Product Description:

• Puregon 300 IU/0.36 ml solution for injection contains follitropin beta, a hormone called follicle-stimulating hormone ( FSH ).


• FSH belongs to the group of gonadotropins that play an important role in human fertility and reproduction. In women, FSH is needed for the growth and development of follicles in the ovaries.


• Follicles are small round sacs that contain egg cells. In men, FSH is needed for the production of sperm.

Puregon is used to treat infertility in the following situations:

Women:

• In anovulatory women who do not respond to treatment with clomiphene citrate, Puregon can be used to induce ovulation.


• In women undergoing assisted reproduction, such as in vitro fertilization (IVF) and other methods, Puregon may cause the development of more follicles .

Men:

• In men who are infertile due to lowered hormone levels, Puregon can be used to produce sperm.

How To Use:

• Treatment with Puregon should be initiated under the supervision of a physician experienced in the treatment of fertility problems.


• The first injection of Puregon should be given under medical supervision.

Dosage:

Dosage for women:

• There are large inter- and intra-individual variations in the response of the ovaries to exogenously supplied gonadotropins.


• This makes it impossible to give a general dosage schedule.


• Dosage must therefore be individualized depending on the response of the ovaries.


• For this, an ultrasound examination of follicle development is required.


• Concomitant determination of serum estrogen levels may also be useful.


• When using the injection pen, one should be aware that the pen is a precision instrument that delivers exactly the dose that is set.


• It has been found that on average 18% higher amount of FSH is given with the pen compared to a regular syringe.


• This can be of particular importance when switching between the injection pen and a regular syringe during the same treatment cycle.


• Especially when switching from the syringe to the pen, small dose adjustments may be necessary to prevent overdosing .


• Based on comparative clinical studies , it is considered appropriate to give a lower total dose of Puregon for a shorter treatment period than that generally given with urinary FSH , not only to optimize follicular growth but also to reduce the risk of unwanted ovarian hyperstimulation .

Anovulation:

• In general, a sequential treatment is preferred.


• You start with a daily administration of 50 IU Puregon. This starting dose is maintained for at least 7 days.


• If no ovarian response is obtained, the daily dose may be increased gradually until follicular growth and/or plasma estrogen levels indicate adequate pharmacodynamic response.


• A daily increase in estrogen levels of 40-100% is considered optimal.


• The daily dose is then maintained until preovulatory conditions are reached.


• Preovulatory conditions have been reached when a dominant follicle with a diameter of at least 18 mm verified by ultrasound and/or plasma estradiol levels of 300-900 picograms/ml (1,000-3,000 pmol/l) have been measured.


• Usually 7 to 14 days of treatment is enough to reach this stage.


• Administration of Puregon should then cease and ovulation should be induced with chorionic gonadotropin ( hcg ).


• If the number of follicles is too high or estradiol levels increase too quickly, more than doubling per day for 2-3 days, the daily dose should be reduced.

Because follicles larger than 14 mm can lead to pregnancy, multiple preovulatory follicles canover 14 mm lead to multiple pregnancies.

 In that case hcg should not be given and pregnancy should be avoided to prevent multiple births.

Controlled overstimulation in medically supervised fertilization:

• Different stimulation protocols can be used. A starting dose of 100-225 IU is recommended for at least the first four days.


• The dose can then be adjusted individually according to the response of the ovaries.


• In clinical studies, it has been shown that a maintenance dose in the range of 75-375 IU for six to twelve days is sufficient, although longer treatment may be necessary.


• Puregon can be given either alone or to prevent premature luteinization in combination with a gnrh agonist or antagonist.


• When using gnrh agonist, a higher total treatment dose of Puregon may be necessary to obtain adequate follicular response.


• The ovarian response must be followed with an ultrasound examination.


• Concomitant determination of serum estrogen levels may also be useful.


• When ultrasound examination shows the presence of at least three follicles with a size of 16-20 mm, and there is evidence of a good estradiol response [plasma levels of approx.


• 300-400 picograms/ml (1,000-1,300 pmol/l) for each follicle with a diameter greater than 18 mm], the final stage of maturation should be induced by administration of hcg.


• Oocyte collection should be done 34-35 hours later.

Dosage for men:

• Puregon should be given in a dose of 450 IU/week, preferably divided into 3 doses of 150 IU, together with hcg.


• Treatment with Puregon and hcg should last at least 3 to 4 months before an improvement in spermatogenesis can be expected.


• To evaluate the effect, analysis of the seminal fluid is recommended 4-6 months after the start of the treatment.


• If the patient has not responded after this period, the combination therapy can be continued; recent clinical experience indicates that treatment for 18 months or longer may be needed to achieve spermatogenesis .

Pediatric population:

• There is no relevant use of Puregon in a pediatric population for the approved indication.

Warnings And Precautions:

Talk to your doctor before using Puregon if you:

• Have had an allergic reaction to certain antibiotics ( neomycin and/or streptomycin).


• Have uncontrolled problems with the pituitary gland or hypothalamus.


• Have an underproduction in the thyroid gland ( hypothyroidism ).


• Have adrenal glands that are not working properly (adrenocortical insufficiency).


• Have high prolactin levels in the blood ( hyperprolactinemia ).


• Have any other medical conditions (eg diabetes , heart disease or any other long-term illness).

Ingredients:

• Follitropin beta.

Its available with different concentrations:

• 150 IU/0.18 ml.


• 300 IU 0.36 ml.


• 600 IU/0.72 ml.


• 900 IU/1.08 ml.

Product Details:

• Brand: Puregon
• Product Form: Cartridges
• Quantity: 1 Pc