Nafarelin Nasal Spray

(naf a' re lin)

Brand Name(s): Synarel^®

WHY is this medicine prescribed?

Nafarelin nasal spray is used to manage endometriosis (a condition in which the type of tissue that lines the uterus [womb] grows in other areas of the body and causes infertility, pain before and during menstrual periods, pain during and after sexual activity, and heavy or irregular bleeding). Nafarelin nasal spray is also used to treat central precocious puberty (CPP; a condition causing children to enter puberty too soon, resulting in faster than normal bone growth and development of sexual characteristics) in young boys and girls. Nafarelin is in a class of medications called gonadotropin-releasing hormone (GnRH) agonists. It works by decreasing the amount of certain hormones in the body.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Nafarelin comes as a solution (liquid) to spray in the nose. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use nafarelin exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor. Do not stop using nafarelin nasal spray without talking to your doctor.

If you are using nafarelin nasal spray to treat endometriosis, it is usually used twice a day (about 12 hours apart) as one spray in one nostril in the morning and one spray in the other nostril in the evening, for total of 2 sprays per day. Nafarelin should be started between the second and fourth days of your menstrual period. After 2 months and depending on your response, your doctor may increase your dose to 1 spray in each nostril twice a day, for a total of 4 sprays per day. The length of treatment is usually about 6 months.

If you are using nafarelin nasal spray to treat precocious puberty, it is usually sprayed in each nostril 2 or 3 times a day. If you are using nafarelin nasal spray 2 times a day, it is usually used as 2 sprays in each nostril, for a total of 8 sprays per day. It may also be used as 3 sprays in alternating nostrils 3 times a day, for a total of 9 sprays per day.

Avoid sneezing or blowing your nose during or immediately after using nafarelin nasal spray. This decreases nafarelin's effectiveness.

Before you use nafarelin nasal spray for the first time, read the written directions that come with it. Ask your doctor or pharmacist if you have any questions about how to use the nasal spray.

To use the nasal spray, follow these steps:

1. Remove the plastic cap and safety clip from the nasal spray pump.
2. If you are using the nasal spray pump for the first time, you must prime the pump. Hold the bottle upright with the applicator between your forefinger and middle finger and your thumb under the bottle. Point the bottle upright and away from your face. Press your thumb and fingers firmly and quickly against the pump 7 to 10 times until you see a fine spray.
3. Before and after using nafarelin nasal spray, hold the spray pump horizontally, and rinse the tip of the spray pump with warm water for 15 seconds while wiping the tip with a cloth or your finger. Wipe the tip with a clean tissue to dry.
4. Blow your nose until your nostrils are clear.
5. Close one nostril by gently placing your finger against the side of your nose, tilt your head slightly forward and, keeping the bottle upright, insert the nasal tip into the other nostril. Children using the nasal spray should have their head tilted slightly back. Point the tip toward the back and outer side of the nose.
6. Begin to breathe in through your nose. While you are breathing, press firmly and quickly upwards with the thumb at the base while holding the white shoulder portion of the pump between your index and middle fingers. Remove the sprayer from your nose and tilt your head back for a few seconds.
7. If your doctor told you to use two sprays in the same nostril, you should wait 30 seconds and then repeat steps 5 and 6 in the same nostril.
8. If your doctor told you to use the spray in the other nostril, repeat steps 5 through 6 in the other nostril.
9. Repeat step 3 to clean the spray tip and replace the cap and safety clip.

What SPECIAL PRECAUTIONS should I follow?

Before using nafarelin,

• tell your doctor and pharmacist if you are allergic to nafarelin, goserelin (Zoladex), histrelin (Supprelin LA), leuprolide (Camcevi, Eligard, Fensolvi, Lupron, Lutrate), triptorelin (Triptodur, Trelstar), any other medications, or any of the ingredients in nafarerlin nasal spray. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while using nafarelin nasal spray. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• If you are using nasal spray decongestants such as oxymetazoline (Afrin, others), use them at least 2 hours after using nafarelin nasal spray.

• tell your doctor if you have unusual vaginal bleeding. Your doctor may tell you not to use nafarelin nasal spray.

• tell your doctor if you have a history of drinking alcohol or using tobacco products for a long period of time, or if you or anyone in your family has or has ever had osteoporosis (condition where bones are thin and more likely to break). Also tell your doctor if you have or have ever had ovarian cysts, seizures, brain tumors, cerebrovascular disease (clogging or weakening of the blood vessels within the brain or leading to the brain), chronic rhinitis (runny nose), or mental problems such as depression.

• tell your doctor if you are pregnant or plan to become pregnant. Do not use nafarelin nasal spray if you are pregnant or think you are pregnant. You will need to use a reliable non-hormonal method of birth control to prevent pregnancy while using nafarelin nasal spray (e.g., condom or diaphragm). If you become pregnant while using nafarelin, call your doctor immediately. Nafarelin may harm the fetus.

• tell your doctor if you are breastfeeding. You should not breastfeed while you are using nafarelin nasal spray.

What should I do IF I FORGET to take a dose?

Use the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not use a double dose to make up for a missed one.

If doses are missed, you may experience breakthrough menstrual bleeding or signs of puberty. Do not be alarmed, but inform your doctor.

What SIDE EFFECTS can this medicine cause?

Nafarelin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• acne
• changes in breast size
• vaginal bleeding (menstruation should stop with this medication)
• mood swings
• increase in pubic hair
• body odor
• oily, flaky, or scaly skin
• nasal irritation
• headache
• hot flashes
• vaginal dryness or vaginal discharge
• change in sex drive
• muscle aches
• rhinitis (stuffy or runny nose)

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

• abdominal or pelvic pain
• rash, hives, itching, shortness of breath or difficulty breathing, or chest pain
• crying, irritability, impatience, anger, or aggressive behavior
• depression
• sudden headache, blurred vision, vision changes, eye pain, ringing in the ears, dizziness, or nausea
• seizures

Nafarelin may cause a decrease in the density of your bones, which can increase the chance of broken bones. Talk to your doctor about the risks of using this medication and to find out what you can do to decrease these risks.

In children receiving nafarelin nasal spray for precocious puberty, new or worsening symptoms of sexual development may occur during the first month of treatment. In girls receiving nafarelin nasal spray for precocious puberty, the onset of menstruation or spotting (light vaginal bleeding) and breast enlargment may occur during the first month of treatment. If bleeding continues beyond the second month, call your doctor.

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).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the container it came in, upright, tightly closed, and out of reach of children. Store it at room temperature and away from light, 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

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests before you begin treatment and during your treatment.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™. © Copyright, 2024. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: April 15, 2023.