Lupron Package Insert Information
- Advocates Protecting Children
- Jan 13, 2022
- 9 min read
Lupron is being used off-label by gender clinics and doctors to prevent children from entering puberty. Transgender-rights activists tell people that Lupron is perfectly safe for children. Here's what Abbvie, Lupron's maker, is obliged by law to put in Lupron's package insert.
Please note the conditions for which Lupron is approved: Central Precocious Puberty (pre-pubescent children, 1 in 5000-10,000 children), Endometriosis (adult women), Fibroids (adult women), and Prostate Cancer (adult men). Lupron has not been approved by the FDA for use in otherwise healthy gender dysphoric (transgender-identified children), but it is being used to stop puberty in exactly that population.
Highlighted below are the known side effects for the FDA approved uses of Lupron. Lupron has not been approved for gender dysphoria and has not been proven to be an effective treatment. In addition, most of these treatments are limited to fewer than twelve months of use, whereas many children with gender dysphoria are frequently treated with Lupron for three years or longer. There is no research to determine the long term side effects of Lupron, especially in children.
LUPRON PACKAGE INSERT
Prescribing Information
CHILDREN Central Precocious Puberty
WOMEN Endometriosis
WOMEN Fibroids
MEN Prostate CancerUses1-3
Endometriosis
LUPRON DEPOT® (leuprolide acetate for depot suspension) 3.75 mg for 1‑month and 11.25 mg for 3‑month administration are prescription medications used for the management of endometriosis, including pain relief and reduction of endometriotic lesions. LUPRON DEPOT 3.75 mg for 1‑month and 11.25 mg for 3‑month may be used with daily norethindrone acetate 5 mg as add‑back therapy for initial management of the painful symptoms of endometriosis and for management of recurrence of symptoms. Add‑back therapy is intended to reduce the thinning of bone and reduce hot flashes associated with LUPRON DEPOT. For safe and effective use of norethindrone acetate with LUPRON DEPOT 11.25 mg, refer to the norethindrone acetate prescribing information.
Initial treatment course of LUPRON DEPOT (whether used alone or with add‑back therapy) is limited to 6 months. A single retreatment course of not more than 6 months of LUPRON DEPOT plus add-back therapy may be used if symptoms recur. LUPRON DEPOT should not be used alone for retreatment. The total duration of therapy with LUPRON DEPOT plus add-back therapy should not exceed 12 months due to concerns about adverse impact on bone thinning.
Uterine Fibroids
LUPRON DEPOT® (leuprolide acetate for depot suspension) 3.75 mg for 1‑month and 11.25 mg for 3‑month administration are prescription medications used with iron therapy before fibroid surgery to improve anemia from fibroids. Your doctor may prescribe a 1‑month trial of iron alone as some patients’ anemia will improve with iron alone. LUPRON DEPOT with norethindrone acetate is not used for this condition.
A patient may receive up to 3 monthly injections of LUPRON DEPOT 3.75 mg. Alternatively, a single injection of LUPRON DEPOT 11.25 mg may be used only if your doctor decides 3 months of hormonal suppression is necessary.
Advanced Prostate Cancer
LUPRON DEPOT® (leuprolide acetate for depot suspension) 7.5 mg for 1‑month, 22.5 mg for 3‑month, 30 mg for 4‑month, and 45 mg for 6‑month administration are prescribed for the palliative treatment of advanced prostate cancer. LUPRON DEPOT is a prescription medication that must be administered in your doctor’s office.
Central Precocious Puberty (CPP)
LUPRON DEPOT-PED® (leuprolide acetate for depot suspension) 7.5 mg, 11.25 mg, and 15 mg for 1‑month and 11.25 mg and 30 mg for 3‑month administration are prescribed for the treatment of children with central precocious puberty (CPP). Doctors may diagnose children with CPP when signs of sexual maturity begin to develop in girls under the age of 8 or boys under the age of 9. Your doctor should perform tests to rule out possible causes of early puberty that would require different treatment (e.g., tumors). It is not known if LUPRON DEPOT‑PED is safe and effective in children under 2 years of age.
Important Safety Information
General Information
People who have experienced any type of allergic reaction to LUPRON DEPOT or similar drugs should not take LUPRON DEPOT or LUPRON DEPOT‑PED.
Females who are or may be pregnant, are breastfeeding, or have undiagnosed uterine bleeding should not receive LUPRON DEPOT or LUPRON DEPOT‑PED.
Seizures have been observed in patients taking GnRH agonists, like leuprolide acetate, including patients who have a history of seizures, epilepsy, or brain or brain vessel (cerebrovascular) problems or tumors, and in those taking a medicine that has been connected to seizures, such as bupropion or selective serotonin reuptake inhibitors (SSRIs). Seizures have also been reported in patients without any of these conditions.
LUPRON DEPOT must be administered in your doctor’s office.
Safety Information for Use in Endometriosis
If your doctor prescribes you norethindrone acetate in combination with LUPRON DEPOT 11.25 mg, please refer to the norethindrone acetate prescribing information for more information about its safe and effective use.
You should not take norethindrone acetate with LUPRON DEPOT 3.75 mg if you currently have or have previously had any clotting disorder, heart disease, stroke, impaired liver function or liver disease, or breast cancer.
Tell your healthcare provider before beginning treatment with norethindrone acetate and LUPRON DEPOT 3.75 mg if you currently have or have previously had high cholesterol, migraines, epilepsy, depression, or if you smoke.
During treatment with norethindrone acetate and LUPRON DEPOT 3.75 mg, immediately tell your doctor if you have a sudden loss of vision or double vision, or if migraine headaches occur. You should notify your doctor if you experience fluid retention, seizure, asthma or worsening of asthmatic symptoms, or heart or kidney problems.
Thinning of the bones may occur during therapy with LUPRON DEPOT alone, which may not be completely reversible in some patients. Since some conditions may increase the possibility of bone thinning, you should tell your doctor if you smoke, use alcohol in excess, have a family history of osteoporosis (thinning of the bones with fractures), or are taking other medications that can cause thinning of the bones. You should be aware that if you have these conditions, treatment with LUPRON DEPOT alone is not advisable and combination with norethindrone acetate should be considered. Add-back therapy can help reduce the bone loss that occurs with the use of LUPRON DEPOT alone. If a second course of treatment with LUPRON DEPOT is being considered, bone mineral testing is recommended and retreatment should include combination with norethindrone acetate.
LUPRON DEPOT may cause harm to your unborn child. LUPRON DEPOT is not a method of birth control. Even though you may not have periods, unprotected intercourse could result in pregnancy. You should use non‑hormonal birth control, such as condoms, a diaphragm with contraceptive jelly, or a copper IUD, to prevent pregnancy. If you think you have become pregnant while on LUPRON DEPOT, talk to your doctor immediately.
Asthma was reported in women with a history of asthma, sinusitis, and environmental or drug allergies. Serious allergic reactions have also occurred.
After beginning LUPRON DEPOT, your estrogen levels will increase during the first days of therapy. During this time, you may notice an increase in your current symptoms. You should notify your doctor if you develop any new or worsened symptoms after beginning LUPRON DEPOT treatment.
Depression may worsen while taking norethindrone acetate. Patients who have a history of depression should be carefully observed during treatment. Talk to your doctor if you are experiencing any new or worsening signs of depression.
The most common side effects of LUPRON DEPOT included hot flashes/sweats, headache/migraine, decreased libido (interest in sex), depression/emotional lability (changes in mood), dizziness, nausea/vomiting, pain, vaginitis, and weight gain. These are not all of the possible side effects of LUPRON DEPOT. Talk to your doctor for medical advice about side effects.
LUPRON DEPOT for treatment of endometriosis has been limited to women 18 years of age and older. LUPRON DEPOT is not indicated in postmenopausal women.
If your doctor prescribes you norethindrone acetate in combination with LUPRON DEPOT, please refer to the norethindrone acetate prescribing information for more information about its safe and effective use.
Safety Information for Anemia Associated with Uterine Fibroids
Thinning of the bones may occur during therapy with LUPRON DEPOT, which may not be completely reversible in some patients. The duration of therapy with LUPRON DEPOT is limited to 3 months. The symptoms associated with fibroids will return after stopping therapy. Since some conditions may increase the possibility of bone thinning, you should tell your doctor if you smoke, use alcohol in excess, have a family history of osteoporosis (thinning of the bones with fractures), or are taking other medications that can cause thinning of the bones.
LUPRON DEPOT may cause harm to your unborn child. LUPRON DEPOT is not a method of birth control. Even though you may not have periods, unprotected intercourse could result in pregnancy. You should use non‑hormonal birth control, such as condoms, a diaphragm with contraceptive jelly, or a copper IUD, to prevent pregnancy. If you think you have become pregnant while on LUPRON DEPOT, talk to your doctor immediately.
Asthma was reported in women with a history of asthma, sinusitis, and environmental or drug allergies. Serious allergic reactions have also occurred.
After beginning LUPRON DEPOT, your estrogen levels will increase during the first days of therapy. During this time, you may notice an increase in your current symptoms. You should notify your doctor if you develop any new or worsened symptoms after beginning LUPRON DEPOT treatment.
Depression may worsen while taking norethindrone acetate. Patients who have a history of depression should be carefully observed during treatment. Talk to your doctor if you are experiencing any new or worsening signs of depression. LUPRON DEPOT with norethindrone acetate is not used for this condition.
The most common side effects of LUPRON DEPOT included hot flashes/sweats, headache/migraine, decreased libido (interest in sex), depression/emotional lability (changes in mood), dizziness, nausea/vomiting, pain, vaginitis, and weight gain. These are not all of the possible side effects of LUPRON DEPOT. Talk to your doctor for medical advice about side effects.
LUPRON DEPOT for treatment of anemia from fibroids has been limited to women 18 years of age and older. LUPRON DEPOT is not indicated in postmenopausal women.
Safety Information for Use in Advanced Prostate Cancer
LUPRON DEPOT causes an increase in testosterone during the first few weeks of therapy.
Some men may experience temporary new or worsening symptoms of prostate cancer, including urinary symptoms and/or bone pain.
If your cancer has spread to the spine or urinary tract, urinary blockage or pressure in the spine may occur and can sometimes lead to paralysis, which may be life-threatening.
You may require close medical attention during the first few weeks of therapy. Notify your doctor if you develop any new or worsened symptoms after beginning LUPRON DEPOT treatment.
High blood sugar and increased risk of diabetes can occur in men using LUPRON DEPOT. Your doctor will monitor your blood sugar during treatment.
Increased risk of heart attack, sudden death, and stroke can occur in men using LUPRON DEPOT. Discuss this increased risk with your doctor before starting treatment and report any new symptoms during treatment.
LUPRON DEPOT can affect the electrical activity of your heart. Your doctor must determine if the benefits of using LUPRON DEPOT outweigh the risks, especially if you have congenital long QT syndrome, abnormal blood tests for electrolytes, congestive heart failure, or if you take medications to regulate your heartbeat.
Regular blood tests are needed to check your testosterone and prostate‑specific antigen (PSA) levels.
LUPRON DEPOT may cause fetal harm if administered to a pregnant woman.
LUPRON DEPOT may cause impotence.
The most common side effects of LUPRON DEPOT include hot flashes/sweats; injection site reaction/pain; general pain; swelling; testicular shrinkage; difficulty urinating; fatigue/weakness; headache; and joint, gastrointestinal, and respiratory problems.
Safety Information for Use in Central Precocious Puberty
During the first 2 to 4 weeks of treatment, LUPRON DEPOT-PED can cause an increase in some hormones. During this time, you may notice more signs of puberty in your child, including vaginal bleeding. Call your doctor if these signs continue after the second month of treatment with LUPRON DEPOT-PED.
Some people taking gonadotropin-releasing hormone (GnRH) agonists like LUPRON DEPOT-PED have had new or worsened mental (psychiatric) problems. Mental (psychiatric) problems may include emotional symptoms such as: crying, irritability, restlessness (impatience), anger, and acting aggressive.
Call your child’s doctor right away if your child has any new or worsening mental symptoms or problems or if your child experiences a seizure while taking LUPRON DEPOT-PED.
Before your child receives LUPRON DEPOT-PED, tell your doctor about all of your child’s medical conditions, including if they have a history of mental (psychiatric) problems, seizures, epilepsy, brain or brain vessel (cerebrovascular) problems or tumors, if they are taking a medicine that has been connected to seizures, such as bupropion or selective serotonin reuptake inhibitors (SSRIs), and if they are breastfeeding or plan to breastfeed. It is not known if LUPRON DEPOT-PED passes into the breast milk. Tell your doctor about all the medicines your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Keep all scheduled visits to the doctor. If a scheduled dose is missed, your child may start having signs of puberty again. The doctor will do regular exams and blood tests to check for signs of puberty.
The most common side effects of LUPRON DEPOT-PED received 1 time each month include: injection site reactions such as pain, swelling, and abscess; weight gain; pain throughout body; headache; acne or red, itchy rash and white scales (seborrhea); serious skin rash (erythema multiforme); mood changes; swelling of vagina (vaginitis), vaginal bleeding, and vaginal discharge. The most common side effects of LUPRON DEPOT-PED received every 3 months include: injection site pain, weight gain, headache, mood changes, injection site swelling.
These are not all of the possible side effects of LUPRON DEPOT and LUPRON DEPOT-PED. Call your doctor for medical advice about side effects.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
This is the most important information to know about LUPRON DEPOT and LUPRON DEPOT-PED. For more information, talk to your doctor or healthcare provider.
If you cannot afford your medication, contact www.pparx.org for assistance.
References: 1. LUPRON DEPOT GYN 3.75 mg and 3‑Month 11.25 mg [package insert]. North Chicago, IL: AbbVie Inc.
2. LUPRON DEPOT URO [package insert]. North Chicago, IL: AbbVie Inc.
3. LUPRON DEPOT-PED [package insert]. North Chicago, IL: AbbVie Inc.
Why would any responsible medical practitioner give a drug that is this toxic to healthy children?
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