ELIGARD PACKAGE INSERT PDF

It is designed to deliver leuprolide acetate at a controlled rate over a 1-, 3-, 4-, or 6-month therapeutic period. However, there is no known cure for advanced prostate cancer. It is not a cure for advanced prostate cancer. Please see Full Prescribing Information for additional important safety information.

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It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. If you have any concerns about being given this medicine, ask your doctor or pharmacist. ELIGARD is used to reduce the symptoms of advanced cancer of the prostate gland, or to treat high-risk localised prostate cancer in combination with radiotherapy. This medicine is similar to a hormone called gonadotrophin releasing hormone, which is normally released from the brain.

When it is given regularly to males, this medicine works by reducing the amount of testosterone produced. This inhibits the growth of prostate cancers which rely on testosterone to grow. Ask your doctor if you have any questions about why this medicine has been prescribed for you. Some of the symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty breathing; swelling of the face, lips, tongue or other parts of the body; rash, itching, or hives on the skin.

You must not be given this medicine if you are pregnant or plan to become pregnant or are breastfeeding. You must not be given this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.

If you are not sure whether you should be given this medicine, talk to your doctor. Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have nerve problems caused by bone lesions in the spine, problems passing urine or blood in your urine. These conditions may get worse for a short time after treatment is started. Tell your doctor if you have or ever had any of the following medical conditions:. This medicine may impair fertility in men. Use of this medicine for a short time has shown a full return to fertility after stopping the medicine. Fertility suppression may or may not be permanent when the medicine is given for a long time.

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop. ELIGARD may increase the risk of heart rhythm problems when used with other medicines which also have the same risk, such as:. Your doctor and pharmacist may have more information. The contents of the two syringes in the ELIGARD kit one containing the active ingredient and the other containing the delivery system will be mixed together, then injected underneath the skin.

The site of the injection should be varied from time to time. This medicine helps control your condition, but does not cure it. It is important that you continue to receive your medicine even if you feel well. However, if you think that you or anyone else may have been given too much ELIGARD, immediately telephone your doctor or the Poisons Information Centre telephone 13 11 26 in Australia, or call in New Zealand for advice, or go to Accident and Emergency at the nearest hospital.

Tell any other doctors, dentists, and pharmacists who are treating you that you are being given this medicine. If you are going to have any blood tests, tell your doctor that you are taking this medicine. Your doctor may do some blood and other tests from time to time to make sure the medicine is working. Do not give your medicine to anyone else, even if they have the same condition as you. This medicine may cause fatigue, dizziness and visual disturbances in some people.

If you have these symptoms, take care when driving or operating machines. This medicine helps most people with prostate cancer, but it may have unwanted side effects in a few people.

All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects. Tell your doctor, nurse or pharmacist if you notice any of the following and they worry you:.

Tell your doctor, nurse or pharmacist as soon as possible if you notice any of the following:. If any of the following happen, tell your doctor or nurse immediately, or go to Accident and Emergency at your nearest hospital:. Tell your doctor, nurse or pharmacist if you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some people. Some of these side effects can only be found when your doctor does tests from time to time to check your progress.

Do not leave it on a window sill or in the car. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

If your doctor tells you to stop using this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over. The tray containing syringe B contains a syringe filled with a powder which is the active ingredient, plus a needle and a desiccant pack to absorb moisture. Once the contents of syringe A and syringe B have been mixed together prior to injection , the colour of the resulting liquid will be:.

The mixed solution may appear slightly grey due to tiny air bubbles. This is acceptable and not representative of product quality. Leuprorelin acetate is a white to near white powder, freely soluble in water and glacial acetic acid. Chemical structure. CAS number. Eligard is a sterile polymeric matrix formulation of leuprorelin acetate for subcutaneous injection. It is designed to deliver leuprorelin acetate at a controlled rate over a therapeutic period.

Leuprorelin acetate is a synthetic nonapeptide analogue of naturally occurring gonadotropin releasing hormone GnRH or LHRH that, when given continuously, inhibits pituitary gonadotropin secretion and suppresses testicular steroidogenesis. The analogue possesses greater potency than the natural hormone. Eligard 1 month contains Eligard 1 month delivers 7. The approximate weight of the administered formulation is mg. It is designed to deliver 7.

Eligard 3 month contains Eligard 3 month delivers It is designed to deliver Eligard 4 month contains Eligard 4 month delivers 30 mg of leuprorelin acetate equivalent to approximately 28 mg leuprorelin free base dissolved in It is designed to deliver 30 mg of leuprorelin acetate at a controlled rate over a 4 month therapeutic period. Eligard 6 month contains Eligard 6 month delivers 45 mg of leuprorelin acetate equivalent to approximately 42 mg leuprorelin free base dissolved in mg N -methylpyrrolidone and mg polyglactin.

It is designed to deliver 45 mg of leuprorelin acetate at a controlled rate over a 6 month therapeutic period. The Atrigel delivery system is a polymeric nongelatin containing delivery system consisting of a biodegradable polyglactin. The polymer is dissolved in a biocompatible solvent, N-methylpyrrolidone. The polyglactin mixture and volume differ with each presentation of Eligard. Eligard contains no antimicrobial agent. Eligard does not contain: lactose, sucrose, gluten, tartrazine, or any other azo dyes.

Eligard is a modified release suspension syringe, available in a single use kit. Eligard is prefilled and supplied in two separate, 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. Eligard is administered subcutaneously where it forms a solid drug delivery depot. Mechanism of action. Leuprorelin acetate, an LHRH agonist, acts as a potent inhibitor of gonadotropin secretion when given continuously in therapeutic doses.

Animal and human studies indicate that after an initial stimulation, chronic administration of leuprorelin acetate results in suppression of testicular steroidogenesis. This effect is reversible upon discontinuation of drug therapy. Administration of leuprorelin acetate has resulted in inhibition of the growth of certain hormone dependent tumours prostatic tumours in Noble and Dunning male rats and DMBA induced mammary tumours in female rats as well as atrophy of the reproductive organs.

In humans, administration of leuprorelin acetate results in an initial increase in circulating levels of luteinizing hormone LH and follicle stimulating hormone FSH , leading to a transient increase in levels of the gonadal steroids testosterone and dihydrotestosterone in males and oestrone and oestradiol in premenopausal females.

These decreases occur within two to six weeks after initiation of treatment. Leuprorelin acetate is not active when given orally. Clinical trials. In the open label, multicentre studies conducted with Eligard patients with advanced prostate cancer were treated with monthly injections of Eligard 1 month for 6 months, a single injection of Eligard 3 month, given once every three months for 6 months, a single injection of Eligard 4 month, given once every four months for 8 months or a single injection of Eligard 6 month, given once every six months for 12 months.

Patient stages in the open label, multicentre studies are described in Table 4. The Eligard 1 month and Eligard 3 month studies evaluated the achievement and maintenance of serum testosterone suppression over six months of therapy. The Eligard 4 month study evaluated the achievement and maintenance of serum testosterone suppression over eight months of therapy.

The Eligard 6 month study evaluated the achievement and maintenance of serum testosterone suppression over twelve months of therapy. Eligard 1 month.

The mean testosterone concentration increased from The mean serum testosterone concentration then decreased to below baseline by day 10 and was At the conclusion of the study month 6 , mean testosterone concentration was 6.

The remaining seven patients all attained the castrate threshold by day

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Activate ELIGARD’s Clinical Effect

On a clean field open both trays, discard the desiccant packs from each package and ensure all contents are in place. Gently insert the long white plunger rod from the Syringe A package into the gray primary stopper inside Syringe B by twisting it into place. Hold syringes vertically with Syringe B on the bottom. Syringes should remain securely coupled.

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