Lupron Depot CPP - Consumer Medicine Information
|Condition:||Endometriosis, Hirsutism, Prostate Cancer, Uterine Fibroids|
|Class:||Gonadotropin releasing hormones, Hormones/antineoplastics|
|Form:||Liquid solution, Intramuscular (IM)|
|Ingredients:||leuprolide acetate, carboxymethylcellulose sodium, DL-lactic and glycolic acids copolymer, and D-mannitol, gelatine, glacial acetic acid, polysorbate 80, water for injection|
leuprolide acetate for depot suspension
About this medication
What the medication is used for:
- LUPRON DEPOT (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 DEPOT is a hormone-like agent. It is given by injection once a month to adjust your child's body clock (daily 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 DEPOT 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 DEPOT.
- 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:
Carboxymethylcellulose sodium, DL-lactic and glycolic acids copolymer, and D-mannitol, gelatine, glacial acetic acid, polysorbate 80 and water for injection..
What dosage forms it comes in:
LUPRON DEPOT is available in a pre-filled dual-chamber syringe containing leuprolide acetate as sustained-release microspheres and must be reconstituted with a special diluent prior to intramuscular injection. LUPRON DEPOT is available in four strengths: 3.75, 7.5, 11.25 and 15.0 mg (1-Month SR) and is supplied in single-dose kits containing one prefilled dual- chamber syringe with 23 G needle, two alcohol swabs, Patient Information Leaflet, Special Instructions for Use, and Package Insert.
Warnings and precautions
BEFORE your child takes LUPRON DEPOT 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 DEPOT 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 only needs one injection a month, as prescribed by your child’s doctor. It is very important that the doctor check your child’s progress at regular medical visits. Your child’s doctor, or healthcare provider, will administer LUPRON DEPOT during your child’s scheduled visit.
|In case of overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.|
Adherence to 4-week drug administration schedules must be accepted if therapy is to be successful. For best results, your child should have the right amount of LUPRON DEPOT in his or her body at all times. If your child misses a dose, the pubertal development could restart.
If you need more information, ask your doctor.
Regular injections are important!
Side effects and what to do about theM
Postmarketing reports of convulsions have been observed in patients taking LUPRON DEPOT. 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 DEPOT, 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 DEPOT.
- 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 doctor.
Serious side effects, how often they happen and what to do about them
|Symptom/effect||Talk with your doctor or pharmacist||Stop taking drug and call your doctor or pharmacist|
|Only if severe||In all cases|
|Common||Abnormal swelling or numbness of limbs||√|
|Severe bone pain||√|
|Severe pain in chest or abdomen||√|
|Skin reactions including reaction at site of injection||√|
|Skin reactions including reaction at site of injection||√|
This is not a complete list of side effects. For any unexpected effects while taking LUPRON DEPOT, contact your doctor or pharmacist.
How to store it
Store between 15 and 25°C. Protect from freezing.
|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.