Erlotinib

ERLOTINIB (ADCO-ERLOTINIB®) — CLINICIAN SUMMARY

(Source: SAHPRA-approved Patient Information Leaflet)

🔴 RED FLAG (IMPORTANT) INFORMATION

(Most critical safety information from the leaflet)

• Severe diarrhoea and dehydration may occur → can be life-threatening if untreated.

• Serious lung problems (interstitial lung disease–like reactions) have been reported → new or worsening shortness of breath, cough, or fever requires immediate discontinuation and urgent assessment.

• Severe skin reactions (rash, blistering, peeling) may occur and can require treatment interruption or discontinuation.

• Liver toxicity has been reported → severe liver failure and deaths have occurred.

• Gastrointestinal perforation has been reported (rare but serious).

• Eye disorders including corneal ulceration may occur → urgent ophthalmology review required if eye pain or visual changes develop.

• Smoking reduces erlotinib levels and effectiveness.

• Not safe in pregnancy or breastfeeding.

1. BASIC INFORMATION

• Generic name: Erlotinib

• Brand name: Adco-Erlotinib®

• Drug class: Tyrosine kinase inhibitor

• Formulation: Film-coated tablets

• Strengths: 25 mg, 100 mg, 150 mg

• Route: Oral

• Scheduling status: S4

2. INDICATIONS

Adco-Erlotinib® is used to treat lung cancer:

• Non-small cell lung cancer (NSCLC):

  • After failure of at least one prior chemotherapy regimen

3. DOSING & ADMINISTRATION

• Recommended dose:

  • 150 mg once daily

• Administration instructions:

  • Take at least 1 hour before or 2 hours after food

  • Swallow tablets whole with water

• Missed dose:

  • Do not take an extra dose

  • Take next dose at the usual time

4. DOSE MODIFICATIONS

• Dose interruption or reduction may be required for:

  • Severe diarrhoea

  • Severe skin reactions

  • Liver toxicity

  • Lung toxicity

• Permanent discontinuation required if serious lung disease is confirmed

5. CO-MEDICATIONS

Avoid / Use with caution

• Smoking (reduces drug levels)

• Medicines that alter stomach acid (may reduce absorption)

• Anticoagulants (increased bleeding risk)

• CYP3A4-interacting medicines

Patients must inform clinicians of all medicines, including OTC and traditional remedies.

6. CONTRAINDICATIONS

• Hypersensitivity to erlotinib or excipients

• Pregnancy

• Breastfeeding

7. MONITORING REQUIREMENTS

Clinical

• Diarrhoea severity and hydration status

• Skin toxicity (rash, blistering, peeling)

• Respiratory symptoms (cough, dyspnoea, fever)

• Eye symptoms (pain, redness, visual disturbance)

• Bleeding symptoms

Laboratory

• Liver function tests, especially in patients with pre-existing liver disease

8. SIDE EFFECTS

Very common

• Rash

• Diarrhoea

• Loss of appetite

• Fatigue

Common

• Nausea and vomiting

• Mouth inflammation

• Dry skin

• Itching

• Hair changes

• Nosebleeds

Serious

• Interstitial lung disease-like reactions

• Severe liver injury

• Gastrointestinal perforation

• Severe skin reactions

• Eye ulceration

9. DRUG INTERACTIONS

• Smoking decreases erlotinib exposure

• Acid-reducing agents may reduce absorption

• Increased bleeding risk with anticoagulants

• CYP3A4 inhibitors or inducers may alter levels

10. USE IN SPECIAL POPULATIONS

• Pregnancy: Contraindicated

• Breastfeeding: Contraindicated

• Hepatic impairment: Increased risk of toxicity

• Renal impairment: Use with caution

• Children: Not recommended

11. DURATION OF USE / WHEN TO STOP

• Continue treatment until disease progression or unacceptable toxicity

• Stop immediately if:

  • Severe lung toxicity occurs

  • Life-threatening adverse reactions develop

12. TOXICITY MANAGEMENT (SIMPLIFIED – FROM PIL)

Diarrhoea

• Start antidiarrhoeal treatment early

• Maintain hydration

• Interrupt treatment if severe

Skin reactions

• Supportive skin care

• Dose interruption or discontinuation if severe

Respiratory symptoms

• Immediate discontinuation

• Urgent medical assessment

https://pi-pil-repository.sahpra.org.za/wp-content/uploads/2022/08/Final_PIL_Adco-Erlotinib_Applicant.pdf