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 ingredients in Juluca, are an integrase strand transfer inhibitor and a non‑nucleoside reverse transcriptase inhibitor presented as a 50 mg/25 mg oral tablet for oral use. It is used for maintenance therapy of HIV‑1 infection in adults with virologically suppressed viral load.
GNH India supplies Juluca as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

Manufacturer / TM Owner

Viiv Healthcare B.V.

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Indications & Clinical Uses

Juluca is indicated for HIV‑1 infection and is used as part of antiretroviral therapy to maintain viral suppression.

  • HIV‑1 infection (maintenance): Maintains virologic suppression in adults with HIV‑1 RNA < 50 copies/mL on a stable regimen.
  • Combination antiretroviral therapy: Provides a two‑drug oral option when used with other antiretrovirals to sustain viral load control.
  • Virologically suppressed patients: Offers a simplified regimen for adults who have achieved stable viral suppression.

How It Works

  • Dolutegravir sodium binds to the active site of HIV integrase, blocking the insertion of viral DNA into the host genome. Rilpivirine hydrochloride attaches to the reverse transcriptase enzyme, preventing transcription of viral RNA into DNA. Together they halt two critical steps in the HIV replication cycle, resulting in sustained viral suppression when used with other antiretrovirals.

Side Effects

Common Side Effects

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

Serious or Rare Side Effects

  • Severe hypersensitivity: including fever, swelling, and difficulty breathing.
  • Stevens‑Johnson syndrome or toxic epidermal necrolysis: extensive skin detachment.
  • Hepatotoxicity: marked elevation of liver enzymes or jaundice.
  • Depression or suicidal ideation: new or worsening mood changes.
  • Immune reconstitution inflammatory syndrome: inflammatory response after viral suppression.

Precautions & Warnings

Before initiating Juluca, consider the following precautions:

  • Pregnancy: Category B; use only if the potential benefit justifies the potential risk to the fetus.
  • Renal impairment: Assess renal function; dose adjustment may be required in severe impairment.
  • Hepatic impairment: Use with caution in patients with moderate to severe liver disease; monitor liver enzymes.
  • Drug resistance: Avoid in patients with known resistance to integrase inhibitors or NNRTIs.
  • Concomitant medications: Review all co‑administered drugs for potential interactions, especially enzyme inducers.
  • Store at ambient temperature: keep below 25 °C, retain in the original pack, and protect from moisture.

Avoid Interactions

Juluca may interact with several medicines; monitoring is essential.

Major Interactions (Avoid)

  • Rifampin, carbamazepine, phenytoin, or St. John's wort: strong enzyme inducers that markedly reduce dolutegravir exposure.
  • Antacids containing aluminum or magnesium: can lower rilpivirine absorption if taken simultaneously.

Moderate Interactions (Monitor Closely)

  • Proton pump inhibitors (e.g., omeprazole): may decrease rilpivirine levels; separate dosing by at least 12 hours.
  • Certain protease inhibitors (e.g., ritonavir): may increase dolutegravir concentrations.
  • H2‑blockers (e.g., ranitidine): may modestly reduce rilpivirine absorption; consider timing adjustments.

Frequently Asked Questions

Juluca is a fixed‑dose combination of dolutegravir sodium and rilpivirine hydrochloride indicated for the maintenance treatment of HIV‑1 infection in adults who have already achieved virologic suppression on a stable antiretroviral regimen.

Dolutegravir sodium inhibits the HIV integrase enzyme, preventing the integration of viral DNA into the host cell genome, which is a critical step for viral replication and persistence.

The prescribed dose of Juluca is determined by a qualified healthcare professional based on the patient’s clinical status and treatment history; patients should follow the prescriber’s instructions exactly.

Juluca is classified as pregnancy category B, indicating no evidence of risk in animal studies but limited human data. It should be used during pregnancy only if the potential benefit justifies any potential risk. Breastfeeding decisions should be made in consultation with a healthcare provider.

To order Juluca, submit an enquiry on the product page at gnhindia.com, specifying the required quantity. GNH India supplies hospitals, pharmacies and procurement teams worldwide, verifies trade or institutional credentials, and then provides pricing, availability, shipping details (including any cold‑chain requirements), and necessary import documentation.

Juluca combines two potent agents—dolutegravir (an integrase inhibitor) and rilpivirine (an NNRTI)—into a single tablet, offering a simplified regimen compared with multi‑pill regimens. It is particularly useful for patients who are already virologically suppressed, whereas other options may include protease inhibitors or additional nucleoside reverse transcriptase inhibitors.

Juluca tablets should be stored at ambient temperature, below 25 °C, in the original packaging to protect from moisture and light. Keep the container tightly closed and out of reach of children.

Juluca is taken orally as a single tablet once daily, preferably with a meal to enhance rilpivirine absorption. Swallow the tablet whole with water; do not crush or chew.

Serious risks include severe hypersensitivity reactions, Stevens‑Johnson syndrome or toxic epidermal necrolysis, significant liver enzyme elevations, and neuropsychiatric events such as depression or suicidal thoughts. Patients should seek immediate medical attention if any of these occur.

Juluca should not be used by patients with known resistance to integrase inhibitors or non‑nucleoside reverse transcriptase inhibitors, or by those taking contraindicated strong enzyme inducers such as rifampin or certain anticonvulsants without appropriate dose adjustments.

Published by

GNH India Pharmaceuticals Limited

Licensed pharmaceutical supplier

Last updated:

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