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.
Afinitor Disperz (Everolimus)
Prescription Required
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Product Details
Description
Afinitor Disperz, or Everolimus, is an mTOR inhibitor that targets specific proteins within cells. It works by interfering with cell growth, particularly of cells that have mutated or proliferated abnormally. Healthcare providers may prescribe this medication to manage seizures associated with tuberous sclerosis complex (TSC) in both adults and children aged two years and above. Additionally, Afinitor Disperz is used in the treatment of various cancers.
Fact Table
Formula
C53H83NO14
License
US FDA (2012, for Afinitor Disperz)
Bioavailability
~30% (oral)
Legal status
Prescription only (?)
Chemical Name
(1R,9S,12S,15R,16E,18R,19R,21R,23S,24E,26R,28R)-1,18-Dihydroxy-12-[(1S)-2-[(1R)-1-hydroxyethyl]-1-methylethyl]-19,30-dimethoxy-15,17,21,23,29-pentamethyl-11,14-dioxa-4-azatricyclo[23.3.1.0^4,9]octacosa-4(9),5,7,24,26-pentaene-2,3,10,20-tetrone
Elimination half-life
30 hours
Dosage (Strength)
2 mg, 3 mg, 5 mg, and 7 mg tablets for oral suspension
Pregnancy
Not recommended (Category D)
Brands
Afinitor, Afinitor Disperz
Protein binding
~74%
PubChem CID
6442177
MedlinePlus
a609005
ChEBI
CHEBI:7845
ATC code
L01XE10
DrugBank
DB01590
KEGG
D04193
Routes of administration
Oral
Directions
The standard Afinitor Disperz dosage varies depending on the condition being treated. The usual dosage for breast cancer and neuroendocrine tumors of pancreatic origin, for example, is 10 mg once daily. It should only be used as directed by a healthcare provider. Patients should take Afinitor Disperz as an oral suspension; the tablets must not be chewed, crushed, or swallowed whole. Instead, they should be dispersed in water and taken by mouth.
Ingredients
Afinitor Disperz contains the active ingredient Everolimus. It also contains several inactive ingredients that help stabilize and promote the absorption of the drug.
Contraindications
This medication should be avoided if you have a known or suspected hypersensitivity to Everolimus, rapamycin derivatives, or any ingredients in the drug.
Cautions
- Talk to a healthcare provider about the following before taking Afinitor Disperz for the first time:
- If you take other medications
- Whether you have other medical conditions
- If you have allergies
- Whether you’re pregnant or breastfeeding
- Be alert for signs of lung issues, such as difficulty breathing or a persistent cough. Depending on the severity, it may be necessary to adjust or stop the medication.
- Afinitor Disperz can increase your susceptibility to infections. Monitor closely for any signs of infection, and consult your doctor if any arise. Treatment adjustments may be required based on infection severity.
- If you experience a significant allergic reaction, discontinue Afinitor Disperz immediately.
- Those taking ACE inhibitors should be aware of the heightened risk of angioedema (swelling). Discontinue the medication if this occurs.
- Using a dexamethasone alcohol-free mouthwash from the start of treatment may help prevent stomatitis.
- Kidney function should be checked before starting and throughout the treatment with Afinitor Disperz.
- Withhold the medication for at least a week before elective surgery and do not resume until at least two weeks post-surgery and after adequate wound healing.
- Older patients may need dose adjustments due to potential adverse reactions.
- Keep an eye on your blood sugar and cholesterol levels before and during treatment, as adjustments may be needed.
- Regular monitoring of your blood cell counts is important, as treatment may need to be modified based on these results.
- Avoid live vaccines and close contact with those who have received live vaccines. Ensure all vaccinations are up to date before starting treatment.
- If you're undergoing radiation therapy, be aware that Afinitor Disperz can intensify reactions to radiation.
- Afinitor Disperz can be harmful to an unborn baby. Effective contraception should be used by patients of reproductive potential.
Side Effects
Commonly reported side effects of Afinitor Disperz include infections, rash, weakness or tiredness, diarrhea, swelling of various body parts, abdominal pain, nausea, fever, cough, headache, and decreased appetite.
Serious side effects include problems with wound healing, increased blood sugar and fat levels, and decreased blood cell counts. Patients should inform their healthcare provider about any planned surgeries and discuss any concerns regarding fertility. Regular blood tests for monitoring blood sugar, cholesterol, and blood cell counts are recommended. Patients should seek immediate medical attention for severe symptoms or side effects.
References:
- Afinitor Disperz (Everolimus) Product Monograph. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2022.
- Afinitor Disperz (Everolimus) Drug Label Information. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2023.
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 : 14546
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