Nafarelin (Nasal)

Nafarelin (Nasal) spray is a man-made hormone that is similar to a natural hormone made in the brain. It is used to treat:

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

When given regularly to boys and girls with early puberty, nafarelin slows down the development of genital areas in both sexes. It will also slow breast development in girls. This medicine will delay puberty as long as the child continues to use it.

When given regularly to women, nafarelin lowers estrogen levels, which helps treat endometriosis. It prevents the growth of tissue caused by endometriosis in adult women during treatment and for 6 months after treatment ends.

Lowering estrogen can lead to thinning of the bones or slowing of growth. This is a concern for adult women whose bones are no longer growing. Slowing bone growth is a positive effect for girls and boys whose bones grow too fast when puberty starts too early. Boys and girls may gain height in adulthood when nafarelin helps their bones grow at the right rate for children.

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

It is very important for your doctor to regularly check how you or your child are doing with this medicine to ensure it is working properly. Blood tests may be required to look for any unwanted effects. Make sure to keep all your appointments.

For female patients: You should not use this medicine if you are pregnant or might become pregnant. Using this medicine while pregnant can harm your unborn baby. Use an effective form of birth control to avoid getting pregnant during treatment with this medicine. If you think you might be pregnant while using the medicine, tell your doctor immediately.

For children using nafarelin spray for central precocious puberty (CPP): This medicine can cause a brief increase in blood levels of some hormones. During this time, you might notice more signs of puberty in your child, such as 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, your symptoms might get worse. This is normal. Do not stop using this medicine. Talk with your doctor if you are concerned about this.
• While using nafarelin, your menstrual period may become irregular, or you may not have a period at all. This is expected during treatment with this medicine. If your regular menstruation does not start within 2 to 3 months after stopping this medicine, check with your doctor.
• While 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 spermicide. If you have questions about this, check with your doctor.
• If vaginal dryness is a problem, use a water-based vaginal lubricant. Ensure the lubricant you choose is safe to use with a latex birth control device if you are using one. Some lubricants contain oils that can damage latex condoms, cervical caps, or diaphragms, causing them to break.
• This medicine can decrease your bone mineral density, which may lead to osteoporosis or weak bones. Talk with your doctor about how this risk may affect you.
• If you think you may be pregnant, stop using this medicine and consult your doctor immediately. Continuing to use nafarelin during pregnancy could cause birth defects or a miscarriage.

This medicine may cause depression, especially in women. Contact your doctor right away if you experience feelings of sadness, emptiness, irritability, decreased appetite, loss of interest or pleasure, tiredness, trouble concentrating, or trouble sleeping.

This medicine may make some people feel agitated, irritable, or exhibit other unusual behaviors. Make sure your doctor knows if you have trouble sleeping, become easily upset, have a significant increase in energy, or start acting recklessly. Also inform your doctor if you experience sudden or intense feelings, such as nervousness, anger, restlessness, violence, or fear. If you or your caregiver notice any of these side effects, inform your doctor immediately.

Using this medicine may increase your risk of having seizures. Contact your doctor right away if you experience muscle spasms or jerking in all extremities, seizures, sudden loss of consciousness, or loss of bladder control.

Nafarelin spray can raise your risk of developing cysts in the ovaries. Discuss this risk with your doctor.

This medicine may cause intracranial hypertension or pseudotumor cerebri (increased pressure in the head) in children. Contact your doctor immediately if your child experiences blurred or double vision, changes in color vision, persistent ringing or buzzing in the ears, dizziness, eye pain, hearing loss, nausea and vomiting, or severe headaches.

Before any medical tests, inform the doctor in charge that you are using this medicine. The results of some tests may be influenced by this medicine.

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

In deciding to use a medicine, you and your doctor need to weigh the risks of taking the medicine against the benefits it may provide. The following points should be considered for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies have not shown any specific problems that would limit the use of nafarelin nasal spray in children. Nafarelin will stop working soon after a child treated for central precocious puberty stops using it, and puberty will continue normally.

Studies have not been conducted to determine how age affects the use of nafarelin nasal spray for treating endometriosis in children. Safety and effectiveness have not been established.

Geriatric

No information is available on how age affects the use of nafarelin nasal spray in older patients.

Breast Feeding

Studies in breastfeeding women have shown harmful effects on infants. An alternative to this medication should be prescribed, or you should stop breastfeeding while using this medicine.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may adjust the dose or take other precautions. When taking this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been chosen based on their potential importance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Bepridil
• Cisapride
• Dronedarone
• Levoketoconazole
• Mesoridazine
• Pimozide
• Piperaquine
• Saquinavir
• Sparfloxacin
• Terfenadine
• Thioridazine
• Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency of one or both medicines.

• Adagrasib
• Alfuzosin
• Amiodarone
• Amisulpride
• Amitriptyline
• Anagrelide
• Apomorphine
• Aripiprazole
• Aripiprazole Lauroxil
• Arsenic Trioxide
• Asenapine
• Astemizole
• Atazanavir
• Azithromycin
• Bedaquiline
• Buprenorphine
• Ceritinib
• Chloroquine
• Chlorpromazine
• Ciprofloxacin
• Citalopram
• Clarithromycin
• Clofazimine
• Clomipramine
• Clothiapine
• Clozapine
• Crizotinib
• Cyclobenzaprine
• Dabrafenib
• Dasatinib
• Delamanid
• Desipramine
• Deutetrabenazine
• Dexmedetomidine
• Disopyramide
• Dofetilide
• Dolasetron
• Domperidone
• Donepezil
• Doxepin
• Droperidol
• Ebastine
• Efavirenz
• Encorafenib
• Entrectinib
• Eribulin
• Erythromycin
• Escitalopram
• Etrasimod
• Famotidine
• Felbamate
• Fexinidazole
• Fingolimod
• Flecainide
• Fluconazole
• Fluoxetine
• Formoterol
• Foscarnet
• Fosphenytoin
• Fostemsavir
• Galantamine
• Gatifloxacin
• Gemifloxacin
• Gepirone
• Glasdegib
• Granisetron
• Halofantrine
• Haloperidol
• Hydroquinidine
• Hydroxychloroquine
• Hydroxyzine
• Ibutilide
• Iloperidone
• Imipramine
• Inotuzumab Ozogamicin
• Itraconazole
• Ivabradine
• Ivosidenib
• Ketoconazole
• Lapatinib
• Lefamulin
• Lenvatinib
• Leuprolide
• Levofloxacin
• Lofexidine
• Lumefantrine
• Macimorelin
• Mefloquine
• Methadone
• Metronidazole
• Mifepristone
• Mirtazapine
• Mizolastine
• Mobocertinib
• Moxifloxacin
• Nelfinavir
• Nilotinib
• Norfloxacin
• Octreotide
• Ofloxacin
• Olanzapine
• Ondansetron
• Osilodrostat
• Osimertinib
• Oxaliplatin
• Ozanimod
• Pacritinib
• Paliperidone
• Panobinostat
• Paroxetine
• Pasireotide
• Pazopanib
• Pentamidine
• Perphenazine
• Phenobarbital
• Pimavanserin
• Pipamperone
• Pitolisant
• Ponesimod
• Posaconazole
• Primidone
• Probucol
• Procainamide
• Prochlorperazine
• Promethazine
• Propafenone
• Protriptyline
• Quetiapine
• Quinidine
• Quinine
• Quizartinib
• Ranolazine
• Relugolix
• Ribociclib
• Rilpivirine
• Risperidone
• Ritonavir
• Selpercatinib
• Sertindole
• Sertraline
• Sevoflurane
• Siponimod
• Sodium Phosphate
• Sodium Phosphate, Dibasic
• Sodium Phosphate, Monobasic
• Solifenacin
• Sorafenib
• Sotalol
• Sulpiride
• Sunitinib
• Tacrolimus
• Tamoxifen
• Telaprevir
• Telavancin
• Telithromycin
• Tetrabenazine
• Tolterodine
• Toremifene
• Trazodone
• Triclabendazole
• Trimipramine
• Vandetanib
• Vardenafil
• Vemurafenib
• Venlafaxine
• Vilanterol
• Vinflunine
• Voclosporin
• Voriconazole
• Vorinostat
• Zuclopenthixol

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken around the time of eating certain foods because interactions may happen. Using alcohol or tobacco with some medicines may also cause interactions. Discuss with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Other medical issues may affect how this medicine works. Be sure to inform 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.

• History of brain tumors or
• History of seizures or epilepsy—Use with caution. May increase the risk of seizures.

• History of depression or
• History of mental problems or
• Polycystic ovarian disease (PCOD) or
• Pituitary gland problem or
• Rhinitis (swelling or irritation of the nose)—Use with caution. May worsen these conditions.

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 common

For 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
• rash, hives or welts, itching
• redness of the skin

Less common or rare

For 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 the breasts
• unusual tiredness or 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
• sweating
• trouble breathing
• vomiting
• yellow eyes or skin

Incidence not known

• Anxiety or mental depression
• blurred or double vision
• change in ability to see colors, especially blue or yellow
• changes in vision
• cold, clammy, or pale skin
• confusion
• discouragement
• eye pain
• feeling sad or empty
• headache
• irregular heartbeats
• irritability
• lack of appetite
• loss of interest or pleasure
• nightmares or unusually vivid dreams
• seizures
• slow heart rate
• trouble concentrating
• trouble sleeping
• vomiting
• weakness

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 common

For 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 rare

For adults (female)

• Breast pain
• headache (mild and transient)
• irritated or runny nose
• mental depression (mild and transient)

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.

In the U.S.

• Synarel

Available Dosage Forms:

• Spray

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Luteinizing Hormone Releasing Hormone Agonist

Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. Do not change your dose or stop using this medicine without checking first with your doctor.

This medicine comes with patient instructions. Read and follow these instructions carefully and make sure you understand:

• How to prepare the nasal spray.
• How to use the spray.
• How long the spray can be stored.

This medicine is only used in the nose. Do not get it in your eyes or on your skin. If it does get on these areas, 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 primed first. To do this, point the bottle away from you and pump the bottle firmly about 7 times until a fine mist spray appears. 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 use nafarelin spray, 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.
• For central precocious 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. At the same time, let your child sniff in the spray as you pump the bottle once. Allow 30 seconds between sprays in the same nostril. Keep your child's head tilted back for a few seconds after spraying this medicine to let the spray get onto the back of the nose.
• For endometriosis: Lean your head forward. 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 with your finger. At the same time, sniff in the spray as you pump the bottle once. 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 to let the spray get onto the back of your nose.
• Repeat these steps for each dose of the 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 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.

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 this medicine regularly. Nafarelin must be given on a regular schedule.

Women with endometriosis should start using this medicine between the 2nd and 4th day of their menstrual period, unless instructed otherwise by your doctor. This medicine is used for six months.

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 2 times a day, 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 3 times a day to provide a total of 9 sprays per day. For treatment of endometriosis: Adults—One spray into one nostril in the morning and one spray into the other nostril in the evening, taken for 6 months. Start your treatment between Days 2 and 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

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.

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

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.