Gonal-F RFF 75iu Inj, 1 Vial (10vl)
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
Category X
FDA Approved
Sep 1997
DEA Schedule
Not Controlled
Overview
What is this medicine?
Gonal-F RFF is a man-made hormone similar to one naturally produced in your body (FSH). It helps your ovaries produce eggs in women, or helps sperm production in men, 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 the storage instructions provided by your doctor or pharmacist.
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 the storage instructions provided by your doctor or pharmacist.
Missed Dose
If you miss a dose, contact your doctor to determine the best course of action.
Lifestyle & Tips
- Follow your doctor's instructions precisely regarding dose and timing of injections.
- Learn proper self-injection technique from a healthcare professional.
- Store medication as directed (refrigerated, protect from light).
- Do not shake the vial.
- Report any signs of Ovarian Hyperstimulation Syndrome (OHSS) immediately.
- Be aware of the increased risk of multiple pregnancies (twins, triplets, etc.).
- Avoid alcohol and smoking as they can negatively impact fertility.
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 SC for 14 days. Adjust by 37.5-75 IU at weekly intervals. Max daily dose: 300 IU. Once adequate follicular development is achieved, hCG is administered.
Controlled Ovarian Hyperstimulation (ART):
Initial: 150-225 IU/day SC for 5 days. Adjust based on ovarian response. Max daily dose: 450 IU. Continue until adequate follicular development, then hCG is administered.
Spermatogenesis Induction (hypogonadotropic hypogonadism):
Initial: 150 IU SC 3 times/week, in conjunction with hCG. Continue for at least 3-6 months.
Ovulation Induction (PCOS):
Initial: 75 IU/day SC for 14 days. Adjust by 37.5-75 IU at weekly intervals. Max daily dose: 300 IU. Once adequate follicular development is achieved, hCG is administered.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Limited data; generally not indicated for prepubertal children. For adolescent males with hypogonadotropic hypogonadism, similar dosing to adults may be considered under specialist supervision.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended. Use with caution due to potential for reduced clearance.
Dialysis:
Not available. Use with caution.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended. Use with caution due to potential for reduced clearance.
Confidence:
Medium
Pharmacology
Mechanism of Action
Follitropin alfa is a recombinant human follicle-stimulating hormone (r-hFSH). It binds to FSH receptors on granulosa cells of the ovarian follicle and Sertoli cells of the testis, stimulating follicular growth and development in women and spermatogenesis in men with hypogonadotropic hypogonadism.
Pharmacokinetics
Absorption:
Bioavailability:
66% (subcutaneous)
Tmax:
6-48 hours (single dose), 9 hours (steady state)
FoodEffect:
Not applicable (parenteral administration)
Distribution:
Vd:
Approximately 10 L
ProteinBinding:
Not extensively protein bound
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 18-47 hours (terminal half-life after multiple doses)
Clearance:
Approximately 0.6 L/hr
ExcretionRoute:
Renal (approximately 10% of administered dose)
Unchanged:
Approximately 10% (renal excretion)
Pharmacodynamics
OnsetOfAction:
Follicular growth typically begins within days of initiation, but clinical effect (ovulation/spermatogenesis) requires several days to weeks of treatment.
PeakEffect:
Peak follicular response and estradiol levels are typically observed after 5-10 days of stimulation.
DurationOfAction:
Effects persist as long as treatment continues, with follicular development regressing upon cessation if hCG is not administered.
Confidence:
Medium
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical help 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
Swelling of the abdomen
Mood changes
Severe lung problems, which can be life-threatening. Seek medical attention immediately if you experience:
+ Shortness of breath or other breathing difficulties
+ Cough
+ Fever
Blood clots, which can be life-threatening. Seek medical attention immediately if you experience:
+ 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), a severe side effect that can occur in some individuals. Seek medical attention immediately if you experience:
- Severe stomach pain or bloating
- Nausea, vomiting, or diarrhea
- Rapid weight gain
- Shortness of breath
- Changes in urine output
Males:
+ Enlarged breasts
Other Possible Side Effects
Most people do not experience severe side effects, and some may only have minor side effects. However, if you experience any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:
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
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 experience any of the following symptoms, contact your doctor or seek medical help 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
Swelling of the abdomen
Mood changes
Severe lung problems, which can be life-threatening. Seek medical attention immediately if you experience:
+ Shortness of breath or other breathing difficulties
+ Cough
+ Fever
Blood clots, which can be life-threatening. Seek medical attention immediately if you experience:
+ 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), a severe side effect that can occur in some individuals. Seek medical attention immediately if you experience:
- Severe stomach pain or bloating
- Nausea, vomiting, or diarrhea
- Rapid weight gain
- Shortness of breath
- Changes in urine output
Males:
+ Enlarged breasts
Other Possible Side Effects
Most people do not experience severe side effects, and some may only have minor side effects. However, if you experience any of the following side effects or any other unusual symptoms, contact your doctor or seek medical help:
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
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
- Rapid weight gain (more than 2 pounds in a day)
- Decreased urination
- Shortness of breath or difficulty breathing
- Pain, swelling, warmth, or redness in an arm or leg (signs of blood clot)
- Sudden chest pain or cough
- Severe headache or vision changes
- Signs of allergic reaction (rash, itching, hives, swelling of face/lips/tongue, 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 allergic reaction and its symptoms.
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 that you are not pregnant before starting treatment.
If you are breastfeeding. It is recommended that you do not breastfeed while taking this medication.
For Male Patients:
If you are experiencing infertility or have a tumor in your male reproductive organs.
Additional Considerations:
This is not an exhaustive list of potential interactions with this medication. It is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you may have.
Before starting, stopping, or changing the dosage of any medication, 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 allergic reaction and its symptoms.
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 that you are not pregnant before starting treatment.
If you are breastfeeding. It is recommended that you do not breastfeed while taking this medication.
For Male Patients:
If you are experiencing infertility or have a tumor in your male reproductive organs.
Additional Considerations:
This is not an exhaustive list of potential interactions with this medication. It is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you may have.
Before starting, stopping, or changing the dosage of any medication, consult with your doctor to ensure it is safe to do so in conjunction with this medication.
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. Regular blood work and laboratory tests should be conducted as directed by your doctor.
Special Considerations for Female Patients
While using this medication, you will need to undergo regular ultrasound examinations. Discuss the details with your doctor. Be aware that this medication may increase the risk of:
Multiple pregnancies (getting pregnant with more than one baby)
Ovarian enlargement and ovarian cysts that can rupture, which can be life-threatening in rare cases
Ovarian torsion (twisting of the ovaries), particularly in individuals with certain health conditions, which can cut off blood flow to the ovary
If your ovaries become enlarged, your doctor may advise you to avoid sexual intercourse, as it may cause an ovarian cyst to rupture. Discuss this with your doctor.
Additionally, this medication may increase the risk of ectopic pregnancy (pregnancy outside the uterus). If you have questions or concerns, consult your doctor. Seek immediate medical attention if you experience symptoms such as:
Vaginal bleeding
Nausea or vomiting
Abdominal pain
Pelvic or rectal pain
Shoulder or neck pain
Dizziness or fainting
Rapid heartbeat
Pale, sweaty, or clammy skin
Confusion
* Other severe or unusual effects
Exercise Precautions
While undergoing ovarian stimulation, limit your physical activity and discuss any concerns with your doctor.
Pregnancy Loss and Long-Term Risks
The rate of pregnancy loss (miscarriage) is higher with medications like this one compared to natural pregnancies. It is unclear whether these medications contribute to this increased risk. If you have questions, consult your doctor. Furthermore, using medications like this one multiple times to achieve pregnancy may increase the risk of developing tumors in the ovaries or other reproductive organs. Discuss this 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. Regular blood work and laboratory tests should be conducted as directed by your doctor.
Special Considerations for Female Patients
While using this medication, you will need to undergo regular ultrasound examinations. Discuss the details with your doctor. Be aware that this medication may increase the risk of:
Multiple pregnancies (getting pregnant with more than one baby)
Ovarian enlargement and ovarian cysts that can rupture, which can be life-threatening in rare cases
Ovarian torsion (twisting of the ovaries), particularly in individuals with certain health conditions, which can cut off blood flow to the ovary
If your ovaries become enlarged, your doctor may advise you to avoid sexual intercourse, as it may cause an ovarian cyst to rupture. Discuss this with your doctor.
Additionally, this medication may increase the risk of ectopic pregnancy (pregnancy outside the uterus). If you have questions or concerns, consult your doctor. Seek immediate medical attention if you experience symptoms such as:
Vaginal bleeding
Nausea or vomiting
Abdominal pain
Pelvic or rectal pain
Shoulder or neck pain
Dizziness or fainting
Rapid heartbeat
Pale, sweaty, or clammy skin
Confusion
* Other severe or unusual effects
Exercise Precautions
While undergoing ovarian stimulation, limit your physical activity and discuss any concerns with your doctor.
Pregnancy Loss and Long-Term Risks
The rate of pregnancy loss (miscarriage) is higher with medications like this one compared to natural pregnancies. It is unclear whether these medications contribute to this increased risk. If you have questions, consult your doctor. Furthermore, using medications like this one multiple times to achieve pregnancy may increase the risk of developing tumors in the ovaries or other reproductive organs. Discuss this with your doctor if you have concerns.
Overdose Information
Overdose Symptoms:
- Symptoms of Ovarian Hyperstimulation Syndrome (OHSS) including severe abdominal pain, bloating, nausea, vomiting, diarrhea, rapid weight gain, decreased urination, shortness of breath, fluid accumulation in abdomen or chest.
- No specific symptoms other than those related to OHSS are expected.
What to Do:
Seek immediate medical attention. Call 911 or your local emergency number. Management is supportive, focusing on fluid and electrolyte balance, pain management, and prevention of complications like thromboembolism. In the US, you can also call Poison Control at 1-800-222-1222.
Drug Interactions
Moderate Interactions
- Clomiphene citrate (may potentiate ovarian response, requiring lower follitropin alfa doses)
- GnRH agonists/antagonists (may require higher follitropin alfa doses to achieve desired ovarian response)
Monitoring
Baseline Monitoring
Ovarian reserve assessment (e.g., FSH, AMH, AFC)
Rationale: To assess baseline fertility potential and guide dosing.
Timing: Prior to initiation of treatment.
Thyroid function tests (TSH)
Rationale: To rule out underlying thyroid dysfunction that could affect fertility.
Timing: Prior to initiation of treatment.
Prolactin levels
Rationale: To rule out hyperprolactinemia.
Timing: Prior to initiation of treatment.
Pelvic ultrasound
Rationale: To assess baseline ovarian morphology and rule out cysts.
Timing: Prior to initiation of treatment.
Semen analysis (for male factor infertility)
Rationale: To confirm diagnosis of hypogonadotropic hypogonadism and assess baseline sperm parameters.
Timing: Prior to initiation of treatment.
Routine Monitoring
Serum Estradiol (E2) levels
Frequency: Every 1-3 days during stimulation phase
Target: Varies based on number and size of follicles; typically rising levels indicating follicular growth.
Action Threshold: Rapidly rising E2 or very high E2 levels may indicate risk of OHSS or multiple gestations, requiring dose adjustment or cycle cancellation.
Transvaginal Ultrasound (TVUS)
Frequency: Every 1-3 days during stimulation phase
Target: Follicle size (e.g., 17-20 mm for mature follicle), endometrial thickness.
Action Threshold: Presence of too many follicles, or follicles growing too rapidly, indicates risk of OHSS or multiple gestations, requiring dose adjustment or cycle cancellation.
Sperm count and motility (for male spermatogenesis induction)
Frequency: Every 1-2 months after 3-6 months of treatment
Target: Increasing sperm count and motility.
Action Threshold: Lack of improvement after adequate treatment duration may indicate need for dose adjustment or re-evaluation.
Symptom Monitoring
- Symptoms of Ovarian Hyperstimulation Syndrome (OHSS) including abdominal pain, bloating, nausea, vomiting, diarrhea, rapid weight gain, decreased urination, shortness of breath.
- Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing).
- Symptoms of thromboembolic events (pain, swelling, warmth, redness in an arm or leg; sudden chest pain; shortness of breath).
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 its use could potentially harm the fetus.
Trimester-Specific Risks:
First Trimester:
Not applicable; contraindicated.
Second Trimester:
Not applicable; contraindicated.
Third Trimester:
Not applicable; contraindicated.
Lactation
Not recommended for use during lactation. It is not known if follitropin alfa is excreted in human milk. However, administration of gonadotropins may suppress lactation.
Infant Risk:
Potential for suppression of milk production. Unknown direct effects on the breastfed infant.
Pediatric Use
Generally not indicated for pediatric use. Safety and effectiveness in pediatric patients (prepubertal) have not been established. Limited use in adolescent males for spermatogenesis induction under specialist supervision.
Geriatric Use
Not typically indicated for geriatric patients. Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Fertility treatment is generally not pursued in this age group.
Clinical Information
Clinical Pearls
- Gonal-F RFF is a highly potent gonadotropin; careful monitoring of ovarian response (ultrasound and estradiol levels) is crucial to minimize the risk of Ovarian Hyperstimulation Syndrome (OHSS) and multiple gestations.
- Dosing is highly individualized and requires frequent adjustments based on patient response. Start low and titrate slowly.
- Patients should be thoroughly counseled on the risks of OHSS and multiple pregnancies before starting treatment.
- Proper self-injection technique is essential for patient safety and medication efficacy. Provide clear instructions and demonstrations.
- For male hypogonadotropic hypogonadism, treatment with hCG is typically initiated first to achieve normal testosterone levels, followed by follitropin alfa to induce spermatogenesis. Treatment duration can be prolonged (e.g., 3-6 months or more) before sperm production is observed.
- Reconstituted solution should be used immediately or stored as directed by the manufacturer (e.g., refrigerated for up to 28 days for multi-dose vials).
Alternative Therapies
- Other recombinant FSH products (e.g., Follistim AQ, Elonva)
- Urinary-derived FSH products (e.g., Bravelle)
- Human Menopausal Gonadotropins (hMG) containing both FSH and LH activity (e.g., Menopur)
- Clomiphene citrate (oral ovulation induction agent)
- Letrozole (aromatase inhibitor, oral ovulation induction agent)
- hCG (human chorionic gonadotropin, used to trigger ovulation)
- GnRH agonists/antagonists (used in ART cycles to prevent premature ovulation)
Cost & Coverage
Average Cost:
Varies widely, typically $500 - $1500+ per vial/pen depending on strength and quantity. per vial/pen
Insurance Coverage:
Specialty Tier (Tier 3 or 4) - often requires prior authorization and may have high co-pays or co-insurance. Coverage for fertility treatments varies significantly by insurance plan and state.
General Drug Facts
If your symptoms or health issues persist or worsen, it's 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 be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.