Follicle stimulating hormone injections

Follicle Stimulating Hormone

Follicle stimulating hormone is a man-made form of a hormone that occurs naturally in the body. This hormone regulates ovulation, the growth and development of eggs in a woman’s ovaries.

Follicle stimulating hormone is used to treat infertility in women who cannot ovulate and do not have primary ovarian failure.

Follicle stimulating hormone is also used to stimulate sperm production in men.

Follicle stimulating hormone is often used together with another medication called human chorionic gonadotropin (hCG).

Follicle stimulating hormone may also be used for purposes not listed in this medication guide.

Do not use this medication if you are already pregnant. Your doctor may give you a pregnancy test to make sure you are not pregnant before you receive follicle stimulating hormone.

Follicle stimulating hormone is not effective in women with primary ovarian failure or in men with primary testicular failure.

You should not use this medicine if you are allergic to follicle stimulating hormone, neomycin (Mycifradin, Neo-Fradin) or streptomycin, or if you have an untreated or uncontrolled endocrine disorder (thyroid, pituitary gland, or adrenal gland), heavy or abnormal vaginal bleeding that has not been checked by a doctor, an ovarian cyst, or cancer of the breast, ovary, uterus, or testicle.

Before using follicle stimulating hormone, tell your doctor if you have polycystic ovary disease, asthma, or a history of stroke or blood clot.

You should not breast-feed while you are using follicle stimulating hormone.

Avoid having sex and call your doctor right away if you have any of the following symptoms of a fluid buildup in your stomach or chest area: severe pain in your lower stomach, nausea, vomiting, diarrhea, bloating, feeling short of breath, swelling or weight gain, or urinating less than usual.

Fertility treatment may increase your chance of having twins, triplets, etc (multiple births). These are high-risk pregnancies both for the mother and the babies. Talk to your doctor if you have concerns about this risk.

This medication is not effective in women with primary ovarian failure (when the ovaries are unable to produce an egg).

This medication is not effective in men with primary testicular failure (when the testicles are unable to produce sperm).

You should not use follicle stimulating hormone if you are allergic to it, if you are already pregnant, or if you have:

  • an untreated or uncontrolled disorder of the thyroid, pituitary gland, or adrenal glands;
  • heavy or abnormal vaginal bleeding that has not been checked by a doctor;
  • an ovarian cyst;
  • cancer of the breast, ovary, uterus, testicle, hypothalamus, or pituitary gland; or
  • if you are allergic to neomycin (Mycifradin, Neo-Fradin) or streptomycin.

To make sure you can safely use follicle stimulating hormone, tell your doctor if you have:

  • polycystic ovary disease;
  • asthma; or
  • a history of stroke or blood clot.

FDA pregnancy category X. Follicle stimulating hormone can harm an unborn baby or cause birth defects. Do not use this medication if you are already pregnant. Your doctor may give you a pregnancy test to make sure you are not pregnant before you receive follicle stimulating hormone. Tell your doctor right away if you become pregnant during treatment.

Fertility treatment may increase your chance of having twins, triplets, etc (multiple births). These are high-risk pregnancies both for the mother and the babies. Talk to your doctor if you have concerns about this risk.

It is not known whether follicle stimulating hormone passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are using follicle stimulating hormone.

Recombinant human follicle-stimulating hormone: a scientific step to clinical improvement

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Gonal-F

SIDE EFFECTS

Women

The safety of Gonal-f® was examined in four clinical studies that enrolled 691 patients into two studies for ovulation induction (454 patients) and two studies for ART (237 patients).

Adverse events occurring in more than 10% of patients were headache, ovarian cyst, nausea, and upper respiratory tract infection in the U.S. ovulation induction study and headache in the U.S. ART study. Adverse events (without regard to causality assessment) occurring in at least 2% of patients are listed in Table 13 and Table 14.

Table 13: US Controlled Trial in Ovulation Induction, Study 5727

Additional adverse events not listed in Table 13 that occurred in 1 to 2% of Gonal-f® treated patients in the US ovulation induction study included the following: leukorrhea, vaginal hemorrhage, migraine, fatigue, asthma, nervousness, somnolence, and hypotension.

Table 14: US Controlled Trial in ART, Study 5533

Additional adverse events not listed in Table 14 that occurred in 1 to 2% of Gonal-f® treated patients in the U.S. Assisted Reproductive Technology (ART) study included the following: D&C following delivery or abortion, dysmenorrhea, vaginal hemorrhage, diarrhea, tooth disorder, vomiting, dizziness, paraesthesia, abdomen enlarged, chest pain, fatigue, dyspnea, anorexia, anxiety, somnolence, injection site inflammation, injection site reaction, pruritus, pruritus genital, myalgia, thirst, and palpitation. Two additional clinical studies (for ovulation induction and ART, respectively) were conducted in Europe. The safety profiles from these two studies were comparable to that of the data presented above.

Gonal-f® Multi-Dose was examined in twenty-five healthy volunteers who received 300 IU each of Gonal-f® from single- dose ampules and multi-dose vials. Overall, both presentations were well tolerated and local tolerability between the two groups was comparable. Injection site inspections revealed very rare local reactions (mild redness in one patient after single-dose injection and mild bruising in two subjects after multi-dose injection). Subjective assessments indicated minimal or mild transient pain in two and five subjects who received Gonal-f® single-dose and Gonal-f® multi-dose, respectively.

The following medical events have been reported subsequent to pregnancies resulting from gonadotropins in controlled clinical studies:

  1. Spontaneous Abortion
  2. Ectopic Pregnancy
  3. Premature Labor
  4. Postpartum Fever
  5. Congenital Abnormalities

Two incidents of congenital cardiac malformations have been reported in children born following pregnancies resulting from treatment with Gonal-f® and hCG in Gonal-f® clinical studies 5642 and 5727. In addition, a pregnancy occurring in study 5533 following treatment with Gonal-f® and hCG was complicated by apparent failure of intrauterine growth and terminated for a suspected syndrome of congenital abnormalities. No specific diagnosis was made. The incidence does not exceed that found in the general population.

The following adverse reactions have been previously reported during menotropin therapy:

  1. Pulmonary and vascular complications (see WARNINGS),
  2. Adnexal torsion (as a complication of ovarian enlargement),
  3. Mild to moderate ovarian enlargement,
  4. Hemoperitoneum

There have been infrequent reports of ovarian neoplasms, both benign and malignant, in women who have undergone multiple drug regimens for ovulation induction; however, a causal relationship has not been established.

Men

The safety of Gonal-f® was examined in 3 clinical studies that enrolled 72 patients for induction of spermatogenesis and fertility of whom 56 patients received Gonal-f® . One hundred and twenty-three adverse events, including 7 serious events, were reported in 34 of the 56 patients during Gonal-f® treatment.

In Study 5844, 21 adverse events, including 4 serious adverse events, were reported by 14 of the 26 patients (53.8%) treated with Gonal-f® . Events occurring in more than one patient were varicocele (4) and injection site reactions (4). The 4 serious adverse events were testicular surgery for cryptorchidism, which existed prestudy, hemoptysis, an infected pilonidal cyst, and lymphadenopathy associated with an Epstein-Barr viral infection.

In Study 6410, 3 adverse events were reported in 2 of the 8 patients (24%) treated with Gonal-f® . One serious adverse event was reported, surgery for gynecomastia which existed at baseline.

In the interim analysis of Study 6793, 18 of 22 patients (81.8%) reported a total of 99 adverse events during Gonal-f® treatment. The most common events of possible, probable, or definite relationship to study drug therapy occurring in more than 2 patients were: acne (25 events in 13 patients; 59% of patients); breast pain (4 events in 3 patients; 13.6% of patients); and fatigue, gynecomastia, and injection site pain (each of which was reported as 2 events by 2 patients; 9.1% of patients). Two serious adverse events (hospitalization for drug abuse and depression) were reported by a single patient in the interim analysis.

A total of 12,026 injections of Gonal-f® were administered by the 56 patients who received Gonal-f® in Studies 5844, 6410, and 6793 combined. The injections were well-tolerated, with no or mild reactions (redness, swelling, bruising and itching) reported by patients for 93.3% of injections. Moderate and severe reactions, consisting primarily of pain, were reported for 4.8% of injections, and no self-assessment was available for 1.9% of injections.

Postmarketing Experience

In addition to adverse events reported from clinical trials, the following events have been reported during postmarketing use of Gonal-f® . Because these reactions were reported voluntarily from a population of uncertain size, the frequency or a causal relationship to Gonal-f® , can not be reliably determined.

Body As A Whole

General

Hypersensitivity reactions including anaphylactoid reactions.

Respiratory System

asthma

Read the entire FDA prescribing information for Gonal-F (Follitropin Alfa)

Urofollitropin, FSH Injection

What is this medicine?

UROFOLLITROPIN is a fertility medicine. It is used to stimulate the ovaries. This may increase the chance of pregnancy.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Bravelle

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

  • adrenal problem

  • pituitary tumor

  • ovarian cyst or failure

  • thyroid disease

  • unusual vaginal bleeding

  • an unusual or allergic reaction to urofollitropin, FSH, other hormones, medicines, foods, dyes, or preservatives

  • pregnant

  • breast-feeding

How should I use this medicine?

This medicine is for injection under the skin or into a muscle. You will be taught how to prepare and give this medicine. Use exactly as directed. Take your medicine at regular intervals. Do not take your medicine more often than directed.

It is important that you put your used needles and syringes in a special sharps container. Do not put them in a trash can. If you do not have a sharps container, call your pharmacist or healthcare provider to get one.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses. Tell your doctor if you miss a dose of this medicine.

What may interact with this medicine?

  • herbal or dietary supplements, like blue cohosh, black cohosh, or chasteberry

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Visit your doctor for regular check ups. You will need to have important lab work done while you are taking this medicine.

If you get pregnant while taking this medicine, you may have multiple babies, like twins or triplets.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

  • breathing problems

  • change in the amount of urine

  • fever or chills

  • nausea, vomiting

  • stomach or pelvic bloat, pain

  • sudden weight gain

  • swelling of any area of the body

  • unusual bleeding

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • acne

  • angry, irritable, or restless

  • breast tenderness

  • diarrhea

  • headache

  • hot flashes

  • pain or redness at site where injected

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 3 and 25 degrees C (37 and 77 degrees F). Protect from light. After mixing, use the solution immediately and throw away any unused materials. Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

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Top 5 Injectable Infertility Treatments

What Are the 5 Most Common Injectable Fertility Drugs?

  1. hMG, or human menopausal gonadotropin (Pergonal, Repronex, and Metrodin): This drug is made up of two human hormones, follicle-stimulating hormone (FSH) and luteinizing hormone (LH). Gonadotropins are commonly administered to women undergoing assisted reproduction technology treatments with the goal of stimulating the ovaries to produce multiple follicles (eggs) during one cycle. FSH and LH are the hormones that normally regulate the ovarian cycle and stimulate egg development and ovulation, and injections of this drug typically are given daily for 7 to 12 days in the first half of the menstrual cycle.
  2. FSH, or follicle stimulating hormone, may also be given on its own for the same purpose and in a similar manner as hMG. Brand names for FSH include Follistim, Fertinex, Bravelle, Menopur, and Gonal-F.
  3. Human chorionic gonadotropin, or hCG (Pregnyl, Novarel, Ovidrel, and Profasi) is a hormone used to trigger release of the eggs from the follicles (ovulation). This is given in combination with other fertility drugs that stimulate follicle production and is administered at a precise time during the menstrual cycle, based upon the results of blood tests and ultrasound examinations. This is the same hormone that is produced by placenta during pregnancy and is measured in pregnancy tests.
  4. Gonadotropin Releasing Hormone Agonists, or GnRH agonists (Lupron, Zoladex, and Synarel) work by shutting down the body’s production of ovarian hormones such as FSH and LH, lowering the body’s estrogen levels. Normally in the body, GnRH is produced by the pituitary gland and stimulates the ovaries to produce hormones. When GnRH agonist is taken as a medication, there is an initial increase in hormone production and then a decline as the body senses that too much hormone is being made. Shutting down the normal hormone production by the ovaries allows for the precise control of egg development during a fertility treatment cycle. For example, a woman undergoing IVF may start taking this drug in the second half of her menstrual cycle, prior to the cycle in which she will attempt IVF. After the body’s natural hormone production is shut down, gonadotropin drugs (see above) will be given to stimulate follicle production. Another advantage of GnRH agonists is that the body’s natural production of LH, which triggers ovulation, is shut off, meaning that ovulation cannot occur prematurely and will not occur until the hCG injection (see above) is given.
  5. Gonadotropin Releasing Hormone Antagonist or GnRH antagonists (Antagon, Ganirelix, and Cetrotide) have a similar effect as GnRH agonists, but rather than initially stimulating and then down-regulating ovarian hormone production, GnRH antagonists work by immediately blocking the release of ovarian hormones. Typically, fewer injections of GnRH antagonists are required because of their stronger effect in reducing ovarian hormone production.

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