"A$" "" }X2Dr(`2,"6'Dj lf.N fs*H^~)f". J2796 Injection, romiplostim, 10 micrograms; 10 mcg = 1 billable unit NDC(s): Nplate 125 mcg single-dose vial: 55513-0223-xx Nplate 250 mcg single-dose vial: 55513-0221-xx Nplate 500 Q6M6uW8R":%C$guPqF**we&pRP'Ic[ Romiplostim may encourage the progression of myelodysplasia to acute myeloid leukemia.. An 85-year-old woman with thrombocytopenia, thought to be immune but actually secondary to myelodysplasia, was given romiplostim, initially 1 microgram/kg/week, increasing weekly to 10 micrograms/kg/week [27].After 6 weeks she developed leukemic skin lesions with Romiplostim 1 mcg/kg (actual body weight) subcutaneous injection, Once Weekly Example: Patient weight of 150 lbs. FULL PRESCRIBING INFORMATION RHOPHYLAC Rh O (D) Immune Globulin Intravenous (Human) WARNING: INTRAVASCULAR HEMOLYSIS IN ITP This warning does not apply to Rh(D)-negative patients treated for the If platelet count is > 400 109/L, do not dose.Continue to assess the platelet count weekly. The Fc component of the romiplostim peptibody extends the half-life, allowing it to remain active in the circulation much longer than endogenous TPO; it is eventually removed by the n[6 Dg For injection: 125 mcg, 250 mcg or 500 mcg of romiplostim as a lyophilized powder in single-dose vials. Class/mechanism: Thrombopoietin (TPO/cMpl) receptor agonist. 375 mcg ; add : 0.72 mL = 250 mcg in 0.5 mL : 500 mcg/mL : 500 mcg ; 625 mcg : h;09TD %M5zJ^7ozoZM.iF!&ymMB]jPc0W3z: ` ;E&mbo;B0kYbCSrOP 72 0 obj <>stream %%EOF 0 The most common side effects of DOPTELET when used to treat low blood platelet counts in adults with chronic immune thrombocytopenia (ITP) are: headache. \t=L7{q!RwQz(L)E34#;4}v NPlate [package insert]. In accordance with its package insert, azacitidine was delayed in 1-week increments for adverse events. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information. upper respiratory tract infection. indigestion. A90 of Romiplostim Sterile Water for Injection* Deliverable Product and Volume Final Concentration 250 mcg 375 mcg add 0.72 mL = 250 mcg in 0.5 mL 500 mcg/mL 500 mcg 625 mcg add 1.2 mL = hb```e``e`a` @1V 8 e``bzAmbZEn9)%qg7xo(,w%EyDGcGkDiG[GKEJFGCGG610q4iA 'i"lh[L`)axI>f"6 u0 (a\i{wt0e`Cl^NO~%NbW &mG&o= p#GFwi !^HVajerMVhB4GLZ3CUsV:D=B#M@u8^GgVr`C.8{HZGz0?oE"_vaNiZz|W}0-vom@3iK^k)+eUTemMp8J:8Np[~+`veI.+/Mv O=!Wr?5~b#%'kaN4S&`oH4@w#Sp-sRr*}N&, If platelet count is > 200 109/L and 400 109/L for 2 consecutive weeks, reduce the dose by 1 mcg/kg. None. (= 193 0 obj <>/Filter/FlateDecode/ID[<261D20F0EE8C2240A72EADCA9223D80B>]/Index[172 37]/Info 171 0 R/Length 104/Prev 258045/Root 173 0 R/Size 209/Type/XRef/W[1 3 1]>>stream Vz{c$BOpVwIn(q32=QWRlEYl6To^+ Inject Dose A) Gently hold a fold of skin on your thigh or abdomen and insert the needle straight into the folded skin (Figure K). h`F; 6|H!|R References 1. NPlate [package insert]. endstream endobj 3103 0 obj <>stream ((Iv-VSIpg|i\Up|nz{rggE6jFr"Kf Qx]nW/g%l0!8b4W-|Ja)pNyy&2l`Y8WtY.s3M %PDF-1.6 % >GIV(jB4 @x:=\G BBAD@*:gkCF = 68 kg, therefore the dose would be 68 mcg subcutaneously once weekly -u~_ TqB$vK%aN5RQW(aoAsW^,gS4AGM?+(jBR3+"sP+? Accessed August 2018. Through this mechanism, romiplostim reduces the need for other treatments and decreases bleeding events in patients with thrombocytopenia. !,FOHLg*R,T3Ku!. Only use romiplostim in ITP patients who are at an increased risk of bleeding. Nplate is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in adult patients with immune thrombocytopenia (ITP) who have had an insufficient response to endstream endobj 75 0 obj <> endobj 76 0 obj <>/Font<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI]>>/Rotate 0/StructParents 9/Tabs/S/Type/Page>> endobj 77 0 obj <>stream __c; ^h3kPHHr. M^]H{2wHptrPx{H?I"KN| b@d@SBL!6fvd{U,UmjOO )cg4X16UJ9^CT|KK05%hKhzO4 , zGsl!n !``DsNf)q. 2. Thrombopoietin (TPO) is the major regulator of both megakaryopoiesis and platelet production. G.:hJ(hTjb |]:Ul,*vkuN41Nw{U+srkqPQuH~t(BjSUxOq @8cg`ZH5"fw"9J:xJ)I8a-u}^*NHW z_;R[E($w>4[. TPO is a glycoprotein primarily produced in the liver. ,$*8U xTBu<1`q"0Ab#;(#-) XJO^,cy|AU3? upper respiratory tract infection. The recommended dose is 45 mg initially and 4 weeks later, followed by 45 mg every 12 weeks. endstream endobj startxref In pediatric trials the most common adverse events were headache, upper respiratory infection, and gastrointestinal complaints (mild). d";Y$'Z (c{YKW hN1T@KS9Qub%[,5-wL5CQ)? TPO, when binding to its receptor (c-Mpl), triggers a signaling cascade that leads to the differentiation and proliferation of megakaryocytes, with a concomitant increase in platelets. Page 3 | NPLATE (romiplostim) Prior Auth Criteria Proprietary Information. r1%I hko:c b;~$DvCZ;TBJ lc!dLwrslK0 G?D1 HrsO# 4DxKs )aG!#\kqP2` k\B`V59, ${Q,OgN.i>K9: ^ =c;8zM`Q)Mx|D}\`?vxzBnG'v=;`]2->!xW~W*b wc"?Vx?}>S$ vtE^|qx ZPL:Jrc:2^}LsL"v8Ea"pxnTx.g1_t`hf$mLw\be0GVA7(E:gE6/ &NWE6f^_ BdO9l0sb{;O7z{9pD7sD^~{\E1|0,E'=Uoegz365 CJJJ* J2796 Injection, romiplostim, 10 micrograms; 10 mcg = 1 billable unit NDC(s): Nplate 125 mcg single-dose vial: 55513-0223-xx Nplate 250 mcg single-dose vial: 55513-0221-xx Nplate 500 b-'mat#t\L^M#MLEwDBC OnwrF3qkkg(C Neunert C, Lim W, Crowther M, et al. 0 bleeding gums. pain in mouth and throat (oropharyngeal pain) The most common side effects of romiplostim in children 1 year of age and older include: bruising. purple or red spots on your skin. New Policy titled Nplate (romiplostim) No policy changes made This Medical Policy is designed for informational purposes only and is not an authorization, an explanation of benefits, or a contract. J2796 Injection, romiplostim, 10 micrograms: 10 mcg = 1 billable unit NDC(s): Nplate 250 mcg single-dose vial: 55513-0221-xx Nplate 500 mcg single-dose vial: 55513-0222-xx VII. hbbd```b`` hbbd```b``n DJ e5LOQn0lB,A$'axHt3X%#L dP Nplate (romiplostim) (Subcutaneous) Document Number: IH-0089 Last Review Date: 01/07/2019 1. With few adverse effects, romiplostim is effective in raising the platelet count in over 80% of ITP patients, allowing them to discontinue other therapies, reduce the need for splenectomy, and improve their quality of life. joint pain. Abstract. [s+iJ(8W86s:y.\ks`Xrl044qQ;1g=6w"C) *" ']UJ#*R="-NFi`-JCNt@s&. "3l}4<0=ieoGWii#JK ) V5CScp_8g:;y_=T1n $}dBZf)OM\^f{u>MdW4VP For injection: 250 mcg or 500 mcg of deliverable romiplostim as a sterile, lyophilized, solid white powder in single-dose vials. Nplate (romiplostim) is used to treat low blood platelet counts in adults with chronic immune (idiopathic) thrombocytopenia (ITP), when certain other medicines, or surgery to remove the [1][2][3] For other Grade 3 or 4 toxicities hold treatment and restart treatment at 1 mg less than the previous dose when toxicity has re solved to less than or Route: SC endstream endobj startxref Romiplostim. 3 Adjust the dose as follows for adult patients: If the platelet count is < 50 109/L, increase the dose by 1 mcg/kg. 0 56 0 obj <>/Filter/FlateDecode/ID[]/Index[31 42]/Info 30 0 R/Length 121/Prev 102207/Root 32 0 R/Size 73/Type/XRef/W[1 3 1]>>stream bruising. Dk7@LUsn{b,jW.y$ zdb~ai/ab_wr^!YBp'hBev]Sk@P\b=hL-.>rI\Q eFw!| AaumkymS7 BeSq5 "9|KlA[3M'}fA^gz}!MQt[2[|&o]Y:Q)vJV9Om]K{C/>MM. Extravasation: n/a, For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. %PDF-1.5 % 250 mcg . h1 [1], From HemOnc.org - A Hematology Oncology Wiki, Romiplostim (Nplate) patient drug information (Chemocare), Romiplostim (Nplate) patient drug information (UpToDate), Romiplostim (Nplate) package insert (locally hosted backup), https://hemonc.org/w/index.php?title=Romiplostim_(Nplate)&oldid=52500, About HemOnc.org - A Hematology Oncology Wiki, 12/14/2018: Approved for pediatric patients 1 year of age and older with, This page was last edited 03:26, 20 September 2021 by. K1iF\F\ upper respiratory tract infection. For injection: 250 mcg or 500 mcg of deliverable romiplostim as a . pH|7Y_8MmuwB}Km+ +nr *j2NS]Z*#mJ*IXX -l-lGC*>j~ Y(=/{9ZKRfS%vQL`I8i?Os& FTMQA\d`QF-\lo,F) JwP9KMyW"7;6K^#UwO,k Romiplostim is an Fc-peptide fusion protein (peptibody) that interacts with the TPO receptor to trigger downstream signal cascades that ultimately stimulate platelet production by promoting proliferation and differentiation of megakaryocytes from bone marrow progenitor cells. Used to treat thrombocytopenia associated with chronic immune thrombocytopenia (ITP). hbbd``b`$c`_b 0*H" f" @I dJ8|$ Romiplostim is given to patients with low platelet counts in order to increase the platelet count to a range that will prevent potentially life-threatening bleeding. Although romiplostim can increase the platelet count to a safe range, it is generally not considered a cure for ITP. Nvc$\z1kW\844rO/&~k7jw}nEzJo DlKA Nh Y$} 2s1,M W V!&\ADp>-,DPBzQn;1tevVD ip!n2 + rUw^?+w?Xzy\q|Y}"{kp6%_}nB=NY{.LMr !Oae1l&w*k(5(Am+$.nn{_rzrC$iC9& ;`h2R{vQ!-Tu[a',hL]G92{ t107|YFdrD:X@D^ho>!A\?oUo>oO|U5H 4*$^Fxp&/GsocF! endstream endobj 177 0 obj <>stream %PDF-1.6 % of Romiplostim Sterile Water for Injection* Deliverable Product and Volume Final Concentration . Do not use romiplostim in an attempt to normalize platelet counts. wy wEh~|p %er w.Y7GYw}/)[#-9I &{2#O>x %XYn?p[naV @=TH3AVf'Y;)2O t=Zn\&NmtNj1w_k[hM#I\ieYh5m&t\,4/[8VOM`+*NQgG.&~ES 3S9%0[g;- 'f(79"48oK[wYr }ZGzrYH5l,O{s%SK ] Nplate [package insert]. T+.q>tw|]8xT}:qcE:.#j'= r _p P-O ( tw;8 rMJr50h5d35eRgO"'"IRiV ]Ok2B0N7?86XQQ{>Z3a62\Cfa p Initial phase 1 and phase 2 clinical trials of romiplostim in adult patients with chronic ITP demonstrated platelet responses within the targeted platelet range, 50 to 450 10 9 /L, and HSJvS[w`6+e-pf)}[du-. }|{cBLlSQwz!v2!F%B'Z1zTAx)zz;D@8@XTC)'J6- Platelets help clot the blood. Thousand Oaks, CA; Amgen Inc; December 2018. Thousand Oaks, CA; Amgen Inc; October 2017. Nplate Romiplostim has no amino acid sequence homology to endogenous TPO. Nplate is supplied as either 125 mcg per Romiplostim is an Fc-peptide fusion protein (peptibody) that interacts with the TPO receptor to trigger downstream signal cascades that ultimately stimulate platelet production by promoting If platelet or neutrophil counts had not recovered by day 42 of a cycle, a 50% lower dose was administered starting on day 42. cough. p\To~qPgjQmpFm9yE(Z ~hUgh1V UvvjAp*7!e% &0&,-J$1aRCEar:I-@PNX^^N*A"K/J} 2 dX 79Q%zQu'y,e> %PDF-1.6 % iZ`i?b={9~tABP 31 0 obj <> endobj Romiplostim is produced by recombinant DNA technology in Escherichia coli (E. coli). nausea. wmV. Eltrombopag package insert recommends a starting dose of 50 mg/day with dose modifications of 25-mg increment for age 6 years, while the starting dose for children 5 years is 25 mg. 208 0 obj <>stream (hqnNaqzj HWm&=XBUR> R~D*w{'=>{,6&`3-|nEX?%~{,1|M|uqv3X+?1(1XFLHFHHg=?[gJfO`kwg}#[^aU{gKT{]YLT8`L'#,)E+i_ -PUj]:pa9CwK Restricted Access Do not disseminate or copy Q {gg=HT$h39W Romiplostim binds to and activates the TPO receptor on megakaryocyte precursors, thus promoting cell proliferation and viability, resulting in increased platelet production. Thousand Oaks, CA: Amgen Inc.; February 2022. hVmo8+- Mt]P|p-H)vl]CI# endstream endobj 173 0 obj <> endobj 174 0 obj <>/Font<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI]>>/Rotate 0/StructParents 0/Type/Page>> endobj 175 0 obj <>stream 172 0 obj <> endobj .oZSLq)XKU &95Icx)77}}"#ZK2=[2$Fs$-{7mz LK[v-PWmyD*>8PS\DTj+2\{%AOcR#!ow>OZK6)KeoM U(kc\ JQFZrl`JbFqc,SgDd].^Vw}kt .F/eNS%l{1z*xLmYSLy&I. at,&tHU`30B[3hGa=}65kl,X*&{drKdsfa,n-OqET7@&Lt#i1k313yM=:)dy bggvX OyBS!vfDcpsHKJ#)&oK` T@YRA BFiQoIm J.|{.^ [34386] - See package insert for detailed storage information - Store in carton - Store unreconstituted product in refrigerator (36 to (3) -----CONTRAINDICATIONS----- None (4) -----WARNINGS AND PRECAUTIONS----- Subcutaneous Adult Dosage Regimen. tiredness. lyophilized powder in single-dose vials. 116 0 obj <>stream Romiplostim works by stimulating the bone marrow to produce more platelets. For patients with co-existent moderate-to-severe plaque psoriasis weighing more than 100 kg, the recommended dose is 90 mg initially and 4 weeks later, followed by 90 mg every 12 weeks. endstream endobj startxref HWI7?`Vkafr$A2RJ=I&`rP^jj/?omcPBNyVi/+>}x84x fDexRy y,,}CXn Romiplostim is used after a splenectomy (surgery to remove the spleen) or when other medicines (eg, steroids or immunoglobulins) have not worked well enough in patients with ITP for at least 6 months. Nplate (romiplostim) for injection is supplied as a sterile, preservative-free, lyophilized, solid white powder for subcutaneous use. 4 CONTRAINDICATIONS . Nplate (romiplostim) Background Nplate (romiplostim) works as an analog to the protein thrombopoietin (TPO) and binds to the 1. 3102 0 obj <>stream For injection: 125 mcg, 250 mcg or 500 mcg of deliverable romiplostim as a lyophilized powder in single-dose vials. ( 3) Thrombotic/thromboembolic complications may result from increases in platelet counts with Nplate use. Portal vein thrombosis has been reported in patients with chronic liver disease receiving Nplate. ( 5.2) ^)vkE3'0z\-'y n_+i;?I7"x]O-ev)Em4t 0 >stream "h `"8qNSU6GM[[X&_U%x#Td_Li}6v/OWG a)UWJi[ .Dc">u ec4_t\ jZ||Uu}v;VQ%B O 'd6+#D8mCD}eUj;lvwIO{z81K h9Aubx3u&U7m1wgyEF8jt*L? p|HUh#umT-HjERx-3]V05k"0M7|1*\)>/Kk 0z_o VdLJHRRdH| sbE^3ZMA5E#>R! Romiplostim (Nplate) Romiplostim is a subcutaneous injection into the skin It is supplied in 250 mcg and 500 mcg vials. Each patients dose will be determined based upon their actual body weight and platelet count at the time of dosing Injection site irritation may occur Romiplostim should NOT be given intravenously Romiplostim is a fusion protein thrombopoietin (TPO) peptide analog that increases platelet counts by binding to and activating the human TPO receptor. /C^Z:Zc3Cl `h[c#tle%[=_{}gcz_g{ wFd_~n3CfjF;:+]`j|n`Rp0GVx Accessed December 2018. & ~&F FW0 N %%EOF HWYn0=A%Y3 r(VIQI!0b{D{2.p1,~k C9@-UD|1uFj[oq.^8.u %%EOF hb```f``J``e``ad@ A+6yr;00\S I)GKI\ ^%@Z%"X2`3gb[v]0N6o L9Nl%T*q@.b3 o" endstream endobj 32 0 obj <> endobj 33 0 obj <> endobj 34 0 obj <>stream J2796 Injection, romiplostim, 10 micrograms: 10 mcg = 1 billable unit NDC(s): Nplate 250 mcg single-dose vial: 55513-0221-xx Nplate 500 mcg single-dose vial: 55513-0222-xx VII. ;[qY"(9/ diarrhea. It works by causing the cells in the bone marrow to produce more platelets. nosebleed. Nplate can cause serious side effects, including: Worsening of a precancerous blood condition to a blood cancer (leukemia): Nplate is not for use in people with a precancerous condition called &?C|ka"lCwv#WP*o%o='m{W$IqCg_==8'vtkj+.Kc |bY\9raV]Xx~m8I\&,qn>5I}N05. Teriparatide injection is available as single-patient-use pens in the following package size: 620 mcg/2.48 mL (250 mcg/mL) NDC 47781-652-89. Romiplostim is in a class of medications called thrombopoietin receptor agonists. ENII8?3:8A mkT6CBI7-0 ~kPS(k=^`s-3ZFA934d+]z/wtfqw%H9` 11 When azacitidine was delayed, treatment with romiplostim or placebo was continued. 93 0 obj <>/Filter/FlateDecode/ID[<351E6B6A21414C4186FAEA762BE9F578><3ECE648FC974A24A863E65B9E774749A>]/Index[74 43]/Info 73 0 R/Length 94/Prev 138751/Root 75 0 R/Size 117/Type/XRef/W[1 2 1]>>stream hb```,VVeAd`a`bnJH&hdq }pBaW;Ys%5TXc0QaG..\R!,A@)GI:GM=y,6k$%>p${3^2)v$tP4$30/{X , hr%%%e:KKL"X'T1y0r100s``ald+`F`g43Dx0,b0 >c hXn7>&(\ 0`Yq,4u,6mW'V^`y(P+bI 0In .8ai$h-'Z 74 0 obj <> endobj Nplate (romiplostim) for injection is supplied as a sterile, preservative-free, solid white lyophilized powder in single-dose vials that deliver 125 mcg (NDC-55513-223-01), 250 mcg (NDC 55513-221-01) and 500 mcg (NDC 55513-222-01) of romiplostim. Romiplostim injection is used to increase the number of platelets enough to lower the risk of bleeding, but it is not used to increase the number of platelets to a normal level. WARNINGS AND PRECAUTIONS . Romiplostim (Nplate ), a thrombopoietin receptor agonist, is the first FDA-approved thrombopoiesis-stimulating protein for the treatment of low platelet (PLT) counts in adults with chronic immune thrombocytopenia. NPLATE.
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