Gonal-F Redi-Ject 900iu Inj, 1.44ml
It is used to help people get pregnant. It is used to help make sperm.
Drug Class
Gonadotropin
Pharmacologic Class
Follicle-stimulating hormone (FSH) analog
Pregnancy Category
Category X
FDA Approved
Sep 1995
DEA Schedule
Not Controlled
Overview
What is this medicine?
Follitropin alfa is a man-made hormone similar to the 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. 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 vial formulations, 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 heat the medication.
Storage and Disposal
For vial formulations, 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 vial formulations, 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 heat the medication.
Storage and Disposal
For vial formulations, 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 dosing and administration.
- Attend all scheduled monitoring appointments (ultrasounds, blood tests) as these are crucial for safe and effective treatment.
- Report any signs of Ovarian Hyperstimulation Syndrome (OHSS) immediately.
- Avoid sexual intercourse or use barrier contraception during treatment and for a few days after hCG administration to reduce the risk of multiple pregnancy or ovarian torsion.
- Maintain a healthy diet and moderate exercise as advised by your doctor.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Highly individualized based on patient response (ultrasound and serum estradiol levels). Dosing typically starts with a low dose and is adjusted based on follicular development.
Dose Range:
75 - 450 mg
Condition-Specific Dosing:
anovulation:
Initial dose: 75 IU/day subcutaneously for 14 days. Dose may be increased by 37.5 IU at weekly intervals up to 225 IU/day. Once adequate follicular development is achieved, hCG is administered. If no response after 4 weeks, discontinue cycle.
controlledOvarianHyperstimulation (ART):
Initial dose: 150-225 IU/day subcutaneously for 5 days. Dose may be adjusted based on ovarian response, not exceeding 450 IU/day. Continue until adequate follicular development, then administer hCG.
spermatogenesis induction (with hCG):
Initial dose: 150 IU three times per week subcutaneously for up to 12 months, in conjunction with hCG (e.g., 1000-2000 IU two to three times per week).
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (use in adolescents for fertility treatment is off-label and highly specialized, typically following adult protocols with careful monitoring)
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, but monitor response carefully.
Moderate:
No specific dose adjustment recommended, but monitor response carefully.
Severe:
No specific dose adjustment recommended, but monitor response carefully. Caution advised due to potential for altered drug clearance.
Dialysis:
Not available
Hepatic Impairment:
Mild:
No specific dose adjustment recommended, but monitor response carefully.
Moderate:
No specific dose adjustment recommended, but monitor response carefully.
Severe:
No specific dose adjustment recommended, but monitor response carefully. Caution advised due to potential for altered drug clearance.
Confidence:
Medium
Pharmacology
Mechanism of Action
Follitropin alfa is a recombinant human follicle-stimulating hormone (r-hFSH). It stimulates ovarian follicular growth in women who do not have primary ovarian failure. In men, in conjunction with human chorionic gonadotropin (hCG), it stimulates spermatogenesis in men with hypogonadotropic hypogonadism.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 66% (subcutaneous)
Tmax:
Approximately 6-48 hours (single dose), 9 hours (multiple doses)
FoodEffect:
Not applicable (parenteral administration)
Distribution:
Vd:
Approximately 10 L
ProteinBinding:
Not extensively protein bound
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 18-32 hours (terminal half-life)
Clearance:
Approximately 0.6 L/hour
ExcretionRoute:
Primarily renal (urine)
Unchanged:
Approximately 10% (urine)
Pharmacodynamics
OnsetOfAction:
Follicular growth typically observed within days to weeks of initiation, depending on the individual's response.
PeakEffect:
Peak follicular response and estradiol levels are achieved during the stimulation phase, typically 7-14 days after initiation.
DurationOfAction:
Effects persist as long as treatment continues, with a return to baseline after discontinuation.
Confidence:
Medium
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
Swelling of the abdomen
Mood changes
Severe lung problems, which can be life-threatening. Watch for symptoms such as:
+ Shortness of breath
+ Trouble breathing
+ Cough
+ Fever
Blood clots, which can be life-threatening. Seek medical help 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
+ 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), a severe side effect that can occur in some individuals. Seek medical help if you experience:
- Severe stomach pain or bloating
- Nausea, vomiting, or diarrhea
- Rapid weight gain
- Shortness of breath
- Change in urine output
Males:
+ Enlarged breasts (gynecomastia)
Other Possible Side Effects:
This medication can cause a range of side effects, from mild to severe. While many people may not experience any side effects or only minor ones, it's essential to report any concerns to your doctor. Common side effects include:
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
If you experience any of these side effects or any other symptoms that bother you or do not go away, contact your doctor for guidance.
Reporting Side Effects:
If you have questions or concerns about side effects, call 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
Swelling of the abdomen
Mood changes
Severe lung problems, which can be life-threatening. Watch for symptoms such as:
+ Shortness of breath
+ Trouble breathing
+ Cough
+ Fever
Blood clots, which can be life-threatening. Seek medical help 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
+ 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), a severe side effect that can occur in some individuals. Seek medical help if you experience:
- Severe stomach pain or bloating
- Nausea, vomiting, or diarrhea
- Rapid weight gain
- Shortness of breath
- Change in urine output
Males:
+ Enlarged breasts (gynecomastia)
Other Possible Side Effects:
This medication can cause a range of side effects, from mild to severe. While many people may not experience any side effects or only minor ones, it's essential to report any concerns to your doctor. Common side effects include:
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
If you experience any of these side effects or any other symptoms that bother you or do not go away, contact your doctor for guidance.
Reporting Side Effects:
If you have questions or concerns about side effects, call 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 per day)
- Decreased urination
- Shortness of breath or difficulty breathing
- Pain, swelling, warmth, or redness in your leg or arm (signs of a blood clot)
- Sudden, severe headache or vision changes
- Severe pain in one side of your lower abdomen (may indicate ovarian torsion)
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 to this drug, its components, or other substances, including foods and medications. Describe the allergic reaction you experienced, such as symptoms and signs.
Certain medical conditions, including:
+ 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 reproductive organs
+ Enlarged ovaries or ovarian cysts
+ Unexplained vaginal bleeding
If you are experiencing infertility due to reproductive organ problems.
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 potential interactions with this medication. It is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist.
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 to this drug, its components, or other substances, including foods and medications. Describe the allergic reaction you experienced, such as symptoms and signs.
Certain medical conditions, including:
+ 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 reproductive organs
+ Enlarged ovaries or ovarian cysts
+ Unexplained vaginal bleeding
If you are experiencing infertility due to reproductive organ problems.
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 potential interactions with this medication. It is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist.
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 crucial that you 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 essential to discuss the following potential risks with your doctor:
Increased chance of multiple pregnancies (having more than one baby)
Elevated risk of severe side effects, including ovarian enlargement and rupture of ovarian cysts, which can be life-threatening
Potential for ovarian torsion (twisting of the ovaries), particularly in individuals with certain health conditions, which can disrupt blood flow to the ovary
Increased risk of ectopic pregnancy (pregnancy outside the uterus)
If you experience any symptoms such as vaginal bleeding, nausea or 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.
To minimize risks, limit your physical activity while undergoing ovarian stimulation, and consult with your doctor for guidance.
Additional Risks and Considerations
The rate of pregnancy loss (miscarriage) is higher with medications like this one compared to natural pregnancies. However, it is unclear whether these medications are the cause of this increased risk. If you have concerns, discuss them with your doctor.
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.
It is crucial that you 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 essential to discuss the following potential risks with your doctor:
Increased chance of multiple pregnancies (having more than one baby)
Elevated risk of severe side effects, including ovarian enlargement and rupture of ovarian cysts, which can be life-threatening
Potential for ovarian torsion (twisting of the ovaries), particularly in individuals with certain health conditions, which can disrupt blood flow to the ovary
Increased risk of ectopic pregnancy (pregnancy outside the uterus)
If you experience any symptoms such as vaginal bleeding, nausea or 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.
To minimize risks, limit your physical activity while undergoing ovarian stimulation, and consult with your doctor for guidance.
Additional Risks and Considerations
The rate of pregnancy loss (miscarriage) is higher with medications like this one compared to natural pregnancies. However, it is unclear whether these medications are the cause of this increased risk. If you have concerns, discuss them with your doctor.
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.
Overdose Information
Overdose Symptoms:
- Ovarian Hyperstimulation Syndrome (OHSS) with severe symptoms (e.g., ascites, pleural effusion, renal failure, thromboembolism)
- Multiple gestations (higher order multiples)
What to Do:
There is no specific antidote for follitropin alfa overdose. Management is supportive, primarily focusing on managing symptoms of OHSS. Seek immediate medical attention. Call 911 or your local emergency number. For general overdose information, call a poison control center (e.g., 1-800-222-1222 in the US).
Drug Interactions
Monitoring
Baseline Monitoring
Complete gynecological examination (women)
Rationale: To rule out primary ovarian failure, sex hormone-dependent tumors, or other contraindications.
Timing: Prior to initiation of treatment
Thyroid and adrenal function tests
Rationale: To rule out uncontrolled thyroid or adrenal dysfunction.
Timing: Prior to initiation of treatment
Semen analysis (male partner)
Rationale: To assess male factor infertility.
Timing: Prior to initiation of treatment
Semen analysis (men with hypogonadotropic hypogonadism)
Rationale: To establish baseline sperm count and motility.
Timing: Prior to initiation of treatment
Routine Monitoring
Transvaginal ultrasound
Frequency: Daily or every other day during stimulation phase
Target: Number and size of developing follicles
Action Threshold: Risk of OHSS or multiple pregnancy if too many large follicles develop; adjust dose or withhold hCG.
Serum estradiol (E2) levels
Frequency: Daily or every other day during stimulation phase
Target: Rising E2 levels indicating follicular growth
Action Threshold: Rapidly rising or excessively high E2 levels indicate increased risk of OHSS; adjust dose or withhold hCG.
Semen analysis (men)
Frequency: Every 2-3 months
Target: Increasing sperm count and motility
Action Threshold: Lack of improvement may indicate need for dose adjustment or re-evaluation of treatment.
Symptom Monitoring
- Signs and symptoms of Ovarian Hyperstimulation Syndrome (OHSS): abdominal pain, bloating, nausea, vomiting, diarrhea, rapid weight gain, decreased urination, 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.
- Symptoms of ovarian torsion: severe unilateral lower abdominal pain, nausea, vomiting.
Special Patient Groups
Pregnancy
Contraindicated in pregnant women. Follitropin alfa is used to induce ovulation, and its use during pregnancy is not appropriate. There is no indication for follitropin alfa in pregnant women.
Trimester-Specific Risks:
First Trimester:
Contraindicated
Second Trimester:
Contraindicated
Third Trimester:
Contraindicated
Lactation
Not recommended during lactation. It is not known if follitropin alfa is excreted in human milk. However, FSH is a large protein and unlikely to pass into breast milk in significant amounts. The primary concern is the potential for hormonal effects on the nursing infant or interference with lactation itself. Given its indication for fertility, it is generally not used in nursing mothers.
Infant Risk:
L5 (Contraindicated/High Risk)
Pediatric Use
Safety and effectiveness in pediatric patients (pre-pubertal) have not been established. Use in adolescents for fertility treatment is off-label and requires careful consideration and monitoring.
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, fertility treatments are not indicated in post-menopausal women. For men, age-related decline in spermatogenesis may influence response.
Clinical Information
Clinical Pearls
- Gonal-F dosing is highly individualized; close monitoring with ultrasound and serum estradiol is paramount to prevent OHSS and multiple gestations.
- Patients should be thoroughly educated on the signs and symptoms of OHSS and instructed to report them immediately.
- The 900 IU Redi-Ject pen allows for multiple doses from a single pen, requiring careful patient instruction on dose setting and administration.
- Ensure patients understand the importance of proper storage (refrigeration before first use, room temperature after first use for a limited time).
- In men, treatment for spermatogenesis induction is prolonged, often requiring 6-12 months to see significant improvement in sperm parameters.
Alternative Therapies
- Other recombinant FSH products (e.g., Follistim AQ, Elonva)
- Urinary-derived FSH products (e.g., Bravelle)
- Human Menopausal Gonadotropins (hMG) which contain both FSH and LH activity (e.g., Menopur, Repronex)
- Clomiphene citrate (oral ovulation induction agent, often first-line for anovulation)
- Letrozole (aromatase inhibitor, off-label for ovulation induction)
Cost & Coverage
Average Cost:
Varies widely, typically several hundred to over a thousand USD per pen/vial per 900 IU/1.44 mL pen
Insurance Coverage:
Specialty Tier (requires prior authorization, often limited to specific fertility diagnoses)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.