Plenaxis

(Generic versions may still be available.)

DRUG DESCRIPTION

Abarelix for injectable suspension (Plenaxis™ ) is a synthetic decapeptide with potent antagonistic activity against naturally occurring gonadotropin releasing-hormone (GnRH). Plenaxis™ inhibits gonadotropin and related androgen production by directly and competitively blocking GnRH receptors in the pituitary.

Abarelix is chemically described as acetyl-D-?-naphthylalanyl-D-4-chlorophenylalanyl- D-3-pyridylalanyl-L-seryl-L-N-methyl-tyrosyl-D-asparagyl-L-leucyl-L-N(?)-isopropyllysyl- L-prolyl-D-alanyl-amide. It is initially manufactured as an acetate water complex and converted to a carboxymethylcellulose (CMC) water complex in manufacturing the drug product. The molecular weight for abarelix anhydrous free base is 1416.06.

The structural formula for abarelix peptide is:

Plenaxis™  (abarelix) Structural Formula Illustration

Abarelix for injectable suspension is supplied as a white to off-white sterile dry powder which, when mixed with the diluent, 0.9% Sodium Chloride Injection, USP, becomes a depot suspension intended for intramuscular (IM) injection. The single-dose vial contains 113 mg of anhydrous free base abarelix peptide (net) supplied in an abarelix CMC complex. This complex also contains 19.1 to 31 mg of CMC. After the vial is reconstituted with 2.2 mL of 0.9% sodium chloride injection, 2 mL is administered to deliver a dose of 100 mg of abarelix (net) as the abarelix CMC complex at a pH of 5±1.

What are the possible side effects of abarelix (Plenaxis)?

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.

Other, less serious side effects may be more likely to occur. Talk to your doctor if you experience

  • hot flashes;
  • sleep disturbances;
  • breast...

Read All Potential Side Effects and See Pictures of Plenaxis »


Plenaxis Patient Information Including Side Effects

Brand Names: Plenaxis

Generic Name: abarelix (Pronunciation: a BAR eh lix)

  • What is abarelix (Plenaxis)?
  • What are the possible side effects of abarelix (Plenaxis)?
  • What is the most important information I should know about abarelix (Plenaxis)?
  • What should I discuss with my healthcare provider before using abarelix (Plenaxis)?
  • How should I use abarelix (Plenaxis)?
  • What happens if I miss a dose (Plenaxis)?
  • What happens if I overdose (Plenaxis)?
  • What should I avoid while using abarelix (Plenaxis)?
  • What other drugs will affect abarelix (Plenaxis)?
  • Where can I get more information?

What is abarelix (Plenaxis)?

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 are the possible side effects of abarelix (Plenaxis)?

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.

Other, less serious side effects may be more likely to occur. Talk to your doctor if you experience

  • hot flashes;
  • sleep disturbances;
  • breast enlargement or pain;
  • diarrhea or constipation;
  • swelling;
  • nausea;
  • dizziness;
  • headache;
  • fatigue; or
  • changes with or difficulty urinating.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

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

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.

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