Nafarelin

Nafarelin may cause side effects. Usually these symptoms are temporary, lasting only until your body adjusts to the medication. Tell your doctor if any of these symptoms are severe or do not go away:

1. acne
2. breast enlargement
3. vaginal bleeding (menstruation should stop with this medication)
4. mood swings
5. increase in pubic hair
6. body odor
7. seborrhea (skin irritation)
8. nasal irritation
9. headache
10. hot flashes
11. insomnia
12. change in weight
13. vaginal dryness or vaginal discharge
14. change in sex drive
15. oily skin
16. muscle aches
17. rhinitis (runny nose)
18. depression

If you experience any of the following symptoms, call your doctor immediately:

1. stomach pain not related to menstruation
2. shortness of breath or difficulty breathing
3. chest pain
4. rash
5. severe itching

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Dosage Forms & Strengths

nasal spray

• 2mg/mL

Endometriosis

1 spray (200 mcg/spray) in one nostril qAM, 1 spray in the other nostril qPM (total 400 mcg/day) on days 2-4 of menstrual cycle (2 sprays/day)

May increase to 800 mcg/day if still menstruating after 2 month: 1 spray in each nostril twice daily

Maximum treatment duration: 6 months

Dosage Forms & Strengths

nasal spray

• 200mcg/spray

Central Precocious Puberty

<2 years: Safety and efficacy not established

≥2 years: 2 sprays (200 mcg/spray) in each nostril twice daily (total 1600 mcg/day)

May increase to 1800 mcg/day: 3 sprays (200 mcg/spray) into alternating nostrils TID (total 9 sprays/day)

Discontinue when puberty onset is desired

Nafarelin is a prescription medication used to treat women with symptoms of endometriosis including severe menstrual cramps, pain during sexual intercourse, low back pain, and painful bowel movements. It is also used to treat abnormally early sexual development in children, known medically as central precocious puberty (CPP). 

Nafarelin belongs to a group of drugs called synthetic hormones, which help control hormone levels in the body.

This medication comes in the form of a nasal spray. In treating endometriosis, one spray is inhaled in one nostril in the morning, and one spray is inhaled in the other nostril in the evening. In treating CPP, two sprays are inhaled in each nostril every morning.

Common side effects of nafarelin include acne, breast enlargement, and vaginal bleeding.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• medicines for epilepsy (seizures)
• nasal decongestants (if you must take a nasal decongestant, wait at least 2 hours after using nafarelin spray)
• steroids
• vitamins

This is not a complete list of nafarelin drug interactions. Ask your doctor or pharmacist for more information.

It is not known if nafarelin crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using nafarelin.

For treating endometriosis, nafarelin is usually used twice a day: one spray in one nostril in the morning and one spray in the other nostril in the evening. Nafarelin should be started between the second and fourth days of your menstrual period. Nafarelin should not be used for longer than 6 months to treat endometriosis.

For treating precocious puberty, nafarelin is usually used once a day as two sprays in each nostril each morning, for a total of four sprays each morning.

• Store upright at room temperature. Do not freeze.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.
• Throw away any unused portion after 30 days.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

(naf a REL in)

• Nafarelin Acetate

• Synarel

Hypersensitivity to gonadotropin-releasing hormone (GnRH), GnRH-agonist analogs, or any component of the formulation; undiagnosed abnormal vaginal bleeding; pregnant women or those who may become pregnant; breast-feeding

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience headache, hot flashes, acne, muscle pain, weight gain, vaginal irritation, rhinorrhea, emotional instability, decreased libido, enlarged breasts, change in body odor, or signs of puberty. Have patient report immediately to prescriber angina, severe rhinitis, menstruation, depression, mood changes, shortness of breath, abdominal pain, swelling of arms or legs, vaginal discharge, severe vaginal bleeding, bone pain, or signs of pituitary apoplexy (sudden headache, vomiting, passing out, mood changes, eye weakness, unable to move eyes, or vision changes) (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.