Usual Adult Dose for HIV Infection

1 tablet orally once a day with a meal

Use: As a complete regimen, for the treatment of HIV-1 infection to replace a stable antiretroviral regimen in patients 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 the individual components

Renal Dose Adjustments

Mild or moderate renal dysfunction (CrCl at least 30 mL/min): No adjustment recommended.
Severe renal dysfunction (CrCl less than 30 mL/min) or ESRD: Increased monitoring for side effects recommended.

Liver Dose Adjustments

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

Dose Adjustments

Coadministration with rifabutin: An additional 25 mg/day of rilpivirine is recommended.

Precautions

CONTRAINDICATIONS:

• Previous hypersensitivity reaction to either active component
• Coadministration with dofetilide (due to potential for elevated dofetilide plasma levels and risk for serious and/or life-threatening events)
• Coadministration with drugs that significantly decrease rilpivirine plasma levels, including carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, rifapentine, proton pump inhibitors (e.g., esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole), systemic dexamethasone (more than single-dose therapy), St. John's wort

Dialysis

Data not available

Other Comments

Administration advice:

• Perform pregnancy testing before starting this drug in patients of childbearing potential (to exclude use during the first trimester of pregnancy).
• Administer with a meal; a protein drink alone does not replace a meal.
• Administer antacids, laxatives, and other products containing aluminum, magnesium, calcium carbonate, or buffered medications at least 6 hours before or 4 hours after this drug.
• Administer oral calcium or iron supplements (including multivitamins containing calcium or iron) and this drug together with a meal; if these supplements are not administered at the same time as this drug and food, administer oral calcium and iron supplements at least 6 hours before or 4 hours after this drug.
• Administer H2-receptor antagonists at least 12 hours before or 4 hours after this drug.
• Consult the manufacturer product information regarding missed doses.

• Store and dispense in original bottle.
• Protect from moisture; keep bottle tightly closed and do not remove desiccant.
• Store at 20C to 25C (68F to 77F); excursions permitted between 15C and 30C (59F and 86F).

• Each combination tablet contains dolutegravir 50 mg and rilpivirine 25 mg.
• Current HIV guidelines should be consulted regarding use of dolutegravir in patients who are pregnant or of childbearing potential.

• General: Pregnancy testing in patients of childbearing potential (before starting therapy)
• Hepatic: For hepatotoxicity

• Read the US FDA-approved patient labeling (Patient Information).
• Take this drug on a regular dosing schedule; do not miss or skip doses as resistance may develop.
• Contact healthcare provider at once if rash develops; stop this drug 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).
• Monitor for hepatotoxicity during therapy.
• Seek medical evaluation at once if depressive symptoms develop.
• Patients of childbearing potential: Consider an alternative regimen at time of conception through the first trimester of pregnancy. Contact healthcare provider if you plan to become pregnant, become pregnant, or suspect you are pregnant during therapy; consistently use effective contraception.

Frequently asked questions

• What drugs are contained in HIV treatment Juluca?