Nafarelin, Intranasal, for Central Precocious Puberty

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KEY POINTS

• This medicine is sprayed in the nose to treat central precocious puberty. Use it exactly as directed.
• Keep all appointments for tests to see how this medicine affects your child.
• This medicine may cause unwanted side effects. Tell your healthcare provider if your child has any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that your child takes.

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What are other names for this medicine?

Type of medicine: hormone

Generic and brand names: nafarelin, intranasal; Synarel

What is this medicine used for?

This medicine is used to delay sexual maturing in children when signs of puberty start before 8 years of age in girls or 9 years of age in boys. This is called central precocious puberty.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before my child takes this medicine?

Before taking this medicine, tell your healthcare provider if your child has ever had:

• An allergic reaction to any medicine
• Abnormal vaginal bleeding
• Polycystic ovary syndrome

Females of childbearing age: Do not take this medicine if you are pregnant. This medicine has been reported to cause birth defects. Stop taking this medicine at the first sign that you may be pregnant and contact your healthcare provider right away. Do not breast-feed while taking this medicine.

How do I use it?

This medicine is in the form of a nose spray. The medicine is absorbed into the body from the nose. This is not an ordinary nose spray and is not used for colds. Parents should supervise the use of this medicine in children. Be sure that your child gets the correct number of sprays in each nostril the correct number of times each day. Use this medicine each day until the healthcare provider tells you to stop. It is important that your child not miss a dose of this medicine. If you use it incorrectly, the treatment may fail. Follow the healthcare provider's directions exactly.

Check the label on the medicine for directions about your child’s specific dose. Follow the instructions included in the medicine package for proper use, cleaning, and storage of this medicine.

Do not use a nasal decongestant within 2 hours of using this medicine.

Try not to sneeze during or right after using this medicine. Sneezing may keep the medicine from working properly.

What if I miss a dose?

Do not miss doses. If you do miss a dose, contact your healthcare provider right away.

What if I give an overdose?

Symptoms of an acute overdose have not been reported.

What should I watch out for?

During the first month of treatment, vaginal bleeding or breast enlargement may happen and are expected. If these conditions continue more than 2 months, contact the healthcare provider right away.

Your healthcare provider will want to check your child regularly while receiving this medicine. Your child may need tests to see how this medicine affects him or her. Keep all appointments.

If your child needs emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist your child is using this medicine.

What are the possible side effects?

Along with its needed effects, this medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your child’s body adjusts to the medicine. Tell your healthcare provider if your child has any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives; itching; rash; trouble breathing; tightness in the chest; swelling of the lips, tongue, and throat).

Serious (Report these to your healthcare provider right away.): Chest pain, seizures, sudden headache, severe vomiting, vision changes, confusion, vaginal bleeding or breast enlargement that continues more than 2 months.

Other: Acne, increase in pubic hair, body odor, runny or stuffy nose, headache, white or brownish discharge from the vagina, mood changes, hot flashes, flaky skin.

What products might interact with this medicine?

No significant drug interactions have been reported. However, do not use any other nose sprays or drops unless they are approved by the healthcare provider who prescribed this medicine. If your healthcare provider approves another nose spray or nose drops, wait at least 2 hours after using this medicine before you use the other medicine.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your child’s medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that your child takes. Be sure that you tell all healthcare providers who treat your child about all the products your child is taking.

How should I store this medicine?

Store this medicine at room temperature and in an upright position. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.