Orgalutran

The usual dose of Orgalutran (Ganirelix) is 250 µg injected once daily under the skin. The length of treatment is usually about 5 days, but can range from 1 to 19 days. Orgalutran (Ganirelix) should be injected under the skin of the upper thigh, as directed by your doctor.

A health care professional will show you how to use Orgalutran (Ganirelix) properly. Read the patient information leaflet carefully and ask your doctor any questions you may have.

Many things can affect the dose of 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 taking the medication without consulting your doctor.

It is important to use Orgalutran (Ganirelix) exactly as prescribed by your doctor. If you miss a dose, administer it as soon as possible. If you are more than 6 hours late (i.e., the time between 2 injections is longer than 30 hours), give the dose as soon as possible and contact your doctor for further instruction. Do not inject a double dose to make up for a missed dose. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Orgalutran (Ganirelix) at room temperature between 15°C and 30°C, protect it from light, and keep it 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 headaches; it may cause nausea or, rarely, vomiting; it may cause redness and swelling at the injection site; it may cause irregular vaginal bleeding. 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.

Each prefilled syringe of clear, colourless, sterile, ready-to-use solution contains Orgalutran (Ganirelix) 250 µg. Nonmedicinal ingredients: acetic acid and/or sodium hydroxide to adjust pH, glacial acetic acid, mannitol, and water for injection.

The needle shield contains dry natural rubber/latex.

Do not use Orgalutran (Ganirelix) if you:

• are allergic to Orgalutran (Ganirelix), gonadotropin-releasing hormone (GnRH), other GnRH-related hormones, or any of the ingredients of the medication or the container (such as latex)
• are or may be pregnant
• have moderate-to-severe liver or kidney function impairment

Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that 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. 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.

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 Orgalutran (Ganirelix).

Allergic reactions: In rare cases, some people may develop an allergic reaction to Orgalutran (Ganirelix). Signs of an allergic reaction include a severe rash, hives, swollen face or throat, or difficulty breathing. If these occur, get immediate medical attention.

Latex allergy: The packaging of Orgalutran (Ganirelix) contains rubber latex. If you have a latex allergy, talk to your doctor before using Orgalutran (Ganirelix).

Ovarian hyperstimulation syndrome (OHSS): During or following treatment with Orgalutran (Ganirelix), a rare condition called ovarian hyperstimulation syndrome (OHSS) may develop. With OHSS, too many follicles grow and can cause abdominal discomfort or pain, nausea, diarrhea, rapid weight gain, decreased urination, and sometimes difficulty breathing. If you experience any of these symptoms, contact your doctor immediately.

Pregnancy: Orgalutran (Ganirelix) should not be used during pregnancy.

Breast-feeding: It is not known if Orgalutran (Ganirelix) passes into breast milk. If you are a breast-feeding mother and are taking Orgalutran (Ganirelix), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.

Children: The safety and effectiveness of using Orgalutran (Ganirelix) have not been established for children.

Seniors: The safety and effectiveness of using Orgalutran (Ganirelix) have not been established for seniors.

This product must be injected under the skin (subcutaneously), according to the technique you were shown. Be sure to choose a different injection site each time. Dispose of used syringes and needles safely. Your pharmacist can tell you the best way to do this. This medication is typically used only once a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you. Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed. You should take this medication at approximately the same time each day. If you forget a dose, contact your pharmacist.