Follitropin Beta for Infertility in Women - A Comprehensive Guide

Overview:

A recombinant version of follicle-stimulating hormone (FSH) called Follitropin beta is used in assisted reproductive technologies to treat infertility, especially in women. The pituitary gland naturally produces the hormone FSH, which is essential for controlling the menstrual cycle and the production of eggs in the ovaries. Follitropin beta received FDA (Food and Drug Administration) clearance in 1997 to be used in the treatment of female infertility. Speak with a healthcare provider to fully comprehend this medicine's precise indications, dosage, and possible adverse effects.

Drug Group:

Follitropin beta is a member of the gonadotropin medication class. Hormones called gonadotropins activate the gonads, which are the testes in men and the ovaries in women. Follicle-stimulating hormone (FSH), a gonadotropin essential for controlling reproductive activities, is synthesized as Follitropin beta.

Available Doses and Dosage Forms:

Common dosage amounts and configurations might be:

• Follitropin Beta Vials: Vials containing the lyophilized powder are frequently provided. The medicine content of the vials may differ, as may the concentration of the reconstituted solution.

• Follitropin Beta Pens: Several formulations are available in pre-filled pens for easy subcutaneous injection. These pens are easier to use and can provide patients with a more convenient choice.

• Dosing Regimens: Follitropin beta dosages are customized according to each patient's unique requirements and response to therapy. Fertility specialists use blood tests and ultrasounds to monitor the ovarian response, which they use to establish the right beginning dose and may modify it during the treatment cycle.

For Patients:

What Is Infertility in Women?

The inability to have a child while engaging in frequent, unprotected sexual activity for a year or more is known as infertility in women. Female infertility can result from several causes, including endometriosis, hormonal imbalances, irregularities in the structure of the reproductive organs, ovulation difficulties, and age-related loss in fertility, which is most noticeable after age 35.

A thorough assessment is required for the diagnosis, which includes ovulation testing, uterine and fallopian tube health assessments, and a male partner's fertility assessment. A customized treatment plan is created when the underlying reason has been found.

Intrauterine insemination (IUI), in which sperm is inserted directly into the uterus, is one method of inducing ovulation. Other treatment options include more sophisticated methods like in vitro fertilization (IVF), in which sperm and eggs are combined outside of the body, and the resulting embryos are transferred to the uterus. To address structural concerns, surgical procedures could be advised in some situations.

How Does Follitropin Beta Work?

Follitropin beta is used in conjunction with fertility treatments to cause regulated ovarian stimulation. It is given to the ovaries to encourage the production of several follicles, each of which can mature into an egg. This is especially crucial when using assisted reproductive technologies like in vitro fertilization (IVF), which requires retrieving and fertilizing numerous eggs in a lab.

Follitropin beta injection is closely regulated and observed to best time the development of eggs. Human chorionic gonadotropin (hCG), another drug, is frequently given to the follicles after they reach the proper size to initiate the final maturation of the eggs. This lays the groundwork for the extraction of developed eggs for use in assisted reproductive techniques.

What Is the Dosage of Follitropin Beta?

Follitropin beta is given to the ovaries to encourage the production of several follicles, each of which can mature into an egg. This is especially crucial when using assisted reproductive technologies like in vitro fertilization (IVF), which requires retrieving and fertilizing numerous eggs in a lab.

Dosage:

• 175 IU (international unit) per 0.210 mL (milliliter).

• 350 IU per 0.420 mL.

• 650 IU per 0.780 mL.

• 975 IU per 1.170 mL.

How Effective Is Follitropin Beta?

Like with other fertility drugs, the efficacy of Follitropin beta varies from patient to patient based on a variety of factors, including age, overall health, and the reason for infertility. Numerous factors affect the success rates, such as the type of fertility therapy being sought (in vitro fertilization, for example), the quality of eggs recovered, the outcome of fertilization, and the state of the uterus at the time of embryo implantation (fertilized egg attaches to the lining of the uterus). Fertility specialists collaborate closely with patients to customize treatment regimens and increase the likelihood of a healthy pregnancy.

Patients receiving infertility treatments must be upfront and honest with their healthcare professionals about the possible consequences of their therapies, as well as having reasonable expectations.

What Are the Things to Inform the Doctor Before Taking the Drug?

It is important to let the healthcare practitioner know the following before beginning Follitropin beta or any other fertility medication:

• Medical History: Provide a thorough medical history that includes information about any known allergies, surgeries, fertility treatments, and pre-existing diseases.

• Current Medication: Let the doctor know about all the prescription and over-the-counter medications and any herbal or vitamin supplements used.

• Pregnancy and Breastfeeding Status: The healthcare professional should take these factors into account when providing fertility drugs if the patient is nursing or may become pregnant in the future.

• Ovulatory Abnormalities: Let the physician know about irregular menstrual periods or any known ovulatory abnormalities.

• Ovarian Cysts: Report any past instances of polycystic ovarian syndrome (PCOS) (ovarian cysts).

• Allergic Reactions: It is important to let the doctor know about any allergic response to Follitropin beta or any related drugs.

How Is Follitropin Beta Administered?

Typically, the steps entail:

1. Reconstitution: If the drug is given as a freeze-dried powder that has been lyophilized, the patient or healthcare professional will reconstitute it with a diluent according to the directions.

2. Injection: A subcutaneous injection (injecting medicine into the tissue layer directly beneath the skin) of the reconstituted fluid is administered, often into the lower abdomen. Patients are usually advised to alternate injection sites to reduce pain; however, injection locations might vary.

3. Timing: The injection timing must be carefully considered based on the treatment regimen. Fertility specialists will give detailed advice on when and how to take the drug.

4. Dosage:

• Anovulatory Women Undergoing Induction - At least a daily dose of 50 international units of Follitropin beta is given subcutaneously for the first seven days. Every week, the dosage is raised by 25 or 50 international units until blood estradiol levels and follicular development show a sufficient response.

• Normal Ovulating Women Undergoing IVF - A starting dose of 200 international units (real cartridge doses) of Follitropin beta is given subcutaneously for at least the first seven days of therapy. Based on the ovarian response assessed by ultrasound measurement of follicular development and blood estradiol levels, subsequent doses may be changed up or down. From the sixth day of therapy forward, dosage decrease in high responders may be considered based on the individual.

What Are the Side Effects of Follitropin Beta?

• When women undergo ovulation induction, the most frequent adverse responses (≥2 percent) include lower abdomen pain, stomach discomfort, ovarian hyperstimulation syndrome, multiple pregnancies (twins or triplets), and ovarian cysts.

• When women undergo controlled ovarian stimulation as part of an IVF or ICSI (intracytoplasmic sperm injection) cycle, pelvic discomfort, headaches, ovarian hyperstimulation syndrome, pelvic pain, nausea, and exhaustion are the most frequent adverse effects (≥2 percent).

Dietary Considerations:

It is usually advised to have a healthy, balanced diet when using Follitropin beta. It is critical to drink enough water, particularly if ovarian hyperstimulation is an issue. Since dietary requirements differ from person to person, it is best to get personalized guidance from a healthcare professional or nutritionist.

Missed Dose:

Getting advice from a healthcare professional is crucial if a Follitropin beta dosage is missed. If a dosage is missed, it may affect the course of therapy. The medical team can advise whether to deliver the missed dose or modify the treatment plan.

Overdose:

Seeking quick medical assistance is vital if there is a suspicion of overdosing. Severe stomach discomfort, nausea, vomiting, and respiratory difficulty are possible overdose symptoms. The medical professional can evaluate the circumstances and administer the necessary care.

Storage

• Until the expiration date, keep the Follitropin beta refrigerated between two and eight degrees Celsius (36 and 46 degrees Fahrenheit).

• Follitropin beta can be kept for three months or until the expiration date, whichever comes first, at or below 25 degrees Celsius (77 degrees Fahrenheit). After a needle punctures the rubber inlay of the Follitropin beta, the product should only be kept at two to twenty-five degrees Celsius (36–77°F) for a maximum of 28 days.

• It should not be exposed to light.

• Refrain from freezing.

• Keep all medications, including the Follitropin, out of children's reach.

For Doctors:

Indication:

• Inducing ovulation and pregnancy in anovulatory infertile women whose primary ovarian failure is not the cause of their infertility.

• Pregnancy in normally ovulatory women getting in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) through controlled ovarian stimulation.

• Men with primary and secondary hypogonadotropic hypogonadism (HH) whose infertility is not caused by primary testicular failure: induction of spermatogenesis.

Dose:

Follitropin beta is usually administered subcutaneously, with the exact dosage determined by the indication and the patient. General dosing guidelines:

• Women: Anovulation/oligo Ovulation: 75 to 150 IU daily, beginning on day three or five of the menstrual cycle.

• COH (Controlled Ovarian Hyperstimulation) for ART (Assisted Reproductive Technology): 75 to 300 IU daily, beginning on day two or three of the menstrual cycle, with dose adjustments based on ovarian response.

Dosing Considerations:

Factors specific to each patient, including age, weight, and ovarian reserve reasons behind infertility.:

• Objectives for treatment.

• Reaction to the medical intervention.

It is crucial to remember that these are only broad recommendations, and a trained healthcare provider should establish the right dosage. They will consider the unique demands and circumstances throughout therapy and change the dosage as necessary. The following extra variables may also need to be taken into account when determining dosage:

• Previous Ovarian Stimulation Experience: If one has previously had ovarian stimulation, one may react differently to FSH this time. The physician will modify the dosage in light of the prior experiences.

• Ovarian Hyperstimulation Syndrome (OHSS) Risk: FSH medication can have a major negative impact on OHSS. The physician will monitor the risk of OHSS and may change the dosage as necessary.

• Concurrent Medication: FSH and some medicines may interact. Any drugs must be disclosed to the doctor to prevent any potential interactions.

Pharmacological Aspects of Follitropin Beta

• Pharmacodynamics:

1. Target: Follitropin beta increases the growth and maturation of ovarian follicles by acting mainly on the ovaries in females.

2. Impact on the Follicles: The granulosa cells in the ovarian follicles have follicle-stimulating hormone (FSH) receptors bound by Follitropin beta. This binding sets a series of biochemical processes in motion, encouraging the development and maturation of several follicles.

3. Ovulation Stimulation: Follitropin beta's ultimate objective is to provide regulated ovarian stimulation, which creates many mature eggs inside the ovaries.

• Mechanism:

1. Recombinant DNA Technology: The synthetic type of FSH known as Follitropin beta is created via recombinant DNA technology. It is designed to mimic the pituitary gland's normal production of FSH precisely.

2. FSH Receptor Binding: Follicin beta attaches to FSH receptors on ovarian follicle granulosa cells to initiate intracellular signaling cascades.

3. Follicle Formation: This activation causes the granulosa cells to secrete a range of growth factors that aid in forming and expanding ovarian follicles. The recruitment, maturation, and selection of follicles are significantly influenced by Follitropin beta.

• Pharmacokinetics:

1. Absorption: Follitropin beta is injected subcutaneously, facilitating rapid and effective bloodstream absorption.

2. Distribution: The drug is spread all over the body, but it has a special attraction for the ovaries, which are where it mostly affects women.

3. Metabolism: The body metabolizes Follitropin beta in a manner akin to that of endogenous FSH.

4. Excretion: Renal excretion is the main route by which Follitropin beta is eliminated.

5. Half-Life: Follitropin beta's half-life varies from person to person but is usually short, requiring daily administration when using protocols for regulated ovarian stimulation.

Toxicity:

Although Follitropin beta is usually well accepted, some adverse effects may exist. The most typical adverse reactions are:

1. Mild:

• Side effects at the injection site (pain, redness, edema).

• Headache.

• Nausea.

• Pain in the abdomen.

• Enlargement of the ovaries.

• Soreness in the breasts.

2. Severe:

• Syndrome of Ovarian Hyperstimulation (OHSS): Breathing difficulties, ovarian cysts, stomach discomfort, and fluid accumulation in the chest and belly are all possible symptoms of this uncommon but dangerous illness.

• Reactions to Allergens: These can vary in severity from minor skin irritation to potentially fatal anaphylaxis.

• Thromboembolic Events (Blood Clots): Blood clots, or thromboembolic events, are uncommon but can be fatal.

Clinical Studies:

Follitropin beta has been the subject of several clinical trials that have assessed its effectiveness and safety in treating infertility. According to this research, Follitropin beta can help women with anovulation or oligo-ovulation become pregnant by promoting ovulation and follicle development. To increase pregnancy rates, it can also be used in combination with assisted reproductive methods like IVF and ICSI (intracytoplasmic sperm injection).

What Are the Contraindications of Follitropin Beta?

1. An earlier case of hypersensitivity to FSH (follicle stimulating hormone) recombinant products.

2. Elevated FSH levels suggest primary gonadal dysfunction.

3. Existence of non-gonadal endocrinopathies that are out of control.

4. Neomycin or streptomycin-related hypersensitivity responses.

5. Ovarian, breast, uterine, testicular, hypothalamic, or pituitary tumors.

6. Ladies who are pregnant.

7. Unidentified source of vaginal bleeding, either heavy or irregular.

8. Cysts or enlargements of the ovaries that are not related to PCOS (polycystic ovarian syndrome).

Warnings and Precautions:

Follitropin beta treatment may cause:

1. Abnormal ovarian enlargement.

2. Syndrome of ovarian hyperstimulation (OHSS).

3. Complications from the heart and vascular system.

4. Torsion of the ovary.

5. Multifetal birth and gestation.

6. Birth deformities.

7. Natural abortion.

8. Ectopic pregnancy.

9. Neoplasms of the ovaries.

Drug Interactions

A few drugs interact with Follitropin beta, which may affect their efficacy or raise the possibility of adverse consequences. This is a synopsis:

1. Recognized Interactions:

• Gonadorelin: When coupled with FSH, this medicine might cause the ovaries to become overstimulated. Generally speaking, using Follitropin beta concurrently is not advised.

• Zimelidine: When used with Follitropin beta, this medicine might lessen its efficacy despite its uncommon use.

• Acalabrutinib: Follitropin beta's efficacy may also be lowered by Acalabrutinib, a medicine used to treat certain malignancies.

2. Potential Interactions:

• Antagonists of Gonadotropin-Releasing Hormone (GnRH): These drugs are frequently used with Follitropin beta (COH) for regulated ovarian hyperstimulation. Even though they do not usually interact directly, using them together calls for cautious supervision to prevent overstimulation.

• Cimetidine: This drug may raise Follitropin beta levels in the blood, which might result in more adverse effects.

• CYP3A4 Inducers: Drugs like Rifampicin can lower blood levels of Follitropin beta, which may lessen the drug's efficacy.

Specific Considerations:

• Pregnancy: Follitropin beta should not be used in pregnant women.

• Nursing Mothers: It is unknown if this medication is eliminated in human milk. Considering the significance of the drug to the mother, a decision should be made regarding whether to stop nursing or stop taking Follitropin beta, as many drugs are excreted in human milk and may cause serious adverse reactions in the infant.

• Use in Pediatrics: It is unknown if treating pediatric patients is safe or effective.

• Use in the Elderly: Subjects 65 years of age and older were not included in clinical trials of Follitropin beta.