Pricing
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All price changes →Indications & Uses
Signera is a kinase inhibitor indicated: As a single agent, for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer, to follow adjuvant Trastuzumab based therapy. In combination with Capecitabine, 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.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Premedication for diarrhea: When not using dose escalation, initiate loperamide with the first dose of Neratinib and continue during the first 56 days of treatment. After day 56, use loperamide to maintain 1–2 bowel movements per day.Extended adjuvant treatment of early-stage breast cancer: 240 mg (6 tablets) given orally once daily, with food, continuously until disease recurrence for up to one year.Advanced or metastatic breast cancer: 240 mg (6 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 Neratinib may also be initiated.Hepatic impairment: Reduce starting dose to 80 mg in patients with severe hepatic impairment.Dose Modifications- Recommended starting dose: 240 mg daily First dose reduction: 200 mg daily Second dose reduction: 160 mg daily Third dose reduction: 120 mg daily
Side Effects
The most common adverse reactions (reported in ≥5% of patients) were: Signera as a single agent: diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increased, nail disorder, dry skin, abdominal distention, epistaxis, weight decreased, and urinary tract infection. Signera in combination with capecitabine: diarrhea, nausea, vomiting, decreased appetite, constipation, fatigue/asthenia, weight decreased, dizziness, back pain, arthralgia, urinary tract infection, upper respiratory tract infection, abdominal distention, renal impairment, and muscle spasms.
Cautions & Contraindications
Warnings & Precautions
Diarrhea: Diarrhea should be managed through either Signera dose escalation or loperamide prophylaxis. If diarrhea occurs despite recommended prophylaxis, treat with additional antidiarrheals, fluids, and electrolytes as clinically indicated. Withhold Signera in patients experiencing severe and/or persistent diarrhea. Signera should be Permanently discontinued in patients experiencing Grade 4 diarrhea or Grade ≥2 diarrhea that occurs after maximal dose reduction.Hepatotoxicity: Signera should be Withhold in patients experiencing Grade 3 liver abnormalities and permanently discontinue Signera in patients experiencing Grade 4 liver abnormalities.Embryo-Fetal Toxicity: Signera can cause fetal harm. Should Advise patients of potential risk to a fetus and to use effective contraception
Contraindications
It is contraindicated in patients with known hypersensitivity to Neratinib or any other components of this product.