Gonal-F 450iu Vial
It is used to help people get pregnant. It is used to help make sperm.
Drug Class
Gonadotropin, Ovulation Stimulant
Pharmacologic Class
Recombinant Follicle-Stimulating Hormone (rFSH)
Pregnancy Category
Category X
FDA Approved
Sep 1995
DEA Schedule
Not Controlled
Overview
What is this medicine?
Gonal-F is a medicine that contains a hormone called FSH (follicle-stimulating hormone). It helps your ovaries grow eggs if you're a woman trying to get pregnant, or helps your body make sperm if you're a man with certain fertility issues. It's given as an injection under the skin.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Carefully follow all instructions to ensure safe and effective use.
Administration
This medication is administered via injection into the fatty tissue under the skin. If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique. Before and after use, wash your hands thoroughly. Rotate the injection site as directed by your doctor to minimize the risk of adverse reactions.
Important Safety Precautions
Do not use the medication if the solution appears cloudy, is leaking, or contains particles. Additionally, do not use the solution if it has changed color. Dispose of used needles and syringes in a designated sharps disposal container. Never reuse needles or other injection equipment. When the disposal container is full, follow local regulations for proper disposal. If you have any questions or concerns, consult your doctor or pharmacist.
Preparing the Medication
For vials, this medication must be mixed before use. Follow the mixing instructions provided by your doctor.
Storage and Preparation
For prefilled pens and multidose vials, if stored in the refrigerator, allow the medication to reach room temperature before use. Remove it from the refrigerator and let it sit at room temperature for at least 30 minutes. Do not attempt to heat the medication.
Storage and Disposal
For vials, follow proper storage and disposal procedures.
Missed Dose
If you miss a dose, contact your doctor to determine the best course of action.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Carefully follow all instructions to ensure safe and effective use.
Administration
This medication is administered via injection into the fatty tissue under the skin. If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique. Before and after use, wash your hands thoroughly. Rotate the injection site as directed by your doctor to minimize the risk of adverse reactions.
Important Safety Precautions
Do not use the medication if the solution appears cloudy, is leaking, or contains particles. Additionally, do not use the solution if it has changed color. Dispose of used needles and syringes in a designated sharps disposal container. Never reuse needles or other injection equipment. When the disposal container is full, follow local regulations for proper disposal. If you have any questions or concerns, consult your doctor or pharmacist.
Preparing the Medication
For vials, this medication must be mixed before use. Follow the mixing instructions provided by your doctor.
Storage and Preparation
For prefilled pens and multidose vials, if stored in the refrigerator, allow the medication to reach room temperature before use. Remove it from the refrigerator and let it sit at room temperature for at least 30 minutes. Do not attempt to heat the medication.
Storage and Disposal
For vials, follow proper storage and disposal procedures.
Missed Dose
If you miss a dose, contact your doctor to determine the best course of action.
Lifestyle & Tips
- Follow injection instructions carefully, including proper storage and disposal of needles.
- Keep all appointments for blood tests and ultrasounds, as these are crucial for monitoring your response and preventing complications.
- Report any unusual symptoms immediately to your healthcare provider, especially severe abdominal pain, bloating, or rapid weight gain.
- Avoid sexual intercourse or use barrier contraception during treatment and for a few days after hCG administration to reduce the risk of multiple pregnancies or ovarian hyperstimulation syndrome (OHSS).
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Highly individualized based on indication and patient response. For anovulation, initial dose typically 75 IU/day subcutaneously for 7-14 days. For ART, initial dose typically 150-225 IU/day subcutaneously for 5 days, then adjusted. For male infertility, 150 IU 3 times weekly with hCG.
Dose Range:
75 - 450 mg
Condition-Specific Dosing:
anovulation:
Initial: 75 IU/day SC for 7-14 days. Dose may be increased by 37.5 IU after 14 days, then by 37.5 IU weekly, up to 300 IU/day. Administer hCG 24-48 hours after last Gonal-f dose when adequate follicular development is achieved.
assistedReproductiveTechnology (ART):
Initial: 150-225 IU/day SC for 5 days, starting on cycle day 2 or 3. Dose may be adjusted based on ovarian response, up to 450 IU/day. Continue until adequate follicular development, then administer hCG.
maleInfertility (with hCG):
150 IU subcutaneously 3 times weekly, administered concurrently with hCG (e.g., 1000-2000 IU 3 times weekly) for at least 4-6 months.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (not indicated for pediatric use for fertility)
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, but use with caution.
Moderate:
No specific dose adjustment recommended, but use with caution.
Severe:
No specific dose adjustment recommended, but use with caution.
Dialysis:
No specific data; use with caution and close monitoring.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended, but use with caution.
Moderate:
No specific dose adjustment recommended, but use with caution.
Severe:
No specific dose adjustment recommended, but use with caution.
Pharmacology
Mechanism of Action
Follitropin alfa is a recombinant human follicle-stimulating hormone (rFSH). It stimulates ovarian follicular growth in women who do not have primary ovarian failure. In men, in conjunction with hCG, it stimulates spermatogenesis in men with primary or secondary hypogonadotropic hypogonadism.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 66% (subcutaneous)
Tmax:
6-12 hours (single dose); 9 hours (multiple doses)
FoodEffect:
Not applicable (parenteral administration)
Distribution:
Vd:
Approximately 10 L
ProteinBinding:
Low
CnssPenetration:
No
Elimination:
HalfLife:
Approximately 24-49 hours (terminal half-life after multiple doses)
Clearance:
Approximately 0.6 L/hour
ExcretionRoute:
Renal (approximately 10% of administered dose excreted unchanged)
Unchanged:
Approximately 10%
Pharmacodynamics
OnsetOfAction:
Gradual (follicular development occurs over days of treatment)
PeakEffect:
Variable, depends on individual response and duration of treatment (peak estradiol levels and follicular size are monitored)
DurationOfAction:
Related to half-life, effects persist for several days after discontinuation.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Breast pain
Abnormal heartbeat
Blue or gray discoloration of the skin, lips, nail beds, fingers, or toes
Pale skin
Abdominal swelling
Mood changes
Severe Lung Problems
This medication can cause severe lung problems, which can be life-threatening. If you experience any of the following symptoms, contact your doctor right away:
Shortness of breath
Trouble breathing
Cough
Fever
Blood Clots
This medication can increase the risk of blood clots, which can be life-threatening. If you experience any of the following symptoms, contact your doctor right away:
Chest, arm, back, neck, or jaw pain or pressure
Coughing up blood
Numbness or weakness on one side of the body
Trouble speaking or thinking
Change in balance
Change in eyesight
Shortness of breath
Swelling, warmth, or pain in the leg or arm
Sex-Specific Side Effects
Females:
+ Abnormal vaginal bleeding
+ Ovarian hyperstimulation syndrome (OHSS), which can cause:
- Severe stomach pain or bloating
- Nausea, vomiting, or diarrhea
- Rapid weight gain
- Shortness of breath
- Changes in urine output
Males:
+ Enlarged breasts (gynecomastia)
Other Possible Side Effects
Most people do not experience significant side effects, but some may occur. If you experience any of the following side effects, contact your doctor if they bother you or do not go away:
Injection site irritation
Acne
Headache
Upset stomach
Stomach pain or diarrhea
Gas
Fatigue or weakness
Nasal or throat irritation
Back pain
* Common cold symptoms
Reporting Side Effects
If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Breast pain
Abnormal heartbeat
Blue or gray discoloration of the skin, lips, nail beds, fingers, or toes
Pale skin
Abdominal swelling
Mood changes
Severe Lung Problems
This medication can cause severe lung problems, which can be life-threatening. If you experience any of the following symptoms, contact your doctor right away:
Shortness of breath
Trouble breathing
Cough
Fever
Blood Clots
This medication can increase the risk of blood clots, which can be life-threatening. If you experience any of the following symptoms, contact your doctor right away:
Chest, arm, back, neck, or jaw pain or pressure
Coughing up blood
Numbness or weakness on one side of the body
Trouble speaking or thinking
Change in balance
Change in eyesight
Shortness of breath
Swelling, warmth, or pain in the leg or arm
Sex-Specific Side Effects
Females:
+ Abnormal vaginal bleeding
+ Ovarian hyperstimulation syndrome (OHSS), which can cause:
- Severe stomach pain or bloating
- Nausea, vomiting, or diarrhea
- Rapid weight gain
- Shortness of breath
- Changes in urine output
Males:
+ Enlarged breasts (gynecomastia)
Other Possible Side Effects
Most people do not experience significant side effects, but some may occur. If you experience any of the following side effects, contact your doctor if they bother you or do not go away:
Injection site irritation
Acne
Headache
Upset stomach
Stomach pain or diarrhea
Gas
Fatigue or weakness
Nasal or throat irritation
Back pain
* Common cold symptoms
Reporting Side Effects
If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe abdominal pain or bloating
- Nausea, vomiting, or diarrhea
- Rapid weight gain (more than 2 pounds in 24 hours)
- Decreased urination
- Shortness of breath or difficulty breathing
- Pain, swelling, warmth, or redness in your leg (signs of a blood clot)
- Sudden severe headache or vision changes
- Signs of allergic reaction: rash, itching, swelling (especially of face/tongue/throat), severe dizziness, trouble breathing.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following conditions to ensure safe treatment:
For All Patients:
- Any allergies to this medication, its components, or other substances, including foods and drugs. Describe the allergic reaction and its symptoms.
- Certain health conditions, including adrenal gland disease, brain tumor, pituitary gland disease, or thyroid gland disease.
For Female Patients:
- If you have primary ovarian failure, meaning your ovaries have stopped producing eggs.
- If you have any of the following health issues:
- Tumors in the female organs.
- Enlarged ovaries or ovarian cysts.
- Unexplained vaginal bleeding.
- If you are unable to conceive due to problems with your reproductive organs.
- If you are pregnant or think you might be pregnant. This medication is contraindicated during pregnancy, and a pregnancy test will be required before starting treatment to confirm you are not pregnant.
- If you are breastfeeding. You should not breastfeed while taking this medication.
For Male Patients:
- If you have issues with sperm production or have a tumor in your male reproductive organs.
General Considerations:
This list does not encompass all possible drug interactions or health problems that may affect the use of this medication. Therefore, it is crucial to:
- Inform your doctor and pharmacist about all medications you are taking, including prescription drugs, over-the-counter medications, natural products, and vitamins.
- Discuss all your health problems with your doctor.
- Verify that it is safe to take this medication with your other drugs and health conditions.
- Do not initiate, cease, or adjust the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following conditions to ensure safe treatment:
For All Patients:
- Any allergies to this medication, its components, or other substances, including foods and drugs. Describe the allergic reaction and its symptoms.
- Certain health conditions, including adrenal gland disease, brain tumor, pituitary gland disease, or thyroid gland disease.
For Female Patients:
- If you have primary ovarian failure, meaning your ovaries have stopped producing eggs.
- If you have any of the following health issues:
- Tumors in the female organs.
- Enlarged ovaries or ovarian cysts.
- Unexplained vaginal bleeding.
- If you are unable to conceive due to problems with your reproductive organs.
- If you are pregnant or think you might be pregnant. This medication is contraindicated during pregnancy, and a pregnancy test will be required before starting treatment to confirm you are not pregnant.
- If you are breastfeeding. You should not breastfeed while taking this medication.
For Male Patients:
- If you have issues with sperm production or have a tumor in your male reproductive organs.
General Considerations:
This list does not encompass all possible drug interactions or health problems that may affect the use of this medication. Therefore, it is crucial to:
- Inform your doctor and pharmacist about all medications you are taking, including prescription drugs, over-the-counter medications, natural products, and vitamins.
- Discuss all your health problems with your doctor.
- Verify that it is safe to take this medication with your other drugs and health conditions.
- Do not initiate, cease, or adjust the dosage of any medication without first consulting your doctor.
Precautions & Cautions
Important Information for All Patients Taking This Medication
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Additionally, follow your doctor's instructions for regular blood work and other laboratory tests.
Special Considerations for Female Patients
While using this medication, you will need to undergo ultrasound examinations as directed by your doctor. It is crucial to be aware of the following potential risks:
This medication may increase the likelihood of becoming pregnant with multiple babies.
There is a risk of severe side effects, including enlarged ovaries and ovarian cysts that can rupture, which in rare cases can be life-threatening. Discuss these risks with your doctor.
If your ovaries become overly enlarged, your doctor may advise you to avoid sexual intercourse, as it may cause an ovarian cyst to rupture. Consult with your doctor for guidance.
In some individuals with pre-existing health conditions, this medication may increase the risk of ovarian torsion (twisting of the ovaries), which can cut off blood flow to the ovary. Discuss this risk with your doctor.
* The risk of ectopic pregnancy (pregnancy outside the uterus) may be higher in some individuals. If you have questions or concerns, consult with your doctor. Seek immediate medical attention if you experience symptoms such as vaginal bleeding, nausea or vomiting, stomach pain, pelvic or rectal pain, shoulder or neck pain, dizziness, fainting, rapid heartbeat, pale, sweaty, or clammy skin, confusion, or other severe or unusual effects.
Additional Precautions
While undergoing ovarian stimulation, it is recommended to limit physical activity. Consult with your doctor for guidance.
Pregnancy Loss and Long-Term Risks
The rate of pregnancy loss (miscarriage) is higher when using medications like this one compared to natural pregnancy. Although it is unclear whether these medications cause this effect, it is essential to discuss any questions or concerns with your doctor. Furthermore, if you have used medications like this one multiple times to become pregnant, you may be at a higher risk of developing tumors in your ovaries or other reproductive organs.
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Additionally, follow your doctor's instructions for regular blood work and other laboratory tests.
Special Considerations for Female Patients
While using this medication, you will need to undergo ultrasound examinations as directed by your doctor. It is crucial to be aware of the following potential risks:
This medication may increase the likelihood of becoming pregnant with multiple babies.
There is a risk of severe side effects, including enlarged ovaries and ovarian cysts that can rupture, which in rare cases can be life-threatening. Discuss these risks with your doctor.
If your ovaries become overly enlarged, your doctor may advise you to avoid sexual intercourse, as it may cause an ovarian cyst to rupture. Consult with your doctor for guidance.
In some individuals with pre-existing health conditions, this medication may increase the risk of ovarian torsion (twisting of the ovaries), which can cut off blood flow to the ovary. Discuss this risk with your doctor.
* The risk of ectopic pregnancy (pregnancy outside the uterus) may be higher in some individuals. If you have questions or concerns, consult with your doctor. Seek immediate medical attention if you experience symptoms such as vaginal bleeding, nausea or vomiting, stomach pain, pelvic or rectal pain, shoulder or neck pain, dizziness, fainting, rapid heartbeat, pale, sweaty, or clammy skin, confusion, or other severe or unusual effects.
Additional Precautions
While undergoing ovarian stimulation, it is recommended to limit physical activity. Consult with your doctor for guidance.
Pregnancy Loss and Long-Term Risks
The rate of pregnancy loss (miscarriage) is higher when using medications like this one compared to natural pregnancy. Although it is unclear whether these medications cause this effect, it is essential to discuss any questions or concerns with your doctor. Furthermore, if you have used medications like this one multiple times to become pregnant, you may be at a higher risk of developing tumors in your ovaries or other reproductive organs.
Overdose Information
Overdose Symptoms:
- Ovarian Hyperstimulation Syndrome (OHSS) with or without pulmonary or vascular complications (e.g., ascites, pleural effusion, dyspnea, oliguria, thromboembolic events)
What to Do:
There is no specific antidote. Management is supportive and symptomatic, often requiring hospitalization for severe OHSS. Call 1-800-222-1222 (Poison Control) or seek immediate medical attention.
Drug Interactions
Moderate Interactions
- Gonadotropin-releasing hormone (GnRH) agonist or antagonist co-administration (requires higher doses of follitropin alfa)
Monitoring
Baseline Monitoring
Pregnancy test
Rationale: To rule out existing pregnancy before starting treatment.
Timing: Prior to initiation of therapy.
Ovarian ultrasound
Rationale: To assess baseline ovarian morphology and rule out ovarian cysts.
Timing: Prior to initiation of therapy.
Serum FSH, LH, Estradiol (E2)
Rationale: To assess baseline hormonal status and guide initial dosing.
Timing: Prior to initiation of therapy.
Thyroid and Prolactin levels
Rationale: To rule out other endocrine disorders affecting fertility.
Timing: Prior to initiation of therapy.
Semen analysis (for male infertility)
Rationale: To confirm diagnosis and monitor response to treatment.
Timing: Prior to initiation and periodically during treatment.
Routine Monitoring
Ovarian ultrasound
Frequency: Every 1-3 days during stimulation phase
Target: Follicle size (e.g., dominant follicle(s) 17-20 mm for ovulation induction, multiple follicles for ART)
Action Threshold: Dose adjustment or hCG administration based on follicular development and risk of OHSS.
Serum Estradiol (E2) levels
Frequency: Every 1-3 days during stimulation phase
Target: Rising E2 levels, typically 200-600 pg/mL per mature follicle for ovulation induction; higher for ART.
Action Threshold: Rapidly rising or excessively high E2 levels may indicate increased risk of OHSS; dose adjustment or cycle cancellation.
Symptom Monitoring
- Signs and symptoms of Ovarian Hyperstimulation Syndrome (OHSS): abdominal pain, bloating, nausea, vomiting, diarrhea, rapid weight gain, decreased urine output, shortness of breath.
- Signs of injection site reactions: pain, redness, swelling, bruising.
- Symptoms of thromboembolic events: pain, swelling, warmth, redness in an extremity; sudden chest pain, shortness of breath, coughing up blood.
- Symptoms of ovarian torsion: severe unilateral lower abdominal pain, nausea, vomiting.
Special Patient Groups
Pregnancy
Contraindicated in pregnant women. Gonal-F is used to induce ovulation, and its use during pregnancy is not appropriate. There is no indication for Gonal-F in pregnancy.
Trimester-Specific Risks:
First Trimester:
Contraindicated. Potential for adverse effects on fetal development, though not specifically studied.
Second Trimester:
Contraindicated.
Third Trimester:
Contraindicated.
Lactation
Not recommended during lactation. It is not known if follitropin alfa is excreted in human milk. FSH may affect milk production and composition. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Gonal-F and any potential adverse effects on the breastfed infant from Gonal-F or from the underlying maternal condition.
Infant Risk:
Potential for unknown effects on the infant and potential to suppress milk production. Risk is generally considered moderate to high (L4).
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Not indicated for use in children.
Geriatric Use
Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Not typically indicated for fertility treatment in this age group.
Clinical Information
Clinical Pearls
- Gonal-F dosing is highly individualized and requires close monitoring of ovarian response (ultrasound and estradiol levels) to optimize outcomes and minimize risks like OHSS and multiple gestations.
- Patients should be thoroughly educated on proper subcutaneous injection technique, storage, and disposal of needles.
- The risk of Ovarian Hyperstimulation Syndrome (OHSS) is a significant concern; patients should be counselled on symptoms and when to seek immediate medical attention.
- Multiple gestations (twins, triplets, etc.) are a known risk of gonadotropin therapy; patients should be aware of this possibility.
- For male infertility, Gonal-F (FSH) must be administered concurrently with hCG to stimulate spermatogenesis effectively.
- Ensure patients understand the importance of adhering to the monitoring schedule, as it directly impacts safety and efficacy.
Alternative Therapies
- Other recombinant FSH products (e.g., Follistim AQ, Elonva)
- Urinary-derived FSH products (e.g., Bravelle, Fertinex)
- Human Menopausal Gonadotropins (hMG) (contain FSH and LH, e.g., Menopur, Repronex)
- Clomiphene citrate (oral ovulation stimulant)
- Letrozole (aromatase inhibitor, oral ovulation stimulant)
- Human Chorionic Gonadotropin (hCG) (used for ovulation trigger or in male infertility with FSH)
Cost & Coverage
Average Cost:
High (e.g., $500-$1500+ per vial depending on strength and pharmacy) per vial
Insurance Coverage:
Specialty Tier (often requires prior authorization and may have high co-pays or co-insurance)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.