darunavir ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
HIV protease inhibitors 4143 206361-99-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • darunavir
  • darunavir ethanolate
  • prezista
  • TMC-114
  • TMC 114
  • darunavir ethnolate
An HIV PROTEASE INHIBITOR that is used in the treatment of AIDS and HIV INFECTIONS. Due to the emergence of ANTIVIRAL DRUG RESISTANCE when used alone, it is administered in combination with other ANTI-HIV AGENTS. There was some evidence of in vitro activity against SARS-CoV-2, but no clinical trial data was found to support use in the treatment of COVID-19.
  • Molecular weight: 547.67
  • Formula: C27H37N3O7S
  • CLOGP: 2.89
  • LIPINSKI: 1
  • HAC: 10
  • HDO: 3
  • TPSA: 140.42
  • ALOGS: -3.91
  • ROTB: 11

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

DoseUnitRoute
1.20 g O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.15 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 1.20 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 20.87 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 37 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
CL (Clearance) 7.81 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.05 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 15 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Feb. 12, 2007 EMA Janssen-Cilag International NV
June 23, 2006 FDA JANSSEN PRODS
Nov. 22, 2007 PMDA Janssen Pharmaceutical K.K.

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Exposure during pregnancy 935.38 27.75 451 8699 155096 63324776
Foetal exposure during pregnancy 837.66 27.75 270 8880 31692 63448180
Abortion spontaneous 741.99 27.75 272 8878 46923 63432949
Maternal exposure during pregnancy 356.17 27.75 276 8874 219786 63260086
Virologic failure 281.38 27.75 63 9087 1799 63478073
Premature labour 244.75 27.75 85 9065 12419 63467453
Premature baby 237.07 27.75 95 9055 20640 63459232
Live birth 214.39 27.75 94 9056 25536 63454336
Drug interaction 209.51 27.75 208 8942 228923 63250949
Treatment noncompliance 204.02 27.75 102 9048 37223 63442649
Premature delivery 193.24 27.75 92 9058 30189 63449683
Viral mutation identified 187.14 27.75 45 9105 1765 63478107
Abortion induced 163.96 27.75 60 9090 10182 63469690
Foetal growth restriction 161.99 27.75 55 9095 7498 63472374
Blood HIV RNA increased 156.46 27.75 33 9117 706 63479166
Foetal death 152.64 27.75 58 9092 10922 63468950
Lipodystrophy acquired 149.60 27.75 36 9114 1416 63478456
Immune reconstitution inflammatory syndrome 141.13 27.75 47 9103 6037 63473835
Viral load increased 136.08 27.75 33 9117 1341 63478531
Spina bifida 129.41 27.75 29 9121 830 63479042
Stillbirth 128.62 27.75 45 9105 6705 63473167
Pathogen resistance 127.10 27.75 44 9106 6354 63473518
Premature rupture of membranes 121.52 27.75 40 9110 4953 63474919
Genotype drug resistance test positive 101.28 27.75 21 9129 412 63479460
Low birth weight baby 100.30 27.75 38 9112 7091 63472781
Hepatocellular injury 99.31 27.75 57 9093 27324 63452548
Drug resistance 97.51 27.75 53 9097 22880 63456992
Supernumerary nipple 96.17 27.75 15 9135 48 63479824
Caesarean section 94.32 27.75 47 9103 16985 63462887
Congenital naevus 92.55 27.75 17 9133 171 63479701
Acoustic stimulation tests abnormal 89.86 27.75 15 9135 81 63479791
Anal atresia 85.55 27.75 18 9132 380 63479492
Congenital genital malformation 82.58 27.75 15 9135 141 63479731
Cloacal exstrophy 81.65 27.75 15 9135 151 63479721
Low set ears 80.36 27.75 16 9134 254 63479618
Cholestasis of pregnancy 79.55 27.75 21 9129 1204 63478668
Bladder agenesis 75.84 27.75 14 9136 145 63479727
Genitalia external ambiguous 75.24 27.75 14 9136 152 63479720
Caudal regression syndrome 74.35 27.75 14 9136 163 63479709
Meconium stain 72.57 27.75 14 9136 187 63479685
Congenital heart valve disorder 70.95 27.75 12 9138 71 63479801
Gastrointestinal disorder congenital 70.75 27.75 13 9137 131 63479741
Tethered cord syndrome 67.74 27.75 14 9136 270 63479602
CD4 lymphocytes decreased 67.22 27.75 19 9131 1408 63478464
Pain 66.85 27.75 13 9137 740615 62739257
Sudden infant death syndrome 66.56 27.75 14 9136 295 63479577
Gastroschisis 62.18 27.75 14 9136 409 63479463
Meningomyelocele 62.00 27.75 15 9135 603 63479269
Gastrointestinal malformation 61.16 27.75 12 9138 176 63479696
Congenital pulmonary valve disorder 60.71 27.75 10 9140 49 63479823
Congenital choroid plexus cyst 60.19 27.75 13 9137 312 63479560
Cerebral ventricle dilatation 59.06 27.75 16 9134 1013 63478859
Congenital anomaly 58.83 27.75 18 9132 1758 63478114
Exomphalos 58.35 27.75 14 9136 543 63479329
Gestational diabetes 58.09 27.75 27 9123 8369 63471503
Umbilical cord abnormality 55.93 27.75 14 9136 649 63479223
Coloboma 55.54 27.75 10 9140 89 63479783
CSF HIV escape syndrome 54.77 27.75 10 9140 97 63479775
Hyperadrenocorticism 53.62 27.75 12 9138 341 63479531
Hemivertebra 52.90 27.75 10 9140 119 63479753
Fatigue 52.13 27.75 32 9118 887996 62591876
Foetal malnutrition 48.86 27.75 9 9141 92 63479780
Cushingoid 48.70 27.75 24 9126 8461 63471411
Neonatal respiratory arrest 47.20 27.75 8 9142 48 63479824
Ventricular septal defect 46.34 27.75 19 9131 4359 63475513
Ichthyosis 46.26 27.75 8 9142 55 63479817
Nephropathy toxic 46.18 27.75 24 9126 9455 63470417
Foetal growth abnormality 46.01 27.75 8 9142 57 63479815
Hepatitis B DNA increased 45.43 27.75 10 9140 263 63479609
Eosinophilia 44.22 27.75 32 9118 22724 63457148
Complication of delivery 43.93 27.75 9 9141 166 63479706
Pulmonary valve sclerosis 43.08 27.75 7 9143 31 63479841
Maternal drugs affecting foetus 43.05 27.75 19 9131 5223 63474649
Rash maculo-papular 42.74 27.75 36 9114 31860 63448012
Neural tube defect 42.64 27.75 9 9141 193 63479679
Congenital ectopic bladder 42.03 27.75 8 9142 99 63479773
Pre-eclampsia 41.30 27.75 22 9128 9111 63470761
Lipohypertrophy 41.28 27.75 11 9139 654 63479218
Renal tubular disorder 40.28 27.75 15 9135 2667 63477205
Oligohydramnios 39.52 27.75 19 9131 6347 63473525
Left ventricular dilatation 39.39 27.75 10 9140 491 63479381
Adrenal insufficiency 38.99 27.75 27 9123 17888 63461984
Anencephaly 38.89 27.75 9 9141 298 63479574
Drug ineffective 38.69 27.75 57 9093 1044708 62435164
Endometritis decidual 38.51 27.75 6 9144 19 63479853
Amniotic cavity infection 38.45 27.75 12 9138 1251 63478621
Cholestasis 36.95 27.75 32 9118 29402 63450470
Dermatitis exfoliative generalised 35.19 27.75 15 9135 3792 63476080
Atrial septal defect 35.04 27.75 18 9132 6920 63472952
Psychomotor retardation 34.95 27.75 15 9135 3855 63476017
Central obesity 34.67 27.75 11 9139 1210 63478662
HIV-associated neurocognitive disorder 34.07 27.75 7 9143 131 63479741
Acute kidney injury 34.06 27.75 99 9051 263316 63216556
Total bile acids increased 33.82 27.75 7 9143 136 63479736
Potassium wasting nephropathy 33.68 27.75 6 9144 50 63479822
Skin striae 33.18 27.75 11 9139 1390 63478482
CSF test abnormal 33.15 27.75 8 9142 318 63479554
Fall 33.03 27.75 8 9142 392326 63087546
Congenital anomaly in offspring 32.78 27.75 7 9143 159 63479713
Generalised anxiety disorder 32.62 27.75 12 9138 2062 63477810
Complication of pregnancy 32.61 27.75 9 9141 611 63479261
Alopecia 32.37 27.75 5 9145 337531 63142341
Polyhydramnios 31.56 27.75 12 9138 2259 63477613
Mental disability 30.90 27.75 6 9144 83 63479789
Foetal heart rate disorder 30.64 27.75 6 9144 87 63479785
Abortion 30.46 27.75 12 9138 2484 63477388
Breast disorder 30.30 27.75 12 9138 2518 63477354
Sepsis neonatal 30.14 27.75 8 9142 468 63479404
Large for dates baby 30.03 27.75 8 9142 475 63479397
Ventricular hypertrophy 29.99 27.75 13 9137 3423 63476449
Congenital intestinal malformation 29.36 27.75 5 9145 31 63479841
Glucocorticoids increased 28.54 27.75 6 9144 126 63479746
Dyslipidaemia 28.42 27.75 16 9134 7377 63472495
Fanconi syndrome acquired 28.04 27.75 9 9141 1027 63478845

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Immune reconstitution inflammatory syndrome 526.58 15.47 185 16022 8574 34932150
Foetal exposure during pregnancy 474.95 15.47 266 15941 37835 34902889
Lipodystrophy acquired 412.59 15.47 122 16085 3222 34937502
Drug interaction 338.37 15.47 466 15741 225480 34715244
Mitochondrial toxicity 309.19 15.47 93 16114 2606 34938118
Progressive external ophthalmoplegia 294.46 15.47 78 16129 1357 34939367
Virologic failure 294.06 15.47 95 16112 3385 34937339
Eyelid ptosis 247.14 15.47 95 16112 5671 34935053
Viral mutation identified 179.69 15.47 63 16144 2891 34937833
Blood HIV RNA increased 169.86 15.47 49 16158 1181 34939543
Osteoporosis 156.29 15.47 88 16119 12580 34928144
Pathogen resistance 153.78 15.47 79 16128 9403 34931321
Diplopia 145.43 15.47 93 16114 16750 34923974
Drug resistance 132.69 15.47 104 16103 25823 34914901
Viral load increased 131.46 15.47 48 16159 2479 34938245
Genotype drug resistance test positive 116.37 15.47 36 16171 1109 34939615
Premature baby 114.18 15.47 85 16122 19548 34921176
CD4 lymphocytes decreased 113.09 15.47 39 16168 1702 34939022
Renal tubular disorder 109.49 15.47 50 16157 4593 34936131
HIV-associated neurocognitive disorder 101.55 15.47 25 16182 319 34940405
Dyslipidaemia 92.29 15.47 52 16155 7436 34933288
Syphilis 86.11 15.47 23 16184 413 34940311
Brain stem stroke 82.78 15.47 21 16186 305 34940419
Laryngomalacia 82.40 15.47 21 16186 311 34940413
Trisomy 21 79.34 15.47 23 16184 564 34940160
Gene mutation 77.92 15.47 28 16179 1380 34939344
Hypertriglyceridaemia 73.76 15.47 47 16160 8401 34932323
Ophthalmoplegia 70.63 15.47 28 16179 1812 34938912
Adrenal suppression 64.31 15.47 20 16187 627 34940097
Osteonecrosis 64.05 15.47 54 16153 14836 34925888
Polydactyly 62.93 15.47 23 16184 1190 34939534
Treatment noncompliance 60.83 15.47 70 16137 28030 34912694
Fanconi syndrome acquired 58.41 15.47 25 16182 1966 34938758
Drug reaction with eosinophilia and systemic symptoms 58.03 15.47 74 16133 32938 34907786
Nephropathy toxic 54.86 15.47 46 16161 12542 34928182
Pyelocaliectasis 53.38 15.47 20 16187 1110 34939614
Mycobacterium avium complex infection 52.85 15.47 25 16182 2486 34938238
Genital herpes 52.26 15.47 17 16190 618 34940106
CSF HIV escape syndrome 51.29 15.47 13 16194 188 34940536
Ventricular hypoplasia 50.99 15.47 11 16196 74 34940650
Anogenital dysplasia 50.62 15.47 12 16195 129 34940595
Dyspnoea 49.91 15.47 61 16146 376721 34564003
Congenital hydronephrosis 49.86 15.47 17 16190 716 34940008
Atrioventricular septal defect 49.33 15.47 13 16194 221 34940503
Hemivertebra 49.19 15.47 12 16195 147 34940577
Hepatitis cholestatic 47.51 15.47 35 16172 7912 34932812
Nephrolithiasis 47.12 15.47 64 16143 30269 34910455
Hepatitis B 44.23 15.47 30 16177 5953 34934771
Renal impairment 43.88 15.47 119 16088 94394 34846330
Genital herpes simplex 41.26 15.47 10 16197 119 34940605
Rash maculo-papular 41.15 15.47 58 16149 28393 34912331
Karyotype analysis abnormal 38.16 15.47 8 16199 46 34940678
Drug level increased 37.98 15.47 49 16158 22047 34918677
Hepatitis C 36.91 15.47 33 16174 9797 34930927
Hepatocellular injury 36.23 15.47 48 16159 22163 34918561
Oesophageal atresia 35.30 15.47 12 16195 501 34940223
Ectopic kidney 35.29 15.47 7 16200 29 34940695
Atrial fibrillation 35.17 15.47 7 16200 122386 34818338
Low birth weight baby 34.67 15.47 29 16178 7876 34932848
Hyperlipidaemia 34.51 15.47 38 16169 14491 34926233
Superior mesenteric artery syndrome 33.92 15.47 8 16199 84 34940640
Lipohypertrophy 33.65 15.47 10 16197 268 34940456
Anal cancer stage 0 32.85 15.47 6 16201 14 34940710
Congenital anomaly 32.83 15.47 15 16192 1378 34939346
Coarctation of the aorta 32.25 15.47 11 16196 464 34940260
Neuropsychiatric symptoms 32.10 15.47 13 16194 889 34939835
HIV lipodystrophy 31.51 15.47 6 16201 19 34940705
Congenital mitral valve incompetence 30.09 15.47 8 16199 141 34940583
Heart disease congenital 29.75 15.47 14 16193 1376 34939348
Drug level decreased 28.79 15.47 26 16181 7820 34932904
HIV associated nephropathy 27.75 15.47 9 16198 324 34940400
Acquired gene mutation 27.02 15.47 13 16194 1342 34939382
Foetal growth restriction 26.58 15.47 19 16188 4098 34936626
Foetal death 26.48 15.47 8 16199 227 34940497
Hyperphagia 26.42 15.47 13 16194 1410 34939314
Cushingoid 25.95 15.47 16 16191 2698 34938026
Foetal chromosome abnormality 25.76 15.47 5 16202 18 34940706
Blood pressure increased 25.38 15.47 5 16202 88097 34852627
Pneumocystis jirovecii pneumonia 25.32 15.47 38 16169 19672 34921052
Glycosuria 25.07 15.47 12 16195 1225 34939499
Acute kidney injury 25.03 15.47 233 15974 304755 34635969
Immune reconstitution inflammatory syndrome associated tuberculosis 24.94 15.47 9 16198 449 34940275
Anal cancer 24.84 15.47 9 16198 454 34940270
Conductive deafness 24.30 15.47 8 16199 302 34940422
Urinary tract inflammation 24.25 15.47 7 16200 169 34940555
Cytomegalovirus chorioretinitis 24.18 15.47 17 16190 3572 34937152
Constipation 24.17 15.47 17 16190 136965 34803759
Disease progression 24.04 15.47 10 16197 108067 34832657
Acquired immunodeficiency syndrome 23.86 15.47 9 16198 509 34940215
Hepatic cancer 23.85 15.47 24 16183 8251 34932473
Leishmaniasis 23.76 15.47 8 16199 324 34940400
Small for dates baby 22.81 15.47 17 16190 3910 34936814
Pneumonia 22.71 15.47 89 16118 362538 34578186
Hypercholesterolaemia 22.71 15.47 24 16183 8738 34931986
Maternal drugs affecting foetus 22.66 15.47 17 16190 3948 34936776
Ergot poisoning 22.64 15.47 5 16202 38 34940686
Anogenital warts 22.62 15.47 9 16198 588 34940136
Pulmonary sequestration 22.42 15.47 5 16202 40 34940684
Congenital renal disorder 22.34 15.47 6 16201 110 34940614
Drug abuse 22.31 15.47 9 16198 99087 34841637
CD4 lymphocytes abnormal 22.20 15.47 5 16202 42 34940682
Blood HIV RNA 22.00 15.47 4 16203 9 34940715
Acute myocardial infarction 21.36 15.47 64 16143 53655 34887069
HIV infection 21.25 15.47 11 16196 1328 34939396
Cranial nerve palsies multiple 20.99 15.47 5 16202 55 34940669
Adrenal insufficiency 20.84 15.47 29 16178 14018 34926706
Peripheral swelling 20.72 15.47 5 16202 76536 34864188
Post transplant distal limb syndrome 20.69 15.47 7 16200 288 34940436
Product use complaint 20.55 15.47 11 16196 1421 34939303
Pain 20.43 15.47 40 16167 204635 34736089
Cortisol decreased 20.04 15.47 10 16197 1117 34939607
Hepatitis B DNA assay positive 19.88 15.47 5 16202 70 34940654
Treatment failure 19.87 15.47 57 16150 46640 34894084
Malignant neoplasm progression 19.82 15.47 8 16199 88038 34852686
Eosinophilic pustular folliculitis 19.68 15.47 5 16202 73 34940651
Spinal compression fracture 19.35 15.47 20 16187 7096 34933628
Blood creatine phosphokinase increased 19.32 15.47 55 16152 44802 34895922
Congenital vesicoureteric reflux 19.23 15.47 4 16203 22 34940702
Heart transplant rejection 19.21 15.47 10 16197 1221 34939503
Atypical mycobacterial infection 19.13 15.47 9 16198 884 34939840
Beta 2 microglobulin urine increased 18.92 15.47 5 16202 86 34940638
Fanconi syndrome 18.67 15.47 11 16196 1709 34939015
Proteinuria 18.55 15.47 32 16175 18610 34922114
Product residue present 18.48 15.47 13 16194 2733 34937991
Liver function test abnormal 18.45 15.47 43 16164 31031 34909693
Induration 18.38 15.47 9 16198 966 34939758
Testicular mass 18.26 15.47 5 16202 99 34940625
Oesophageal ulcer 18.23 15.47 14 16193 3367 34937357
Renal tubular dysfunction 18.08 15.47 7 16200 425 34940299
Renal colic 17.99 15.47 11 16196 1828 34938896
ECG signs of ventricular hypertrophy 17.95 15.47 3 16204 3 34940721
17-hydroxyprogesterone increased 17.95 15.47 3 16204 3 34940721
Mycobacterium avium complex immune restoration disease 17.62 15.47 4 16203 35 34940689
Myelocytosis 17.42 15.47 4 16203 37 34940687
Osteoporotic fracture 17.39 15.47 9 16198 1086 34939638
Hyperuricaemia 17.33 15.47 20 16187 8023 34932701
Amyotrophy 17.27 15.47 7 16200 480 34940244
Coccidioidomycosis 17.26 15.47 8 16199 759 34939965
Vitamin D deficiency 16.94 15.47 18 16189 6590 34934134
Hypotension 16.83 15.47 50 16157 221599 34719125
Hypophosphataemia 16.71 15.47 23 16184 11003 34929721
Skin test negative 16.71 15.47 4 16203 45 34940679
Hyperphosphatasaemia 16.55 15.47 4 16203 47 34940677
Retinitis pigmentosa 16.40 15.47 4 16203 49 34940675
Viraemia 16.35 15.47 9 16198 1229 34939495
Fatigue 16.27 15.47 103 16104 370550 34570174
Meralgia paraesthetica 16.13 15.47 5 16202 155 34940569
Embolism 16.09 15.47 19 16188 7810 34932914
Joint swelling 16.03 15.47 4 16203 59886 34880838
Stevens-Johnson syndrome 15.99 15.47 30 16177 18609 34922115
Hepatic cytolysis 15.91 15.47 26 16181 14470 34926254
Chest discomfort 15.90 15.47 3 16204 54527 34886197
Lymphoma 15.90 15.47 24 16183 12483 34928241
VIIIth nerve injury 15.88 15.47 3 16204 9 34940715
Hypo HDL cholesterolaemia 15.88 15.47 3 16204 9 34940715
Vth nerve injury 15.88 15.47 3 16204 9 34940715
Progressive multifocal leukoencephalopathy 15.76 15.47 21 16186 9743 34930981
Liver disorder 15.74 15.47 42 16165 32955 34907769
Duodenal atresia 15.64 15.47 3 16204 10 34940714
Congenital ureteric anomaly 15.58 15.47 4 16203 61 34940663
Hypermetabolism 15.58 15.47 5 16202 174 34940550
Relapsing fever 15.55 15.47 5 16202 175 34940549
Viral load 15.52 15.47 4 16203 62 34940662

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Immune reconstitution inflammatory syndrome 620.99 16.19 199 18823 13642 79711724
Drug interaction 572.02 16.19 592 18430 414591 79310775
Virologic failure 563.29 16.19 142 18880 4049 79721317
Abortion spontaneous 538.63 16.19 218 18804 29289 79696077
Lipodystrophy acquired 534.28 16.19 137 18885 4188 79721178
Exposure during pregnancy 510.40 16.19 311 18711 100821 79624545
Viral mutation identified 407.87 16.19 108 18914 3750 79721616
Mitochondrial toxicity 376.57 16.19 97 18925 3017 79722349
Progressive external ophthalmoplegia 350.84 16.19 79 18943 1366 79724000
Pathogen resistance 282.45 16.19 112 18910 14230 79711136
Blood HIV RNA increased 251.54 16.19 63 18959 1745 79723621
Eyelid ptosis 248.46 16.19 95 18927 10949 79714417
Viral load increased 230.03 16.19 65 18957 2883 79722483
Drug resistance 207.88 16.19 128 18894 42085 79683281
Maternal exposure during pregnancy 198.13 16.19 201 18821 136337 79589029
Treatment noncompliance 197.07 16.19 134 18888 52134 79673232
Genotype drug resistance test positive 184.06 16.19 46 18976 1262 79724104
Diplopia 148.46 16.19 95 18927 33371 79691995
Renal tubular disorder 143.02 16.19 55 18967 6431 79718935
Premature labour 142.73 16.19 59 18963 8331 79717035
Abortion induced 141.62 16.19 56 18966 7053 79718313
HIV-associated neurocognitive disorder 140.60 16.19 29 18993 323 79725043
CD4 lymphocytes decreased 139.39 16.19 43 18979 2591 79722775
Osteoporosis 126.13 16.19 104 18918 54008 79671358
Live birth 121.66 16.19 68 18954 18676 79706690
Foetal exposure during pregnancy 109.73 16.19 44 18978 5746 79719620
Premature delivery 107.51 16.19 68 18954 23399 79701967
CSF HIV escape syndrome 106.52 16.19 23 18999 324 79725042
Premature rupture of membranes 106.05 16.19 39 18983 4030 79721336
Nephropathy toxic 100.68 16.19 62 18960 20357 79705009
Adrenal suppression 96.39 16.19 28 18994 1371 79723995
Syphilis 95.81 16.19 23 18999 531 79724835
Hepatocellular injury 93.61 16.19 83 18939 47510 79677856
Dyslipidaemia 88.81 16.19 47 18975 11586 79713780
Brain stem stroke 80.14 16.19 21 19001 698 79724668
Stillbirth 78.23 16.19 31 18991 3924 79721442
Foetal death 77.42 16.19 38 18984 8006 79717360
Acute kidney injury 77.00 16.19 285 18737 519119 79206247
Hypertriglyceridaemia 76.68 16.19 44 18978 12696 79712670
Drug reaction with eosinophilia and systemic symptoms 74.36 16.19 84 18938 64160 79661206
Cushingoid 74.08 16.19 39 18983 9513 79715853
Ophthalmoplegia 72.54 16.19 27 18995 2885 79722481
Fanconi syndrome acquired 70.87 16.19 26 18996 2668 79722698
Osteonecrosis 68.77 16.19 58 18964 31037 79694329
Lipohypertrophy 66.74 16.19 19 19003 865 79724501
Rash maculo-papular 66.05 16.19 74 18948 56004 79669362
Pain 62.72 16.19 46 18976 703756 79021610
Renal impairment 59.30 16.19 122 18900 157661 79567705
Hepatitis cholestatic 58.15 16.19 38 18984 13814 79711552
Cholestasis of pregnancy 55.89 16.19 17 19005 976 79724390
Genital herpes 54.40 16.19 20 19002 2064 79723302
Joint swelling 53.58 16.19 4 19018 288642 79436724
Mycobacterium avium complex infection 51.16 16.19 24 18998 4576 79720790
Dyspnoea 50.74 16.19 79 18943 856946 78868420
Nephrolithiasis 50.62 16.19 63 18959 53228 79672138
Gene mutation 49.47 16.19 20 19002 2666 79722700
Caesarean section 49.25 16.19 33 18989 12502 79712864
Premature baby 49.19 16.19 22 19000 3758 79721608
Hyperadrenocorticism 47.47 16.19 12 19010 345 79725021
Anogenital dysplasia 47.27 16.19 10 19012 127 79725239
Psychomotor retardation 47.24 16.19 25 18997 6159 79719207
Gastroschisis 46.49 16.19 8 19014 29 79725337
Hepatitis B DNA increased 46.08 16.19 14 19008 801 79724565
Adrenal insufficiency 45.02 16.19 44 18978 28443 79696923
Hepatitis C 43.54 16.19 30 18992 11895 79713471
Anal cancer stage 0 42.48 16.19 7 19015 18 79725348
Renal tubular dysfunction 42.45 16.19 13 19009 764 79724602
Infusion related reaction 40.51 16.19 4 19018 230233 79495133
Multiple-drug resistance 39.03 16.19 25 18997 8783 79716583
Renal colic 38.54 16.19 17 19005 2810 79722556
Genital herpes simplex 37.05 16.19 10 19012 373 79724993
Endometritis decidual 36.54 16.19 6 19016 15 79725351
HIV lipodystrophy 36.54 16.19 6 19016 15 79725351
Nasopharyngitis 36.44 16.19 8 19014 253873 79471493
Alopecia 35.94 16.19 6 19016 231349 79494017
Trisomy 21 35.70 16.19 7 19015 59 79725307
Central obesity 35.52 16.19 14 19008 1747 79723619
Hepatitis B 35.32 16.19 23 18999 8309 79717057
Skin striae 34.57 16.19 14 19008 1874 79723492
Arthralgia 34.44 16.19 52 18970 571751 79153615
Foetal growth abnormality 34.20 16.19 6 19016 25 79725341
HIV associated nephropathy 33.55 16.19 9 19013 328 79725038
Proteinuria 33.41 16.19 40 18982 32462 79692904
Superior mesenteric artery syndrome 33.35 16.19 8 19014 184 79725182
Total bile acids increased 33.01 16.19 7 19015 90 79725276
Generalised anxiety disorder 32.52 16.19 14 19008 2183 79723183
Complication of pregnancy 32.45 16.19 9 19013 372 79724994
Oesophageal atresia 32.33 16.19 7 19015 100 79725266
Acute myocardial infarction 31.82 16.19 62 18960 76974 79648392
Liver function test abnormal 31.79 16.19 56 18966 64419 79660947
Neuropsychiatric symptoms 31.19 16.19 12 19010 1403 79723963
Fatigue 30.90 16.19 116 18906 929611 78795755
Peripheral swelling 30.60 16.19 13 19009 269604 79455762
Eosinophilia 30.00 16.19 45 18977 45300 79680066
Dermatitis exfoliative 29.88 16.19 23 18999 10806 79714560
Immune reconstitution inflammatory syndrome associated tuberculosis 29.35 16.19 10 19012 826 79724540
Fanconi syndrome 29.01 16.19 14 19008 2842 79722524
Pneumocystis jirovecii pneumonia 28.60 16.19 37 18985 32471 79692895
Congenital intestinal malformation 28.47 16.19 5 19017 21 79725345
Therapeutic product effect decreased 28.42 16.19 3 19019 163860 79561506
Cholestasis 27.97 16.19 47 18975 52062 79673304
Blood HIV RNA 27.92 16.19 5 19017 24 79725342
Renal tubular necrosis 27.70 16.19 32 18990 25007 79700359
Diabetes mellitus 27.54 16.19 59 18963 78331 79647035
Pulmonary sequestration 27.28 16.19 5 19017 28 79725338
Ventricular hypoplasia 26.59 16.19 4 19018 4 79725362
Conductive deafness 26.56 16.19 7 19015 238 79725128
Foetal growth restriction 26.52 16.19 12 19010 2107 79723259
Teratogenicity 26.39 16.19 7 19015 244 79725122
Vitamin D deficiency 26.28 16.19 24 18998 14255 79711111
Glycosuria 26.15 16.19 12 19010 2176 79723190
Urinary tract inflammation 26.15 16.19 7 19015 253 79725113
Eosinophilic pustular folliculitis 26.00 16.19 6 19016 116 79725250
Blood pressure increased 25.95 16.19 9 19013 211351 79514015
Constipation 25.79 16.19 18 19004 283032 79442334
Gestational diabetes 25.77 16.19 17 19005 6276 79719090
Polyhydramnios 25.59 16.19 11 19011 1709 79723657
Amniotic cavity infection 25.58 16.19 9 19013 818 79724548
Glucocorticoids increased 25.44 16.19 6 19016 128 79725238
Infection 25.35 16.19 13 19009 241699 79483667
CSF test abnormal 25.12 16.19 8 19014 535 79724831
Atrial fibrillation 25.04 16.19 8 19014 197878 79527488
Spina bifida 24.73 16.19 6 19016 145 79725221
Sinusitis 24.57 16.19 8 19014 195493 79529873
Immunosuppressant drug level increased 24.53 16.19 19 19003 9008 79716358
Anogenital warts 24.51 16.19 9 19013 925 79724441
CD4 lymphocytes abnormal 24.46 16.19 5 19017 53 79725313
Abdominal discomfort 24.11 16.19 15 19007 250712 79474654
Hypoplastic left heart syndrome 24.08 16.19 4 19018 11 79725355
Pre-eclampsia 24.04 16.19 17 19005 7024 79718342
Potassium wasting nephropathy 24.02 16.19 6 19016 164 79725202
New onset diabetes after transplantation 24.02 16.19 6 19016 164 79725202
Hepatic cancer 24.02 16.19 20 19002 10509 79714857
White matter lesion 23.88 16.19 11 19011 2011 79723355
Fall 23.38 16.19 51 18971 487578 79237788
Coarctation of the aorta 23.25 16.19 5 19017 69 79725297
Cortisol decreased 23.13 16.19 11 19011 2161 79723205
Testicular mass 23.05 16.19 5 19017 72 79725294
Hypercholesterolaemia 23.05 16.19 28 18994 23067 79702299
Drug level increased 22.95 16.19 37 18985 39614 79685752
Cytomegalovirus chorioretinitis 22.89 16.19 15 19007 5475 79719891
Abortion threatened 22.75 16.19 7 19015 418 79724948
Blood creatine phosphokinase increased 22.36 16.19 49 18973 66041 79659325
Pain in extremity 22.06 16.19 33 18989 364505 79360861
Labelled drug-drug interaction medication error 22.05 16.19 30 18992 27620 79697746
Hyperlipidaemia 21.87 16.19 29 18993 26064 79699302
Pancreatitis acute 21.81 16.19 41 18981 49563 79675803
Face oedema 21.65 16.19 30 18992 28106 79697260
Prurigo 21.18 16.19 9 19013 1360 79724006
Cranial nerve palsies multiple 20.84 16.19 5 19017 115 79725251
Atrioventricular septal defect 20.80 16.19 5 19017 116 79725250
Dizziness 20.64 16.19 61 18961 526380 79198986
Cushing's syndrome 20.38 16.19 8 19014 987 79724379
Post transplant distal limb syndrome 20.37 16.19 7 19015 593 79724773
Benign prostatic hyperplasia 20.36 16.19 19 19003 11593 79713773
Hyperbilirubinaemia 20.16 16.19 27 18995 24491 79700875
Hyperuricaemia 20.11 16.19 19 19003 11780 79713586
Discomfort 20.08 16.19 3 19019 125614 79599752
ECG signs of ventricular hypertrophy 19.95 16.19 3 19019 3 79725363
Acquired gene mutation 19.86 16.19 10 19012 2223 79723143
Secondary adrenocortical insufficiency 19.73 16.19 11 19011 3003 79722363
Hypophosphataemia 19.64 16.19 24 18998 19889 79705477
Swelling 19.44 16.19 14 19008 216697 79508669
HIV infection 19.42 16.19 8 19014 1119 79724247
Feeling abnormal 19.16 16.19 7 19015 159192 79566174
Musculoskeletal stiffness 18.97 16.19 9 19013 174999 79550367
Back pain 18.92 16.19 27 18995 304153 79421213
Mitochondrial cytopathy 18.80 16.19 6 19016 404 79724962
Hyperproteinaemia 18.78 16.19 5 19017 177 79725189
Blood triglycerides increased 18.59 16.19 24 18998 21016 79704350
Stomatitis 18.45 16.19 6 19016 146751 79578615
Wheezing 18.16 16.19 3 19019 116661 79608705
Rhabdomyolysis 18.13 16.19 60 18962 103071 79622295
Drug-induced liver injury 17.98 16.19 45 18977 66072 79659294
Hypo HDL cholesterolaemia 17.87 16.19 3 19019 9 79725357
Vth nerve injury 17.87 16.19 3 19019 9 79725357
Disease progression 17.76 16.19 11 19011 184351 79541015
Hepatitis acute 17.42 16.19 20 19002 15522 79709844
Progressive multifocal leukoencephalopathy 17.42 16.19 23 18999 20577 79704789
Embolism 17.40 16.19 19 19003 13963 79711403
Mobility decreased 17.22 16.19 4 19018 122171 79603195
Arteriovenous graft site pseudoaneurysm 17.20 16.19 3 19019 12 79725354
Drug intolerance 16.87 16.19 23 18999 264096 79461270
Pneumonia 16.70 16.19 91 18931 660155 79065211
Hepatic cytolysis 16.62 16.19 26 18996 27125 79698241
Renal failure 16.62 16.19 93 18929 200875 79524491
Encephalitis 16.56 16.19 19 19003 14741 79710625
Heart disease congenital 16.44 16.19 6 19016 606 79724760
Amyotrophy 16.37 16.19 6 19016 614 79724752
Coagulation factor V level decreased 16.26 16.19 6 19016 625 79724741
Acute haemorrhagic conjunctivitis 16.19 16.19 3 19019 18 79725348

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC J05AE10 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Protease inhibitors
ATC J05AR14 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Antivirals for treatment of HIV infections, combinations
ATC J05AR22 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Antivirals for treatment of HIV infections, combinations
ATC J05AR26 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIVIRALS FOR SYSTEMIC USE
DIRECT ACTING ANTIVIRALS
Antivirals for treatment of HIV infections, combinations
FDA MoA N0000000246 HIV Protease Inhibitors
MeSH PA D019380 Anti-HIV Agents
MeSH PA D000890 Anti-Infective Agents
MeSH PA D044966 Anti-Retroviral Agents
MeSH PA D000998 Antiviral Agents
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D017320 HIV Protease Inhibitors
MeSH PA D011480 Protease Inhibitors
MeSH PA D000084762 Viral Protease Inhibitors
FDA EPC N0000175889 Protease Inhibitor
FDA MoA N0000182137 Cytochrome P450 2D6 Inhibitors
FDA MoA N0000190114 Cytochrome P450 3A Inhibitors
CHEBI has role CHEBI:35660 HIV protease inhibitors
CHEBI has role CHEBI:36044 antiviral drugs

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

DiseaseRelationSNOMED_IDDOID
Human immunodeficiency virus infection indication 86406008 DOID:526
Coronavirus infection off-label use 186747009
Hypercholesterolemia contraindication 13644009
Cirrhosis of liver contraindication 19943007 DOID:5082
Hereditary factor VIII deficiency disease contraindication 28293008 DOID:12134
Hereditary factor IX deficiency disease contraindication 41788008 DOID:12259
Hepatic failure contraindication 59927004
Chronic type B viral hepatitis contraindication 61977001
Diabetes mellitus contraindication 73211009 DOID:9351
Hyperglycemia contraindication 80394007 DOID:4195
Chronic hepatitis C contraindication 128302006
Liver function tests abnormal contraindication 166603001
Disease of liver contraindication 235856003 DOID:409
Hypertriglyceridemia contraindication 302870006
Breastfeeding (mother) contraindication 413712001




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 13.67 acidic
pKa2 1.64 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
150MG;800MG PREZCOBIX JANSSEN PRODS N205395 Jan. 29, 2015 RX TABLET ORAL 8148374 Sept. 3, 2029 TREATMENT OF HIV INFECTION IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 40KG USING A COMPOSITION CONTAINING A PHARMACOKINETIC ENHANCER THAT INHIBITS CYTOCHROME P450 MONOOXYGENASE
150MG;800MG PREZCOBIX JANSSEN PRODS N205395 Jan. 29, 2015 RX TABLET ORAL 8148374 Sept. 3, 2029 TREATMENT OF HIV INFECTION USING A COMPOSITION CONTAINING A PHARMACOKINETIC ENHANCER THAT INHIBITS CYTOCHROME P450 MONOOXYGENASE
150MG;800MG;200MG;EQ 10MG BASE SYMTUZA JANSSEN PRODS N210455 July 17, 2018 RX TABLET ORAL 8148374 Sept. 3, 2029 TREATMENT OF HIV-1 INFECTION USING A COMPOSITION CONTAINING A PHARMACOKINETIC ENHANCER THAT INHIBITS CYTOCHROME P450 MONOOXYGENASE IN ADULTS WHO ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS
150MG;800MG;200MG;EQ 10MG BASE SYMTUZA JANSSEN PRODS N210455 July 17, 2018 RX TABLET ORAL 8148374 Sept. 3, 2029 TREATMENT OF HIV-1 INFECTION USING A COMPOSITION CONTAINING A PHARMACOKINETIC ENHANCER THAT INHIBITS CYTOCHROME P450 MONOOXYGENASE IN ADULTS WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY
150MG;800MG;200MG;EQ 10MG BASE SYMTUZA JANSSEN PRODS N210455 July 17, 2018 RX TABLET ORAL 8148374 Sept. 3, 2029 TREATMENT OF HIV-1 INFECTION USING A COMPOSITION CONTAINING A PK ENHANCER THAT INHIBITS CY P450 MONOXYGENASE IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 40KG WHO ARE VIROLOGICALLY SUPPRESSED ON A STABLE ARV REGIMEN FOR AT LEAST 6 MONTHS
150MG;800MG;200MG;EQ 10MG BASE SYMTUZA JANSSEN PRODS N210455 July 17, 2018 RX TABLET ORAL 8148374 Sept. 3, 2029 TREATMENT OF HIV-1 INFECTION USING A COMPOSITION CONTAINING A PK ENHANCER THAT INHIBITS CY P450 MONOXYGENASE IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 40KG WHO HAVE NO PRIOR ARV TREATMENT HISTORY
150MG;800MG;200MG;EQ 10MG BASE SYMTUZA JANSSEN PRODS N210455 July 17, 2018 RX TABLET ORAL 8148374 Sept. 3, 2029 TX OF HIV1 INFECTION USING A COMPOSITION CONTAINING A PK ENHANCER THAT INHIBITS CY P450 MONOXYGENASE IN ADULTS & PEDIATRIC PATIENTS AT LEAST 40KG HAVING NO PRIOR ARV TX HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ARV REGIMEN FOR AT LEAST 6 MO
150MG;800MG;200MG;EQ 10MG BASE SYMTUZA JANSSEN PRODS N210455 July 17, 2018 RX TABLET ORAL 8148374 Sept. 3, 2029 TX OF HIV-1 INFECTION USING A COMPOSITION CONTAINING A PK ENHANCER THAT INHIBITS CYTOCHROME P450 MONOOXYGENATES IN ADULTS WHO HAVE NO PRIOR ANTIRETROVIRAL TX HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS
150MG;800MG;200MG;EQ 10MG BASE SYMTUZA JANSSEN PRODS N210455 July 17, 2018 RX TABLET ORAL 8754065 Aug. 15, 2032 TREATMENT OF HIV-1 INFECTION IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 40 KG WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS
150MG;800MG;200MG;EQ 10MG BASE SYMTUZA JANSSEN PRODS N210455 July 17, 2018 RX TABLET ORAL 8754065 Aug. 15, 2032 TREATMENT OF HIV-1 INFECTION IN ADULTS WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS
150MG;800MG;200MG;EQ 10MG BASE SYMTUZA JANSSEN PRODS N210455 July 17, 2018 RX TABLET ORAL 9296769 Aug. 15, 2032 TREATMENT OF HIV-1 INFECTION IN ADULTS AND PEDIATRIC PATIENTS WEIGHING AT LEAST 40 KG WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS
150MG;800MG;200MG;EQ 10MG BASE SYMTUZA JANSSEN PRODS N210455 July 17, 2018 RX TABLET ORAL 9296769 Aug. 15, 2032 TREATMENT OF HIV-1 INFECTION IN ADULTS WHO HAVE NO PRIOR ANTIRETROVIRAL TREATMENT HISTORY OR ARE VIROLOGICALLY SUPPRESSED ON A STABLE ANTIRETROVIRAL REGIMEN FOR AT LEAST 6 MONTHS
150MG;800MG;200MG;EQ 10MG BASE SYMTUZA JANSSEN PRODS N210455 July 17, 2018 RX TABLET ORAL 10786518 July 19, 2038 TREATMENT OF HIV-1 INFECTION IN ADULT OR PEDIATRIC PATIENTS (>=40 KG) WITH <50 COPIES/ML HIV-1 RNA AFTER >= 6 MONTHS ON PRIOR ANTIRETROVIRAL REGIMEN AND NO KNOWN DARUNAVIR OR TENOFOVIR RESISTANCE-ASSOCIATED SUBSTITUTIONS

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
800MG DARUNAVIR LUPIN LTD A202073 Sept. 29, 2022 RX TABLET ORAL Nov. 28, 2023 PATENT CHALLENGE

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Multidrug resistance protein 1 Transporter IC50 5.18 CHEMBL
Pol polyprotein Enzyme INHIBITOR Ki 10.85 CHEMBL CHEMBL
Gag-Pol polyprotein Polyprotein Ki 9.66 WOMBAT-PK
Protease Enzyme IC50 10.21 CHEMBL
Protease Unclassified Ki 10.96 CHEMBL
Protease Unclassified Ki 10.82 CHEMBL

External reference:

IDSource
4025441 VUID
N0000179778 NUI
D03656 KEGG_DRUG
635728-49-3 SECONDARY_CAS_RN
4025441 VANDF
4025493 VANDF
C1435444 UMLSCUI
CHEBI:367163 CHEBI
017 PDB_CHEM_ID
CHEMBL1323 ChEMBL_ID
CHEMBL1201127 ChEMBL_ID
D000069454 MESH_DESCRIPTOR_UI
DB01264 DRUGBANK_ID
11243 IUPHAR_LIGAND_ID
8305 INN_ID
YO603Y8113 UNII
213039 PUBCHEM_CID
460132 RXNORM
21619 MMSL
310017 MMSL
83005 MMSL
d05825 MMSL
011599 NDDF
011600 NDDF
423888002 SNOMEDCT_US
424096001 SNOMEDCT_US
428318002 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
PREZCOBIX HUMAN PRESCRIPTION DRUG LABEL 2 50090-1723 TABLET, FILM COATED 800 mg ORAL NDA 29 sections
PREZISTA HUMAN PRESCRIPTION DRUG LABEL 1 53808-0672 TABLET, FILM COATED 400 mg ORAL NDA 31 sections
PREZISTA HUMAN PRESCRIPTION DRUG LABEL 1 53808-0773 TABLET, FILM COATED 600 mg ORAL NDA 31 sections
PREZISTA HUMAN PRESCRIPTION DRUG LABEL 1 54868-5969 TABLET, FILM COATED 400 mg ORAL NDA 31 sections
PREZISTA HUMAN PRESCRIPTION DRUG LABEL 1 54868-6369 TABLET, FILM COATED 600 mg ORAL NDA 31 sections
PREZISTA HUMAN PRESCRIPTION DRUG LABEL 1 59676-562 TABLET, FILM COATED 600 mg ORAL NDA 31 sections
PREZISTA HUMAN PRESCRIPTION DRUG LABEL 1 59676-562 TABLET, FILM COATED 600 mg ORAL NDA 31 sections
PREZISTA HUMAN PRESCRIPTION DRUG LABEL 1 59676-562 TABLET, FILM COATED 600 mg ORAL NDA 31 sections
PREZISTA HUMAN PRESCRIPTION DRUG LABEL 1 59676-562 TABLET, FILM COATED 600 mg ORAL NDA 31 sections
PREZISTA HUMAN PRESCRIPTION DRUG LABEL 1 59676-563 TABLET, FILM COATED 75 mg ORAL NDA 31 sections
PREZISTA HUMAN PRESCRIPTION DRUG LABEL 1 59676-563 TABLET, FILM COATED 75 mg ORAL NDA 31 sections
PREZISTA HUMAN PRESCRIPTION DRUG LABEL 1 59676-563 TABLET, FILM COATED 75 mg ORAL NDA 31 sections
PREZISTA HUMAN PRESCRIPTION DRUG LABEL 1 59676-563 TABLET, FILM COATED 75 mg ORAL NDA 31 sections
PREZISTA HUMAN PRESCRIPTION DRUG LABEL 1 59676-564 TABLET, FILM COATED 150 mg ORAL NDA 31 sections
PREZISTA HUMAN PRESCRIPTION DRUG LABEL 1 59676-564 TABLET, FILM COATED 150 mg ORAL NDA 31 sections
PREZISTA HUMAN PRESCRIPTION DRUG LABEL 1 59676-564 TABLET, FILM COATED 150 mg ORAL NDA 31 sections
PREZISTA HUMAN PRESCRIPTION DRUG LABEL 1 59676-564 TABLET, FILM COATED 150 mg ORAL NDA 31 sections
PREZISTA HUMAN PRESCRIPTION DRUG LABEL 1 59676-565 SUSPENSION 100 mg ORAL NDA 31 sections
PREZISTA HUMAN PRESCRIPTION DRUG LABEL 1 59676-565 SUSPENSION 100 mg ORAL NDA 31 sections
PREZISTA HUMAN PRESCRIPTION DRUG LABEL 1 59676-565 SUSPENSION 100 mg ORAL NDA 31 sections
PREZISTA HUMAN PRESCRIPTION DRUG LABEL 1 59676-565 SUSPENSION 100 mg ORAL NDA 31 sections
PREZISTA HUMAN PRESCRIPTION DRUG LABEL 1 59676-566 TABLET, FILM COATED 800 mg ORAL NDA 31 sections
PREZISTA HUMAN PRESCRIPTION DRUG LABEL 1 59676-566 TABLET, FILM COATED 800 mg ORAL NDA 31 sections
PREZISTA HUMAN PRESCRIPTION DRUG LABEL 1 59676-566 TABLET, FILM COATED 800 mg ORAL NDA 31 sections
PREZISTA HUMAN PRESCRIPTION DRUG LABEL 1 59676-566 TABLET, FILM COATED 800 mg ORAL NDA 31 sections
PREZCOBIX HUMAN PRESCRIPTION DRUG LABEL 2 59676-575 TABLET, FILM COATED 800 mg ORAL NDA 30 sections
PREZCOBIX HUMAN PRESCRIPTION DRUG LABEL 2 59676-575 TABLET, FILM COATED 800 mg ORAL NDA 30 sections
PREZCOBIX HUMAN PRESCRIPTION DRUG LABEL 2 59676-575 TABLET, FILM COATED 800 mg ORAL NDA 30 sections
PREZCOBIX HUMAN PRESCRIPTION DRUG LABEL 2 59676-575 TABLET, FILM COATED 800 mg ORAL NDA 30 sections
Symtuza HUMAN PRESCRIPTION DRUG LABEL 4 59676-800 TABLET, FILM COATED 800 mg ORAL NDA 34 sections