Product image of Juluca (Dolutegravir Sodium, Rilpivirine Hydrochloride) supplied by GNH India

Juluca

Active Ingredient:
Dolutegravir Sodium, Rilpivirine Hydrochloride
Origin:
EU

Juluca (Dolutegravir Sodium, Rilpivirine Hydrochloride)

Dolutegravir Sodium and Rilpivirine Hydrochloride, the active ingredient in Juluca, is an integrase strand transfer inhibitor and non‑nucleoside reverse transcriptase inhibitor presented as a 50 mg/25 mg film‑coated tablet for oral use. It treats HIV‑1 infection as a maintenance therapy in virologically suppressed adults.

GNH India supplies Juluca as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies, and clinics worldwide, ensuring quality and regulatory compliance across markets.

Manufacturer / TM Owner

Viiv Healthcare B.V.

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Indications & Clinical Uses

Juluca is indicated for HIV‑1 infection as part of antiretroviral therapy in virologically suppressed adults.

  • Maintenance therapy for HIV‑1 infection: provides continued viral suppression in adults who are already virologically suppressed.
  • Switching from current antiretroviral regimen: enables transition to a single‑tablet regimen while maintaining viral control.
  • HIV‑1 infected adults without resistance to integrase inhibitors or NNRTIs: suitable as a complete regimen for patients meeting resistance criteria.

How It Works

  • Dolutegravir sodium binds to the active site of HIV integrase, blocking the insertion of viral DNA into the host genome, while rilpivirine hydrochloride attaches to the reverse transcriptase enzyme, preventing transcription of viral RNA into DNA. The combined inhibition halts viral replication and maintains suppression of HIV‑1 in treated individuals.

Side Effects

Juluca may cause a range of adverse reactions. Patients should be monitored for any new symptoms.

Common Side Effects

  • Headache: mild to moderate intensity.
  • Nausea: occasional, may improve with food.
  • Diarrhea: watery stools, usually transient.
  • Insomnia: difficulty falling or staying asleep.
  • Fatigue: generalized tiredness.
  • Rash: mild skin irritation or erythema.

Serious or Rare Side Effects

  • Hepatic failure: signs include jaundice, dark urine, and abdominal pain.
  • Severe depression or suicidal ideation: mood changes requiring immediate evaluation.
  • Hypersensitivity reactions: including angioedema or anaphylaxis.
  • Stevens‑Johnson syndrome or toxic epidermal necrolysis: severe skin blistering.
  • Elevated serum creatinine: indicating possible renal impact.
  • QT interval prolongation: may predispose to cardiac arrhythmias.

Precautions & Warnings

Before initiating Juluca, clinicians should assess patient history and monitor relevant parameters.

  • Resistance testing: ensure no prior resistance to integrase inhibitors or NNRTIs.
  • Liver function: evaluate hepatic enzymes in patients with existing liver disease.
  • Psychiatric assessment: screen for depression or suicidal thoughts.
  • Drug interactions: review concomitant medications for potential interactions.
  • Pregnancy and breastfeeding: weigh benefits against unknown risks.
  • Store at ambient temperature below 25°C: keep in the original packaging, protect from moisture and direct sunlight.

Avoid Interactions

Juluca can interact with several drug classes; careful review is essential.

Major Interactions (Avoid)

  • Antacids containing aluminum or magnesium: reduce rilpivirine absorption.
  • Rifampicin or other strong enzyme inducers: markedly lower dolutegravir levels.
  • Carbamazepine, phenytoin, or phenobarbital: may decrease efficacy of both components.

Moderate Interactions (Monitor Closely)

  • Proton pump inhibitors: may affect rilpivirine exposure; consider timing adjustments.
  • St. John’s wort: can reduce dolutegravir concentrations.
  • Certain antidiabetic agents: monitor blood glucose as rilpivirine may affect metabolism.

Frequently Asked Questions

Juluca is prescribed for adults with HIV‑1 infection who have already achieved viral suppression. It serves as a maintenance therapy to keep the virus at undetectable levels and can be used when switching from a previous antiretroviral regimen to a single‑tablet option.

Dolutegravir sodium inhibits the HIV integrase enzyme, preventing the integration of viral DNA into the host cell genome. This blocks a critical step in the viral replication cycle, helping to maintain viral suppression when combined with rilpivirine.

The prescribed dose of Juluca is determined by the treating healthcare professional based on the patient’s clinical status and treatment history. The standard tablet contains 50 mg of dolutegravir and 25 mg of rilpivirine, taken once daily as directed.

The safety of Juluca in pregnancy and breastfeeding has not been fully established. Clinicians should weigh the potential benefits against unknown risks and consider alternative regimens when appropriate. Pregnant or nursing individuals should discuss options with their healthcare provider.

To request Juluca, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India works with hospitals, pharmacies, and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details, and any necessary import documentation.

Juluca combines two active agents—dolutegravir (an integrase inhibitor) and rilpivirine (a non‑nucleoside reverse transcriptase inhibitor)—into a single tablet, offering a convenient once‑daily regimen. Compared with multi‑tablet regimens, it reduces pill burden while maintaining efficacy similar to other recommended combination therapies.

Juluca tablets should be stored at ambient temperature below 25 °C. Keep them in the original blister pack, protect from moisture and direct sunlight, and ensure the container is tightly closed to maintain product stability.

Juluca is taken orally as a film‑coated tablet. Patients should swallow the tablet whole with water, preferably on an empty stomach or at least two hours after a meal, unless directed otherwise by their prescriber.

Serious risks include hepatic failure, severe depression or suicidal thoughts, hypersensitivity reactions such as anaphylaxis, and rare skin conditions like Stevens‑Johnson syndrome. Patients should seek immediate medical attention if they experience any signs of these serious adverse events.

Juluca is contraindicated in patients with known resistance to either dolutegravir or rilpivirine, and in those with severe hepatic impairment. Individuals taking strong enzyme inducers (e.g., rifampicin) or antacids containing aluminum/magnesium that cannot be timed appropriately should avoid using this medication.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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