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ERLOTINIB tablet, film coated


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[see Adverse Reactions (6.1)].
  • Advise patients that erlotinib tablets can increase the risk of bullous and exfoliative skin disorders and to seek immediately medical attention for severe skin reactions[see Warnings 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[see Adverse 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 of worsening unexplained shortness of breath or coughing[see Dosage and Administration (2.4) and Warnings 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[see Warnings and Precautions (5.2)].

Hepatotoxicity

Advise patients to immediately report signs or symptoms of hepatotoxicity[see Warnings 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[see Dosage and Administration (2.4) and Warnings and Precautions (5.4)].

Cerebrovascular accident
Advise patients of the risk of cerebrovascular accident and see immediate medical attention[see Dosage and Administration (2.4) and Warnings 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[see Dosage and Administration (2.4) and Warnings 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[see Warnings and Precautions (5.9) and Drug Interactions (7)].

Hair and nail disorders
Advise patients that hair and nail disorders, including hirsutism and brittle and loose nails, have been reported[see Adverse 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[see Warnings 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[see Use in Specific Populations (8.3)].

    Lactation

  • Advise women not to breastfeed during treatment with erlotinib tablets and for 2 weeks after the final dose[see Use 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[see Drug Interactions (7) and Clinical Pharmacology (12.3)]
  • Advise patients to stop smoking[see Clinical Pharmacology (12.3)].

For further information please call 1-888-838-2872.

Manufactured In Croatia By:
Pliva Hrvatska d.o.o.
Zagreb, Croatia

Manufactured For:
Teva Pharmaceuticals USA, Inc.
North Wales, PA 19454

Rev. A 2/2019



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