Follitropin Delta - Injection

Pronunciation: FOL-i-TROE-pin DEL-ta

Common Brand Name(s): Rekovelle

Important: How To Use This Information

This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

Uses

This medication contains follicle-stimulating hormone (FSH), a hormone that your body normally makes. It is used in assisted reproduction programs to treat certain fertility problems. Follitropin delta works by helping healthy ovaries to produce eggs. This medication is usually used in combination with another hormone (hCG) to cause the growth and release of mature eggs (ovulation). The eggs are then collected and fertilized in the lab. Talk with your doctor about the risks and benefits of using this medication, including multiple births, birth defects, and miscarriage.

This medication is not recommended for women whose ovaries no longer make eggs properly (primary ovarian failure).

How To Use

Read the Patient Information Leaflet if available from your pharmacist before you start using follitropin delta and each time you get a refill. Learn all preparation and usage instructions from your health care professional and the product package. If you have any questions, ask your doctor or pharmacist.

Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.

This medication is injected under the skin of the abdomen as directed by your doctor, usually once a day. Your doctor may direct you to use this medication in a treatment cycle (for example, only on certain days each month). Carefully follow your doctor's instructions.

The dosage is based on your medical condition, response to treatment, and lab tests.

Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin. Learn how to store and discard needles and medical supplies safely.

Use this medication exactly as directed by your doctor to get the most benefit from it. Do not increase your dose or use this drug more often or for longer than prescribed.

Side Effects

Redness/pain at the injection site, headache, pelvic discomfort/pain, or tiredness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

  • bleeding from the vagina/uterus

This medication may rarely cause blood clots (such as pulmonary embolism, stroke, heart attack, deep vein thrombosis). You may be at increased risk for blood clots if you have a history of blood clots, or if you are immobile (such as on very long plane flights or being bedridden). Before using this medication, if you have any of these conditions report them to your doctor or pharmacist. Get medical help right away if any of these side effects occur:

  • shortness of breath/rapid breathing
  • chest/jaw/left arm pain
  • unusual sweating
  • confusion
  • sudden dizziness/fainting
  • pain/swelling/warmth in the groin/calf
  • sudden severe headaches
  • trouble speaking
  • weakness on one side of the body
  • sudden vision changes

This medication may cause a condition known as ovarian hyperstimulation syndrome (OHSS). This condition may occur during or after treatment. Rarely, serious OHSS causes fluid to suddenly build up in the stomach, chest, and heart area. Get medical help right away if you develop the following side effects: severe pain or swelling in the lower abdominal (pelvic) area, nausea/vomiting, diarrhea, sudden/rapid weight gain, or shortness of breath.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

  • rash
  • itching/swelling (especially of the face/tongue/throat)
  • severe dizziness
  • trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other products containing follicle-stimulating hormone (FSH); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

  • other fertility problems (such as primary ovarian failure, early menopause)
  • abnormal bleeding from the vagina/uterus
  • thyroid problems
  • adrenal gland problems
  • cancer of the reproductive organs (such as breast, uterus, ovary)
  • tumor in the brain (such as pituitary tumor)
  • ovarian cysts or enlarged ovaries
  • blood clots

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Multiple births may occur as a result of this treatment. Consult your doctor for more details.

Stop using this medication if you become pregnant. This medication must not be used during pregnancy. If you think you may be pregnant, tell your doctor right away.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

A product that may interact with this drug is:

  • gonadorelin

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as vaginal ultrasound, hormone levels, liver tests) may be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Missed Dose

If you miss a dose, contact your doctor or pharmacist right away to establish a new dosing schedule. Do not double the dose to catch up.

Storage

Store the unused cartridge/prefilled pen in the refrigerator. If needed, the unused cartridge/prefilled pen may also be stored at room temperature for up to 3 months.

Once used, this product may be stored in the refrigerator or at room temperature. Throw away the used cartridge/prefilled pen after 28 days.

Do not freeze. Protect from light. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Is it an emergency?

If you or someone in your care has chest pains, difficulty breathing, or severe bleeding, it could be a life-threatening emergency. Call 9-1-1 or the local emergency number immediately.
If you are concerned about a possible poisoning or exposure to a toxic substance, call Poison Control now at 1-800-567-8911.

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