Orserdu (Elacestrant)

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.

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  • Product Details

    Description

    Orserdu (Elacestrant) is an estrogen receptor antagonist used to treat advanced or metastatic breast cancer. It works by blocking the effects of estrogen in the body. This drug is classified as a Selective Estrogen Receptor Degrader (SERD). It's approved for postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated breast cancer.

    Directions

    Orserdu should be taken orally as prescribed by a healthcare provider. The typical dosage is 345 mg once daily. It's important to take the medication with food to improve absorption. Swallow the tablet whole; do not crush, chew, or split it. Patients should follow a consistent schedule, taking the tablet at the same time each day to maintain stable drug levels in the body.

    Ingredients

    Elacestrant is the active ingredient in Orserdu.

    Contraindications

    Avoid taking or using this medication if any of the following apply:

    • Hypersensitivity to Elacestrant or any of its ingredients
    • Severe liver impairment
    • Pregnancy or breastfeeding

    Cautions

    • Before beginning treatment with Orserdu, it's important to discuss the following with your healthcare provider:
      • Your current health conditions
      • Any allergies you may have
      • All medications you are currently using
      • Whether you are pregnant or breastfeeding
    • High cholesterol and triglyceride levels have been reported in about 30% and 27% of patients, respectively. Severe cases are rare but possible. Your doctor will check your lipid levels before and during treatment to manage any changes.
    • Orserdu can harm an unborn baby, as shown by studies in animals where it caused developmental problems at doses lower than the human recommended dose. If you are pregnant or might become pregnant, discuss the risks with your doctor. Women of reproductive potential should use effective contraception during treatment and for one week after the final dose. Men with partners of reproductive potential should also use effective contraception during treatment and for one week after the last dose to prevent harm to the unborn baby.

    Side Effects

    Orserdu side effects often include musculoskeletal pain, nausea, and fatigue. Other frequent side effects include vomiting, decreased appetite, diarrhea, and constipation. Some people may also experience abdominal pain, hot flushes, and dyspepsia (indigestion). These side effects are typically manageable but can affect daily activities.

    In rare cases, Orserdu can lead to severe side effects such as serious musculoskeletal pain, severe nausea, and changes in liver function tests, which might require adjusting or stopping the medication. It’s important to monitor for symptoms like severe stomach pain or jaundice (yellowing of the skin or eyes), as these may indicate serious underlying conditions.

    References

    1. Orserdu (Elacestrant) Product Monograph. New York, NY: Stemline Therapeutics, Inc.; 2023.
    2. Orserdu (Elacestrant) Drug Label Information. New York, NY: Stemline Therapeutics, Inc.; 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 : 14956

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