Eligard

Eligard (Leuprolide) is given as an injection under the skin by your doctor. Depending on the dosage form used, it may be given once every 1, 3, 4, or 6 months.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are receiving the medication without consulting your doctor.

It is very important to receive Eligard (Leuprolide) exactly as recommended by your doctor. If you miss an appointment to receive Eligard (Leuprolide), contact your doctor as soon as possible to reschedule your appointment.

Eligard (Leuprolide) vials or kits should be stored in the refrigerator (between 2°C and 8°C) and protected from light. Eligard (Leuprolide) may be stored at room temperature in the original packaging for up to 8 weeks before it is used. Keep out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause hot flashes; it may cause dizziness - use caution when getting up from a lying or sitting position and use caution if driving; it may cause unusual tiredness; it may cause nausea or, rarely, vomiting; it could cause water retention and swelling; it may cause changes in body weight. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

7.5 mg vial
Eligard 7.5 mg (1-month) is supplied in two separate prefilled, sterile syringes whose contents are mixed immediately prior to administration. The two syringes are joined and the single dose product is mixed until it is homogenous. One syringe contains the Atrigel Delivery System, and the other contains Eligard (Leuprolide) acetate. The Atrigel Delivery System is a polymeric (non-gelatin containing) delivery system consisting of a biodegradable, 34% poly (DL-Lactide-co-glycolide; PLG) polymer formulation dissolved in a biocompatible solvent, 66% N-methyl-2-pyrrolidone (NMP). PLG is a copolymer with a 50:50 molar ratio of DL-lactide to glycolide containing carboxyl end groups. The second syringe contains 10.2 mg lyophilized Eligard (Leuprolide) acetate and is designed to deliver 7.5 mg of Eligard (Leuprolide) acetate at the time of subcutaneous injection. Eligard 7.5 mg (1-month) is available in a single use pouch packaging. The pouch packaging contains the two-syringe mixing system, a 20-gauge half-inch needle, and a silicone desiccant pouch to control moisture uptake.

22.5 mg vial
Eligard 22.5 mg (3-month) is supplied in two separate prefilled, sterile syringes whose contents are mixed immediately prior to administration. The two syringes are joined and the single dose product is mixed until it is homogenous. One syringe contains the Atrigel Delivery System, and the other contains Eligard (Leuprolide) acetate. The Atrigel Delivery System is a polymeric (non-gelatin containing) delivery system consisting of a biodegradable, 45% poly (DL-Lactide-co-glycolide; PLG) polymer formulation dissolved in a biocompatible solvent, 55% N-methyl-2-pyrrolidone (NMP). PLG is a copolymer with a 75:25 molar ratio of DL-lactide to glycolide with hexanediol. The second syringe contains 28.2 mg lyophylized Eligard (Leuprolide) acetate and is designed to deliver 22.5 mg of Eligard (Leuprolide) acetate at the time of SC injection. Eligard 22.5 mg (3-month) is available in a single use pouch or tray packaging. The pouch and the tray packaging contain the two-syringe mixing system, a 20-gauge half-inch needle, and a silicone desiccant pouch (two for the tray packaging) to control moisture uptake.

30 mg vial
Eligard 30 mg (4-month) is supplied in two separate prefilled, sterile syringes whose contents are mixed immediately prior to administration. The two syringes are joined and the single dose product is mixed until it is homogenous. One syringe contains the Atrigel Delivery System, and the other contains Eligard (Leuprolide) acetate. The Atrigel Delivery System is a polymeric (non-gelatin containing) delivery system consisting of a biodegradable, 45% poly (DL-Lactide-co-glycolide; PLG) polymer formulation dissolved in a biocompatible solvent, 55% N-methyl-2-pyrrolidone (NMP). PLG is a copolymer with a 75:25 molar ratio of DL-lactide to glycolide with hexanediol. The second syringe contains 35.8 mg lyophilized Eligard (Leuprolide) acetate and is designed to deliver 30 mg of Eligard (Leuprolide) acetate at the time of subcutaneous injection. Eligard 30 mg (4-month) is available in a single use pouch or tray packaging. The pouch and the tray packaging contain the two-syringe mixing system, a 20-gauge 5/8-inch needle, and a silicone desiccant pouch (two for the tray packaging) to control moisture uptake.

45 mg vial
Eligard 45 mg (6-month) is supplied in two separate prefilled, sterile syringes whose contents are mixed immediately prior to administration. The two syringes are joined and the single dose product is mixed until it is homogenous. One syringe contains the Atrigel Delivery System, and the other contains Eligard (Leuprolide) acetate. The Atrigel Delivery System is a polymeric (non-gelatin containing) delivery system consisting of a biodegradable, 50% poly (DL-Lactide-co-glycolide; PLG) polymer formulation dissolved in a biocompatible solvent, 50% N-methyl-2-pyrrolidone (NMP). PLG is a copolymer with a 85:15 molar ratio of DL-lactide to glycolide with hexanediol. The second syringe contains 58.2 mg lyophilized Eligard (Leuprolide) acetate and is designed to deliver 45 mg of Eligard (Leuprolide) acetate at the time of subcutaneous injection. Eligard 45 mg (6-month) is available in a single use tray packaging. The tray packaging contains the two-syringe mixing system, a 18-gauge 5/8-inch needle, and two silicone desiccant pouches to control moisture uptake.

Do not use Eligard (Leuprolide) if you:

• are allergic to Eligard (Leuprolide) or any ingredients of Eligard (Leuprolide)
• are allergic to medications called GnRH agonists or LHRH agonists (e.g., Buserelin, Goserelin)
• are breast-feeding
• are pregnant or may become pregnant while receiving the medication

There may be an interaction between Eligard (Leuprolide) and any of the following:

• Alfuzosin
• amantadine
• amiodarone
• androgens (e.g., methyltestosterone, nandrolone, testosterone)
• antihistamines (e.g., cetirizine, doxylamine, Diphenhydramine, Hydroxyzine, Loratadine)
• antipsychotics (e.g., Chlorpromazine, Clozapine, Haloperidol, Olanzapine, Quetiapine, Risperidone)
• Apomorphine
• “azole” antifungals (e.g., itraconazole, ketoconazole, Voriconazole)
• Buprenorphine
• chloral hydrate
• chloroquine
• diabetes medications (e.g., chlorpropamide, glipizide, Glyburide, insulin, Metformin, Nateglinide, Rosiglitazone)
• Disopyramide
• Domperidone
• Dronedarone
• estrogens (e.g., conjugated estrogen, Estradiol, ethinyl estradiol)
• Fingolimod
• flecainide
• formoterol
• Galantamine
• HIV protease inhibitors (e.g., darunavir, indinavir, lopinavir, saquinavir, tipranavir)
• Indapamide
• lithium
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• Maprotiline
• Mefloquine
• Methadone
• Metoclopramide
• Metronidazole
• mifepristone
• Nilotinib
• Octreotide
• pentamidine
• Pimozide
• Primaquine
• procainamide
• Propafenone
• Romidepsin
• quinidine
• quinine
• quinolone antibiotics (e.g., ciprofloxacin, Norfloxacin, Ofloxacin)
• salbutamol
• saquinavir
• selective serotonin reuptake inhibitors (SSRIs, e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
• serotonin antagonists (anti-emetic medications; e.g., Granisetron, Ondansetron)
• Solifenacin
• sotalol
• sulfamethoxazole
• Tacrolimus
• Tamoxifen
• Tetrabenazine
• thioridazine
• Trazodone
• Trimethoprim
• tricyclic antidepressasnts (e.g., Amitriptyline, Clomipramine, Desipramine, Trimipramine)
• tyrosine kinase inhibitors (e.g., Dasatinib, imatinib, nilotinib)
• Vardenafil
• Venlafaxine
• vilanterol

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Eligard (Leuprolide). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Eligard (Leuprolide).

Anemia: Reduced testosterone levels contribute to low levels of red blood cells. If you experience symptoms of reduced red blood cell count (anemia) such as shortness of breath, pale skin, or feeling unusually tired, contact your doctor as soon as possible.

Your doctor will do blood tests regularly to monitor the number of specific types of blood cells, including red blood cells, in your blood.

Depression: Changed levels of hormones in the body have been known to cause mood swings and symptoms of depression. If you have depression or a history of depression, discuss with your doctor how Eligard (Leuprolide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Eligard (Leuprolide), and whether any special monitoring is needed.

If you experience symptoms of depression such as poor concentration, changes in weight, changes in sleep, or decreased interest in activities, or notice them in a family member who is taking Eligard (Leuprolide),contact your doctor as soon as possible.

Diabetes: Eligard (Leuprolide) may cause a loss of blood glucose control, and glucose tolerance may change. People with diabetes may find it necessary to monitor their blood sugar more frequently while using Eligard (Leuprolide).

If you have diabetes or are at risk for developing diabetes, discuss with your doctor how Eligard (Leuprolide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Eligard (Leuprolide), and whether any special monitoring is needed.

Heart problems: Eligard (Leuprolide) may increase the risk of heart problems such as changes in heart rhythm. You may be more at risk of experiencing heart problems if you have congenital long QT syndrome, electrolyte (e.g., potassium) abnormalities, or Congestive Heart Failure, or you are taking medications that affect heart rhythm (e.g., quinidine, procainamide, Amiodarone, Sotalol, Flecainide). Discuss with your doctor how Eligard (Leuprolide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Eligard (Leuprolide), and whether any special monitoring is needed.

Medical conditions: If you have urinary tract obstruction (a blockage in the urinary tract), reduced kidney or liver function, spinal cord compression, or cancer that has spread to the bones of the spine, discuss with your doctor how Eligard (Leuprolide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Eligard (Leuprolide), and whether any special monitoring is needed.

Men and the heart: There may be an increased risk of heart-related events (e.g., heart attacks, stroke, heart-related death) in men being treated for prostate cancer with GnRH medications. Before you start treatment, tell your doctor if you have diabetes, heart disease, had a previous heart attack or stroke, or have cardiovascular risk factors (e.g., high blood pressure, smoking, or cholesterol). If you have any of these conditions, discuss with your doctor how Eligard (Leuprolide) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Eligard (Leuprolide), and whether any special monitoring is needed.

Osteoporosis: Eligard (Leuprolide) can cause the bones to lose thickness. Your doctor will monitor you for this while you are using Eligard (Leuprolide). If you have osteoporosis or are at risk for it (e.g., have been smoking or drinking excessive amounts of alcohol for a long time, have a family history of osteoporosis, or are taking medications such as Prednisone or anti-seizure medications), discuss with your doctor how Eligard (Leuprolide) may affect your medical condition and whether any special monitoring is needed.

Starting treatment: During the first week of treatment with Eligard (Leuprolide), you may notice that your signs and symptoms temporarily get worse. This is due to a sudden increase in hormones that will normalize once the right dose for you has been found.

Pregnancy: Eligard (Leuprolide) should not be used during pregnancy. Eligard (Leuprolide) is not recommended for use by women.

Breast-feeding: It is not known if Eligard (Leuprolide) passes into breast milk. Eligard (Leuprolide) is not recommended for use by women.

Children: The safety and effectiveness of using Eligard (Leuprolide) have not been established for children under 12 years of age.

This product is usually injected into a muscle (intramuscularly) by a health professional. The injection may be sore for a few days. This product affects hormonal balance and will affect men and women differently: In men: it may temporarily increase bone pain. In women: it may stop menstruation or cause irregular bleeding, temporarily increase abdominal pain or increase male characteristics (e.g., increased hair growth, oily skin, deeper voice). Use this medication regularly and continuously to maintain its beneficial effects.