juluca
Juluca is a combination medicine containing Dolutegravir Sodium and Rilpivirine Hydrochloride.
Dolutegravir Sodium and Rilpivirine Hydrochloride · by Viiv Hlthcare
Key facts
- Active ingredient
- Dolutegravir Sodium and Rilpivirine Hydrochloride
- Form
- Tablet
- Strength
- Dolutegravir Sodium EQ 50MG Base; Rilpivirine Hydrochloride EQ 25MG Base
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Viiv Hlthcare
- Half-life
- about 14 hours (how long it stays in your system)
- FDA application
- NDA210192
What is Juluca?
From the FDA label:JULUCA is a fixed-dose combination tablet containing dolutegravir (as dolutegravir sodium), an INSTI, and rilpivirine (as rilpivirine hydrochloride), an NNRTI. The chemical name of dolutegravir sodium is sodium (4 R ,12a S )-9-{[(2,4-difluorophenyl)methyl]carbamoyl}-4-methyl-6,8-dioxo-3,4,6,8,12,12a-hexahydro-2 H -pyrido[1',2':4,5]pyrazino[2,1- b ][1,3]oxazin-7-olate. The empirical formula is C 20 H 18 F 2 N 3 NaO 5, and the molecular weight is 441.36 g/mol. It has the following structural formula: Dolutegravir sodium is a white to light yellow powder and is slightly soluble in water. The chemical name for rilpivirine hydrochloride is 4-[[4-[[4-[(E)-2-cyanoethenyl]-2,6-dimethylphenyl]amino]-2-pyrimidinyl]amino]benzonitrile monohydrochloride. Its molecular formula is C 22 H 18 N 6 • HCl and its molecular weight is 402.88 g/mol. Rilpivirine hydrochloride has the following structural formula: Rilpivirine hydrochloride is a white to almost white powder. Rilpivirine hydrochloride is practically insoluble in water over a wide pH range. JULUCA tablets are for oral administration. Each film-coated tablet contains the active ingredients 50 mg of dolutegravir (equivalent to 52.6 mg dolutegravir sodium) and 25 mg of rilpivirine (equivalent to 27.5 mg rilpivirine hydrochloride) and the inactive ingredients croscarmellose sodium, D-mannitol, lactose monohydrate, magnesium stearate,…
How to use
One tablet taken orally once daily with a meal. ( 2.1 ) • Rifabutin coadministration: Take an additional 25-mg tablet of rilpivirine with JULUCA once daily with a meal for the duration of the rifabutin coadministration. ( 2.2 ) 2.1 Recommended Dosage The recommended dosage of JULUCA is one tablet taken orally once daily with a meal [see Clinical Pharmacology ( 12.3 )] . One tablet of JULUCA contains 50 mg of dolutegravir and 25 mg of rilpivirine. 2.2 Recommended Dosage with Rifabutin Coadministration If JULUCA is coadministered with rifabutin, take an additional 25-mg tablet of rilpivirine with JULUCA once daily with a meal for the duration of the rifabutin coadministration [see Drug Interactions ( 7.4 )] .
Side effects
The following adverse reactions are described below and in other sections of the labeling: • Skin and hypersensitivity reactions [see Warnings and Precautions ( 5.1 )]. • Hepatotoxicity [see Warnings and Precautions ( 5.2 )]. • Depressive disorders [see Warnings and Precautions ( 5.3 )]. The most common adverse reactions (all grades) observed in at least 2% of subjects were diarrhea, headache, and nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact ViiV Healthcare at 1-877-844-8872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety assessment of JULUCA is based on the pooled primary Week 48 analyses of data from 2 identical, international, multicenter, open-label trials, SWORD-1 and SWORD-2, including additional follow up through Week 148. A total of 1,024 adult HIV-1-infected subjects who were on a stable suppressive antiretroviral regimen (containing 2 nucleoside reverse transcriptase inhibitors [NRTIs] plus either an integrase strand transfer inhibitor [INSTI], a non-nucleoside reverse transcriptase inhibitor [NNRTI], or a protease inhibitor [PI]) for at least…
Warnings
Important safety information
Severe skin and hypersensitivity reactions characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury, have been reported with the individual components. Discontinue JULUCA immediately if signs or symptoms of severe skin or hypersensitivity reactions develop, as a delay in stopping treatment may result in a life-threatening reaction. ( 5.1 ) • Hepatotoxicity has been reported in patients receiving a dolutegravir- or rilpivirine-containing regimen. Monitoring for hepatotoxicity is recommended. ( 5.2 ) • Depressive disorders have been reported with the use of rilpivirine- or dolutegravir-containing regimens. Immediate medical evaluation is recommended for severe depressive symptoms. ( 5.3 , 6.1 ) 5.1 Skin and Hypersensitivity Reactions Hypersensitivity reactions have been reported with dolutegravir and were characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury. These events were reported in less than 1% of subjects receiving dolutegravir in Phase 3 clinical trials. Severe skin and hypersensitivity reactions have been reported during postmarketing experience, including cases of Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), with rilpivirine-containing regimens. While some skin reactions were accompanied by constitutional symptoms such as fever, other skin reactions were associated with organ dysfunctions, including elevations in hepatic serum biochemistries. During the Phase 3 clinical trials of rilpivirine, treatment-related rashes with at least Grade 2 severity were reported in 3% of subjects. No Grade 4 rash was reported [see Adverse Reactions ( 6.2 )] . Discontinue JULUCA immediately if signs or symptoms of severe skin or hypersensitivity reactions develop (including, but not limited to, severe rash or rash accompanied by fever, general malaise, fatigue, muscle or joint aches, blisters or peeling of the skin, mucosal involvement [oral blisters or lesions], conjunctivitis, facial edema, hepatitis, eosinophilia, angioedema, difficulty breathing). Clinical status, including laboratory parameters with liver aminotransferases, should be monitored and appropriate therapy initiated. Delay in stopping treatment with JULUCA after the onset of hypersensitivity may result in a life-threatening reaction [see Contraindications ( 4 )] . 5.2 Hepatotoxicity Hepatic adverse events have been reported in patients receiving a dolutegravir- or rilpivirine-containing regimen [see Adverse Reactions ( 6.1 )] . Patients with underlying hepatitis B or C or marked elevations in transaminases prior to treatment may be at increased risk for worsening or development of transaminase elevations. Additionally, in some patients receiving dolutegravir-containing regimens, the elevations in transaminases were consistent with immune reconstitution syndrome or hepatitis B reactivation particularly in the setting where anti-hepatitis therapy was withdrawn. Cases of hepatic toxicity, including elevated serum liver biochemistries and hepatitis, have also been reported in patients receiving a dolutegravir- or rilpivirine-containing regimen who had no pre-existing hepatic disease or other identifiable risk factors. Drug-induced liver injury leading to acute liver failure has been reported with dolutegravir-containing products, including liver transplant with TRIUMEQ (abacavir, dolutegravir, and lamivudine). Monitoring for hepatotoxicity is recommended. 5.3 Depressive Disorders Depressive disorders (including depressed mood, depression, dysphoria, major depression, mood altered, negative thoughts, suicide attempt, and suicidal ideation) have been reported with rilpivirine [see Adverse Reactions ( 6.1 )] . For information regarding depressive disorders reported in patients taking dolutegravir, [see Adverse Reactions ( 6.1 )] . Promptly evaluate patients with severe depressive symptoms to assess whether the symptoms are related to JULUCA and to determine whether the risks of continued therapy outweigh the benefits. 5.4 Risk of Adverse Reactions or Loss of Virologic Response Due to Drug Interactions The concomitant use of JULUCA and other drugs may result in known or potentially significant drug interactions, some of which may lead to [see Contraindications ( 4 ), Drug Interactions ( 7.4 )] : • Loss of therapeutic effect of JULUCA and possible development of resistance. • Possible clinically significant adverse reactions from greater exposures of concomitant drugs. In healthy subjects, 75 mg once daily of rilpivirine (3 times the dose in JULUCA) and 300 mg once daily (12 times the dose in JULUCA) have been shown to prolong the QTc interval of the electrocardiogram [see Drug Interactions ( 7.3 ), Clinical Pharmacology ( 12.2 )] . Consider alternatives to JULUCA when coadministered with a drug with a known risk of Torsade de Pointes. See Table 4 for steps to prevent or manage these possible and known significant drug interactions, including dosing recommendations. Consider the potential for drug interactions prior to and during therapy with JULUCA; review concomitant medications during therapy with JULUCA; and monitor for the adverse reactions associated with the concomitant drugs.
Who should not take Juluca
JULUCA is contraindicated in patients: • with previous hypersensitivity reaction to dolutegravir or rilpivirine [see Warnings and Precautions ( 5.1 )] . • receiving dofetilide due to the potential for increased dofetilide plasma concentrations and the risk for serious and/or life-threatening events [see Drug Interactions ( 7 )] . • receiving other coadministered drugs in Table 1 that significantly decrease rilpivirine plasma concentrations [see Drug Interactions ( 7 ), Clinical Pharmacology ( 12.3 )] . Table 1. Drugs That Are Contraindicated with JULUCA Drug Class Contraindicated Drugs in Class Clinical Comment Antiarrhythmic Dofetilide Potential for serious and/or life-threatening events due to the potential for increased dofetilide plasma concentrations. Anticonvulsants Carbamazepine Oxcarbazepine Phenobarbital Phenytoin Potential for significant decreases in rilpivirine plasma concentrations due to cytochrome P450 (CYP)3A enzyme induction, which may result in loss of virologic response. Antimycobacterials Rifampin Rifapentine Glucocorticoid (systemic) Dexamethasone (more than a single-dose treatment) Herbal Products St John’s wort ( Hypericum perforatum ) Proton Pump Inhibitors e.g., Esomeprazole Lansoprazole Omeprazole Pantoprazole Rabeprazole Potential for significant decreases in rilpivirine plasma concentrations due to gastric pH increase, which may result in loss of virologic response. • Previous hypersensitivity reaction to dolutegravir or rilpivirine. ( 4 ) • Coadministration with dofetilide. ( 4 ) • Coadministration with drugs where significant decreases in rilpivirine plasma concentrations may occur, which may result in loss of virologic response. ( 4 )
Overdose — what happens if you take too much
There is no known specific treatment for overdose with JULUCA. If overdose occurs, the patient should be monitored and standard supportive treatment applied as required, including monitoring of vital signs and ECG (QT interval) as well as observation of the clinical status of the patient. As both dolutegravir and rilpivirine are highly bound to plasma proteins, it is unlikely that either would be significantly removed by dialysis.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Because JULUCA is a complete regimen, coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended. ( 7.1 ) • Refer to the full prescribing information for important drug interactions with JULUCA. ( 4 , 5.4 , 7 ) • Drugs that induce or inhibit cytochrome P450 (CYP)3A4 or uridine diphosphate glucuronosyltransferase (UGT)1A1 may affect the plasma concentrations of the components of JULUCA. ( 7.3 ) • Drugs that increase gastric pH or containing polyvalent cations may decrease plasma concentrations of the components of JULUCA. ( 4 , 7.3 , 7.4 ) • Consider alternatives to prescribing JULUCA with drugs with a known risk of Torsade de Pointes. ( 7.3 ) 7.1 Concomitant Use with Other Antiretroviral Medicines Because JULUCA is a complete regimen, coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended [see Indications and Usage ( 1 )] . Information regarding potential drug-drug interactions with other antiretroviral medications is not provided [see Contraindications ( 4 ), Warnings and Precautions ( 5.4 ), Clinical Pharmacology ( 12.3 )] . 7.2 Potential for JULUCA to Affect Other Drugs Dolutegravir, a component of JULUCA, inhibits the renal organic cation transporters (OCT)2 and multidrug and toxin extrusion transporter (MATE)1, thus it may increase plasma concentrations of drugs eliminated via OCT2 or MATE1 such as dofetilide, dalfampridine, and metformin [see Contraindications ( 4 ), Drug Interactions ( 7.4 )] . 7.3 Potential for Other Drugs to Affect the Components of JULUCA Dolutegravir Dolutegravir is metabolized by uridine diphosphate (UDP)-glucuronosyl transferase (UGT)1A1 with some contribution from cytochrome P450 (CYP)3A. Dolutegravir is also a substrate of UGT1A3, UGT1A9, breast cancer resistance protein (BCRP), and P-glycoprotein (P-gp) in vitro. Drugs that induce those enzymes and transporters may decrease dolutegravir plasma concentrations and reduce the therapeutic effect of dolutegravir [see Drug Interactions ( 7.4 )] . Coadministration of dolutegravir and other drugs that inhibit these enzymes may increase dolutegravir plasma concentrations. Coadministration of dolutegravir with polyvalent cation-containing products may lead to decreased absorption of dolutegravir [see Drug Interactions ( 7.4 )] . Rilpivirine Rilpivirine is primarily metabolized by CYP3A, and drugs that induce or inhibit CYP3A may affect the clearance of rilpivirine. Coadministration of JULUCA and drugs that induce CYP3A may result in decreased plasma concentrations of rilpivirine and loss of virologic response and possible resistance to rilpivirine or to the class of NNRTIs [see Contraindications ( 4 ), Drug Interactions ( 7.4 )] . Coadministration of JULUCA and drugs that inhibit CYP3A may result in increased plasma concentrations of rilpivirine. Coadministration of JULUCA with drugs that increase gastric pH may result in decreased plasma concentrations of rilpivirine and loss of virologic response and possible resistance to rilpivirine or to the class of NNRTIs [see Contraindications ( 4 ), Drug Interactions ( 7.4 ), Clinical Pharmacology ( 12.3 )] . QT-Prolonging Drugs: In healthy subjects, 75 mg once daily of rilpivirine (3 times the dose in JULUCA) and 300 mg once daily (12 times the dose in JULUCA) have been shown to prolong the QTc interval of the electrocardiogram [see Clinical Pharmacology ( 12.2 )] . Consider alternatives to JULUCA when coadministered with a drug with a known risk of Torsade de Pointes. 7.4 Established and Other Potentially Significant Drug Interactions Information regarding potential drug interactions with dolutegravir and rilpivirine are provided in Table 4 . These recommendations are based on either drug interaction trials of individual components or predicted interactions due to the expected magnitude of interaction and potential for serious adverse events or loss of efficacy [see Contraindications ( 4 ), Warnings and Precautions ( 5.4 ), Clinical Pharmacology ( 12.3 )] . Table 4. Established and Other Potentially Significant Drug Interactions: Alterations in Dose or Regimen May Be Recommended Based on Drug Interaction Trials or Predicted Interactions a ↑ = Increase, ↓ = Decrease, ↔ = No change. a This table is not all inclusive. b See Clinical Pharmacology ( 12.3 ) for magnitude of interaction. Concomitant Drug Class: Drug Name Effect on Concentration Clinical Comment Antacids (e.g., aluminum or magnesium hydroxide, calcium carbonate) ↓Rilpivirine Administer JULUCA 4 hours before or 6 hours after taking antacids. Antiarrhythmic: Dofetilide ↑Dofetilide Coadministration is contraindicated with JULUCA [see Contraindications ( 4 )] . Anticonvulsants: Carbamazepine Oxcarbazepine Phenobarbital Phenytoin ↓Dolutegravir ↓Rilpivirine Coadministration is contraindicated with JULUCA due to decreased rilpivirine concentrations [see Contraindications ( 4 )] . Antidiabetic: Metformin b ↑Metformin Refer to the prescribing information for metformin for assessing the benefit and risk of concomitant use of JULUCA and metformin. Antimycobacterials: Rifampin Rifapentine ↓Dolutegravir ↓Rilpivirine Coadministration is contraindicated with JULUCA due to decreased rilpivirine concentrations [see Contraindications ( 4 )] . Antimycobacterial: Rifabutin b ↔Dolutegravir ↔Rifabutin ↓Rilpivirine An additional rilpivirine 25-mg tablet should be taken with JULUCA once daily with a meal when rifabutin is coadministered. Glucocorticoid (systemic): Dexamethasone (more than a single-dose treatment) ↓Rilpivirine Coadministration is contraindicated with JULUCA due to decreased rilpivirine concentrations [see Contraindications ( 4 )] . H 2 -receptor antagonists: Famotidine Cimetidine Nizatidine Ranitidine ↔Dolutegravir ↓Rilpivirine JULUCA should only be administered at least 4 hours before or 12 hours after taking H 2 -receptor antagonists. Herbal product: St John’s wort ( Hypericum perforatum ) ↓Dolutegravir ↓Rilpivirine Coadministration is contraindicated with JULUCA due to decreased rilpivirine concentrations [see Contraindications ( 4 )] . Macrolide or ketolide antibiotics: Clarithromycin Erythromycin Telithromycin ↔Dolutegravir ↑Rilpivirine Where possible, consider alternatives, such as azithromycin. Medications containing polyvalent cations (e.g., Mg or Al): Cation-containing products b or laxatives Sucralfate Buffered medications ↓Dolutegravir Administer JULUCA 4 hours before or 6 hours after taking products containing polyvalent cations. Narcotic analgesic: Methadone b ↔Dolutegravir ↓Methadone ↔Rilpivirine No dose adjustments are required when starting coadministration of methadone with JULUCA. However, clinical monitoring is recommended as methadone maintenance therapy may need to be adjusted in some patients. Oral calcium and iron supplements , including multivitamins containing calcium or iron b (non-antacid) ↓Dolutegravir Administer JULUCA and supplements containing calcium or iron together with a meal or take JULUCA 4 hours before or 6 hours after taking these supplements. Potassium channel blocker: Dalfampridine ↑Dalfampridine Elevated levels of dalfampridine increase the risk of seizures. The potential benefits of taking dalfampridine concurrently with JULUCA should be considered against the risk of seizures in these patients. Proton pump inhibitors: e.g., Esomeprazole Lansoprazole Omeprazole Pantoprazole Rabeprazole ↓Rilpivirine Coadministration is contraindicated with JULUCA due to decreased rilpivirine concentrations [see Contraindications ( 4 )] .
How long does Dolutegravir Sodium and Rilpivirine Hydrochloride stay in your body?
The elimination half-life of dolutegravir sodium and rilpivirine hydrochloride is about 14 hours — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. This is the terminal (elimination) half-life, which the TIVICAY label gives as "approximately 14 hours," based on population pharmacokinetic analyses; the label reports no separate distribution-phase half-life. Dolutegravir is not a prodrug, and the label describes no active metabolite — it is metabolized mainly by UGT1A1 (with some CYP3A) to an ether glucuronide and oxidative metabolites that the label does not characterize as active, and just over half the dose leaves unchanged in the feces. On populations the label names: age had no clinically relevant effect on dolutegravir pharmacokinetics; mild and moderate kidney impairment had no clinically relevant effect on exposure, and in severe kidney impairment (CrCl under 30 mL/min) exposure was actually lower, not higher (AUC down 40%), with too little information to recommend dosing in people on dialysis; in moderate liver impairment (Child-Pugh B) exposure was similar to healthy controls, and severe liver impairment (Child-Pugh C) has not been studied. The label frames these as changes in exposure rather than stating a revised half-life for each group. People with UGT1A1 genotypes conferring poor metabolism had 32% lower clearance and 46% higher AUC. This figure describes how long the drug itself is cleared from plasma — it is not a drug-test detection window (metabolites can be detected far longer) and not dosing guidance.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: DailyMed — TIVICAY (dolutegravir sodium) tablet, film coated — Clinical Pharmacology (12.3).
Dosage forms
Tablet
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
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Frequently asked questions
- Is there a coupon or discount for Juluca?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Juluca. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Juluca?
- Juluca is marketed by Viiv Hlthcare. You can see Viiv Hlthcare's full profile, rating, and other products on pharmaranks.
- Is Juluca a brand-name or generic drug?
- Juluca is a brand-name product with the active ingredient Dolutegravir Sodium and Rilpivirine Hydrochloride.
- Is Juluca available over the counter?
- No. Juluca is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Juluca come in?
- Juluca is currently marketed as tablet, per the FDA's National Drug Code Directory.
- Is Juluca FDA-registered?
- Juluca is on record with the U.S. FDA under application number NDA210192. You can verify this on its official FDA label.
- Is Juluca safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Juluca. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Juluca?
- Juluca's side effects are taken directly from its FDA label. From the label: The following adverse reactions are described below and in other sections of the labeling: • Skin and hypersensitivity reactions [see Warnings and Precautions ( 5.1 )]. • Hepatotoxicity [see Warnings and Precautions ( 5.2 )]. • Depressive disorders [see Warnings and Precautions ( 5.3 )].… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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