Luveris 75 unit

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Using LUVERIS in the Mono Pack or the LUVERIS & GONAL-f Combination Pack

A Few Words About LUVERIS

LUVERIS (lutropin alpha for injection) is one option available to help women with hypgonadotropic hypogonadism achieve development of ovarian follicles. It is a purified hormone and should be taken under the close supervision of the doctor who prescribed it. Before you begin treatment, it is important that you understand what LUVERIS is, how it can help you and what you can expect from it. Please read this information, carefully, and discuss any question or concerns you may have with your doctor.

What is LUVERIS?

LUVERIS (Lutropin alpha for injection) is a gonadotrophin hormone produced by recombinant DNA technology. It consists of highly purified LH (luteinizing hormone) and contains no FSH (follicle stimulating hormone).

LUVERIS is usually prescribed in conjunction with GONAL-f (follitropin alpha for injection). GONAL-f is also a gonadotrophin hormone produced by recombinant DNA technology. It consists of highly purified FSH (follicle stimulating hormone), and contains no LH (luteinizing hormone).

LUVERIS provides you with LH that may be necessary to be given along with GONAL-f that provides you with FSH. FSH is necessary for the recruitment, growth, and maturation of the ovarian follicles which contain eggs known as ova or oocytes. The addition of LUVERIS to GONAL-f may enhance this process. This occurs during the first half of the female reproductive cycle. After LUVERIS and GONAL-f are given to help develop ovarian follicles, another hormone, hCG (human chorionic gonadotropin), may be given mid-cycle to mature the eggs and cause ovulation.

Why Have I Been Prescribed LUVERIS and GONAL-f?

Your doctor has probably prescribed LUVERIS (Lutropin alpha for injection) to be given with GONAL-f (follitropin alpha for injection) because your pituitary gland does not release FSH or LH. This means that the follicles are unable to develop and mature, so ovulation cannot take place. LUVERIS and GONAL-f help to provide the required amount of LH and FSH to the ovaries thereby allowing the ovarian follicles to develop.

How is Luveris Different From Other Treatments?

Over the years, the gonadotrophin drugs used in the treatment of infertility have undergone significant changes. Previous gonadotrophin products were derived from the urine of postmenopausal women and contain FSH, varying amounts of LH, and urinary proteins.

Through recombinant DNA (rDNA) technology the products manufactured are composed of highly purified hormones that offer a consistent dosage and do not contain urinary proteins. LUVERIS is produced through rDNA technology and consists of highly purified LH with no FSH or urinary proteins. GONAL-f is produced through rDNA technology and consists of highly purified FSH with no LH or urinary proteins.

How is LUVERIS Administered?

LUVERIS (Lutropin alpha for injection) cannot be taken orally because it would be digested in the stomach and for this reason, it must be taken by injection. Due to its high level of purity, LUVERIS is approved for subcutaneous injection (under the skin), which makes it easier and less painful than intramuscular injections. In fact, with professional guidance, you can learn to inject yourself, in the comfort and privacy of your own home.

LUVERIS can be mixed in the same syringe as GONAL-f, so that when these medications are taken together it requires only one injection.

How Long Will My Treatment Last?

This depends on your response to therapy. Every treatment is individualized and your doctor will need to carefully evaluate how you respond. If you fail to achieve pregnancy your doctor will discuss further options.

Are There Any Side Effects for Luveris With LUVERIS?

All drugs have the potential to cause side effects and LUVERIS (Lutropin alpha for injection) is no exception.

Local skin reactions (pain, redness, itching, and swelling) have been observed in some cases.

The most frequent adverse events reported are: headache, breast tenderness, abdominal pain, ovarian cysts, nausea, somnolence (drowsiness).

When given in combination with GONAL-f, you may experience headache, pelvic and abdominal pain, breast pain, nausea, somnolence, and ovarian cysts.

You may experience allergic sensitivity such as a rash and local swelling at the injection site. You should report this, as well as any unusual symptoms to your doctor immediately.

What are the Risks Associated with LUVERIS?

When LUVERIS (lutropin alpha for injection) and GONAL-f (follitropin alpha for injection) are used together multiple births may occur, at a rate similar to that found with other gonadotropins. The protocol, or combination and amount of medication prescribed by your physician, is a factor that may increase your risk of multiple births. Your doctor will monitor your response to the medication, carefully, to help minimize the chance of having multiple births.

The greatest concern your doctor will have is ovarian hyperstimulation syndrome (OHSS). To avoid the development of OHSS, your doctor will carefully monitor your response to GONAL-f/LUVERIS. Ovarian enlargement, sometimes accompanied by abdominal bloating and pain, may occur in about 20% of women taking gonadotrophins. This is generally reversed with cessation of treatment and severe life-threatening cases are rare.

Rarely abnormal blood clotting has been seen to occur with similar medicines, so this could possibly occur with LUVERIS/follitropin alpha/hCG therapy. Ectopic pregnancy (embryo implanted outside the womb) may occur especially in women with a history of prior tubal disease. Following treatment with LUVERIS when human chorionic gonadotropin is administered, a condition called ovarian hyperstimulation syndrome (OHSS) can occur. This syndrome is characterised by large ovarian cysts. First symptoms of ovarian hyperstimulation are pain in the lower abdominal region, possibly in combination with nausea, vomiting and weight gain. Should the above-mentioned symptoms occur, a careful medical examination is indicated as soon as possible. In serious, but rare cases, an ovarian hyperstimulation syndrome with clearly enlarged ovaries, can go hand in hand with possible accumulation of fluid in the abdomen or thorax as well as more serious thromboembolic complications. In rare cases, the latter can also be found independently of ovarian hyperstimulation syndrome. Torsion of the ovary and bleeding into the abdomen have not been reported with LUVERIS, however, there have been rare cases reported following treatment with hMG, a urine-derived medication also containing LH.

How to Inject LUVERIS

A Step by Step Guide

Before you Start...

It is important that you read this information. It will help familiarize you with the correct procedure for injecting LUVERIS (Lutropin alpha for injection) and clarify any concerns you may have. This information relates only to the use of LUVERIS. If you have been prescribed any fertility treatment other than LUVERIS, consult your physician.

Understandably, you may be a little apprehensive at first about injecting yourself. That is why this booklet has been produced. Refer to it as necessary and follow each instruction step by step. If you have any questions or concerns that are not addressed here, please consult your clinic office.

Every treatment is individualized. Yours has been carefully designed for you by your doctor according to your own specific needs. It is very important that you keep your appointments and follow your doctor's instructions, particularly with regard to the amount and frequency of the medication you are taking. If you forget or miss an injection, do not panic, but you should call your doctor or nurse for advice.

Important Points to Remember

  • LUVERIS (Lutropin alpha for injection) should be stored in the refrigerator or at stable room temperature (2-25°C). Avoid exposure to extreme heat or cold and store away from light.

  • Always check the expiry date before use—never use expired LUVERIS.

  • Only make up the LUVERIS solution when you are ready to use it. DO NOT USE IF CLOUDY, LUMPY, OR DISCOLOURED. BE SURE TO USE THE CORRECT AMOUNT OF DILUENT.

  • Check site of previous injection, and choose a different injection site each day.

  • It is recommended that you inject LUVERIS at around the same time each day.

  • Discard any unused solution.

LUVERIS may be mixed in the same syringe with GONAL-f and the combination given in one injection. If you are unsure about the mixing of the solution, or have difficulty with the injections, call your clinic office immediately.

Technical Information