SYNAREL® Other (nafarelin acetate) | Pfizer Medical Information - US

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CENTRAL PRECOCIOUS PUBERTY (FOR ENDOMETRIOSIS, SEE REVERSE SIDE)

PHYSICIAN LABELING

LAB-1048-4.0
Revised: April 2022

Synarel®
(nafarelin acetate)
nasal solution

ENDOMETRIOSIS (FOR CENTRAL PRECOCIOUS PUBERTY, SEE REVERSE SIDE)

PHYSICIAN LABELING

LAB-0173-13.0
Revised: January 2023

If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

SYNAREL® Quick Finder

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INDICATIONS AND USAGE FOR CENTRAL PRECOCIOUS PUBERTY

(For Endometriosis, See Reverse Side)

SYNAREL is indicated for treatment of ...

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DOSAGE AND ADMINISTRATION

For the treatment of central precocious puberty (CPP), the recommended daily dose of SYNAREL is 1600 µg. The dose can be increased to 1800 µg daily if adequate suppression cannot be achieved at 1600...

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CONTRAINDICATIONS

1. Hypersensitivity to GnRH, GnRH agonist analogs or any of the excipients in SYNAREL;

2. Undiagnosed abnormal vaginal bleeding;

3. Use in pregnancy or in women who may become pregnant while...

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WARNINGS

The diagnosis of central precocious puberty (CPP) must be established before treatment is initiated. Regular monitoring of CPP patients is needed to assess both patient response as well as...

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ADVERSE REACTIONS

In clinical trials of 155 pediatric patients, 2.6% reported symptoms suggestive of drug sensitivity, such as shortness of breath, chest pain, urticaria, rash, and pruritus.

In these 155 patients...

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OVERDOSAGE

In experimental animals, a single subcutaneous administration of up to 60 times the recommended human dose (on a µg/kg basis, not adjusted for bioavailability) had no adverse effects. At present, there is no...

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DESCRIPTION

SYNAREL (nafarelin acetate) Nasal Solution is intended for administration as a spray to the nasal mucosa. Nafarelin acetate, the active component of SYNAREL Nasal Solution, is a decapeptide with the chemical name...

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CLINICAL PHARMACOLOGY

Nafarelin acetate is a potent agonistic analog of gonadotropin-releasing hormone (GnRH). At the onset of administration, nafarelin stimulates the release of the pituitary gonadotropins, LH and FSH,...

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HOW SUPPLIED

Each 0.5 ounce bottle (NDC 0025-0166-08) contains 8 mL SYNAREL (nafarelin acetate) Nasal Solution 2 mg/mL (as nafarelin base), and is supplied with a metered spray pump that delivers 200 µg of nafarelin per...

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MEDICATION...

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CENTRAL PRECOCIOUS PUBERTY (FOR ENDOMETRIOSIS, SEE REVERSE SIDE)

PHYSICIAN LABELING...

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Pfizer Safety

To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.