Nafarelin

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.

Nafarelin is a prescription medicine used to relieve the symptoms of:

• endometriosis
• abnormally early sexual development in children, a condition known as central precocious puberty (CPP)

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

Nafarelin may be found in some form under the following brand names:

• Synarel

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:

• acne
• breast enlargement
• vaginal bleeding (menstruation should stop with this medication)
• mood swings
• increase in pubic hair
• body odor
• seborrhea (skin irritation)
• nasal irritation
• headache
• hot flashes
• insomnia
• change in weight
• vaginal dryness or vaginal discharge
• change in sex drive
• oily skin
• muscle aches
• rhinitis (runny nose)
• depression

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

• stomach pain not related to menstruation
• shortness of breath or difficulty breathing
• chest pain
• rash
• severe itching

This is not a complete list of nafarelin side effects. For more information ask your doctor or pharmacist.

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.

You should not use nafarelin if

• you are pregnant
• you are breastfeeding
• you have abnormal vaginal bleeding that has not been checked into by your doctor
• you are allergic to any ingredient of this medication

Your child should not use nafarelin if she/he is allergic to GnRH or GnRH agonist analogues or to any of the ingredients of nafarelin.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of nafarelin, there are no specific foods that you must exclude from your diet when receiving this medication.

Tell your doctor if you:

• are allergic to nafarelin, gonadotropin-releasing hormones, or any other medicines
• have or ever have had osteoporosis, ovarian cysts, ovarian tumors, ovarian cancer, chronic runny nose (rhinitis), a history of depression
• are pregnant, plan to become pregnant, or are breastfeeding

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

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Nafarelin falls into category X. This medication should not be used during pregnancy.

It is important to use a non-hormonal means of contraception (birth control) while using nafarelin (e.g., condom or diaphragm). If you become pregnant while using nafarelin, call your doctor immediately.

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.

Nafarelin is a prescription medicine that should be used according to the doctor's directions. Nafarelin comes as a special nasal spray that gives a measured amount of medicine. 

Important Information about Nafarelin - Endometriosis

1. It is important to use a non-hormonal method of contraception (such as diaphragm with contraceptive jelly, IUD, condoms) while taking nafarelin. You should not use birth control pills while taking nafarelin.
2. If you miss 1 or more doses of nafarelin, vaginal bleeding (often called breakthrough bleeding) may occur. If you miss successive doses of nafarelin and have not been using contraception as described above, release of an egg from the ovary (ovulation) may occur, with the possibility of pregnancy. Under these circumstances you must see your physician to make sure you are not pregnant. If you should become pregnant while using nafarelin, you must discuss the possible risks to the fetus and the choices available to you with your physician.
3. Because nafarelin works by temporarily reducing the body's production of estrogen, a female hormone produced by the ovary, you may have some of the same changes that normally occur at the time of menopause, when the body's production of estrogen naturally decreases. For the first two months after you start using nafarelin, you may experience some irregular vaginal spotting or bleeding. The duration and intensity of this bleeding may vary; it may be similar to your usual menstruation, or it may be lighter or heavier. The duration may also vary from brief to prolonged. In any case, you can expect this bleeding to stop by itself. After the first two months of treatment with nafarelin, you can expect a decrease in menstrual flow, and your periods may stop altogether. However, if you miss one or more doses of nafarelin, you may continue to experience vaginal bleeding. If you continue to experience normal menstrual cycles after two months use of nafarelin, you should see your doctor about the continued periods. Other changes due to decreased estrogen include hot flashes, vaginal dryness, headaches, mood changes, and decreased interest in sex. Most of these changes are caused by low estrogen levels and may occur during treatment with nafarelin. Some patients may also experience acne, muscle pain, reduced breast size, and irritation of the tissues inside the nose. These symptoms should disappear after you stop taking the drug.
4. When you take nafarelin, your estrogen levels will be low. Low estrogen levels can result in a small loss of mineral from bone, some of which may not be reversible. During one six-month treatment period, this small loss of mineral from bone should not be important. There are certain conditions that may increase the possibility of the thinning of your bones when you take a drug such as nafarelin. They are:
   • excessive use of alcohol;
   • smoking;
   • family history of osteoporosis (thinning of the bones with fractures);
   • taking other medications that can cause thinning of the bones. You should discuss the possibility of osteoporosis or thinning of the bones with your physician before starting nafarelin. You should also be aware that repeat treatments are not recommended since they may put you at greater risk of bone thinning, particularly if you have the above conditions.
5. During studies, menstruation usually resumed within 2 to 3 months of stopping treatment with nafarelin. At the end of treatment 60% of patients treated with nafarelin were symptom free, 32% had mild symptoms, 7% had moderate symptoms and 1% had severe symptoms. 
   Of the 60% of patients who had complete relief of symptoms at the end of treatment, 17% had moderate symptoms at the end of the six month post-treatment period; 33% had mild symptoms; 50% were symptom free; no patient had severe symptoms.
6. Retreatment cannot be recommended since the safety of such retreatment is not known.
7. It is all right to use a nasal decongestant spray while you are being treated with nafarelin if you follow these simple rules. Use nafarelin first. Wait at least 2 hours after using nafarelin before you use the decongestant spray.
8. You should avoid sneezing during or immediately after using nafarelin, if possible, since sneezing may impair drug absorption.

Proper use of Nafarelin for Treatment of Endometriosis

1. When you start to use nafarelin, the first dose should be taken between the second and fourth day after the beginning of your menstrual bleeding. You should continue taking nafarelin every day as prescribed. Do not miss a single dose.
2. Unless your doctor has given you special instructions, follow the steps for using nafarelin twice each day, about 12 hours between doses:
   • once in the morning in one nostril (for example, 7 a.m.)
   • once in the evening in the other nostril (for example, 7 p.m.)
   The length of treatment is usually about 6 months, unless your doctor has given you special instructions.
3. Because it is so important that you do not miss a single dose of nafarelin, here are some suggestions to help you remember:
   • Keep your nafarelin in a place where you will be reminded to use it each morning and each evening — next to your toothbrush is one possibility.
   • Keep track of each dose on a calendar.
   • Make a note on your calendar on the day you start a new bottle of nafarelin. You can also mark the date you started right on the bottle. Be sure to refill your prescription before the 30 days are up so you will have a new bottle on hand.
4. A bottle of nafarelin should not be used for longer than 30 days (60 sprays). Each bottle contains sufficient quantity of nasal solution for initial priming of the pump and 30 days (60 sprays) of treatment. At the end of 30 days, a small amount of liquid will be left in the bottle. Do not try to use up that leftover amount because you might get too low a dose, which could interfere with the effectiveness of your treatment. Dispose of the bottle and do not reuse.
5. If your doctor increases your daily dose of nafarelin, then your bottle will not last the standard 30 days. Please discuss this with your doctor to be sure that you have an adequate supply for uninterrupted treatment with nafarelin to complete the recommended treatment period.

Preparation of the nafarelin Nasal Spray unit - For use in your nose only.

Before you use nafarelin nasal spray for the first time, you will need to prime it. This will ensure that you get the right dose of medicine each time you use it.

Important Tips about using nafarelin 

• Your pump should produce a fine mist, which can only happen by a quick and firm pumping action. It is normal to see some larger droplets of liquid within the fine mist. However, if nafarelin comes out of the pump as a thin stream of liquid instead of a fine mist, nafarelin may not work as well, and you should talk to your pharmacist.
• Be sure to clean the Spray Tip before and after every use. Failure to do this may result in a clogged tip that may cause you not to get the right amount of medicine that is prescribed for you.
• The pump is made to deliver only a set amount of medicine, no matter how hard you pump it.
• Do not try to make the tiny hole in the spray tip larger. If the hole is made larger the pump will deliver a wrong dose of nafarelin.

Nafarelin - central precocious puberty (CPP)

To be effective, nafarelin must be used every day, twice a day, until you and your child's doctor decide that resumption of puberty is desired for your child. If your child doesn't take the right amount every day, or if she/he doesn't take nafarelin on the regular prescribed schedule, pubertal development may be restarted and/or the beneficial effects on height may be lost.

Menstrual flow may occur in girls during the first six weeks of treatment, whether or not they had been menstruating before starting treatment with nafarelin. Menstrual flow should stop soon after the first six weeks.

In children receiving nafarelin for central precocious puberty, some signs of puberty (for example breast enlargement in girls) may increase during the first month of treatment. This is a normal effect of the drug. You should continue treatment at the prescribed dose.

It is all right for your child to use a nasal decongestant spray while she/he is being treated with nafarelin if you follow these simple rules. Use nafarelin first. Wait at least 2 hours after using nafarelin before your child uses the decongestant spray.

Your child should avoid sneezing during or immediately after using nafarelin, if possible, since sneezing may impair drug absorption.

Proper Use of nafarelin for Treatment of Central Precocious Puberty

1. When your child starts to use nafarelin she/he should continue taking it every day as prescribed. 
   Do not miss any doses.
2. Unless your child's doctor has given you special instructions, Central Precocious Puberty patients should follow the steps for using nafarelin twice each day in both nostrils, about 12 hours between doses:
   • two sprays in each nostril (4 sprays total) in the morning (for example, 7 a.m.);
   • two sprays in each nostril (4 sprays total) in the evening (for example, 7 p.m.).
   The head should be tilted slightly back, and you should wait about 30 seconds between sprays into the same nostril. More detailed instructions follow.
3. Treatment for central precocious puberty should continue until you and your child's doctor decide that it is appropriate for puberty to resume.
4. Because it is so important that your child not miss a single dose of nafarelin, here are some suggestions to help you remember:
   • Keep your child's nafarelin in a place where you will be reminded for her/him to use it each morning and each evening — next to your toothbrush is one possibility.
   • Keep track of each dose on a calendar.
   • Make a note on your calendar on the day you start a new bottle of nafarelin. You can also mark directly on the bottle the date it was started. Be sure to refill your child's prescription before the 7 days are up so you will have a new bottle on hand.
5. A bottle of nafarelin for central precocious puberty patients should not be used for longer than 7 days, unless your child's doctor specifically tells you it may be used for a longer time. If the doctor tells you to use a bottle only for 7 days, then a small amount of liquid will be left in the bottle. Do not try to use up the leftover amount because your child might get too low a dose, which could interfere with the effectiveness of the treatment. Dispose of the used bottle properly and do not reuse.
6. If the doctor increases your child's daily dose of nafarelin, then one bottle will not last the standard 7 days. Please discuss this with your child's doctor to be sure that you have an adequate supply for uninterrupted treatment with nafarelin.

Preparation of the nafarelin - Nasal Spray unit

For use in your nose only.

Before you use a bottle of nafarelin nasal spray for the first time, you will need to prime it. This will ensure that you get the right dose of medicine each time you use it.

Important Tips about using nafarelin:

• Your pump should produce a fine mist, which can only happen by a quick and firm pumping action. It is normal to see some larger droplets of liquid within the fine mist. However, if nafarelin comes out of the pump as a thin stream of liquid instead of a fine mist, nafarelin may not work as well, and you should talk to your pharmacist.
• Be sure to clean the Spray Tip before and after every use. Failure to do this may result in a clogged tip that may cause you not to get the right amount of medicine that is prescribed for you.
• The pump is made to deliver only a set amount of medicine, no matter how hard you pump it.
• Do Not try to make the tiny hole in the spray tip larger. If the hole is made larger the pump will deliver a wrong dose of 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.

If you take too much nafarelin, call your doctor or local Poison Control Center right away.

• Store nafarelin at 59°F to 86°F (15°C to 30°C).
• Store the nafarelin bottle upright.
• Keep nafarelin out of the light.
• Do not freeze nafarelin.

Keep out of the reach of children and use carefully as directed.