Eligard

Eligard is a prescription hormone medication used to treat advanced prostate cancer.

Eligard belongs to a group of drugs called GnRH agonists, which work by decreasing the amount of certain hormones in the body.

Eligard comes as a long-acting suspension that is injected just under the skin by a healthcare provider in a medical office or clinic and is usually given every 1, 3, 4, or 6 months.

Common side effects include hot flashes, generalized pain, and irritation or pain at the site of injection.

Eligard is a prescription hormone medication used to treat advanced prostate cancer.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Sanofi-Aventis U.S. LLC

• TOLMAR Inc.

Serious side effects have been reported. See the “Drug Precautions” section.

Common side effects include:

• hot flashes
• headache
• generalized pain
• irritation or pain at the site of injection
• mood changes
• fatigue
• acne
• rash
• swelling
• vaginal bleeding or discharge, dryness, and itching
• weight gain

This is not a complete list of Eligard side effects. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• amiodarone (Cordarone, Pacerone)
• bupropion (Zyban, Wellbutrin)
• dexamethasone (Decadron)
• disopyramide (Norpace)
• methylprednisolone (Medrol)
• prednisone (Deltasone)
• procainamide (Procanbid)
• quinidine
• sotalol (Betapace)
• seizure medications
• selective serotonin reuptake inhibitors (SSRIs) such as escitalopram (Lexapro), sertraline (Zoloft), citalopram (Celexa), vilazodone (Viibryd), paroxetine (Paxil), fluoxetine (Prozac, Sarafem, Symbyax), and fluvoxamine (Luvox)

This is not a complete list of Eligard drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Eligard including:

• signs of puberty
• seizures
• urinary blockage
• increased risk for heart attack or stroke
• increased risk for osteoporosis or fractures
• increased risk for diabetes or raised blood glucose (sugar) levels
• impotence
• worsening of depression

Do not take Eligard if you:

• are allergic to any of its ingredients
• have vaginal bleeding
• are pregnant or planning to become pregnant
• are breastfeeding

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Eligard, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Eligard, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic Eligard
• have a history of seizures
• have a history of brain trauma or injury
• have a history of heart attack
• have osteoporosis
• are unable to urinate
• have anemia
• have epilepsy
• are pregnant or planning to become pregnant
• are breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Eligard falls into category X. This medication is not to be used in women who are or may become pregnant. If this drug is used during pregnancy, or if you become pregnant while taking the drug, be aware of the potential risk to the unborn child. The possibility exists that spontaneous abortion may occur if the drug is taken during pregnancy.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known whether this medication is excreted in human milk. Nursing mothers should not use Eligard.

Take Eligard exactly as prescribed.

Eligard comes as a long-acting suspension that is injected just under the skin by a healthcare provider in a medical office or clinic and is usually given every 1, 3, 4, or 6 months.

• Do not store near a radiator or other very warm place.
• Do not freeze.
• Protect from light
• Store vial in carton until use.
• Keep this and all medicines out of the reach of children.