LEUPROLIDE ACETATE

LEUPROLIDE ACETATE is an FDA-registered drug product whose active ingredient is LEUPROLIDE ACETATE. It is labelled by Zydus Pharmaceuticals USA Inc. and marketed as a human prescription drug product. Identifiers on file: NDC 70710-1769, application ANDA215826, label effective 20260525. It is one of 8 FDA drug label records sharing the active ingredient LEUPROLIDE ACETATE. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

Across FDA labelling, products containing LEUPROLIDE ACETATE are most often described in connection with: usage leuprolide, acetate injection, palliative treatment, advanced prostatic. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

INDICATIONS AND USAGE Leuprolide acetate injection is indicated in the palliative treatment of advanced prostatic cancer.

DOSAGE AND ADMINISTRATION The recommended dose is 1 mg (0.2 mL or 20 unit mark) administered as a single daily subcutaneous injection. As with other drugs administered chronically by subcutaneous injection, the injection site should be varied periodically. Each 0.2 mL contains 1 mg of leuprolide acetate, USP, sodium chloride, USP for tonicity adjustment, 1.8 mg of benzyl alcohol, NF as preservative and water for injection, USP. The pH may have been adjusted with sodium hydroxide, NF and/or Glacial acetic acid, USP. Follow the pictorial directions on the reverse side of this package insert for administration. NOTE: As with all parenteral products, inspect the solution for discoloration and particulate matter before each use.

CONTRAINDICATIONS Leuprolide acetate injection is contraindicated in patients known to be hypersensitive to GnRH, GnRH agonist analogs or any of the excipients in leuprolide acetate injection: Reports of anaphylactic reactions to GnRH agonist analogs have been reported in the medical literature.

WARNINGS Initially, leuprolide acetate injection, like other LH-RH agonists, causes increases in serum levels of testosterone. Transient worsening of symptoms, or the occurrence of additional signs and symptoms of prostate cancer, may develop during the first few weeks of leuprolide acetate injection treatment. Patients may experience a temporary increase in bone pain, which can be managed symptomatically. As with other LH-RH agonists, ureteral obstruction and spinal cord compression have been observed, which may contribute to paralysis with or without fatal complications. Safe use of leuprolide acetate in pregnancy has not been established clinically. Leuprolide acetate injection may cause fetal harm. Periodic monitoring of serum testosterone and prostate-specific antigen (PSA) levels is recommended, especially if the anticipated clinical or biochemical response to treatment has not been achieved. It should be noted that results of testosterone determinations are dependent on assay methodology. It is advisable to be aware of the type and precision of the assay methodology to make appropriate clinical and therapeutic decisions. Severe Cutaneous Adverse Reactions Leuprolide acetate can cause severe cutaneous adverse reactions (SCARs), including Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), drug reaction with eosinophilia and systemic symptoms (DRESS) and acute generalized exanthematous pustulosis (AGEP). SCARs, including SJS/TEN, DRESS, and AGEP, occurred in patients receiving leuprolide acetate; including cases with visceral involvement and/or requiring skin grafts [see Adverse Reactions]. Monitor patients for the development of SCARs. If a SCAR is suspected, interrupt leuprolide acetate until the etiology of the reaction has been determined. Consultation with a dermatologist is recommended. If a SCAR is confirmed or for other grade 4 skin reactions, permanently discontinue leuprolide acetate.

ADVERSE REACTIONS Clinical Trials In the majority of patients testosterone levels increased above baseline during the first week, declining thereafter to baseline levels or below by the end of the second week of treatment. This transient increase was occasionally associated with a temporary worsening of signs and symptoms, usually manifested by an increase in bone pain (see WARNINGS section). Cases of temporary worsening of existing hematuria and urinary tract obstruction have occurred during the first week. Temporary weakness and paresthesia of the lower limbs have been reported. Potential exacerbations of signs and symptoms during the first few weeks of treatment is a concern in patients with vertebral metastases and/or urinary obstruction which, if aggravated, may lead to neurological problems or increase the obstruction. In a comparative trial of leuprolide acetate injection versus DES, in 5% or more of the patients receiving either drug, the following adverse reactions were reported to have a possible or probable relationship to drug as ascribed by the treating physician. Often, causality is difficult to assess in patients with metastatic prostate cancer. Reactions considered not drug related are excluded. Leuprolide Acetate Injection (N=98) DES (N=101) Number of Reports Cardiovascular System Congestive heart failure 1 5 ECG changes/ischemia 19 22 High blood pressure 8 5 Murmur 3 8 Peripheral edema 12 30 Phlebitis/thrombosis 2 10 Gastrointestinal System Anorexia 6 5 Constipation 7 9 Nausea/vomiting 5 17 Endocrine System *Decreased testicular size 7 11 *Gynecomastia/breast tenderness or pain 7 63 *Hot flashes 55 12 *Impotence 4 12 Hemic and Lymphatic System Anemia 5 5 Musculoskeletal System Bone pain 5 2 Myalgia 3 9 Central/Peripheral Nervous System Dizziness/lightheadedness 5 7 General pain 13 13 Headache 7 4 Insomnia/sleep disorders 7 5 Respiratory System Dyspnea 2 8 Sinus congestion 5 6 Integumentary System Dermatitis 5 8 Urogenital System Frequency/urgency 6 8 Hematuria 6 4 Urinary tract infection 3 7 Miscellaneous Asthenia 10 10 * Physiologic effect of decreased testosterone. In this same study, the following adverse reactions were reported in less than 5% of the patients on leuprolide acetate injection. Cardiovascular System - Angina, Cardiac arrhythmias, Myocardial infarction, Pulmonary emboli Gastrointestinal System - Diarrhea, Dysphagia, Gastrointestinal bleeding, Gastrointestinal disturbance, Peptic ulcer, Rectal polyps Endocrine System - Libido decrease, Thyroid enlargement Musculoskeletal System - Joint pain Central/Peripheral Nervous System - Anxiety, Blurred vision, Lethargy, Memory disorder, Mood swings, Nervousness, Numbness, Paresthesia, Peripheral neuropathy, Syncope/blackouts, Taste disorders Respiratory System - Cough, Pleural rub, Pneumonia, Pulmonary fibrosis Integumentary System - Carcinoma of skin/ear, Dry skin, Ecchymosis, Hair loss, Itching, Local skin reactions, Pigmentation, Skin lesions Urogenital System - Bladder spasms, Dysuria, Incontinence, Testicular pain, Urinary obstruction Miscellaneous - Depression, Diabetes, Fatigue, Fever/chills, Hypoglycemia, Increased BUN, Increased calcium, Increased creatinine, Infection/inflammation, Ophthalmologic disorders, Swelling (temporal bone). In an additional clinical trial and from long-term observation of both studies, the following additional adverse reactions were reported for patients receiving leuprolide acetate injection. Cardiovascular System - Bradycardia, Carotid bruit, Extrasystole, Palpitations, Perivascular cuffing (eyes), Ruptured aortic aneurysm, Stroke, Tachycardia, Transient ischemic attack Gastrointestinal System - Flatus, Dryness of mouth and throat, Hepatitis, Hepatomegaly, Occult blood (rectal exam), Rectal fistula/erythema Endocrine System - Libido increase, Thyroid nodule Musculoskeletal System - Ankylosing spondylosis, Arthritis, Blurred disc margins, Bone fracture, Muscle stiffness, Muscle tenderness, Pelvic fibrosis, Spasms/cramps Central/Peripheral Nervous System - Auditory hallucinations/tinnitus, Decreased hearing, Decreased reflexes, Euphoria, Hyperreflexia, Loss of smell, Motor deficiency Respiratory System - Chest tightness, Decreased breathing sounds, Hemoptysis, Pleuritic chest pain, Pulmonary infiltrate, Rales/rhonchi, Rhinitis, Strep throat, Wheezing/bronchitis Integumentary System - Boil (pubic), Bruises, Hives, Keratosis, Mole, Shingles, Spiders Urogenital System - Blisters on penis, Inguinal hernia, Penile swelling, Post void residual, Prostatic pain, Pyuria Miscellaneous - Abdominal distention, Facial swelling/edema, Feet burning, Flu, Eyelid growth, Hypoproteinemia, Accidental injury, Knee effusion, Mass, Pallid, Sallow, Weakness. Postmarketing During postmarketing surveillance which includes other dosage forms and other patient populations, the following adverse reactions were reported. Symptoms consistent with an anaphylactoid or asthmatic process have been rarely (incidence rate of about 0.002%) reported. Symptoms consistent with fibromyalgia (e.g., joint and muscle pain, headaches, sleep disorders, gastrointestinal distress, and shortness of breath) have been reported individually and collectively. Cardiovascular System - Hypotension, Myocardial infarction, Pulmonary embolism Endocrine System - Diabetes Gastrointestinal System - Hepatic dysfunction Hepato-biliary disorder - Serious drug-induced liver injury Hemic and Lymphatic System - Decreased WBC Skin and Subcutaneous Tissue Disorders – Rash, Urticaria, Photosensitivity, Hair growth, SJS/TEN, DRESS, AGEP, Dermatitis exfoliative, Bullous dermatitis, Erythema multiforme; Central/Peripheral Nervous System - Convulsion, Peripheral neuropathy, Spinal fracture/paralysis, Hearing disorder Miscellaneous - Hard nodule in throat, Weight gain, Increased uric acid Musculoskeletal System - Tenosynovitis-like symptoms Respiratory System - Respiratory disorders, Interstitial lung disease Urogenital System - Prostate pain. General disorders and administration site conditions – injection site reactions including induration, abscess and necrosis. Psychiatric disorders – Suicidal ideation and attempt; Changes in Bone Density: Decreased bone density has been reported in the medical literature in men who have had orchiectomy or who have been treated with an LH-RH agonist analog. In a clinical trial, 25 men with prostate cancer, 12 of whom had been treated previously with leuprolide acetate for at least six months, underwent bone density studies as a result of pain. The leuprolide-treated group had lower bone density scores than the nontreated control group. It can be anticipated that long periods of medical castration in men will have effects on bone density. 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 leuprolide acetate injection package inserts for other events reported in the same and different patient populations.

FDA lists 8 drug label records with LEUPROLIDE ACETATE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

What is LEUPROLIDE ACETATE used for?
INDICATIONS AND USAGE Leuprolide acetate injection is indicated in the palliative treatment of advanced prostatic cancer.

Who makes LEUPROLIDE ACETATE?
Zydus Pharmaceuticals USA Inc. is the labeler of record for LEUPROLIDE ACETATE. 8 FDA label records share the active ingredient LEUPROLIDE ACETATE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

Is LEUPROLIDE ACETATE prescription or over-the-counter?
The FDA label for this product is recorded as human prescription drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing LEUPROLIDE ACETATE?
Yes. 8 FDA drug label records list LEUPROLIDE ACETATE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has LEUPROLIDE ACETATE been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.