Fensolvi 45 mg subcutaneous syringe

Generic name:
Leuprolide 6 month pediatric - subcutaneous injection

Pronunciation
(LOO-proe-lide)

Brand name(s)
Fensolvi

Leuprolide is used to stop early puberty (precocious puberty) in children. It helps to delay sexual development (such as growth of the breasts/testicles) and the start of menstrual periods. It also helps slow down early bone growth to increase the likelihood of reaching normal adult height. Leuprolide works by decreasing the amount of sex hormones that a child's body makes (estrogen in girls, testosterone in boys).

This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used for gender dysphoria or disorders of the uterus (including endometriosis, fibroids).

Read the Medication Guide provided by 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 under the skin by a health care professional as directed by the doctor, usually every 6 months. This product slowly releases the medication into the blood over a 6-month period.

In children, the dosage is based on weight and response to treatment. The doctor should consider stopping treatment before age 11 for girls and age 12 for boys. Consult the doctor for details.

If you are using this medication at home, learn all preparation and usage instructions from the 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 30 minutes of mixing. If more than 30 minutes have passed since mixing, throw out the product and prepare another syringe/dose.

Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar to keep track of when your child should receive the next dose.

During the first few weeks of treatment, hormone levels will actually go up before they go down. This is a normal response to this medication. You may notice worsening symptoms of early puberty (such as menstrual periods) at the start of treatment. However, you should see an improvement in symptoms usually within 1 to 2 months. Tell the doctor promptly if new or worsened symptoms develop after starting treatment.

Mild pain/irritation at the injection site, hot flashes (flushing), increased sweating, night sweats, headache, breast changes, acne/seborrhea, joint/muscle aches, vaginal discomfort/dryness, vaginal bleeding/discharge, or increased weight may occur. If any of these effects last or get worse, tell the doctor or pharmacist promptly.

When this medication is used regularly, it is expected that the menstrual period will stop or decrease to light bleeding/spotting during the first 2 months. Tell the doctor promptly if regular periods continue after 2 months of treatment with leuprolide.

Remember that this medication has been prescribed because the doctor has judged that the benefit 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 non-stop crying, irritability, mood swings, aggression)

Get medical help right away if you have any very serious side effects, including:

• seizures

Children using leuprolide may be at risk for increased pressure around the brain (intracranial hypertension). Get medical help right away if your child has any of these very serious side effects:

• nausea/vomiting that doesn't stop
• headache that is severe or doesn't go away
• eye pain
• vision changes (such as blurred/double vision, decreased vision)
• ringing in the ears

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:

• fever
• swollen lymph nodes
• 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 the 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.

Before using leuprolide, tell the doctor or pharmacist if your child is allergic to it; or to similar drugs (such as histrelin, triptorelin); or if your child has any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to the pharmacist for more details.

Before using this medication, tell the doctor or pharmacist the child's medical history, especially of:

• mental/mood problems (such as depression)
• seizures

Before having surgery, tell the doctor or dentist about all the products being used (including prescription drugs, nonprescription drugs, and herbal products).

This medication must not be used during pregnancy. It may harm an unborn baby. 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, breastfeeding is not recommended while using this medication. Consult your doctor before breastfeeding.

Drug interactions may change how medications work or increase the risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products your child uses (including prescription/nonprescription drugs and herbal products) and share it with the doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without the doctor's approval.

This medication may interfere with certain lab tests possibly causing false test results. Make sure lab personnel and all the doctors know your child uses this drug.

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 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as hormone levels, height measurements, bone tests) should be done while using this medication. Keep all medical and lab appointments. Consult the doctor for more details.

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.

Store in the refrigerator. Do not freeze. If necessary, this drug may be stored at room temperature in the original packaging for up to 8 weeks. Once mixed, use the medication right away. Throw away the mixed medication if not used within 30 minutes. 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.

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.