Usual Adult Dose for HIV Infection

Therapy-naive or therapy-experienced integrase strand transfer inhibitor (INSTI)-naive patients or virologically-suppressed (HIV-1 RNA less than 50 copies/mL) patients switching to this drug plus rilpivirine: 50 mg orally once a day

Therapy-naive or therapy-experienced INSTI-naive patients when coadministered with certain UGT1A or CYP450 3A inducers: 50 mg orally twice a day

INSTI-experienced patients with certain INSTI-associated resistance substitutions or clinically suspected INSTI resistance: 50 mg orally twice a day

Comments:

• Rilpivirine dose is 25 mg orally once a day for patients switching to this drug plus rilpivirine.
• The manufacturer product information should be consulted for relevant UGT1A or CYP450 3A inducers.
• In INSTI-experienced patients, alternative combinations that do not include metabolic inducers should be considered where possible.

• In combination with other antiretroviral agents, for the treatment of HIV-1 infection in therapy-naive or therapy-experienced adults
• In combination with rilpivirine, as a complete regimen, for the treatment of HIV-1 infection to replace a stable antiretroviral regimen in adults who are virologically-suppressed (HIV-1 RNA less than 50 copies/mL) for at least 6 months with no history of treatment failure and no known substitutions associated with resistance to either drug

Usual Adult Dose for Nonoccupational Exposure

US CDC Recommendations: 50 mg orally once a day
Duration of therapy: 28 days

Comments:

• This drug plus (emtricitabine-tenofovir disoproxil fumarate [DF] or lamivudine/zidovudine) is recommended as a preferred regimen for nonoccupational postexposure prophylaxis of HIV infection.
• This drug should not be used in nonpregnant females of childbearing potential who are sexually active or have been sexually assaulted and who are not using effective contraception; and,
• This drug should not be used in pregnant women early in pregnancy as the risk of an unborn infant developing a neural tube defect is during the first 28 days.
• Prophylaxis should be started as soon as possible, within 72 hours of exposure.
• Current guidelines should be consulted for additional information.

Usual Pediatric Dose for HIV Infection

4 WEEKS OR OLDER:
Tablets for Oral Suspension:

• Weight 3 to less than 6 kg: 5 mg orally once a day
• Weight 6 to less than 10 kg: 15 mg orally once a day
• Weight 10 to less than 14 kg: 20 mg orally once a day
• Weight 14 to less than 20 kg: 25 mg orally once a day
• Weight at least 20 kg: 30 mg orally once a day

• Weight 14 to less than 20 kg: 40 mg orally once a day
• Weight at least 20 kg: 50 mg orally once a day

• If switching from the tablet formulation to the tablets for oral suspension formulation, the recommended dosage for Tablets for Oral Suspension should be followed.
• If switching from the tablets for oral suspension formulation to the tablet formulation, the recommended dosage for Tablets should be followed.
• The tablet formulation should not be used in patients weighing 3 to 14 kg; the tablets for oral suspension formulation is preferred in patients weighing less than 20 kg.
• If certain UGT1A or CYP450 3A inducers are coadministered, the recommended dose should be administered twice a day; the manufacturer product information should be consulted for relevant inducers.
• Safety and efficacy not established in INSTI-experienced patients with documented/clinically suspected resistance to other INSTIs (e.g., raltegravir, elvitegravir).

Usual Pediatric Dose for Nonoccupational Exposure

US CDC Recommendations:
13 years or older and weighing at least 40 kg: 50 mg orally once a day
Duration of therapy: 28 days

Comments:

• This drug plus (emtricitabine-tenofovir DF or lamivudine/zidovudine) is recommended as a preferred regimen for nonoccupational postexposure prophylaxis of HIV infection.
• This drug should not be used in nonpregnant females of childbearing potential who are sexually active or have been sexually assaulted and who are not using effective contraception; and,
• This drug should not be used in pregnant women early in pregnancy as the risk of an unborn infant developing a neural tube defect is during the first 28 days.
• Prophylaxis should be started as soon as possible, within 72 hours of exposure.
• Current guidelines should be consulted for additional information.

Renal Dose Adjustments

Therapy-naive or therapy-experienced INSTI-naive patients:

• Mild, moderate, or severe renal dysfunction: No adjustment recommended.

• Mild or moderate renal dysfunction: No adjustment recommended.
• Severe renal dysfunction: Caution recommended.

• INSTI-experienced patients with severe renal dysfunction: Reduced dolutegravir levels may lead to loss of therapeutic effect and development of resistance to this drug or other concomitant antiretroviral agents.

Liver Dose Adjustments

Mild to moderate liver dysfunction (Child-Pugh A or B): No adjustment recommended.
Severe liver dysfunction (Child-Pugh C): Not recommended.

Precautions

CONTRAINDICATIONS:
Previous hypersensitivity reaction to the active component; coadministration with dofetilide

Safety and efficacy have not been established in patients younger than 4 weeks or weighing less than 3 kg or in any pediatric patients who are INSTI-experienced with documented/clinically suspected resistance to other INSTIs (e.g., raltegravir, elvitegravir).

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:

• Pregnancy testing is recommended before starting this drug in adolescents and adults of childbearing potential.
• Administer with or without food.
• For pediatric patients: Do not interchange the tablet formulation and the tablets for oral suspension formulation on a mg-per-mg basis (due to differing pharmacokinetic profiles); if a patient is switched from 1 formulation to the other, adjust the dose for the new formulation.
• Tablets for Oral Suspension: Do not chew, cut, or crush. Either:
• Swallow tablet(s) whole (if more than 1 tablet is needed, swallow 1 tablet at a time to reduce risk of choking), or
• Fully disperse tablet(s) in 5 mL of drinking water (if using 1 or 3 tablets) or 10 mL (if using 4, 5, or 6 tablets) in the supplied cup; swirl the suspension so no lumps remain. After full dispersion, administer the oral suspension within 30 minutes of mixing.
• Administer products containing polyvalent cations (e.g., aluminum or magnesium) and oral supplements containing calcium or iron (including multivitamins containing calcium or iron) 6 hours before or 2 hours after this drug; may administer supplements/multivitamins containing calcium or iron and this drug at the same time with food
• Consult the manufacturer product information regarding missed doses.

• Tablets: Store at 25C (77F); excursions permitted to 15C to 30C (59F to 86F).
• For 10 mg tablets: Store and dispense in original bottle, protect from moisture, and keep bottle tightly closed; do not remove desiccant.
• Tablets for Oral Suspension: Store below 30C (86F); store and dispense in original bottle, protect from moisture, and keep bottle tightly closed; do not remove desiccant.

• Tablets for Oral Suspension: The manufacturer product information should be consulted.

• General: Pregnancy testing in adolescents and adults of childbearing potential (before starting therapy)
• Hepatic: For hepatotoxicity (during therapy), especially in patients with liver disease such as hepatitis B or C

• Read the US FDA-approved patient labeling (Patient Information and Instructions for Use).
• Contact healthcare provider at once if rash develops; stop this drug and other suspect agents immediately and seek medical attention if rash associated with any of the following symptoms develop: fever, general ill feeling, extreme tiredness, muscle/joint aches, blisters/peeling of skin, oral blisters/lesions, eye inflammation, facial swelling, swelling of eyes/lips/tongue/mouth, difficulty breathing, and/or signs/symptoms of liver problems (e.g., yellowing of skin/whites of eyes, dark/tea-colored urine, pale-colored stools/bowel movements, nausea, vomiting, loss of appetite, pain/aching/sensitivity on right side below ribs).
• Adolescents and adults of childbearing potential (including those actively trying to become pregnant): Discuss the risks and benefits of this drug with healthcare provider to decide if alternative therapy should be considered at time of conception through the first trimester of pregnancy; contact healthcare provider if pregnancy is confirmed in the first trimester.
• Adolescents and adults of childbearing potential: The consistent use of effective contraception is recommended.
• Consult healthcare provider at once if any signs/symptoms of infection.
• Visually inspect the tablets to verify the correct formulation.

Frequently asked questions

• What drugs are contained in HIV treatment Juluca?