Nafarelin (naf-a-REL-in)

Treats endometriosis and premature puberty.

Brand Name(s):

Synarel

When This Medicine Should Not Be Used:

How to Use This Medicine:

Spray

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• This medicine is for use only in the nose. Do not get any of it in your eyes or on your skin. If it does get on these areas, rinse it off right away.
• To use:
• Blow your or your child's nose gently to clear the nostrils. You can also use a bulb syringe to clean your child's nose.
• Take the cap off the bottle and remove the clip from the neck of the pump.
• If you are using the medicine for the first time, you will need to prime the spray pump.
• To do this, hold the spray bottle with your thumb on the bottom of the bottle and your index and middle fingers on the 2 flaps on the side of the pump.
• Push down with your index and middle fingers. Keep pumping until you see some of the medicine spray from the bottle.
• For premature puberty:
  • Tilt your child's head back slightly. Put the tip of the bottle into your child's nostril.
  • Close the other nostril with your finger and spray the medicine into your child's nostril while at the same time sniffing gently.
  • Allow 30 seconds between sprays in the same nostril.
  • Keep your child's head tilted back for a few seconds after spraying this medicine.
• For endometriosis:
  • Lean your head forward and put the tip of the bottle into your nostril.
  • Close the other nostril with your finger. Spray the medicine once into your nostril while at the same time sniffing gently.
  • Do not spray this medicine in your other nostril unless your doctor tells you to.
  • Tilt your head backwards for a few seconds after spraying this medicine.
  • You should start using this medicine between the 2nd and 4th day of your menstrual period, unless instructed otherwise by your doctor. This medicine is used for six months.
• Avoid sneezing during or right after using this medicine.
• After using the nasal spray, wipe the tip of the bottle with a clean tissue and put the cap back on.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose. It is important to use this medicine regularly without missing doses.
• Keep the bottle tightly closed when not using it. Store at room temperature, away from heat and direct light. Keep the bottle upright. Do not freeze. 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.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how nafarelin works. Tell your doctor if you are using medicines to treat depression (including bupropion), seizure medicines, or steroids.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine.
• Tell your doctor if you have polycystic ovarian disease, rhinitis (stuffy or runny nose), or a history of depression, mental illness, seizures, brain tumor, or osteoporosis. Tell your doctor if you smoke or drink alcohol.
• Women: Your menstrual periods should stop, but you might have light bleeding or spotting. If you continue to have a period after taking this medicine for more than a month, call your doctor.
• This medicine may cause the following problems:
  • Depression
  • Changes in mood or behavior
  • Increased risk for seizures
  • Cysts in the ovaries
  • Weaker bones, which may lead to osteoporosis
  • Intracranial hypertension or pseudotumor cerebri (increased pressure in the head) in children
• Your symptoms might get worse when you first start using this medicine, but they should get better as the medicine starts to work. If your condition does not begin to improve after using this medicine for 2 months, check with your doctor.
• If you get a stuffy nose, and need to use a nasal decongestant, call your doctor. If your doctor tells you to use a decongestant, wait at least 2 hours after using nafarelin to use the decongestant.
• You should not get pregnant while using this medicine to treat endometriosis. Talk to your doctor about effective methods of birth control to use. If you do get pregnant, tell your doctor right away.
• Women: Your menstrual periods should stop but you might have light bleeding or spotting. If you continue to have a period after taking this medicine for more than a month, call your doctor.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Bloating, stomach discomfort, pain, or heaviness
• Blurred or change in vision, eye pain, dizziness, severe headache, nausea, vomiting
• Depression, mood, or behavior changes
• Heavy vaginal bleeding
• Seizures
• Unusual or severe bone or back pain

If you notice these less serious side effects, talk with your doctor:

• Acne, skin rash, flaking
• Changes in breast size
• Dryness of vagina
• Irritation of the nostrils
• Loss of interest in sex
• Muscle aches
• Warmth or redness in your face, neck, arms, or upper chest
• Weight gain or fluid retention

If you notice other side effects that you think are caused by this medicine, tell your doctor

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