Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Orgalutran (Ganirelix). If you are concerned about side effects, discuss the risks and benefits of Orgalutran (Ganirelix) with your doctor.

The following side effects have been reported by at least 1% of people taking Orgalutran (Ganirelix). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

• dizziness
• feeling generally unwell
• headache
• lack or loss of strength or energy
• nausea
• redness, swelling, or irritation at the place of injection

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

• abdominal discomfort or pain, nausea, Diarrhea, difficulty breathing

Stop taking the medication and seek immediate medical attention if any of the following occur:

• signs of a Anaphylaxis (severe allergic reaction) (Hives; difficulty breathing; swelling of the face, throat, or tongue)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Orgalutran (Ganirelix).

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.