Amgen publishing on 'emerging modality', RNAi:Plasma and liver protein binding of GalNAc conjugated | ARWR Message Board Posts

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Msg  10011 of 10060  at  6/18/2019 9:57:31 PM  by

Steve_382


 In response to msg 10010 by  jetmanbash
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Re: Amgen publishing on 'emerging modality', RNAi:Plasma and liver protein binding of GalNAc conjugated siRNA

Repatha sounds like a pain in the arm, so to speak. Can be monthly SC at 420mg, but requires 3 shots 30 minutes apart or an on body infusor for 9 minutes. Otherwise, it's every two weeks SC at 140mg.
 
 

The recommended subcutaneous dosage of REPATHA in adults with established cardiovascular disease or in adults with primary hyperlipidemia (including heterozygous familial hypercholesterolemia [HeFH]) is either 140 mg every 2 weeks OR 420 mg once monthly, based on patient preference for dosing frequency and injection volume. When switching dosage regimens, administer the first dose of the new regimen on the next scheduled date of the prior regimen.

The recommended subcutaneous dosage of REPATHA in patients with HoFH is 420 mg once monthly. In patients with HoFH, measure LDL-C levels 4 to 8 weeks after starting REPATHA, since response to therapy will depend on the degree of LDL-receptor function.

When monitoring LDL-C for patients receiving REPATHA 420 mg once monthly, note that LDL-C can vary considerably during the dosing interval in some patients [see Clinical Studies (14)].

If a dose is missed, instruct the patient to administer REPATHA within 7 days from the missed dose and resume the patient’s original schedule.

  • If an every-2-week dose is not administered within 7 days, instruct the patient to wait until the next dose on the original schedule.
  • If a once-monthly dose is not administered within 7 days, instruct the patient to administer the dose and start a new schedule based on this date.

Important Administration Instructions

  • The 420 mg dose of REPATHA can be administered:
    ○ over 9 minutes by using the single-use on-body infusor with prefilled cartridge, or
    ○ by giving 3 injections consecutively within 30 minutes using the single-use prefilled autoinjector or single-use prefilled syringe.
  • Provide proper training to patients and/or caregivers on how to prepare and administer REPATHA prior to use, according to the Instructions for Use, including aseptic technique. Instruct patients and/or caregivers to read and follow the Instructions for Use each time they use REPATHA.
  • Keep REPATHA in the refrigerator. Prior to use, allow REPATHA to warm to room temperature for at least 30 minutes for the single-use prefilled autoinjector or single-use prefilled syringe and for at least 45 minutes for the single-use on-body infusor with prefilled cartridge. Do not warm in any other way. Alternatively, for patients and caregivers, REPATHA can be kept at room temperature at 68°F to 77°F (20°C to 25°C) in the original carton. However, under these conditions, REPATHA must be used within 30 days [see How Supplied/Storage and Handling (16)].
  • Visually inspect REPATHA for particles and discoloration prior to administration. REPATHA is a clear to opalescent, colorless to pale yellow solution. Do not use if the solution is cloudy or discolored or contains particles.
  • Administer REPATHA subcutaneously into areas of the abdomen, thigh, or upper arm that are not tender, bruised, red, or indurated using a single-use prefilled syringe, single-use prefilled autoinjector, or single-use on-body infusor with prefilled cartridge.
  • Do not co-administer REPATHA with other injectable drugs at the same administration site.
  • Rotate the site of each subcutaneous administration.
 


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