Juluca

Last updated on RxList: 8/2/2021
Juluca Side Effects Center

What Is Juluca?

Juluca (dolutegravir and rilpivirine) is a combination of a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI) and an HIV-1non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated as a complete regimen for the treatment of HIV-1 infection in adults to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen for at least 6months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Juluca.

What Are Side Effects of Juluca?

Common side effects of Juluca include:

  • diarrhea and
  • headache.

Dosage for Juluca

The dose of Juluca is one tablet taken orally once daily with a meal.

What Drugs, Substances, or Supplements Interact with Juluca?

Juluca may interact with:

  • other antiretroviral medications,
  • dofetilide,
  • metformin,
  • antacids,
  • anticonvulsants,
  • antimycobacterials,
  • glucocorticoids,
  • H2-receptor antagonists,
  • St John's wort,
  • macrolide or ketolide antibiotics,
  • cation-containing products or laxatives,
  • sucralfate,
  • buffered medications,
  • narcotic analgesics,
  • oral calcium and iron supplements (including multivitamins containing calcium or iron),
  • and proton pump inhibitors (PPIs).

Tell your doctor all medications and supplements you use.

Juluca During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Juluca; it is unknown how it would affect a fetus. There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Juluca during pregnancy. It is unknown if Juluca passes into breast milk, however, breastfeeding is not recommended due to the potential for HIV transmission.

Additional Information

Our Juluca (dolutegravirand rilpivirine) Tablets Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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Juluca Consumer Information

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Stop taking this medicine and get emergency medical help if you have signs of an allergic reaction: fever, general ill feeling, trouble breathing, extreme tiredness; mouth sores, redness or swelling in your eyes; blistering or peeling skin; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • thoughts about suicide or hurting yourself;
  • anxiety, sadness, feeling hopeless; or
  • liver problems--nausea, vomiting, loss of appetite, right-sided upper stomach pain, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Dolutegravir and rilpivirine affects your immune system, which may cause certain side effects (even weeks or months after you've taken this medicine). Tell your doctor if you have:

  • signs of a new infection--fever, night sweats, swollen glands, cold sores, cough, wheezing, diarrhea, weight loss;
  • trouble speaking or swallowing, problems with balance or eye movement, weakness or prickly feeling; or
  • swelling in your neck or throat (enlarged thyroid), menstrual changes, impotence.

Common side effects may include:

  • headache; or
  • diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Juluca (Dolutegravir and Rilpivirine Tablets, for Oral Use)

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Juluca Professional Information

SIDE EFFECTS

The following adverse reactions are described below and in other sections of the labeling:

  • Skin and hypersensitivity reactions [see WARNINGS AND PRECAUTIONS].
  • Hepatotoxicity [see WARNINGS AND PRECAUTIONS].
  • Depressive disorders [see WARNINGS AND PRECAUTIONS].

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 in HIV-1–infected, virologically suppressed subjects switching from their current antiretroviral regimen to dolutegravir plus rilpivirine is based on the pooled primary Week 48 analyses of data from 2 identical, international, multicenter, open-label trials, SWORD-1 and SWORD-2.

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 6 months with no history of treatment failure and no known substitutions associated with resistance to dolutegravir or rilpivirine, were randomized and received treatment. Subjects were randomized 1:1 to continue their current antiretroviral regimen or be switched to dolutegravir plus rilpivirine administered once daily. In the pooled analyses, the proportion of subjects who discontinued treatment due to an adverse event was 4% in subjects receiving dolutegravir plus rilpivirine once daily and less than 1% in subjects who remained on their current antiretroviral regimen. The most common adverse events leading to discontinuation were psychiatric disorders: 2% of subjects receiving dolutegravir plus rilpivirine and less than 1% on the current antiretroviral regimen.

The most common adverse reactions (ARs) (all grades) reported in at least 2% of subjects in the Week 48 pooled analyses from SWORD-1 and SWORD-2 are provided in Table 2.

Table 2. Adverse Reactions (Grades 1 to 4) Reported in at Least 2% of Virologically Suppressed Subjects with HIV-1 Infection in SWORD-1 and SWORD-2 Trials (Week 48 Pooled Analyses)

Adverse Reaction Dolutegravir plus Rilpivirine
(n = 513)
Current Antiretroviral Regimen
(n = 511)
Diarrhea 2% <1%
Headache 2% 0

Less Common Adverse Reactions

The following ARs occurred in less than 2% of subjects receiving dolutegravir plus rilpivirine or are from studies described in the prescribing information of the individual components, TIVICAY (dolutegravir) and EDURANT (rilpivirine). Some events have been included because of their seriousness and assessment of potential causal relationship.

General Disorders: Fatigue.

Gastrointestinal Disorders: Abdominal pain, abdominal discomfort, flatulence, nausea, upper abdominal pain, vomiting.

Hepatobiliary Disorders: Cholecystitis, cholelithiasis, hepatitis.

Immune System Disorders: Immune reconstitution syndrome.

Metabolism and Nutrition Disorders: Decreased appetite.

Musculoskeletal Disorders: Myositis.

Nervous System Disorders: Dizziness, somnolence.

Psychiatric Disorders: Depressive disorders including depressed mood; depression; suicidal ideation, attempt, behavior, or completion. These events were observed primarily in subjects with a pre-existing history of depression or other psychiatric illness. Other reported psychiatric adverse reactions include anxiety, insomnia, sleep disorders, and abnormal dreams.

Renal and Urinary Disorders: Glomerulonephritis membranous, glomerulonephritis mesangioproliferative, nephrolithiasis, renal impairment.

Skin and Subcutaneous Tissue Disorders: Pruritus, rash.

Laboratory Abnormalities

Selected laboratory abnormalities with a worsening grade from baseline and representing the worst-grade toxicity in at least 2% of subjects are presented in Table 3.

Table 3. Selected Laboratory Abnormalities (Grades 2 and 3 to 4; Week 48 Pooled Analyses) in SWORD-1 and SWORD-2 Trials

Laboratory Parameter Preferred Term Dolutegravir plus Rilpivirine
(n = 513)
Current Antiretroviral Regimen
(n = 511)
ALT
  Grade 2 (>2.5-5.0 x ULN) 2% <1%
  Grade 3 to 4 (>5.0 x ULN) <1% <1%
AST
  Grade 2 (>2.5-5.0 x ULN) <1% 2%
  Grade 3 to 4 (>5.0 x ULN) <1% <1%
Total Bilirubin
  Grade 2 (1.6-2.5 x ULN) 2% 4%
  Grade 3 to 4 (>2.5 x ULN) 0 3%
Creatine kinase
  Grade 2 (6.0-9.9 x ULN) <1% <1%
  Grade 3 to 4 (≥10.0 x ULN) 1% 2%
Hyperglycemia
  Grade 2 (126-250 mg/dL) 4% 5%
  Grade 3 to 4 (>250 mg/dL) <1% <1%
Lipase
  Grade 2 (>1.5-3.0 x ULN) 5% 5%
  Grade 3 to 4 (>3.0 x ULN) 2% 2%
ULN = Upper limit of normal.

Changes in Serum Creatinine

Dolutegravir and rilpivirine have been shown to increase serum creatinine due to inhibition of tubular secretion of creatinine without affecting renal glomerular function [see CLINICAL PHARMACOLOGY]. Increases in serum creatinine occurred within the first 4 weeks of treatment with dolutegravir plus rilpivirine and remained stable through 48 weeks. A mean change from baseline of 0.093 mg per dL (range: -0.30 to 0.58 mg per dL) was observed after 48 weeks of treatment with dolutegravir plus rilpivirine. These changes are not considered to be clinically relevant.

Serum Lipids

At 48 weeks, total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, and total cholesterol to HDL ratio were similar between the treatment arms.

Bone Mineral Density Effects

Mean bone mineral density (BMD) increased from baseline to Week 48 in subjects who switched from an antiretroviral treatment (ART) regimen containing tenofovir disoproxil fumarate (TDF) to dolutegravir plus rilpivirine (1.34% total hip and 1.46% lumbar spine) compared with those who continued on treatment with a TDF-containing antiretroviral regimen (0.05% total hip and 0.15% lumbar spine) in a dual-energy X-ray absorptiometry (DXA) substudy. BMD declines of 5% or greater at the lumbar spine were experienced by 2% of subjects receiving JULUCA and 5% of subjects who continued their TDF-containing regimen. The long-term clinical significance of these BMD changes is not known.

Fractures (excluding fingers and toes) were reported in 3 (0.6%) subjects who switched to dolutegravir plus rilpivirine and 9 (1.8%) subjects who continued their current antiretroviral regimen through 48 weeks.

Adrenal Function

In the pooled Phase 3 trials results analysis of rilpivirine, at Week 96, there was an overall mean change from baseline in basal cortisol of -0.69 (-1.12, 0.27) micrograms/dL in the rilpivirine group and of -0.02 (-0.48, 0.44) micrograms/dL in the efavirenz group. The clinical significance of the higher abnormal rate of 250 micrograms ACTH stimulation tests in the rilpivirine group is not known. Refer to the EDURANT (rilpivirine) Prescribing Information for additional information.

Postmarketing Experience

The following adverse reactions have been identified during postmarketing experience in patients receiving a dolutegravir-or rilpivirine-containing regimen. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Hepatobiliary Disorders

Acute liver failure, hepatotoxicity.

Investigations

Weight increased.

Musculoskeletal Disorders

Arthralgia, myalgia.

Renal And Genitourinary Disorders

Nephrotic syndrome.

Skin And Subcutaneous Tissue Disorders

Severe skin and hypersensitivity reactions, including DRESS.

DRUG INTERACTIONS

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]. Information regarding potential drug-drug interactions with other antiretroviral medications is not provided [see CONTRAINDICATIONS, WARNINGS AND PRECAUTIONS, CLINICAL PHARMACOLOGY].

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, Established And Other Potentially Significant Drug Interactions].

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 CYP3A. 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 Established And Other Potentially Significant Drug Interactions]. 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 Established And Other Potentially Significant Drug Interactions].

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, Potential For Other Drugs To Affect The Components Of JULUCA]. 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, Established And Other Potentially Significant Drug Interactions, CLINICAL PHARMACOLOGY].

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]. Consider alternatives to JULUCA when coadministered with a drug with a known risk of Torsade de Pointes.

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, WARNINGS AND PRECAUTIONS, CLINICAL PHARMACOLOGY].

Table 4. Established and Other Potentially Significant Drug Interactions: Alterations in Dose or Regimen May Be Recommended Based on Drug Interaction Trials or Predicted Interactionsa

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].
Anticonvulsants: Carbamazepine
Oxcarbazepine
Phenobarbital
Phenytoin
↓Dolutegravir
↓Rilpivirine
Coadministration is contraindicated with JULUCA due to decreased rilpivirine concentrations [see CONTRAINDICATIONS].
Antidiabetic: Metforminb ↑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].
Antimycobacterial: Rifabutinb ↔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].
H2-receptor antagonists: Famotidine
Cimetidine
Nizatidine
Ranitidine
↔Dolutegravir
↓Rilpivirine
JULUCA should only be administered at least 4 hours before or 12 hours after taking H2-receptor antagonists.
Herbal product: St John’s wort (Hypericum perforatum) ↓ Dolutegravir
↓Rilpivirine
Coadministration is contraindicated with JULUCA due to decreased rilpivirine concentrations [see CONTRAINDICATIONS].
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 productsb
  or laxatives   Sucralfate
  Buffered medications
↓Dolutegravir Administer JULUCA 4 hours before or 6 hours after taking products containing polyvalent cations.
Narcotic analgesic: Methadoneb ↔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 ironb (nonantacid) ↓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].
↑ = Increase, ↓ = Decrease, ↔ = No change.
a This table is not all inclusive.
b See CLINICAL PHARMACOLOGY for magnitude of interaction.

Read the entire FDA prescribing information for Juluca (Dolutegravir and Rilpivirine Tablets, for Oral Use)

© Juluca Patient Information is supplied by Cerner Multum, Inc. and Juluca Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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