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Drug Notebook

Generic Name: abarelix

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Plenaxis
A Hormone Antagonist - treats Prostate Cancer
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FDA Alerts

    Restricted Distribution Program
  • May be prescribed only by clinicians who have enrolled in the Plenaxis® PLUS program. (See General under Dosage and Administration.)

    Patient Selection
  • Use only in patients who have met specific pretreatment criteria. (See Prostate Cancer under Uses.)
    Tolerance
  • Overall effectiveness decreases with continued use in some patients. (See Tolerance under Cautions.) Efficacy beyond 12 months not established.
  • To monitor treatment response or failure, measure serum testosterone concentration just prior to administration on day 29 and every 8 weeks thereafter. (See Laboratory Monitoring under Cautions.)
    Hypersensitivity Reactions
  • Risk of immediate-onset systemic allergic reactions (e.g., urticaria, pruritus, hypotension, syncope) within minutes after any dose, including the first dose. Cumulative risk increases with duration of treatment.
  • Observe patients for at least 30 minutes after each dose; if an allergic reaction occurs, institute appropriate therapy. (See Hypersensitivity Reactions under Cautions.)

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What is the most important information I should know about abarelix?

In some cases, the use of abarelix has resulted in serious allergic reactions. An allergic reaction may occur after any injection of the medication, including, but not limited to the first dose. Patients should be observed in the doctor's office for at least 30 minutes following each dose so that immediate treatment of an allergic reaction can be obtained if needed.

Treatment with abarelix may become less effective over time in some patients. Monitoring blood levels of testosterone will be done on a regular basis with blood tests to monitor the effectiveness of the medication.

Abarelix is not intended for use by women. Abarelix is in the FDA pregnancy category X. This means that abarelix will cause birth defects in an unborn baby. Do not use this medication if you are pregnant or if you could become pregnant during treatment.

What is abarelix?

Abarelix reduces the amount of testosterone produced in the body.

Abarelix is used in the palliative treatment of advanced prostate cancer.

Abarelix may also be used for purposes other than those listed in this medication guide.

What should I discuss with my healthcare provider before using abarelix?

Before using abarelix, tell your doctor if you

You may not be able to use abarelix, or you may require a dosage adjustment or special monitoring during treatment.

Abarelix is not intended for use by women. Abarelix is in the FDA pregnancy category X. This means that abarelix will cause birth defects in an unborn baby. Do not use this medication if you are pregnant or if you could become pregnant during treatment. Abarelix is not intended for use by women. It is not known whether abarelix passes into breast milk. Do not use this medication without first talking to your doctor if you are breast-feeding a baby.
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