Generic Name: nafarelin (Nasal route)
Commonly used brand name(s):
In the U.S.
Available Dosage Forms:
Therapeutic Class: Endocrine-Metabolic Agent
Pharmacologic Class: Luteinizing Hormone Releasing Hormone Agonist
Nafarelin is a hormone similar to the one normally released from the hypothalamus gland in the brain. It is used in the treatment of:
Nafarelin works by decreasing the amount of estrogen and testosterone in the blood.
When given regularly to boys and girls, this medicine helps to prevent them from continuing to develop the sexual features associated with puberty, slowing down the development of breasts in girls and the development of genital areas in boys and girls. This medicine delays puberty in a child only as long as the child continues to take it.
Nafarelin prevents the growth of tissue associated with endometriosis in adult women during treatment and for 6 months after treatment is discontinued. Reducing the amount of estrogen in the body is one way of treating endometriosis.
Suppressing estrogen can thin the bones or slow their growth. This is a problem for adult women whose bones are no longer growing like the bones of children. Slowing the growth of bones is a positive effect for girls and boys whose bones grow too fast when puberty begins too early. This is why nafarelin is used only for up to 6 months in adult women treated for endometriosis, but often is used for a longer time in girls and boys with pubertal problems. Boys and girls may benefit by adding inches to their adult height when nafarelin causes their bones to grow at a proper rate.
Nafarelin is available only with your doctor's prescription.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Studies of this medicine for treatment of endometriosis have been done only in adult patients, and there is no specific information comparing use of nafarelin to treat this condition in children younger than 18 years of age with use in other age groups. Endometriosis is not likely to occur before puberty.
When used to treat a child for central precocious puberty, nafarelin will stop having an effect soon after the child stops using it, and puberty will advance normally. It is not known if nafarelin causes:
It is especially important that you discuss with the child's doctor the good that this medicine may do as well as the risks of using it.
|All Trimesters||X||Studies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.|
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
You will be given a fact sheet with your prescription for nafarelin that explains how to use the pump spray bottle. If you have any questions about using the pump spray, ask your health care professional.
To use nafarelin spray:
It is important to avoid sneezing when spraying and immediately after using the medicine. If you sneeze, the medicine may not be absorbed as well.
Use this medicine only as directed by your doctor. Do not use more or less of it, and do not use it more often than your doctor ordered. The exact amount of medicine you need has been carefully worked out. Using too much may increase the chance of side effects, while using too little may not improve your condition.
Many boys and girls who have central precocious puberty will not feel sick or will not understand the importance of taking the medicine regularly. It is very important that the medicine is used exactly as directed and that the proper amount is used at the proper time. It works best when there is a constant amount in the blood. To help keep the amount constant, nafarelin must be given on a regular schedule.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
The bottle should be stored standing upright, with the tip up.
All scheduled visits to the doctor should be kept, even if the medicine seems to be working properly and you feel well. This is especially important for children using the medicine for treatment of central precocious puberty, even if their condition improves. Their progress still must be checked by the doctor when they are no longer using the medicine.
For children treated for central precocious puberty— Tell the doctor if nafarelin does not stop puberty from progressing within 6 to 8 weeks. You may notice puberty progressing in your child for the first few weeks of therapy, but you should see signs that puberty is stopping within 4 weeks after your child begins nafarelin therapy.
For adult women treated for endometriosis—
In the first few weeks of therapy, you may notice puberty progressing in your child, including vaginal bleeding and breast enlargement in girls. Within 4 weeks after nafarelin has had time to begin working properly, you should see signs in boys and girls that puberty is stopping. However, pubic hair may continue to show or grow in either boys or girls.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:More commonFor adults (female)
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:More commonFor adults (female)
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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