Ganirelix: Difference between revisions

Ganirelix
	Adult Indications & Dosage
	Pediatric Indications & Dosage
	Contraindications
	Warnings & Precautions
	Adverse Reactions
	Drug Interactions
	Use in Specific Populations
	Administration & Monitoring
	Overdosage
	Pharmacology
	Clinical Studies
	How Supplied
	Images
	Patient Counseling Information
	Precautions with Alcohol
	Brand Names
	Look-Alike Names

VisualWikitext

Revision as of 15:27, 13 February 2015

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]

Disclaimer

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Overview

Ganirelix is a Endocrine-Metabolic Agent that is FDA approved for the treatment of inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation.. Common adverse reactions include Abdominal Pain (gynecological), Headache, Ovarian Hyperstimulation Syndrome, Vaginal Bleeding.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

Ganirelix Acetate Injection is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation.

Dosage

After initiating FSH therapy on Day 2 or 3 of the cycle, Ganirelix Acetate Injection 250 mcg may be administered subcutaneously once daily during the mid to late portion of the follicular phase. By taking advantage of endogenous pituitary FSH secretion, the requirement for exogenously administered FSH may be reduced. Treatment with Ganirelix Acetate should be continued daily until the day of hCG administration. When a sufficient number of follicles of adequate size are present, as assessed by ultrasound, final maturation of follicles is induced by administering hCG. The administration of hCG should be withheld in cases where the ovaries are abnormally enlarged on the last day of FSH therapy to reduce the chance of developing OHSS (Ovarian Hyperstimulation Syndrome).

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Ganirelix in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Ganirelix in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Ganirelix in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Ganirelix in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Ganirelix in pediatric patients.

Contraindications

Ganirelix Acetate Injection is contraindicated under the following conditions:

Known hypersensitivity to Ganirelix Acetate or to any of its components. Known hypersensitivity to GnRH or any other GnRH analog. Known or suspected pregnancy

Warnings

Description

Precautions

Description

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Ganirelix in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Ganirelix in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

Drug

Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

Pregnancy Category

Pregnancy Category (AUS):

Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Ganirelix in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Ganirelix during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Ganirelix with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Ganirelix with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Ganirelix with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Ganirelix with respect to specific gender populations.

Race

There is no FDA guidance on the use of Ganirelix with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Ganirelix in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Ganirelix in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Ganirelix in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Ganirelix in patients who are immunocompromised.

Administration and Monitoring

Administration

Directions for Using Ganirelix Acetate Injection Ganirelix Acetate Injection is supplied in a sterile, prefilled syringe and is intended for SUBCUTANEOUS administration only. Wash hands thoroughly with soap and water. The most convenient sites for SUBCUTANEOUS injection are in the abdomen around the navel or upper thigh. The injection site should be swabbed with a disinfectant to remove any surface bacteria. Clean about two inches around the point where the needle will be inserted and let the disinfectant dry for at least one minute before proceeding. With syringe held upward, remove needle cover. Pinch up a large area of skin between the finger and thumb. Vary the injection site a little with each injection. The needle should be inserted at the base of the pinched-up skin at an angle of 45–90° to the skin surface. When the needle is correctly positioned, it will be difficult to draw back on the plunger. If any blood is drawn into the syringe, the needle tip has penetrated a vein or artery. If this happens, withdraw the needle slightly and reposition the needle without removing it from the skin. Alternatively, remove the needle and use a new, sterile, prefilled syringe. Cover the injection site with a swab containing disinfectant and apply pressure; the site should stop bleeding within one or two minutes. Once the needle is correctly placed, depress the plunger slowly and steadily, so the solution is correctly injected and the skin is not damaged. Pull the syringe out quickly and apply pressure to the site with a swab containing disinfectant. Use the sterile, prefilled syringe only once and dispose of it properly.

Monitoring

There is limited information regarding Monitoring of Ganirelix in the drug label.

Description

IV Compatibility

There is limited information regarding IV Compatibility of Ganirelix in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

Description

Management

Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Ganirelix in the drug label.

Pharmacology

There is limited information regarding Ganirelix Pharmacology in the drug label.

Mechanism of Action

Structure

File:Ganirelix01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Ganirelix in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Ganirelix in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Ganirelix in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Ganirelix in the drug label.

How Supplied

Storage

There is limited information regarding Ganirelix Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Ganirelix |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Ganirelix |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Ganirelix in the drug label.

Precautions with Alcohol

Alcohol-Ganirelix interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

®^[1]

Look-Alike Drug Names

A® — B®^[2]

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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[1]

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+Ganirelix Acetate Injection is supplied in a sterile, prefilled syringe and is intended for SUBCUTANEOUS administration only.
-* Intravenous
+Wash hands thoroughly with soap and water.
+The most convenient sites for SUBCUTANEOUS injection are in the abdomen around the navel or upper thigh.
+The injection site should be swabbed with a disinfectant to remove any surface bacteria. Clean about two inches around the point where the needle will be inserted and let the disinfectant dry for at least one minute before proceeding.
+With syringe held upward, remove needle cover.
+Pinch up a large area of skin between the finger and thumb. Vary the injection site a little with each injection.
+The needle should be inserted at the base of the pinched-up skin at an angle of 45–90° to the skin surface.
+When the needle is correctly positioned, it will be difficult to draw back on the plunger. If any blood is drawn into the syringe, the needle tip has penetrated a vein or artery. If this happens, withdraw the needle slightly and reposition the needle without removing it from the skin. Alternatively, remove the needle and use a new, sterile, prefilled syringe. Cover the injection site with a swab containing disinfectant and apply pressure; the site should stop bleeding within one or two minutes.
+Once the needle is correctly placed, depress the plunger slowly and steadily, so the solution is correctly injected and the skin is not damaged.
+Pull the syringe out quickly and apply pressure to the site with a swab containing disinfectant.
+Use the sterile, prefilled syringe only once and dispose of it properly.
 |monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.