LUPRON: SAFETY INFORMATION FOR USE IN PRECOCIOUS PUBERTY

AS AT 13 MAY 2024 – ABBVIE

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, experiences a seizure, or becomes pregnant while taking LUPRON DEPOT-PED.
• Increased pressure in the fluid around the brain can happen in children taking gonadotropin-releasing hormone (GnRH) agonist medicines, including LUPRON DEPOT-PED. Call your child’s doctor right away if your child develops any of the following symptoms during treatment with LUPRON DEPOT-PED: headache, eye problems (including blurred vision, double vision, and decreased eyesight), eye pain, ringing in the ears, dizziness, or nausea.
• Before your child receives LUPRON DEPOT-PED, tell their 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 child’s doctor about all the medicines your child takes, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
• LUPRON DEPOT-PED is given as a single-dose injection into your child’s muscle each month, every 3 months, or every 6 months by a doctor or trained nurse. Your doctor will decide how often your child will receive the injection.
• 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; and 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 reactions such as pain and swelling, weight gain, headache, and mood changes. The most common side effects of LUPRON DEPOT-PED received every 6 months include: injection site reactions such as pain, swelling, and abscess; headache; mood changes; upper stomach pain; diarrhea; bleeding; nausea and vomiting; fever; itching; pain in extremities; rash; back pain; ligament sprain; weight gain; fracture; breast tenderness; difficulty sleeping; chest pain; and excessive sweating. These are not all of the possible side effects of LUPRON DEPOT-PED. Call your doctor or your child’s doctor for medical advice about side effects.