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Synarel

Generic Name: nafarelin (Nasal route)

naf-a-REL-in

Commonly used brand name(s)

In the U.S.

  • Synarel

Available Dosage Forms:

  • Spray

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Luteinizing Hormone Releasing Hormone Agonist

Uses For Synarel

Nafarelin is a man-made version of a hormone that is similar to the one normally released from the hypothalamus gland in the brain. Nafarelin nasal spray is used for the treatment of:

  • Central precocious puberty (CPP), a condition that causes early puberty in boys (before 9 years of age) and in girls (before 8 years of age).
  • Endometriosis, a painful condition caused by extra tissue growing inside or outside of the uterus (womb).

When given regularly to boys and girls experiencing early puberty, nafarelin slows down the development of genital areas in both sexes and breast development in girls. This medicine delays puberty in a child only as long as the child continues to take it.

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When given regularly to women, nafarelin prevents the growth of tissue caused by endometriosis in adult women during treatment and for 6 months after treatment is discontinued. Reducing the amount of estrogen in the body is one way of treating endometriosis.

Suppressing estrogen can cause thinning of the bones or slowing of growth. This is a problem for adult women whose bones are no longer growing like the bones of children. Slowing the growth of bones is a positive effect for girls and boys whose bones grow too fast when puberty begins too early. Boys and girls may benefit by adding inches to their adult height when nafarelin causes their bones to grow at the proper and expected rate for children.

This medicine is available only with your doctor's prescription.

Before Using Synarel

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of nafarelin nasal spray in children. Nafarelin will stop having an effect on a child treated for central precocious puberty soon after the child stops using it, and puberty will advance normally. It is not known if using nafarelin nasal spray around the time of puberty causes changes in boys' and girls' future abilities to have babies. Their chances of having children later are thought to be normal. It is especially important that you discuss with the child's doctor the benefit of this medicine as well as the risk of using it.

Appropriate studies have not been performed on the relationship of age to the effects of nafarelin nasal spray for the treatment of endometriosis in the pediatric population. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of nafarelin nasal spray in geriatric patients.

Pregnancy

Pregnancy Category Explanation
All Trimesters X Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Abnormal or unusual vaginal bleeding—Should not be used in patients with this condition.
  • Alcohol abuse or
  • Cigarette smoking or
  • Conditions that increase the chances of developing thinning bones or
  • Osteoporosis (brittle bones), or history of—Increases your risk of developing osteoporosis.
  • Ovarian cysts or
  • Pituitary gland problem or
  • Rhinitis (swelling or irritation of the nose)—Use with caution. May make these conditions worse.

Proper Use of Synarel

Use this medicine only as directed by your doctor. Do not use more of it and do not use it more often than your doctor ordered. To do so may increase the amount that is absorbed from the nose and the chance of unwanted effects. Do not change your dose or stop using this medicine without checking with your doctor first.

This medicine comes with patient instructions. Read and follow the instructions carefully. Ask your doctor if you have any questions.

This medicine is only used in the nose. Do not get it in your eyes. If it does get in the eyes, rinse them with water right away and call your doctor.

To use nafarelin spray:

  • Before you use each new bottle of nafarelin, the spray pump needs to be started. To do this, point the bottle away from you and pump the bottle firmly about 7 times. This only needs to be done once for each new bottle of nafarelin. Be careful not to breathe in this spray. You could inhale extra doses of nafarelin, since the medicine is dissolved in the spray.
  • Before you take your daily doses of nafarelin, blow your nose gently. Hold your head forward a little. Put the spray tip into one nostril. Aim the tip toward the back and outside of your nostril. You do not need to put the tip too far into your nose.
  • Close your other nostril off by pressing on the outside of your nose with a finger. Then, sniff in the spray as you pump the bottle once.
  • Take the spray bottle out of your nose. Tilt your head back for 30 seconds, to let the spray get onto the back of your nose.
  • Repeat these steps for each dose of medicine.
  • Each time you use the spray bottle, wipe off the tip with a clean tissue or cloth. Keep the white safety clip and plastic cap on the bottle when you are not using it.
  • Be sure to clean the tip of the spray bottle before and after every use. To do this, hold the bottle sideways. Rinse the tip with warm water, while wiping the tip with your finger or a soft cloth for about 15 seconds. Dry the tip with a soft cloth or tissue. Replace the cap right after use. Be careful not to get water into the bottle, since this could dilute the medicine.
  • Do not try to make the tiny hole in the spray tip larger. Doing so, may deliver a wrong dose of the medicine.

If you are also using a topical nasal decongestant, do not use it at the same time you are using this medicine. Wait at least 2 hours after using nafarelin spray before using the nasal decongestant.

It is important to avoid sneezing when spraying and immediately after using the medicine. If you sneeze, the medicine may not be absorbed as well.

Many boys and girls who have central precocious puberty will not feel sick or will not understand the importance of taking the medicine regularly. It is very important that the medicine is used exactly as directed and that the proper amount is used at the proper time. It works best when there is a constant amount in the blood. To help keep the amount constant, nafarelin must be given on a regular schedule.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For nasal dosage form (spray):
    • For treatment of central precocious puberty:
      • Children—Two sprays in each nostril two times a day, taken in the morning and in the evening. This provides a total dose of 8 sprays a day. Some patients may need a larger dose by using 3 sprays in alternating nostrils three times a day to provide a total of 9 sprays per day.
    • For treatment of endometriosis:
      • Adults—One spray in one nostril in the morning and one spray into the other nostril in the evening, taken for 6 months. Begin your treatment on Day 2, 3, or 4 of your menstrual period.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

After you prime the bottle, there will only be 60 doses or sprays. Keep track of the number of sprays you use. Throw the bottle away after you use 60 sprays (for 30 days) even if some liquid remains in the bottle.

Precautions While Using Synarel

It is very important that your doctor check the progress of you or your child at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects. Be sure to keep all appointments.

For female patients: You should not take this medicine if you are pregnant or may become pregnant. Using this medicine while you are pregnant can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

For children using nafarelin spray for central precocious puberty: The medicine can cause a brief increase in blood levels of some hormones. During this time, you may notice more signs of puberty in your child, including light vaginal bleeding and breast enlargement in girls. If your child's symptoms do not improve within 4 weeks, or if they get worse, call your doctor.

For adult women using nafarelin spray for endometriosis:

  • For the first few days of treatment, the symptoms of your condition may get worse. This is normal. Do not stop using this medicine. Talk with your doctor if you have concerns about this.
  • During the time you are receiving nafarelin, your menstrual period may not be regular or you may not have a menstrual period at all. This is to be expected when being treated with this medicine. If regular menstruation does not begin within 2 to 3 months after you stop using this medicine, check with your doctor.
  • During the time you are using nafarelin spray, you should use birth control methods that do not contain hormones, such as condoms, IUD, a diaphragm or a cervical cap with a spermicide. If you have any questions about this, check with your doctor.
  • Use a water-based vaginal lubricant product if dryness of the vagina causes problems, such as pain during sexual intercourse. Make sure the lubricant you choose can be used with a latex birth control device if you are using one. Some lubricants contain oils, which can break down the latex rubber of condoms, a cervical cap, or a diaphragm, and cause them to rip or tear.
  • If you suspect you may have become pregnant, stop using this medicine and check with your doctor. There is a chance that continued use of nafarelin during pregnancy could cause birth defects or a miscarriage.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Synarel Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More commonFor adults (female)
  • Breast enlargement
  • light vaginal bleeding between regular menstrual periods called spotting
  • longer or heavier menstrual periods
  • vaginal bleeding between regular menstrual periods called breakthrough bleeding
For children (male)
  • Body odor
  • growth of pubic hair
For children (female)
  • Body odor
  • breast enlargement
  • growth of pubic hair
  • light vaginal bleeding between regular menstrual periods called spotting
  • longer or heavier menstrual periods
  • vaginal bleeding between regular menstrual periods called breakthrough bleeding
Less common
  • Chest pain
  • hives or welts
  • itching skin
  • redness of the skin
  • skin rash
  • shortness of breath
Less common or rareFor adults (female)
  • Fast or irregular heartbeat
  • numbness or tingling of the hands or feet
  • pain in the eyes or joints
  • patchy brown or dark brown discoloration of the skin
  • pelvic bloating or tenderness
  • unexpected or excess milk flow from breasts
  • unusual tiredness or weakness
For children (male and female)
  • Chest pain
  • hives
  • shortness of breath
Incidence not known
  • Anxiety or mental depression
  • changes in vision
  • chest pain or discomfort
  • cold, clammy, or pale skin
  • confusion
  • convulsions
  • headache
  • irregular heartbeats
  • nightmares or unusually vivid dreams
  • slow heart rate
  • vomiting
  • weakness
Incidence not known - For adults (female)
  • Cough
  • difficulty with speaking
  • dizziness or lightheadedness
  • double vision
  • fainting
  • fast heartbeat
  • inability to move the arms, legs, or facial muscles
  • inability to speak
  • nausea
  • pain or discomfort in the arms, jaw, back, or neck
  • pain, redness, or swelling in the arm or leg
  • slow speech
  • sudden shortness of breath or troubled breathing
  • sweating
  • vomiting
  • yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More commonFor adults (female)
  • Acne
  • dandruff
  • hot flashes
  • increase or decrease in sexual desire
  • increased hair growth, often abnormally distributed
  • mood swings
  • muscle pain
  • oily skin
  • pain during sexual intercourse
  • rapid weight gain
  • reduced breast size
  • stopping of menstrual periods
  • swelling of the feet or lower legs
  • vaginal dryness
For children (male)
  • Acne
  • dandruff
  • mood swings
  • oily skin
For children (female)
  • Acne
  • dandruff
  • hot flashes
  • mood swings
  • oily skin
Less common or rareFor adults (female)
  • Breast pain
  • headache (mild and transient)
  • irritated or runny nose
  • mental depression (mild and transient)
  • skin rash
For children (male)
  • Irritated or runny nose
For children (female)
  • Irritated or runny nose
  • white or brownish vaginal discharge

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

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