GNH USA

Europe — EMA

Juluca

GNH USA supplies Juluca (dolutegravir sodium and rilpivirine hydrochloride), an antiretroviral for adult HIV‑1 infection in selected patients.

Dolutegravir Sodium, Rilpivirine Hydrochloride

Request sourcing

1
Pack/s

What is Dolutegravir Sodium, Rilpivirine Hydrochloride?

Dolutegravir sodium and rilpivirine hydrochloride, the active ingredient in Juluca, is a antiretroviral (integrase strand transfer inhibitor + non‑nucleoside reverse transcriptase inhibitor) presented as a 50 mg dolutegravir sodium / 25 mg rilpivirine hydrochloride film‑coated tablet for oral use. It treats HIV‑1 infection in treatment‑experienced adults with no prior resistance to integrase inhibitors or NNRTIs.

GNH USA supplies Juluca as a licensed, GDP‑compliant international pharmaceutical supplier serving hospitals, pharmacies and clinics worldwide.

What is Dolutegravir Sodium, Rilpivirine Hydrochloride used for?

Juluca is indicated for HIV‑1 infection, acting on viral replication through integrase inhibition and reverse‑transcriptase inhibition.

HIV‑1 treatment‑experienced adult infection: used as a complete regimen for adults who have previously received antiretroviral therapy and have no documented resistance to integrase inhibitors or NNRTIs. Maintenance therapy for HIV‑1 infection: provides ongoing viral suppression as a once‑daily oral regimen. Switch therapy for virologically suppressed patients: enables transition from multi‑tablet regimens to a single‑tablet regimen while maintaining efficacy.

What are the side effects of Dolutegravir Sodium, Rilpivirine Hydrochloride?

Adverse reactions reported with Juluca vary in frequency and severity.

Common Side Effects: - Nausea: mild to moderate stomach upset. - Headache: transient headache. - Diarrhea: loose stools. - Insomnia: difficulty sleeping.

Serious or Rare Side Effects: - Severe hypersensitivity reactions: rash, fever, eosinophilia, or anaphylaxis. - Elevated liver enzymes: potential hepatotoxicity requiring monitoring.

What precautions apply to Dolutegravir Sodium, Rilpivirine Hydrochloride?

Before initiating Juluca, several clinical considerations should be evaluated.

Assess resistance profile: confirm no prior resistance to integrase inhibitors or NNRTIs. Monitor hepatic function: check liver enzymes periodically during therapy. Evaluate renal function: consider dose adjustment in patients with severe renal impairment. Review concomitant medications: identify potential drug‑drug interactions that may affect efficacy or safety. Pregnancy and breastfeeding: use only if the expected benefit justifies the potential risk, as data are limited. Store at ambient temperature: keep below 25 °C, retain in the original packaging, and protect from moisture.

What does Dolutegravir Sodium, Rilpivirine Hydrochloride interact with?

Juluca may interact with other medicines; interactions are classified by their clinical significance.

Major Interactions (Avoid): - Rifampin: strong enzyme inducer that markedly reduces dolutegravir and rilpivirine concentrations. - Antacids containing polyvalent cations (e.g., aluminum, magnesium): decrease rilpivirine absorption when taken concurrently. - St. John’s wort: potent CYP3A4 inducer that lowers rilpivirine levels.

Moderate Interactions (Monitor Closely): - Hepatitis C protease inhibitors (e.g., boceprevir): may increase dolutegravir exposure. - Metformin: dolutegravir can increase plasma metformin concentrations, requiring monitoring. - Oral contraceptives: rilpivirine may reduce contraceptive efficacy; advise additional non‑hormonal methods.

Frequently asked questions

What is Juluca used for?+
Juluca is a fixed‑dose combination tablet containing dolutegravir sodium and rilpivirine hydrochloride. It is prescribed for treatment‑experienced adult patients with HIV‑1 infection who have no known resistance to integrase inhibitors or non‑nucleoside reverse transcriptase inhibitors, and it can also be used as a maintenance regimen to keep the virus suppressed.
How does dolutegravir sodium work?+
Dolutegravir sodium belongs to the integrase strand transfer inhibitor class. It binds to the active site of the HIV integrase enzyme, preventing the insertion of viral DNA into the host cell genome, a critical step required for viral replication. By blocking integration, dolutegravir stops the virus from establishing a permanent infection in the cell.
How does rilpivirine hydrochloride work?+
Rilpivirine hydrochloride is a non‑nucleoside reverse transcriptase inhibitor. It attaches to a specific site on the HIV reverse transcriptase enzyme, causing a conformational change that inhibits the enzyme’s ability to convert viral RNA into DNA. This interruption halts the early stage of viral replication, complementing the action of dolutegravir.
What is the usual dose of Juluca?+
The prescribed dose of Juluca is determined by the treating clinician based on the patient’s medical history, resistance profile, and concomitant medications. The product is supplied as a single film‑coated tablet containing 50 mg dolutegravir sodium and 25 mg rilpivirine hydrochloride, taken orally once daily with food, unless the prescriber advises otherwise.
Is Juluca safe during pregnancy or breastfeeding?+
Safety data for Juluca in pregnancy and lactation are limited. The medication should only be used if the potential benefits to the mother outweigh the possible risks to the fetus or infant. Healthcare providers typically assess individual risk factors and may consider alternative regimens when safer options are available.
How do I order Juluca from GNH USA?+
To request Juluca, visit the product page on gnh-usa.com, enter the required quantity, and submit the enquiry form. GNH USA 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.
How does Juluca compare with other HIV single‑tablet regimens?+
Juluca combines an integrase inhibitor with a non‑nucleoside reverse transcriptase inhibitor, whereas many other single‑tablet regimens pair an integrase inhibitor with two nucleoside reverse transcriptase inhibitors. This difference can reduce pill burden and may be preferred for patients who have contraindications to nucleoside agents, but efficacy and safety should be evaluated individually.
What are the storage requirements for Juluca?+
Juluca tablets should be stored at ambient temperature, below 25 °C (77 °F). Keep the medication in its original blister pack or container, protect it from moisture and direct sunlight, and ensure the packaging remains tightly closed until use.
How is Juluca administered?+
Juluca is taken orally as a single film‑coated tablet once daily, preferably with a meal to enhance rilpivirine absorption. Swallow the tablet whole with water; do not crush, chew, or split it unless specifically instructed by a healthcare professional.
Who should not take Juluca?+
Juluca is contraindicated in patients with known hypersensitivity to either dolutegravir sodium, rilpivirine hydrochloride, or any of the tablet’s excipients. It should also be avoided in individuals with documented resistance to integrase inhibitors or NNRTIs, and caution is advised for patients with severe hepatic impairment or those taking interacting medications listed as major interactions.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Dolutegravir Sodium, Rilpivirine Hydrochloride
Route
Oral Use
Manufacturer
Viiv Healthcare B.V.
Origin
EU

Related products