Orgalutran (Ganirelix)

(℞) Prescription Required

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Orgalutran Injection 0.25mg/0.5mL

Product of Canada
Manufactured by: Merck Sharp & Dohme
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Orgalutran Injection 0.25mg/0.5mL
Product of Canada
Manufactured by Merck Sharp & Dohme
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Orgalutran (Ganirelix) Dosage and Side Effects

Orgalutran is used to prevent the premature LH surges in women undergoing Controlled ovarian hyperstimulation (COH). Orgalutran allows the release of an egg to be controlled so that it occurs at an optimal time for pregnancy to occur.

Proper Use of this medication

Always use ORGALUTRAN exactly as your doctor has told you. You should check with your doctor if you are not sure.

Daily treatment with ORGALUTRAN should be continued for the time interval determined by your doctor. Your doctor can determine this using techniques such as ultrasound.

Instructions for use:

Injection site:

ORGALUTRAN is supplied in pre-filled syringes and should be injected slowly, just under the skin, preferably in the upper leg.

Inspect the solution before use. Do not use if the solution contains particles or is not clear. If you administer the injections yourself or have it done by your partner, follow the instructions below carefully. Do not mix ORGALUTRAN with any other medicines.

Checking the correct needle position:

Gently draw back the plunger to check if the needle is positioned correctly. Any blood drawn into the syringe means the needle tip has penetrated a blood vessel. If this happens, do not inject ORGALUTRAN, but remove the syringe, cover the injection site with a swab containing disinfectant and apply pressure; bleeding should stop in a minute or two.

Do not use this syringe and dispose of it properly. Start again with a new syringe.

Injecting the solution:

After the needle position has been checked as described above, depress the plunger slowly and steadily, so the solution is correctly injected and the skin tissues are not damaged.

Removing the syringe:

Pull the syringe out quickly and apply pressure to the site with a swab containing disinfectant.

Use the pre-filled syringe only once and dispose of it properly.

Overdose:

If you inject more ORGALUTRAN than you should:

Contact your doctor.

In case of overdose, contact your doctor or pharmacist, emergency department of the nearest hospital, or a poison control centre immediately.

Missed dose:

If you realize that you forgot a dose, administer it as soon as possible.

Do not inject a double dose to make up for forgotten individual doses.

If you are more than 6 hours late (so the time between two injections is longer than 30 hours) administer the dose as soon as possible, and contact your doctor for further advice.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

Side Effects

ORGALUTRAN may cause a skin reaction such as redness, with or without swelling at the injection site. These skin reactions normally disappear within 4 hours of injection.

Very rarely, more widespread possibly allergic reactions (including various symptoms such as rash, facial swelling and dyspnea) have been observed, as early as with the first dose.

Other side effects may be headache, nausea, dizziness, asthenia (lack or loss of strength and energy) and malaise (general unwell feeling).

Additional side effects which have been known to occur with controlled ovarian hyperstimulation treatment include abdominal pain, ovarian hyperstimulation syndrome (OHSS), ectopic pregnancy (fertilized egg attaches to fallopian tube instead of the womb) and miscarriage.

During or following hormonal stimulation of the ovaries, ovarian hyperstimulation syndrome may develop. Ovarian hyperstimulation syndrome (OHSS) is a rare condition which occurs when too many follicles (part of the ovary that forms into an egg) grow and cause abdominal distension, abdominal discomfort or pain, nausea, diarrhea and sometimes difficulty in breathing. If you experience these symptoms, contact your doctor immediately as OHSS is a very serious side effect which may require treatment in the hospital.

There is one case where a patient who had eczema reported that it got worse after the first ORGALUTRAN dose.

The effects of ORGALUTRAN on the ability to drive and use machines have not been studied.

Warnings and Precautions

ORGALUTRAN should be prescribed and managed by a doctor experienced in infertility treatment.

Before you use ORGALUTRAN, tell your doctor if any of these conditions apply to you:

  • if you are pregnant or breast-feeding.
  • if you have an allergy or any active allergic condition. Your doctor will decide, depending on the severity, if additional monitoring is required during treatment. Cases of allergic reactions have been reported as early as with the first dose.
  • if you are sensitive to natural rubber latex since the packaging of ORGALUTRAN (needle cover) contains natural rubber latex which may cause allergic reactions.
  • if you are taking or have recently taken other medications including those not requiring a prescription.
  • if you weigh less than 50 kg or more the 90 kg.

The incidence of ectopic pregnancies might be increased in women undergoing assisted reproduction. Your doctor will perform an ultrasound scan early during pregnancy to confirm that a pregnancy is intrauterine.

The incidence of congenital malformations after assisted reproduction techniques may be slightly higher than after spontaneous conceptions. This slightly higher incidence is thought to be related to characteristics of the patients undergoing fertility treatment (e.g. age of the female, sperm characteristics) and to the higher incidence of multiple gestations after assisted reproduction techniques. The incidence of congenital malformations after assisted reproduction techniques using ORGALUTRAN is not different from that after using other GnRH analogues in the course of assisted reproduction techniques.

 

Interactions with this medication

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The above information is an educational aid only. It is not intended as medical advice for individual conditions or treatments. Talk to your doctor, nurse or pharmacist before following any medical regimen to see if it is safe and effective for you.

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