Juluca Side Effects

Generic name: dolutegravir / rilpivirine

Medically reviewed by Drugs.com. Last updated on Apr 23, 2023.

Note: This document contains side effect information about dolutegravir / rilpivirine. Some dosage forms listed on this page may not apply to the brand name Juluca.

Applies to dolutegravir / rilpivirine: oral tablet.

Serious side effects of Juluca

Along with its needed effects, dolutegravir/rilpivirine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking dolutegravir / rilpivirine:

Less common

• Abnormal dreams
• anxiety
• cloudy or bloody urine
• dark urine
• decreased frequency or amount of urine
• depressed mood
• gaseous stomach pain
• increased blood pressure
• increased thirst
• indigestion
• light-colored stools
• loss of appetite
• lower back or side pain
• nausea
• recurrent fever
• severe nausea or vomiting
• stomach fullness or pain
• swelling of the face, fingers, feet, or lower legs
• thoughts or attempts at killing oneself
• trouble sleeping
• trouble breathing
• unusual tiredness or weakness
• upper right abdominal or stomach pain
• vomiting
• weight gain
• yellow eyes or skin

Incidence not known

• Black, tarry stools
• chest pain
• chills
• cough
• decreased appetite
• difficulty swallowing
• fast heartbeat
• fever
• headache
• painful or difficult urination
• skin itching, rash, or redness
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• stomach tenderness
• stomach pain, continuing
• swelling of the face, throat, or tongue
• swollen glands
• unusual bleeding or bruising

Other side effects of Juluca

Some side effects of dolutegravir / rilpivirine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Bloated feeling
• diarrhea
• dizziness
• excess air or gas in the stomach or bowels
• feeling of fullness
• muscle pain
• passing gas
• sleepiness or unusual drowsiness

Incidence not known

• Difficulty in moving
• joint pain or swelling
• muscle ache, cramp, or stiffness

For Healthcare Professionals

Applies to dolutegravir / rilpivirine: oral tablet.

General

In clinical trials, dolutegravir plus rilpivirine was discontinued due to side effects in 4% of patients. The most common side effects leading to discontinuation were psychiatric disorders.^[Ref]

Nervous system

Very common (10% or more): Headache, dizziness

Common (1% to 10%): Somnolence

Dolutegravir:

-Very common (10% or more): Headache

-Common (1% to 10%): Dizziness

Rilpivirine:

-Common (1% to 10%): Headache, dizziness

-Uncommon (0.1% to 1%): Somnolence^[Ref]

Gastrointestinal

Very common (10% or more): Nausea, increased pancreatic amylase, diarrhea

Common (1% to 10%): Abdominal pain, vomiting, elevated lipase, gastroenteritis, dyspepsia, upper abdominal pain, constipation, flatulence, abdominal distention, abdominal discomfort, dry mouth

Dolutegravir:

-Very common (10% or more): Nausea, diarrhea

-Common (1% to 10%): Abdominal pain, vomiting, flatulence, upper abdominal pain, abdominal discomfort

Rilpivirine:

-Common (1% to 10%): Abdominal pain, nausea, vomiting

-Uncommon (0.1% to 1%): Abdominal discomfort^[Ref]

Grade 2 and grade 3 to 4 elevations in lipase were reported in 5% and 2% of patients, respectively.^[Ref]

Other

Very common (10% or more): Increased fasted total cholesterol, increased fasted low-density lipoprotein cholesterol

Common (1% to 10%): Fatigue, asthenia, syphilis, increased fasted triglycerides

Dolutegravir:

-Common (1% to 10%): Fatigue

-Postmarketing reports: Increased weight

Rilpivirine:

-Common (1% to 10%): Fatigue^[Ref]

Psychiatric

Very common (10% or more): Insomnia

Common (1% to 10%): Depression, abnormal dreams, sleep disorders, depressed mood, anxiety

Uncommon (0.1% to 1%): Suicidal ideation, suicide attempt

Frequency not reported: Depressive disorders (including depressed mood, depression, suicidal ideation/attempt/behavior/completion)

Dolutegravir:

-Common (1% to 10%): Insomnia, abnormal dreams, depression, anxiety

-Uncommon (0.1% to 1%): Suicidal ideation, suicide attempt

Rilpivirine:

-Common (1% to 10%): Depression, insomnia, abnormal dreams, sleep disorders

-Uncommon (0.1% to 1%): Depressed mood^[Ref]

Suicidal ideation or suicide attempt was reported, mainly in patients with history of depression or psychiatric illness.

Depressive disorders occurred primarily in patients with history of depression or other psychiatric illness.^[Ref]

Hepatic

Grade 2 and grade 3 to 4 elevations in ALT were reported in 2% and less than 1% of patients, respectively. Grade 2 elevations in total bilirubin were reported in 2% of patients. Grade 2 and grade 3 to 4 elevations in AST were each reported in less than 1% of patients.

The incidence of liver chemistry elevations was higher in patients coinfected with hepatitis C than in those who were not coinfected.

In some patients using dolutegravir-containing regimens, elevations in transaminases were consistent with immune reconstitution syndrome or hepatitis B reactivation, especially when antihepatitis therapy was stopped.^[Ref]

Very common (10% or more): Increased transaminases (elevated ALT and/or AST)

Common (1% to 10%): Elevated ALT, elevated total bilirubin

Uncommon (0.1% to 1%): Hepatitis

Frequency not reported: Cholecystitis, cholelithiasis, elevated AST, hepatic toxicity, elevated serum liver biochemistries, liver chemistry elevations

Dolutegravir:

-Uncommon (0.1% to 1%): Hepatitis

-Frequency not reported: Elevations in transaminases (consistent with immune reconstitution syndrome or hepatitis B reactivation)

-Postmarketing reports: Acute liver failure, hepatotoxicity

Rilpivirine:

-Common (1% to 10%): Increased transaminases^[Ref]

Metabolic

Common (1% to 10%): Hyperglycemia, decreased appetite

Rilpivirine:

-Common (1% to 10%): Decreased appetite^[Ref]

Grade 2 and grade 3 to 4 hyperglycemia were reported in 4% and less than 1% of patients, respectively.^[Ref]

Musculoskeletal

Common (1% to 10%): Elevated creatine phosphokinase, decreased bone mineral density (BMD), arthralgia, back pain, pain in extremity

Uncommon (0.1% to 1%): Fractures (excluding fingers and toes), myalgia

Frequency not reported: Myositis, increased BMD, asymptomatic elevated creatine phosphokinase

Dolutegravir:

-Postmarketing reports: Arthralgia, myalgia^[Ref]

BMD increased (total hip and lumbar spine) from baseline to week 48 in patients who switched from a tenofovir disoproxil fumarate (DF)-containing antiretroviral regimen to dolutegravir plus rilpivirine compared with patients who continued using a tenofovir DF-containing antiretroviral regimen. BMD declines of at least 5% at the lumbar spine were reported in 2% of patients using this drug and 5% of patients who continued using a tenofovir DF-containing antiretroviral regimen. The long-term clinical relevance of such BMD changes has not been established.

Grade 2 and grade 3 to 4 elevations in creatine phosphokinase were reported in less than 1% and 1% of patients, respectively.

Elevated creatine phosphokinase was reported, primarily associated with exercise.^[Ref]

Dermatologic

Common (1% to 10%): Rash, pruritus

Dolutegravir:

-Common (1% to 10%): Rash, pruritus

Rilpivirine:

-Common (1% to 10%): Rash

-Postmarketing reports: Severe skin and hypersensitivity reactions (including drug reaction with eosinophilia and systemic symptoms [DRESS])^[Ref]

Grade 2 to 3 therapy-related rashes were reported in 3% of patients during phase 3 trials of rilpivirine.^[Ref]

Respiratory

Common (1% to 10%): Nasopharyngitis, upper respiratory tract infection, bronchitis, sinusitis, influenza

Hematologic

Common (1% to 10%): Decreased WBC count, decreased hemoglobin, decreased platelet count

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity

Dolutegravir:

-Uncommon (0.1% to 1%): Hypersensitivity reactions (characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury)^[Ref]

Renal

Frequency not reported: Membranous glomerulonephritis, mesangioproliferative glomerulonephritis, nephrolithiasis, renal impairment, increased serum creatinine

Rilpivirine:

-Postmarketing reports: Nephrotic syndrome^[Ref]

Both components of this drug have increased serum creatinine due to inhibition of tubular secretion of creatinine without affecting renal glomerular function. Increased serum creatinine was reported within the first 4 weeks of therapy and remained stable through 48 weeks. A mean change from baseline of 0.093 mg/dL (range: -0.3 to 0.58 mg/dL) or 8.22 mcmol/L (range: -26.5 to 51.2 mcmol/L) was reported after 48 weeks of therapy; these changes were not considered clinically significant.^[Ref]

Immunologic

Frequency not reported: Immune reconstitution syndrome

Dolutegravir:

-Uncommon (0.1% to 1%): Immune reconstitution syndrome

Combination antiretroviral therapy:

-Frequency not reported: Immune reconstitution/reactivation syndrome, autoimmune disorders in the setting of immune reconstitution (e.g., Graves' disease, polymyositis, Guillain-Barre syndrome, autoimmune hepatitis)^[Ref]

Endocrine

Rilpivirine:

-Frequency not reported: Decreased basal cortisol, abnormal 250 mcg adrenocorticotropic hormone (ACTH) stimulation test, adrenal insufficiency^[Ref]

In the pooled phase 3 trials, at week 96, there was an overall mean change from baseline in basal cortisol of -0.69 mcg/dL in the rilpivirine group, and of -0.02 mcg/dL in the efavirenz group.

In the rilpivirine group, 43 of 588 patients with normal 250 mcg ACTH stimulation test at baseline developed abnormal 250 mcg ACTH stimulation test (peak cortisol level less than 18.1 mcg/dL) during the trial versus 18 of 561 patients in the efavirenz group. Abnormal 250 mcg ACTH stimulation test at week 96 was seen in 14 of the 43 rilpivirine patients and 9 of the 18 efavirenz patients. Overall, there were no serious side effects, deaths, or treatment discontinuations that could clearly be attributed to adrenal insufficiency. Clinical significance of abnormal 250 mcg ACTH stimulation tests in the rilpivirine group has not been established.^[Ref]

Frequently asked questions

• What drugs are contained in HIV treatment Juluca?

Further information

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

Some side effects may not be reported. You may report them to the FDA.

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