NERLYNX FILM-COATED TABLETS 40 MG

EXCELLA GMBH & CO. KG (GERMANY)🇸🇬 Health Sciences Authority

Approval Date: Nov 25, 2019
Approval ID: 94717924415b9cfa
Company: EXCELLA GMBH & CO. KG (GERMANY)
Type: Therapeutic

Approval Details

Approval Id: 94717924415b9cfa
Drug Name: NERLYNX FILM-COATED TABLETS 40 MG
Product Name: NERLYNX FILM-COATED TABLETS 40 MG
Approval Number: SIN15861P
Approval Date: 2019-11-25
Registrant: SPECIALISED THERAPEUTICS ASIA PTE LTD
Licence Holder: SPECIALISED THERAPEUTICS ASIA PTE LTD
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: TABLET, FILM COATED
Dosage: 2 DOSAGE AND ADMINISTRATION 2.1 Premedication for Diarrhea When not using dose escalation [see Dosage and Administration (2.2)], administer antidiarrheal prophylaxis during the first 56 days of treatment and initiate with the first dose of NERLYNX [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]. Instruct patients to take loperamide as directed in Table 1. Titrate Loperamide to 1–2 bowel movements per day. <img src="/TGIF/Nerlynx-Table1_071222.png" alt="Nerlynx Dosage Table 1" /> If diarrhea occurs despite prophylaxis, treat with additional antidiarrheals, fluids and electrolytes as clinically indicated. NERLYNX dose interruptions and dose reductions may also be required to manage diarrhea [see Dosage and Administration (2.3)]. 2.2 Recommended Dose and Schedule Extended Adjuvant Treatment of Early-Stage Breast Cancer The recommended dose of NERLYNX is 240 mg (six tablets) given orally once daily, with food, continuously until disease recurrence or for up to one year. Treatment with NERLYNX should be initiated within 1 year after completion of trastuzumab therapy. Advanced or Metastatic Breast Cancer The recommended dose of NERLYNX is 240 mg (six tablets) given orally once daily with food on Days 1–21 of a 21-day cycle plus capecitabine (750 mg/m2 given orally twice daily) on Days 1–14 of a 21-day cycle until disease progression or unacceptable toxicities. Dose Escalation A two week dose escalation for NERLYNX may be considered instead of starting at the 240 mg daily dose for patients with early-stage breast cancer and metastatic breast cancer, as described in Table 2 [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]. <img src="/TGIF/Nerlynx-Table2_140922.png" alt="Nerlynx Dosage Table 2" /> If diarrhea occurs, treat with antidiarrheal medications, fluids, and electrolytes as clinically indicated. NERLYNX dose interruptions and dose reductions may also be required to manage diarrhea [see Dosage and Administration (2.3)]. Administration Instructions Instruct patients to take NERLYNX at approximately the same time every day. NERLYNX tablets should be swallowed whole (tablets should not be chewed, crushed, or split prior to swallowing). If a patient misses a dose, do not replace missed dose, and instruct the patient to resume NERLYNX with the next scheduled daily dose. 2.3 Dosage Modifications for Adverse Reactions NERLYNX dose modification is recommended based on individual safety and tolerability. Management of some adverse reactions may require dose interruption and/or dose reduction as shown in Table 3 to Table 6. Discontinue NERLYNX for patients with adverse reactions that fail to recover to Grade 0–1 or baseline, with toxicities that result in a treatment delay > 3 weeks, or if unable to tolerate 120 mg daily. Additional clinical situations may result in dose adjustments as clinically indicated (e.g. intolerable toxicities, persistent Grade 2 adverse reactions, etc.). When NERLYNX is used in combination with capecitabine, refer to the capecitabine prescribing information for dose modifications of capecitabine. <img src="/TGIF/Nerlynx-Table3_140922.png" alt="Nerlynx Dosage Table 3" /> <img src="/TGIF/Nerlynx-Table4_071222.png" alt="Nerlynx Dosage Table 4" /> <img src="/TGIF/Nerlynx-Table5_140922.png" alt="Nerlynx Dosage Table 5" /> <img src="/TGIF/Nerlynx-Table6_140922.png" alt="Nerlynx Dosage Table 6" /> 2.4 Dosage Modifications for Hepatic Impairment No dose modifications are recommended for patients with mild to moderate hepatic impairment (Child Pugh A or B). Treatment of patients with severe hepatic impairment (Child Pugh C) is not recommended [see Use in Specific Populations (8.6) and Clinical Pharmacology (11.3) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]. 2.5 Concomitant Use with Gastric Acid Reducing Agents Proton pump inhibitors (PPI): Avoid concomitant use with NERLYNX [see Drug Interactions (7.1) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]. H2-receptor antagonists: Take NERLYNX at least 2 hours before the next dose of the H2-receptor antagonist or 10 hours after the H2-receptor antagonist [see Drug Interactions (7.1) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]. Antacids: Separate dosing of NERLYNX by 3 hours after antacids [see Drug Interactions (7.1) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].
Route Of Administration: ORAL
Indication Info: 1 INDICATIONS AND USAGE 1.1 Extended Adjuvant Treatment of Early-Stage Breast Cancer NERLYNX as a single agent is indicated for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy [see Clinical Studies (13.1) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information]. 1.2 Advanced or Metastatic Breast Cancer NERLYNX in combination with capecitabine is indicated for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting [see Clinical Studies (13.2) – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information].
Contraindications: 4 CONTRAINDICATIONS Hypersensitivity to the active substance or to any of the excipients contained in NERLYNX.
Atc Code: L01EH02
Atc Item Name: neratinib
Pharma Manufacturer Name: SPECIALISED THERAPEUTICS ASIA PTE. LTD.
Company Detail Path: /organization/specialised-therapeutics-asia-pte-ltd

Active Ingredients

Neratinib Maleate eqv Neratinib

40 mg

Neratinib Maleate eqv Neratinib

40 mg

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Nov 25, 2019

Approval ID

94717924415b9cfa

Type

Therapeutic

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