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SYNAREL
(nafarelin acetate? Nasal Spray

Patient Instructions for Use

Introduction

The doctor has prescribed SYNAREL Nasal Solution to treat your child's abnormally early sexual development, which is called central precocious puberty. This pamphlet has two purposes:

1. to review information your doctor has given you about SYNAREL; and
2. to give you information about how to use SYNAREL properly.

Please read this pamphlet carefully. If you still have questions after reading it or if you have questions at any time during your child's treatment with SYNAREL, be sure to check with your child's doctor.

“Central precocious puberty” is called by that name because it is sexual development and growth (puberty) which happens at an abnormally young age (precocious). It is caused by early awakening of a small gland in the brain. Since the brain is part of the “central nervous system,” this early sexual development is called “central.”

In children, SYNAREL is used to relieve the symptoms of central precocious puberty (CPP). CPP is normal puberty that happens at an abnormally young age. In children who are going through puberty (whether it's normal puberty or CPP), a small gland at the base of the brain makes some normal substances that cause the ovaries in girls to make estrogen and progesterone, the female hormones. In boys, it causes the testes to make testosterone, the male hormone. Estrogen and testosterone are the hormones that make girls and boys change into adults. These changes are mainly of 2 kinds: sexual development and a growth spurt. Sexual development includes things like breast and sexual hair growth and menstruation in girls, and growth of sexual organs, sexual hair and facial hair, and voice deepening in boys. The growth spurt during puberty occurs when estrogen (girls) and testosterone (boys) make the long bones of the body grow, so that the child gets taller quickly. When this growth spurt starts at a young age as it does in CPP, children become too tall for their age, but are usually shorter than average as adults.

SYNAREL helps relieve the symptoms of CPP by temporarily preventing the small gland at the base of the brain from making and sending its substances to the ovaries and testes. The ovaries and testes stop producing their hormones as long as SYNAREL is taken regularly, and puberty is interrupted.

Important Information about SYNAREL

1. Your child should not use SYNAREL if she/he is allergic to GnRH or GnRH agonist analogues or to any of the ingredients of SYNAREL (nafarelin acetate, benzalkonium chloride, acetic acid, sodium hydroxide, hydrochloric acid, sorbitol, purified water).
2. SYNAREL is a prescription medicine that should be used according to the doctor's directions. SYNAREL comes as a special nasal spray that gives a measured amount of medicine. To be effective, SYNAREL must be used every day, twice a day, until you and your child's doctor decide that resumption of puberty is desired for your child. If your child doesn't take the right amount every day, or if she/he doesn't take SYNAREL on the regular prescribed schedule, pubertal development may be restarted and/or the beneficial effects on height may be lost.
3. Menstrual flow may occur in girls during the first six weeks of treatment, whether or not they had been menstruating before starting treatment with SYNAREL. Menstrual flow should stop soon after the first six weeks.
4. In children receiving SYNAREL for central precocious puberty, some signs of puberty (for example breast enlargement in girls) may increase during the first month of treatment. This is a normal effect of the drug. You should continue treatment at the prescribed dose.
5. It is all right for your child to use a nasal decongestant spray while she/he is being treated with SYNAREL if you follow these simple rules. Use SYNAREL first. Wait at least 2 hours after using SYNAREL before your child uses the decongestant spray.
6. Your child should avoid sneezing during or immediately after using SYNAREL, if possible, since sneezing may impair drug absorption.

Proper Use of SYNAREL for Treatment of Central Precocious Puberty

1. When your child starts to use SYNAREL she/he should continue taking it every day as prescribed. Do not miss any dose.
2. Unless your child's doctor has given you special instructions, Central Precocious Puberty patients should follow the steps for using SYNAREL twice each day in both nostrils, about 12 hours between doses:
   • two sprays in each nostril (4 sprays total) in the morning (for example, 7 a.m.);
   • two sprays in each nostril (4 sprays total) in the evening (for example, 7 p.m.).
     The head should be tilted slightly back, and you should wait about 30 seconds between sprays into the same nostril. More detailed instructions follow.
3. Treatment for central precocious puberty should continue until you and your child's doctor decide that it is appropriate for puberty to resume.
4. Because it is so important that your child not miss a single dose of SYNAREL, here are some suggestions to help you remember:
   • Keep your child's SYNAREL in a place where you will be reminded for her/him to use it each morning and each evening next to your toothbrush is one possibility.
   • Keep track of each dose on a calendar.
   • Make a note on your calendar on the day you start a new bottle of SYNAREL. You can also mark directly on the bottle the date it was started. Be sure to refill your child's prescription before the 7 days are up so you will have a new bottle on hand.
5. A bottle of SYNAREL for central precocious puberty patients should not be used for longer than 7 days, unless your child's doctor specifically tells you it may be used for a longer time. If the doctor tells you to use a bottle only for 7 days, then a small amount of liquid will be left in the bottle. Do not try to use up the leftover amount because your child might get too low a dose, which could interfere with the effectiveness of the treatment. Dispose of the used bottle properly and do not reuse.
6. If the doctor increases your child's daily dose of SYNAREL, then one bottle will not last the standard 7 days. Please discuss this with your child's doctor to be sure that you have an adequate supply for uninterrupted treatment with SYNAREL.

Preparation of the SYNAREL Nasal Spray unit

For use in your nose only.

Before you use a bottle of 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

• Your pump should produce a fine mist, which can only happen by a quick and firm pumping action. 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.
• Be sure to clean the Spray Tip before and after every use. (See Step 4). Failure to do this may result in a clogged tip that may cause you not to get the right amount of medicine that is prescribed for you.
• The pump is made to deliver only a set amount of medicine, no matter how hard you pump it.
• Do Not try to make the tiny hole in the spray tip larger. If the hole is made larger the pump will deliver a wrong dose of SYNAREL.

Figure A

To Prime the Pump:

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

Figure B

2. Hold the bottle in an upright position away from you. Put two 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 spray. Usually you will see the spray after about 7 pumps. (See Figure C).

Figure C

3. The pump is now primed. Priming only needs to be done 1 time, when you start using a new bottle of SYNAREL. You will waste your medicine if you prime the pump every time you use it and may not have enough medicine for the recommended treatment period.

4. Clean the Spray Tip after Priming:

• Hold the bottle in horizontal position. Rinse spray the 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.
• Replace the white safety clip and the clear plastic dust cover on the spray bottle. (See Figure D).
• Do Not try to clean the spray tip using a pointed object. Do Not take apart the pump.

Figure D

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

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

Figure E

6. Clean the Spray Tip. Remove and save the white safety clip and the clear plastic dust cover from the spray bottle (See Figure F).

Hold the bottle in 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 F

7. 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 G).

Figure G

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

Figure H

9. Apply 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 apply 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 6 Clean the Spray Tip).

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

Figure I

11. Clean the Spray Tip after use (See Step 4).

Figure J

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.

Last reviewed on RxList: 1/30/2012
This monograph has been modified to include the generic and brand name in many instances.