romiplostim 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
colony stimulating factors	4996	267639-76-9

Description:

Molecule	Description
Synonyms: romiplostim nplate AMG-531 AMG531	Romiplostim, a member of the TPO mimetic class, is an Fc-peptide fusion protein (peptibody) that activates intracellular transcriptional pathways leading to increased platelet production via the TPO receptor (also known as cMpl). The peptibody molecule contains two identical single-chain subunits, each consisting of human immunoglobulin IgG1 Fc domain, covalently linked at the C-terminus to a peptide containing two thrombopoietin receptor-binding domains. Romiplostim has no amino acid sequence homology to endogenous TPO. Romiplostim is produced by recombinant DNA technology in Escherichia coli. Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Synonyms:

romiplostim
nplate
AMG-531
AMG531

Romiplostim, a member of the TPO mimetic class, is an Fc-peptide fusion protein (peptibody) that activates intracellular transcriptional pathways leading to increased platelet production via the TPO receptor (also known as cMpl). The peptibody molecule contains two identical single-chain subunits, each consisting of human immunoglobulin IgG1 Fc domain, covalently linked at the C-terminus to a peptide containing two thrombopoietin receptor-binding domains. Romiplostim has no amino acid sequence homology to endogenous TPO. Romiplostim is produced by recombinant DNA technology in Escherichia coli.

Molecular weight:
Formula:
CLOGP:
LIPINSKI: None
HAC: None
HDO: None
TPSA:
ALOGS:
ROTB: None

Drug dosage:

Dose	Unit	Route
30	mcg	P

ADMET properties:

None

Approvals:

Date	Agency	Company
Feb. 4, 2009	EMA
Aug. 22, 2008	FDA	AMGEN
Jan. 21, 2011	PMDA	Kyowa Hakko Kirin

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Platelet count abnormal	1806.32	20.25	342	11924	3022	63473734
Platelet count decreased	1351.64	20.25	583	11683	115539	63361217
Therapeutic response decreased	1110.41	20.25	424	11842	61101	63415655
Thrombocytopenia	583.06	20.25	362	11904	150795	63325961
Thrombocytosis	475.14	20.25	127	12139	5691	63471065
Platelet count increased	300.20	20.25	117	12149	17594	63459162
Splenectomy	274.76	20.25	53	12213	515	63476241
Petechiae	272.10	20.25	102	12164	13795	63462961
Myelofibrosis	270.95	20.25	61	12205	1316	63475440
Biopsy bone marrow abnormal	235.58	20.25	42	12224	252	63476504
Drug ineffective	230.32	20.25	571	11695	1044194	62432562
Haemorrhage	216.40	20.25	139	12127	60883	63415873
Bone marrow reticulin fibrosis	193.21	20.25	34	12232	187	63476569
Immune thrombocytopenia	176.20	20.25	69	12197	10487	63466269
Death	163.60	20.25	273	11993	374108	63102648
Myelodysplastic syndrome	145.52	20.25	69	12197	16685	63460071
Purpura	127.60	20.25	56	12210	11329	63465427
Deep vein thrombosis	123.13	20.25	113	12153	83687	63393069
Epistaxis	102.81	20.25	96	12170	72629	63404127
Hospitalisation	99.10	20.25	101	12165	84980	63391776
Off label use	88.56	20.25	308	11958	674154	62802602
Contusion	81.23	20.25	121	12145	149923	63326833
Chronic lymphocytic leukaemia	80.97	20.25	27	12239	2587	63474169
Mucosal haemorrhage	79.90	20.25	22	12244	1099	63475657
Gingival bleeding	74.50	20.25	40	12226	12547	63464209
Vaginal haemorrhage	69.77	20.25	51	12215	27436	63449320
Therapy non-responder	65.52	20.25	77	12189	75824	63400932
Pulmonary embolism	57.32	20.25	90	12176	116594	63360162
Bone marrow disorder	51.92	20.25	19	12247	2395	63474361
Mouth haemorrhage	50.05	20.25	25	12241	6758	63469998
Haematological malignancy	47.28	20.25	12	12254	436	63476320
Haemorrhage intracranial	46.08	20.25	30	12236	13389	63463367
Leukocytosis	44.04	20.25	38	12228	25897	63450859
Ecchymosis	43.57	20.25	27	12239	11067	63465689
Melaena	42.70	20.25	40	12226	30325	63446431
Acute myeloid leukaemia	41.67	20.25	31	12235	17116	63459640
Cerebral haemorrhage	40.40	20.25	39	12227	30690	63446066
Drug effective for unapproved indication	39.15	20.25	17	12249	3347	63473409
Drug hypersensitivity	38.10	20.25	7	12259	310680	63166076
Rheumatoid arthritis	37.74	20.25	3	12263	253816	63222940
Aplastic anaemia	36.85	20.25	23	12243	9546	63467210
Headache	36.74	20.25	228	12038	633013	62843743
Infusion related reaction	36.23	20.25	3	12263	245518	63231238
Cerebral venous thrombosis	36.16	20.25	14	12252	2060	63474696
Thrombosis	36.10	20.25	53	12213	64702	63412054
Leukoerythroblastic anaemia	36.08	20.25	6	12260	22	63476734
White blood cell count increased	34.99	20.25	45	12221	48516	63428240
Toxicity to various agents	33.93	20.25	4	12262	247246	63229510
Joint swelling	33.17	20.25	11	12255	327655	63149101
Rectal haemorrhage	31.57	20.25	43	12223	48987	63427769
Gastrointestinal haemorrhage	31.03	20.25	56	12210	81120	63395636
Drug intolerance	30.14	20.25	11	12255	308650	63168106
Platelet disorder	30.12	20.25	12	12254	1904	63474852
Embolism arterial	29.92	20.25	10	12256	964	63475792
Cerebral venous sinus thrombosis	29.79	20.25	12	12254	1960	63474796
Mucocutaneous haemorrhage	28.51	20.25	6	12260	93	63476663
Reticulin increased	27.44	20.25	4	12262	4	63476752
Sudden hearing loss	27.33	20.25	10	12256	1259	63475497
Arthropathy	27.29	20.25	6	12260	234786	63241970
Product use issue	26.95	20.25	5	12261	220515	63256241
Rash maculo-papular	26.90	20.25	32	12234	31864	63444892
Portal vein thrombosis	26.46	20.25	12	12254	2618	63474138
Blood blister	26.45	20.25	11	12255	1947	63474809
Occupational exposure to product	25.82	20.25	11	12255	2067	63474689
Abdominal discomfort	25.80	20.25	15	12251	320870	63155886
Chronic myelomonocytic leukaemia	25.77	20.25	7	12259	332	63476424
Diarrhoea	25.16	20.25	64	12202	715302	62761454
Swelling	24.94	20.25	11	12255	275367	63201389
Marrow hyperplasia	24.80	20.25	8	12258	690	63476066
Splenomegaly	24.52	20.25	19	12247	11138	63465618
Antibody test	24.42	20.25	4	12262	13	63476743
Bone pain	23.88	20.25	40	12226	54601	63422155
Megaloblasts increased	22.66	20.25	3	12263	0	63476756
Blood smear test abnormal	22.56	20.25	5	12261	100	63476656
Cerebrovascular accident	22.21	20.25	58	12208	107966	63368790
Peripheral swelling	21.99	20.25	12	12254	265930	63210826
Pain	21.85	20.25	72	12194	740556	62736200
Condition aggravated	21.23	20.25	28	12238	402189	63074567
Bone marrow myelogram abnormal	21.11	20.25	4	12262	35	63476721
Musculoskeletal stiffness	20.88	20.25	5	12261	184613	63292143
Embolism	20.80	20.25	15	12251	7891	63468865
Nausea	20.72	20.25	90	12176	854381	62622375
Dyspnoea	20.39	20.25	63	12203	661250	62815506

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Platelet count abnormal	1043.47	19.08	230	10766	2692	34943243
Therapeutic response decreased	821.51	19.08	318	10678	28995	34916940
Platelet count decreased	767.80	19.08	472	10524	119245	34826690
Drug ineffective	373.36	19.08	574	10422	456177	34489758
Bone marrow reticulin fibrosis	319.10	19.08	54	10942	118	34945817
Platelet count increased	271.91	19.08	105	10891	9421	34936514
Thrombocytosis	268.18	19.08	84	10912	4028	34941907
Thrombocytopenia	244.81	19.08	272	10724	155975	34789960
Myelodysplastic syndrome	218.64	19.08	111	10885	19097	34926838
Coombs positive haemolytic anaemia	195.11	19.08	48	10948	924	34945011
Myelofibrosis	166.51	19.08	47	10949	1564	34944371
Lymphadenitis	160.14	19.08	48	10948	1980	34943955
Splenectomy	159.24	19.08	35	10961	400	34945535
Petechiae	138.88	19.08	65	10931	9353	34936582
Haematological malignancy	137.17	19.08	32	10964	486	34945449
Immune thrombocytopenia	134.45	19.08	63	10933	9089	34936846
Biopsy bone marrow abnormal	124.20	19.08	27	10969	292	34945643
Haemolysis	122.87	19.08	57	10939	8037	34937898
Hospitalisation	121.01	19.08	117	10879	56785	34889150
Therapeutic product effect decreased	119.52	19.08	94	10902	34649	34911286
Death	97.83	19.08	310	10686	397739	34548196
Deep vein thrombosis	83.99	19.08	103	10893	65145	34880790
Haemorrhage	82.70	19.08	91	10905	51279	34894656
Chronic lymphocytic leukaemia	80.81	19.08	35	10961	4197	34941738
Migraine	77.27	19.08	55	10941	17423	34928512
Acute myeloid leukaemia	75.08	19.08	55	10941	18215	34927720
Epistaxis	59.39	19.08	82	10914	58169	34887766
Gingival bleeding	58.58	19.08	33	10963	6967	34938968
Off label use	54.69	19.08	268	10728	419256	34526679
Investigation	52.37	19.08	17	10979	913	34945022
Drug interaction	50.44	19.08	6	10990	225940	34719995
Therapy non-responder	49.03	19.08	61	10935	39085	34906850
Toxicity to various agents	48.16	19.08	4	10992	200358	34745577
Ecchymosis	46.17	19.08	28	10968	6775	34939160
Contusion	46.08	19.08	57	10939	36307	34909628
Embolism arterial	45.24	19.08	14	10982	643	34945292
Pulmonary embolism	42.75	19.08	90	10906	89656	34856279
Cellulitis gangrenous	41.11	19.08	10	10986	183	34945752
Mouth haemorrhage	38.97	19.08	23	10973	5296	34940639
Bone marrow disorder	38.61	19.08	16	10980	1719	34944216
Evans syndrome	37.77	19.08	10	10986	260	34945675
Hepatic enzyme increased	36.82	19.08	53	10943	39027	34906908
Platelet disorder	35.38	19.08	15	10981	1706	34944229
Thrombosis	31.82	19.08	57	10939	50401	34895534
Marrow hyperplasia	30.26	19.08	12	10984	1151	34944784
Diarrhoea	29.88	19.08	48	10948	389864	34556071
Mesenteric vascular insufficiency	29.66	19.08	7	10989	112	34945823
Embolism	28.66	19.08	22	10974	7807	34938128
Cerebrovascular accident	28.28	19.08	74	10922	84737	34861198
Reticulin increased	28.26	19.08	4	10992	0	34945935
Non-Hodgkin's lymphoma	27.12	19.08	12	10984	1513	34944422
Myeloproliferative neoplasm	26.30	19.08	9	10987	569	34945366
Therapeutic response delayed	25.43	19.08	9	10987	629	34945306
Lymphoma	23.35	19.08	24	10972	12483	34933452
Condition aggravated	23.28	19.08	16	10980	192180	34753755
Mucosal haemorrhage	23.28	19.08	11	10985	1614	34944321
Infusion related reaction	22.71	19.08	51	10945	53006	34892929
Refusal of treatment by patient	22.61	19.08	16	10980	5016	34940919
Bone pain	22.38	19.08	30	10966	20656	34925279
Protein-losing gastroenteropathy	22.10	19.08	7	10989	347	34945588
Leukocytosis	21.73	19.08	32	10964	24033	34921902
White blood cell count increased	21.61	19.08	43	10953	41108	34904827
Chronic myelomonocytic leukaemia	21.49	19.08	8	10988	646	34945289
Vomiting	21.36	19.08	28	10968	247593	34698342
Hypotension	21.31	19.08	23	10973	221626	34724309
Thrombocytopenia neonatal	21.24	19.08	7	10989	394	34945541
Completed suicide	20.92	19.08	3	10993	98165	34847770
Acute kidney injury	20.22	19.08	41	10955	304947	34640988
Neutralising antibodies positive	20.18	19.08	5	10991	99	34945836
Blood blister	20.06	19.08	10	10986	1649	34944286
Dyspnoea	19.97	19.08	57	10939	376725	34569210
Dehydration	19.88	19.08	8	10988	129961	34815974
Anti-platelet antibody positive	19.81	19.08	6	10990	256	34945679

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Platelet count abnormal	2127.58	19.05	423	16522	4439	79723004
Platelet count decreased	1429.88	19.05	733	16212	193931	79533512
Therapeutic response decreased	772.98	19.05	345	16600	66508	79660935
Thrombocytosis	669.00	19.05	184	16761	8342	79719101
Thrombocytopenia	514.56	19.05	435	16510	264824	79462619
Platelet count increased	359.13	19.05	146	16799	22260	79705183
Petechiae	333.00	19.05	135	16810	20430	79707013
Myelofibrosis	326.91	19.05	81	16864	2419	79725024
Bone marrow reticulin fibrosis	282.21	19.05	51	16894	299	79727144
Drug ineffective	233.00	19.05	623	16322	1080290	78647153
Biopsy bone marrow abnormal	226.20	19.05	45	16900	468	79726975
Coombs positive haemolytic anaemia	206.60	19.05	48	16897	1082	79726361
Myelodysplastic syndrome	203.28	19.05	108	16837	30193	79697250
Splenectomy	200.97	19.05	44	16901	751	79726692
Haemorrhage	199.97	19.05	161	16784	90957	79636486
Immune thrombocytopenia	177.29	19.05	83	16862	17722	79709721
Off label use	161.59	19.05	489	16456	906726	78820717
Deep vein thrombosis	151.56	19.05	156	16789	120763	79606680
Lymphadenitis	139.40	19.05	48	16897	4607	79722836
Epistaxis	136.37	19.05	142	16803	111373	79616070
Haemolysis	128.39	19.05	60	16885	12752	79714691
Hospitalisation	124.27	19.05	125	16820	94111	79633332
Gingival bleeding	123.41	19.05	63	16882	16213	79711230
Purpura	115.36	19.05	64	16881	19463	79707980
Death	110.49	19.05	316	16629	566198	79161245
Contusion	98.80	19.05	139	16806	148637	79578806
Therapy non-responder	87.64	19.05	103	16842	92202	79635241
Therapeutic product effect decreased	85.79	19.05	137	16808	163726	79563717
Pulmonary embolism	79.75	19.05	136	16809	171518	79555925
Mucosal haemorrhage	71.01	19.05	25	16920	2561	79724882
Haematological malignancy	68.06	19.05	19	16926	906	79726537
Mouth haemorrhage	67.88	19.05	37	16908	10862	79716581
Toxicity to various agents	64.93	19.05	7	16938	421533	79305910
Vaginal haemorrhage	64.25	19.05	46	16899	21771	79705672
Ecchymosis	63.91	19.05	40	16905	15166	79712277
Acute myeloid leukaemia	60.19	19.05	51	16894	30834	79696609
Investigation	54.31	19.05	20	16925	2331	79725112
Platelet disorder	53.53	19.05	21	16924	2908	79724535
Drug interaction	50.50	19.05	13	16932	415170	79312273
Chronic lymphocytic leukaemia	49.40	19.05	23	16922	4843	79722600
Marrow hyperplasia	49.36	19.05	17	16928	1631	79725812
White blood cell count increased	48.40	19.05	69	16876	74564	79652879
Drug effective for unapproved indication	47.73	19.05	24	16921	5977	79721466
Leukocytosis	45.44	19.05	51	16894	43404	79684039
Migraine	44.16	19.05	72	16873	87421	79640022
Cellulitis gangrenous	41.20	19.05	10	16935	273	79727170
Neutralising antibodies positive	40.92	19.05	10	16935	281	79727162
Leukoerythroblastic anaemia	40.10	19.05	6	16939	7	79727436
Reticulin increased	39.66	19.05	6	16939	8	79727435
Headache	39.20	19.05	255	16690	653517	79073926
Mucocutaneous haemorrhage	38.89	19.05	9	16936	199	79727244
Cerebral haemorrhage	36.92	19.05	53	16892	57620	79669823
Bone pain	36.82	19.05	52	16893	55690	79671753
Evans syndrome	36.80	19.05	10	16935	431	79727012
Gastrointestinal haemorrhage	36.29	19.05	90	16855	147629	79579814
Blood blister	35.92	19.05	16	16929	3041	79724402
Diarrhoea	35.34	19.05	85	16860	880404	78847039
Condition aggravated	34.99	19.05	33	16912	501091	79226352
Product preparation error	34.24	19.05	19	16926	5774	79721669
Drug hypersensitivity	33.31	19.05	11	16934	298905	79428538
Haemorrhage intracranial	33.12	19.05	34	16911	26159	79701284
Cerebrovascular accident	32.40	19.05	89	16856	155203	79572240
Melaena	31.93	19.05	51	16894	60839	79666604
Joint swelling	31.51	19.05	11	16934	288635	79438808
Dyspnoea	31.11	19.05	87	16858	856938	78870505
Cerebral venous thrombosis	31.04	19.05	14	16931	2739	79724704
Mesenteric vascular insufficiency	30.73	19.05	7	16938	144	79727299
Product use issue	28.69	19.05	5	16940	209817	79517626
Bone marrow disorder	28.45	19.05	14	16931	3329	79724114
Thrombosis	27.03	19.05	57	16888	84043	79643400
Megakaryocytes increased	26.89	19.05	6	16939	112	79727331
Drug intolerance	25.67	19.05	12	16933	264107	79463336
Intercepted medication error	25.58	19.05	9	16936	920	79726523
Sudden hearing loss	25.38	19.05	11	16934	1958	79725485
Anti-platelet antibody positive	25.38	19.05	7	16938	319	79727124
Vomiting	25.33	19.05	66	16879	665762	79061681
Splenomegaly	24.55	19.05	26	16919	20728	79706715
Antibody test	24.54	19.05	4	16941	11	79727432
Cerebral venous sinus thrombosis	23.79	19.05	11	16934	2280	79725163
Therapeutic response delayed	23.77	19.05	9	16936	1133	79726310
Rectal haemorrhage	23.70	19.05	51	16894	76249	79651194
Portal vein thrombosis	23.66	19.05	15	16930	5812	79721631
Peripheral swelling	23.62	19.05	14	16931	269603	79457840
Bone marrow myelogram abnormal	23.44	19.05	5	16940	75	79727368
Red blood cell abnormality	23.37	19.05	8	16937	754	79726689
Upper respiratory tract inflammation	23.21	19.05	13	16932	4022	79723421
Haemorrhagic diathesis	23.07	19.05	15	16930	6069	79721374
Antiphospholipid syndrome	22.55	19.05	10	16935	1881	79725562
Megaloblasts increased	22.37	19.05	3	16942	0	79727443
Haemolytic anaemia	22.29	19.05	23	16922	17797	79709646
Megakaryocytes abnormal	22.13	19.05	5	16940	99	79727344
Chronic myeloid leukaemia	21.61	19.05	12	16933	3652	79723791
Myeloproliferative neoplasm	21.33	19.05	8	16937	981	79726462
Neutralising antibodies	21.05	19.05	4	16941	32	79727411
Hypotension	20.52	19.05	39	16906	440278	79287165
Acute kidney injury	20.10	19.05	51	16894	519353	79208090
Neoplasm malignant	20.01	19.05	29	16916	31781	79695662

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	B02BX04	BLOOD AND BLOOD FORMING ORGANS ANTIHEMORRHAGICS VITAMIN K AND OTHER HEMOSTATICS Other systemic hemostatics
FDA MoA	N0000175968	Thrombopoietin Receptor Agonists
FDA PE	N0000175969	Increased Megakaryocyte Maturation
FDA PE	N0000175970	Increased Platelet Production
FDA EPC	N0000175973	Thrombopoietin Receptor Agonist

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Chronic idiopathic thrombocytopenic purpura	indication	13172003
Aplastic anemia	indication	306058006	DOID:12449

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Thrombopoietin receptor	Membrane receptor	P40238	TPOR_HUMAN	AGONIST				DRUG LABEL	DRUG LABEL

External reference:

ID	Source
D08990	KEGG_DRUG
4028106	VUID
N0000177934	NUI
4028106	VANDF
CHEMBL1201832	ChEMBL_ID
C488777	MESH_SUPPLEMENTAL_RECORD_UI
6974	IUPHAR_LIGAND_ID
DB05332	DRUGBANK_ID
805452	RXNORM
147787	MMSL
25808	MMSL
d07320	MMSL
012794	NDDF
439122000	SNOMEDCT_US
441077008	SNOMEDCT_US
C2364481	UMLSCUI
8587	INN_ID
5329098	PUBCHEM_CID
GN5XU2DXKV	UNII

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Nplate	HUMAN PRESCRIPTION DRUG LABEL	1	55513-221	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	250 ug	SUBCUTANEOUS	BLA	28 sections
Nplate	HUMAN PRESCRIPTION DRUG LABEL	1	55513-221	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	250 ug	SUBCUTANEOUS	BLA	28 sections
Nplate	HUMAN PRESCRIPTION DRUG LABEL	1	55513-221	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	250 ug	SUBCUTANEOUS	BLA	28 sections
Nplate	HUMAN PRESCRIPTION DRUG LABEL	1	55513-222	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	500 ug	SUBCUTANEOUS	BLA	28 sections
Nplate	HUMAN PRESCRIPTION DRUG LABEL	1	55513-222	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	500 ug	SUBCUTANEOUS	BLA	28 sections
Nplate	HUMAN PRESCRIPTION DRUG LABEL	1	55513-222	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	500 ug	SUBCUTANEOUS	BLA	28 sections
Nplate	HUMAN PRESCRIPTION DRUG LABEL	1	55513-223	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	125 ug	SUBCUTANEOUS	BLA	28 sections
Nplate	HUMAN PRESCRIPTION DRUG LABEL	1	55513-223	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	125 ug	SUBCUTANEOUS	BLA	28 sections
Nplate	HUMAN PRESCRIPTION DRUG LABEL	1	55513-223	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	125 ug	SUBCUTANEOUS	BLA	28 sections