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ERLOTINIB HYDROCHLORIDE
DIR Classification
Classification:Less-DIR concern
Severity Score:1
Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF
- ADVERSE REACTIONS
- Post-Marketing Experience
- The following adverse reactions have been identified during post approval use of TARCEVA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
- Musculoskeletal and Connective Tissue Disorders: myopathy, including rhabdomyolysis, in combination with statin therapy
- Eye Disorders: ocular inflammation including uveitis
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
Rhabdomyolysis
36
42876
Other ADRs
38808
14078471
Odds Ratio = 0.305
Drug Property Information
ATC Code(s):
- L01XE03 - erlotinib hydrochloride
- L01XE - Protein kinase inhibitors
- L01X - OTHER ANTINEOPLASTIC AGENTS
- L01 - ANTINEOPLASTIC AGENTS
- L - ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
Active Ingredient:erlotinib hydrochloride
Active Ingredient UNII:DA87705X9K
Drugbank ID:DB00530
PubChem Compound:176870
CAS Number:183321-74-6
Dosage Form(s):tablet
Route(s) Of Administrator:oral
Daily Dose:
Chemical Structure: 
SMILE Code:
COCCOC1=C(C=C2C(=C1)C(=NC=N2)NC3=CC=CC(=C3)C#C)OCCOC
COCCOC1=C(C=C2C(=C1)C(=NC=N2)NC3=CC=CC(=C3)C#C)OCCOC
Reference
COHORT STUDY:
N/AOTHER REFERENCE(S):
1: A phase I study of high-dose rosuvastatin with standard dose erlotinib in patients with advanced solid malignancies.
[Goss Glenwood D,Jonker Derek J,Laurie Scott A,Weberpals Johanne I,Oza Amit M,Spaans Johanna N,la Porte Charles,Dimitroulakos Jim]J Transl Med.2016 Mar 31;14:83. doi: 10.1186/s12967-016-0836-6. PMID: 27036206
2: Erlotinib-related rhabdomyolysis: the role of pharmacogenetics and drug-drug interaction.
[Koršić Marta,Muršić Davorka,Badovinac Sonja,Božina Nada,Roglić Mihovil,Jakopović Marko,Čučević Branka]Cancer Chemother Pharmacol.2015 Dec;76(6):1317-9. doi: 10.1007/s00280-015-2885-6. Epub 2015 Oct 20. PMID: 26482820
3: Rhabdomyolysis from erlotinib: a case report.
[Moscetti Luca,Nelli Fabrizio,Ruggeri Enzo Maria]Tumori.2011 May-Jun;97(3):415-6. doi: 10.1700/912.10044. PMID: 21789026
4: Rhabdomyolysis resulting from pharmacologic interaction between erlotinib and simvastatin.
[Veeraputhiran Muthu,Sundermeyer Mark]Clin Lung Cancer.2008 Jul;9(4):232-4. doi: 10.3816/CLC.2008.n.036. PMID: 18650173
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