Neratinib
Breast Neoplasms
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Drug Status
Government Approvals
US(FDA)
WHO Essential Medicine
NO
Known Teratogen
No
Pharmaceutical Class
Kinase Inhibitor
Controlled Drug Substance
No
Neratinib
Summary
Neratinib is used to treat early-stage and advanced HER2-positive breast cancer. It's often used after other treatments like trastuzumab to improve patient outcomes.
Neratinib works by blocking the action of proteins involved in the growth and spread of cancer cells. By inhibiting these proteins, it helps slow or stop the progression of HER2-positive breast cancer.
For adults, the usual daily dose of Neratinib is 240 mg taken orally once daily with food. This dosage is consistent for both early-stage and advanced breast cancer treatments. It's not recommended for children as its safety and efficacy haven't been established in pediatric patients.
Common side effects of Neratinib include diarrhea, nausea, abdominal pain, and vomiting. Fatigue and weight loss are also reported. Serious adverse effects include severe diarrhea, hepatotoxicity, and embryofetal toxicity.
Neratinib can cause fetal harm and is not recommended during pregnancy. Women of reproductive potential should use effective contraception during treatment. It's also advised not to breastfeed while taking Neratinib and for at least one month after the last dose.
Indications and Purpose
How does Neratinib work?
Neratinib is a kinase inhibitor that blocks the action of proteins involved in the growth and spread of cancer cells. By inhibiting these proteins, it helps slow or stop the progression of HER2-positive breast cancer.
Is Neratinib effective?
Neratinib has been shown to be effective in clinical trials. In the ExteNET trial, it significantly improved invasive disease-free survival in patients with early-stage HER2-positive breast cancer. In the NALA trial, it demonstrated improved progression-free survival in patients with advanced or metastatic HER2-positive breast cancer.
What is Neratinib?
Neratinib is used to treat early-stage and advanced HER2-positive breast cancer. It works by inhibiting kinase proteins that promote cancer cell growth, thereby slowing or stopping the spread of cancer cells. It is often used after other treatments, like trastuzumab, to improve patient outcomes.
Directions for Use
For how long do I take Neratinib?
Neratinib is typically used for one year when treating early-stage breast cancer. For advanced or metastatic breast cancer, it is used in cycles until the disease progresses or unacceptable side effects occur.
How do I take Neratinib?
Take Neratinib with food, at the same time each day. Avoid grapefruit and grapefruit juice, as they can interact with the medication. Follow your doctor's instructions carefully and do not alter the dosage without consulting them.
How should I store Neratinib?
Store Neratinib at room temperature, between 68°F to 77°F (20°C to 25°C). Keep it in its original container, tightly closed, and out of reach of children. Avoid storing it in the bathroom to prevent exposure to moisture.
What is the usual dose of Neratinib?
For adults, the usual daily dose of Neratinib is 240 mg, taken orally once daily with food. This dosage is consistent for both early-stage and advanced breast cancer treatments. There is no established dosage for children as the safety and efficacy of Neratinib in pediatric patients have not been established.
Warnings and Precautions
Can I take Neratinib with other prescription drugs?
Neratinib interacts with gastric acid-reducing agents, CYP3A4 inhibitors, and inducers. Avoid using proton pump inhibitors and separate dosing with H2-receptor antagonists and antacids. Strong CYP3A4 inhibitors can increase Neratinib toxicity, while inducers can reduce its effectiveness.
Can Neratinib be taken safely while breastfeeding?
Women are advised not to breastfeed while taking Neratinib and for at least one month after the last dose due to the potential for serious adverse reactions in breastfed infants.
Can Neratinib be taken safely while pregnant?
Neratinib can cause fetal harm and is not recommended during pregnancy. Women of reproductive potential should use effective contraception during treatment and for at least one month after the last dose. If pregnancy occurs, contact a healthcare provider immediately.
Is Neratinib safe for the elderly?
In clinical trials, elderly patients (65 years and older) experienced a higher frequency of treatment discontinuations due to adverse reactions compared to younger patients. It is important for elderly patients to be closely monitored for side effects, and dosage adjustments may be necessary based on individual tolerability.
Who should avoid taking Neratinib?
Neratinib can cause severe diarrhea, hepatotoxicity, and embryo-fetal toxicity. Patients should be monitored for these conditions, and appropriate measures should be taken to manage them. It is contraindicated in pregnant women due to potential harm to the fetus.
