Romiplostim. 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. __c; ^h3kPHHr. M^]H{2wHptrPx{H?I"KN| b@d@SBL!6fvd{U,UmjOO )cg4X16UJ9^CT|KK05%hKhzO4 , zGsl!n !``DsNf)q. 208 0 obj <>stream 72 0 obj <>stream Nvc$\z1kW\844rO/&~k7jw}nEzJo DlKA Accessed December 2018. Thousand Oaks, CA; Amgen Inc; December 2018. hb```,VVeAd`a`bnJH&hdq }pBaW;Ys%5TXc0QaG..\R!,A@)GI:GM=y,6k$%>p${3^2)v$tP4$30/{X , hr%%%e:KKL"X'T1y0r100s``ald+`F`g43Dx0,b0 >c (= bleeding gums. endstream endobj startxref "3l}4<0=ieoGWii#JK ) V5CScp_8g:;y_=T1n $}dBZf)OM\^f{u>MdW4VP ^)vkE3'0z\-'y n_+i;?I7"x]O-ev)Em4t 0 >stream If platelet count is > 200 109/L and 400 109/L for 2 consecutive weeks, reduce the dose by 1 mcg/kg. hb```e``e`a` @1V 8 e``bzAmbZEn9)%qg7xo(,w%EyDGcGkDiG[GKEJFGCGG610q4iA 'i"lh[L`)axI>f"6 u0 Thrombopoietin (TPO) is the major regulator of both megakaryopoiesis and platelet production. 3 Adjust the dose as follows for adult patients: If the platelet count is < 50 109/L, increase the dose by 1 mcg/kg. Inject Dose A) Gently hold a fold of skin on your thigh or abdomen and insert the needle straight into the folded skin (Figure K). 250 mcg . ENII8?3:8A mkT6CBI7-0 ~kPS(k=^`s-3ZFA934d+]z/wtfqw%H9` For injection: 250 mcg or 500 mcg of deliverable romiplostim as a . endstream endobj 3103 0 obj <>stream 4 CONTRAINDICATIONS . Nplate (romiplostim) Background Nplate (romiplostim) works as an analog to the protein thrombopoietin (TPO) and binds to the 1. With few adverse effects, romiplostim is effective in raising the platelet count in over 80% of ITP patients, allowing them to discontinue other therapies, reduce the need for splenectomy, and improve their quality of life. 2. hbbd``b`$c`_b 0*H" f" @I dJ8|$ &?C|ka"lCwv#WP*o%o='m{W$IqCg_==8'vtkj+.Kc |bY\9raV]Xx~m8I\&,qn>5I}N05. 193 0 obj <>/Filter/FlateDecode/ID[<261D20F0EE8C2240A72EADCA9223D80B>]/Index[172 37]/Info 171 0 R/Length 104/Prev 258045/Root 173 0 R/Size 209/Type/XRef/W[1 3 1]>>stream Vz{c$BOpVwIn(q32=QWRlEYl6To^+ 0 hVmo8+- Mt]P|p-H)vl]CI# diarrhea. Abstract. ( tw;8 rMJr50h5d35eRgO"'"IRiV ]Ok2B0N7?86XQQ{>Z3a62\Cfa p (3) -----CONTRAINDICATIONS----- None (4) -----WARNINGS AND PRECAUTIONS----- ((Iv-VSIpg|i\Up|nz{rggE6jFr"Kf Qx]nW/g%l0!8b4W-|Ja)pNyy&2l`Y8WtY.s3M 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. References 1. nosebleed. 0 NPlate [package insert]. Used to treat thrombocytopenia associated with chronic immune thrombocytopenia (ITP). Page 3 | NPLATE (romiplostim) Prior Auth Criteria Proprietary Information. 116 0 obj <>stream 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$iC9& ;`h2R{vQ!-Tu[a',hL]G92{ HWYn0=A%Y3 r(VIQI!0b{D{2.p1,~k For patients with co-existent moderate-to-severe plaque psoriasis weighing more than 100 kg, the recommended dose is 90 mg initially and 4 weeks later, followed by 90 mg every 12 weeks. %PDF-1.6 % New Policy titled Nplate (romiplostim) No policy changes made This Medical Policy is designed for informational purposes only and is not an authorization, an explanation of benefits, or a contract. of Romiplostim Sterile Water for Injection* Deliverable Product and Volume Final Concentration 250 mcg 375 mcg add 0.72 mL = 250 mcg in 0.5 mL 500 mcg/mL 500 mcg 625 mcg add 1.2 mL = Romiplostim has no amino acid sequence homology to endogenous TPO. The most common side effects of DOPTELET when used to treat low blood platelet counts in adults with chronic immune thrombocytopenia (ITP) are: headache. [1], From HemOnc.org - A Hematology Oncology Wiki, Romiplostim (Nplate) patient drug information (Chemocare), Romiplostim (Nplate) patient drug information (UpToDate), Romiplostim (Nplate) package insert (locally hosted backup), https://hemonc.org/w/index.php?title=Romiplostim_(Nplate)&oldid=52500, About HemOnc.org - A Hematology Oncology Wiki, 12/14/2018: Approved for pediatric patients 1 year of age and older with, This page was last edited 03:26, 20 September 2021 by. wy wEh~|p %er w.Y7GYw}/)[#-9I &{2#O>x %XYn?p[naV b-'mat#t\L^M#MLEwDBC OnwrF3qkkg(C h`F; 6|H!|R Q {gg=HT$h39W [34386] - See package insert for detailed storage information - Store in carton - Store unreconstituted product in refrigerator (36 to 0 The recommended dose is 45 mg initially and 4 weeks later, followed by 45 mg every 12 weeks. pH|7Y_8MmuwB}Km+ +nr *j2NS]Z*#mJ*IXX -l-lGC*>j~ Y(=/{9ZKRfS%vQL`I8i?Os& FTMQA\d`QF-\lo,F) None. h1 Restricted Access Do not disseminate or copy Romiplostim is produced by recombinant DNA technology in Escherichia coli (E. coli). hb```f``J``e``ad@ A+6yr;00\S I)GKI\ ^%@Z%"X2`3gb[v]0N6o L9Nl%T*q@.b3 o" 74 0 obj <> endobj pain in mouth and throat (oropharyngeal pain) The most common side effects of romiplostim in children 1 year of age and older include: bruising. Neunert C, Lim W, Crowther M, et al. If platelet count is > 400 109/L, do not dose.Continue to assess the platelet count weekly. 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 Accessed August 2018. 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. \t=L7{q!RwQz(L)E34#;4}v HWm&=XBUR> R~D*w{'=>{,6&`3-|nEX?%~{,1|M|uqv3X+?1(1XFLHFHHg=?[gJfO`kwg}#[^aU{gKT{]YLT8`L'#,)E+i_ -PUj]:pa9CwK of Romiplostim Sterile Water for Injection* Deliverable Product and Volume Final Concentration . indigestion. Class/mechanism: Thrombopoietin (TPO/cMpl) receptor agonist. h;09TD %M5zJ^7ozoZM.iF!&ymMB]jPc0W3z: ` ;E&mbo;B0kYbCSrOP 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 Only use romiplostim in ITP patients who are at an increased risk of bleeding. C9@-UD|1uFj[oq.^8.u upper respiratory tract infection. tiredness. [s+iJ(8W86s:y.\ks`Xrl044qQ;1g=6w"C) *" ']UJ#*R="-NFi`-JCNt@s&. = 68 kg, therefore the dose would be 68 mcg subcutaneously once weekly Through this mechanism, romiplostim reduces the need for other treatments and decreases bleeding events in patients with thrombocytopenia. "A$" "" }X2Dr(`2,"6'Dj lf.N fs*H^~)f". Romiplostim binds to and activates the TPO receptor on megakaryocyte precursors, thus promoting cell proliferation and viability, resulting in increased platelet production. %%EOF lyophilized powder in single-dose vials. Romiplostim (Nplate) Romiplostim is a subcutaneous injection into the skin It is supplied in 250 mcg and 500 mcg vials. Each patients dose will be determined based upon their actual body weight and platelet count at the time of dosing Injection site irritation may occur Romiplostim should NOT be given intravenously 56 0 obj <>/Filter/FlateDecode/ID[]/Index[31 42]/Info 30 0 R/Length 121/Prev 102207/Root 32 0 R/Size 73/Type/XRef/W[1 3 1]>>stream (a\i{wt0e`Cl^NO~%NbW &mG&o= p#GFwi !^HVajerMVhB4GLZ3CUsV:D=B#M@u8^GgVr`C.8{HZGz0?oE"_vaNiZz|W}0-vom@3iK^k)+eUTemMp8J:8Np[~+`veI.+/Mv O=!Wr?5~b#%'kaN4S&`oH4@w#Sp-sRr*}N&, hbbd```b`` Romiplostim (Nplate ), a thrombopoietin receptor agonist, is the first FDA-approved thrombopoiesis-stimulating protein for the treatment of low platelet (PLT) counts in adults with chronic immune thrombocytopenia. Route: SC iZ`i?b={9~tABP For other Grade 3 or 4 toxicities hold treatment and restart treatment at 1 mg less than the previous dose when toxicity has re solved to less than or NPLATE. hbbd```b``n DJ e5LOQn0lB,A$'axHt3X%#L dP r1%I purple or red spots on your skin. 11 When azacitidine was delayed, treatment with romiplostim or placebo was continued. endstream endobj startxref 3102 0 obj <>stream 172 0 obj <> endobj 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 }|{cBLlSQwz!v2!F%B'Z1zTAx)zz;D@8@XTC)'J6- For injection: 125 mcg, 250 mcg or 500 mcg of romiplostim as a lyophilized powder in single-dose vials. 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 (hqnNaqzj upper respiratory tract infection. at,&tHU`30B[3hGa=}65kl,X*&{drKdsfa,n-OqET7@&Lt#i1k313yM=:)dy bggvX OyBS!vfDcpsHKJ#)&oK` T@YRA BFiQoIm J.|{.^ Nplate (romiplostim) for injection is supplied as a sterile, preservative-free, lyophilized, solid white powder for subcutaneous use. For injection: 250 mcg or 500 mcg of deliverable romiplostim as a sterile, lyophilized, solid white powder in single-dose vials. HWI7?`Vkafr$A2RJ=I&`rP^jj/?omcPBNyVi/+>}x84x fDexRy y,,}CXn If platelet or neutrophil counts had not recovered by day 42 of a cycle, a 50% lower dose was administered starting on day 42. WARNINGS AND PRECAUTIONS . hXn7>&(\ 0`Yq,4u,6mW'V^`y(P+bI 0In .8ai$h-'Z 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 Nplate Thousand Oaks, CA: Amgen Inc.; February 2022. t=Zn\&NmtNj1w_k[hM#I\ieYh5m&t\,4/[8VOM`+*NQgG.&~ES -u~_ TqB$vK%aN5RQW(aoAsW^,gS4AGM?+(jBR3+"sP+? J2796 Injection, romiplostim, 10 micrograms; 10 mcg = 1 billable unit NDC(s): Nplate 125 mcg single-dose vial: 55513-0223-xx Nplate 250 mcg single-dose vial: 55513-0221-xx Nplate 500 3S9%0[g;- 'f(79"48oK[wYr }ZGzrYH5l,O{s%SK ] It works by causing the cells in the bone marrow to produce more platelets. T+.q>tw|]8xT}:qcE:.#j'= r _p P-O J2796 Injection, romiplostim, 10 micrograms: 10 mcg = 1 billable unit NDC(s): Nplate 250 mcg single-dose vial: 55513-0221-xx Nplate 500 mcg single-dose vial: 55513-0222-xx VII. %PDF-1.5 % In accordance with its package insert, azacitidine was delayed in 1-week increments for adverse events. Nplate is supplied as either 125 mcg per & ~&F FW0 N Romiplostim is given to patients with low platelet counts in order to increase the platelet count to a range that will prevent potentially life-threatening bleeding. Although romiplostim can increase the platelet count to a safe range, it is generally not considered a cure for ITP. The Fc component of the romiplostim peptibody extends the half-life, allowing it to remain active in the circulation much longer than endogenous TPO; it is eventually removed by the [1][2][3] endstream endobj startxref Romiplostim is a fusion protein thrombopoietin (TPO) peptide analog that increases platelet counts by binding to and activating the human TPO receptor. A90 Eltrombopag package insert recommends a starting dose of 50 mg/day with dose modifications of 25-mg increment for age 6 years, while the starting dose for children 5 years is 25 mg. hko:c b;~$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* K1iF\F\ 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) %%EOF 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. %PDF-1.6 % p|HUh#umT-HjERx-3]V05k"0M7|1*\)>/Kk 0z_o VdLJHRRdH| sbE^3ZMA5E#>R! G.:hJ(hTjb |]:Ul,*vkuN41Nw{U+srkqPQuH~t(BjSUxOq @8cg`ZH5"fw"9J:xJ)I8a-u}^*NHW z_;R[E($w>4[. Dk7@LUsn{b,jW.y$ 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. bruising. .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. d";Y$'Z (c{YKW hN1T@KS9Qub%[,5-wL5CQ)? NPlate [package insert]. !,FOHLg*R,T3Ku!. JwP9KMyW"7;6K^#UwO,k t107|YFdrD:X@D^ho>!A\?oUo>oO|U5H 4*$^Fxp&/GsocF! 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 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. Thousand Oaks, CA; Amgen Inc; October 2017. HSJvS[w`6+e-pf)}[du-. endstream endobj 177 0 obj <>stream Romiplostim works by stimulating the bone marrow to produce more platelets. Romiplostim 1 mcg/kg (actual body weight) subcutaneous injection, Once Weekly Example: Patient weight of 150 lbs. 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. upper respiratory tract infection. Q6M6uW8R":%C$guPqF**we&pRP'Ic[ 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. %PDF-1.6 % %%EOF Nplate [package insert]. Romiplostim is in a class of medications called thrombopoietin receptor agonists. joint pain. 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 /C^Z:Zc3Cl `h[c#tle%[=_{}gcz_g{ wFd_~n3CfjF;:+]`j|n`Rp0GVx In pediatric trials the most common adverse events were headache, upper respiratory infection, and gastrointestinal complaints (mild). Subcutaneous Adult Dosage Regimen. TPO is a glycoprotein primarily produced in the liver. @=TH3AVf'Y;)2O p\To~qPgjQmpFm9yE(Z ~hUgh1V UvvjAp*7!e% &0&,-J$1aRCEar:I-@PNX^^N*A"K/J} 2 dX 79Q%zQu'y,e> cough. ,$*8U xTBu<1`q"0Ab#;(#-) XJO^,cy|AU3? ;[qY"(9/ 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 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 Platelets help clot the blood. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information. 375 mcg ; add : 0.72 mL = 250 mcg in 0.5 mL : 500 mcg/mL : 500 mcg ; 625 mcg : 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 Do not use romiplostim in an attempt to normalize platelet counts. 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 31 0 obj <> endobj nausea. wmV. >GIV(jB4 @x:=\G BBAD@*:gkCF Nplate (romiplostim) (Subcutaneous) Document Number: IH-0089 Last Review Date: 01/07/2019 1. n[6 Dg 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 "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? endstream endobj 32 0 obj <> endobj 33 0 obj <> endobj 34 0 obj <>stream Reported in patients with chronic liver disease receiving Nplate page 3 | Nplate ( romiplostim Prior... 0M7|1 * \ ) > /Kk 0z_o VdLJHRRdH| sbE^3ZMA5E # > R Crowther M, et.... 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