Puregon Cartridge

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 Cartridge (Follitropin-beta). If you are concerned about side effects, discuss the risks and benefits of Puregon Cartridge (Follitropin-beta) with your doctor.

The following side effects have been reported by at least 1% of people taking Puregon Cartridge (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 Cartridge (Follitropin-beta).

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 Cartridge (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 Cartridge (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 Cartridge (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 Cartridge (Follitropin-beta).

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

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

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

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