Consumer Information for: LUPRON DEPOT
Consumer Information
Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.
What the medication is used for
LUPRON®
- LUPRON® is used in the palliative treatment of prostate cancer. Palliative treatment is the relief of symptoms associated with a disease; it is not a cure.
LUPRON DEPOT®
- LUPRON DEPOT® is used in the palliative treatment of prostate cancer. Palliative treatment is the relief of symptoms associated with a disease; it is not a cure.
What it does
LUPRON®
Leuprolide acetate is chemically similar to gonadotropin-releasing hormone (GnRH or LHRH); a hormone which occurs naturally in your body. Normally, your body releases small amounts of LHRH and this leads to events which stimulate the production of sex hormones. However, when you inject LUPRON®, the normal events that lead to sex hormone production are interrupted and testosterone is no longer produced by the testes. Decreasing the levels of testosterone leads to decreased symptoms associated with prostate cancer.
LUPRON DEPOT®
Leuprolide acetate is chemically similar to gonadotropin-releasing hormone (GnRH or LHRH); a hormone which occurs naturally in your body. Normally, your body releases small amounts of LHRH and this leads to events which stimulate the production of sex hormones. However when you inject LUPRON DEPOT®, the normal events that lead to sex hormone production are interrupted and testosterone is no longer produced by the testes. Decreasing the levels of testosterone leads to decreased symptoms associated with prostate cancer.
When it should not be used
LUPRON®
LUPRON® should not be used:
- if you are allergic to leuprolide acetate, any similar nonapeptides (e.g., histrelin, desorelin), or any of the non-medicinal ingredients in LUPRON®
- in women who are or may become pregnant
- in women who are breast-feeding
LUPRON DEPOT®
LUPRON DEPOT® should not be used:
- if you are 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 or may become pregnant
- in women who are breast-feeding
What the medicinal ingredient is
LUPRON®
leuprolide acetate
LUPRON DEPOT®
leuprolide acetate
What the non-medicinal ingredients are
LUPRON®
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.
LUPRON DEPOT®
LUPRON DEPOT® 7.5 mg (1-Month SR) also contains:
carboxymethylcellulose sodium, DL-lactic and glycolic acids
copolymer, D-mannitol, glacial acetic acid, polysorbte 80, purified
gelatin, and water for injection.A
LUPRON DEPOT® 22.5 mg (3-Month SR) and 30.0 mg
(4-month SR) also contain: carboxymethylcellulose sodium, Dmannitol,
glacial acetic acid, polylactic acid, polysorbate 80, and
water for injection.
What dosage form it comes in
LUPRON®
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.
LUPRON DEPOT®
LUPRON DEPOT® is available in a prefilled 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 three strengths: 7.5 mg (1-Month SR), 22.5 mg (3-Month SR) and 30.0 mg (4-Month SR).
Warnings and precautions
LUPRON®
Serious Warnings and Precautions
LUPRON® should be prescribed by a doctor experienced with
this type of drug.
LUPRON® may cause:
- worsening of symptoms of prostate cancer at the beginning of the treatment
- bone thinning (osteoporosis)
BEFORE you use LUPRON® talk to your doctor or pharmacist if:
- You are allergic to any component of the medication.
- You have previous history of obstructive uropathy (difficulty urinating due to a block in the urinary tract).
- You have family history of osteoporosis or are 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.
- You have had or are suspected of having seizures, epilepsy, cerebrovascular disorder, central nervous system anomalies, or brain tumor.
- You are taking other medication(s) that have been associated with convulsions or seizures such as bupropion and any selective serotonin reuptake inhibitor (SSRI) medication for depression.
- You have a history of heart disease or disorders, or have a genetic heart condition called “long QT syndrome”.
- You have high blood sugar (diabetes). LUPRON® may affect your blood sugar and you may need to test your blood sugar more frequently while receiving treatment with LUPRON®.
- You have low red blood cell counts. LUPRON® may cause a decrease in red blood cells (anemia).
During the first few weeks of treatment with LUPRON®, you may experience worsening of symptoms or onset of new symptoms; including bone pain, presence of blood in the urine or difficulty urinating.
LUPRON DEPOT®
Serious Warnings and Precautions
LUPRON DEPOT® should be prescribed by a doctor
experienced with this type of drug.
LUPRON DEPOT® may cause:
- worsening of symptoms of prostate cancer at the beginning of the treatment
- bone thinning (osteoporosis)
BEFORE you use LUPRON DEPOT® talk to your doctor or pharmacist if:
- You are allergic to any component of the medication
- You have previous history of obstructive uropathy (difficulty urinating due to a block in the urinary tract)
- You have family history of osteoporosis or are 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.
- You have had or are suspected of having seizures, epilepsy, cerebrovascular disorder, central nervous system anomalies, or brain tumor.
- You are taking other medication(s) that have been associated with convulsions or seizures such as bupropion and any selective serotonin reuptake inhibitor (SSRI) medication for depression.
- You have a history of heart disease or disorders, or have a genetic heart condition called “long QT syndrome”.
- You have high blood sugar (diabetes). LUPRON DEPOT® may affect your blood sugar and you may need to test your blood sugar more frequently while receiving treatment with LUPRON DEPOT®.
- You have low red blood cell counts. LUPRON DEPOT® may cause a decrease in red blood cells (anemia).
During the first few weeks of treatment with LUPRON DEPOT®, you may experience worsening of symptoms or onset of new symptoms, including bone pain, presence of blood in the urine or difficulty urinating.
Interactions with this medication
LUPRON®
Tell your doctor and pharmacist if you are taking, have been
taking, or are planning to take any other medicines, including
nonprescription drugs (such as drug products for colds or nausea).
In particular, if you take the following medicines:
- medicines used to correct heart rhythm such as quinidine, disopyramide, amiodarone, dronedarone, sotalol, dofetilide, ibutilide (e.g., Corvert®), flecainide (e.g., Tambocor®), propafenone (e.g., Rythmol®)
- medicines used to treat schizophrenia such as chlorpromazine
- medicines to treat depression such as amitriptyline, nortriptyline
- morphine-like medicines (e.g., methadone)
- certain antibiotics and antimicrobials such as erythromycin, clarithromycin (e.g., Biaxin®), azithromycin (e.g., Zithromax®), moxifloxacin (e.g., Avelox®)
- antimalarials (e.g., quinine)
- antifungals
- medicines used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy and surgery such as ondansetron (e.g., Zofran®)
- medicines used for the relief of bronchospasm in conditions like asthma and chronic obstructive pulmonary disease such as salbutamol (e.g., Ventolin®)
LUPRON DEPOT®
Tell your doctor and pharmacist if you are taking, have been
taking, or are planning to take any other medicines, including nonprescription
drugs (such as drug products for colds or nausea).
In particular, if you take the following medicines:
- medicines used to correct heart rhythm such as quinidine, disopyramide, amiodarone, dronedarone, sotalol, dofetilide, ibutilide (e.g., Corvert®), flecainide (e.g., Tambocor®), propafenone (e.g., Rythmol®)
- medicines used to treat schizophrenia such as chlorpromazine
- medicines to treat depression such as amitriptyline, nortriptyline
- morphine-like medicines (e.g., methadone)
- certain antibiotics and antimicrobials such as erythromycin, clarithromycin (e.g., Biaxin®), azithromycin (e.g., Zithromax®), moxifloxacin (e.g., Avelox®)
- antimalarials (e.g., quinine)
- antifungals
- medicines used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy and surgery such as ondansetron (e.g., Zofran®)
- medicines used for the relief of bronchospasm in conditions like asthma and chronic obstructive pulmonary disease such as salbutamol (e.g., Ventolin®)
Proper use of this medication
LUPRON®
Usual dose
The recommended dose of LUPRON® is 1 mg (0.2 mL), as a single
daily subcutaneous injection.
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:
Overdose
Missed Dose
Follow these instructions unless instructed otherwise by your
doctor: if you miss an injection at the usual time, take it as soon as
you remember, if you remember on the same day. If not, do not
take the missed dose at all. Simply wait until it is time for your
next dose. Do not take two doses at once.
Do not stop your daily injections because you feel better. You
need one injection a day to make sure LUPRON® keeps working
for you.
It is very important that your doctor check your progress at
regular medical visits.
LUPRON DEPOT®
Usual dose
If you are taking LUPRON DEPOT® 7.5 mg (1-Month SR) report
to your doctor once every month for your injection.
If you are taking LUPRON DEPOT® 22.5 mg (3-Month SR),
report to your doctor once every three months for your injection.
If you are taking LUPRON DEPOT® 30.0 mg (4-Month SR),
report to your doctor once every four months for your injection.
It is very important that your doctor check your progress at regular
medical visits. Your doctor, or healthcare provider, will administer
LUPRON DEPOT® for you during your scheduled visits.
If you need more information, ask your doctor.
Overdose
Side effects and what to do about them
LUPRON®
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 testosterone
levels will initially increase and then decline over several weeks.
During this period some patients may experience worsening of
urinary symptoms and/or a temporary increase in bone pain.
Should this occur, contact your doctor immediately.
The following side effects are commonly experienced after the
initial rise and occur due to decreasing levels of testosterone in
the body:
- general pain or flu-like symptoms
- hot flashes/sweats
- joint and muscle pain
- emotional changes such as feeling depressed
- worsening urinary symptoms
Should these side effects persist or if they are severe, contact your
doctor immediately.
Notify your doctor if you develop new or worsened symptoms of
depression after beginning LUPRON DEPOT® treatment
A local 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.
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and talk with your doctor or pharmacist |
|---|---|---|---|
| Common | |||
| Decrease in testicular size | ✔ | ||
| Difficulty urinating | ✔ | ||
| Headache | ✔ | ||
| Hot flashes | ✔ | ||
| Impotence/ decrease in libido | ✔ | ||
| Itching rash | ✔ | ||
| Skin reactions including reaction at site of injection | ✔ | ||
| Vomiting/nausea | ✔ | ||
| Uncommon | |||
| Abnormal swelling or numbness of limbs | ✔ | ||
| Convulsion | ✔ | ||
| Severe bone pain | ✔ | ||
| Severe pain in chest or abdomen | ✔ | ||
| Vision changes | ✔ | ||
| Reported from postmarketing with unknown frequency | |||
| New onset or worsening of shortness of breath, especially with exertion; dry cough/interstitial lung disease, an inflammation of lung tissue | ✔ | ||
| Serious liver injury (yellow skin, yellow eyes, nausea/vomiting, decreased or loss of appetite, fatigue, itching, abdominal pain and bleeding and bruising) | ✔ | ✔ | |
This is not a complete list of side effects. For any unexpected effects while taking LUPRON®, contact your doctor or pharmacist.
LUPRON DEPOT®
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
testosterone levels will initially increase and then decline over
several weeks. During this period some patients may experience
worsening of urinary symptoms and/or a temporary increase in
bone pain. Should this occur, contact your doctor immediately.
The following side effects are commonly experienced after the
initial rise and occur due to decreasing levels of testosterone in
the body:
- general pain or flu-like symptoms
- hot flashes/sweats
- joint and muscle pain
- emotional changes such as feeling depressed
- worsening urinary symptoms
Should these side effects persist or if they are severe, contact your
doctor immediately.
Notify your doctor if you develop new or worsened symptoms of
depression after beginning LUPRON DEPOT® treatment.
A local 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.
| Symptom / effect | Talk with your doctor, nurse, or pharmacist only if severe | Talk with your doctor, nurse, or pharmacist in all cases | Stop taking drug and talk with your doctor or pharmacist |
|---|---|---|---|
| Common | |||
| Decrease in testicular size | ✔ | ||
| Headache | ✔ | ||
| Hot flashes | ✔ | ||
| Impotence/ decrease in libido | ✔ | ||
| Itching rash | ✔ | ||
| Skin reactions including reaction at site of injection | ✔ | ||
| Uncommon | |||
| Abnormal swelling or numbness of limbs | ✔ | ||
| Convulsion | ✔ | ||
| Severe bone pain | ✔ | ||
| Severe pain in chest or abdomen | ✔ | ||
| Vision changes | ✔ | ||
| Reported from postmarketing with unknown frequency | |||
| New onset or worsening of shortness of breath, especially with exertion; dry cough/interstitial lung disease, an inflammation of lung tissue | ✔ | ||
| Serious liver injury (yellow skin, yellow eyes, nausea/vomiting, decreased or loss of appetite, fatigue, itching, abdominal pain and bleeding and bruising) | ✔ | ✔ | |
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
LUPRON®
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.
LUPRON DEPOT®
Store between 15 and 25°C. Protect from freezing.
Reporting 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:
- Report online at www.healthcanada.gc.ca/medeffect
- Call toll-free at 1-866-234-2345
- Complete a Canada Vigilance Reporting Form and:
- Fax toll-free to 1-866-678-6789
- Mail to: Canada Vigilance Program
Health Canada
Postal Locator 0701D
Ottawa, ON K1A 0K9
Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffectTM Canada Web site at www.healthcanada.gc.ca/medeffect.
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.
More information
The most recent version of this document plus the full Product
Monograph, prepared for health professionals, can be found at:
www.abbvie.ca
or by contacting the sponsor, AbbVie Corporation, Saint-Laurent,
Qc H4S 1Z1 at:
1-888-704-8271.
This leaflet was prepared by AbbVie Corporation.
Last revised: August 9, 2013
Avelox®, Biaxin®, Corvert®, Rythmol®, Tambocor®, Ventolin®, Zithromax®, and Zofran® are trademarks of their respective owners and are not trademarks of AbbVie Corporation.
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