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Lupron Depot-Ped

Last reviewed on RxList: 6/10/2020
Lupron Depot-Ped Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Lupron Depot-Ped?

Lupron Depot-Ped (leuprolide acetate for depot suspension) is a gonadotropin releasing hormone (GnRH) agonist used to treat children with central precocious puberty.

What Are Side Effects of Lupron Depot-Ped?

Side effects of Lupron Depot-Ped include:

Dosage for Lupron Depot-Ped

Lupron Depot-Ped is administered as a single intramuscular injection. The starting dose 7.5 mg, 11.25 mg, or 15 mg for 1-month administration is based on the child's weight. The doses are either 11.25 mg or 30 mg for 3-month administration.

Lupron Depot-Ped In Children

Safety and effectiveness of Lupron Depot-Ped in pediatric patients below the age of 2 years have not been established. The use of Lupron Depot-Ped in children under 2 years is not recommended.

What Drugs, Substances, or Supplements Interact with Lupron Depot-Ped?

No drug interaction studies have been conducted with Lupron Depot-Ped; however, drug interactions are not expected to occur.

Tell your doctor all medications and supplements you use.

Lupron Depot-Ped During Pregnancy and Breastfeeding

Lupron Depot-Ped is not recommended for use during pregnancy; it may harm a fetus. It is unknown if Lupron Depot-Ped passes into breast milk. Breastfeeding is not recommended while using Lupron Depot-Ped.

Additional Information

Our Lupron Depot-Ped (leuprolide acetate for depot suspension) Injection, Powder, Lyophilized, for Suspension Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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 at 1-800-FDA-1088.

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 at 1-800-FDA-1088.

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Lupron Depot-Ped Consumer Information

Get emergency medical help if you have signs of an allergic reaction (hives, sweating, fast heartbeats, dizziness, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Call your doctor at once if you have:

  • problems with your pituitary gland--sudden severe headache, vomiting, problems with your eyes or vision, changes in mood or behavior;
  • 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; or
  • high blood sugar--increased thirst, increased urination, hunger, dry mouth, fruity breath odor.

Rare but serious side effects may occur. Call your doctor if you have:

  • pain or unusual sensations in your back, numbness, weakness, or tingly feeling in your legs or feet;
  • muscle weakness or loss of use, loss of bowel or bladder control;
  • 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 (especially on one side of the body), sudden severe headache, slurred speech.

Common side effects may include:

  • pituitary gland problems;
  • cold symptoms such as stuffy nose, sneezing, sore throat, cough with or without mucus;
  • fever, tiredness, not feeling well;
  • stomach pain, nausea, vomiting, constipation;
  • wheezing, chest tightness, trouble breathing;
  • hot flashes, sweating;
  • dizziness, mood changes;
  • headache, general pain;
  • vaginal swelling, itching, or discharge;
  • weight changes;
  • decreased testicle size;
  • decreased interest in sex; or
  • redness, pain, swelling, or oozing where the shot was given.

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 at 1-800-FDA-1088.

Read the entire detailed patient monograph for Lupron Depot-Ped (Leuprolide Acetate for Depot Suspension)

Lupron Depot-Ped Professional Information

SIDE EFFECTS

The most common adverse reactions with GnRH agonists including LUPRON DEPOT-PED 7.5 mg, 11.25 mg, or 15 mg for 1-month administration and LUPRON DEPOT-PED 11.25 mg or 30 mg for 3-month administration are injection site reactions/pain including abscess, general pain, headache, emotional lability and hot flushes/sweating.

During the early phase of therapy, gonadotropins and sex steroids rise above baseline because of the initial stimulatory effect of the drug (hormonal flare effect). Therefore, an increase in clinical signs and symptoms of puberty may be observed [see WARNINGS AND PRECAUTIONS].

LUPRON DEPOT-PED 7.5 mg, 11.25 mg, Or 15 mg For 1-Month Administration Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

In two studies of children with central precocious puberty, in 2% or more of the patients receiving the drug, the following adverse reactions were reported to have a possible or probable relationship to drug as ascribed by the treating physician. Reactions which are not considered drug-related are excluded.

Table 2: Percentage of Patients with Treatment-Emergent Adverse Reactions Occurring in ≥2% of Pediatric Patients Receiving LUPRON DEPOT-PED 1-month

Number of Patients
(N = 421)
N(%)
Body as a Whole
Injection Site Reactions Including Abscess*37(9)
General Pain12(3)
Headache11(3)
Cardiovascular System
Vasodilation9(2)
Integumentary System (Skin and Appendages)
Acne/Seborrhea13(3)
Rash Including Erythema Multiforme12(3)
Psychiatric System
Emotional Lability19(5)
Urogenital System
Vaginitis/Vaginal Bleeding/Vaginal Discharge13(3)
* Most events were mild or moderate in severity.

Less Common Adverse Reactions

The following treatment-emergent adverse reactions were reported in less than 2% of the patients and are listed below by body system.

Body as a Whole - aggravation of preexisting tumor and decreased vision, allergic reaction, body odor, fever, flu syndrome, hypertrophy, infection; Cardiovascular System - bradycardia, hypertension, peripheral vascular disorder, syncope; Digestive System - constipation, dyspepsia, dysphagia, gingivitis, increased appetite, nausea/vomiting; Endocrine System - accelerated sexual maturity, feminization, goiter; Hemic and Lymphatic System - purpura; Metabolic and Nutritional Disorders - growth retarded, peripheral edema, weight gain; Musculoskeletal System - arthralgia, joint disorder, myalgia, myopathy; Nervous System - hyperkinesia, somnolence; Psychiatric System - depression, nervousness; Respiratory System - asthma, epistaxis, pharyngitis, rhinitis, sinusitis; Integumentary System (Skin and Appendages) - alopecia, hair disorder, hirsutism, leukoderma, nail disorder, skin hypertrophy; Urogenital System - cervix disorder/neoplasm, dysmenorrhea, gynecomastia/breast disorders, menstrual disorder, urinary incontinence.

Laboratory

The following laboratory events were reported as adverse reactions: antinuclear antibody present and increased sedimentation rate.

LUPRON DEPOT-PED 11.25 mg Or 30 mg For 3-Month Administration -Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

Table 3: Percentage of Patients with Treatment-Emergent Adverse Reactions Occurring in ≥2 Pediatric Patients Receiving LUPRON DEPOT-PED 11.25 mg or 30 mg for 3-month administration.

11.25 mg every 3 Months
N=42
30 mg every 3 Months
N=42
Overall
N= 84
N%N%N%
Injection site pain8(19)9(21)17(20)
Weight increased3(7)3(7)6(7)
Headache1(2)3(7)4(5)
Mood altered2(5)2(5)4(5)
Injection site swelling1(2)1(2)2(2)

Less Common Adverse Reactions

The following treatment-emergent adverse reactions were reported in one patient and are listed below by system organ class:

Gastrointestinal Disorders - abdominal pain, nausea; General Disorders and Administration Site Conditions - asthenia, gait disturbance, injection site abscess sterile, injection site hematoma, injection site induration, injection site warmth, irritability; Metabolic and Nutritional Disorders - decreased appetite, obesity; Musculoskeletal and Connective Tissue Disorders musculoskeletal pain, pain in extremity; Nervous System Disorders - dizziness; Psychiatric Disorders - crying, tearfulness; Respiratory, Thoracic and Mediastinal Disorders - cough; Skin and Subcutaneous Tissue Disorders - hyperhidrosis; Vascular Disorders - pallor.

Postmarketing

The following adverse events have been observed with this or other formulations of leuprolide acetate injection. As leuprolide has multiple indications, and therefore patient populations, some of these adverse events may not be applicable to every patient.

Allergic reactions (anaphylactic, rash, urticaria, and photosensitivity reactions) have also been reported.

Gastrointestinal Disorders: nausea, abdominal pain, vomiting;

General Disorders and Administration Site Conditions: chest pain, injection site reactions including induration and abscess have been reported;

Investigations: decreased WBC, weight increased;

Metabolism and Nutrition Disorders: diabetes mellitus;

Musculoskeletal and Connective Tissue Disorders: tenosynovitis-like symptoms, severe muscle pain;

Psychiatric Disorders: Emotional lability, such as crying, irritability, impatience, anger, and aggression has been observed with GnRH agonists, including LUPRON DEPOT-PED [see WARNINGS AND PRECAUTIONS]; Depression, including rare reports of suicidal ideation and attempt, has been reported for GnRH agonists, including LUPRON DEPOT-PED, in children treated for central precocious puberty. Many, but not all, of these patients had a history of psychiatric illness or other comorbidities with an increased risk of depression.

Nervous System Disorders: neuropathy peripheral, convulsion [see WARNINGS AND PRECAUTIONS], spinal fracture/paralysis;

Skin and Subcutaneous Tissue Disorders: hot flush, flushing, hyperhidrosis;

Reproductive System and Breast Disorders: prostate pain;

Vascular Disorders: hypertension, hypotension.

Pituitary apoplexy: During post-marketing surveillance, rare cases of pituitary apoplexy (a clinical syndrome secondary to infarction of the pituitary gland) have been reported after the administration of gonadotropin-releasing hormone agonists. In a majority of these cases, a pituitary adenoma was diagnosed, with a majority of pituitary apoplexy cases occurring within 2 weeks of the first dose, and some within the first hour. In these cases, pituitary apoplexy has presented as sudden headache, vomiting, visual changes, ophthalmoplegia, altered mental status, and sometimes cardiovascular collapse. Immediate medical attention has been required.

See other LUPRON DEPOT and LUPRON Injection package inserts for other events reported in different patient populations.

Read the entire FDA prescribing information for Lupron Depot-Ped (Leuprolide Acetate for Depot Suspension)

Related Resources for Lupron Depot-Ped

© Lupron Depot-Ped Patient Information is supplied by Cerner Multum, Inc. and Lupron Depot-Ped Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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