Pronunciation: loo-pron dep-oh
Generic name: leuprolide acetate for depot suspension
Brand names: Lupron Depot, Lupron Depot-Ped 
Dosage form: injectable injection
Drug classes: Gonadotropin releasing hormones, Hormones / antineoplastics

Medically reviewed by Carmen Pope, BPharm. Last updated on Sep 9, 2024.

What is Lupron Depot?

Lupron Depot (leuprolide acetate) and Lupron Depot-Ped are prescription hormonal injections used to treat various hormone-related conditions, such as advanced prostate cancer, endometriosis, uterine fibroids, and central precocious puberty (Lupron Depot-Ped).

• Lupron Depot and Lupron Depot-Ped are available in different strengths.
• How much Lupron Depot you receive and how often you receive it depends on the condition being treated.
• Lupron Depot-Ped is only for central precocious puberty (CPP). 

Lupron Depot injection is a long-acting form of leuprolide, which belongs to the class of drugs called gonadotropin-releasing hormone (GnRH) agonists. The mechanism of action of Lupron Depot and Lupron Depot-Ped involves initially activating the pituitary gland in your brain to release certain hormones, which creates a surge in the sex hormones (testosterone in men, estrogen in women). This surge triggers your body to stop producing sex hormones. As a result, Lupron Depot stops testosterone production by the testes in males. In females, it causes the ovaries to stop making estrogen and progesterone. Once treatment is stopped, hormone levels typically return to normal.

Lupron Depot first gained FDA approval on April 9, 1985. There is no Lupron Depot generic available.

Lupron Depot uses

Lupron Depot may be used to treat the following conditions: 

• Advanced prostate cancer
• Endometriosis
• Uterine Fibroids (uterine leiomyomata).

Lupron Depot-Ped is used to treat children with central precocious puberty.

These conditions or their symptoms generally improve once the body stops making sex hormones.

Lupron Depot side effects

The most common side effects of Lupron Depot administered for advanced prostate cancer are:

• general pain
• hot flashes or body sweats
• gastrointestinal disturbances
• swelling (edema)
• respiratory problems
• urinary problems
• injection site reactions, such as redness, swelling, or pain at the injection site
• joint problems
• shrinking of the testes
• weakness, lack of energy, or fatigue
• skin reactions.

The most common side effects of Lupron Depot administered for endometriosis or uterine fibroids are:

• hot flashes or body sweats
• headache or migraine
• vaginal inflammation with vaginal itching, discharge, or pain
• depression or mood swings
• general pain
• weight gain/loss
• nausea or vomiting
• decreased sex drive
• dizziness.

The most common side effects of Lupron Depot-Ped in children with central precocious puberty are:

• injection site reactions such as pain, swelling, and abscess
• weight gain
• pain throughout body
• headache
• acne or red, itchy, rash, and white scales (seborrhea)
• serious skin rash (erythema multiforme)
• mood changes
• swelling of the vagina (vaginitis), vaginal bleeding, and vaginal discharge.

When Lupron Depot-Ped is administered once every 6 months, other common side effects include upper stomach pain, bleeding, diarrhea, nausea and vomiting, fever, itching, pain, rash, ligament sprain, fracture, breast tenderness, difficulty sleeping, chest pain, and excessive sweating.

Serious side effects and warnings

Lupron Depot and Lupron Depot-Ped may cause the following serious side effects.

Your symptoms may become temporarily worse during the first 2 to 4 weeks of treatment when you first start using Lupron Depot. In adults with prostate cancer, increases in serum testosterone of more than 50% above baseline may cause a tumor flare. Tell your healthcare provider immediately if you develop increased bone pain, nerve pain, blood in your urine, difficulty urinating, or spinal pain.

In adults or children prescribed Lupron Depot for other conditions this may cause transient worsening of symptoms, including the signs and symptoms of endometriosis or uterine fibroids during the first few weeks of treatment. In children, there may be a temporary increase in the clinical signs and symptoms of puberty, including vaginal bleeding. Tell your doctor if any increase in symptoms continues for longer than 2 months.

Cardiovascular disease. There is an increased risk of serious cardiovascular problems, including heart attacks, sudden cardiac death, and strokes in men receiving Lupron Depot. Your doctor will monitor your heart health more closely while you're on this medication. Tell your healthcare provider immediately if you experience chest pain or pressure, shortness of breath, or sudden weakness or numbness, especially on one side of the body.

GnRH analogs may be associated with an increased risk of seizures. The risk of seizures may be higher in people who have a history of seizures, have a history of epilepsy, have a history of brain or brain vessel (cerebrovascular) problems or tumors, are taking a medicine that has been connected to seizures such as bupropion or selective serotonin reuptake inhibitors (SSRIs). Seizures have also happened in people without any of these problems. Call your healthcare provider right away if you, your child, or the person you are caring for has a seizure while taking Lupron Depot or Lupron Depot-Ped.

Lupron Depot or Lupron Depot-Ped may increase the risk of psychiatric events or mood changes, such as emotional lability (eg, crying, irritability, impatience, anger, and aggression). Call your healthcare provider at once if you, your child, or someone you are caring for has unusual changes in mood or behavior. 

Increased pressure in the fluid around the brain (Pseudotumor Cerebri) can happen in people receiving GnRH agonist medicines such as Lupron Depot or Lupron Depot-Ped. Call your healthcare provider right away if you, your child, or the person you are caring for has any of the following symptoms during treatment:

• headache
• eye problems, including blurred vision, double vision, or decreased eyesight
• eye pain
• ringing in the ears
• dizziness
• nausea.

There is an increased risk of developing diabetes in people receiving GnRH analogs such as Lupron Depot. Your doctor will monitor your blood glucose level and manage any changes according to guidelines..

Lupron Depot can harm an unborn baby or cause birth defects. Do not use it if you are pregnant or breastfeeding.

Lupron Depot or Lupron Depot-Ped may cause an allergic reaction. Get emergency medical help if you develop signs of an allergic reaction such as hives, sweating, fast heartbeats, dizziness, difficulty breathing, swelling in your face or throat, or a severe skin reaction which may include a red or purple skin rash that spreads and causes blistering and peeling.

Also, call your healthcare provider at once if you have:

• A sudden severe headache
• A wheezing, dry cough, or hack
• Bone pain
• Heart attack symptoms - chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating; or
• High blood sugar, symptoms may include increased thirst, increased urination, hunger, dry mouth, or fruity breath odor
• Loss of movement in any part of your body
• Muscle weakness or loss of use, loss of bowel or bladder control
• Pain or unusual sensations in your back, numbness, weakness, or tingly feeling in your legs or feet
• Painful or difficult urination
• Problems with your eyes or vision
• Rapid weight gain
• Signs of a stroke - sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech
• Sudden chest pain or discomfort
• Swelling
• Unusual changes in mood or behavior (crying spells, anger, feeling irritable)
• Vomiting.

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

Before taking this medicine

Do not use Lupron Depot or Lupron Depot-Ped if you are allergic to leuprolide or similar medicines such as buserelin, goserelin, histrelin, or nafarelin; Lupron Depot, Lupron Depot-Ped, any of the inactive ingredients in the injection, or if you have abnormal vaginal bleeding that a doctor has not checked.

Certain brands or strengths of leuprolide are used to treat only men and should not be used in women or children. Always check your medicine to make sure you have received the correct brand and strength. Ask the pharmacist if you have any questions about the medicine you receive at the pharmacy.

To make sure Lupron Depot is safe for you, tell your healthcare provider about all your medical conditions including if you have ever had:

• depression, mental illness, or psychosis
• seizures or epilepsy
• a blood vessel disorder
• a brain tumor or spinal cord injury
• heart disease, congestive heart failure, long QT syndrome
• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood) or
• risk factors for bone loss (personal or family history of osteoporosis, smoking, alcohol use, taking steroid or seizure medicines long term).

Call your doctor if your periods continue while you are being treated with this medicine.

Do not give this medicine to any child without medical advice.

Pregnancy and Breastfeeding

Lupron Depot usually causes women to stop ovulating or having menstrual periods. However, you may still be able to get pregnant. Leuprolide can cause birth defects and should not be used if you are pregnant. Use a condom or diaphragm with spermicide to prevent pregnancy because leuprolide can make hormonal birth control less effective. Tell your doctor right away if you inadvertently become pregnant.

You should not breastfeed while using leuprolide.

Leuprolide may cause infertility, although research shows full reversibility of fertility suppression when leuprolide is discontinued after continuous administration for up to 24 weeks. Lupron may be used to delay egg release for IVF treatment.

How is Lupron administered?

Initially, Lupron Depot must be administered under the supervision of a healthcare provider, although some people can be taught how to self-administer it themselves.

• Lupron Depot is given into a muscle.
• The dosing schedule varies depending on the condition being treated but it may be every 1, 3, 4, or 6 months.

Different brands or strengths of leuprolide are used to treat different conditions.

• Always check your medication to make sure you have received the correct brand and type prescribed by your doctor.

You may need frequent medical tests while using this medicine.

Keep all scheduled visits to the doctor. If a scheduled dose is missed, the person receiving Lupron Depot or Lupron Depote-Ped may start having symptoms or signs of puberty again.

• Your healthcare provider will do regular exams and blood tests.

Lupron Depot Dosage

Lupron Depot dosage for advanced prostate cancer:

Lupron Depot dosage for endometriosis

Lupron Depot 3.75 mg administered as a single intramuscular (IM) injection once every month for up
to six injections (6 months of therapy).

• May be administered alone or in combination with daily norethindrone acetate 5 mg (add-back treatment)
• If endometriosis symptoms recur after the initial course of therapy, retreatment for no more than six months may be considered but only with the addition of norethindrone acetate add-back therapy. Do not re-treat with Lupron Depot 3.75 mg alone. 

Lupron Depot dosage for uterine fibroids

• Lupron Depot 3.75 mg administered as a single intramuscular (IM) injection once every month for up to three injections (3 months of therapy).

Lupron Depot-Ped dosage for central precocious puberty (CPP)

The dosage of Lupron Depot-Ped must be individualized for each child. Dosage recommendations are based on body weight.

• Adjust dosages as body weight changes.
• The dosage may be increased if adequate hormonal and clinical suppression is not achieved.
• Your healthcare provider will monitor your child's response to Lupron Depot-Ped.

Dosage Lupron Depot-Ped for 1-month administration

• Administer Lupron Depot-Ped 7.5 mg, 11.25 mg, or 15 mg for 1-month administration as a single-dose intramuscular injection once every month.

Dosage Lupron Depot-Ped for 3-month administration

• Administer Lupron Depot-Ped 11.25 mg or 30 mg for 3-month administration as a single-dose intramuscular injection once every 3 months (12 weeks).

Dosage Lupron Depot-Ped for 6-month administration

• Administer Lupron Depot-Ped 45 mg for 6-month administration as a single-dose intramuscular injection once every 6 months (24 weeks).

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose.

What happens if I overdose?

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

What should I avoid while using Lupron Depot?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What other drugs will affect Lupron Depot?

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

Other drugs may interact with leuprolide, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Storage

Store Lupron Depot and Lupron Depot-Ped in the original carton at room temperature, away from moisture and heat. Protect from light.

Keep out of reach of children.

Ingredients

Lupron Depot ingredients

Lupron Depot 3.75 mg for 1-month administration

Active ingredients: leuprolide acetate 3.75 mg
Inactive Ingredients: acetic acid, water for injection, polysorbate 80, mannitol, purified gelatin, 
carboxymethylcellulose sodium, 

Lupron Depot 7.5mg for 1-month administration

Active ingredients: leuprolide acetate 7.5 mg

Inactive ingredients: purified gelatin, DL-lactic and glycolic acids copolymer, D-mannitol, carboxymethylcellulose sodium, polysorbate 80, water for injection, USP, glacial acetic acid, USP to control pH.

Lupron Depot 22.5 mg for 3-month administration

Active ingredients: leuprolide acetate 22.5 mg

Inactive ingredients: polylactic acid, D-mannitol, carboxymethylcellulose sodium, polysorbate 80, water for injection, USP, and glacial acetic acid, USP to control pH.

Lupron Depot 30 mg for 4-month administration

Active ingredients: leuprolide acetate 30 mg

Inactive ingredients: polylactic acid, D-mannitol, carboxymethylcellulose sodium, polysorbate 80, water for injection, USP, and glacial acetic acid, USP to control pH.

Lupron Depot 45 mg for 6-month administration

Active ingredients: leuprolide acetate 45 mg

Inactive ingredients: polylactic acid, D-mannitol, stearic acid, carboxymethylcellulose sodium, polysorbate 80, water for injection, USP, and glacial acetic acid, USP to control pH.

Lupron Depot-Ped ingredients

Lupron Depot-PED 7.5 mg, 11.25 mg, or 15 mg for 1-month administration:
Active Ingredients: leuprolide acetate for depot suspension
Inactive Ingredients: purified gelatin, DL-lactic and glycolic acids copolymer, D-mannitol,
carboxymethylcellulose sodium, polysorbate 80, water for injection, USP, and glacial acetic acid, USP to
control pH.

Lupron Depot-Ped 11.25 mg or 30 mg for 3-month administration:
Active Ingredients: leuprolide acetate for depot suspension
Inactive Ingredients: polylactic acid, D-mannitol, carboxymethylcellulose sodium, polysorbate 80, water
for injection, USP, and glacial acetic acid, USP to control pH.

Lupron Depot-Ped 45 mg for 6-month administration:
Active Ingredients: leuprolide acetate for depot suspension
Inactive Ingredients: polylactic acid, D-mannitol, and stearic acid, carboxymethylcellulose sodium, Dmannitol, polysorbate 80, water for injection, USP, and glacial acetic acid, USP to control pH. 

Who makes Lupron Depot and Lupron Depot-Ped?

AbbVie Inc. makes Lupron Depot and Lupron Depot-Ped.

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