lupron depot-ped kit
Lupron Depot-Ped Kit (Leuprolide Acetate) is a gonadotropin releasing hormone receptor agonist used to treat Breast Neoplasms, Endometriosis, Infertility, Leiomyoma.
Leuprolide Acetate · by Abbvie Endocrine Inc
Key facts
- Active ingredient
- Leuprolide Acetate
- Form
- Kit
- Strength
- Leuprolide Acetate 11.25MG · Leuprolide Acetate 15MG · Leuprolide Acetate 3.75MG,7.5MG **Federal Register Determination That Product was not Discontinued or Withdrawn for Safety or Effectiveness reasons** · Leuprolide Acetate 30MG · Leuprolide Acetate 45MG · Leuprolide Acetate 7.5MG · Leuprolide Acetate 7.5MG,7.5MG **Federal Register Determination That Product was not Discontinued or Withdrawn for Safety or Effectiveness reasons**
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- breast neoplasms, endometriosis, infertility
- Manufacturer
- Abbvie Endocrine Inc
- What the pharmacy pays
- ~$6171.24 for 30 — not your price
- FDA application
- NDA020263
What is Lupron Depot-Ped Kit?
From the FDA label:LUPRON DEPOT-PED contains active ingredient, leuprolide, in the form of acetate salt, a gonadotropin-releasing hormone (GnRH) agonist. It is a synthetic nonapeptide analog of naturally occurring gonadotropin-releasing hormone (GnRH or LH-RH). The analog possesses greater potency than the natural hormone. The chemical name of leuprolide acetate is 5-oxo-L-prolyl-L-histidyl-L-tryptophyl-L-seryl-L-tyrosyl-D-leucyl-L-leucyl-L-arginyl-N-ethyl-L-prolinamide acetate, which has molecular formula of C 59 H 84 N 16 O 12 .(C 2 H 4 O 2 ) n , n=1 or 2, with the following structural formula: LUPRON DEPOT-PED for 1-month administration LUPRON DEPOT-PED is available in a prefilled dual-chamber single-dose syringe containing sterile lyophilized microsphere powder incorporated in a biodegradable lactic acid/glycolid acid copolymer which, when mixed with diluent, becomes a suspension for intramuscular injection. When mixed with 1 milliliter of accompanying diluent, LUPRON DEPOT-PED for 1-month administration is administered as a single-dose intramuscular injection. The front chamber of LUPRON DEPOT-PED 7.5 mg, 11.25 mg, and 15 mg a prefilled dual-chamber syringe contains leuprolide acetate (7.5 mg equivalent to 6.83-7.15 mg leuprolide / 11.25 mg equivalent to 10.24 – 10.72 mg leuprolide / 15 mg equivalent to 13.65 – 14.30 mg leuprolide), purified gelatin (1.3/1.95/2.6 mg), DL-lactic and glycolic…
How to use
Must be administered by a healthcare professional. ( 2.1 ) Select appropriate LUPRON DEPOT-PED syringe for the intended dosing frequency and administer intramuscularly. ( 2.1 ) For 1-month administration: Starting dose is 7.5, 11.25, or 15 mg based on the patient’s weight. ( 2.2 ) For 3-month administration: Doses are either 11.25 or 30 mg. ( 2.3 ) For 6-month administration: Dose is 45 mg. ( 2.4 ) Monitor hormonal and clinical parameters during treatment to ensure adequate suppression. ( 2.2 , 2.3 , 2.4 ) Rotate injection site periodically. ( 2.5 ) See Full Prescribing Information for administration and reconstitution instructions. ( 2.5 , 2.6 ) Figure 1 Figure 2 blue line syringe shake Figure 5 lupro loc click one 2.1 Important Dosing Information LUPRON DEPOT-PED must be administered by a healthcare professional. Individualize the dose of LUPRON DEPOT-PED for each patient. Select the appropriate LUPRON-DEPOT PED syringe for the intended dosing frequency and administer intramuscularly. Each LUPRON DEPOT-PED strength and formulation has different release characteristics. Do not use partial syringes or a combination of syringes to achieve a particular dose. In the case of inadequate suppression of pituitary gonadotropins and peripheral sex steroids with a maximal dosage, consider other available gonadotropin releasing hormone (GnRH) agonists indicated for the treatment of…
Side effects
The following serious adverse reactions are described here and elsewhere in the label: Initial rise in gonadotropin and sex steroid levels [see Warnings and Precautions ( 5.1 ) ] . Psychiatric Events [see Warnings and Precautions ( 5.2 ) ] . Convulsions [see Warnings and Precautions ( 5.3 ) ] . Severe Cutaneous Adverse Reactions (SCARs) [see Warnings and Precautions ( 5.4 )] Pseudotumor Cerebri (Idiopathic Intracranial Hypertension) [see Warnings and Precautions ( 5.5 ) ] Adverse events related to suppression of endogenous sex steroid secretion and injection site reactions including abscess may occur with LUPRON DEPOT-PED 7.5 mg, 11.25 mg, or 15 mg for 1-month administration. ( 6.1 , 6.2 ) In the clinical studies for LUPRON DEPOT-PED 7.5 mg, 11.25 mg, or 15mg for 1-month administration the most common (≥2%) adverse reactions were: emotional lability, headache, general pain, acne/seborrhea, rash including erythema multiforme and vaginitis/vaginal bleeding/vaginal discharge. ( 6.1 ) In the clinical studies for LUPRON DEPOT-PED 11.25 mg or 30 mg for 3-month administration the most common ( > 2%) adverse reactions were: injection site pain, weight increased, headache, mood altered, and injection site swelling. ( 6.1 ) In the clinical study for LUPRON DEPOT-PED 45 mg for 6-month administration the most common (≥4%) adverse reactions were: injection site reactions, headache,…
Warnings
Important safety information
Initial Rise of Gonadotropins and Sex Steroid Levels: During the early phase of therapy, gonadotropins and sex steroids may rise above baseline because of the initial stimulatory effect of the drug. Therefore, an increase in clinical signs and symptoms of puberty, including vaginal bleeding, may be observed during the first weeks of therapy or after subsequent doses. ( 5.1 ) Psychiatric events : Have been reported in patients taking GnRH agonists. Events include emotional lability, such as crying, irritability, impatience, anger, and aggression. Monitor for development or worsening of psychiatric symptoms. ( 5.2 ) Convulsions : Have been observed in patients with or without a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and in patients on concomitant medications that have been associated with convulsions. ( 5.3 ) Severe Cutaneous Adverse Reactions (SCARs) : Have been reported in patients receiving GnRH agonists, including leuprolide products. Interrupt LUPRON DEPOT-PED if signs or symptoms of SCARs develop. Permanently discontinue LUPRON DEPOT-PED if a SCAR is confirmed. ( 5.4 ) Pseudotumor C erebri (I diopathic I ntracranial H ypertension ): Have been reported in pediatric patients receiving GnRH agonists, including LUPRON DEPOT-PED. Monitor patients for headache, papilledema, and blurred vision. ( 5.5 ) 5.1 Initial Rise of Gonadotropins and Sex Steroid Levels During the early phase of therapy or after subsequent doses, gonadotropins and sex steroids may rise above baseline because of a transient stimulatory effect of the drug [see Clinical Pharmacology ( 12.2 )] . Therefore, an increase in clinical signs and symptoms of puberty, including vaginal bleeding, may be observed during the first weeks of therapy or after subsequent doses [see Adverse Reactions ( 6 )] . 5.2 Psychiatric Events Psychiatric events have been reported in patients taking GnRH agonists, including LUPRON DEPOT-PED. Postmarking reports with this class of drugs include symptoms of emotional lability, such as crying, irritability, impatience, anger and aggression. Monitor for development or worsening of psychiatric symptoms during treatment with LUPRON DEPOT-PED [see Adverse Reactions ( 6.2 ) ] . 5.3 Convulsions Postmarketing reports of convulsions have been observed in patients receiving GnRH agonists, including LUPRON DEPOT-PED. These included patients with a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies or tumors, and patients on concomitant medications that have been associated with convulsions such as bupropion and SSRIs. Convulsions have also been reported in patients in the absence of any of the conditions mentioned above [see Adverse Reactions ( 6.2 ) ] . 5.4 Severe Cutaneous Adverse Reactions Severe cutaneous adverse reactions (SCARs) have been reported in patients receiving GnRH agonists, including leuprolide products [see Adverse Reactions ( 6.2 )] . These reactions include Stevens-Johnson syndrome/toxic epidermal necrolysis (SJS/TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP), including cases with visceral involvement and/or requiring skin grafts. Monitor patients for signs and symptoms of SCARs such as fever, flu-like symptoms, mucosal lesions, progressive skin rash or lymphadenopathy. Advise patients and caregivers of the signs and symptoms of SCARs. If a SCAR is suspected, interrupt LUPRON DEPOT-PED. Consult a healthcare provider with expertise in the diagnosis and management of SCARs. If a diagnosis of SCAR is confirmed permanently discontinue LUPRON DEPOT-PED. 5.5 Pseudotumor Cerebri (Idiopathic Intracranial Hypertension) Pseudotumor cerebri (idiopathic intracranial hypertension) have been reported in pediatric patients receiving GnRH agonists, including LUPRON DEPOT-PED. Monitor patients for signs and symptoms of pseudotumor cerebri, including headache, papilledema, blurred vision, diplopia, loss of vision, pain behind the eye or pain with eye movement, tinnitus, dizziness, and nausea.
Who should not take Lupron Depot-Ped Kit
Hypersensitivity to GnRH, GnRH agonists or any of the excipients in LUPRON DEPOT-PED. Anaphylactic reactions to synthetic GnRH or GnRH agonists have been reported [see Adverse Reactions ( 6.2 )] . Pregnancy: LUPRON DEPOT-PED may cause fetal harm [see Use in Specific Populations ( 8.1 )] . Hypersensitivity reactions to GnRH, GnRH agonists or any of the excipients in LUPRON DEPOT-PED ( 4 ) Pregnancy ( 4 , 8.1 )
Overdose — what happens if you take too much
No specific antidotes for LUPRON DEPOT-PED are known. Contact Poison Control (1-800-222-1222) for latest recommendations. In cases of overdosage, standard of care monitoring and management principles should be followed.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
No pharmacokinetic-based drug-drug interaction studies have been conducted with LUPRON DEPOT-PED [see C linical P harmacology ( 12.3 ) ] . 7.2 Drug-Laboratory Test Interactions Administration of LUPRON DEPOT-PED in therapeutic doses results in suppression of the pituitary-gonadal system. Therefore, diagnostic tests of pituitary gonadotropic and gonadal functions conducted during treatment and up to six months after discontinuation of LUPRON DEPOT-PED may be affected. Normal pituitary-gonadal function is usually restored within six months after treatment with LUPRON DEPOT-PED is discontinued. 7.1 Drug Interactions No pharmacokinetic-based drug-drug interaction studies have been conducted with LUPRON DEPOT-PED [see C linical P harmacology ( 12.3 ) ] .
Drug class
May treat (source: NIH RxClass)
See how Lupron Depot-Ped Kit ranks — best-rated gonadotropin releasing hormone receptor agonist for:
Dosage forms
Kit
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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Frequently asked questions
- What does Lupron Depot-Ped Kit treat?
- Lupron Depot-Ped Kit (Leuprolide Acetate) may be used to treat breast neoplasms, endometriosis, infertility, leiomyoma, ovarian neoplasms, prostatic hyperplasia, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How much does Lupron Depot-Ped Kit cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $6171.24 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Lupron Depot-Ped Kit?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Lupron Depot-Ped Kit. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Lupron Depot-Ped Kit?
- Lupron Depot-Ped Kit is marketed by Abbvie Endocrine Inc. You can see Abbvie Endocrine Inc's full profile, rating, and other products on pharmaranks.
- Is Lupron Depot-Ped Kit a brand-name or generic drug?
- Lupron Depot-Ped Kit is a brand-name product with the active ingredient Leuprolide Acetate.
- Is Lupron Depot-Ped Kit available over the counter?
- No. Lupron Depot-Ped Kit is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Lupron Depot-Ped Kit come in?
- Lupron Depot-Ped Kit is currently marketed as kit, per the FDA's National Drug Code Directory.
- What class of drug is Lupron Depot-Ped Kit?
- Lupron Depot-Ped Kit is classified as gonadotropin releasing hormone receptor agonist, per the FDA's Established Pharmacologic Class.
- Is Lupron Depot-Ped Kit FDA-registered?
- Lupron Depot-Ped Kit is on record with the U.S. FDA under application number NDA020263. You can verify this on its official FDA label.
- Is Lupron Depot-Ped Kit safe?
- There's no single safe-or-not verdict, and we don't yet have a composite recall-safety score for Lupron Depot-Ped Kit. Review its FDA-label side effects and warnings below, and always consult a licensed professional.
- What are the side effects of Lupron Depot-Ped Kit?
- Lupron Depot-Ped Kit's side effects are taken directly from its FDA label. From the label: The following serious adverse reactions are described here and elsewhere in the label: Initial rise in gonadotropin and sex steroid levels [see Warnings and Precautions ( 5.1 ) ] . Psychiatric Events [see Warnings and Precautions ( 5.2 ) ] . Convulsions [see Warnings and Precautions ( 5.3 ) ] .… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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