Lupron Pediatric

Last reviewed on RxList: 5/1/2018
Lupron Pediatric Side Effects Center

Last reviewed on RxList 5/1/2018

Lupron Depot Pediatric (leuprolide acetate) is a manmade form of a gonadotropin-releasing hormone (GnRH or LH-RH) used to treat precocious (early-onset) puberty in both male and female children. Common side effects of Lupron Depot Pediatric include acne, increased growth of facial hair, breakthrough vaginal bleeding in a female child during the first 2 months of Lupron Depot Pediatric treatment, dizziness, weakness, tired feeling, hot flashes, night sweats, chills, clammy skin, nausea, diarrhea, constipation, stomach pain, skin redness, skin itching or scaling, rash, joint or muscle pain, vaginal itching or discharge, breast swelling or tenderness, testicle pain, impotence, loss of interest in sex, depression, mood swings, sleep problems (insomnia), memory problems, headache, or injection site reactions (redness, burning, itching, swelling, or abscess).

Lupron Depot Pediatric is administered under the supervision of a physician, and is given as a single intramuscular injection once a month. The starting dose is dictated by the child's weight. Other drugs may interact with Lupron Depot. Tell your doctor all medications and supplements you use. Do not use Lupron Depot if you are pregnant. It can cause birth defects. Tell your doctor right away if you become pregnant during treatment. Use an effective barrier form of birth control (such as a condom or diaphragm with spermicide gel or inserts). Hormonal forms of contraception may not be effective in preventing pregnancy while using this drug. Breastfeeding while using Lupron Depot is not recommended.

Our Lupron Depot Pediatric (leuprolide acetate) 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.

Lupron Pediatric 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 Pediatric (Leuprolide Acetate Injection)

Lupron Pediatric Professional Information

SIDE EFFECTS

The most common adverse reactions with GnRH agonists including LUPRON DEPOT-PED 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 natural initial stimulatory effect of the drug (hormonal flare effect). Therefore, an increase in clinical signs and symptoms may be observed [see WARNINGS AND PRECAUTIONS].

LUPRON DEPOT-PED–1 Month (7.5 mg, 11.25 mg, and 15 mg Injection) - 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 Pain 12 (3)
  Headache 11 (3)
Cardiovascular System
  Vasodilation 9 (2)
Integumentary System (Skin and Appendages)
  Acne/Seborrhea 13 (3)
  Rash Including Erythema Multiforme 12 (3)
Nervous System
  Emotional Lability 19 (5)
Urogenital System
  Vaginitis/Vaginal Bleeding/Vaginal Discharge 13 (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 – depression, hyperkinesia, nervousness, somnolence; 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.

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;

Nervous System Disorders: neuropathy peripheral, convulsion, 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 Pediatric (Leuprolide Acetate Injection)

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

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