What is histrelin?

Histrelin overstimulates the body’s own production of certain hormones, which causes that production to shut down temporarily.

The Supprelin LA brand of histrelin is used to treat precocious puberty in both male and female children who are at least 2 years old.

The Vantas brand of histrelin is used to treat symptoms of prostate cancer in men. Vantas treats only the symptoms of prostate cancer but does not treat the cancer itself.

Histrelin may also be used for purposes not listed in this medication guide.

Histrelin side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Histrelin may cause serious side effects. Call your doctor at once if you have:

• bone pain, numbness or weakness in your legs or feet;
• painful or difficult urination, blood in your urine;
• a seizure;
• increased pressure inside the skull–severe headaches, ringing in your ears, dizziness, nausea, vision problems, pain behind your eyes; or
• mental problems–crying spells, anger, aggression, feeling restless or irritable.

Common side effects of histrelin may include:

• constipation;
• urination problems;
• breast swelling;
• hot flashes;
• feeling tired;
• erectile dysfunction (impotence), decreased testicle size; or
• pain, redness, bruising, swelling, or skin irritation where the implant was inserted.

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 FDA .

Warnings

Histrelin can harm an unborn baby or cause a miscarriage. Do not use if you are pregnant.

Histrelin can cause side effects such as crying spells, anger, aggression, and feeling restless or irritable. Call your doctor if you have any new or worsening mental problems.

Before taking this medicine

You should not be treated with histrelin if you are allergic to histrelin or to similar hormone medications such as leuprolide, nafarelin, ganirelix, Eligard, Lupron, Viadur, and others.

Do not use histrelin if you are pregnant. It could harm the unborn baby or cause a miscarriage. Use effective birth control to prevent pregnancy and tell your doctor right away if you become pregnant.

Vantas should not be used in women or children.

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

• mental illness or psychosis;
• epilepsy or other seizure disorder;
• a tumor or blood vessel disorder in your brain; or
• if you take a medicine that can cause seizures (such as an antidepressant).

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

• a bladder obstruction or other urination problems;
• diabetes;
• heart problems, heart attack, or stroke;
• long QT syndrome (in you or a family member);
• low bone mineral density (osteoporosis); or
• a condition affecting your spine.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Supprelin LA should not be used in a child younger than 2 years old. Vantas is not approved for use by anyone younger than 18 years old.

How is histrelin given?

Histrelin is given in a tiny implant inserted under the skin on the inside of your upper arm. You will receive this implant with a minor surgical procedure in a clinic or doctor’s office.

It is best to place the implant into your non-dominant arm (your left arm if you are right-handed). Be sure to tell your doctor which arm you use most often.

The skin of your upper arm will be treated with a numbing medicine to keep you from feeling pain during the insertion. Your doctor will use a scalpel to cut a small incision where the implant will be inserted.

The histrelin implant is inserted using a special tool that pushes the implant into place through the incision in your skin. After injecting the implant and removing the insertion tool, your doctor will then feel your arm to make sure the implant has been correctly placed.

The incision in your skin may be closed with stitches or surgical strips. Follow your doctor’s instructions about caring for the incision and keeping it bandaged and clean until it heals completely. Keep your arm dry for at least 24 hours.

You will most likely be able to feel the implant through your skin, but it should not cause pain or discomfort.

Call your doctor if you have any pain, swelling, tenderness, itching, tingling, bruising, or redness where the implant was inserted, or if the implant comes through the skin or falls out.

A histrelin implant is usually left in place for 12 months and then must be removed through a surgical incision. Do not try to remove the implant yourself. Your doctor will determine whether you need another implant for continued treatment.

You may have a temporary increase in precocious puberty symptoms for a week or so after you have received the Supprelin LA implant.

You may need medical tests to help your doctor determine how long to treat you with histrelin.

Histrelin can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using histrelin.

Histrelin dosing information

Usual Adult Dose for Prostate Cancer:

VANTAS:
One 50 mg implant inserted subcutaneously in the inner aspect of the upper arm
Duration of therapy: The implant should be removed after 12 months.
NOTE: The implant is designed to allow for a few additional weeks of drug release to allow flexibility of medical appointments); when an implant is removed, another implant may be inserted to continue therapy.

Use: Vantas: Palliative treatment of advanced prostate cancer

Usual Pediatric Dose for Precocious Puberty:

SUPPRELIN LA:
2 years and older:
One 50 mg implant inserted subcutaneously in the inner aspect of the upper arm
Duration of therapy: The implant should be removed after 12 months.
NOTE: When an implant is removed, another implant may be inserted to continue therapy.

Comments:
-Discontinuation of therapy should be considered at the discretion of the physician and at the appropriate time point for the onset of puberty (approximately 11 years for females and 12 years for males).

Use:
Supprelin LA: Treatment of children with central precocious puberty

What happens if I miss a dose?

Since histrelin is given as an implant, it does not have a daily dosing schedule.

The implant should not be left in your arm for longer than 12 months. Call your doctor when it is time for your implant to be removed.

What happens if I overdose?

Since the histrelin implant contains a specific amount of the medicine, you are not likely to receive an overdose.

What should I avoid after receiving a histrelin implant?

For at least 7 days after your implant is inserted, avoid strenuous exercise or heavy lifting.

What other drugs will affect histrelin?

Other drugs may affect histrelin, 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.

What is leuprolide?

Leuprolide injection (Eligard, Lupron Depot) is used to treat the symptoms associated with advanced prostate cancer.

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

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 and causes pain, heavy or irregular menstruation [periods], and other symptoms).

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

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

Leuprolide side effects

Get emergency medical help if you have signs of an allergic reaction to leuprolide (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

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

Your symptoms may become temporarily worse when you first start using leuprolide, including new or worsening symptoms of sexual development in children. Tell your doctor if this continues for longer than 2 months.

Leuprolide may cause serious side effects. Call your doctor at once 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 spells, anger, feeling irritable);
• sudden chest pain or discomfort, wheezing, dry cough or hack;
• painful or difficult urination;
• pain or unusual sensations in your back, numbness, weakness, or tingly feeling in your legs or feet;
• muscle weakness or loss of muscle use, loss of bladder or bowel control;
• problems with your pituitary gland – sudden severe headache, vomiting, problems with your eyes or vision, changes in mood or behavior;
• high blood sugar – increased thirst, increased urination, hunger, dry mouth, fruity breath odor;
• heart attack symptoms – chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating; or
• signs of a stroke – sudden numbness or weakness, severe headache, slurred speech, problems with vision or balance.

Common leuprolide side effects may include:

• pituitary gland problems;
• acne, itching, rash, white scales (seborrhea);
• cold symptoms such as stuffy nose, sneezing, sore throat, cough with or without mucus;
• fractures, ligament sprain;
• fever, tiredness, not feeling well;
• stomach pain, nausea, vomiting, diarrhea, constipation;
• wheezing, chest tightness, trouble breathing;
• breast tenderness, hot flashes, sweating;
• dizziness, sleep problems, mood changes;
• headache, general pain;
• vaginal swelling, itching, or discharge;
• weight changes;
• decreased testicle size;
• irregular menstrual periods, decreased interest in sex; or
• redness, pain, swelling, or oozing where the medicine was injected.

Leuprolide can affect growth in children. Tell your doctor if your child is not growing at a normal rate 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 may report side effects to FDA .

Warnings

Your symptoms may become temporarily worse when you first start using leuprolide, including new or worsening symptoms of sexual development in children. Tell your doctor if this continues for longer than 2 months.

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

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

Before taking 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 abnormal 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 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).

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

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

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

Ask a doctor if it is safe to breastfeed while using this medicine.

How should I use leuprolide?

Uae leuprolide as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

There are many brands, strengths, or forms of leuprolide used to treat different conditions. Avoid medication errors by using only the medicine your doctor prescribes.

Leuprolide is usually administered by a healthcare provider.

Leuprolide is injected under the skin or into a muscle, once every month or once every 3 to 6 months. A healthcare provider may teach you how to properly use the medication by yourself.

Your symptoms may become temporarily worse as your hormones adjust to leuprolide. A child using this medicine may have increased signs of puberty (such as vaginal bleeding) during the first weeks of treatment.

You may need frequent medical tests while using leuprolide.

Do not reuse a needle or syringe. Place them in a puncture-proof “sharps” container and dispose of it following state or local laws. Keep out of the reach of children and pets.

Follow all storage instructions provided with leuprolide. Your pharmacist can provide more information about how to store this medicine.

Dosing Information

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 this drug for endometriosis, hormone replacement therapy is recommended to reduce bone mineral density loss and vasomotor symptoms.

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 Prostate Cancer:

Eligard: administered by subcutaneous injection and provides continuous release of leuprolide acetate over a one, three, four, or six-month period:

• One 7.5 mg injection every month; or
• One 22.5 mg injection 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 in the inner aspect of the upper arm and provides continuous release of leuprolide for 12 months of hormonal 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. Greater than 25 kg to 37.5 kg: 11.25 mg IM once a month. Greater 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:
-Doses should be titrated to the individual.
-Hormone 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 has been determined, 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.
-Therapy should be discontinued at the appropriate age of 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:
-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); 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 show a significantly advanced bone age that can result in diminished adult height

What is Lupron Depot?

Lupron Depot is a long-acting, prescription hormonal injection used to treat various hormone-related conditions, such as advanced prostate cancer, endometriosis, uterine fibroids, and central precocious puberty (CPP) in children (Lupron Depot-Ped only).

• Lupron Depot and Lupron Depot-Ped are given by injection every 1, 3, 4, or 6 months depending on the condition.
• Lupron Depot-Ped is only for CPP. 
• “Depot” refers to the delivery system. The medication is suspended in microspheres that slowly break down over 1-6 months.

Lupron Depot (leuprolide acetate) first gained FDA approval on April 9, 1985. There is no generic.

FDA approvals and indications

Lupron Depot is approved for advanced prostate cancer, endometriosis, and uterine fibroids.

Advanced prostate cancer

The treatment of advanced prostate cancer.

Endometriosis

The management of endometriosis, including pain relief and reduction of endometriotic lesions.

• May be used alone or in combination with norethindrone acetate (add-back therapy) to reduce bone loss and hot flashes associated with Lupron depot use. 
• The total duration of treatment should not exceed 12 months.

Uterine Fibroids

To improve anemia due to vaginal bleeding from uterine fibroids (uterine leiomyomata) in combination with iron therapy in patients in whom 3 months of hormonal suppression is deemed necessary.

• The duration of treatment is limited to 3 months.
• The symptoms associated with fibroids will return after stopping therapy.

Healthcare providers may consider a 1-month trial of iron alone, as some women will respond to iron alone.

• Lupron Depot may be added if the response to iron alone is inadequate.

Central Precocious Puberty

Lupron Depot-Ped is approved to treat children aged at least 1 year with central precocious puberty (CPP).

Side effects

Prostate Cancer

The most common side effects of Lupron Depot are:

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

Endometriosis or Uterine Fibroids

The most common side effects of Lupron Depot 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.

Central Precocious Puberty

The most common side effects of Lupron Depot-Ped 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

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.

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.

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 agonists 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.

How does Lupron Depot work?

Lupron Depot (leuprolide acetate) works by suppressing the body’s production of certain hormones through a process called “chemical castration” or “medical castration.” This creates a temporary state of low sex hormones, which can be beneficial for treating conditions that are stimulated or worsened by these hormones.

Mechanism of Action: Lupron is a gonadotropin-releasing hormone (GnRH) agonist. When first administered, it briefly stimulates the pituitary gland to release luteinizing hormone (LH) and follicle-stimulating hormone (FSH).

Down-regulation: With continuous use, Lupron causes desensitization and down-regulation of GnRH receptors in the pituitary gland. This leads to a dramatic decrease in the production of LH and FSH.

Hormone Suppression: The reduction in LH and FSH leads to significantly decreased production of sex hormones (testosterone in men, estrogen in women).

• In men: Testosterone levels drop significantly
• In women: Estrogen levels decrease substantially.

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 is 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 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. AbbVie is headquartered in North Chicago, Illinois, USA. It was formed in 2013 when it split off from Abbott Laboratories as an independent biopharmaceutical company.