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Dolutegravir / Rilpivirine Dosage

Medically reviewed by Drugs.com. Last updated on Jan 7, 2020.

Applies to the following strengths: 50 mg-25 mg

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): 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 drugs for which elevated plasma levels are associated with serious and/or life-threatening events or that may significantly decrease rilpivirine plasma levels
-Coadministration with dofetilide, carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifampin, rifapentine, proton pump inhibitors (e.g., esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole), systemic dexamethasone (more than a single dose), St. John's wort

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for dosing related precautions.

Dialysis

ESRD: Increased monitoring for side effects recommended.

Other Comments

Administration advice:
-Perform pregnancy testing before starting this drug in patients of reproductive 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.

Storage requirements:
-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 to 15C to 30C (59F to 86F).

General:
-Each combination tablet contains dolutegravir 50 mg and rilpivirine 25 mg.
-The Department of Health and Human Services Antiretroviral Guidelines Panels provide the following interim recommendations regarding use of dolutegravir in women who are pregnant or of reproductive potential:
---Women not known to be pregnant should have a negative pregnancy test before starting dolutegravir.
---Women currently using a dolutegravir-containing regimen or who wish to be started on dolutegravir should be apprised of the potential risk of neural tube defects when dolutegravir is used near time of conception; neural tube defects occur within the first 28 days after conception or 6 weeks from the last menstrual period.
---Within 8 weeks from last menstrual period, pregnant women using dolutegravir should consult healthcare providers regarding the risks and benefits of their current regimens; if good alternative options are available, then patients should be switched to a regimen without dolutegravir.
---Pregnant women at least 8 weeks from last menstrual period may start or continue dolutegravir-containing regimens.
-Current HIV guidelines should be consulted for additional information.

Monitoring:
-Hepatic: For hepatotoxicity

Patient advice:
-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).
-Monitoring for hepatotoxicity is recommended.
-Seek medical evaluation at once if depressive symptoms develop.
-Patients of childbearing potential: Contact healthcare provider if you plan to become pregnant, become pregnant, or suspect you are pregnant during therapy; consistently use effective contraception.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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