*Each JULUCA tablet contains 50 mg of dolutegravir and 25 mg of rilpivirine, and is a pink, oval, film-coated, biconvex tablet debossed with “SV J3T” on one side.
|packLabel=zzz
*Bottle of 30 tablets with child-resistant closure (contains a desiccant) NDC 49702-242-13.
|fdaPatientInfo=(Patient Counseling Information)
|storage=
|nlmPatientInfo=(Link to patient information page)
*Store and dispense in the original package, protect from moisture, and keep the bottle tightly closed. Do not remove desiccant.
|lookAlike=* (Paired Confused Name 1a) — (Paired Confused Name 1b)
*Store at 20°C to 25°C (68°F to 77°F); excursions permitted 15°C to 30°C (59°F to 86°F).
* (Paired Confused Name 2a) — (Paired Confused Name 2b)
|packLabel=
* (Paired Confused Name 3a) — (Paired Confused Name 3b)
[[image:julucalabel.jpeg|none|thumb|400px|This image is provided by the National Library of Medicine.]]
|fdaPatientInfo=
*Advise the patient to read the FDA-approved patient labeling.
=====Severe Skin and Hypersensitivity Reactions=====
*Advise patients to immediately contact their healthcare provider if they develop a rash. Instruct patients to immediately stop taking JULUCA and seek medical attention if they develop a rash associated with any of the following symptoms, as it may be a sign of a more serious reaction such as DRESS severe hypersensitivity: fever; generally ill feeling; extreme tiredness; muscle or joint aches; blisters or peeling of the skin; oral blisters or lesions; eye inflammation; facial swelling; swelling of the eyes, lips, tongue, or mouth; breathing difficulty; and/or signs and symptoms of liver problems (e.g., yellowing of the skin or whites of the eyes; dark or tea-colored urine; pale-colored stools or bowel movements; nausea; vomiting; loss of appetite; or pain, aching, or sensitivity on the right side below the ribs). Advise patients that if hypersensitivity occurs, they will be closely monitored, laboratory tests will be ordered, and appropriate therapy will be initiated.
=====Hepatotoxicity=====
*Inform patients that hepatotoxicity has been reported with rilpivirine and dolutegravir, components of JULUCA. Inform patients that monitoring for hepatotoxicity is recommended.
=====Depressive Disorders=====
*Inform patients that depressive disorders (depressed mood, depression, dysphoria, major depression, mood altered, negative thoughts, suicide attempt, suicidal ideation) have been reported with the components of JULUCA. Advise patients to seek immediate medical evaluation if they experience depressive symptoms.
=====Drug Interactions=====
*JULUCA may interact with many drugs; therefore, advise patients to report to their healthcare provider the use of any other prescription or nonprescription medication or herbal products including St. John’s wort.
=====Administration Instruction=====
*Inform patients that it is important to take JULUCA once daily on a regular dosing schedule with a meal and to avoid missing doses as it can result in development of resistance. Instruct patients that if they miss a dose of JULUCA, to take it as soon as they remember with a meal. Advise patients not to double their next dose. Advise the patient a protein drink alone does not replace a meal.
=====Pregnancy Registry=====
*Inform patients that there is an antiretroviral pregnancy registry to monitor fetal outcomes of pregnant women exposed to JULUCA.
=====Lactation=====
*Instruct women with HIV-1 infection not to breastfeed because HIV-1 can be passed to the baby in the breast milk.
=====Storage=====
*Instruct patients to store JULUCA in the original bottle to protect from moisture and keep the bottle tightly closed. Do not remove desiccant.
*JULUCA, TIVICAY, and TRIUMEQ are trademarks owned by or licensed to the ViiV Healthcare group of companies.
*The other brand listed is a trademark owned by or licensed to its respective owner and is not a trademark owned by or licensed to the ViiV Healthcare group of companies. The maker of this brand is not affiliated with and does not endorse the ViiV Healthcare group of companies or its products.
[[image:julucapatientinsert.png|none|thumb|400px|This image is provided by the National Library of Medicine.]]
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Black Box Warning
Warning Title
See full prescribing information for complete Boxed Warning.
Condition Name: (Content)
Overview
Dolutegravir / rilpivirine is a Acetylcholine release inhibitor, Adrenergic receptor agonist that is FDA approved for the (type of indication of drug) of a list of indications, separated by commas.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include a list of adverse reactions, separated by commas..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Condition 1
Dosing Information
(Dosage)
Condition 2
Dosing Information
(Dosage)
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
Condition 1
Developed by: (Organisation)
Class of Recommendation: (Class) (Link)
Strength of Evidence: (Category A/B/C) (Link)
Dosing Information/Recommendation
(Dosage)
Condition 2
Developed by: (Organisation)
Class of Recommendation: (Class) (Link)
Strength of Evidence: (Category A/B/C) (Link)
Dosing Information/Recommendation
(Dosage)
Non–Guideline-Supported Use
Condition 1
Dosing Information
(Dosage)
Condition 2
Dosing Information
(Dosage)
Condition 3
Dosing Information
(Dosage)
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Condition 1
Dosing Information
(Dosage)
Condition 2
Dosing Information
(Dosage)
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
Condition 1
Developed by: (Organisation)
Class of Recommendation: (Class) (Link)
Strength of Evidence: (Category A/B/C) (Link)
Dosing Information/Recommendation
(Dosage)
Condition 2
Developed by: (Organisation)
Class of Recommendation: (Class) (Link)
Strength of Evidence: (Category A/B/C) (Link)
Dosing Information/Recommendation
(Dosage)
Non–Guideline-Supported Use
Condition 1
Dosing Information
(Dosage)
Condition 2
Dosing Information
(Dosage)
Condition 3
Dosing Information
(Dosage)
Contraindications
CONTRAINDICATIONS
Warnings
Warning Title
See full prescribing information for complete Boxed Warning.
Condition Name: (Content)
Conidition 1
(Description)
Conidition 2
(Description)
Conidition 3
(Description)
Adverse Reactions
Clinical Trials Experience
Central Nervous System
(list/description of adverse reactions)
Cardiovascular
(list/description of adverse reactions)
Respiratory
(list/description of adverse reactions)
Gastrointestinal
(list/description of adverse reactions)
Hypersensitive Reactions
(list/description of adverse reactions)
Miscellaneous
(list/description of adverse reactions)
Condition 2
Central Nervous System
(list/description of adverse reactions)
Cardiovascular
(list/description of adverse reactions)
Respiratory
(list/description of adverse reactions)
Gastrointestinal
(list/description of adverse reactions)
Hypersensitive Reactions
(list/description of adverse reactions)
Miscellaneous
(list/description of adverse reactions)
Postmarketing Experience
(Description)
Drug Interactions
Drug 1
Drug 2
Drug 3
Drug 4
Drug 5
Drug 1
(Description)
Drug 2
(Description)
Drug 3
(Description)
Drug 4
(Description)
Drug 5
(Description)
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
(Description)
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Dolutegravir / rilpivirine in women who are pregnant.
Labor and Delivery
(Description)
Nursing Mothers
(Description)g
Pediatric Use
(Description)
Geriatic Use
(Description)
Gender
(Description)
Race
(Description)
Renal Impairment
(Description)
Hepatic Impairment
(Description)
Females of Reproductive Potential and Males
(Description)
Immunocompromised Patients
(Description)
Others
(Description)
Administration and Monitoring
Administration
(Oral/Intravenous/etc)
Monitoring
Condition 1
(Description regarding monitoring, from Warnings section)
Condition 2
(Description regarding monitoring, from Warnings section)
Condition 3
(Description regarding monitoring, from Warnings section)
IV Compatibility
There is limited information regarding the compatibility of Dolutegravir / rilpivirine and IV administrations.
Each JULUCA tablet contains 50 mg of dolutegravir and 25 mg of rilpivirine, and is a pink, oval, film-coated, biconvex tablet debossed with “SV J3T” on one side.
Bottle of 30 tablets with child-resistant closure (contains a desiccant) NDC 49702-242-13.
Storage
Store and dispense in the original package, protect from moisture, and keep the bottle tightly closed. Do not remove desiccant.
Store at 20°C to 25°C (68°F to 77°F); excursions permitted 15°C to 30°C (59°F to 86°F).
Images
Drug Images
{{#ask: Page Name::Dolutegravir / rilpivirine
|?Pill Name
|?Drug Name
|?Pill Ingred
|?Pill Imprint
|?Pill Dosage
|?Pill Color
|?Pill Shape
|?Pill Size (mm)
|?Pill Scoring
|?NDC
|?Drug Author
|format=template
|template=DrugPageImages
|mainlabel=-
|sort=Pill Name
}}
Package and Label Display Panel
This image is provided by the National Library of Medicine.
Advise the patient to read the FDA-approved patient labeling.
Severe Skin and Hypersensitivity Reactions
Advise patients to immediately contact their healthcare provider if they develop a rash. Instruct patients to immediately stop taking JULUCA and seek medical attention if they develop a rash associated with any of the following symptoms, as it may be a sign of a more serious reaction such as DRESS severe hypersensitivity: fever; generally ill feeling; extreme tiredness; muscle or joint aches; blisters or peeling of the skin; oral blisters or lesions; eye inflammation; facial swelling; swelling of the eyes, lips, tongue, or mouth; breathing difficulty; and/or signs and symptoms of liver problems (e.g., yellowing of the skin or whites of the eyes; dark or tea-colored urine; pale-colored stools or bowel movements; nausea; vomiting; loss of appetite; or pain, aching, or sensitivity on the right side below the ribs). Advise patients that if hypersensitivity occurs, they will be closely monitored, laboratory tests will be ordered, and appropriate therapy will be initiated.
Hepatotoxicity
Inform patients that hepatotoxicity has been reported with rilpivirine and dolutegravir, components of JULUCA. Inform patients that monitoring for hepatotoxicity is recommended.
Depressive Disorders
Inform patients that depressive disorders (depressed mood, depression, dysphoria, major depression, mood altered, negative thoughts, suicide attempt, suicidal ideation) have been reported with the components of JULUCA. Advise patients to seek immediate medical evaluation if they experience depressive symptoms.
Drug Interactions
JULUCA may interact with many drugs; therefore, advise patients to report to their healthcare provider the use of any other prescription or nonprescription medication or herbal products including St. John’s wort.
Administration Instruction
Inform patients that it is important to take JULUCA once daily on a regular dosing schedule with a meal and to avoid missing doses as it can result in development of resistance. Instruct patients that if they miss a dose of JULUCA, to take it as soon as they remember with a meal. Advise patients not to double their next dose. Advise the patient a protein drink alone does not replace a meal.
Pregnancy Registry
Inform patients that there is an antiretroviral pregnancy registry to monitor fetal outcomes of pregnant women exposed to JULUCA.
Lactation
Instruct women with HIV-1 infection not to breastfeed because HIV-1 can be passed to the baby in the breast milk.
Storage
Instruct patients to store JULUCA in the original bottle to protect from moisture and keep the bottle tightly closed. Do not remove desiccant.
JULUCA, TIVICAY, and TRIUMEQ are trademarks owned by or licensed to the ViiV Healthcare group of companies.
The other brand listed is a trademark owned by or licensed to its respective owner and is not a trademark owned by or licensed to the ViiV Healthcare group of companies. The maker of this brand is not affiliated with and does not endorse the ViiV Healthcare group of companies or its products.
This image is provided by the National Library of Medicine.
Precautions with Alcohol
Alcohol-Dolutegravir / rilpivirine interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.
Brand Names
Juluca
Look-Alike Drug Names
There is limited information regarding Dolutegravir / rilpivirine Look-Alike Drug Names in the drug label.
