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Lenacapavir LuciLenacap Anti-HIV Agent

Brand Name:	Lucius
Model Number:	-
MOQ:	1 PCS
Price:	Please contact a specialist WhatsApp：55342706
Delivery Time:	Negotiable
Payment Terms:	Western Union, MoneyGram, T/T

Detail Information

Product Description

Detail Information

Place of Origin:

Lucius Pharmaceuticals (Lao) Co.,Ltd

Certification:

Drug production license

Specification:

300mg * 5 Tablets Per Box/463.5mg/1.5mL Per Single Prefilled Syringe

Indications::

For Adult Patients Infected With Multidrug-resistant HIV-1, Used In Combination With Other Sensitive Antiretroviral Drugs; The Injectable Formulation Serves As Long-acting Maintenance Therapy

Target::

HIV-1 Capsid Protein CA, The World's Pioneering Capsid Inhibitor

Product Name::

Lenacapavir

Recommended::

Tablets: Strictly Follow Medical Advice, And Cooperate With Long-acting Injection Maintenance After Completing Induction Administration Injection: Only Subcutaneous Injection By Medical Staff; Maintenance Administration Once Every Six Months

Storage:

Seal The Original Container, Store At Room Temperature 20–25°C Away From Light; Keep The Outer Carton Of Injection For Light Shielding

Packaging Details:

Negotiable

Supply Ability:

Negotiable

Highlight:

LuciLenacap Lenacapavir Anti-HIV Agent

Generic Sunlenca Lenacapavir HIV Treatment

Lucius Lenacapavir Long-Acting HIV Injection

Product Description

LuciLena (Lenacapavir Sodium Injection) Brief Instructions

For use only under the guidance of a physician

Manufacturer: Lucius Medicines Technology (Lao) Co., Ltd.

English Name: Lenacapavir Sodium Injection

Medicinal Product Approval Number: 05-LM-10018-26

Indications

LuciLena is a human immunodeficiency virus type 1 (HIV-1) capsid inhibitor, indicated for the following two scenarios:

HIV-1 Treatment: In combination with other antiretroviral medicinal products for the treatment of HIV-1-infected adults who meet all of the following criteria: harbor multidrug resistance; have received multiple prior lines of antiretroviral therapy (i.e., heavily treatment-experienced); and have failed their current antiviral regimen due to medicinal product resistance, medicinal product intolerance or safety concerns.

HIV-1 Pre-Exposure Prophylaxis (PrEP): For pre-exposure prophylaxis in adults and adolescents weighing at least 35 kg to reduce the risk of sexually acquired HIV-1.

Note: Individuals must test HIV-1 negative prior to initiation.

Dosage and Administration

Pre-administration screening: For PrEP use, HIV-1 screening must be performed and confirmed negative before the first injection and each subsequent injection.

The recommended dosing regimen of LuciLena consists of an induction phase and a maintenance phase, detailed as follows:

Induction Phase (Regimens differ for treatment vs. PrEP)

Regimen 1 (for both Treatment & PrEP): Subcutaneous injection of 927 mg LuciLena (2 syringes of 1.5 mL each) on Day 1, accompanied by oral 600 mg (2 tablets of 300 mg each); oral 600 mg (2 tablets of 300 mg each) on Day 2.

Regimen 2 (Treatment only): Oral 600 mg (2 tablets of 300 mg each) on Day 1 and Day 2; oral 300 mg (1 tablet of 300 mg) on Day 8; subcutaneous injection of 927 mg LuciLena (2 syringes of 1.5 mL each) on Day 15.

Maintenance Phase

Subcutaneous injection of 927 mg LuciLena (2 syringes of 1.5 mL each) every 6 months (26 weeks, ±2 weeks) counting from the date of the last injection.

Scheduled missed injection (oral bridging)

If a planned injection will be delayed by more than 2 weeks, oral tablets may be used as bridging therapy for up to 6 months maximum.

(For PrEP patients, the bridging dose is 300 mg taken orally once every 7 days.)

Unscheduled missed injection

If more than 28 weeks have passed since the last injection without oral bridging tablets taken, restart the full induction phase regimen starting from Day 1 based on clinical judgment.

Administration Restrictions

Tablets may be taken with or without food.

The injection is for subcutaneous administration only by qualified medical personnel (abdomen or thigh). Intradermal injection is strictly prohibited, as it may trigger severe injection-site reactions.

Specification

Injection: Single-dose prefilled syringe, 463.5 mg/1.5 mL (309 mg/mL).

Contraindications

For both Treatment and PrEP: Concomitant use with strong CYP3A inducers is contraindicated.

PrEP only: Contraindicated in individuals with unknown or positive HIV-1 status.

Warnings and Precautions

PrEP Resistance Risk: Resistance mutations have been identified when this product is used for PrEP in undiagnosed HIV-1-positive individuals. Patients found to be HIV-1 positive must immediately switch to a complete therapeutic antiretroviral regimen.

Immune Reconstitution Syndrome: Treated patients may require further evaluation and targeted management.

Long-Acting Property: Circulating medicinal product residual concentrations may persist in the body for up to 12 months or longer. Initiation of other CYP3A-metabolized medicinal products within 9 months after the last injection may increase systemic exposure and the risk of adverse reactions.

Injection-Site Reactions: Local reactions such as persistent nodules and induration may occur. Accidental intradermal injection can lead to severe adverse effects including skin necrosis or ulceration.

Adverse Reactions

The most common adverse reactions (incidence ≥5%) observed in clinical trials are injection-site reactions, headache and nausea.

Medicinal Product Interactions

CYP3A Inducers: Strong or moderate CYP3A inducers may markedly reduce plasma concentrations of this product. Co-administration with strong inducers is contraindicated; co-administration with moderate inducers is not recommended (dose adjustment is required if concomitant use is unavoidable).

Combined Inhibitors: Co-administration with combined P-gp, UGT1A1 and strong CYP3A inhibitors may elevate medicinal product concentrations, and concurrent use is not advised.

Use in Special Populations

Pregnancy and Lactation

This medicinal product is excreted in human breast milk. No adverse reactions have been observed in breastfed infants to date. The benefits of breastfeeding shall be weighed against the mother’s clinical treatment needs.

Pediatric Population

Safety and efficacy for the PrEP indication have been established in adolescents weighing at least 35 kg. Safety and efficacy for the therapeutic indication have not been established in pediatric patients.

Renal and Hepatic Impairment

No dose adjustment is needed for patients with mild, moderate or severe renal impairment (CrCl ≥15 mL/min) or mild/moderate hepatic impairment. This product has not been evaluated in patients with end-stage renal disease (ESRD) or severe hepatic impairment.

Storage

Store at 20°C to 25°C; excursions between 15°C and 30°C are permitted. Protect from light (keep in the original outer carton at all times until administration).

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products details

Lenacapavir LuciLenacap Anti-HIV Agent

LuciLenacap Lenacapavir Anti-HIV Agent

Generic Sunlenca Lenacapavir HIV Treatment

Lucius Lenacapavir Long-Acting HIV Injection

Indications

Dosage and Administration

Induction Phase (Regimens differ for treatment vs. PrEP)

Maintenance Phase

Scheduled missed injection (oral bridging)

Unscheduled missed injection

Administration Restrictions

Specification

Contraindications

Warnings and Precautions

Adverse Reactions

Medicinal Product Interactions

Use in Special Populations

Pregnancy and Lactation

Pediatric Population

Renal and Hepatic Impairment

Storage