Gonal-F RFF 75iu Inj, 1 Vial
It is used to help people get pregnant. It is used to help make sperm.
Drug Class
Gonadotropin
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 RFF is a man-made hormone similar to a natural hormone in your body called Follicle-Stimulating Hormone (FSH). It is used to help women develop eggs in their ovaries for fertility treatments and to help men produce sperm.
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. It is essential to follow all instructions carefully.
Administration
This medication is administered via injection into the fatty tissue under the skin. If you are 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. It is essential to follow all instructions carefully.
Administration
This medication is administered via injection into the fatty tissue under the skin. If you are 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 your doctor's instructions exactly regarding dose and timing of injections.
- Learn proper self-injection technique from your healthcare provider.
- Store the medication as directed (refrigerated, protect from light).
- Do not shake the vial.
- Report any unusual symptoms immediately to your doctor.
- Attend all scheduled monitoring appointments (blood tests and ultrasounds) as these are crucial for your safety and treatment success.
- 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 if OHSS is a concern.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Highly individualized based on indication and patient response.
Dose Range:
75 - 450 mg
Condition-Specific Dosing:
Ovulation Induction (Anovulatory Patients):
Initial: 75 IU/day subcutaneously for 14 days. Adjust by 37.5-75 IU at 7-day intervals based on ovarian response. Maximum daily dose: 300 IU. If no response after 4 weeks, discontinue. Once adequate follicular development is achieved, administer hCG.
Assisted Reproductive Technologies (ART):
Initial: 150-225 IU/day subcutaneously for 5 days, starting on cycle day 2 or 3. Adjust dose based on ovarian response (estradiol levels and follicular ultrasound). Maximum daily dose: 450 IU. Continue until adequate follicular development, then administer hCG.
Induction of Spermatogenesis (Hypogonadotropic Hypogonadism in Males):
150 IU subcutaneously 3 times a week, administered concurrently with hCG (e.g., 1000-2000 IU 3 times a week). Treatment duration typically 3-6 months or longer until spermatogenesis is achieved.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (Safety and efficacy not established in pediatric patients. Use in adolescents is generally limited to specific cases of hypogonadotropic hypogonadism under specialist guidance.)
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, use with caution.
Moderate:
No specific dose adjustment recommended, use with caution.
Severe:
No specific dose adjustment recommended, use with caution. Limited data available.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended, use with caution.
Moderate:
No specific dose adjustment recommended, use with caution.
Severe:
No specific dose adjustment recommended, use with caution. Limited data available.
Pharmacology
Mechanism of Action
Follitropin alfa is a recombinant human follicle-stimulating hormone (rFSH). It binds to FSH receptors on granulosa cells in the ovarian follicle and Sertoli cells in the testes. In women, it stimulates ovarian follicular growth and development in the absence of adequate endogenous FSH. In men, in conjunction with human chorionic gonadotropin (hCG), it stimulates spermatogenesis in men with primary or secondary hypogonadotropic hypogonadism.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 70% (subcutaneous)
Tmax:
6-48 hours (subcutaneous)
FoodEffect:
Not applicable (parenteral administration)
Distribution:
Vd:
Approximately 10 L (after IV administration)
ProteinBinding:
Not extensively protein bound
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 18-48 hours (terminal half-life after multiple subcutaneous doses)
Clearance:
Approximately 0.6 L/hour (after IV administration)
ExcretionRoute:
Primarily renal (approximately 10% of administered dose excreted unchanged in urine)
Unchanged:
Approximately 10%
Pharmacodynamics
OnsetOfAction:
Days to weeks (dependent on follicular response)
PeakEffect:
Variable, typically observed with peak estradiol levels and follicular size during treatment cycle.
DurationOfAction:
Effects persist as long as treatment continues and until follicular maturation is complete.
Confidence:
Medium
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice 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
Swelling of the abdomen
Mood changes
Severe lung problems, which can be life-threatening. Watch for symptoms like:
+ Shortness of breath
+ Trouble breathing
+ Cough
+ Fever
Blood clots, which can be life-threatening. Seek help if you experience:
+ Chest, arm, back, neck, or jaw pain or pressure
+ Coughing up blood
+ Numbness or weakness on one side of your 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:
+ Unusual vaginal bleeding
+ Ovarian hyperstimulation syndrome (OHSS), a severe side effect that may 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 severe side effects, but some may occur. If you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or do not go away:
Irritation at the injection site
Acne
Headache
Upset stomach
Stomach pain or diarrhea
Gas
Fatigue or weakness
Nose or throat irritation
Back pain
* Signs of a common cold
Reporting Side Effects:
This is not an exhaustive list of possible 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, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice 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
Swelling of the abdomen
Mood changes
Severe lung problems, which can be life-threatening. Watch for symptoms like:
+ Shortness of breath
+ Trouble breathing
+ Cough
+ Fever
Blood clots, which can be life-threatening. Seek help if you experience:
+ Chest, arm, back, neck, or jaw pain or pressure
+ Coughing up blood
+ Numbness or weakness on one side of your 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:
+ Unusual vaginal bleeding
+ Ovarian hyperstimulation syndrome (OHSS), a severe side effect that may 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 severe side effects, but some may occur. If you notice any of the following symptoms, contact your doctor or seek medical attention if they bother you or do not go away:
Irritation at the injection site
Acne
Headache
Upset stomach
Stomach pain or diarrhea
Gas
Fatigue or weakness
Nose or throat irritation
Back pain
* Signs of a common cold
Reporting Side Effects:
This is not an exhaustive list of possible 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 that doesn't go away
- Rapid weight gain (more than 2 pounds in a day)
- Decreased urination
- Shortness of breath or difficulty breathing
- Pain or swelling in your legs or arms
- Severe headache or vision changes
- Signs of an allergic reaction (hives, rash, 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 might 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 the medications you are taking (prescription, over-the-counter, natural products, and vitamins) and any health problems you have.
Before starting, stopping, or changing the dose of any medication, you must consult with your doctor to ensure it is safe to do so in conjunction with this medication.
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 might 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 the medications you are taking (prescription, over-the-counter, natural products, and vitamins) and any health problems you have.
Before starting, stopping, or changing the dose of any medication, you must consult with your doctor to ensure it is safe to do so in conjunction with this medication.
Precautions & Cautions
Important Warnings and Cautions for Patients Taking This Medication
If you are taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, about your treatment. Regular blood work and laboratory tests, as directed by your doctor, are crucial to monitor your health.
Special Considerations for Female Patients
While using this medication, you will need to undergo regular ultrasound examinations, as advised by your doctor. It is vital to be aware of the following potential risks:
Increased chance of multiple pregnancies (e.g., twins, triplets)
Higher risk of severe side effects, including ovarian enlargement and rupture of ovarian cysts, which can be life-threatening in rare cases
Potential for ovarian torsion (twisting of the ovaries), which can cut off blood flow to the ovary, particularly in individuals with pre-existing health conditions
Elevated risk of ectopic pregnancy (pregnancy outside the uterus)
If you experience any symptoms such as vaginal bleeding, nausea, vomiting, stomach pain, pelvic or rectal pain, shoulder or neck pain, dizziness, fainting, rapid heartbeat, pale or sweaty skin, or confusion, seek immediate medical attention.
Additional Precautions
To minimize risks, limit your physical activity while undergoing ovarian stimulation, and consult your doctor for guidance. Be aware that the rate of pregnancy loss (miscarriage) may be higher when using medications like this one compared to natural pregnancies. Although the exact cause is unknown, it is essential to discuss any concerns with your doctor.
Long-Term Risks
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 to understand the implications and necessary precautions.
If you are taking this medication, it is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, about your treatment. Regular blood work and laboratory tests, as directed by your doctor, are crucial to monitor your health.
Special Considerations for Female Patients
While using this medication, you will need to undergo regular ultrasound examinations, as advised by your doctor. It is vital to be aware of the following potential risks:
Increased chance of multiple pregnancies (e.g., twins, triplets)
Higher risk of severe side effects, including ovarian enlargement and rupture of ovarian cysts, which can be life-threatening in rare cases
Potential for ovarian torsion (twisting of the ovaries), which can cut off blood flow to the ovary, particularly in individuals with pre-existing health conditions
Elevated risk of ectopic pregnancy (pregnancy outside the uterus)
If you experience any symptoms such as vaginal bleeding, nausea, vomiting, stomach pain, pelvic or rectal pain, shoulder or neck pain, dizziness, fainting, rapid heartbeat, pale or sweaty skin, or confusion, seek immediate medical attention.
Additional Precautions
To minimize risks, limit your physical activity while undergoing ovarian stimulation, and consult your doctor for guidance. Be aware that the rate of pregnancy loss (miscarriage) may be higher when using medications like this one compared to natural pregnancies. Although the exact cause is unknown, it is essential to discuss any concerns with your doctor.
Long-Term Risks
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 to understand the implications and necessary precautions.
Overdose Information
Overdose Symptoms:
- Symptoms of Ovarian Hyperstimulation Syndrome (OHSS) may be exacerbated, including severe abdominal pain, bloating, nausea, vomiting, diarrhea, rapid weight gain, decreased urine output, and shortness of breath.
- Increased risk of multiple gestations.
What to Do:
There is no specific antidote. Management is supportive, primarily focusing on managing OHSS symptoms. Seek immediate medical attention. Call 911 or your local emergency number. For general information, call 1-800-222-1222 (Poison Control).
Drug Interactions
Monitoring
Baseline Monitoring
Complete gynecological examination
Rationale: To rule out primary ovarian failure, uterine/tubal abnormalities, or other contraindications.
Timing: Prior to initiation of treatment
Serum Estradiol (E2) levels
Rationale: To assess baseline ovarian function and guide initial dosing.
Timing: Prior to initiation of treatment (typically early follicular phase)
Transvaginal Ultrasound
Rationale: To assess baseline ovarian morphology, rule out ovarian cysts, and count antral follicles.
Timing: Prior to initiation of treatment (typically early follicular phase)
Thyroid and Adrenal function tests
Rationale: To rule out underlying endocrine disorders that may affect fertility.
Timing: Prior to initiation of treatment
Semen analysis (for male factor infertility)
Rationale: To assess male fertility status.
Timing: Prior to initiation of treatment
Routine Monitoring
Serum Estradiol (E2) levels
Frequency: Every 1-3 days during stimulation phase
Target: Varies based on protocol and number of developing follicles (e.g., typically rising, but specific thresholds for hCG trigger or OHSS risk)
Action Threshold: Rapid rise or excessively high levels may indicate risk of OHSS; slow rise may indicate inadequate response.
Transvaginal Ultrasound (Follicular Monitoring)
Frequency: Every 1-3 days during stimulation phase
Target: Number and size of developing follicles (e.g., 1-3 follicles >17mm for ovulation induction; multiple follicles >16-18mm for ART)
Action Threshold: Excessive number of large follicles may indicate risk of OHSS or multiple gestations; inadequate growth indicates poor response.
Signs and symptoms of Ovarian Hyperstimulation Syndrome (OHSS)
Frequency: Daily during stimulation and for 2 weeks post-hCG
Target: Absence of symptoms
Action Threshold: Abdominal pain, bloating, nausea, vomiting, diarrhea, rapid weight gain, dyspnea, oliguria. Requires immediate medical evaluation.
Symptom Monitoring
- Abdominal pain or discomfort
- Abdominal bloating or distension
- Nausea
- Vomiting
- Diarrhea
- Rapid weight gain
- Shortness of breath or difficulty breathing
- Decreased urine output
- Pain, redness, swelling, or bruising at injection site
- Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
Special Patient Groups
Pregnancy
Contraindicated in pregnant women. Follitropin alfa is used to achieve pregnancy, not during pregnancy. There is no indication for use in pregnancy, and animal studies have shown adverse effects.
Trimester-Specific Risks:
First Trimester:
Contraindicated. No data on human fetal risk, but not indicated for use.
Second Trimester:
Contraindicated. Not indicated for use.
Third Trimester:
Contraindicated. Not indicated for use.
Lactation
Not recommended during breastfeeding. It is unknown if follitropin alfa is excreted in human milk. However, FSH is a large protein and unlikely to pass into milk in significant amounts. The primary concern is the potential for suppression of milk production, as FSH can affect lactation.
Infant Risk:
L5 (Contraindicated/High Risk - due to potential for suppression of milk production and lack of data on infant exposure).
Pediatric Use
Safety and effectiveness have not been established in pediatric patients. Use is generally not indicated.
Geriatric Use
Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Generally, follitropin alfa is not indicated for use in postmenopausal women.
Clinical Information
Clinical Pearls
- Gonal-F RFF is a highly potent gonadotropin; careful monitoring of ovarian response (ultrasound and estradiol levels) is essential to minimize the risk of Ovarian Hyperstimulation Syndrome (OHSS) and multiple gestations.
- Patients should be thoroughly educated on proper self-injection technique and storage of the medication.
- The 75 IU vial is often used for initial low-dose stimulation protocols or for dose adjustments in higher-dose protocols.
- Ensure patients understand the signs and symptoms of OHSS and when to seek immediate medical attention.
- Treatment cycles should be individualized based on patient's response, age, and specific fertility diagnosis.
- In male hypogonadotropic hypogonadism, treatment with follitropin alfa (with hCG) can be prolonged (months to years) to achieve spermatogenesis.
Alternative Therapies
- Clomiphene citrate (oral ovulation stimulant)
- Letrozole (aromatase inhibitor, oral ovulation stimulant)
- Human Chorionic Gonadotropin (hCG) for ovulation trigger or male spermatogenesis induction (often used in conjunction with FSH)
- Dopamine agonists (for hyperprolactinemia-induced anovulation)
Cost & Coverage
Average Cost:
$500 - $2000+ per vial/pen (highly variable by strength and quantity)
Insurance Coverage:
Specialty Tier (often requires prior authorization and may have high co-pays/coinsurance)
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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.