Details of the Drug Formulations

General Information of Drug (ID: DMGW1ID)

Drug Name
Sirolimus Drug Info
Synonyms
53123-88-9; Rapamune; Rapamycin (Sirolimus); AY-22989; Rapammune; sirolimusum; WY-090217; RAPA; Antibiotic AY 22989; AY 22989; UNII-W36ZG6FT64; CCRIS 9024; CHEBI:9168; SILA 9268A; W36ZG6FT64; HSDB 7284; C51H79NO13; NSC 226080; DE-109; NCGC00021305-05; DSSTox_CID_3582; DSSTox_RID_77091; DSSTox_GSID_23582; Cypher; Supralimus; Wy 090217; Perceiva; RAP; RPM; Rapamycin from Streptomyces hygroscopicus; SIIA 9268A; LCP-Siro; MS-R001; Rapamune (TN); Rapamycin (TN); Sirolimus (RAPAMUNE); Rapamycin C-7, analog 4; Sirolimus (USAN/INN); Sirolimus [USAN:BAN:INN]; Sirolimus, Rapamune,Rapamycin; Heptadecahydro-9,27-dihydroxy-3-[(1R)-2-[(1S,3R,4R)-4-hydroxy; 23,27-Epoxy-3H-pyrido(2,1-c)(1,4)oxaazacyclohentriacontine; 23,27-Epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclohentriacontine; 23,27-epoxy-3H-pyrido[2,1-c][1,4]oxaazacyclohentriacontine-1,5,11,28,29; 3H-pyrido(2,1-c)(1,4)oxaazacyclohentriacontine-1,5,11,28,29(4H,6H,31H)-pentone; Sirolimus (MTOR inhibitor)
Indication
Disease Entry ICD 11 Status REF
Advanced cancer 2A00-2F9Z Approved [1]
Brainstem neoplasm Approved [1]
Graft-versus-host disease 4B24 Approved [1]
Intracranial meningioma Approved [1]
Lung cancer 2C25.0 Approved [1]
Lung lymphangioleiomyomatosis Approved [1]
Lymphangioleiomyomatosis CB07 Approved [2]
Mucosal melanoma Approved [1]
Multiple myeloma 2A83 Approved [3]
Multiple sclerosis 8A40 Approved [1]
Non-small-cell lung cancer 2C25.Y Approved [1]
Organ transplant rejection NE84 Approved [4]
Plasma cell myeloma 2A83.1 Approved [1]
Prostate cancer 2C82.0 Approved [1]
Salivary gland squamous cell carcinoma Approved [1]
Uveitis 9A96.Z Phase 3 [5]
Coronavirus Disease 2019 (COVID-19) 1D6Y Phase 2 [6]
Dutch elm disease 8D64 Phase 1/2 [4]
Castration-resistant prostate carcinoma Investigative [1]
Neuroblastoma 2D11.2 Investigative [1]
Pancreatic acinar cell carcinoma Investigative [1]
Polycystic kidney disease GB8Y Investigative [1]
Rheumatoid arthritis FA20 Investigative [1]
Therapeutic Class
Immunosuppressive Agents
Cross-matching ID
PubChem CID
5284616
ChEBI ID
CHEBI:9168
CAS Number
53123-88-9
TTD ID
D03LJR
VARIDT ID
DR00262
INTEDE ID
DR1489
ACDINA ID
D00627

Full List of Drug Formulations Containing This Drug

Sirolimus 2 mg tablet
Company Formulation ID FDA Description
Dr Reddy's Laboratories F20273 Lactose monohydrate; Fd&c red no. 40; Alpha-tocopherol; Magnesium stearate; Mannitol; Ammonia; Ferric oxide red; Ferric oxide yellow; Propylene glycol; Sucrose; Titanium dioxide; Poloxamer 188; Povidone; Carnauba wax; Cellulose, microcrystalline; Ethylcelluloses; Hypromellose 2910 (5 mpa.s); Polyethylene glycols; Shellac
Pfizer F20272 Lactose monohydrate; Magnesium stearate; Calcium sulfate, unspecified form; Sucrose; Talc; Titanium dioxide; Poloxamer 188; Povidone k30; Alpha.-tocopherol acetate; Carnauba wax; Glyceryl oleate; Microcrystalline cellulose; Polyethylene glycol 8000
Greenstone F20271 Lactose monohydrate; Magnesium stearate; Calcium sulfate, unspecified form; Sucrose; Talc; Titanium dioxide; Poloxamer 188; Alpha.-tocopherol acetate; Carnauba wax; Glyceryl oleate; Microcrystalline cellulose; Polyethylene glycol 8000; Povidone k29/32
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Sirolimus 1 mg tablet
Company Formulation ID FDA Description
Dr Reddy's Laboratories F20269 Lactose monohydrate; Fd&c red no. 40; Alpha-tocopherol; Magnesium stearate; Mannitol; Ammonia; Propylene glycol; Sucrose; Titanium dioxide; Poloxamer 188; Povidone; Carnauba wax; Cellulose, microcrystalline; Ethylcelluloses; Hypromellose 2910 (5 mpa.s); Polyethylene glycols; Shellac
American Health Packaging F20268 Lactose monohydrate; Fd&c red no. 40; Alpha.-tocopherol; Magnesium stearate; Mannitol; Ammonia; Propylene glycol; Sucrose; Titanium dioxide; Poloxamer 188; Carnauba wax; Cellulose, microcrystalline; Diacetylated monoglycerides; Ethylcelluloses; Hypromellose 2910 (5 mpa.s); Polyethylene glycol 8000; Povidones; Shellac
Cardinal Health F20270 Lactose; Alpha-tocopherol; Magnesium stearate; Calcium sulfate; Sucrose; Talc; Titanium dioxide; Poloxamer 188; Povidone; 1-glyceryl monooleate; Carnauba wax; Cellulose, microcrystalline; Polyethylene glycol; Polyethylene glycol 8000; Shellac
Pfizer F20267 Lactose monohydrate; Magnesium stearate; Calcium sulfate, unspecified form; Sucrose; Talc; Titanium dioxide; Poloxamer 188; Povidone k30; Alpha.-tocopherol acetate; Carnauba wax; Glyceryl oleate; Microcrystalline cellulose; Polyethylene glycol 8000
Greenstone F20266 Lactose monohydrate; Magnesium stearate; Calcium sulfate, unspecified form; Sucrose; Talc; Titanium dioxide; Poloxamer 188; Alpha.-tocopherol acetate; Carnauba wax; Glyceryl oleate; Microcrystalline cellulose; Polyethylene glycol 8000; Povidone k29/32
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Sirolimus 0.5 mg tablet
Company Formulation ID FDA Description
Zydus Pharmaceuticals F20263 Lactose monohydrate; Fd&c yellow no. 5; Alpha-tocopherol acetate; Glyceryl monooleate; Citric acid monohydrate; Ferric oxide yellow; Sucrose; Talc; Titanium dioxide; Crospovidone; Poloxamer 188; Povidone; Cellulose, microcrystalline; Hypromelloses; Polyethylene glycols
Cadila Healthcare F20262 Lactose monohydrate; Fd&c yellow no. 5; Alpha-tocopherol acetate; Citric acid monohydrate; Ferric oxide yellow; Sucrose; Talc; Titanium dioxide; Poloxamer 188; Povidone; Cellulose, microcrystalline; Crospovidone (15 mpa.s at 5%); Glyceryl oleate; Hypromelloses; Polyethylene glycols
American Health Packaging F20261 Lactose monohydrate; Fd&c yellow no. 5; Citric acid monohydrate; Ferric oxide yellow; Sucrose; Talc; Titanium dioxide; Poloxamer 188; Alpha.-tocopherol acetate; Crospovidone (15 mpa.s at 5%); Glyceryl oleate; Hypromellose, unspecified; Microcrystalline cellulose; Polyethylene glycol, unspecified; Povidone, unspecified
Pfizer F20265 Lactose monohydrate; Magnesium stearate; Calcium sulfate, unspecified form; Ferric oxide yellow; Sucrose; Talc; Titanium dioxide; Poloxamer 188; Povidone k30; Alpha.-tocopherol acetate; Carnauba wax; Glyceryl oleate; Microcrystalline cellulose; Polyethylene glycol 8000
Greenstone F20264 Lactose monohydrate; Magnesium stearate; Calcium sulfate, unspecified form; Ferric oxide yellow; Sucrose; Talc; Titanium dioxide; Poloxamer 188; Alpha.-tocopherol acetate; Carnauba wax; Glyceryl oleate; Microcrystalline cellulose; Polyethylene glycol 8000; Povidone k29/32
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References

1 Sirolimus FDA Label
2 FDA Approved Drug Products from FDA Official Website. 2019. Application Number: (ANDA) 201578.
3 Drugs@FDA. U.S. Food and Drug Administration. U.S. Department of Health & Human Services. 2015
4 URL: http://www.guidetopharmacology.org Nucleic Acids Res. 2015 Oct 12. pii: gkv1037. The IUPHAR/BPS Guide to PHARMACOLOGY in 2016: towards curated quantitative interactions between 1300 protein targets and 6000 ligands. (Ligand id: 6031).
5 Clinical pipeline report, company report or official report of the Pharmaceutical Research and Manufacturers of America (PhRMA)
6 ClinicalTrials.gov (NCT04341675) Sirolimus Treatment in Hospitalized Patients With COVID-19 Pneumonia. U.S. National Institutes of Health.