Follitropin delta belongs to the class of medications called gonadotropins. It is a synthetic hormone similar to the human hormone called follicle stimulating hormone (FSH), a hormone produced by the pituitary gland that helps eggs mature and become ready for release by the ovaries.

Follitropin delta works by helping to stimulate the development of eggs in the ovaries. It is used by women having assisted reproductive technology (ART) procedures (e.g., in-vitro fertilization) in fertility clinics.

This medication may be available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms or approved for all of the conditions discussed here. As well, some forms of this medication may not be used for all of the conditions discussed here.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

The recommended starting dose of follitropin delta is based on body weight, and the level of a hormone in your body called anti-Müllerian hormone (AMH). Your doctor will calculate the starting dose. After the first cycle of treatment, your doctor will adjust the dose based on how well your ovaries responded to the previous cycle. This medication is injected subcutaneously (under the skin), once daily, starting 2 or 3 days after menstrual bleeding begins. Your doctor will monitor for follicle development with ultrasounds or blood tests. Once an appropriate number of follicles have matured, follitropin delta is stopped and another medication, human chorionic gonadotropin (hCG) will be given to cause ovulation.

If you are injecting this medication yourself, your doctor or nurse will show you how to use this medication properly. If you are not sure how to use it or have questions about how to use it, contact your doctor. Before using this medication, thoroughly read the patient information provided and ask your doctor if you have any questions.

Many things can affect the dose of 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 taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor.

If you miss a dose, contact your doctor for instructions. Do not take a double dose to make up for a missed one.

Store this medication 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.

Each 1 mL of clear, sterile solution for injection contains 33.3 mg of follitropin delta. Nonmedicinal ingredients: phenol, polysorbate 20, L-methionine, sodium sulfate decahydrate, disodium hydrogen phosphate dodecahydrate, phosphoric acid, sodium hydroxide and water for injections.

Do not take this medication if you:

• are allergic to follitropin delta or to any of the ingredients of the medication
• are pregnant or breast-feeding
• have conditions where pregnancy can 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 ovarian cysts or enlargement not due to polycystic ovary syndrome (PCOD)
• have tumours of the ovary, breast, uterus, hypothalamus, or pituitary gland
• have ovaries that no longer produce and release eggs
• have fibroid tumours in the uterus that prevents completing a pregnancy

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 this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. 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.

• abdominal discomfort
• breast pain or tenderness
• constipation
• diarrhea
• dizziness
• drowsiness
• fatigue
• headache
• nausea
• pain, swelling, or redness at the injection site
• vomiting

Although most of the 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 discomfort
• mood swings
• ovarian or tubal pain
• signs of a blood clot in blood vessels, such as sudden vision change or dizziness, chest pain, pain and swelling in one leg muscle
• vaginal bleeding

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

• symptoms of a 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 this medication.

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 this medication.

Blood clots: This medication may increase the risk of forming 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.

Ectopic pregnancies: This medication 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.

Lung Problems: The use of other gonadotropin medications for fertility treatment has been associated with breathing problems. This can include flare-ups of asthma symptoms, fluid collecting in the lungs, making it difficult to breathe, or a collapsed lung. If you experience any difficulty breathing while you are using follitropin delta or after it has been stopped, contact your doctor as soon as possible.

Multiple births: This medication 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 this medication 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.

Pregnancy: This medication should not be used by pregnant women. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: This medication should not be used by breast-feeding women.

Children: This medication is intended for use by people of child-bearing age. Its safety and effectiveness have not been established for children.

Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that 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. 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.