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FDA Approval

Synarel

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Pfizer Laboratories Div Pfizer Inc
DUNS: 134489525
Effective Date
February 22, 2023
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Nafarelin(2 mg in 1 mL)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Pharmacia & Upjohn Company LLC

Pfizer Laboratories Div Pfizer Inc

618054084

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Synarel

Product Details

NDC Product Code
0025-0166
Application Number
NDA019886
Marketing Category
NDA (C73594)
Route of Administration
NASAL
Effective Date
February 8, 2023
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7Class: IACT
ACETIC ACIDInactive
Code: Q40Q9N063PClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
NafarelinActive
Code: 8ENZ0QJW4HClass: ACTIMQuantity: 2 mg in 1 mL
SORBITOLInactive
Code: 506T60A25RClass: IACT

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

WARNINGS SECTION

WARNINGS

Safe use of nafarelin acetate in pregnancy has not been established clinically. Before starting treatment with SYNAREL, pregnancy must be excluded.

When used regularly at the recommended dose, SYNAREL usually inhibits ovulation and stops menstruation. Contraception is not insured, however, by taking SYNAREL, particularly if patients miss successive doses. Therefore, patients should use nonhormonal methods of contraception. Patients should be advised to see their physician if they believe they may be pregnant. If a patient becomes pregnant during treatment, the drug must be discontinued and the patient must be apprised of the potential risk to the fetus.

Clinical Depression

Depression may occur or worsen during treatment with GnRH agonists including SYNAREL 2 mg/mL. Carefully observe women for depression, especially those with a history of depression and consider whether the risks of continuing SYNAREL 2 mg/mL outweigh the benefits. Women with new or worsening depression should be referred to a mental health professional, as appropriate [see Precautions].

SPL PATIENT PACKAGE INSERT SECTION

Instructions for Use
SYNAREL(sin-na-rell)
(nafarelin acetate)
nasal solution

For use in the nose only.

Figure A

Figure A

Before you use SYNAREL nasal spray for the first time, you will need to prime it. This will make sure that you get the right dose of medicine each time you use it. Priming only needs to be done 1 time, when you start using a new bottle of SYNAREL.

To Prime the Pump:

Figure B
Figure B

 
Remove and save the white safety clip and the clear plastic dust cover from the spray bottle (See Figure B).

Figure C
Figure C

 
Hold the bottle in an upright position away from you. Put 2 fingers on the "shoulders" of the spray bottle and put your thumb on the bottom of the bottle. Apply pressure**evenly** to the "shoulders" and push down**quickly and firmly** 7 to 10 times, until you see a fine mist spray. Usually you will see the spray after about 7 pumps. (See Figure C). The pump is now primed.

It is normal to see some larger droplets of liquid within the fine mist. However, if SYNAREL comes out of the pump as a thin stream of liquid instead of a fine mist, SYNAREL may not work as well, and you should talk to your pharmacist.

Figure D
Figure D
Figure E
Figure E

 
**Clean the Spray Tip after Priming:**

•

Hold the bottle in sideways (horizontal) position (see Figure D).

Rinse the "spray tip" withwarm water while wiping the tip with your finger or soft cloth for 15 seconds.

•

Wipe the spray tip with a soft cloth or tissue to dry.

•

Replace the white safety clip and the clear plastic dust cover on the spray bottle. (See Figure E).

•

**Do not** try to clean the spray tip using a pointed object.

•

**Do not** take apart the pump.

How to use the SYNAREL Nasal Spray for the treatment of Central Precocious Puberty

Figure F
Figure F

 
Have your child blow their nose to clear both nostrils before using SYNAREL nasal spray (see Figure F). If the child is too young to blow their nose, you may need to clear the child's nostrils with a bulb syringe.

Figure G
Figure G

 
**Clean the Spray Tip each time before and after using SYNAREL.**

•

Remove and save the white safety clip and the clear plastic dust cover from the spray bottle (See Figure G).

•

Hold the bottle in sideways (horizontal) position. Rinse the spray tip with**warm** water while wiping the tip with your finger or soft cloth for 15 seconds.

•

Wipe the spray tip with a soft cloth or tissue to dry.

•

**Do not** try to clean the spray tip using a pointed object.

•

**Do not** try to take apart the pump.

Figure H
Figure H

 
The child's head should be bent back a little and the spray tip put into one nostril. The tip should**not** reach too far into the nose. Aim the spray tip toward the**back and outer side** of the nose (See Figure H).

Figure I
Figure I

 
Close the other nostril with a finger (See Figure I).

Put pressureevenly to the "shoulders" and push downquickly and firmly. Pump the sprayer 1 time, at the same time as the child sniffs in gently. Wait about 30 seconds and put one more spray in the same nostril. Repeat this process in the other nostril, for a total of four sprays. If the sprayer fails to deliver the dose, clean the spray tip (See Step 5Clean the Spray Tip each time before and after using SYNAREL).

Figure J
Figure J

 
Remove the spray tip from the child's nose after all sprays are completed. Keep the child's head tilted back for a few seconds. This lets the SYNAREL spray spread over the back of the nose (See Figure J).

Figure K
Figure K

 
Clean the Spray Tip after use (See Step 5. Put on the white safety clip and the clear plastic dust cover (see Figure K).

It is important that you clean the spray tip before and after every use. Not doing this may result in a clogged tip that may cause you to get the wrong dose of medicine.

How should I store SYNAREL?

•

Store SYNAREL at room temperature between 59°F to 86°F (15°C to 30°C).

•

Store the SYNAREL bottle upright.

•

Keep SYNAREL out of the light.

Keep SYNAREL and all medicines out of the reach of children.

For more information call 1-800-438-1985.

This Medication Guide and Instructions for Use have been approved by the U.S. Food and Drug Administration.

Manufactured for: Pfizer Inc., 235 East 42nd Street, New York, NY, 10017

Logo

LAB-1049-3.0
Revised: April 2022

HOW SUPPLIED SECTION

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 spray. A dust cover and a leaflet of patient instructions are also included.

Store upright at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. Protect from light.

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