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.
Erleada (Apalutamide)
Prescription Required
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Product Details
Description
Erleada, also known by its generic name Apalutamide, works as an androgen receptor inhibitor. It targets and blocks the action of androgens, which are male hormones that can promote tumor growth in the prostate gland. Classified as a nonsteroidal antiandrogen, Erleada is primarily used in the treatment of certain types of prostate cancer. The drug is effective for patients with metastatic castration-sensitive prostate cancer as well as those with non-metastatic castration-resistant prostate cancer.
Fact Table
Formula
C21H15F4N5O3S
License
US FDA (2018)
Bioavailability
Approximately 100% (oral)
Legal status
Prescription only (?)
Chemical Name
4-[7-(6-Cyano-5,5-dimethylpyrimidin-4-yl)-6-fluoro-3H-[1,2,3]triazolo[4,5-b]pyridin-3-yl]-2-fluoro-N-(trifluoromethyl)benzamide
Elimination half-life
3 days
Dosage (Strength)
60 mg tablets
Pregnancy
Not recommended (Category X)
Brands
Erleada
Protein binding
95%
PubChem CID
71225661
MedlinePlus
a618034
ChEBI
134722
ATC code
L02BB05
DrugBank
DB11901
KEGG
D10805
Routes of administration
Oral
Directions
Erleada comes as an oral tablet, usually prescribed at a dosage of 240 mg taken once per day. It can be taken with or without food, and it's crucial to swallow the tablets whole without chewing, crushing, or opening them. Consistency in timing daily doses helps maintain even levels of the medication in the body, so it’s important that patients take it at the same time each day. Erleada should be taken along with a gonadotropin-releasing hormone (GnRH) analog or after a bilateral orchiectomy.
Ingredients
Erleada contains the active ingredient Apalutamide and contains several inactive elements to form its final tablet composition. In each film-coated tablet, alongside Apalutamide, you may find compounds such as microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, and magnesium stearate.
Contraindications
There are no listed contraindications on the FDA label. However, anyone with a known allergic reaction to Apalutamide or any component of Erleada should not take this medication.
Cautions
- Tell your doctor or healthcare provider about any of the following before taking Erleada:
- Other medical conditions you have
- Other medications being taken
- Whether your partner is pregnant or breastfeeding
- Patients taking Erleada have experienced events related to the brain's blood vessels and heart, like strokes and heart disease. It's crucial to monitor for signs and symptoms of these conditions and manage any cardiovascular risk factors effectively.
- There's an increased likelihood of fractures in those receiving Erleada. Patients should be assessed for their risk of fractures, and those at high risk may need treatment according to established guidelines for bone health.
- Especially in elderly patients, falls have been more common among those taking Erleada. Evaluating patients for any factors that might increase their risk of falling is important.
- Though rare, occurring in about 0.4% of patients, seizures have been reported in those taking Erleada. If a seizure occurs during treatment, Erleada should be discontinued permanently.
- Serious skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have occurred in patients treated with Erleada. If signs or symptoms of these severe cutaneous adverse reactions develop, the medication should be interrupted, and if confirmed, it should be discontinued permanently.
- Erleada can cause harm to a fetus. Men with partners who could become pregnant should use effective contraception to avoid causing harm to the unborn child.
Side Effects
Erleada side effects may include fatigue, weight loss, joint pain, high blood pressure, rash, hot flashes, diarrhea, decreased appetite, fractures, and falls. Erleada can also lead to serious health problems like heart disease, stroke, or mini-stroke. Symptoms to watch for include chest pain, shortness of breath, speech or vision problems, numbness, dizziness, and balance issues.
The medication may also increase the risk of falls, fractures, and seizures. Severe skin reactions, potentially life-threatening, include worsening rashes, fever, swollen lymph nodes, blisters, and peeling skin. Immediate medical attention should be sought for any serious side effects.
References:
- Erleada (Apalutamide) Product Monograph. Horsham, PA: Janssen Pharmaceuticals; 2023.
- Erleada (Apalutamide) Drug Label Information. Horsham, PA: Janssen Pharmaceuticals; 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 : 14542
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