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ERLOTINIB HYDROCHLORIDE tablet, film coated


  1. Patient Information
  2. Diarrhea:
  3. Interstitial Lung Disease:
  4. Renal Failure:
  5. Hepatotoxicity:
  6. Gastrointestinal Perforations:
  7. Cerebrovascular Accident:
  8. Ocular Disorders:
  9. Hemorrhage In Patients Taking Warfarin:
  10. Hair And Nail Disorders:
  11. Embryo-fetal Toxicity:
  12. Lactation:
  13. Smoking:

Patient Information 

Skin Rash, Bullous and Exfoliative Skin Disorders

Advise patients that skin reactions can occur or worsen on sun-exposed areas while taking erlotinib tablets, and proactive intervention may include alcohol-free emollient cream and use of sunscreen or avoidance of sun exposure. Advise patients that hyperpigmentation or dry skin, with or without digital skin fissures, have been reported and in the majority of cases were associated with rash[seeAdverse Reactions (6.1)].
Advise patients that erlotinib tablets can increase the risk of bullous and exfoliative skin disorders and to seek immediate medical attention for severe skin reactions[seeWarnings and Precautions (5.5)].

Diarrhea: 

Advise patients that diarrhea can usually be managed with loperamide and to contact their healthcare provider for severe or persistent diarrhea[seeAdverse Reactions (6.1)].

Interstitial Lung Disease: 

Advise patients of the risk of severe or fatal ILD, including pneumonitis. Advise patients to contact their healthcare provider immediately to report new or worsening unexplained shortness of breath or coughing[seeDosage and Administration (2.4)andWarnings and Precautions (5.1)].

Renal Failure: 

Advise patients of the risk of developing renal failure. Inform patients of the need for the healthcare provider to monitor kidney function and electrolytes[seeWarnings and Precautions (5.2)].

Hepatotoxicity: 

Advise patients to immediately report signs or symptoms of hepatotoxicity[seeWarnings and Precautions (5.3)].

Gastrointestinal Perforations: 

Advise patients that erlotinib tablets can increase the risk of gastrointestinal perforation or fistula and to seek immediate medical attention for severe abdominal pain[seeDosage and Administration (2.4)andWarnings and Precautions (5.4)].

Cerebrovascular Accident: 

Advise patients of the risk of cerebrovascular accident and see immediate medical attention[seeDosage and Administration (2.4)andWarnings and Precautions (5.6)].

Ocular Disorders: 

Advise patients promptly to contact their healthcare provider if they develop eye signs or symptoms, lacrimation, light sensitivity, blurred vision, eye pain, red eye, or changes in vision[seeDosage and Administration (2.4)andWarnings and Precautions (5.8)].

Hemorrhage In Patients Taking Warfarin: 

Advise patients who are receiving warfarin of the need to monitor INR or other coumarin-derivative anticoagulants[seeWarnings and Precautions (5.9)andDrug Interactions (7)].

Hair And Nail Disorders: 

Advise patients that hair and nail disorders, including hirsutism and brittle and loose nails, have been reported[seeAdverse Reactions (6.1)].

Embryo-fetal Toxicity: 

Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy[seeWarnings and Precautions (5.10),Use in Specific Populations (8.1)].
Advise females of reproductive potential to use effective contraception during treatment with erlotinib tablets, and for 1 month after the last dose[seeUse in Specific Populations (8.3)].

Lactation: 

Advise women not to breastfeed during treatment with erlotinib tablets and for 2 weeks after the final dose[seeUse in Specific Populations (8.2)].

Smoking: 

Advise patients to contact their health care provider for any changes in smoking status and that the dose of erlotinib tablets may need to be adjusted if they smoke[seeDrug Interactions (7)andClinical Pharmacology (12.3)].
Advise patients to stop smoking[seeClinical Pharmacology (12.3)].

For further information please call Mylan at 1-877-446-3679 (1-877-4-INFO-RX).

The brands listed are trademarks of their respective owners.

Mylan Pharmaceuticals Inc.
Morgantown, WV 26505 U.S.A.

Revised: 1/2019
ERLO:R7



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