Follitropin alfa

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Update Date 11/05/2020 . 11 mins read
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Uses

What is Follitropin alfa used for?

Follitropin alfa contains follicle-stimulating hormone (FSH) and is used to treat certain fertility problems in women. Follitropin alfa helps stimulate healthy ovaries to produce eggs. This medication is usually used in combination with another hormone (hCG) to bring about the growth and release of a mature egg (ovulation).

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

How should I take Follitropin alfa?

Learn all preparation and usage instructions from your health care professional and the product package. Follow the instructions for adding the mixing liquid to the medication. Do not shake the vial. Once mixed, use the liquid right away.

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

Inject this medication under the skin or into a muscle 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.

Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin.

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

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.

Learn how to store and discard needles and medical supplies safely.

How do I store Follitropin alfa?

Follitropin alfa is best stored at room temperature away from direct light and moisture. To prevent drug damage, you should not store Follitropin alfa in the bathroom or the freezer. There may be different brands of Follitropin alfa that may have different storage needs. It is important to always check the product package for instructions on storage, or ask your pharmacist. For safety, you should keep all medicines away from children and pets.

You should not flush Follitropin alfa down the toilet or pour them into a drain unless instructed to do so. It is important to properly discard this product when it is expired or no longer needed. Consult your pharmacist for more details about how to safely discard your product.

Precautions & warnings

What should I know before using Follitropin alfa?

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), 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, stroke, certain heart diseases (such as angina, heart attack), lung problems (such as asthma).

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 when 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.

Is it safe during pregnancy or breast-feeding?

There are no adequate studies in women for determining risk when using this Follitropin alfa during pregnancy or while breastfeeding. Please always consult with your doctor to weigh the potential benefits and risks before taking Follitropin alfa. Follitropin alfa is pregnancy risk category X according to the US Food and Drug Administration (FDA).

FDA pregnancy risk category reference below:

  • A=No risk,
  • B=No risk in some studies,
  • C=There may be some risk,
  • D=Positive evidence of risk,
  • X=Contraindicated,
  • N=Unknown

Side effects

What side effects can occur from Follitropin alfa?

Headache, mild stomach/abdominal pain, bloating, redness/pain at the injection site, or breast tenderness/pain 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, swelling of ankles/hands/feet.

Get medical help right away if you have any very serious side effects, including: 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 headache, 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, sudden/rapid weight gain, or decreased urination.

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.

Not everyone experiences these side effects. There may be some side effects not listed above. If you have any concerns about a side-effect, please consult your doctor or pharmacist.

Interactions

What drugs may interact with Follitropin alfa?

A product that may interact with this drug is: gonadorelin.

Follitropin alfa may interact with other drugs that you are currently taking, which can change how your drug works or increase your risk for serious side effects. To avoid any potential drug interactions, you should keep a list of all the drugs you are using (including prescription drugs, nonprescription drugs and herbal products) and share it with your doctor and pharmacist. For your safety, do not start, stop, or change the dosage of any drugs without your doctor’s approval.

Does food or alcohol interact with Follitropin alfa?

Follitropin alfa may interact with food or alcohol by altering the way the drug works or increase the risk for serious side effects. Please discuss with your doctor or pharmacist any potential food or alcohol interactions before using this drug.

What health conditions may interact with Follitropin alfa?

Follitropin alfa may interact with your health condition. This interaction may worsen your health condition or alter the way the drug works. It is important to always let your doctor and pharmacist know all the health conditions you currently have.

Dosage

The information provided is not a substitute for any medical advice. You should ALWAYS consult with your doctor or pharmacist before using this Follitropin alfa.

What is the dose of Follitropin alfa for an adult?

Usual Adult Dose for Ovulation Induction

Anovulatory Infertility:

Follitropin alpha:

Initial dose: 75 international units subcutaneously (SC) daily for 14 days

Maximum dose: 300 international units daily

Follitropin beta:

Initial dose: 50 international units SC daily for 7 days

Maximum dose: 250 international units daily

Duration of therapy: Until an adequate ovarian response is achieved

Comments:

-When pre-ovulatory condition is obtained, administer human chorionic gonadotropin (hCG) to induce final oocyte maturation and ovulation.

-Adequate ovarian response is assessed with serum estrogen concentrations and/or ultrasound examination.

-Withhold hCG when monitoring suggests an increased risk of Ovarian Hyperstimulation Syndrome (OHSS).

-Recommend daily intercourse, beginning the day prior to hCG administration and until ovulation becomes apparent.

-Discourage intercourse when the risk for OHSS is increased.

-If an excessive response is obtained, stop treatment and withhold hCG.

-In general, do not exceed 35 days of treatment.

Assisted Reproduction:

Follitropin alpha:

Initial dose: 150 international units SC daily for 5 days

Maximum dose: 450 international units daily

Follitropin beta:

Initial dose: 200 international units SC daily for 7 days

Maximum dose: 500 international units daily

Comments:

-When sufficient follicular development is obtained, as determined by ultrasound and estradiol levels, administer hCG.

-Withhold hCG when monitoring suggests an increased risk of OHSS.

Spermatogenesis:

Follitropin beta:

Initial dose: 225 international units SC twice a week; or 150 international units SC three times a week (total of 450 international units every week)

Comments:

-Pretreatment with hCG is required prior to concomitant therapy with follitropin beta and hCG.

-At least 3 to 4 months of concomitant therapy are needed before any improvement in spermatogenesis can be expected.

-Response to treatment may take up to 12 months.

Uses:

-Induction of ovulation and pregnancy in anovulatory women in whom the cause of infertility is functional and not due to primary ovarian failure.

-Development of multiple follicles in ovulatory women as part of an Assisted Reproductive Technology (ART) Cycle.

-Follitropin beta: Induction of spermatogenesis in men with primary and secondary Hypogonadotropic Hypogonadism (HH) in whom the cause of infertility is not due to primary testicular failure.

Usual Adult Dose for Hypogonadism – Male

Anovulatory Infertility:

Follitropin alpha:

Initial dose: 75 international units subcutaneously (SC) daily for 14 days

Maximum dose: 300 international units daily

Follitropin beta:

Initial dose: 50 international units SC daily for 7 days

Maximum dose: 250 international units daily

Duration of therapy: Until an adequate ovarian response is achieved

Comments:

-When pre-ovulatory condition is obtained, administer human chorionic gonadotropin (hCG) to induce final oocyte maturation and ovulation.

-Adequate ovarian response is assessed with serum estrogen concentrations and/or ultrasound examination.

-Withhold hCG when monitoring suggests an increased risk of Ovarian Hyperstimulation Syndrome (OHSS).

-Recommend daily intercourse, beginning the day prior to hCG administration and until ovulation becomes apparent.

-Discourage intercourse when the risk for OHSS is increased.

-If an excessive response is obtained, stop treatment and withhold hCG.

-In general, do not exceed 35 days of treatment.

Assisted Reproduction:

Follitropin alpha:

Initial dose: 150 international units SC daily for 5 days

Maximum dose: 450 international units daily

Follitropin beta:

Initial dose: 200 international units SC daily for 7 days

Maximum dose: 500 international units daily

Comments:

-When sufficient follicular development is obtained, as determined by ultrasound and estradiol levels, administer hCG.

-Withhold hCG when monitoring suggests an increased risk of OHSS.

Spermatogenesis:

Follitropin beta:

Initial dose: 225 international units SC twice a week; or 150 international units SC three times a week (total of 450 international units every week)

Comments:

-Pretreatment with hCG is required prior to concomitant therapy with follitropin beta and hCG.

-At least 3 to 4 months of concomitant therapy are needed before any improvement in spermatogenesis can be expected.

-Response to treatment may take up to 12 months.

Uses:

-Induction of ovulation and pregnancy in anovulatory women in whom the cause of infertility is functional and not due to primary ovarian failure.

-Development of multiple follicles in ovulatory women as part of an Assisted Reproductive Technology (ART) Cycle.

-Follitropin beta: Induction of spermatogenesis in men with primary and secondary Hypogonadotropic Hypogonadism (HH) in whom the cause of infertility is not due to primary testicular failure.

Usual Adult Dose for Follicle Stimulation

Anovulatory Infertility:

Follitropin alpha:

Initial dose: 75 international units subcutaneously (SC) daily for 14 days

Maximum dose: 300 international units daily

Follitropin beta:

Initial dose: 50 international units SC daily for 7 days

Maximum dose: 250 international units daily

Duration of therapy: Until an adequate ovarian response is achieved

Comments:

-When pre-ovulatory condition is obtained, administer human chorionic gonadotropin (hCG) to induce final oocyte maturation and ovulation.

-Adequate ovarian response is assessed with serum estrogen concentrations and/or ultrasound examination.

-Withhold hCG when monitoring suggests an increased risk of Ovarian Hyperstimulation Syndrome (OHSS).

-Recommend daily intercourse, beginning the day prior to hCG administration and until ovulation becomes apparent.

-Discourage intercourse when the risk for OHSS is increased.

-If an excessive response is obtained, stop treatment and withhold hCG.

-In general, do not exceed 35 days of treatment.

Assisted Reproduction:

Follitropin alpha:

Initial dose: 150 international units SC daily for 5 days

Maximum dose: 450 international units daily

Follitropin beta:

Initial dose: 200 international units SC daily for 7 days

Maximum dose: 500 international units daily

Comments:

-When sufficient follicular development is obtained, as determined by ultrasound and estradiol levels, administer hCG.

-Withhold hCG when monitoring suggests an increased risk of OHSS.

Spermatogenesis:

Follitropin beta:

Initial dose: 225 international units SC twice a week; or 150 international units SC three times a week (total of 450 international units every week)

Comments:

-Pretreatment with hCG is required prior to concomitant therapy with follitropin beta and hCG.

-At least 3 to 4 months of concomitant therapy are needed before any improvement in spermatogenesis can be expected.

-Response to treatment may take up to 12 months.

Uses:

-Induction of ovulation and pregnancy in anovulatory women in whom the cause of infertility is functional and not due to primary ovarian failure.

-Development of multiple follicles in ovulatory women as part of an Assisted Reproductive Technology (ART) Cycle.

-Follitropin beta: Induction of spermatogenesis in men with primary and secondary Hypogonadotropic Hypogonadism (HH) in whom the cause of infertility is not due to primary testicular failure.

Dose Adjustments

Follitropin beta:

-The pen injector device delivers on average an 18% higher amount of follitropin beta when compared to a conventional syringe and needle.

-Consider a lower starting dose when using the pen.

-Switching brands (manufacturers), types (recombinant, urinary), and/or methods of administration (pen, conventional syringe) may require dose adjustment.

Ovulation induction:

-The dosing scheme is stepwise and is individualized for each woman.

-Use dose adjustments to prevent multiple follicular growth and cycle cancellation.

Follitropin alpha:

-Starting doses less than 37.5 international units have not been studied and are not recommended.

-After the first cycle, determine the starting dose and dosage adjustments based on ovarian response.

-If needed, after the initial 14 days, make incremental dose adjustments, up to 37.5 international units, every 7 days.

Follitropin beta:

-After the first cycle, make dose adjustments weekly intervals based upon ovarian response.

-Make adjustments by 25 or 50 international units at weekly intervals until follicular growth and/or serum estradiol levels indicate an adequate ovarian response.

Assisted Reproduction:

Follitropin alpha:

-In women aged 35 years or older whose endogenous gonadotropin levels are suppressed, initiate treatment at 225 international units subcutaneously daily for 5 days.

-Adjust the dose after the first 5 days based on ovarian response, as determined by ultrasound evaluation of follicular growth and serum estradiol levels.

-Do not adjust dose more than every 3 to 5 days or by more than 75 to 150 international units at each adjustment.

-In most cases, therapy should not exceed 10 days.

Follitropin beta:

-Adjust the dose after the first 7 days of treatment based on ovarian response, as determined by ultrasound evaluation of follicular growth and serum estradiol levels.

-For high responding women [those at particular risk of abnormal ovarian enlargement and/or ovarian hyperstimulation syndrome (OHSS)], decrease or temporarily stop the daily dose, or discontinue the cycle according to individual response.

Spermatogenesis:

-Based on delivery of a higher dose of follitropin beta with the pen injector, a lower dose may be considered.

Other Comments

Administration advice:

-Inspect for particulate matter and discoloration prior to administration.

-Alternate injection site daily.

-Administer subcutaneously in the abdomen or intramuscularly.

-If using intramuscularly, a healthcare provider should administer the product.

Reconstitution/preparation techniques: The manufacturer product information should be consulted.

General:

-Treatment should be initiated under the supervision of a physician experienced in the treatment of fertility disorders.

Patient advice:

-Prior to beginning therapy, inform patients about the time commitment and monitoring procedures necessary for treatment.

-If a dose is missed, the next dose should not be doubled. The patient should call the healthcare provider for further dosing instructions.

-Caution patients not to change the dosage or the schedule of administration unless told to do so by their healthcare provider.

What is the dose of Follitropin alfa for a child?

The dosage has not been established in pediatric patients. It may be unsafe for your child. It is always important to fully understand the safety of the drug before using. Please consult with your doctor or pharmacist for more information.

How is Follitropin alfa available?

Follitropin alfa is available in the following dosage forms and strengths:

  • Injectable powder for injection
  • Injectable solution
  • Subcutaneous solution
  • Subcutaneous powder for injection

What should I do in case of an emergency or overdose?

In case of an emergency or an overdose, call your local emergency services or go to your nearest emergency room.

What should I do if I miss a dose?

If you miss a dose of Follitropin alfa, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and take your regular dose as scheduled. Do not take a double dose.

Hello Health Group does not provide medical advice, diagnosis or treatment.

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