Leuprolide

By Medically reviewed by hellodoktor

Generic Name: Leuprolide Brand Name(s): Generics only. No brands available.

Uses

What is Leuprolide used for?

Leuprolide is used to treat advanced prostate cancer in men. It is not a cure. Most types of prostate cancer need the male hormone testosterone to grow and spread. Leuprolide works by reducing the amount of testosterone that the body makes. This helps slow or stop the growth of cancer cells and helps relieve symptoms such as painful/difficult urination. Talk to your doctor about the risks and benefits of treatment.

Leuprolide is also used to stop early puberty (precocious puberty) in children. It helps to delay sexual development (such as growth of the breasts/testicles) and the start of menstrual periods. It also helps slow down early bone growth to increase the likelihood of reaching normal adult height. Leuprolide works by decreasing the amount of sex hormones that a child’s body makes (estrogen in girls, testosterone in boys).

How should I take Leuprolide?

This medication is given by injection under the skin as directed by your doctor, usually once a day.

In children, the dosage is based on weight and response to treatment. The doctor should consider stopping treatment before age 11 for girls and age 12 for boys. Consult the doctor for details.

If you are using this medication at home, learn all preparation and usage instructions from your health care professional and the product package. Learn how to store and discard medical supplies safely.

Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time each day.

During the first few weeks of treatment, your hormone levels will actually go up before they go down. This is a normal response to this medication. Your symptoms may get worse for a few weeks.

If you have prostate cancer that has spread to the spine or caused urinary blockage, you may require closer monitoring by your doctor, especially when you first start treatment. Tell your doctor right away if you have any bone pain, numbness/tingling/weakness of the arms/legs, blood in the urine, painful/difficult urination, unusual weakness, or inability to move.

If you are using this medication to stop early puberty, you may notice worsening symptoms (such as menstrual periods) at the start of treatment. However, you should see an improvement in symptoms usually within 1 to 2 months. Tell the doctor promptly if new or worsened symptoms develop after starting treatment.

How do I store Leuprolide?

Store below 77°F (25°C). Do not freeze. Do not store near a radiator or other very warm place. Protect from light; store vial in carton until use.

Most of the time, leuprolide injection (prostate) will be given in a hospital or doctor’s office. If stored at home, follow how to store as you were told by the doctor.

Precautions & warnings

What should I know before using Leuprolide?

Before using leuprolide, tell your doctor or pharmacist if you are allergic to it; or of any other allergies. This product may contain inactive ingredients (such as benzyl alcohol), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: diabetes, heart disease (such as heart attack), stroke, high cholesterol, mental/mood problems (such as depression), seizures.

In adults, leuprolide may weaken your bones and increase your risk for bone loss (osteoporosis) if used for a long time. Before using this medication, tell your doctor or pharmacist if you have osteoporosis or if you have any of the following risk factors for osteoporosis: long-term alcohol use, smoking, family history of osteoporosis and broken bones, use of certain medications (for example, corticosteroids such as prednisone, certain anti-seizure drugs such as phenytoin).

In adults, leuprolide may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.

The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using leuprolide, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).

Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/”water pills”) or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using leuprolide safely.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products being used (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).

This medication must not be used during pregnancy. It may harm an unborn baby. It is important to prevent pregnancy while using this medication. Consult your doctor for more details and to discuss using reliable forms of non-hormonal birth control (such as condoms, diaphragm with spermicide) while using this medication. If you become pregnant or think you may be pregnant, tell your doctor right away.

It is unknown if leuprolide passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Leuprolide during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Leuprolide. Leuprolide is pregnancy risk category X according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Leuprolide?

Mild burning/pain/bruising at the injection site, hot flashes (flushing), increased sweating, night sweats, tiredness, headache, upset stomach, breast changes, acne, joint/muscle aches, trouble sleeping, reduced sexual interest, vaginal discomfort/dryness, vaginal bleeding, swelling of the ankles/feet, increased urination at night, or dizziness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Infrequently in men, shrinking of the testicles, breast tenderness/swelling, and reduced sexual interest/ability may also occur as a result of lowered testosterone levels. Talk to your doctor if these effects occur.

In girls, when this medication is used regularly, it is expected that the menstrual period will stop or decrease to light bleeding/spotting during the first 2 months. Tell the doctor promptly if regular periods continue after 2 months of treatment with leuprolide.

Remember that the doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if any of these serious side effects occur: new/worsening bone pain (in adults), easily broken bones (in adults), increased thirst/urination (in adults), mental/mood changes (such as depression, thoughts of suicide, mood swings, aggression).

In adults, this medication may rarely cause heart problems and stroke. Get medical help right away if any of these very serioussymptoms of a heart attack (such as chest/jaw/left arm pain, shortness of breath, unusual sweating), signs of a stroke (such as weakness on one side of the body, trouble speaking, sudden vision changes, confusion), fast/irregular heartbeat, severe dizziness, fainting.

Get medical help right away if any of these very serious side effects occur: seizures.

Rarely, a very serious problem with your pituitary gland (pituitary apoplexy) may occur, usually in the first hour to 2 weeks after the first injection. Get medical help right away if any of these very serious side effects occur: sudden severe headache, sudden severe mental/mood changes (such as severe confusion, difficulty concentrating), vision changes, severe vomiting, fainting.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Leuprolide?

This medication may interfere with certain lab tests, possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

Leuprolide may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Leuprolide?

Leuprolide may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Leuprolide?

Leuprolide may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Leuprolide.

What is the dose of Leuprolide for an adult?

Usual Adult Dose for Prostate Cancer

1 mg injection subcutaneously once a day or

7.5 mg depot IM or depot subcutaneously once a month or

22.5 mg depot IM once every 3 months or

30 mg depot IM once every 4 months or

45 mg subcutaneous injection every 6 months or

65 mg subcutaneous implant once every 12 months

Use: Palliative treatment of advanced prostate cancer

Usual Adult Dose for Endometriosis

3.75 mg IM once a month for up to 6 months or 11.25 mg depot every 3 months

Comments:

-In women receiving leuprorelin for endometriosis, hormone replacement therapy is recommended to reduce bone mineral density loss and vasomotor symptoms. The risks and benefits of each therapy should be considered.

Uses: Management of endometriosis (including pain relief and reduction of endometriotic lesions), preoperative hematologic improvement of patients with anemia caused by uterine leiomyomata

Usual Adult Dose for Uterine Leiomyomata

3.75 mg IM once a month for up to 6 months or 11.25 mg depot every 3 months

Comments:

-In women receiving leuprorelin for endometriosis, hormone replacement therapy is recommended to reduce bone mineral density loss and vasomotor symptoms. The risks and benefits of each therapy should be considered.

Uses: Management of endometriosis (including pain relief and reduction of endometriotic lesions), preoperative hematologic improvement of patients with anemia caused by uterine leiomyomata

Other Comments

Administration advice:

-The injection site should be varied periodically.

-Avoid areas with brawny or fibrous subcutaneous tissue or locations that could be rubbed or compressed (e.g., with a belt or clothing waistband)

Storage requirements:

-The manufacturer product information should be consulted.

Reconstitution/preparation techniques:

-The manufacturer product information should be consulted.

Monitoring:

-Metabolic: Blood glucose and/or glycosylated hemoglobin (HbA1c) periodically

Patient advice:

-This drug can influence the ability to drive and use machines.

What is the dose of Leuprolide for a child?

Usual Pediatric Dose for Precocious Puberty

Depot injection:

Body weight: Less than or equal to 25 kg: 7.5 mg IM once a month

Body weight: Greater than 25 kg to 37.5 kg: 11.25 mg IM once a month

Body weight: Greater than 37.5 kg: 15 mg IM once a month

Comments:

-Hormonal levels should be tested after 1 to 2 months of therapy and with each dose change to ensure adequate pituitary gonadotropin suppression.

-Once a dose that results in adequate hormonal suppression, it can often be maintained for the duration of therapy in most children; however, hormonal suppression should be verified as weight can increase significantly while on therapy.

Subcutaneous Injection:

Initial dose: 50 mcg/kg/day subcutaneously. If total downregulation is not achieved, the dose should be titrated upward by 10 mcg/kg/day. This dose will be considered the maintenance dose.

Comments:

-The dosage should be adjusted for weight changes.

-Discontinuation of therapy be considered before age 11 for females and before age 12 for males.

Use: Treatment of children with central precocious puberty (CPP)

Dose Adjustments

-Pediatric patients: If adequate hormonal and clinical suppression is not reached with the starting dose, it should be increased to the next available higher dose (e.g. 11.25 mg or 15 mg at the next monthly injection).

Precautions

Safety and efficacy have not been established in patients younger than 2 years.

How is Leuprolide available?

Leuprolide is available in the following dosage forms and strengths:

  • Subcutaneous powder for injection, extended release,
  • Subcutaneous implant,
  • Intramuscular kit,
  • Intramuscular powder for injection, extended release,
  • Subcutaneous solution,
  • Subcutaneous kit,
  • Intramuscular powder for injection.

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Leuprolide, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

Review Date: March 14, 2018 | Last Modified: September 12, 2019

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