Lupron CPP - Consumer Medicine Information
|Condition:||Endometriosis, Hirsutism, Prostate Cancer, Uterine Fibroids|
|Class:||Gonadotropin-releasing hormone antagonists, Hormones/antineoplastics|
|Form:||Liquid solution, Subcutaneous (SC)|
|Ingredients:||leuprolide acetate, benzyl alcohol, sodium chloride, sterile water for injection|
About this medication
What the medication is used for:
- LUPRON (leuprolide acetate injection) is indicated in the treatment of children with central precocious puberty.
What is precocious puberty?
Precocious puberty occurs when girls under the age of 8 or boys under the age of 9 begin to develop signs of sexual maturity.
Signs and symptoms:
- Girls develop breasts and may have monthly periods.
- The penis and testicles of boys grow larger.
- Behavior may change; children may become aggressive or moody.
- Pubic hair grows in both sexes.
- Children may have oily skin and/or acne.
- Children may be the tallest in the class; there is a sudden growth spurt like that usually seen in teenagers.
Why does it happen:
In most cases, there is no special reason for this early development. It is not caused by anything we do and is not necessarily passed on from parents to children. However, there may be some physical problem, like a tumor, causing precocious puberty; this would require other treatment. A doctor will need to perform tests to rule out some possible physical causes.
What the medication does:
LUPRON is a hormone-like agent. It is given by injection once a day to adjust your child's body clock (monthly injections are also available).
- Your child will stop making some hormones at adult levels.
- Pubertal changes (pubic hair, girl's period, breasts, etc.) should stop and may even become less obvious.
- Growth rate becomes more normal.
- When it's right for your child, your child’s doctor will stop administering the shots and puberty will begin again.
When it should not be used:
LUPRON should not be used:
- If your child is allergic to leuprolide acetate, any similar nonapeptides (e.g., histrelin, desorelin), or any of the non-medicinal ingredients in LUPRON.
- In women who are pregnant or may become pregnant.
- In women who are breast-feeding.
What the medicinal ingredient is:
What the important non-medicinal ingredients are:
Each 2.8 mL multiple-dose vial contains benzyl alcohol, sodium chloride, and sterile water for injection. Each vial also contains sodium hydroxide and/or acetic acid.
What dosage forms it comes in:
LUPRON is a drug which contains 5 mg of leuprolide acetate per mL. It comes in 2.8 mL multiple-dose vials. LUPRON is supplied as a 14-day kit.
Warnings and precautions
Before your child takes LUPRON tell your child’s doctor if:
- Your child is allergic to any component of the medication
- Your child has a family history of osteoporosis or is a chronic user of drugs that can reduce bone mass such as anticonvulsants, corticosteroids, alcohol and/or tobacco. LUPRON can cause thinning of the bone and may pose additional risk in patients with such a history.
- Your child has had or is suspected of having seizures, epilepsy, cerebrovascular disorder, central nervous system anomalies, or brain tumor.
- Your child is taking other medication(s) that have been associated with convulsions or seizures such as bupropion and any SSRI medication for depression.
Interactions with this medication
Tell your child’s doctor and pharmacist if your child is taking, has been taking, or planning to take any other medicines, including non-prescription drugs (such as drug products for colds or nausea).
Proper use of this medication
Your child needs one injection a day, as prescribed by your child’s doctor.
It is very important that the doctor check your child’s progress at regular medical visits.
Only a small amount of LUPRON is needed once a day. Use the recommended ½ cc presterilized disposable syringe (see Instructions for Use Leaflet). Syringes are provided in the Patient Administration Kit.
Change the site of injection as instructed by your doctor.
As a guide, the usual sites of injection are indicated below:
SUGGESTED ROTATION OF THE INJECTION SITE
|In case of overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.|
Follow these instructions unless instructed otherwise by your child’s doctor: if your child misses an injection at the usual time, give it to him/her as soon as you remember, if you remember on the same day. If not, do not give him/her the missed dose at all. Simply wait until it is time for your child’s next dose. Do not give two doses at once. If you need more information, ask your child’s doctor.
Side effects and what to do about them
Postmarketing reports of convulsions have been observed in patients taking LUPRON®. These included patients in the female and pediatric populations, patients with a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and in patients on concomitant medications that have been associated with convulsions such as bupropion and SSRIs. Convulsions have also been reported in patients in the absence of any of the conditions mentioned above.
In the first few weeks of taking LUPRON, your child’s hormone levels will initially increase and then decline over several weeks. During this period some patients may experience worsening of symptoms.
The following items are not necessarily problems, but your child’s doctor will want to know about them. Call your child’s doctor or tell the doctor at your child’s next appointment if:
- Pubertal changes continue.
- Your daughter has a period, especially after the first month of treatment with LUPRON.
- Your child has substantial mood swings (write down the date this happens).
- You observe any behavioural changes in your child (boys may become aggressive; girls may become moody).
A skin reaction may occur: itching, redness, burning, and/or swelling at the injection site. These reactions usually are mild and disappear after a few days. If they persist or worsen, tell your child’s doctor.
Serious side effects, how often they happen and what to do about them
|Symptom/effect||Talk with your doctor or pharmacist||Stop taking
|Common||Abnormal swelling or numbness of limbs||√|
|Severe bone pain||√|
|Severe pain in chest or abdomen||√|
|Skin reactions including reaction at site of injection||√|
This is not a complete list of side effects. For any unexpected effects while taking LUPRON, contact your doctor or pharmacist.
How to store it
Store LUPRON vials or kits in the refrigerator (2 to 8°C) and protect from light (keep in carton until use).
As with other medications, KEEP OUT OF REACH OF CHILDREN.
|REPORTING SUSPECTED SIDE EFFECTS
You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:
NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.
This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, AbbVie Corporation at 1-800-699-9948.