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

Stem definition	Drug id	CAS RN
enzymes	5135	143831-71-4

Description:

Molecule	Description
Synonyms: dornase alfa dornase alfa (genetical recombination) desoxyribonuclease pulmozyme recombinant deoxyribonuclease	A recombinant human deoxyribonuclease I (rhDNAse) with selective DNA cleaving activity. Upon intrapleural administration, dornase alfa catalyzes the degradation of extracellular DNA in airway secretions, which can reduce their viscosity. Thus, dornase alfa may both promote the clearing of airway mucus and improve pulmonary function. Molecular weight: Formula: CLOGP: LIPINSKI: None HAC: None HDO: None TPSA: ALOGS: ROTB: None

Molecule

Description

Synonyms:

dornase alfa
dornase alfa (genetical recombination)
desoxyribonuclease
pulmozyme
recombinant deoxyribonuclease

A recombinant human deoxyribonuclease I (rhDNAse) with selective DNA cleaving activity. Upon intrapleural administration, dornase alfa catalyzes the degradation of extracellular DNA in airway secretions, which can reduce their viscosity. Thus, dornase alfa may both promote the clearing of airway mucus and improve pulmonary function.

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

Drug dosage:

Dose	Unit	Route
2.50	mg	Inhal.solution

ADMET properties:

None

Approvals:

Date	Agency	Company	Orphan
Dec. 30, 1993	FDA	GENENTECH

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
Infective pulmonary exacerbation of cystic fibrosis	3924.25	26.50	746	9911	8071	63470294
Hospitalisation	998.38	26.50	413	10244	84668	63393697
Cystic fibrosis	788.42	26.50	167	10490	3129	63475236
Pulmonary function test decreased	407.85	26.50	101	10556	3846	63474519
Haemoptysis	290.67	26.50	126	10531	28600	63449765
Cystic fibrosis respiratory infection suppression	260.78	26.50	45	10612	256	63478109
Bacterial disease carrier	199.38	26.50	46	10611	1285	63477080
Pneumonia	173.29	26.50	289	10368	456478	63021887
Bronchial secretion retention	170.47	26.50	47	10610	2726	63475639
Pseudomonas infection	156.72	26.50	62	10595	11151	63467214
Superinfection	154.79	26.50	43	10614	2564	63475801
Infection	148.21	26.50	187	10470	228986	63249379
Sinus operation	145.98	26.50	41	10616	2545	63475820
Cough	145.38	26.50	210	10447	292533	63185832
Bronchospasm	112.82	26.50	56	10601	17224	63461141
Distal intestinal obstruction syndrome	110.32	26.50	23	10634	395	63477970
Treatment noncompliance	110.27	26.50	72	10585	37253	63441112
Disease complication	103.39	26.50	33	10624	3176	63475189
Sputum increased	99.04	26.50	30	10627	2429	63475936
Forced expiratory volume decreased	96.68	26.50	35	10622	4933	63473432
Scoliosis	94.32	26.50	39	10618	7849	63470516
Sleep disorder due to a general medical condition	87.04	26.50	42	10615	12146	63466219
Drug ineffective	84.90	26.50	35	10622	1044730	62433635
Atelectasis	82.55	26.50	49	10608	21434	63456931
Productive cough	82.48	26.50	75	10582	63133	63415232
Influenza	72.10	26.50	90	10567	108632	63369733
Nonspecific reaction	71.50	26.50	23	10634	2269	63476096
Cystic fibrosis lung	70.71	26.50	13	10644	111	63478254
Lung disorder	66.23	26.50	66	10591	62195	63416170
Aggression	63.74	26.50	43	10614	23455	63454910
Illness	63.57	26.50	58	10599	49001	63429364
Eosinophilia	62.58	26.50	42	10615	22714	63455651
Lung transplant	60.72	26.50	22	10635	3106	63475259
Viral infection	57.99	26.50	48	10609	35615	63442750
Wheezing	56.86	26.50	75	10582	95520	63382845
Rib fracture	55.74	26.50	39	10618	22558	63455807
Anxiety	51.44	26.50	113	10544	217428	63260937
Dyspnoea	49.24	26.50	230	10427	661083	62817282
Staphylococcal infection	48.10	26.50	46	10611	41210	63437155
Pancreatic failure	48.07	26.50	14	10643	989	63477376
Emergency care	47.12	26.50	14	10643	1060	63477305
Cystic fibrosis related diabetes	47.05	26.50	8	10649	41	63478324
Pneumonia pseudomonal	46.14	26.50	17	10640	2516	63475849
Impaired quality of life	41.68	26.50	27	10630	13756	63464609
Sinus disorder	39.81	26.50	33	10624	24520	63453845
Asthma	35.64	26.50	71	10586	127490	63350875
Pseudomonas test positive	33.91	26.50	10	10647	738	63477627
Rhinovirus infection	33.52	26.50	16	10641	4513	63473852
Bronchiectasis	33.29	26.50	25	10632	16117	63462248
Pneumothorax	33.12	26.50	25	10632	16236	63462129
Chest discomfort	32.89	26.50	63	10594	109906	63368459
Pulmonary haemorrhage	31.88	26.50	18	10639	7163	63471202
Respiration abnormal	30.99	26.50	17	10640	6400	63471965
Toxicity to various agents	30.69	26.50	3	10654	247247	63231118
Infusion related reaction	30.42	26.50	3	10654	245518	63232847
Heart rate increased	29.43	26.50	55	10602	94183	63384182
Condition aggravated	29.13	26.50	139	10518	402078	63076287
Steatorrhoea	28.56	26.50	8	10649	491	63477874
Pharyngitis streptococcal	27.67	26.50	19	10638	10653	63467712
Anaemia	26.79	26.50	8	10649	293422	63184943

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
Infective pulmonary exacerbation of cystic fibrosis	2787.70	29.24	573	8093	6228	34942037
Hospitalisation	714.35	29.24	325	8341	56577	34891688
Cystic fibrosis	648.70	29.24	135	8531	1523	34946742
Pulmonary function test decreased	332.55	29.24	98	8568	4877	34943388
Cystic fibrosis respiratory infection suppression	245.93	29.24	44	8622	201	34948064
Sputum increased	209.13	29.24	58	8608	2312	34945953
Disease complication	196.44	29.24	57	8609	2679	34945586
Infection	173.29	29.24	158	8508	90757	34857508
Pneumonia	160.22	29.24	305	8361	362322	34585943
Haemoptysis	158.53	29.24	102	8564	34904	34913361
Cough	148.52	29.24	184	8482	149956	34798309
Forced expiratory volume decreased	117.66	29.24	40	8626	3163	34945102
Spinal muscular atrophy	108.11	29.24	24	8642	372	34947893
Pseudomonas infection	106.94	29.24	55	8611	12327	34935938
Increased bronchial secretion	103.84	29.24	32	8634	1849	34946416
Influenza	101.69	29.24	90	8576	49576	34898689
Pneumococcal sepsis	91.96	29.24	26	8640	1111	34947154
Lung transplant	85.16	29.24	28	8638	1996	34946269
Respiratory tract infection bacterial	80.43	29.24	26	8640	1756	34946509
Productive cough	76.32	29.24	68	8598	37745	34910520
Motor neurone disease	76.13	29.24	19	8647	498	34947767
Condition aggravated	72.61	29.24	152	8514	192044	34756221
Ischaemic cerebral infarction	72.17	29.24	22	8644	1225	34947040
Stoma closure	71.19	29.24	16	8650	263	34948002
Chest X-ray abnormal	64.01	29.24	28	8638	4370	34943895
Distal intestinal obstruction syndrome	62.14	29.24	15	8651	341	34947924
Lower respiratory tract infection bacterial	61.87	29.24	16	8650	485	34947780
Bronchial disorder	61.41	29.24	20	8646	1383	34946882
Lymphadenectomy	60.89	29.24	15	8651	372	34947893
Resuscitation	56.73	29.24	19	8647	1434	34946831
Metabolic disorder	55.07	29.24	25	8641	4258	34944007
Cystic fibrosis related diabetes	54.79	29.24	12	8654	174	34948091
Dyspnoea	54.33	29.24	210	8456	376572	34571693
Brain injury	52.20	29.24	27	8639	6115	34942150
Secretion discharge	50.30	29.24	26	8640	5879	34942386
Lung consolidation	50.17	29.24	26	8640	5910	34942355
Cystic fibrosis lung	48.09	29.24	9	8657	55	34948210
Scoliosis	44.64	29.24	19	8647	2774	34945491
Motor dysfunction	43.55	29.24	25	8641	6949	34941316
Sputum discoloured	43.50	29.24	26	8640	7786	34940479
Sinus operation	43.35	29.24	13	8653	684	34947581
Cerebral ischaemia	43.09	29.24	24	8642	6298	34941967
Demyelination	42.04	29.24	19	8647	3202	34945063
Pancreatic failure	41.62	29.24	13	8653	785	34947480
Infective exacerbation of bronchiectasis	39.84	29.24	11	8655	430	34947835
Sinusitis	39.53	29.24	50	8616	41352	34906913
Respiration abnormal	39.14	29.24	18	8648	3158	34945107
Intestinal ischaemia	38.43	29.24	24	8642	7770	34940495
Nasopharyngitis	38.35	29.24	65	8601	69903	34878362
Hypotension	38.11	29.24	5	8661	221644	34726621
Chest discomfort	37.22	29.24	56	8610	54474	34893791
Muscle atrophy	37.01	29.24	23	8643	7381	34940884
Lung disorder	36.49	29.24	44	8622	34652	34913613
Anaemia	36.21	29.24	7	8659	233328	34714937
Respiratory disorder	35.61	29.24	33	8633	19231	34929034
Tachypnoea	33.08	29.24	31	8635	18321	34929944
Viral infection	32.21	29.24	30	8636	17593	34930672
Rubber sensitivity	31.54	29.24	8	8658	224	34948041
Drug ineffective	30.89	29.24	41	8625	456710	34491555
Steatorrhoea	30.13	29.24	10	8656	733	34947532
Pseudomonas test positive	29.67	29.24	11	8655	1118	34947147
Increased viscosity of upper respiratory secretion	29.57	29.24	7	8659	146	34948119

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
Infective pulmonary exacerbation of cystic fibrosis	5223.56	25.18	1027	14013	11824	79717524
Hospitalisation	1272.10	25.18	523	14517	93713	79635635
Cystic fibrosis	1123.95	25.18	235	14805	3645	79725703
Pulmonary function test decreased	563.04	25.18	153	14887	7484	79721864
Cystic fibrosis respiratory infection suppression	367.76	25.18	65	14975	379	79728969
Haemoptysis	359.14	25.18	186	14854	55813	79673535
Disease complication	299.86	25.18	85	14955	4852	79724496
Pneumonia	273.42	25.18	463	14577	659783	79069565
Sputum increased	264.78	25.18	76	14964	4537	79724811
Cough	200.80	25.18	293	14747	366496	79362852
Sinus operation	192.61	25.18	52	14988	2473	79726875
Forced expiratory volume decreased	182.74	25.18	65	14975	7749	79721599
Bacterial disease carrier	182.12	25.18	45	14995	1501	79727847
Bronchial secretion retention	171.87	25.18	53	14987	4051	79725297
Scoliosis	159.19	25.18	58	14982	7406	79721942
Pseudomonas infection	153.00	25.18	76	14964	20827	79708521
Distal intestinal obstruction syndrome	140.13	25.18	32	15008	755	79728593
Superinfection	126.94	25.18	44	14996	4858	79724490
Lung transplant	114.49	25.18	40	15000	4521	79724827
Productive cough	108.94	25.18	107	14933	88224	79641124
Spinal muscular atrophy	108.48	25.18	23	15017	380	79728968
Bronchospasm	108.09	25.18	64	14976	24795	79704553
Atelectasis	107.22	25.18	70	14970	32187	79697161
Increased bronchial secretion	106.42	25.18	35	15005	3292	79726056
Influenza	100.51	25.18	123	14917	129483	79599865
Dyspnoea	89.61	25.18	358	14682	856667	78872681
Treatment noncompliance	89.23	25.18	76	14964	52192	79677156
Respiratory tract infection bacterial	87.71	25.18	27	15013	2050	79727298
Condition aggravated	84.61	25.18	246	14794	500878	79228470
Sleep disorder due to a general medical condition	81.67	25.18	44	14996	14233	79715115
Pancreatic failure	80.94	25.18	24	15016	1604	79727744
Pneumococcal sepsis	80.45	25.18	24	15016	1638	79727710
Infection	79.45	25.18	154	14886	241558	79487790
Cystic fibrosis related diabetes	78.90	25.18	16	15024	210	79729138
Drug ineffective	78.88	25.18	54	14986	1080859	78648489
Cystic fibrosis lung	78.84	25.18	15	15025	138	79729210
Motor neurone disease	78.22	25.18	19	15021	589	79728759
Stoma closure	73.91	25.18	16	15024	293	79729055
Respiration abnormal	68.10	25.18	32	15008	7756	79721592
Bronchial disorder	67.00	25.18	23	15017	2466	79726882
Nonspecific reaction	66.61	25.18	23	15017	2509	79726839
Wheezing	66.14	25.18	95	14945	116569	79612779
Lower respiratory tract infection bacterial	65.05	25.18	18	15022	938	79728410
Rhinovirus infection	64.41	25.18	31	15009	7922	79721426
Infective exacerbation of bronchiectasis	64.03	25.18	17	15023	757	79728591
Lung disorder	61.67	25.18	76	14964	80481	79648867
Steatorrhoea	61.11	25.18	17	15023	904	79728444
Toxicity to various agents	60.86	25.18	5	15035	421535	79307813
Ischaemic cerebral infarction	58.92	25.18	21	15019	2514	79726834
Pneumonia pseudomonal	57.02	25.18	26	15014	5885	79723463
Staphylococcal infection	56.33	25.18	62	14978	58233	79671115
Chest discomfort	55.47	25.18	96	14944	137948	79591400
Viral infection	54.65	25.18	53	14987	42963	79686385
Bronchiectasis	51.97	25.18	39	15001	22347	79707001
Anaemia	50.76	25.18	11	15029	445004	79284344
Chest X-ray abnormal	49.91	25.18	26	15014	7857	79721491
Illness	49.38	25.18	52	14988	46459	79682889
Resuscitation	48.73	25.18	18	15022	2386	79726962
Hypotension	48	25.18	12	15028	440305	79289043
Lymphadenectomy	47.43	25.18	15	15025	1244	79728104
Lung consolidation	46.81	25.18	26	15014	8921	79720427
Asthma	46.68	25.18	88	14952	135007	79594341
Brain injury	45.78	25.18	28	15012	11489	79717859
Confusional state	45.25	25.18	4	15036	317993	79411355
Rib fracture	44.36	25.18	39	15001	27908	79701440
Sinus disorder	43.17	25.18	35	15005	22429	79706919
Blood alkaline phosphatase increased	42.30	25.18	56	14984	63608	79665740
Pneumothorax	41.93	25.18	38	15002	28285	79701063
Metabolic disorder	40.87	25.18	24	15016	9146	79720202
Alanine aminotransferase increased	39.88	25.18	92	14948	162478	79566870
Secretion discharge	39.00	25.18	28	15012	14994	79714354
Thrombocytopenia	38.66	25.18	3	15037	265256	79464092
Pseudomonas test positive	38.03	25.18	14	15026	1838	79727510
Sputum discoloured	37.87	25.18	32	15008	21711	79707637
Bronchopulmonary aspergillosis allergic	37.74	25.18	16	15024	3045	79726303
Aggression	37.26	25.18	47	14993	50911	79678437
Aspartate aminotransferase increased	36.83	25.18	81	14959	138560	79590788
Impaired quality of life	35.49	25.18	26	15014	14360	79714988
Rash morbilliform	35.30	25.18	19	15021	6131	79723217
Cerebral ischaemia	34.05	25.18	23	15017	11172	79718176
Muscle atrophy	33.98	25.18	23	15017	11209	79718139
Cystic fibrosis hepatic disease	33.65	25.18	6	15034	37	79729311
Eosinophilia	33.43	25.18	42	14998	45303	79684045
Product dose omission issue	32.83	25.18	112	14928	247425	79481923
Neutropenia	31.02	25.18	8	15032	287702	79441646
Respiratory disorder	30.63	25.18	40	15000	44816	79684532
Demyelination	30.60	25.18	19	15021	8004	79721344
Motor dysfunction	30.54	25.18	24	15016	14709	79714639
Intestinal ischaemia	30.53	25.18	23	15017	13247	79716101
Infusion related reaction	29.94	25.18	4	15036	230233	79499115
Mechanical ventilation	29.34	25.18	13	15027	2751	79726597
Asthenia	29.32	25.18	32	15008	511657	79217691
Tachypnoea	29.07	25.18	33	15007	32030	79697318
Staphylococcus test positive	28.98	25.18	17	15023	6464	79722884
Completed suicide	28.14	25.18	6	15034	245761	79483587
Peripheral swelling	26.32	25.18	9	15031	269608	79459740
Hypertension	26.11	25.18	15	15025	330977	79398371
Anxiety	25.87	25.18	104	14936	248408	79480940

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	B06AA02	BLOOD AND BLOOD FORMING ORGANS OTHER HEMATOLOGICAL AGENTS OTHER HEMATOLOGICAL AGENTS Enzymes
ATC	B06AA10	BLOOD AND BLOOD FORMING ORGANS OTHER HEMATOLOGICAL AGENTS OTHER HEMATOLOGICAL AGENTS Enzymes
ATC	R05CB13	RESPIRATORY SYSTEM COUGH AND COLD PREPARATIONS EXPECTORANTS, EXCL. COMBINATIONS WITH COUGH SUPPRESSANTS Mucolytics
FDA CS	M0006007	Deoxyribonuclease I
FDA CS	M0018641	Recombinant Proteins
FDA PE	N0000008867	Decreased Respiratory Secretion Viscosity
FDA EPC	N0000175958	Recombinant Human Deoxyribonuclease 1

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

Disease	Relation	SNOMED_ID	DOID
Cystic fibrosis	indication	190905008	DOID:1485

🐶 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:

None

External reference:

ID	Source
953A26OA1Y	UNII
D03896	KEGG_DRUG
4018657	VANDF
4020830	VANDF
C1135662	UMLSCUI
CHEMBL1201431	ChEMBL_ID
DB00003	DRUGBANK_ID
CHEMBL1201459	ChEMBL_ID
7167	INN_ID
C568813	MESH_SUPPLEMENTAL_RECORD_UI
DB09551	DRUGBANK_ID
3210	RXNORM
3148	MMSL
4633	MMSL
7401	MMSL
d03173	MMSL
001889	NDDF
004413	NDDF
108630006	SNOMEDCT_US
330151006	SNOMEDCT_US
386882003	SNOMEDCT_US
416394007	SNOMEDCT_US

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Pulmozyme	HUMAN PRESCRIPTION DRUG LABEL	1	50242-100	SOLUTION	1 mg	RESPIRATORY (INHALATION)	BLA	27 sections
Pulmozyme	HUMAN PRESCRIPTION DRUG LABEL	1	50242-100	SOLUTION	1 mg	RESPIRATORY (INHALATION)	BLA	27 sections