Generic Name: Nafarelin Brand Name(s): Generics only. No brands available.

Uses

What is Nafarelin used for?

Nafarelin is used in women to treat a condition in which the tissue that normally lines the inside of the uterus grows in the wrong place (endometriosis). This medication helps to decrease the abnormal tissue and also the symptoms of endometriosis (such as pelvic pain, painful menstrual cramps, and pain during/after sex).

This medication is also used in children to treat a certain type of early puberty (central precocious puberty, gonadotropin-dependent). It helps to slow the bone aging and height growth rate so that both are near normal, and it helps to stop or reverse signs of early puberty (such as breast growth in girls, growth of sexual organs in boys).

Nafarelin is similar to a natural hormone made by the body (gonadotropin-releasing hormone-GnRH). It works by decreasing the testosterone hormones in boys and estrogen hormones in women and girls.

How should I take Nafarelin?

Follow the instructions for test sprays in the air if you are using a bottle for the first time. A fine mist is a sign that the spray is working properly.

Gently blow your nose before using this drug. For very young children, it may be necessary to clear the nose with a bulb syringe.

Use this medication as directed by your doctor, usually twice daily (about every 12 hours). If you are using more than 1 spray at a time, wait 30 seconds between each spray. Avoid spraying this medication in your eyes. Also, avoid sneezing during or right after using this medication because this may decrease the amount of medication absorbed. Follow the detailed instructions for cleaning the spray tip. It is important to clean the spray tip after each use.

The dosage and length of treatment are based on your medical condition and response to treatment.

It is very important to continue using this medication exactly as prescribed by your doctor. Do not skip any doses. To help you remember, use it at the same times each day.

Ask your doctor or pharmacist to find out how long each bottle of the nasal spray should last. Do not use the nasal spray bottle longer, even if there is medication left over, because you will not get a full dose. Make sure to get your medication refills a few days early so that you will not run out of your medication.

Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

If you need to use a nasal decongestant spray while using this medication, wait at least 2 hours after using this medication before using the decongestant.

 

When you first start this medication, worsening of symptoms may occur (such as increased vaginal bleeding for women treating endometriosis, or vaginal bleeding/period, increase in breast size/pubic hair, oily skin, or body odor for children treating early puberty). These symptoms should get better after the first month of treatment. Tell your doctor if your symptoms do not get better or if they get worse after 2 months of treatment.

How do I store Nafarelin?

Nafarelin is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Nafarelin in the bathroom or the freezer. There may be different brands of Nafarelin that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Nafarelin down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Nafarelin?

Before using nafarelin, tell your doctor or pharmacist if you are allergic to it; or to GnRH or other GnRH-like hormones (such as leuprolide); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: unexplained abnormal vaginal bleeding, smoking, daily alcohol use, bone loss (osteoporosis) or family history of osteoporosis, polycystic ovarian disease, high cholesterol/triglyceride levels, seizures, mental/mood problems (such as depression).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication must not be used during pregnancy. It may harm an unborn baby. Women should start this medication between days 2 and 4 of their period. Although periods and the release of eggs (ovulation) may stop while you are using this drug, this is not a reliable form of birth control. Discuss the use of non-hormonal forms of birth control (such as condoms, diaphragm with spermicide) with your doctor. If you become pregnant or think you may be pregnant, tell your doctor right away.

It is unknown if this medication passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Nafarelin during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Nafarelin. Nafarelin is pregnancy risk category X according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Nafarelin?

Nasal irritation, hot flashes, or vaginal discharge may occur in children. Nasal irritation, hot flashes, headaches, decreased sexual interest, muscle pain, vaginal dryness, acne, or decrease in breast size may occur in women. If any of these effects last or get worse, tell the doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell the doctor right away if any of these serious side effects occur: mental/mood changes (such as depression, thoughts of suicide, mood swings, aggression).

Get medical help right away if any of these very serious side effects occur: seizures.

Rarely, a very serious problem with the pituitary gland (pituitary apoplexy) may occur, usually in the first hour to 2 weeks after the first dose of this medication. Get medical help right away if any of these very serious side effects occur: sudden severe headache, sudden severe mental/mood changes (such as severe confusion, difficulty concentrating), vision changes, vomiting.

For women using this medication, tell your doctor right away if you have any serious side effects, including: abdominal/lower back pain, bone pain, fast/pounding heartbeat, numbness/tingling of arms/legs, eye pain.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Nafarelin?

This medication may interfere with certain lab tests (such as tests for pituitary gonadotropic and gonadal functions), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

Nafarelin may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Nafarelin?

Nafarelin may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Nafarelin?

Nafarelin may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Nafarelin.

What is the dose of Nafarelin for an adult?

Usual Adult Dose for Endometriosis

200 mcg (as 1 spray into 1 nostril) intranasally 2 times a day

-Maximum dose: 800 mcg/day (as 1 spray into each nostril 2 times a day)

-Duration of therapy: 6 months

Comments:

-Doubling the recommended dose should be considered in compliant patients who experience menstruation for 2 months after starting treatment.

-Treatment should begin between days 2 and 4 of the menstrual cycle.

-Patients receiving the recommended dose should alternate nostrils, with administration into one nostril in the morning and the other nostril in the evening.

Use: Management of endometriosis, including pain relief and reduction of endometriotic lesions

Other Comments

Administration advice:

-Patients should tilt their heads slightly back during administration.

-If multiple sprays are required in one nostril, doses should be separated by 30 seconds.

-Patients who sneeze during/immediately after administration should consider repeating the dose.

Storage requirements:

-Protect from light and freezing; store upright when not in use.

General:

-When used to treat endometriosis, this drug produces a menopause-like state via induction of chronic pituitary desensitization.

-Controlled ovulation stimulation should be supervised by an infertility specialist.

-Alternative etiologies should be ruled out in patients with central precocious puberty prior to beginning treatment (e.g., hypothalamic/pituitary/testicular tumors, increased intracranial pressure, congenital adrenal hyperplasia, testotoxicosis, autonomous feminizing/masculinizing disorders).

Monitoring:

-Pregnancy tests prior to treatment and in any patient who misses a dose

-Bone density, especially in patients with a high risk of reduced bone mass and/or receiving 2 or more courses of therapy

-Estradiol and progesterone levels, especially in patients on treatment for controlled ovulation or precocious puberty

-Luteinizing hormone, especially patients on treatment for precocious puberty

-Growth and bone age velocity in patients on treatment for precocious puberty

-Development/worsening of psychiatric symptoms

Patient advice:

-Patients should be advised to speak to their healthcare provider if they are pregnant, intend to become pregnant, or are breastfeeding; patients should be told to use non-hormonal, barrier contraceptives during treatment.

-Patients and/or caregivers should be instructed to maintain complete compliance during treatment; if included, the informational pamphlet should be read prior to use.

-Patients should be told to contact their healthcare providers if doses are missed or menstruation occurs despite compliance.

-Patients should contact their healthcare provider if nasal congestion or rhinitis occurs to determine appropriate treatments. Topical nasal decongestants should be separated by at least 30 minutes.

What is the dose of Nafarelin for a child?

Usual Pediatric Dose for Precocious Puberty

800 mcg (as 2 sprays into each nostril) intranasally 2 times a day

-Maximum dose: 1800 mcg/day (as 3 sprays into alternating nostrils 3 times a day)

Comments:

-If patients do not have symptom resolution within the first 2 months of treatment, compliance and gonadotropin independent sexual precocity should be evaluated; the dose may be increased to 1800 mcg/day if both etiologies are excluded.

-Signs of puberty may occur early in treatment, but should resolve after the first month.

-Treatment may continue until the resumption of puberty is appropriate.

 

Use: Treatment of central/gonadotropin-dependent precocious puberty

Precautions

Safety and efficacy have not been established for the treatment of endometriosis in female patients younger than 18 years.

How is Nafarelin available?

Nafarelin is available in the following dosage forms and strengths:

  • Nasal solution
  • Nasal spray

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Nafarelin, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

 

Hello Health Group does not provide medical advice, diagnosis or treatment.

Sources

Review Date: March 30, 2018 | Last Modified: March 30, 2018