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Plenaxis Side Effects

Generic Name: abarelix

Note: This page contains side effects data for the generic drug abarelix. It is possible that some of the dosage forms included below may not apply to the brand name Plenaxis.

It is possible that some side effects of Plenaxis may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to abarelix: powder for suspension, solution

As well as its needed effects, abarelix (the active ingredient contained in Plenaxis) may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking abarelix, check with your doctor immediately:

Less common
  • Fainting or loss of consciousness
  • fast or irregular breathing
  • itching
  • skin rash
  • swelling of the eyes or eyelids
  • tightness in the chest and/or wheezing
  • trouble with breathing

Some abarelix side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Back pain
  • bladder pain
  • breast enlargement
  • breast pain
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • bloody or cloudy urine
  • body aches or pain
  • burning while urinating
  • chills
  • cough
  • decrease in frequency of urination
  • decrease in urine volume
  • diarrhea
  • difficult, burning, or painful urination
  • difficulty having a bowel movement (stool)
  • difficulty in passing urine (dribbling)
  • dizziness
  • ear congestion
  • feeling of warmth
  • fever
  • frequent urge to urinate
  • headache
  • loss of voice
  • lower back or side pain
  • nasal congestion
  • nausea
  • nipple enlargement
  • pain
  • rapid weight gain
  • redness of the face, neck, arms, and occasionally, upper chest
  • runny nose
  • sneezing
  • sore throat
  • sweating
  • tingling of the hands or feet
  • trouble in holding or releasing urine
  • trouble with sleeping
  • unusual tiredness or weakness
  • unusual weight gain or loss

For Healthcare Professionals

Applies to abarelix: intramuscular powder for injection

Endocrine

Endocrine side effects have included hot flushes (79%), sleep disturbance (44%), breast enlargement (30%), and breast pain/nipple tenderness (20%) as pharmacological consequences of androgen deprivation.[Ref]

General

General side effects including pain (31%) and fatigue (10%) have been reported.[Ref]

Musculoskeletal

Musculoskeletal side effects including back pain (17%) have been reported.[Ref]

Cardiovascular

Physicians should carefully consider whether the risks of abarelix (the active ingredient contained in Plenaxis) outweigh the benefits in patients with baseline QTc values >450 msec and in patients taking class IA or class III antiarrhythmic medications.[Ref]

Cardiovascular side effects including peripheral edema (15%) and prolongation of the QT interval have been reported.[Ref]

Gastrointestinal

Gastrointestinal side effects including constipation (15%), diarrhea (11%), and nausea (10%) have been reported.[Ref]

Nervous system

Nervous system side effects including dizziness (12%) and headache (12%) have been reported.[Ref]

Respiratory

Respiratory side effects including upper respiratory tract infection (12%) have been reported.[Ref]

Genitourinary

Genitourinary side effects including dysuria (10%), micturition frequency (10%), urinary retention (10%), and urinary tract infection (10%) have been reported.[Ref]

Hypersensitivity

Hypersensitivity side effects including immediate-onset allergic reactions (3.7%), sometimes resulting in hypotension and syncope, have been reported to have occurred after administration of abarelix (the active ingredient contained in Plenaxis) [Ref]

The allergic reaction included urticaria, pruritus, hypotension, and syncope.

Immediate-onset reactions have been reported to have occurred following any administration of abarelix, including the initial dose. The cumulative risk for such a reaction increases with the duration of treatment.

Following each injection of abarelix, patients should be observed for at least 30 minutes in the office. If an allergic reaction associated with hypotension and/or syncope does occur, supportive measures such as leg elevation, oxygen, IV fluids, antihistamines, corticosteroids, and epinephrine should be administered as needed.[Ref]

Hepatic

Hepatic side effects including clinically meaningful increases in serum transaminases have been reported in a small percentage of patients.[Ref]

Hematologic

Hematologic side effects including slight decreases in hemoglobin and mean increases in serum triglycerides of approximately 10% have been reported.[Ref]

References

1. "Product Information. Plenaxis (abarelix)." Praecis Pharmaceuticals Inc, Waltham, MA.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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