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Before Using
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:
Allergies
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.
Pediatric
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of leuprolide pediatric injection in children. However, use is not recommended in children younger than 2 years of age. Leuprolide pediatric injection will stop having an effect on a child treated for central precocious puberty soon after the child stops using it, and puberty will advance normally. It is not known if using leuprolide around the time of puberty causes changes in boys' and girls' future abilities to have babies. Their chances of having children later are thought to be normal. It is especially important that you discuss with the child's doctor the benefit of this medicine as well as the risk of using it.
Appropriate studies have not been performed on the relationship of age to the effects of Eligard®, Lupron® injection, Lupron Depot®, Lupron Depot®-3 month, Lupron Depot®-4 month, Lupron Depot®-6 month, or Viadur® in the pediatric population. Safety and efficacy have not been established.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Eligard®, Lupron® injection, Lupron Depot®, Lupron Depot®-3 month, Lupron Depot®-4 month, or Lupron Depot®-6 month in the elderly.
No information is available on the relationship of age to the effects of leuprolide pediatric injection and Viadur® in geriatric patients.
Pregnancy
| Pregnancy Category | Explanation | |
|---|---|---|
| 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. |
Breastfeeding
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.
Drug Interactions
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.
Other Interactions
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.
Other Medical Problems
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:
- Benzyl alcohol allergy, history of—Using Lupron® injection (certain brand) may cause a skin reaction.
- Brain problems (e.g., brain tumors), history of or
- Pituitary gland problem or
- Seizures or epilepsy, history of or
- Stroke, history of—Use with caution. May make these conditions worse.
- Changes in vaginal bleeding from an unknown cause (for use for endometriosis or anemia due to tumors of the uterus)—Leuprolide may delay diagnosis or worsen condition. The reason for the bleeding should be determined before leuprolide is used.
- Conditions that increase the chances of developing thinning bones or
- Osteoporosis (thinning of the bones), family history of—It is important that your doctor know if you already have an increased risk of osteoporosis. Some things that can increase your risk for having osteoporosis include cigarette smoking, alcohol abuse, and a family history of osteoporosis or easily broken bones. Some medicines, such as corticosteroids (cortisone-like medicines) or anticonvulsants (seizure medicine), can also cause thinning of the bones when used for a long time.
- Congestive heart failure or
- Diabetes or
- Electrolyte imbalance or
- Heart or blood vessel disease or
- Heart rhythm problems (e.g., congenital long QT syndrome) or
- Hyperglycemia (high sugar in the blood)—Use with caution. May make these conditions worse in patients treated for prostate cancer.
- Nerve problems caused by bone lesions in the spine (in treatment of cancer of the prostate) or
- Problems in passing urine (in treatment cancer of the prostate)—Conditions may get worse for a short time after leuprolide treatment is started. Your doctor will want to follow your condition carefully.
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