Juluca Side Effects

Generic name: dolutegravir / rilpivirine

Medically reviewed by Drugs.com. Last updated on May 22, 2024.

Note: This document provides detailed information about Juluca.

Applies to dolutegravir / rilpivirine: oral tablet Side Effects associated with dolutegravir / rilpivirine. Some dosage forms listed on this page may not apply specifically to the brand name Juluca.

Applies to dolutegravir / rilpivirine: oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

It is important to tell your doctor if you are pregnant or planning to become pregnant before using this medicine. Using this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Do not use this medicine during the first part of your pregnancy unless your doctor tells you to. Use an effective form of birth control to keep from getting pregnant.

This medicine should not be used together with dexamethasone (Decadron®), dofetilide (Tikosyn®), certain seizure medicines (eg, carbamazepine, oxcarbazepine, phenobarbital, phenytoin, Dilantin®, Tegretol®, Trileptal®), medicine for tuberculosis (eg, rifampin, rifapentine, Priftin®, Rifadin®, Rimactane®), certain stomach medicines (eg, esomeprazole, lansoprazole, omeprazole, pantoprazole, rabeprazole, Aciphex®, Nexium®, Prevacid®, Prilosec®) or St. John's wort.

This medicine may cause serious allergic reactions including anaphylaxis and drug reaction with eosinophilia and systemic symptoms (DRESS), which can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have black, tarry stools, chest pain, chills, cough, fever, painful or difficult urination, rash, itching, hoarseness, lightheadedness or dizziness, sore throat, sores, ulcers, or white spots on the lips or in the mouth, swollen glands, trouble breathing, trouble swallowing, unusual bleeding or bruising, unusual tiredness or weakness, or any swelling of your hands, face, or mouth with this medicine.

This medicine may cause serious liver problems. This may occur in patients with hepatitis B or C infection. Check with your doctor right away if you or your child have clay-colored stools, dark urine, a decreased appetite, fever, headache, itching, nausea and vomiting, skin rash, stomach pain or tenderness, swelling of the feet or lower legs, unusual tiredness or weakness, or yellow eyes or skin.

Tell your doctor right away if you start to feel depressed and have thoughts about hurting yourself. Report any unusual thoughts or behavior that troubles you, especially if they are new or get worse quickly.

This medicine will not keep you from giving HIV to your partner during sex. Make sure you understand this and practice safe sex, even if your partner also has HIV, by using a latex condom or other barrier method. This medicine will also not keep you from giving HIV to other people if they are exposed to your blood. Do not re-use or share needles with anyone.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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:

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:

For healthcare professionals

Applies to dolutegravir / rilpivirine: oral tablet.

General adverse events

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

• 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]

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]

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]

See also:

Frequently asked questions

• What drugs are contained in HIV treatment Juluca?

Further information

Juluca side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer