Gonal-F Redi-Ject 300iu Inj, 0.5ml
It is used to help people get pregnant. It is used to help make sperm.
Drug Class
Gonadotropin; Ovulation Stimulant
Pharmacologic Class
Recombinant Follicle-Stimulating Hormone (rFSH)
Pregnancy Category
Category X
FDA Approved
Sep 1995
DEA Schedule
Not Controlled
Overview
What is this medicine?
Gonal-F Redi-Ject is an injectable medication containing a hormone called follitropin alfa, which is a man-made version of follicle-stimulating hormone (FSH). In women, it helps the ovaries produce and mature eggs for fertility treatments. In men, it helps the testes produce sperm. It is given as a shot under the skin.
How to Use This Medicine
Proper Use of This Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Carefully follow all instructions to ensure safe and effective use.
Administration
This medication is administered via injection into the fatty tissue under the skin. If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique. Before and after use, wash your hands thoroughly. Rotate the injection site as directed by your doctor to minimize the risk of adverse reactions.
Important Safety Precautions
Do not use the medication if the solution appears cloudy, is leaking, or contains particles. Additionally, do not use the solution if it has changed color. Dispose of used needles and syringes in a designated sharps disposal container. Never reuse needles or other injection equipment. When the disposal container is full, follow local regulations for proper disposal. If you have any questions or concerns, consult your doctor or pharmacist.
Preparing the Medication
For vials, this medication must be mixed before use. Follow the mixing instructions provided by your doctor.
Storage and Preparation of Prefilled Pen and Multidose Vial
If stored in the refrigerator, remove the medication and allow it to reach room temperature before use. 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 injection equipment. When the disposal container is full, follow local regulations for proper disposal. If you have any questions or concerns, consult your doctor or pharmacist.
Preparing the Medication
For vials, this medication must be mixed before use. Follow the mixing instructions provided by your doctor.
Storage and Preparation of Prefilled Pen and Multidose Vial
If stored in the refrigerator, remove the medication and allow it to reach room temperature before use. 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 exactly regarding dosage and administration schedule.
- Learn proper self-injection technique from your healthcare provider.
- Store the medication in the refrigerator (2°C to 8°C / 36°F to 46°F) and protect from light. Do not freeze.
- Report any side effects or concerns to your healthcare provider immediately.
- Attend all scheduled monitoring appointments (blood tests and ultrasounds) as these are crucial for safe and effective treatment.
- Avoid alcohol and smoking as they can negatively impact fertility.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Highly individualized based on patient response and indication. For ovulation induction in anovulatory patients: Initial 50 IU/day for 7 days, then adjust based on ovarian response. For controlled ovarian hyperstimulation (COH) in ART: Initial 150-225 IU/day for 5 days, then adjust. For male hypogonadotropic hypogonadism: 150 IU 3 times weekly (often with hCG).
Dose Range:
50 - 450 mg
Condition-Specific Dosing:
ovulationInduction:
Initial 50 IU/day for 7 days, then adjust by 25-50 IU at weekly intervals. Max 450 IU/day.
controlledOvarianHyperstimulation:
Initial 150-225 IU/day for 5 days, then adjust by 75-150 IU every 3-5 days. Max 450 IU/day.
maleHypogonadotropicHypogonadism:
150 IU 3 times weekly (after hCG pre-treatment to normalize testosterone levels).
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended, use with caution.
Moderate:
No specific adjustment recommended, use with caution.
Severe:
No specific adjustment recommended, use with caution due to limited data.
Dialysis:
Not available
Hepatic Impairment:
Mild:
No specific adjustment recommended, use with caution.
Moderate:
No specific adjustment recommended, use with caution.
Severe:
No specific adjustment recommended, use with caution due to limited data.
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 and spermatogenesis in men with hypogonadotropic hypogonadism. It binds to FSH receptors on granulosa cells of the ovarian follicle and Sertoli cells of the testes, promoting follicular maturation and estrogen production in women, and spermatogenesis in men.
Pharmacokinetics
Absorption:
Bioavailability:
66-70% (subcutaneous)
Tmax:
6-12 hours (subcutaneous)
FoodEffect:
Not applicable (parenteral administration)
Distribution:
Vd:
Approximately 10 L
ProteinBinding:
Low
CnssPenetration:
Limited
Elimination:
HalfLife:
18-40 hours (terminal half-life after multiple doses)
Clearance:
Approximately 0.6 L/hr
ExcretionRoute:
Primarily renal (10-15% unchanged)
Unchanged:
10-15%
Pharmacodynamics
OnsetOfAction:
Gradual, reflecting follicular growth (days to weeks)
PeakEffect:
Observed with maximal follicular development and estradiol levels (typically after 5-10 days of stimulation)
DurationOfAction:
Related to half-life, allowing for daily or less frequent dosing based on response
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 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
This medication can cause severe lung problems, which can be life-threatening. If you experience any of the following symptoms, contact your doctor right away:
Shortness of breath
Trouble breathing
Cough
Fever
Blood Clots
This medication can increase the risk of blood clots, which can be life-threatening. If you experience any of the following symptoms, contact your doctor right away:
Chest, arm, back, neck, or jaw pain or pressure
Coughing up blood
Numbness or weakness on one side of the body
Trouble speaking or thinking
Change in balance
Change in eyesight
Shortness of breath
Swelling, warmth, or pain in the leg or arm
Sex-Specific Side Effects
Females:
+ 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
Other Possible Side Effects
Most people do not experience severe side effects, but some may occur. If you experience any of the following side effects, contact your doctor if they bother you or do not go away:
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
If you have questions about side effects or want to report a side effect, 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 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
This medication can cause severe lung problems, which can be life-threatening. If you experience any of the following symptoms, contact your doctor right away:
Shortness of breath
Trouble breathing
Cough
Fever
Blood Clots
This medication can increase the risk of blood clots, which can be life-threatening. If you experience any of the following symptoms, contact your doctor right away:
Chest, arm, back, neck, or jaw pain or pressure
Coughing up blood
Numbness or weakness on one side of the body
Trouble speaking or thinking
Change in balance
Change in eyesight
Shortness of breath
Swelling, warmth, or pain in the leg or arm
Sex-Specific Side Effects
Females:
+ 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
Other Possible Side Effects
Most people do not experience severe side effects, but some may occur. If you experience any of the following side effects, contact your doctor if they bother you or do not go away:
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
If you have questions about side effects or want to report a side effect, 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)
- Shortness of breath or difficulty breathing
- Decreased urination
- Pain, redness, swelling, or bruising at the injection site that worsens
- Signs of an allergic reaction (e.g., rash, itching, hives, swelling of the face, lips, tongue, or 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 to ensure safe treatment:
For All Patients:
- Any known allergies to this medication, its components, or other substances, including foods and drugs. Describe the allergic reaction and its symptoms.
- Presence of certain health conditions, such as adrenal gland disease, brain tumor, pituitary gland disease, or thyroid gland disease.
For Female Patients:
- Primary ovarian failure, where the ovaries no longer produce eggs.
- Health issues related to female organs, including tumors, enlarged ovaries, ovarian cysts, or unexplained vaginal bleeding.
- Infertility due to reproductive organ problems.
- Pregnancy or potential pregnancy, as this medication is contraindicated during pregnancy. A pregnancy test will be required before initiating treatment to confirm you are not pregnant.
- Breastfeeding, as you should not breastfeed while taking this medication.
For Male Patients:
- Inability to produce sperm or presence of tumors in the male reproductive organs.
General Considerations:
This list does not encompass all possible drug interactions or health problems that may affect your treatment. Therefore, it is crucial to:
- Inform your doctor and pharmacist about all medications you are taking, including prescription drugs, over-the-counter medications, natural products, and vitamins.
- Discuss all your health problems to ensure it is safe to take this medication alongside your other treatments.
- Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
It is essential to inform your doctor about the following conditions to ensure safe treatment:
For All Patients:
- Any known allergies to this medication, its components, or other substances, including foods and drugs. Describe the allergic reaction and its symptoms.
- Presence of certain health conditions, such as adrenal gland disease, brain tumor, pituitary gland disease, or thyroid gland disease.
For Female Patients:
- Primary ovarian failure, where the ovaries no longer produce eggs.
- Health issues related to female organs, including tumors, enlarged ovaries, ovarian cysts, or unexplained vaginal bleeding.
- Infertility due to reproductive organ problems.
- Pregnancy or potential pregnancy, as this medication is contraindicated during pregnancy. A pregnancy test will be required before initiating treatment to confirm you are not pregnant.
- Breastfeeding, as you should not breastfeed while taking this medication.
For Male Patients:
- Inability to produce sperm or presence of tumors in the male reproductive organs.
General Considerations:
This list does not encompass all possible drug interactions or health problems that may affect your treatment. Therefore, it is crucial to:
- Inform your doctor and pharmacist about all medications you are taking, including prescription drugs, over-the-counter medications, natural products, and vitamins.
- Discuss all your health problems to ensure it is safe to take this medication alongside your other treatments.
- Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
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 (e.g., twins, triplets)
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 pre-existing health conditions, which can lead to interrupted blood flow to the ovary
Higher risk of ectopic pregnancy (pregnancy outside the uterus), which can be life-threatening; seek immediate medical attention if you experience symptoms such as vaginal bleeding, nausea, stomach pain, pelvic or rectal pain, shoulder or neck pain, dizziness, fainting, rapid heartbeat, pale or sweaty skin, or confusion
To minimize risks, your doctor may advise you to avoid sexual intercourse if your ovaries become enlarged, as this can increase the risk of ovarian cyst rupture. It is also recommended that you limit strenuous exercise while undergoing ovarian stimulation.
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 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 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 (e.g., twins, triplets)
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 pre-existing health conditions, which can lead to interrupted blood flow to the ovary
Higher risk of ectopic pregnancy (pregnancy outside the uterus), which can be life-threatening; seek immediate medical attention if you experience symptoms such as vaginal bleeding, nausea, stomach pain, pelvic or rectal pain, shoulder or neck pain, dizziness, fainting, rapid heartbeat, pale or sweaty skin, or confusion
To minimize risks, your doctor may advise you to avoid sexual intercourse if your ovaries become enlarged, as this can increase the risk of ovarian cyst rupture. It is also recommended that you limit strenuous exercise while undergoing ovarian stimulation.
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 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), which can range from mild (abdominal discomfort, bloating) to severe (severe abdominal pain, ascites, pleural effusion, oliguria, dyspnea, hypovolemia, electrolyte imbalance, thromboembolism).
- Multiple gestations (e.g., twins, triplets, or more).
What to Do:
There is no specific antidote for follitropin alfa overdose. Management is supportive and symptomatic, primarily focused on managing OHSS. This may involve hospitalization, fluid and electrolyte management, pain control, and in severe cases, paracentesis or thoracentesis. Call 1-800-222-1222 (Poison Control) or seek immediate medical attention.
Drug Interactions
Moderate Interactions
- Clomiphene citrate (may potentiate ovarian response, increasing risk of OHSS and multiple gestations)
- GnRH agonists/antagonists (used in conjunction, but require careful dose adjustment of follitropin alfa)
Monitoring
Baseline Monitoring
Complete gynecological/andrological examination
Rationale: To assess reproductive health and rule out contraindications.
Timing: Prior to initiation of treatment
Hormone levels (e.g., FSH, LH, Estradiol, Testosterone, Prolactin, TSH)
Rationale: To assess endocrine status and confirm hypogonadotropic hypogonadism or anovulation.
Timing: Prior to initiation of treatment
Transvaginal ultrasound
Rationale: To assess ovarian morphology, rule out ovarian cysts, and establish baseline follicular status.
Timing: Prior to initiation of treatment
Semen analysis (for male infertility)
Rationale: To assess baseline sperm parameters.
Timing: Prior to initiation of treatment
Routine Monitoring
Serum Estradiol (E2) levels
Frequency: Every 1-3 days during stimulation
Target: Varies based on indication and follicular response; typically rising levels indicating follicular growth
Action Threshold: Rapidly rising E2 levels or excessively high levels may indicate risk of OHSS; dose reduction or cycle cancellation may be required.
Transvaginal ultrasound (follicular development and endometrial thickness)
Frequency: Every 1-3 days during stimulation
Target: Number and size of mature follicles (e.g., >18 mm for ovulation induction); endometrial thickness >7 mm
Action Threshold: Excessive number of large follicles (>10-15 follicles >10mm) or rapid growth may indicate risk of OHSS; cycle cancellation or withholding hCG may be required.
Signs and symptoms of Ovarian Hyperstimulation Syndrome (OHSS)
Frequency: Daily during and after treatment
Target: Absence of symptoms
Action Threshold: Presence of abdominal pain, bloating, nausea, vomiting, diarrhea, rapid weight gain, dyspnea, oliguria. Requires immediate medical evaluation.
Symptom Monitoring
- Abdominal pain
- Abdominal bloating or distension
- Nausea
- Vomiting
- Diarrhea
- Rapid weight gain
- Shortness of breath (dyspnea)
- Decreased urination (oliguria)
- Pain, redness, swelling, or bruising at injection site
- Signs of allergic reaction (rash, itching, hives, swelling of face/lips/tongue/throat, difficulty breathing)
Special Patient Groups
Pregnancy
Follitropin alfa is contraindicated in pregnant women. It is used to induce ovulation and should not be administered once pregnancy is established. There is no indication for use in pregnancy.
Trimester-Specific Risks:
First Trimester:
Contraindicated. Potential for adverse effects on fetal development, though human data are limited.
Second Trimester:
Contraindicated.
Third Trimester:
Contraindicated.
Lactation
It is not known whether follitropin alfa is excreted in human milk. However, the use of follitropin alfa is not recommended during lactation as it may suppress milk production and is not indicated for use in nursing mothers.
Infant Risk:
Risk of potential adverse effects on the breastfed infant is unknown. Risk of suppressing milk production in the mother.
Pediatric Use
The safety and effectiveness of follitropin alfa in pediatric patients have not been established. It is not indicated for use in this population.
Geriatric Use
Follitropin alfa is not indicated for use in postmenopausal women. Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. No specific dose adjustments are recommended for elderly men, but caution is advised.
Clinical Information
Clinical Pearls
- Dosing is highly individualized; close monitoring of ovarian response (serum estradiol and ultrasound) is critical to optimize outcomes and minimize risks like OHSS and multiple gestations.
- Patients should be thoroughly educated 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 demonstrate the process.
- The Redi-ject pen allows for easy and accurate dose selection and administration, which can improve patient adherence.
- Consider withholding hCG administration if ovarian response is excessive (e.g., too many large follicles, rapidly rising estradiol) to reduce the risk of severe OHSS.
- For male hypogonadotropic hypogonadism, treatment with hCG is typically initiated first to normalize testosterone levels before adding follitropin alfa to induce spermatogenesis.
Alternative Therapies
- Clomiphene citrate (oral ovulation stimulant)
- Letrozole (aromatase inhibitor, oral ovulation stimulant)
- Human Chorionic Gonadotropin (hCG - used to trigger ovulation after follicular development)
Cost & Coverage
Average Cost:
Varies significantly, typically $1,000 - $5,000+ per cycle depending on dosage and duration per treatment cycle
Insurance Coverage:
Specialty Tier (often requires prior authorization and may have specific coverage criteria related to infertility diagnosis and treatment)
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 this 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.