Puregon

The dose of Puregon (Follitropin-beta) varies according to the treatment and individual response.

To help induce ovulation, the recommended initial dose of follitropin beta is 50 IU given daily, usually for 7 to 14 days. The dose may be adjusted according to response, which is measured by an ultrasound or by a blood test. When an adequate response is achieved, Puregon (Follitropin-beta) is stopped and another medication, human chorionic gonadotropin (hCG), is given to induce ovulation.

For ART procedures, the usual initial dose is 150 IU to 225 IU daily for 4 days. The dose is then adjusted according to response and is usually continued for 6 to 12 days. When an adequate response is achieved, Puregon (Follitropin-beta) is stopped and another medication, hCG, is given to induce ovulation.

In men, the usual dose is 150 IU given 3 times a week or 225 IU twice a week. Treatment is usually given for at least 3 to 4 months. It is usually given along with another medication, hCG. Response to Puregon (Follitropin-beta) for men is determined by analysis of semen after 4 to 6 months of treatment.

The injections can be given under the skin (subcutaneous) or into a muscle (intramuscular) in women and under the skin (subcutaneous) in men. The best place for subcutaneous injections is around the navel or the upper thigh. The place of injection should be varied for each injection. The best place for intramuscular injections is the upper outer part of the buttock muscle.

A health care professional will show you how to use Puregon (Follitropin-beta) properly. Read the enclosed patient information carefully and ask your doctor any question you might have.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are using the medication without consulting your doctor.

It is very important to use this medication on a regular schedule as prescribed by the doctor. If you miss a dose of Puregon (Follitropin-beta), check with your health care professional. Do not administer a double dose to make up for a missed dose.

Store Puregon (Follitropin-beta) in the refrigerator at 2°C to 8°C (do not freeze). It can also be stored at room temperature (below 25°C) for a maximum of 3 months. Protect it from light, and keep it out of the reach of children. Once the cartridges have been punctured by a needle, store for a maximum of 28 days.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may cause headaches; it may cause constipation - to prevent this, drink plenty of water or juice, and eat more dietary fibre; it may cause stomach ache; it may cause back pain; it may cause nausea or, rarely, vomiting; it may cause your breasts to feel swollen and tender. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

Solution for injection in cartridges

Solution for injection in cartridges contain 833 IU/mL. Cartridges contain a minimum of 400 IU FSH activity in 0.48 mL aqueous solution, which is sufficient for a net deliverable dose of 300 IU; a minimum of 700 IU FSH activity in 0.84 mL aqueous solution, which is sufficient for a net deliverable dose of 600 IU; or a minimum of 1,025 IU FSH activity in 1.23 mL, which is sufficient for a net dose of 900 IU. Nonmedicinal ingredients: benzyl alcohol, L-methionine, polysorbate 20, sodium citrate, and sucrose. Hydrochloric acid 0.1 N and sodium hydroxide 0.1 N (trace amounts for pH adjustment to pH 7.0). May contain traces of streptomycin and neomycin.

The net deliverable dose of 300 IU, 600 IU, and 900 IU are based upon a maximum of six 50 IU injections, six 100 IU injections and nine 100 IU injections respectively. When more injections are given the net total dose may be lowered, because each injection has to be preceded by an air shot.

Solution for injection

Each vial of sterile solution for injection contains follitropin beta (recombinant FSH) 100 IU. Nonmedicinal ingredients: L-methionine, polysorbate 20, sodium citrate, and sucrose. Hydrochloric acid 0.1 N and sodium hydroxide 0.1 N (trace amounts for pH adjustment to pH 7.0). May contain traces of streptomycin and neomycin.

Puregon (Follitropin-beta) should not be used by women who:

• are allergic to follitropin beta or to any of the ingredients of the medication
• are pregnant or breast-feeding
• have conditions where pregnancy cannot or should not occur (e.g., malformation of sexual organs or fibroid tumours of the uterus)
• have heavy or irregular vaginal bleeding of unknown cause
• have high levels of the hormone FSH in the blood
• have ovarian cysts or enlargement not due to Polycystic Ovary Syndrome (PCOD)
• have tumours of the ovary, breast, uterus, hypothalamus, or pituitary gland
• have uncontrolled Thyroid or adrenal dysfunction

Puregon (Follitropin-beta) should not be used by men who:

• are allergic to follitropin beta or to any of the ingredients of the medication
• have tumours of the testicles, pituitary gland, or hypothalamus
• have primary testicular failure

There may be an interaction between follitropin beta and any of the following:

• Clomiphene

If you are taking any of these medications, speak with your doctor or pharmacist. 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.

Medications other than those listed above may interact with Puregon (Follitropin-beta). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications 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.

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 Puregon (Follitropin-beta).

Blood Clots: Puregon (Follitropin-beta) may increase the risk of blood clots, especially if you are already at risk of blood clots. Risk factors for blood clots include being severely overweight and having a personal or family history of blood clots. However, pregnancy itself can also increase the risk of a blood clot.

If you experience symptoms such as sharp pain and swelling in the leg, difficulty breathing, chest pain, blurred vision or difficulty speaking, contact your doctor immediately.

Ectopic pregnancies: Puregon (Follitropin-beta) may increase the risk of having an ectopic pregnancy (where the baby develops in one of the fallopian tubes instead of the uterus). It is important to have an early ultrasound to make sure that the baby is developing inside the uterus.

Multiple births: Puregon (Follitropin-beta) may increase the risk of multiple births (mostly twins). Talk to your doctor about the risks of multiple births before beginning treatment.

Ovarian enlargement: Some women using Puregon (Follitropin-beta) may experience ovarian enlargement associated with abdominal bloating or pain. In most cases, the pain and bloating stop without treatment within 2 or 3 weeks. If you experience these symptoms, contact your doctor.

Ovarian hyperstimulation syndrome (OHSS): Treatment with this medication can cause a condition called ovarian hyperstimulation syndrome (OHSS). With OHSS, too many follicles grow and cause abdominal or pelvic discomfort or pain, nausea, vomiting, and weight gain. Some women may experience difficulty breathing, diarrhea, and decreased urination. OHSS can progress rapidly and may become serious. It can occur even after treatment has stopped. If you experience any of these symptoms, contact your doctor immediately.

Ovarian torsion: Ovarian torsion or twisting of an ovary is a serious potential complication of treatment with follitropin beta and other similar medications. This condition can cause permanent damage to the ovary if it is not treated promptly. If you experience symptoms such as severe pelvic pain, nausea, vomiting, fever and abnormal bleeding, seek immediate medical attention.

Pregnancy: Puregon (Follitropin-beta) should not be used by pregnant women. If you become pregnant while taking Puregon (Follitropin-beta), contact your doctor immediately.

Breast-feeding: Puregon (Follitropin-beta) should not be used by breast-feeding women.

Children: Puregon (Follitropin-beta) is intended for use by people of child-bearing age. Its safety and effectiveness have not been established for children.

Seniors: Puregon (Follitropin-beta) is intended for use by people of child-bearing age. Its safety and effectiveness have not been established for seniors.

This product must be injected under the skin (subcutaneously), according to the technique you were shown. Be sure to choose a different injection site each time. Dispose of used syringes and needles safely. Your pharmacist can tell you the best way to do this. This medication is typically used only once a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you. Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed. You should take this medication at approximately the same time each day.