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Darbepoetin alfa / d ɑːr b ə ˈ p oʊ ɪ t ɪ n / is a re-engineered form of erythropoietin containing 5 amino acid changes (N30, T32, V87, N88, T90) resulting in the creation of 2 new sites for N-linked carbohydrate addition. It has a 3-fold longer serum half-life compared to epoetin alpha and epoetin beta.
Darbepoetin alfa, which early literature during its development often termed as novel erythropoiesis-stimulating protein (NESP), is a form created by five substitutions (Asn-30, Thr-32, Val-87, Asn-88 and Thr-90) that create two new N-glycosylation sites. [24]
The Prescribing Information follows one of two formats: "physician labeling rule" format or "old" (non-PLR) format. For "old" format labeling a "product title" may be listed first and may include the proprietary name (if any), the nonproprietary name, dosage form(s), and other information about the product. The other sections are as follows:
Dosage typically includes information on the number of doses, intervals between administrations, and the overall treatment period. [3] For example, a dosage might be described as "200 mg twice daily for two weeks," where 200 mg represents the individual dose, twice daily indicates the frequency, and two weeks specifies the duration of treatment.
Dosage and Administration: Guidelines on how to properly administer the drug, including dosage amounts and frequency. Contraindications: Situations where the drug should not be used. Warnings and precautions: Important safety information and potential risks associated with the drug. Adverse reactions: Common and serious side effects that may occur.
Amgen advised the U.S. Food and Drug Administration (FDA) regarding the results of the DAHANCA 10 clinical trial. The DAHANCA 10 data monitoring committee found that three-year loco-regional cancer control in subjects treated with Aranesp was significantly worse than for those not receiving Aranesp (p=0.01). [20]
This generally takes the form of subcutaneous injection, e.g. with insulin. Skin popping is a slang term that includes subcutaneous injection, and is usually used in association with recreational drugs. In addition to injection, it is also possible to slowly infuse fluids subcutaneously in the form of hypodermoclysis.
Modified-release dosage is a mechanism that (in contrast to immediate-release dosage) delivers a drug with a delay after its administration (delayed-release dosage) or for a prolonged period of time (extended-release [ER, XR, XL] dosage) or to a specific target in the body (targeted-release dosage). [1] Sustained-release dosage forms are dosage ...