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Created with Pixso. Lenacapavir LuciLenacap Anti-HIV Agent

Lenacapavir LuciLenacap Anti-HIV Agent

Marchio: Lucius
Numero di modello: -
MOQ: 1 pz
prezzo: Please contact a specialist WhatsApp:55342706
Tempi di consegna: Negoziabile
Termini di pagamento: Western Union, MoneyGram, T/T
Informazioni dettagliate
Luogo di origine:
Lucius Pharmaceuticals (Lao) Co.,Ltd
Certificazione:
Drug production license
Specifica:
300 mg * 5 compresse per scatola/463,5 mg/1,5 ml per singola siringa preriempita
Indicazioni::
Per pazienti adulti infetti da HIV-1 multiresistente, usato in combinazione con altri farmaci antire
obiettivo::
Proteina capside CA dell'HIV-1, l'inibitore pionieristico del capside al mondo
Nome del prodotto::
Lenacapavir
Raccomandato::
Compresse: seguire rigorosamente il consiglio medico e collaborare con il mantenimento dell'inie
Magazzinaggio:
Sigillare il contenitore originale, conservare a temperatura ambiente 20–25°C al riparo dalla luce;
Imballaggi particolari:
Negoziabile
Capacità di alimentazione:
Negoziabile
Evidenziare:

LuciLenacap Lenacapavir Anti-HIV Agent

,

Generic Sunlenca Lenacapavir HIV Treatment

,

Lucius Lenacapavir Long-Acting HIV Injection

Descrizione del prodotto
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).