What is a Generic Drug?
A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.
The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.
Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.
Nerlynx (Neratinib)
Prescription Required
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Product Details
Description
Nerlynx, generically known as neratinib, is an oral medication designed for treating certain cases of HER2-positive breast cancer. It works by irreversibly latching onto and blocking certain receptors on the cancer cells — specifically HER2 and EGFR receptors — which are key for the growth and spread of cancer. It is classified as part of the 4-anilino quinazole class of tyrosine kinase inhibitors and given as an oral tablet.
Fact Table
Formula
C30H29ClN6O3
License
US FDA, EMA
Bioavailability
19% (oral)
Legal status
Prescription only (?)
Chemical Name
6,7-Dihydro-8-[4-[(3-chloro-4-pyridyl)amino]quinazolin-6-yloxy]-7-[2-(tetrahydrofuran-3-yloxy)ethyl]-2H-pyrrolo[3,4-b]pyridin-5-one
Elimination half-life
7-17 hours
Dosage (Strength)
40 mg tablets
Pregnancy
Contraindicated
Brands
Nerlynx
Protein binding
99.5%
PubChem CID
9915747
MedlinePlus
a617020
ChEBI
CHEBI:134552
ATC code
L01EH03
DrugBank
DB11828
KEGG
D09640
Routes of administration
Oral
Directions
Nerlynx tablets are taken orally with the recommended dose being one 240 mg tablet once daily, with food, to minimize potential stomach issues. Patients should typically continue treatment for one year. The treatment begins after the completion of trastuzumab-based therapy for early-stage HER2-positive breast cancer. In cases where Nerlynx is used in combination with capecitabine for advanced or metastatic breast cancer, a healthcare provider will offer specific guidance on dosage adjustments.
It's important to swallow the tablets whole without crushing or splitting them. If you miss a dose, take it as soon as you remember unless it’s within 12 hours of the next dose. If that's the case, skip the missed dose and resume your normal schedule. Do not take two doses at the same time to make up for the missed one.
Ingredients
The active ingredient in Nerlynx is neratinib.
Contraindications
There are no specific contraindications stated on the drug label. However, avoid taking this medication if you have a known hypersensitivity to Nerlynx or any of its ingredients.
Cautions
- Before starting treatment with Nerlynx, be sure to inform your healthcare provider about the following:
- Any medical conditions you currently have
- Any allergies
- All medications you are currently taking
- Whether you are pregnant or breastfeeding
- Diarrhea is a common side effect, occurring in up to 95% of patients. It's usually most severe during the first month of treatment. To manage this, start anti-diarrheal medication like loperamide with your first dose of Nerlynx, and continue for the first 56 days. If diarrhea persists, your doctor may adjust your treatment or recommend additional medications. If you experience severe diarrhea, treatment may need to be paused and rehydration measures taken.
- Nerlynx can affect your liver, shown by changes in liver enzymes. Up to 10% of patients may see significant liver enzyme increases. Before starting Nerlynx and during treatment, you'll need regular blood tests to monitor your liver function. If liver enzymes rise significantly, treatment adjustments or discontinuation may be necessary.
- Nerlynx can harm an unborn baby. If you're pregnant or might become pregnant, use effective contraception during treatment and for one month after your last dose. If you become pregnant while taking Nerlynx, inform your doctor immediately.
Side Effects
The most common Nerlynx side effects include diarrhea, nausea, stomach pain, and tiredness. Patients might also experience vomiting, rash, mouth sores, decreased appetite, and muscle spasms. Some people could notice changes in their nail color, dry skin, stomach swelling, nosebleeds, weight loss, and urinary tract infections.
Nerlynx may lead to severe liver problems, indicated by changes in liver function tests. Before starting and during treatment, regular blood tests are key to monitor liver health. Symptoms of liver issues may include unusual tiredness, nausea, vomiting, pain in the upper right stomach area, fever, rash, itching, or yellowing of the skin or eyes. Treatment may be paused or stopped if severe liver problems are detected.
References
- Nerlynx (Neratinib) Product Monograph. Los Angeles, CA: Puma Biotechnology, Inc.; 2021.
- Nerlynx (Neratinib) Drug Label Information. Los Angeles, CA: Puma Biotechnology, Inc.; 2024.
IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.Product Code : 14601
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