Dosing & Uses
Dosage Forms & Strengths
injection, powder for reconstitution
- 7.5mg (monthly) (Eligard)
- 22.5mg (3 months) (Eligard; Lutrate Depot)
- 30mg (4 months) (Eligard)
- 45mg (6 months) (Eligard)
injection, suspension (Lupron Depot)
- 3.75mg (monthly)
- 7.5mg (monthly)
- 11.25mg (3 months)
- 22.5mg (3 months)
- 30mg (4 months)
- 45mg (6 months)
injection, emulsion (Camcevi)
- 42mg/prefilled syringe (6 months)
injection, solution (generic leuprolide acetate)
- 5mg/mL vial (daily)
Advanced Prostate Cancer
Indicated for advanced prostate cancer
Lupron: 7.5 mg IM monthly, 22.5 mg IM every 3 months, 30 mg IM every 4 months, or 45 mg IM every 6 months
Eligard: 7.5 mg SC monthly, 22.5 mg SC every 3 months, 30 mg SC every 4 months, 45 mg SC every 6 months
Lutrate Depot: 22.5 mg SC every 3 months
Leuprolide acetate: 1 mg/0.2 mL/day SC
Camcevi: 42 mg SC every 6 months
Endometriosis
3.75 mg IM monthly for up to 6 months or 11.25 mg IM every 3 months for 2 doses (6 months total)
Recommended duration of treatment is 6 months; may treat again for additional 6 months, but with concomitant administration of norethindrone
Uterine Leiomyomata (Fibroids)
3.75 mg IM monthly for up to 3 months or 11.25 mg IM once
Use concomitant iron treatment
Breast Cancer in Premenopausal Ovarian Ablation (Off-label)
3.75 mg IM every 28 days or 11.25 mg IM every 3 months for up to 24 months
Dosage Modifications
Renal or hepatic impairment
- Pharmacokinetics of leuprolide have not been studied in renally and hepatically impaired patients
Dosing Considerations
Monitoring
- Measure prostate-specific antigen (PSA) in first few weeks of therapy; measure luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels and serum testosterone after 4 weeks of therapy
Dosage Forms & Strengths
injection kit, dual-chambered syringe with lyophilized powder and diluent for reconstitution
- Reconstitution results in suspension for IM injection
-
monthly
- 7.5 mg (Lupron Depot-Ped)
- 11.25 mg (Lupron Depot-Ped)
- 15 mg (Lupron Depot-Ped)
-
3-months
- 11.25 mg (Lupron Depot-Ped)
- 30 mg (Lupron Depot-Ped)
-
6-months
- 45 mg (Lupron Depot-Ped)
kit, injectable suspension
- Reconstitution results in suspension for IM injection
-
Kit contains 2 syringes (Fensolvi)
- Syringe A contains diluent for reconstitution
- Syringe B contains 45 mg lyophilized leuprolide acetate powder
injectable solution
- 5mg/mL (generic)
Central Precocious Puberty
Indicated when signs of sexual maturity begin to develop in girls <8 years old and boys <9 years old; may be discontinued at appropriate age of onset of puberty (eg, 11 years in females and 12 years in males), at physician's discretion
<2 years old: Safety and efficacy not established
Lupron Depot-Ped (monthly dose)
- <25 kg: 7.5 mg IM monthly
- >25 kg to 37.5 kg: 11.25 mg IM monthly
- >37.5 kg: 15 mg IM monthly
- Assess response 1-2 months after initial injection; if adequate hormonal and clinical suppression not achieved with starting doses, increase next monthly dose to the next higher level
- Assess height (for calculation of growth rate) and bone age every 6-12 months
Lupron Depot-Ped (3-month dose)
- 11.25 mg or 30 mg IM injection every 3 months
- Assess response 2-3 months after initial injection and 6 months after injection
- Assess height (for calculation of growth rate) and bone age every 6-12 months
Lupron Depot-Ped (6-month dose)
- 45 mg IM every 6 months
- Monitor response with GnRH stimulation test, basal LH or serum concentration of sex steroid levels at months 5 to 6 and further as judged clinically appropriate, to confirm maintenance of efficacy
- Assess height (for calculation of growth rate) and bone age every 6-12 months
Leuprolide acetate
Fensolvi
- 45 mg SC once q6months
- Discontinue treatment at appropriate age of onset of puberty
- If dose is not adequate, switching to an alternative GnRH agonist may be necessary
Dosage Modifications
Renal or hepatic impairment
- Pharmacokinetics of leuprolide have not been studied in renally and hepatically impaired patients
Dosing Considerations
Monitoring
- Monitor response with a GnRH agonist stimulation test, basal serum luteinizing hormone (LH) levels or serum concentration of sex steroid levels following initiation (frequency depends on product dosage regimen) and as needed to confirm adequate suppression of pituitary gonadotropins, sex steroids, and progression of secondary sexual characteristics
Measure height (for calculation of growth velocity) months and monitor bone age periodically according to specific product recommendations
Noncompliance with drug regimen or inadequate dosing may lead to gonadotropins and/or sex steroids increasing above prepubertal levels resulting in inadequate control of the pubertal process
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (30)
- amiodarone
leuprolide increases toxicity of amiodarone by QTc interval. Contraindicated. Increases risk of torsades de pointes.
- anagrelide
leuprolide increases toxicity of anagrelide by QTc interval. Contraindicated. Increases risk of torsades de pointes.
- arsenic trioxide
leuprolide increases toxicity of arsenic trioxide by QTc interval. Contraindicated. Increases risk of torsades de pointes.
- artemether
leuprolide increases toxicity of artemether by QTc interval. Contraindicated. Increases risk of torsades de pointes.
- artemether/lumefantrine
leuprolide increases toxicity of artemether/lumefantrine by QTc interval. Contraindicated.
- citalopram
leuprolide increases toxicity of citalopram by QTc interval. Contraindicated. Increases risk of torsades de pointes.
- disopyramide
leuprolide increases toxicity of disopyramide by QTc interval. Contraindicated. Increases risk of torsades de pointes.
- dofetilide
leuprolide increases toxicity of dofetilide by QTc interval. Contraindicated. Increases risk of torsades de pointes.
- dronedarone
leuprolide increases toxicity of dronedarone by QTc interval. Contraindicated. Increases risk of torsades de pointes.
- eliglustat
leuprolide increases toxicity of eliglustat by QTc interval. Contraindicated. Increases risk of torsades de pointes.
- escitalopram
leuprolide increases toxicity of escitalopram by QTc interval. Contraindicated. Increases risk of torsades de pointes.
- fluoxetine
leuprolide increases toxicity of fluoxetine by QTc interval. Contraindicated. Increases risk of torsades de pointes.
- ibutilide
leuprolide increases toxicity of ibutilide by QTc interval. Contraindicated. Increases risk of torsades de pointes.
- iloperidone
leuprolide increases toxicity of iloperidone by QTc interval. Contraindicated. Increases risk of torsades de pointes.
- lopinavir
leuprolide increases toxicity of lopinavir by QTc interval. Contraindicated. Increases risk of torsades de pointes.
- lumefantrine
leuprolide increases toxicity of lumefantrine by QTc interval. Contraindicated. Increases risk of torsades de pointes.
- mifepristone
leuprolide increases toxicity of mifepristone by QTc interval. Contraindicated. Increases risk of torsades de pointes.
- nilotinib
leuprolide increases toxicity of nilotinib by QTc interval. Contraindicated. Increases risk of torsades de pointes.
- paliperidone
leuprolide increases toxicity of paliperidone by QTc interval. Contraindicated. Increases risk of torsades de pointes.
- pimozide
leuprolide increases toxicity of pimozide by QTc interval. Contraindicated. Increases risk of torsades de pointes.
- procainamide
leuprolide increases toxicity of procainamide by QTc interval. Contraindicated. Increases risk of torsades de pointes.
- quetiapine
leuprolide increases toxicity of quetiapine by QTc interval. Contraindicated. Increases risk of torsades de pointes.
- quinidine
leuprolide increases toxicity of quinidine by QTc interval. Contraindicated. Increases risk of torsades de pointes.
- sotalol
leuprolide increases toxicity of sotalol by QTc interval. Contraindicated. Increases risk of torsades de pointes.
- tetrabenazine
leuprolide increases toxicity of tetrabenazine by QTc interval. Contraindicated. Increases risk of torsades de pointes.
- thioridazine
leuprolide increases toxicity of thioridazine by QTc interval. Contraindicated. Increases risk of torsades de pointes.
- toremifene
leuprolide increases toxicity of toremifene by QTc interval. Contraindicated. Increases risk of torsades de pointes.
- vandetanib
leuprolide increases toxicity of vandetanib by QTc interval. Contraindicated. Increases risk of torsades de pointes.
- vemurafenib
leuprolide increases toxicity of vemurafenib by QTc interval. Contraindicated. Increases risk of torsades de pointes.
- ziprasidone
leuprolide increases toxicity of ziprasidone by QTc interval. Contraindicated. Increases risk of torsades de pointes.
Serious - Use Alternative (22)
- amisulpride
amisulpride and leuprolide both increase QTc interval. Avoid or Use Alternate Drug. ECG monitoring is recommended if coadministered.
- asenapine
asenapine and leuprolide both increase QTc interval. Avoid or Use Alternate Drug.
- asenapine transdermal
asenapine transdermal and leuprolide both increase QTc interval. Avoid or Use Alternate Drug.
- buprenorphine
buprenorphine and leuprolide both increase QTc interval. Avoid or Use Alternate Drug.
- buprenorphine buccal
buprenorphine buccal and leuprolide both increase QTc interval. Avoid or Use Alternate Drug.
- buprenorphine subdermal implant
buprenorphine subdermal implant and leuprolide both increase QTc interval. Avoid or Use Alternate Drug.
- buprenorphine transdermal
buprenorphine transdermal and leuprolide both increase QTc interval. Avoid or Use Alternate Drug.
- buprenorphine, long-acting injection
buprenorphine, long-acting injection and leuprolide both increase QTc interval. Avoid or Use Alternate Drug.
- desflurane
desflurane and leuprolide both increase QTc interval. Avoid or Use Alternate Drug.
- encorafenib
encorafenib and leuprolide both increase QTc interval. Avoid or Use Alternate Drug.
- entrectinib
leuprolide and entrectinib both increase QTc interval. Avoid or Use Alternate Drug.
- fexinidazole
fexinidazole and leuprolide both increase QTc interval. Avoid or Use Alternate Drug. Avoid coadministration of fexinidazole with drugs known to block potassium channels or prolong QT interval.
- glasdegib
leuprolide and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.
- inotuzumab
inotuzumab and leuprolide both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.
- isoflurane
isoflurane and leuprolide both increase QTc interval. Avoid or Use Alternate Drug.
- lefamulin
lefamulin and leuprolide both increase QTc interval. Avoid or Use Alternate Drug.
- olanzapine
olanzapine and leuprolide both increase QTc interval. Avoid or Use Alternate Drug.
- oxaliplatin
oxaliplatin and leuprolide both increase QTc interval. Avoid or Use Alternate Drug.
- panobinostat
leuprolide and panobinostat both increase QTc interval. Avoid or Use Alternate Drug. Panobinostat is known to significantly prolong QT interval. Panobinostat prescribing information states use with drugs known to prolong QTc is not recommended.
- pitolisant
leuprolide and pitolisant both increase QTc interval. Avoid or Use Alternate Drug.
- sevoflurane
sevoflurane and leuprolide both increase QTc interval. Avoid or Use Alternate Drug.
- siponimod
siponimod and leuprolide both increase QTc interval. Avoid or Use Alternate Drug.
Monitor Closely (80)
- albuterol
albuterol and leuprolide both increase QTc interval. Use Caution/Monitor.
- alfuzosin
leuprolide and alfuzosin both increase QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes
- apomorphine
leuprolide increases toxicity of apomorphine by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- arformoterol
leuprolide increases toxicity of arformoterol by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- aripiprazole
aripiprazole and leuprolide both increase QTc interval. Use Caution/Monitor.
- atomoxetine
atomoxetine and leuprolide both increase QTc interval. Use Caution/Monitor.
- azithromycin
leuprolide increases toxicity of azithromycin by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- bedaquiline
leuprolide increases toxicity of bedaquiline by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- ceritinib
leuprolide increases toxicity of ceritinib by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- chloroquine
leuprolide increases toxicity of chloroquine by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- chlorpromazine
leuprolide increases toxicity of chlorpromazine by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- cholera vaccine
leuprolide decreases effects of cholera vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Immunosuppressive therapies, including irradiation, antimetabolites, alkylating agents, cytotoxic drugs and corticosteroids (used in greater than physiologic doses), may reduce the immune response to cholera vaccine.
- ciprofloxacin
leuprolide increases toxicity of ciprofloxacin by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- clarithromycin
leuprolide increases toxicity of clarithromycin by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- clozapine
leuprolide increases toxicity of clozapine by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- crizotinib
leuprolide increases toxicity of crizotinib by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- dasatinib
dasatinib and leuprolide both increase QTc interval. Use Caution/Monitor.
- degarelix
leuprolide increases toxicity of degarelix by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- dengue vaccine
leuprolide decreases effects of dengue vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Immunosuppressive therapies (eg, irradiation, antimetabolites, alkylating agents, cytotoxic drugs, corticosteroids [greater than physiologic doses]) may reduce immune response to dengue vaccine.
- deutetrabenazine
deutetrabenazine and leuprolide both increase QTc interval. Use Caution/Monitor. At the maximum recommended dose, deutetrabenazine does not prolong QT interval to a clinically relevant extent. Certain circumstances may increase risk of torsade de pointes and/or sudden death in association with drugs that prolong the QTc interval (eg, bradycardia, hypokalemia or hypomagnesemia, coadministration with other drugs that prolong QTc interval, presence of congenital QT prolongation).
- dichlorphenamide
dichlorphenamide and leuprolide both decrease serum potassium. Use Caution/Monitor.
- dolasetron
leuprolide increases toxicity of dolasetron by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- donepezil
donepezil and leuprolide both increase QTc interval. Use Caution/Monitor.
- doxepin
doxepin and leuprolide both increase QTc interval. Use Caution/Monitor.
- droperidol
leuprolide increases toxicity of droperidol by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- efavirenz
efavirenz and leuprolide both increase QTc interval. Use Caution/Monitor.
- eribulin
leuprolide increases toxicity of eribulin by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- erythromycin base
leuprolide increases toxicity of erythromycin base by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- erythromycin ethylsuccinate
leuprolide increases toxicity of erythromycin ethylsuccinate by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- erythromycin lactobionate
leuprolide increases toxicity of erythromycin lactobionate by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- erythromycin stearate
leuprolide increases toxicity of erythromycin stearate by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- ezogabine
leuprolide increases toxicity of ezogabine by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- fingolimod
leuprolide increases toxicity of fingolimod by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- flecainide
leuprolide increases toxicity of flecainide by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- fluconazole
leuprolide increases toxicity of fluconazole by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- formoterol
leuprolide increases toxicity of formoterol by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- fostemsavir
leuprolide and fostemsavir both increase QTc interval. Use Caution/Monitor. QTc prolongation reported with higher than recommended doses of fostemsavir.
- gallium Ga 68 PSMA-11
leuprolide will decrease the level or effect of gallium Ga 68 PSMA-11 by unspecified interaction mechanism. Modify Therapy/Monitor Closely. Androgen deprivation therapy and other therapies targeting the androgen pathway may result in changes in the uptake of gallium Ga 68 PSMA-11 in prostate cancer. The effect of ADT on the performance of gallium Ga 68 PSMA-11 is unknown.
- gemifloxacin
leuprolide increases toxicity of gemifloxacin by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- gemtuzumab
leuprolide and gemtuzumab both increase QTc interval. Use Caution/Monitor.
- gilteritinib
gilteritinib and leuprolide both increase QTc interval. Use Caution/Monitor.
- granisetron
granisetron and leuprolide both increase QTc interval. Use Caution/Monitor.
- haloperidol
leuprolide increases toxicity of haloperidol by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- hydroxyzine
hydroxyzine and leuprolide both increase QTc interval. Use Caution/Monitor.
- indacaterol, inhaled
leuprolide increases toxicity of indacaterol, inhaled by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- itraconazole
itraconazole and leuprolide both increase QTc interval. Use Caution/Monitor.
- lapatinib
leuprolide increases toxicity of lapatinib by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- lenvatinib
leuprolide and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.
- levofloxacin
leuprolide increases toxicity of levofloxacin by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- lithium
lithium and leuprolide both increase QTc interval. Use Caution/Monitor.
- metformin
leuprolide decreases effects of metformin by pharmacodynamic antagonism. Use Caution/Monitor.
- methadone
leuprolide increases toxicity of methadone by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- mirtazapine
mirtazapine and leuprolide both increase QTc interval. Use Caution/Monitor.
- moxifloxacin
leuprolide increases toxicity of moxifloxacin by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- ofloxacin
leuprolide increases toxicity of ofloxacin by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- ondansetron
leuprolide increases toxicity of ondansetron by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- osilodrostat
osilodrostat and leuprolide both increase QTc interval. Use Caution/Monitor.
- osimertinib
leuprolide increases toxicity of osimertinib by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- oxaliplatin
oxaliplatin will increase the level or effect of leuprolide by Other (see comment). Use Caution/Monitor. Monitor for ECG changes if therapy is initiated in patients with drugs known to prolong QT interval.
- pasireotide
leuprolide increases toxicity of pasireotide by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- pazopanib
leuprolide increases toxicity of pazopanib by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- pentamidine
leuprolide increases toxicity of pentamidine by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- perflutren
leuprolide increases toxicity of perflutren by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- primaquine
primaquine and leuprolide both increase QTc interval. Use Caution/Monitor.
- propafenone
leuprolide increases toxicity of propafenone by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- ranolazine
leuprolide increases toxicity of ranolazine by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- romidepsin
leuprolide increases toxicity of romidepsin by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- saquinavir
leuprolide increases toxicity of saquinavir by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- sertraline
sertraline and leuprolide both increase QTc interval. Use Caution/Monitor.
- siponimod
siponimod and leuprolide both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.
- solifenacin
solifenacin and leuprolide both increase QTc interval. Use Caution/Monitor.
- sorafenib
leuprolide increases toxicity of sorafenib by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- sunitinib
leuprolide increases toxicity of sunitinib by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- tacrolimus
tacrolimus and leuprolide both increase QTc interval. Use Caution/Monitor.
- telavancin
leuprolide increases toxicity of telavancin by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- trazodone
leuprolide increases toxicity of trazodone by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- triclabendazole
triclabendazole and leuprolide both increase QTc interval. Use Caution/Monitor.
- valbenazine
valbenazine and leuprolide both increase QTc interval. Use Caution/Monitor.
- voriconazole
leuprolide increases toxicity of voriconazole by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.
- vorinostat
vorinostat and leuprolide both increase QTc interval. Use Caution/Monitor.
Minor (2)
- maitake
maitake increases effects of leuprolide by pharmacodynamic synergism. Minor/Significance Unknown. Maitake mushroom has anti-tumor effects (animal/in vitro research).
- taurine
leuprolide decreases levels of taurine by unspecified interaction mechanism. Minor/Significance Unknown.
Adverse Effects
>10%
Fensolvi
- Injection site pain (31%)
- Nasopharyngitis (22%)
- Pyrexia (17%)
- Headache (16%)
- Cough (13%)
Lupron Depot-Ped (monthly)
- Injection site reactions including abscess (37%)
- Emotional lability (19%)
- Acne/seborrhea (13%)
- Vaginitis/vaginal bleeding or discharge (13%)
- Rash including erythema multiforme (12%)
- General pain (12%)
- Headache (11%)
Lupron Depot-Ped (q3months)
- Injection site pain (19-21%)
Lupron Depot (22.5 mg q3months)
- Hot flashes/sweats (58.5%)
- General pain (26.6%)
- Testicular atrophy (20.2%)
- Gastrointestinal disorders (16%)
- Urinary disorders (14.9%)
- Injection site reaction (13.8%)
- Joint disorders (11.7%)
1-10%
Fensolvi
- Abdominal pain (9%)
- Injection site erythema (9%)
- Nausea (8%)
- Constipation (6%)
- Vomiting (6%)
- Upper respiratory tract infection (6%)
- Bronchospasm (6%)
- Productive cough (6%)
- Hot flush (5%)
- Emotional disorder (2%)
- Irritability (2%)
Eligard
-
<2%
- General: Sweating, insomnia, syncope, rigors, weakness, lethargy
- Gastrointestinal: Flatulence, constipation, dyspepsia
- Hematologic: Decreased red blood cell count, hematocrit and hemoglobin
- Metabolic: Weight gain
- Musculoskeletal: Tremor, backache, joint pain, muscle atrophy, limb pain
- Nervous: Disturbance of smell and taste, depression, vertigo
- Psychiatric: Insomnia, depression, loss of libido
- Renal/urinary: Difficulties with urination, pain on urination, scanty urination, bladder spasm, blood in urine, urinary retention, urinary urgency, incontinence, nocturia, nocturia aggravated
- Reproductive/ urogenital: Testicular soreness/pain, impotence, decreased libido, gynecomastia, breast soreness/tenderness, testicular atrophy, erectile dysfunction, penile disorder, reduced penis size
- Skin: Alopecia, clamminess, night sweats, sweating increased
- Vascular: Hypertension, hypotension
Lupron Depot-Ped (monthly)
- Vasodilation (9%)
-
<2%
- 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 abnormality: Antinuclear antibody present and increased sedimentation rate
Lupron Depot-Ped (q3months)
- Increased weight (7%)
- Headache (2-7%)
- Altered mood (5%)
- Injection site swelling (2%)
Lupron Depot (7.5mg SC monthly)
-
<5%
- Body as a whole: Asthenia, cellulitis, fever, headache, injection site reaction, neoplasm
- Cardiovascular system: Angina, congestive heart failure
- Digestive system: Anorexia, dysphagia, eructation, peptic ulcer
- Hemic and lymphatic system: Ecchymosis
- Laboratory abnormalities: Decreased albumin, decreased hemoglobin/hematocrit, decreased prostatic acid phosphatase, decreased total protein, decreased urine specific gravity, hyperglycemia, hyperuricemia, increased BUN, increased creatinine, increased liver function tests, increased phosphorus, increased platelets, increased prostatic acid phosphatase, increased total cholesterol, increased urine specific gravity, leukopenia
- Musculoskeletal system: Myalgia
- Nervous system: Agitation, insomnia/sleep disorders; neuromuscular disorders
- Respiratory system: Emphysema, hemoptysis, lung edema, and sputum increased
- Skin and appendages: Hair disorder, skin reaction
- Urogenital system: Balanitis, breast enlargement, urinary tract infection
Lupron Depot (22.5 mg q3months)
- Neuromuscular disorders (9.6%)
- Skin reaction (8.5%)
- Insomnia/sleep disorders (8.5%)
- Asthenia (7.4%)
- Headache (6.4%)
- Vertigo (6.4%)
- Respiratory disorders (6.4%)
-
<5%
- Body as a whole: Enlarged abdomen, fever
- Cardiovascular system: Arrhythmia, bradycardia, heart failure, hypertension, hypotension, varicose vein
- Digestive system: Anorexia, duodenal ulcer, increased appetite, thirst/dry mouth
- Hemic and lymphatic system: anemia, lymphedema
- Laboratory abnormalities: Increased BUN, hyperglycemia, hyperlipidemia, hyperphosphatemia, abnormal liver function tests, increased PT, increased PTT; decreased platelets, decreased potassium, increased WBC
- Metabolic and nutritional disorders: dehydration, edema
- Nervous system: Anxiety, delusions, depression, hypesthesia, libido decreased, nervousness, paresthesia
- Respiratory system: Epistaxis, pharyngitis, pleural effusion, pneumonia
- Special senses: Abnormal vision, amblyopia, dry eyes, tinnitus
- Urogenital system - Gynecomastia, impotence, penis disorders, testis disorders
Frequency Not Reported
Lupron Depot-Ped (q3months)
- 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 SC tissue disorders: Hyperhidrosis
- Vascular disorders: Pallor
Postmarketing Reports
Fensolvi
- Allergic Reactions: Anaphylactic, rash, urticaria, and photosensitivity reactions
- General: Chest pain, weight increase, weight decrease, decreased appetite, fatigue
- Laboratory abnormalities: Decreased WBC
- Metabolic: Diabetes mellitus.
- Musculoskeletal and connective tissue: Arthralgia, epiphysiolysis, muscle spasms, myalgia
- Neurologic: Neuropathy peripheral, convulsion, paralysis, insomnia
- Psychiatric: Emotional lability, depression; rare reports of suicidal ideation and attempt, has been reported for GnRH agonists in pediatric patients treated for CPP
- Skin and SC tissue: Injection-site reactions (eg, induration and abscess, flushing, hyperhidrosis)
- Reproductive system: Vaginal bleeding, breast enlargement
- Vascular: Hypertension, hypotension
- Respiratory: Dyspnea
- Pseudotumor cerebri (idiopathic intracranial hypertension)
Eligard
- Pituitary apoplexy occurred within 2 weeks of the first dose, and some within the first hour; patients presented as sudden headache, vomiting, visual changes, ophthalmoplegia, altered mental status, and sometimes cardiovascular collapse; immediate medical attention has been required.
- Nervous System-Convulsions
- Respiratory System-Interstitial lung disease
Lupron Depot
- Cardiovascular system: Hypotension, myocardial infarction, pulmonary embolism
- Respiratory, thoracic and mediastinal disorder: Interstitial lung disease
- Hepatobiliary disorder: Serious drug-induced liver injury
- Hemic and lymphatic system: Decreased WBC
- Central/peripheral nervous system: Convulsion, peripheral neuropathy, spinal fracture/paralysis
- Endocrine system: Diabetes
- Musculoskeletal system: Tenosynovitis-like symptoms
- Urogenital system: Prostate pain
Warnings
Contraindications
Hypersensitivity
Pregnancy
Cautions
May cause fetal harm when administered to pregnant females
Children and young adults
- During early phase of therapy, gonadotropins and sex steroids 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
- Psychiatric adverse events or emotional lability, including crying, irritability, impatience, anger, and aggression, reported; many, but not all, patients had a history of psychiatric illness or other comorbidities with an increased risk of depression
- Postmarketing reports of convulsions reported, including patients with or without a history of seizures, epilepsy, cerebrovascular disorders, central nervous system anomalies, and patients on concomitant medications associated with convulsions such as bupropion and SSRIs
- Pseudotumor cerebri (idiopathic intracranial hypertension) reported in pediatric patients receiving GnRH agonists, including leuprolide acetate; 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
Adults
- Spinal cord compression reported; observe patients closely for weakness and paresthesias in first few weeks of therapy; observe patients with metastatic vertebral lesions closely
- Tumor flare resulting from transient increases in testosterone, leading to bone pain, hematuria, bladder outlet obstruction, and neuropathy in prostate cancer patients reported during first few weeks of therapy
- Closely observe patients for urinary tract obstruction and hematuria in first few weeks of therapy
- Orchiectomy or luteinizing hormone agonists recommended as initial treatment for androgen deprivation in patients with advanced androgen sensitive prostate cancer
- Decrease in bone density reported when drug used for >6 months; use caution if there are additional risk factors for bone loss, including corticosteroid therapy or chronic alcohol use
- Worsening of endometriosis or uterine leiomyomata symptoms with therapy reported initially
- Rare cases of pituitary apoplexy, frequently secondary to pituitary adenoma reported (onset 1hr to usually <2 weeks): may present as sudden headache, vomiting, visual or mental status changes and cardiovascular collapse (rare), requiring immediate medical attention
- Worsening of glycemic control reported in men receiving GnRH agonists; monitor blood glucose and/or glycosylated hemoglobin (HbA1c) periodically in patients receiving a GnRH agonist and manage with current practice for treatment of hyperglycemia or diabetes
- Prostate cancer symptoms may worsen during initial treatment period
- Androgen deprivation therapy may prolong the QT/QTc interval; consider whether benefits of androgen deprivation outweighs potential risks in patients with congenital long QT syndrome, congestive heart failure, frequent electrolyte abnormalities, and patients taking drugs known to prolong the QT interval; correct electrolyte abnormalities and monitor ECG and electrolytes periodically
- Men receiving GnRH agonists for prostate cancer have slightly increased risk of diabetes, heart attack, stroke, and sudden death
- In women, duration of treatment with GnRH agonists not to exceed 1 year, except in treatment of breast cancer
Therapy for hormone receptor-positive breast cancer
-
Ovarian suppression recommended for the following
- Premenopausal women with higher-risk disease in addition to adjuvant endocrine therapy,
- Addition to adjuvant chemotherapy in premenopausal women with stage II or stage III breast cancers
- Stage I or II breast cancers at higher risk of recurrence in addition to endocrine therapy, who might consider chemotherapy
- Women with stage I disease, which does not require chemotherapy should receive endocrine therapy but not ovarian suppression
- Women with node-negative cancers <1 cm (T1A< T1B) should receive endocrine therapy, but not ovarian suppression
Drug interaction overview
- When using drug for management of endometriosis, combination use of norethindrone acetate (add-back therapy) is effective in reducing loss of BMD that occurs with leuprolide acetate; do not retreat with drug without combination norethindrone acetate; assess BMD before retreatment
Pregnancy & Lactation
Pregnancy
Contraindicated
Based on animal data and mechanism of action, fetal harm may occur
Insufficient data available to assess the risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
Exclude pregnancy in females of reproductive potential prior to initiation
Animal data
- Associated with an increased risk of pregnancy complications
- SC administration to rabbits during organogenesis caused embryofetal toxicity, decreased fetal weights, and a dose-dependent increase in major fetal abnormalities in animals at doses less recommended human dose based on body surface area using an estimated daily dose
Contraception
- Females of reproductive potential: Not a contraceptive; if contraception is indicated, use a nonhormonal contraception during treatment
Infertility
- Based on its pharmacodynamic effects of decreasing secretion of gonadal steroids, fertility is expected to be decreased during treatment
- Clinical and pharmacologic studies in adults (>18 years) with leuprolide acetate and similar analogs have shown reversibility of fertility suppression when discontinued after continuous administration for periods of up to 24 weeks
- There is no evidence that pregnancy rates are affected following discontinuation
- Animal studies (prepubertal and adult rats and monkeys) with leuprolide acetate and other GnRH analogs have shown functional recovery of fertility suppression
Lactation
No data available on presence of leuprolide acetate in either animal or human milk, effects on breastfed infants, or effects on milk production
Developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on the breastfed infant therapy or from underlying maternal conditions
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Agonist analogue of luteinizing hormone-releasing hormone (LHRH)
When administered continuously, decreases LH and FSH levels by acting as potent inhibitor of gonadotropin secretion; decrease in LH and FSH levels followed by suppression of ovarian and testicular steroidogenesis; testosterone levels reduced to below castrated levels in males
Absorption
Mean trough plasma level
- Lupron Depot-Ped: 0.77 ng/mL (7.5-mg monthly dose); 1.25 ng/mL (11.25-mg monthly dose); 1.59 ng/mL (15-mg monthly dose)
Peak plasma concentration
- Fensolvi: 212.3 ng/mL (4-hr postdose)
Distribution
VD (steady-state): 27 L (healthy males)
Protein bound: 43-49% (healthy males)
Metabolism
Metabolized to smaller inactive peptides, a pentapeptide (metabolite I), tripeptides (metabolites II and III), and a dipeptide (metabolite IV); these fragments may be further catabolized
Elimination
Half-life: 3 hr
Clearance: 8.34 L/hr
Excretion
- Lupron Depot-Ped: Urine (<5% as parent and major pentapeptide metabolite)
- Fensolvi or Eligard: Not studied
Administration
Preparation
Lupron Depot-Ped or Lupron
- Select appropriate syringe for intended dosing frequency
- 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
- Screw in plunger into end until stopper begins to turn
- Hold syringe upright; release diluent by slowly pushing (6-8 sec) plunger is at the blue line
- Keep syringe upright; mix thoroughly by gently shaking syringe until powder forms into uniform suspension; suspension should appear milk
- Visually inspect syringe; do not use if clumping or caking is evident; a thin layer of powder on the wall of the syringe and diluent should appear clear
- Does not contain preservatives; use suspension immediately or discard within 2 hr
Fensolvi
- Allow product to reach room temperature before reconstitution to allow for easier administration
- Join the 2 syringes together by pushing and gently screwing until secure
- Inject liquid contents of Syringe A into the leuprolide acetate powder contained in Syringe B
- Thoroughly mix for ~45 seconds by pushing the contents back and forth between both syringes to obtain a uniform suspension; the suspension will appear pale yellow
- Once reconstituted, the concentration is 45 mg/0.375 mL
- Administer within 30 minutes or discard
Eligard
- Allow product to reach room temperature before reconstitution to allow for easier administration
- Join the 2 syringes together by pushing and gently screwing until secure
- Inject liquid contents of Syringe A into the leuprolide acetate powder contained in Syringe B
- Thoroughly mix for ~45 seconds by pushing the contents back and forth between both syringes to obtain a uniform suspension; the suspension will appear light tan to tan, or colorless to pale yellow; DO NOT shake
- After mixing, hold syringes vertically with Syringe B on the bottom; draw entire mixed product into Syringe B by depressing the Syringe A plunger; unscrew Syringe A to decouple the syringes
- Note: Small air bubbles will remain in the formulation which is acceptable
- Hold Syringe B vertically; attach needle to Syringe B; do not over twist the needle onto the syringe because the thread may become stripped
Camcevi
- Allow prefilled syringe to sit at room temperature for 30 minutes before SC injection
- On a clean, dry surface, remove prefilled syringe (A) and needle cartridge (B) from the blister carton
- Remove the gray cap from the syringe
- Twist the clear cap off the bottom of the needle cartridge
- Attach the needle to the end of the syringe by pushing and turning the needle until firmly connected to the syringe
- Do not over twist the needle and strip the threading
IM Administration
Lupron Depot-Ped or Lupron
- Administer IM by inserting needle at a 90º angle into gluteal area, anterior thigh, or shoulder; alternate injection sites
- Discard all components safely in an appropriate biohazard container
SC Administration
Fensolvi or Eligard
- Select SC injection site on the abdomen, upper buttocks, or another location with adequate amounts of SC tissue that does not have excessive pigment, nodules, lesions, or hair
- Avoid areas with brawny or fibrous SC or locations that could be rubbed or compressed (eg, by a belt or clothing waistband); rotate injection sites with each injection
- Using dominant hand, insert the needle quickly at a 90° angle to the skin surface; slowly inject; press down on the plunger until the syringe is empty
- Discard all components safely in an appropriate biohazard container
Camcevi
- Choose an injection site on the upper- or mid-abdominal area with sufficient soft or loose SC tissue that has not recently been used
- Clean injection site with alcohol swab
- Do NOT inject in areas with brawny or fibrous SC tissue or locations that can be rubbed or compressed (eg, with a belt or clothing waistband)
- Avoid applying heat directly to injection site
- Grab and bunch skin around injection site with one hand, then insert needle at 90° angle to skin surface, and then release the bunched skin
- Inject the full contents of syringe with a slow and steady push on the plunger, and then withdraw the needle at the same 90° angle used for insertion
Storage
Leuprolide acetate (generic)
- Unused vial: Store below 25ºC (77ºF); do not freeze; protect from light; store vial in carton until use
Lupron Depot-Ped or Lupron
- Undiluted: Store at 25ºC (77ºF); excursions permitted to 15-30ºC (59-86ºF)
- Reconstituted suspension: If not used immediately, discard after 2 hr
Eligard or Fensolvi
- Refrigerate at 2-8ºC (35.6-46.4ºF)
- Once outside the refrigerator, store at room temperature 15-30ºC (59-86ºF) in its original packaging for up to 8 weeks before reconstitution and administration
Camcevi
- Refrigerate at 2-8ºC (36-46ºF)
- Protect from light by storing in original package until time of use
- Do not freeze or shake
- Syringe tip cap and plunger stopper is not made of natural rubber latex
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| Eligard subcutaneous - | 7.5 mg (1 month) suspension |  | |
| leuprolide subcutaneous - | 1 mg/0.2 mL vial |  | |
| leuprolide subcutaneous - | 1 mg/0.2 mL vial |  | |
| leuprolide subcutaneous - | 1 mg/0.2 mL kit |  | |
| leuprolide subcutaneous - | 1 mg/0.2 mL kit |  | |
| leuprolide subcutaneous - | 1 mg/0.2 mL kit |  | |
| Lupron Depot intramuscular - | 7.5 mg syringe |  | |
| Lupron Depot intramuscular - | 3.75 mg syringe |  | |
| Lupron Depot-Ped intramuscular - | 15 mg kit |  | |
| Lupron Depot-Ped intramuscular - | 7.5 mg (Ped) kit |  | |
| Lupron Depot-Ped intramuscular - | 11.25 mg kit |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
leuprolide intramuscular
LEUPROLIDE MONTHLY (3.75 MG) - INJECTION
(LOO-proe-lide)
COMMON BRAND NAME(S): Lupron Depot
USES: Leuprolide is used to treat certain disorders (such as endometriosis, uterine fibroids). For the treatment of uterine fibroids, leuprolide is usually given with iron to help improve anemia that is caused by too much vaginal bleeding. Leuprolide helps to reduce symptoms such as pelvic pain, painful/heavy menstrual periods, and abdominal bloating. It works by shrinking the abnormal tissue that causes these symptoms. The abnormal tissue needs the hormone estrogen to grow and spread. Leuprolide helps to decrease the amount of estrogen that is made in the body.
HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start using leuprolide and each time you get a refill. If you have any questions, ask your doctor or pharmacist.This medication is given by injection into a muscle by a health care professional. It is given as directed by your doctor, usually once every month. This product slowly releases the medication into your blood over a 1-month period.If you are using this medication at home, learn all preparation and usage instructions from your health care professional and the product package. Learn how to store and discard medical supplies safely.Wash your hands and properly mix the medication. Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Inject each dose within 2 hours of mixing. If more than 2 hours have passed since mixing, throw out the product and prepare another syringe/dose.The length of treatment is based on your medical condition, response to treatment, and lab tests.Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar to keep track of when to receive the next dose.During the first few weeks of treatment, your hormone levels will actually go up before they go down. This is a normal response to this medication. Your symptoms may get worse for a few weeks.Tell your doctor if your condition does not get better or if it gets worse. It may take at least 3 months for your symptoms to get better.
SIDE EFFECTS: Hot flashes (flushing), increased sweating, night sweats, tiredness, headache, upset stomach, breast changes, acne, joint/muscle aches, trouble sleeping, reduced sexual interest, vaginal discomfort/dryness, swelling of the ankles/feet, dizziness, or mild burning/pain/bruising at the injection site may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.When this medication is used regularly, your menstrual period should stop (or bleeding should get lighter). Menstrual periods usually return within 3 months after treatment is stopped. Tell your doctor promptly if regular periods continue during treatment with leuprolide.Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as depression, thoughts of suicide, mood swings, aggression), new/worsening bone pain, easily broken bones.Get medical help right away if you have any very serious side effects, including: seizures.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using leuprolide, tell your doctor or pharmacist if you are allergic to it; or to similar drugs (such as histrelin, triptorelin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood fat levels (such as high cholesterol/triglycerides), mental/mood problems (such as depression), vaginal bleeding of unknown cause, seizures.Leuprolide may weaken your bones and increase your risk for bone loss (osteoporosis) if used for a long time. Before using this medication, tell your doctor or pharmacist if you have osteoporosis or if you have any of the following risk factors for osteoporosis: long-term alcohol use, smoking, family history of osteoporosis and broken bones, use of certain medications (for example, corticosteroids such as prednisone, certain anti-seizure drugs such as phenytoin).This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).This medication must not be used during pregnancy. It may harm an unborn baby. It is important to prevent pregnancy while using this medication. Consult your doctor for more details and to discuss using reliable forms of non-hormonal birth control (such as condoms, diaphragm with spermicide) while using this medication. If you become pregnant or think you may be pregnant, tell your doctor right away.It is unknown if leuprolide passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.This medication may interfere with certain lab tests, possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: Do not share this medication with others.Lab and/or medical tests (such as hormone levels, bone tests, cholesterol/triglyceride blood levels) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: It is important to get each dose of this medication as scheduled. If a dose is missed, ask the doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.
STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Once mixed, use the medication right away. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised July 2022. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
Adding plans allows you to compare formulary status to other drugs in the same class.
To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.
Adding plans allows you to:
- View the formulary and any restrictions for each plan.
- Manage and view all your plans together – even plans in different states.
- Compare formulary status to other drugs in the same class.
- Access your plan list on any device – mobile or desktop.
