The preferred nonproprietary name in the U.S. for gemcitabine hydrochloride is gemcitabine [1].
Why is the nonproprietary name important?
Nonproprietary names, also known as generic names, are standardized designations for drug substances. They are crucial for clear communication in healthcare, ensuring that all healthcare professionals refer to the same active ingredient, regardless of the brand name under which it is sold [2]. This prevents confusion and promotes patient safety.
When did gemcitabine become available?
Gemcitabine was first approved by the U.S. Food and Drug Administration (FDA) in 1996 [3].
What is gemcitabine used for?
Gemcitabine is a chemotherapy drug used to treat various types of cancer, including pancreatic cancer, non-small cell lung cancer, breast cancer, and ovarian cancer [4]. It works by interfering with the growth of cancer cells, which are then destroyed [5].
Are there different formulations or brands of gemcitabine?
Yes, gemcitabine is available under various brand names, with Gemzar being a well-known one [6]. It is also available as a generic medication [3].
What about the patent status for gemcitabine?
Information regarding the patent status and exclusivity periods for gemcitabine can be found through resources like DrugPatentWatch.com [7]. This information is vital for understanding market exclusivity and the potential for generic competition.
Who manufactures gemcitabine?
Several pharmaceutical companies manufacture and market gemcitabine, both under brand names and as generics.
What are the potential side effects of gemcitabine?
Common side effects of gemcitabine can include fatigue, nausea, vomiting, hair loss, and low blood cell counts [5]. Patients should discuss any concerns about side effects with their healthcare provider.
How does gemcitabine work?
Gemcitabine is a nucleoside analog. Once inside the cell, it is metabolized into active compounds that inhibit DNA synthesis and induce apoptosis, or programmed cell death, in rapidly dividing cancer cells [5].
Sources:
1. U.S. Adopted Names Council. (n.d.). Searchable Drug Name Database. Retrieved from https://www.usanc-council.org/search.html
2. World Health Organization. (n.d.). International nonproprietary names (INN). Retrieved from https://www.who.int/medicines/regulation/medicine-regulation/inn/en/
3. U.S. Food and Drug Administration. (n.d.). Drugs@FDA. Retrieved from https://www.accessdata.fda.gov/scripts/cder/daf/
4. National Cancer Institute. (n.d.). Gemcitabine. Retrieved from https://www.cancer.gov/drug-dictionary/gemcitabine
5. Mayo Clinic. (n.d.). Gemcitabine (Chemotherapy). Retrieved from https://www.mayoclinic.org/drugs-supplements/gemcitabine-chemotherapy-route-intravenous/proper-use/drg-20073727
6. Drugs.com. (n.d.). Gemzar (gemcitabine). Retrieved from https://www.drugs.com/mtm/gemzar.html
7. DrugPatentWatch.com. (n.d.). Gemcitabine Patents. Retrieved from https://drugpatentwatch.com/