MEDICATION GUIDESYNAREL (sin-na-rell)(nafarelin acetate) nasal solution
What is the most important information I should know about SYNAREL?
Call your child's doctor right away if your child has any new or worsening mental symptoms or problems while taking SYNAREL
Seizures have also happened in people who have not had any of these problems.Call your child's doctor right away if your child has a seizure while taking SYNAREL.
What is SYNAREL? SYNAREL is a gonadotropin releasing hormone (GnRH) medicine used for the treatment of children with central precocious puberty (CPP).
Do not give SYNAREL if your child:
Before your child takes SYNAREL, tell your doctor about all of your child's medical conditions, including if they:
Tell your doctor about all the medicines your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How should your child take SYNAREL?
What should your child avoid while taking SYNAREL?
What are the possible side effects of SYNAREL?SYNAREL may cause serious side effects, including:
The side effects of SYNAREL include:
These are not all of the possible side effects of SYNAREL. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General Information about the safe and effective use of SYNAREL.Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use SYNAREL for a condition for which it is not prescribed. Do not give SYNAREL to other people, even if they have the same symptoms that you have. It may harm them.You can ask your doctor or pharmacist for information about SYNAREL that is written for health professionals.
What are the ingredients in SYNAREL?Active ingredient: nafarelin acetateInactive ingredients: benzalkonium chloride, glacial acetic acid, sodium hydroxide or hydrochloric acid (to adjust pH), sorbitol, and purified water
SYNARELnafarelin acetateNasal Spray
Patient Instructions for Use
Your doctor has prescribed SYNAREL Nasal Solution to treat your symptoms of endometriosis. This pamphlet has two purposes:
Please read this pamphlet carefully. If you still have questions after reading it or if you have questions at any time during your treatment with SYNAREL, be sure to check with your doctor.
SYNAREL is used to relieve the symptoms of endometriosis. The lining of the uterus is called the endometrium, and part of it is shed during menses. In endometriosis, endometrial tissue is also found outside the uterus and, like normal endometrial tissue, can bleed during a menstrual cycle. It is, in part, this monthly activity that causes you to have symptoms during your cycle. Most often, this out-of-place endometrial tissue is found around the uterus, ovaries, the intestine or other organs in the pelvis. Although some women with endometriosis have no symptoms, many have problems such as severe menstrual cramps, pain during sexual intercourse, low back pain, and painful bowel movements.
Endometrial tissue is affected by the body's hormones, especially estrogen, which is made by the ovaries. When estrogen levels are low, endometrial tissue shrinks (perhaps even disappears), and symptoms of endometriosis ease. SYNAREL temporarily reduces estrogen in the body and temporarily relieves the symptoms of endometriosis.
Important Information about SYNAREL
You should discuss the possibility of osteoporosis or thinning of the bones with your physician before starting SYNAREL. You should also be aware that repeat treatments are not recommended since they may put you at greater risk of bone thinning, particularly if you have the above conditions.
Of the 60% of patients who had complete relief of symptoms at the end of treatment, 17% had moderate symptoms at the end of the six month post-treatment period; 33% had mild symptoms; 50% were symptom free; no patient had severe symptoms.
Proper use of SYNAREL for Treatment of Endometriosis
The length of treatment is usually about 6 months, unless your doctor has given you special instructions.
Preparation of the SYNAREL Nasal Spray unit
For use in your nose only.
Before you use SYNAREL nasal spray for the first time, you will need to prime it. This will ensure that you get the right dose of medicine each time you use it.
Important Tips about using SYNAREL
To Prime the Pump:
How to use the SYNAREL Nasal Spray unit for the treatment of Endometriosis
It is important that you clean the spray tip before and after every use. Failure to do this may result in a clogged tip that may cause you to get the wrong dose of medicine.
Important Reminder: Treatment with SYNAREL must be uninterrupted with no missed doses to be effective.Make sure you use SYNAREL exactly as your doctor tells you. Make sure to note the date you start each bottle so you do not run out of medicine and miss doses.
Keep out of the reach of children and use carefully as directed.
This product's label may have been updated. For current full prescribing information, please visit www.pfizer.com.
LAB-0278-9.0Revised: January 2023
Instructions for UseSYNAREL (sin-na-rell)(nafarelin acetate)nasal solution
For use in the nose only.
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.
Figure DFigure E
How to use the SYNAREL Nasal Spray for the treatment of Central Precocious Puberty
Put pressure evenly to the "shoulders" and push down quickly 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 5 Clean the Spray Tip each time before and after using SYNAREL).
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?
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
LAB-1049-3.0Revised: April 2022
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