Follitropin Alfa

Follitropin Alfa is a synthetic form of follicle-stimulating hormone used in assisted reproductive technology to stimulate the development of ovarian follicles in women who are undergoing infertility treatment. It is used in combination with other medications, such as human chorionic gonadotropin (hCG), to induce ovulation and increase the chances of pregnancy. 

Follitropin Alfa is also used to stimulate the production of sperm in cases of male infertilty. 

• Follitropin Alfa is available under the following different brand names: Gonal-f, Gonal-f RFF.

Common side effects of Follitropin Alfa include:

• Redness, swelling, or bruising where an injection was given,
• An ovarian cyst,
• Headache,
• Tiredness,
• Breast pain or swelling,
• Stuffy nose,
• Sneezing,
• Sinus pain,
• Acne, and
• Nausea

Serious side effects of Follitropin Alfa include:

• Hives,
• Difficulty breathing,
• Swelling of the face, lips, tongue, or throat,
• Severe pain in the lower stomach,
• Nausea,
• Vomiting,
• Diarrhea,
• Bloating,
• Rapid weight gain,
• Little or no urination,
• Trouble breathing,
• Severe pelvic pain on one side,
• Cough with bloody mucus,
• Fever,
• Sore throat,
• Swollen glands,
• A lump or swelling in the testicles,
• Fever with shortness of breath or rapid breathing,
• Sudden numbness or weakness,
• Problems with vision or speech, and
• Swelling or redness in an arm or leg

Rare side effects of Follitropin Alfa include:

• None 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Multi-dose vial (Gonal-f)

• 450 IU/vial (i.e., 600 IU/vial delivers 450 IU)
• 1050 IU/vial (ie, 1200 IU/vial delivers 1050 IU)

Single-dose vial (Gonal-f RFF)

• 75 IU (i.e., 82 IU/vial delivers 75 IU)

Redi-ject pen (Gonal-f RFF)

• 300 IU
• 450 IU
• 900 IU

Ovulation Induction

Adult dosage

• Initial dose of a first cycle: 75 IU subcutaneously once a day; after 14 days, increase the dose by increments of up to 37.5 IU; further dose increases, as necessary every 7 days.
• Dose based on effect, with lowest effective dose; maximum recommended dose 300 International Units once a day.
• Treatment maximum of 35 days, unless E2 rise indicates imminent follicular developement.
• To complete follicular development in absence of endogenous LH surge, give chorionic gonadatropin (hCG)- 5000 units 1 day after last dose.
• Withhold if serum estradiol is above 2,000 pg/mL or if abnormal ovarian enlargement/abdominal pain.

Assisted Reproductive Technologies

Adult dosage

• Initial dose on cycle day 2 or 3: 150 IU subcutaneously once a day until sufficient follicular development; typically, does not exceed 10 days.
• If endogenous gonadotropin levels are suppressed, should be started at 225 IU once a day
• Continue until adequate follicular development based on ultrasound and serum estradiol levels; dose adjustments of 75-150 IU may be made every 3-5 Days
• Maximum recommended dose 450 IU once a day
• Once adequate follicular development, administer hCG (5,000-10,0the 00 USP); withhold if ovaries abnormally enlarged on the last day of treatment

Male Patients with Hypogonadotropic Hypogonadism (Gonal-f Only)

Adult dosage

• Pretreat with hCG (1,000- 2,250 USP IU 2-3 week seek) until serum testosterone is within the normal range (may require 3-6 months of treatment)
• Treatment consists of Gonal-f 150 IU subcutaneously 3 times/week used in conjunction with hCG
• hCG 1000 USP Units (or dose to maintain normal serum testosterone levels) 3 per week.
• If azoospermia persists, may increase the dose to 300 IU 3 per week
• May need to administer for up to 18 months for an adequate response.

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Follitropin Alfa has no noted severe interactions with any other drugs.
• Follitropin Alfa has no noted serious interactions with any other drugs.
• Follitropin Alfa has no noted moderate interactions with any other drugs.
• Follitropin Alfa has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• Prior hypersensitivity to recombinant FSH preparations
• High levels of FSH indicating primary gonadal failure
• Uncontrolled thyroid or adrenal dysfunction
• Sex hormone-dependent tumors of the reproductive tract and accessory organs
• Organic intracranial lesion (. g. pituitary tumor)
• Women with abnormal uterine bleeding of undetermined origin; ovarian cyst or enlargement of undetermined origin
• Pregnancy

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Follitropin Alfa?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Follitropin Alfa?”

Cautions

• May cause ovarian hyperstimulation syndrome (OHSS, the dramatic increase in vascular permeability which can result in rapid fluid accumulation in the peritoneal cavity, thorax, and pericardium; accompanied by severe pelvic pain, nausea, vomiting, and weight gain) in women with or without pulmonary or vascular complications.
• If ovaries are abnormally enlarged on the last day of therapy, inform women not to administer hCG and to avoid intercourse.
• Pulmonary conditions (atelectasis, ARDS, & asthma exacerbation) have been reported; in women with recognized risk factors, the benefits of induction of ovulation and ART need to be weighed against risks; during or after the use of the drug, monitor for venous or arterial thromboembolic events
• Possibility of multiple births (range 12.3%-44.0% live births)
• In ovarian torsion, early diagnosis and immediate detorsion limit damage to the ovary due to reduced blood supply
• A thorough gynecologic & endocrinological evaluation should be conducted before treatment to rule out primary ovarian failure, early pregnancy & partner's fertility potential
• The rate of multiple births is dependent on the number of embryos transferred; advise the woman and her partner of the potential risk of multi-fetal gestation and birth before beginning therapy
• Advise women who become pregnant following ART and have: abdominal/pelvic pain (particularly on one side); shoulder, neck, or rectal pain; and nausea and vomiting to seek immediate medical attention; confirm the presence of an intrauterine pregnancy early by β-hCG testing and transvaginal ultrasound
• The risk of spontaneous abortion (miscarriage) is increased with gonadotropin products, however, causality has not been established
• Both benign and malignant ovarian neoplasms are reported in women who have had multiple drug therapy for controlled ovarian stimulation, however, causality has not been established.

Pregnancy and Lactation

• Drug not indicated in pregnant women.
• The incidence of congenital malformations after some assisted reproductive technology, specifically in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI)], may be slightly higher than that after spontaneous conception; this slightly higher incidence is thought to be related to differences in parental characteristics (.g, maternal age, maternal and paternal genetic background, sperm characteristics) and to a higher incidence of multi-fetal gestations after IVF or ICSI; there is no human data that the use of gonadotropins (including drug alone or as part of IVF or ICSI cycles, increases the risk of congenital malformations
• Risk of spontaneous abortion (miscarriage) is increased in women who have used gonadotropin products (including GONAL-F) to achieve pregnancy.
• Verify a negative pregnancy test before administering the drug.
• Lactation
  • There are no data on the presence of the drug in human milk, its effects on the breastfed infant, or milk production; because secretion of prolactin during lactation can result in inadequate response to ovarian stimulation, advise women not to breastfeed during treatment.