(nafarelin acetate) Nasal Spray
Patient Instructions for Use
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:
- to review information your doctor has given you about SYNAREL; and
- 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
- 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,
- 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.
- 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.
- 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.
- 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
- 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
- When your child starts to use SYNAREL she/he should continue taking it every
day as prescribed. Do not miss any dose.
- 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,
- two sprays in each nostril (4 sprays total) in the evening (for example,
The head should be tilted slightly back, and you should wait about 30 seconds
between sprays into the same nostril. More detailed instructions follow.
- Treatment for central precocious puberty should continue until you and your
child's doctor decide that it is appropriate for puberty to resume.
- 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.
- 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.
- 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
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.
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).
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).
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.
How to use the SYNAREL Nasal Spray unit for the treatment of Central Precocious
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).
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.
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).
8. Close the other nostril with a finger (See 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).
11. Clean the Spray Tip after use (See Step 4).
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 to. Make sure to
note the date you start each bottle so you do not run out of medicine and miss
Keep out of the reach of children and use carefully as directed.
- Storage Instructions:
- Store SYNAREL at 59°F to 86°F (15°C to 30°C).
- Store the SYNAREL bottle upright.
- Keep SYNAREL out of the light.
- Do not freeze SYNAREL.