablet with a meal.
Liver chemistries; signs/symptoms of hypersensitivity and/or skin reactions; changes in mood.
HIV-1 preexposure prophylaxis (PrEP) (CDC 2021): Documented negative HIV-1 RNA assay (≤1 week before initiating or reinitiating PrEP, at 1 month post-initiation, then every 2 months while taking PrEP, and following discontinuation of PrEP), assess symptoms of acute HIV infection (prior to initiation of PrEP at 1 month post-initiation, then every 2 months while taking while taking PrEP).
Inhibits HIV integrase by binding to the integrase active site and blocking the strand transfer step of retroviral DNA integration.
Note: Pharmacokinetics in pediatric patients ≥12 years of age weighing ≥35 kg are similar to in adults.
Absorption: Oral: Increased 14% with high-fat meal (compared to fasting) (Patel 2019).
Distribution: Vd: 12.3 L.
Protein binding: >99.8%.
Metabolism: UGT1A1; UGT1A9 (minor).
Half-life elimination: Oral: 41 hours; Injection: 5.6 to 11.5 weeks.
Time to peak: Oral: 3 hours; Injection: 7 days.
Excretion: Urine: 27% (0% as unchanged drug); Feces: 59% (47% as unchanged drug).
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