艾滋病新药：Trogarzo(ibalizumab-uiyk)-首个新治疗方案，全面消除顽固的HIV病毒.
2018年3月6日，美国食药监局FDA批准一种HIV新药上市。Trogarzo (ibalizumab-uiyk)是一种静脉滴注的人源化免疫球蛋白G4单克隆抗体，它与CD4+T细胞受体的第二个胞外区域结合，阻止HIV病毒入侵这些细胞，和PRO140类似都是一种“病毒侵入抑制剂”，但不同于市面上已经使用过的药物的其他结合位点。这种药物的出现可以让那些对目前自己治疗方案耐药的患者在接触到致命数量的病毒之前，将其加入到治疗方案。
适应症
用于那些已对惯用药产生耐药性的成年艾滋病患者：那些曾尝试过多种药物但其HIV病毒的感染水平无法被有效降低或控制的成人患者
用法与用量
Troparzo的使用方法是，患者每14天静脉内注射一次，也可与其他同类药物联合使用。

TROGARZO™(ibalizumab-uiyk) injection
DESCRIPTION
TROGARZO is a CD4-directed post-attachment HIV-1 inhibitor.
Ibalizumab-uiyk is a CD4 domain 2-directed humanized monoclonal antibody of immunoglobulin G (IgG) isotype 4 with a molecular weight of approximately 150 kDa. Ibalizumab-uiyk is produced by recombinant DNA technology in murine myeloma non-secreting 0 (NS0) cells.
TROGARZO Injection is a sterile, colorless to slightly yellow and clear to slightly opalescent solution with no visible particles in a single-dose vial for intravenous infusion. Each single-dose vial delivers approximately 1.33 mL containing 200 mg of ibalizumab-uiyk, and contains the following inactive ingredients: 10 mM L-histidine (2.06 mg), 0.045% polysorbate 80 (0.60 mg), 52 mM sodium chloride (4.04 mg) and 5.2% sucrose (69.2 mg). TROGARZO solution has a pH of 6.0 and contains no preservative
INDICATIONS
TROGARZO, in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced adults with multidrug resistant HIV-1 infection failing their current antiretroviral regimen.
DOSAGE AND ADMINISTRATION
Recommended Dosage
TROGARZO is available in a single-dose, 2 mL vial containing 150 mg/mL of ibalizumab-uiyk. Each vial delivers approximately 1.33 mL containing 200 mg of ibalizumab-uiyk.
TROGARZO is administered intravenously (IV), after diluting the appropriate number of vials in 250 mL of 0.9% Sodium Chloride Injection, USP. Patients should receive a single loading dose of 2,000 mg followed by a maintenance dose of 800 mg every 2 weeks.
Dose modifications of TROGARZO are not required when administered with any other antiretroviral or any other treatments.
Preparation
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard vial if solution is cloudy, if there is pronounced discoloration or if there is foreign particulate matter.
See Table 1 for the appropriate number of vials required to prepare both the loading dose of 2,000 mg and the maintenance doses of 800 mg.
TROGARZO solution for infusion should be prepared by a trained medical professional using aseptic technique as follows:
•Remove the flip-off cap from the single-dose vial and wipe with an alcohol swab.
•Insert sterile syringe needle into the vial through the center of the stopper and withdraw 1.33 mL from each vial (NOTE: a small residual amount may remain in the vial, discard unused portion) and transfer into a 250 mL intravenous bag of 0.9% Sodium Chloride Injection, USP. Other intravenous diluents must not be used to prepare the TROGARZO solution for infusion.
•Once diluted, the TROGARZO solution should be administered immediately.
•If not administered immediately, store the diluted TROGARZO solution at room temperature (20°C to 25°C, 68°F to 77°F) for up to 4 hours, or refrigerated (2°C to 8°C, 36°F to 46°F) for up to 24 hours. If refrigerated, allow the diluted TROGARZO solution to stand at room temperature (20°C to 25°C, 68°F to 77°F) for at least 30 minutes but no more than 4 hours prior to administration.
•Discard partially used vials or empty vials of TROGARZO and any unused portion of the diluted TROGARZO solution.
Administration
Diluted TROGARZO solution should be administered by a trained medical professional.
Administer TROGARZO as an IV infusion in the cephalic vein of the patient’s right or left arm. If this vein is not accessible, an appropriate vein located elsewhere can be used. Do not administer TROGARZO as an intravenous push or bolus.
The duration of the first infusion (loading dose) should be no less than 30 minutes. If no infusion-associated adverse reactions have occurred, the duration of the subsequent infusions (maintenance doses) can be decreased to no less than 15 minutes.
After the infusion is complete, flush with 30 mL of 0.9% Sodium Chloride Injection, USP.
All patients must be observed for 1 hour after completion of TROGARZO administration for at least the first infusion. If the patient does not experience an infusion-associated adverse reaction, the post-infusion observation time can be reduced to 15 minutes thereafter.
If a maintenance dose (800 mg) of TROGARZO is missed by 3 days or longer beyond the scheduled dosing day, a loading dose (2,000 mg) should be administered as early as possible. Resume maintenance dosing (800 mg) every 14 days thereafter.
HOW SUPPLIED
Dosage Forms And Strengths
Injection: 200 mg/1.33 mL (150 mg/mL) colorless to slightly yellow and clear to slightly opalescent solution with no visible particles in a single-dose vial.
Storage And Handling
TROGARZO (ibalizumab-uiyk) injection is a sterile colorless to slightly yellow and clear to slightly opalescent solution with no visible particles for intravenous infusion. It is packaged in a single-dose 2 mL clear glass vial containing 200 mg/1.33 mL (150 mg/mL) of ibalizumab-uiyk.
TROGARZO is available in a carton containing two single-dose vials (NDC 62064-122-02).
Store vials under refrigeration at 2 to 8°C (36-46 °F). Do not freeze and protect from light.
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm599657.htm