Leuprolide

Leuprolide

What is Leuprolide?

Leuprolide injection (Lupron Depot-PED, Fensolvi) is used in children 2 years of age and older to treat central precocious puberty (CPP; a condition that occurs in girls [usually younger than 8 years of age] and boys [usually younger than 9 years of age] entering puberty too early, resulting in faster bone growth and sexual characteristics development than normal).

Leuprolide injection (Lupron Depot) is used alone or with another medication (norethindrone) to treat endometriosis (a condition in which the type of tissue that lines the uterus [womb] grows in other areas of the body, causing pain, heavy or irregular menstruation [periods], and other symptoms).

Leuprolide Injection (Lupron Depot) is also used with other medications to treat anemia (a lower number of red blood cells than normal) caused by uterine fibroids (benign growths in the uterus).

Leuprolide belongs to a class of medications called gonadotropin-releasing hormone (GnRH) agonists. It works by reducing the amount of certain hormones in the body.

Side effects of leuprolide

If necessary, get emergency medical helpSigns of an allergic reaction to leuprolide(hives, difficulty breathing, swelling of the face or throat)or a severe skin reaction(Fever, sore throat, burning eyes, skin pain, red or purple rash with blistering and peeling).

Call your doctor immediately if you have a seizure, unusual changes in mood or behavior (crying spells, irritability, restlessness, anger, aggression), severe headache, ringing in the ears, dizziness, nausea, blurred vision, or pain behind the eyes.

When you start using leuprolide, your symptoms may temporarily worsen, including new or worsening sexual development symptoms in children. Tell your doctor if this persists for more than 2 months.

Leuprolide can cause serious side effects. Call your doctor immediately if you have:

• bone pain, loss of movement in any part of your body;

• swelling, rapid weight gain;

• a seizure;

• unusual changes in mood or behavior (crying fits, anger, irritability);

• sudden chest pain or discomfort, wheezing, dry cough or urge to cough;

• painful or difficult urination;

• pain or unusual sensations in the back, numbness, weakness, or tingling in the legs or feet;

• muscle weakness or loss of use of muscles, loss of bladder or bowel control;

• Problems with your pituitary gland- sudden severe headache, vomiting, eye or vision problems, changes in mood or behavior;

• high blood sugar– increased thirst, increased urination, hunger, dry mouth, fruity breath smell;

• Symptoms of a heart attack– Pain or pressure in the chest, pain spreading to the jaw or shoulder, nausea, sweating; or

• Signs of a stroke- sudden numbness or weakness, severe headache, slurred speech, problems with vision or balance.

Common side effects of leuprolide may include:

• problems with the pituitary gland;

• Acne, itching, rash, white scales (seborrhea);

• Cold symptoms such as stuffy nose, sneezing, sore throat, cough with or without mucus;

• Fractures, ligament strains;

• fever, tiredness, malaise;

• stomach pain, nausea, vomiting, diarrhea, constipation;

• Wheezing, chest tightness, difficulty breathing;

• breast tenderness, hot flashes, sweating;

• Dizziness, sleep problems, mood swings;

• headache, general pain;

• vaginal swelling, itching, or discharge;

• weight changes;

• reduced testicle size;

• irregular menstruation, decreased interest in sex; or

• Redness, pain, swelling or oozing at the injection site.

Leuprolide can affect the growth of children. Tell your doctor if your child does not grow normally while using leuprolide.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You can report side effects to FDA at 1-800-FDA-1088.

Warnings

When you start using leuprolide, your symptoms may temporarily worsen, including new or worsening sexual development symptoms in children. Tell your doctor if this persists for more than 2 months.

Call your doctor immediately if you have a seizure, unusual changes in mood or behavior, severe headache, ringing in the ears, dizziness, nausea, vision problems, or pain behind the eyes.

Do not use leuprolide if you are pregnant.Use effective contraception. Do not use if you have unusual vaginal bleeding that has not been checked by a doctor.

Before you take this medicine

You should not use this medicine if you are allergic to leuprolide or similar medicines such as buserelin, goserelin, histrelin, nafarelin, or if you have unusual vaginal bleeding that has not been checked by a doctor.

To make sure leuprolide is safe for you, tell your doctor if you have ever had:

• depression, mental illness or psychosis;

• seizures or epilepsy;

• a disease of the blood vessels;

• a brain tumor or spinal cord injury;

• heart disease, heart failure, long QT syndrome;

• an electrolyte imbalance (e.g. low levels of potassium or magnesium in your blood); or

• Risk factors for bone loss (personal or family history of osteoporosis, smoking, alcohol consumption, long-term use of steroids or anti-seizure medications).

Leuprolide usually causes women to stop ovulating or menstruating. However, you may still be able to get pregnant. Use barrier contraceptives to prevent pregnancy: condom, diaphragm, cervical cap or contraceptive sponge.

Call your doctor if your period continues while taking leuprolide.

Leuprolide can cause birth defects. Do not use leuprolide if you are pregnant.Tell your doctor if you become pregnant.

Ask a doctor whether breast-feeding is safe while using this medication.

How should I use leuprolide?

Take Uae-leuprolide as prescribed by your doctor. Follow all instructions on your prescription label and read any medication guides or instructions for use.

There are many brands, strengths, or forms of leuprolide used to treat various medical conditions. Avoid medication errors by only taking the medications your doctor prescribes.

Leuprolide is usually administered by a healthcare provider.

Leuprolide is injected under the skin or into a muscle once a month or every 3 to 6 months. A doctor can teach you how to properly use the medication yourself.

Your symptoms may temporarily worsen as your hormones adjust to leuprolide. A child taking this medicine may experience increased signs of puberty (e.g. vaginal bleeding) in the first few weeks of treatment.

Frequent medical examinations may be necessary while using leuprolide.

Do not reuse a needle or syringe. Place them in a puncture-resistant sharps container and dispose of in accordance with state or local laws. Keep out of the reach of children and pets.

Follow all storage instructions provided with leuprolide. Your pharmacist can give you more information about storing this medicine.

Dosage information

Usual adult dosage for endometriosis:

3.75 mg IM once monthly for up to 6 months
OR
11.25 mg depot every 3 months

Comments:
-For women receiving this medication for endometriosis, hormone replacement therapy is recommended to reduce bone mineral density loss and vasomotor symptoms.

Uses: Treatment of endometriosis (including pain relief and reduction of endometriotic lesions), preoperative hematological improvement in patients with anemia caused by uterine leiomyomas

Usual Adult Dose for Prostate Cancer:

Eligard:Administered by subcutaneous injection, providing continuous release of leuprolide acetate over a period of one, three, four or six months:

• One 7.5 mg injection every month; or

• One injection of 22.5 mg every 3 months; or

• One 30 mg injection every 4 months; or

• One 45 mg injection every 6 months,

Viadur: One implant inserted for 12 months. Each implant contains 65 mg leuprolide. The implant is inserted subcutaneously on the inside of the upper arm and provides continuous release of leuprolide during 12 months of hormone therapy.

Usual pediatric dose for precocious puberty:

IM injection:

2 years and older:
One-month depot injection:25 kg or less: 7.5 mg IM once a month. Over 25 kg to 37.5 kg: 11.25 mg IM. once a month. More than 37.5 kg: 15 mg IM. once a month
Three-month depot injection:11.25 mg or 30 mg IM every 3 months

Comments:
-The dosage should be adjusted individually.
-Hormonal levels should be tested after 1 to 2 months of therapy and at each dose change to ensure adequate pituitary gonadotropin suppression.
– Once a dose that provides adequate hormonal suppression has been established, this can often be maintained for the duration of therapy in most children; However, hormone suppression should be checked as weight may increase significantly during therapy.
– Therapy should be discontinued at the appropriate age at the onset of puberty at the discretion of the physician.

Subcutaneous injection:

2 years and older:
Fensolvi(long-acting formulation): 45 mg subcutaneously every 6 months
NOTE: The short-acting formulation has been replaced with long-acting formulations.

Comments:
-Dosage should be adjusted based on weight changes.
– Discontinuation of therapy should be considered before the age of 11 in women and before the age of 12 in men.

Uses: Treatment of children with central precocious puberty (CPP); CPP is defined as early onset of secondary sexual characteristics (generally earlier than 8 years in girls and 9 years in boys) associated with pubertal pituitary gonadotropin activation; It may be a case of significantly advanced bone age, which can lead to reduced adult height

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose or miss an appointment for your injection.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help hotline at 1-800-222-1222.

What should I avoid when using leuprolide?

Follow your doctor's instructions regarding any food, drink, or activity restrictions.

What other drugs will affect leuprolide?

Leuprolide can cause a serious heart problem.Your risk may be higher if you also take certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria or HIV.

Other medications may interact with leuprolide, including prescription and over-the-counter medications, vitamins, and herbal products. Tell your doctor about all other medicines you are taking.

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More information

Remember to keep this and all other medicines out of the reach of children, never share your medicines with others, and use leuprolide only for the prescribed indication.