Gonal-F 1050unit Inj, 1 Vial
It is used to help people get pregnant. It is used to help make sperm.
Drug Class
Gonadotropin; Infertility Agent
Pharmacologic Class
Recombinant Human Follicle-Stimulating Hormone (r-hFSH)
Pregnancy Category
Not applicable (contraindicated once pregnancy achieved)
FDA Approved
Nov 1995
DEA Schedule
Not Controlled
Overview
What is this medicine?
Gonal-F is a man-made hormone that is very similar to a natural hormone in your body called Follicle-Stimulating Hormone (FSH). It is used to help women develop eggs in their ovaries and to help men produce sperm, to treat certain types of infertility.
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 injectable devices. 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 Handling
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 injectable devices. 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 Handling
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 all instructions from your doctor regarding dosage and administration.
- Learn proper subcutaneous injection technique from a healthcare professional.
- Store medication as directed (refrigerated, protect from light).
- Attend all scheduled monitoring appointments (ultrasounds, blood tests) as these are crucial for safe and effective treatment.
- Report any unusual symptoms immediately to your healthcare provider.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Highly individualized based on indication and patient response. Administered subcutaneously.
Dose Range:
75 - 450 mg
Condition-Specific Dosing:
anovulatoryInfertility:
Initial: 75 IU/day SC for 14 days. Adjust by 25-50 IU at weekly intervals. Max: 300 IU/day. Followed by hCG when appropriate.
controlledOvarianHyperstimulationART:
Initial: 150-225 IU/day SC for 5 days. Adjust based on ovarian response (ultrasound, serum estradiol). Max: 450 IU/day. Followed by hCG when appropriate.
spermatogenesisInductionHypogonadotropicHypogonadism:
150 IU 3 times weekly SC, typically after hCG pre-treatment to normalize serum testosterone. Continue for at least 3-6 months.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (not indicated for fertility treatment in this population)
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended, but caution advised due to renal clearance.
Dialysis:
Considerations: Not specifically studied. Caution advised.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended.
Pharmacology
Mechanism of Action
Follitropin alfa is a recombinant human follicle-stimulating hormone (r-hFSH) that binds to FSH receptors on granulosa cells of the ovarian follicle and Sertoli cells of the testis. In women, it stimulates follicular growth and maturation in the ovary. In men, in conjunction with hCG, it stimulates spermatogenesis.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 70% (subcutaneous)
Tmax:
Approximately 6-12 hours (subcutaneous)
FoodEffect:
Not applicable (parenteral administration)
Distribution:
Vd:
Approximately 9-10 L
ProteinBinding:
Not extensively protein bound
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 18-40 hours (subcutaneous)
Clearance:
Approximately 0.6 L/hr
ExcretionRoute:
Renal
Unchanged:
Small percentage
Pharmacodynamics
OnsetOfAction:
Not acutely measurable; effects on follicular growth are observed over days of treatment.
PeakEffect:
Peak follicular response typically observed after several days of treatment, guided by ultrasound and estradiol levels.
DurationOfAction:
Effects persist for several days after the last dose due to half-life.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Immediately
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 right away:
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 immediately:
Shortness of breath or other breathing difficulties
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 immediately:
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 or eyesight
Shortness of breath
Swelling, warmth, or pain in the leg or arm
Sex-Specific Side Effects
Females:
+ Unusual 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 Side Effects
Most people who take this medication do not experience serious side effects. However, some people may experience mild to moderate side effects, including:
Irritation at the injection site
Acne
Headache
Upset stomach
Stomach pain or diarrhea
Gas
Fatigue or weakness
Nasal or throat irritation
Back pain
* Common cold symptoms
If you experience any of these side effects or any other symptoms that concern you, contact your doctor for advice. 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 right away:
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 immediately:
Shortness of breath or other breathing difficulties
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 immediately:
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 or eyesight
Shortness of breath
Swelling, warmth, or pain in the leg or arm
Sex-Specific Side Effects
Females:
+ Unusual 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 Side Effects
Most people who take this medication do not experience serious side effects. However, some people may experience mild to moderate side effects, including:
Irritation at the injection site
Acne
Headache
Upset stomach
Stomach pain or diarrhea
Gas
Fatigue or weakness
Nasal or throat irritation
Back pain
* Common cold symptoms
If you experience any of these side effects or any other symptoms that concern you, contact your doctor for advice. 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 a day)
- Decreased urination
- Shortness of breath or difficulty breathing
- Pain, warmth, or swelling in your legs or arms
- Sudden severe headache or chest pain
- Sudden vision changes
- Signs of an allergic reaction (rash, itching, hives, swelling of face/lips/tongue/throat, difficulty 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 before starting this medication:
Any allergies you have, including allergies to this drug, its components, or other substances. Be sure to describe the symptoms you experienced.
Certain health conditions, such as:
+ Adrenal gland disease
+ Brain tumor
+ Pituitary gland disease
+ Thyroid gland disease
For Female Patients:
If you have primary ovarian failure, meaning your ovaries no longer produce eggs.
If you have any of the following health issues:
+ Tumors in your female organs
+ Enlarged ovaries or ovarian cysts
+ Unexplained vaginal bleeding
If you are experiencing infertility due to problems with your reproductive organs.
If you are pregnant or think you may be pregnant. This medication is not intended for use during pregnancy, and a pregnancy test will be conducted to confirm you are not pregnant before starting treatment.
If you are breastfeeding. You should not breastfeed while taking this medication.
For Male Patients:
If you are unable to produce sperm or have a tumor in your male reproductive organs.
Additional Considerations:
This is not an exhaustive list of all potential interactions with this medication. Therefore, it is crucial to inform your doctor and pharmacist about:
+ All prescription and over-the-counter medications you are taking
+ Any natural products, vitamins, or supplements you are using
+ Your complete medical history
Before starting, stopping, or changing the dosage of any medication, including this one, you must consult with your doctor to ensure your safety.
It is essential to inform your doctor about the following conditions before starting this medication:
Any allergies you have, including allergies to this drug, its components, or other substances. Be sure to describe the symptoms you experienced.
Certain health conditions, such as:
+ Adrenal gland disease
+ Brain tumor
+ Pituitary gland disease
+ Thyroid gland disease
For Female Patients:
If you have primary ovarian failure, meaning your ovaries no longer produce eggs.
If you have any of the following health issues:
+ Tumors in your female organs
+ Enlarged ovaries or ovarian cysts
+ Unexplained vaginal bleeding
If you are experiencing infertility due to problems with your reproductive organs.
If you are pregnant or think you may be pregnant. This medication is not intended for use during pregnancy, and a pregnancy test will be conducted to confirm you are not pregnant before starting treatment.
If you are breastfeeding. You should not breastfeed while taking this medication.
For Male Patients:
If you are unable to produce sperm or have a tumor in your male reproductive organs.
Additional Considerations:
This is not an exhaustive list of all potential interactions with this medication. Therefore, it is crucial to inform your doctor and pharmacist about:
+ All prescription and over-the-counter medications you are taking
+ Any natural products, vitamins, or supplements you are using
+ Your complete medical history
Before starting, stopping, or changing the dosage of any medication, including this one, you must consult with your doctor to ensure your safety.
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 discuss the following potential risks with your doctor:
Increased chance of multiple pregnancies (e.g., twins, triplets)
Elevated risk of severe side effects, including:
+ Enlarged ovaries (ovarian hyperstimulation syndrome)
+ Ovarian cysts that may rupture, which can be life-threatening in rare cases
If your ovaries become overly enlarged, your doctor may advise you to avoid sexual intercourse to prevent the risk of an ovarian cyst rupture
Increased risk of ovarian torsion (twisting of the ovaries), which can cut off blood flow to the ovary, particularly in individuals with certain pre-existing health conditions
Higher chance of ectopic pregnancy (pregnancy outside the uterus); seek immediate medical attention if you experience symptoms such as:
+ Vaginal bleeding
+ Nausea or vomiting
+ Abdominal or pelvic pain
+ Shoulder or neck pain
+ Dizziness or fainting
+ Rapid heartbeat
+ Pale, sweaty, or clammy skin
+ Confusion or other severe or unusual effects
Additional Precautions
Avoid strenuous exercise during ovarian stimulation, as advised by your doctor
Be aware that the risk of pregnancy loss (miscarriage) is higher with medications like this one compared to natural pregnancies; however, it is unclear whether these medications are the direct cause of this increased risk
If you have used medications like this one multiple times to conceive, you may be at a higher risk of developing tumors in your ovaries or other reproductive organs; discuss this potential risk with your doctor if you have concerns.
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 discuss the following potential risks with your doctor:
Increased chance of multiple pregnancies (e.g., twins, triplets)
Elevated risk of severe side effects, including:
+ Enlarged ovaries (ovarian hyperstimulation syndrome)
+ Ovarian cysts that may rupture, which can be life-threatening in rare cases
If your ovaries become overly enlarged, your doctor may advise you to avoid sexual intercourse to prevent the risk of an ovarian cyst rupture
Increased risk of ovarian torsion (twisting of the ovaries), which can cut off blood flow to the ovary, particularly in individuals with certain pre-existing health conditions
Higher chance of ectopic pregnancy (pregnancy outside the uterus); seek immediate medical attention if you experience symptoms such as:
+ Vaginal bleeding
+ Nausea or vomiting
+ Abdominal or pelvic pain
+ Shoulder or neck pain
+ Dizziness or fainting
+ Rapid heartbeat
+ Pale, sweaty, or clammy skin
+ Confusion or other severe or unusual effects
Additional Precautions
Avoid strenuous exercise during ovarian stimulation, as advised by your doctor
Be aware that the risk of pregnancy loss (miscarriage) is higher with medications like this one compared to natural pregnancies; however, it is unclear whether these medications are the direct cause of this increased risk
If you have used medications like this one multiple times to conceive, you may be at a higher risk of developing tumors in your ovaries or other reproductive organs; discuss this potential risk with your doctor if you have concerns.
Overdose Information
Overdose Symptoms:
- Symptoms of Ovarian Hyperstimulation Syndrome (OHSS): severe abdominal pain, abdominal distension, nausea, vomiting, diarrhea, oliguria, dyspnea, ascites, pleural effusion, electrolyte imbalance, hypovolemia, hemoconcentration, thromboembolic events.
What to Do:
Seek immediate medical attention. Management of OHSS is supportive and may require hospitalization, fluid and electrolyte management, and monitoring for complications. Call 911 or your local emergency number. For general overdose information, contact a poison control center (1-800-222-1222).
Drug Interactions
Monitoring
Baseline Monitoring
Pregnancy test (women)
Rationale: To rule out existing pregnancy before starting treatment.
Timing: Prior to initiation of treatment.
Ovarian ultrasound (women)
Rationale: To assess baseline ovarian morphology and rule out ovarian cysts.
Timing: Prior to initiation of treatment.
Serum estradiol (women)
Rationale: To establish baseline hormonal status.
Timing: Prior to initiation of treatment.
Thyroid and prolactin levels (women)
Rationale: To rule out other endocrine disorders affecting fertility.
Timing: Prior to initiation of treatment.
Semen analysis (men)
Rationale: To confirm diagnosis of hypogonadotropic hypogonadism and assess baseline sperm parameters.
Timing: Prior to initiation of treatment.
Routine Monitoring
Transvaginal ultrasound (women)
Frequency: Every 1-3 days during stimulation phase
Target: Follicle size and number (e.g., dominant follicles >16-18 mm)
Action Threshold: Used to guide dose adjustments and timing of hCG administration.
Serum estradiol (E2) levels (women)
Frequency: Every 1-3 days during stimulation phase
Target: Rising E2 levels indicative of follicular growth (e.g., >200 pg/mL per dominant follicle)
Action Threshold: Rapidly rising or excessively high E2 levels may indicate risk of OHSS; low levels may indicate inadequate response.
Semen analysis (men)
Frequency: Every 3-6 months
Target: Improvement in sperm count and motility
Action Threshold: Lack of improvement may indicate need for dose adjustment or re-evaluation.
Symptom Monitoring
- Signs and symptoms of Ovarian Hyperstimulation Syndrome (OHSS): abdominal pain, bloating, nausea, vomiting, diarrhea, rapid weight gain, decreased urine output, dyspnea.
- Signs of allergic reactions: rash, itching, swelling, severe dizziness, trouble breathing.
- Symptoms of thromboembolic events: pain, warmth, redness, numbness, or tingling in an arm or leg; sudden severe headache or chest pain; sudden shortness of breath; sudden vision changes; slurred speech.
Special Patient Groups
Pregnancy
Gonal-F is contraindicated in pregnant women. It is used to achieve pregnancy, but should be discontinued once pregnancy is confirmed.
Trimester-Specific Risks:
First Trimester:
Contraindicated. Potential for adverse effects on fetal development if continued.
Second Trimester:
Contraindicated.
Third Trimester:
Contraindicated.
Lactation
It is not known if Gonal-F is excreted in human milk. Due to the potential for serious adverse reactions in a breast-fed infant, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Generally not recommended.
Infant Risk:
High risk (L5) - potential for serious adverse effects.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Not indicated for fertility treatment in this population.
Geriatric Use
Safety and effectiveness in geriatric patients (postmenopausal women) have not been established. Not indicated for fertility treatment in this population.
Clinical Information
Clinical Pearls
- Careful patient selection and monitoring are critical to minimize the risk of Ovarian Hyperstimulation Syndrome (OHSS) and multiple gestations.
- The 1050 IU vial is a multi-dose vial intended for multiple injections. Patients must be carefully instructed on proper storage, reconstitution (if applicable), and drawing up of doses.
- Patients should be advised on the increased risk of multiple pregnancies (including high-order multiples) with gonadotropin therapy.
- Treatment cycles should be cancelled if ovarian response is excessive to reduce the risk of severe OHSS.
- Male patients undergoing spermatogenesis induction may require prolonged treatment (at least 3-6 months) before significant improvement in sperm parameters is observed.
Alternative Therapies
- Other recombinant FSH products (e.g., Follistim AQ, Elonva)
- Urinary-derived gonadotropins (e.g., Menopur, Bravelle - contain FSH and/or LH activity)
- Clomiphene citrate (oral ovulation induction)
- Letrozole (oral ovulation induction)
- Human Chorionic Gonadotropin (hCG) - often used in conjunction with FSH to trigger ovulation or support spermatogenesis.
Cost & Coverage
Average Cost:
$1000 - $2500+ per 1050 IU vial
Insurance Coverage:
Tier 3 or 4 (Specialty Drug), often requires prior authorization and may have specific fertility benefit limitations.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. 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 information about the medication taken, the amount, and the time it happened.