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Puregon

Puregon

(follitropin-beta)

Follitropin beta belongs to the class of medications called gonadotropins. Follitropin beta contains a hormone similar to the human hormone called follicle stimulating hormone (FSH).

Available form

Dosage

Injectable

100IU/0.5ML

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Puregon information

Dosage

Side Effects

Available Form

Contraindications

Precautions

Warnings

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.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Puregon (Follitropin-beta). If you are concerned about side effects, discuss the risks and benefits of Puregon (Follitropin-beta) with your doctor.

The following side effects have been reported by at least 1% of people taking Puregon (Follitropin-beta). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

aches and pains
Acne
breast development (in men)
breast tenderness
chills
Constipation
Diarrhea
dry skin
fatigue
flu-like symptoms (e.g., Fever, chills, muscle aches, joint pain, headache, fatigue)
general feeling of being unwell)
hair loss
headache
nausea
pain, redness, or irritation at the place of injection (temporary)
vomiting

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

abdominal pain or bloating
pelvic pain
redness, pain, or swelling at injection site (continued)
signs of a blood clot in blood vessels, such as sudden vision change or dizziness, chest pain, pain and swelling in one leg muscle
symptoms of a urinary tract infection (e.g., pain when urinating, urinating more often than usual, low back or flank pain)
testicular cyst
vaginal bleeding

Stop taking the medication and seek immediate medical attention if any of the following occur:

symptoms of a Anaphylaxis (severe allergic reaction) (shortness of breath, swelling of the face or throat, or Hives)
symptoms of ovarian hyperstimulation syndrome (OHSS; abdominal or pelvic discomfort or pain, nausea, vomiting, weight gain, difficulty breathing, diarrhea, decreased urination, rapid weight gain)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Puregon (Follitropin-beta).

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.

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