Nafarelin nasal

Generic Name: nafarelin nasal (NAF a REL in)Brand Names: Synarel

What is nafarelin nasal?

Nafarelin nasal is a man-made form of a protein that is like a hormone in the body that helps regulate the menstrual cycle, fertility, and sexual development during puberty.

Nafarelin nasal is used to treat precocious puberty in both male and female children. It is also used to treat endometriosis in women who are 18 years of age or older.

Nafarelin nasal may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about nafarelin nasal?

This medication can cause birth defects in an unborn baby. Do not use if you are pregnant. Use an effective barrier form of birth control, and tell your doctor if you become pregnant during treatment. Do not use nafarelin nasal if you have ever had an allergic reaction to nafarelin or similar medicines such as gonadorelin (Factrel). Do not use nafarelin nasal if you are pregnant or breast-feeding, or if you have undiagnosed, abnormal vaginal bleeding.

To be sure this medication is helping your condition, your doctor will need to check your progress on a regular basis, especially during the first 6 to 8 weeks of treatment. It is important that you not miss any scheduled visits to your doctor.

When you first start using nafarelin nasal to treat precocious puberty, you may notice an increase in signs of puberty, such as enlarged breasts or vaginal bleeding. These are normal side effects of this medication during the first month of use. If such pubertal signs continue for longer than 1 month, contact your doctor.

Get emergency medical help if you have any of these signs of a rare side effect called pituitary apoplexy: sudden headache with vision changes, vomiting, confusion, slow heart rate, chest pain, weakness, fainting, or cardiac arrest.

What should I discuss with my healthcare provider before using nafarelin nasal?

Do not use nafarelin nasal if you have:
  • a history of allergic reaction to this medication or to similar medicines such as gonadorelin (Factrel);

  • undiagnosed, abnormal vaginal bleeding; or

  • if you are pregnant or breast-feeding.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using nafarelin nasal, tell your doctor if you have:

  • polycystic ovary disease;

  • a personal or family history of osteoporosis;

  • a head cold, allergies, or other causes of a stuffy or runny nose; or

  • if you smoke or drink large amounts of alcohol.

FDA pregnancy category X. This medication can cause birth defects. Do not use nafarelin nasal if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective barrier form of birth control (such as a condom or diaphragm with spermicide gel or inserts). Hormonal forms of contraception (such as birth control pills, injections, implants, skin patches, and vaginal rings) may not be effective enough to prevent pregnancy during your treatment. It is not known whether nafarelin nasal passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use nafarelin nasal?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor.

To use the nasal spray:

  • Before the first use, prime the spray bottle by pumping it 5 to 10 times until a fine spray appears.

  • Gently blow your nose to clear any mucus. Uncap the spray bottle.

  • Insert the tip of the spray bottle into your nostril, pointing it straight upward. Block your other nostril with your finger. Quickly and gently pump the spray bottle one time and sniff gently at the same time. Remove the pump from your nose and tilt your head back slightly for a few seconds.

  • If using more than one spray per nostril, wait at least 30 seconds between each spray.

  • Clean the spray bottle tip with a tissue and recap it.

To be sure this medication is helping your condition, your doctor will need to check your progress on a regular basis, especially during the first 6 to 8 weeks of treatment. It is important that you not miss any scheduled visits to your doctor.

When you first start using nafarelin nasal to treat precocious puberty, you may notice an increase in signs of puberty, such as enlarged breasts or vaginal bleeding. These are normal side effects of this medication during the first month of use. If such pubertal signs continue for longer than 1 month, contact your doctor.

It is important to use nafarelin nasal regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store nafarelin nasal at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of nafarelin nasal is not likely to produce life-threatening symptoms.

What should I avoid while taking nafarelin nasal?

Try not to sneeze or blow your nose just after using the spray. This may decrease the amount of medication your body absorbs.

Nafarelin nasal side effects

Get emergency medical help if you have any of these signs of a rare side effect called pituitary apoplexy: sudden headache with vision changes, vomiting, confusion, slow heart rate, chest pain, weakness, fainting, or cardiac arrest. Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:
  • heavy or continued menstrual bleeding;

  • chest pain, shortness of breath;

  • fast or irregular heartbeats; or

  • pelvic pain or swelling.

Less serious side effects may include:

  • mild itching or skin rash;

  • oily skin or acne, increased body odor;

  • dandruff;

  • changes in breast size;

  • increase in pubic hair growth;

  • nasal irritation or runny nose;

  • hot flashes;

  • mild headache, muscle pain;

  • mood swings;

  • white or brownish vaginal discharge;

  • light and occasional menstrual bleeding;

  • vaginal dryness; or

  • changes in sexual desire.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Nafarelin nasal Dosing Information

Usual Adult Dose for Endometriosis:

200 micrograms intranasally daily. This is achieved by one spray (200 micrograms) into one nostril in the morning and one spray into the other nostril in the evening. Treatment should be started between days 2 and 4 of the menstrual cycle. In an occasional patient, the 400 microgram daily dose may not produce amenorrhea. For these patients with persistent regular menstruation after 2 months of treatment, the dose may be increased to 800 micrograms daily administered as one spray into each nostril in the morning (a total of two sprays) and again in the evening. The recommended duration of treatment is six months. Retreatment cannot be recommended since safety data for retreatment are not available.

Usual Pediatric Dose for Precocious Puberty:

800 micrograms intranasally twice daily. This is achieved by two sprays (400 micrograms) into one nostril and two sprays into the other nostril twice a day. If adequate suppression cannot be achieved, the dosage may be increased to 1800 micrograms intranasally per day administered as 3 sprays (total of 600 micrograms) into alternating nostrils three times a day.

What other drugs will affect nafarelin nasal?

If you have a stuffy nose during your treatment with nafarelin nasal, ask your doctor before using a decongestant. If your doctor recommends a decongestant nasal spray, do not use the decongestant for at least 2 hours after you have used nafarelin nasal.

Before using nafarelin nasal, tell your doctor if you use steroids or medicine to control seizures.
  • seizure medication; or

  • steroids such as prednisone, fluticasone (Advair), mometasone (Asmanex, Nasonex), dexamethasone (Decadron, Hexadrol) and others.

This list is not complete and there may be other drugs that can interact with nafarelin nasal. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

  • Your pharmacist can provide more information about nafarelin nasal.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
Copyright 1996-2006 Cerner Multum, Inc. Version: 2.02. Revision Date: 4/12/2009 4:37:42 PM.
  • nafarelin Nasal Advanced Consumer (Micromedex) - Includes Dosage Information
  • Nafarelin MedFacts Consumer Leaflet (Wolters Kluwer)
  • Synarel Prescribing Information (FDA)
  • Synarel Detailed Consumer Information (PDR)