What Lupron Depot GYN-ENDO is used for and how to use it
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Lupron Depot GYN-ENDO - Consumer Medicine Information

Manufacture: AbbVie
Country: Canada
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, D-mannitol, gelatin, glacial acetic acid, polysorbate 80 and water for injection

LUPRON DEPOT

leuprolide acetate for depot suspension

About this medication

What the medication is used for:

  • LUPRON DEPOT 3.75 mg (1-Month SR) and 11.25 mg (3-Month SR) are used alone or in combination with norethindrone acetate, a progestin, in the treatment of endometriosis, including pain relief and reduction of endometriosis lesions (studied for Lupron only). The treatment is recommended for a period of 6 months only.

What it does:

LUPRON DEPOT works to inhibit the production of gonadotropins from the pituitary gland, thereby decreasing estrogens to post-menopausal levels in pre-menopausal women.

When it should not be used:

Do not take LUPRON DEPOT if you:

  • are allergic to leuprolide acetate, any similar nonapeptides (e.g., histrelin, desorelin), or any of the other ingredients in LUPRON DEPOT.
  • are pregnant or planning to get pregnant.
  • have abnormal vaginal bleeding of unknown cause.
  • are breast-feeding.

    You must use non-hormonal methods of birth control while receiving LUPRON DEPOT.

What the medicinal ingredient is:

leuprolide acetate

What the non-medicinal ingredients are:

LUPRON DEPOT 3.75 mg (1-Month SR) also contains carboxymethylcellulose sodium, DL-lactic and glycolic acids copolymer, D-mannitol, gelatin, glacial acetic acid, polysorbate 80 and water for injection.

LUPRON DEPOT 11.25 mg (3-Month SR) also contains carboxymethylcellulose sodium, D-mannitol, glacial acetic acid, polylactic 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 two strengths: 3.75 mg (1-Month SR) and 11.25 mg (3-Month SR).

Warnings and precautions

BEFORE you use LUPRON DEPOT talk to your doctor or pharmacist if:

  • You are allergic to any component of the medication
  • You suspect that you are pregnant
  • You are planning to become pregnant
  • You take hormonal methods of contraception
  • You are breast-feeding
  • 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.
  • 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 SSRI medication for depression.

Signs and symptoms of endometriosis can worsen at the beginning of therapy with LUPRON DEPOT.

LUPRON DEPOT is not recommended for use in children younger than 18 years of age or women over 65 years of age for the treatment of endometriosis.

Interactions with this medication

Tell your doctor and pharmacist if you are taking, have been taking, or are planning to take any other medicines, including non-prescription drugs (such as drug products for colds or nausea).

Proper use of this medication

LUPRON DEPOT is to be given to you as an injection into the muscle (intramuscular injection).

Usual Dose:

LUPRON DEPOT 3.75 mg (1-Month slow-release) once every month for 6 months, or LUPRON DEPOT 11.25 mg (3-Month slow-release) once every 3 months for 6 months.

Overdose:

In case of overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose:

If you miss an appointment by a few days, it should not disrupt the benefits of treatment, but keeping a consistent schedule of LUPRON DEPOT injections is an important part of treatment.

Side effects and what to do about them

Signs and symptoms of endometriosis can worsen at the beginning of therapy with LUPRON DEPOT.

Possible common side-effects with the use of LUPRON DEPOT include:

  • hot flashes, excessive sweats
  • gastrointestinal problems, nausea, vomiting
  • decreased libido
  • muscle or joint pain
  • breast tenderness / pain and/or vaginitis (inflammation of the vagina)
  • emotional changes such as feeling depressed
  • headache / migraine
  • nervousness / rapid heart beat
  • edema (swelling, water retention)
  • weight gain or loss
  • skin reaction at the injection site such as itching, redness, burning, and/or swelling
  • acne
  • menstrual cramps (dysmenorrhea)

Should these side effects persist or if they are severe, contact your doctor immediately.

Side effects reported after the drug was available for sale (postmarketing) include:

  • convulsion
  • liver problems, including serious liver injury
  • serious allergic reaction (anaphylaxis and anaphylactoid)
  • inflammation of the lung (interstitial lung disease)
  • pituitary apoplexy, symptoms include sudden headache, vomiting, visual changes, problem with eye muscle movement (ophthalmoplegia), altered mental status, and sometimes cardiovascular collapse.

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
Headache
Hot flashes /
sweats
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 post-
marketing
with
unknown
frequency
New onset or
worsening of
shortness of breath,
especially with
exertion; dry
cough/interstitial
lung disease, an
inflammation of
lung tissue

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:
  • 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, or
    • Mail to: Canada Vigilance Program
                    Health Canada
                    Postal Locator 0701C
                    Ottawa, Ontario 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

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.