Gonal-F Redi-Ject 450iu Inj, 0.75ml
It is used to help people get pregnant. It is used to help make sperm.
Drug Class
Infertility agent
Pharmacologic Class
Recombinant human follicle-stimulating hormone (r-hFSH)
Pregnancy Category
Not applicable (Contraindicated)
FDA Approved
Sep 1995
DEA Schedule
Not Controlled
Overview
What is this medicine?
Gonal-F Redi-Ject is a medicine that contains a hormone called follitropin alfa, which is very similar to a natural hormone in your body called Follicle-Stimulating Hormone (FSH). It is used to help women develop eggs in their ovaries for fertility treatments and to help men produce sperm if they have certain hormone deficiencies. It is given as an injection 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
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 vials, follow proper storage and disposal procedures.
Missed Dose
If you miss a dose, contact your doctor to determine the best course of action.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Carefully follow all instructions to ensure safe and effective use.
Administration
This medication is administered via injection into the fatty tissue under the skin. If you will be self-administering the injection, your doctor or nurse will provide guidance on the proper technique. Before and after use, wash your hands thoroughly. Rotate the injection site as directed by your doctor to minimize the risk of adverse reactions.
Important Safety Precautions
Do not use the medication if the solution appears cloudy, is leaking, or contains particles. Additionally, do not use the solution if it has changed color. Dispose of used needles and syringes in a designated sharps disposal container. Never reuse needles or other 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
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 vials, follow proper storage and disposal procedures.
Missed Dose
If you miss a dose, contact your doctor to determine the best course of action.
Lifestyle & Tips
- Follow all instructions for preparing and injecting the medication exactly as shown by your healthcare provider.
- Store the medication as directed (refrigerated before first use, then at room temperature or refrigerated after first use, depending on specific product instructions).
- Do not shake the pen/vial.
- Report any signs of Ovarian Hyperstimulation Syndrome (OHSS) immediately (e.g., severe abdominal pain, bloating, rapid weight gain, decreased urination).
- Avoid sexual intercourse or use barrier contraception during treatment and for several days after hCG administration to reduce the risk of multiple pregnancies or OHSS.
- Attend all scheduled appointments for blood tests and ultrasounds, as these are crucial for safe and effective treatment.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Highly individualized based on indication and patient response. Typical starting doses: Ovulation Induction: 75 IU/day SC. Assisted Reproductive Technologies (ART): 150-225 IU/day SC.
Dose Range:
75 - 450 mg
Condition-Specific Dosing:
Ovulation Induction (anovulatory patients):
Initial: 75 IU/day SC for 14 days. Dose adjustments: Increase by 25-50 IU at weekly intervals, up to a maximum of 150 IU/day. Once ovarian response is adequate, hCG is administered.
Assisted Reproductive Technologies (ART):
Initial: 150-225 IU/day SC for 5 days. Dose adjustments: Based on ovarian response, not to exceed 450 IU/day. Continue until adequate follicular development, then administer hCG.
Spermatogenesis Induction (male hypogonadotropic hypogonadism):
150 IU 3 times weekly SC, typically after hCG pre-treatment to normalize serum testosterone levels.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (limited data, generally not indicated for fertility in this age group unless for specific conditions like hypogonadotropic hypogonadism in males, where adult dosing may be adapted under specialist supervision).
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, but caution advised.
Moderate:
No specific dose adjustment recommended, but caution advised.
Severe:
No specific dose adjustment recommended, but caution advised. Follitropin alfa is primarily cleared by the kidneys, so close monitoring is warranted.
Dialysis:
Considerations: Data limited. Close monitoring of ovarian response is crucial.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
No specific dose adjustment recommended.
Pharmacology
Mechanism of Action
Follitropin alfa is a recombinant human follicle-stimulating hormone (r-hFSH). It binds to FSH receptors on granulosa cells of the ovarian follicle, stimulating follicular growth and development in women. In men, it stimulates spermatogenesis in individuals with hypogonadotropic hypogonadism.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 70% (subcutaneous)
Tmax:
6-12 hours (subcutaneous)
FoodEffect:
Not applicable (parenteral administration)
Distribution:
Vd:
Approximately 8-10 L (after IV administration)
ProteinBinding:
Not extensively protein bound
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 18-40 hours (terminal half-life after multiple subcutaneous doses)
Clearance:
Approximately 0.6 L/hour (after IV administration)
ExcretionRoute:
Renal (approximately 10% of the administered dose is excreted unchanged in urine)
Unchanged:
Approximately 10%
Pharmacodynamics
OnsetOfAction:
Not acutely measurable; effects on follicular growth are observed over days of treatment.
PeakEffect:
Peak follicular response and estradiol levels are typically observed after several days to weeks of treatment, depending on the protocol.
DurationOfAction:
Effects persist for several days after the last dose due to the relatively long half-life.
Confidence:
Medium
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Breast pain
Abnormal heartbeat
Blue or gray discoloration of the skin, lips, nail beds, fingers, or toes
Pale skin
Swelling of the abdomen
Mood changes
Severe Lung Problems
This medication can cause severe lung problems, which can be fatal. If you experience any of the following symptoms, contact your doctor immediately:
Shortness of breath or other breathing difficulties
Cough
Fever
Blood Clots
This medication can increase the risk of blood clots, which can be fatal. If you experience any of the following symptoms, contact your doctor immediately:
Chest, arm, back, neck, or jaw pain or pressure
Coughing up blood
Numbness or weakness on one side of the body
Trouble speaking or thinking
Change in balance
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 cause:
- Severe stomach pain or bloating
- Nausea, vomiting, or diarrhea
- Rapid weight gain
- Shortness of breath
- Changes in urine output
Males:
+ Enlarged breasts (gynecomastia)
Other Side Effects
Most people who take this medication do not experience serious side effects. However, some people may experience mild to moderate side effects, including:
Irritation at the injection site
Acne
Headache
Upset stomach
Stomach pain or diarrhea
Gas
Fatigue or weakness
Nasal or throat irritation
Back pain
Common cold symptoms
If you experience any of these side effects or any other symptoms that concern you, contact your doctor for advice.
Reporting Side Effects
If you experience any side effects, you can report them to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical attention right away:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Breast pain
Abnormal heartbeat
Blue or gray discoloration of the skin, lips, nail beds, fingers, or toes
Pale skin
Swelling of the abdomen
Mood changes
Severe Lung Problems
This medication can cause severe lung problems, which can be fatal. If you experience any of the following symptoms, contact your doctor immediately:
Shortness of breath or other breathing difficulties
Cough
Fever
Blood Clots
This medication can increase the risk of blood clots, which can be fatal. If you experience any of the following symptoms, contact your doctor immediately:
Chest, arm, back, neck, or jaw pain or pressure
Coughing up blood
Numbness or weakness on one side of the body
Trouble speaking or thinking
Change in balance
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 cause:
- Severe stomach pain or bloating
- Nausea, vomiting, or diarrhea
- Rapid weight gain
- Shortness of breath
- Changes in urine output
Males:
+ Enlarged breasts (gynecomastia)
Other Side Effects
Most people who take this medication do not experience serious side effects. However, some people may experience mild to moderate side effects, including:
Irritation at the injection site
Acne
Headache
Upset stomach
Stomach pain or diarrhea
Gas
Fatigue or weakness
Nasal or throat irritation
Back pain
Common cold symptoms
If you experience any of these side effects or any other symptoms that concern you, contact your doctor for advice.
Reporting Side Effects
If you experience any side effects, you can report them 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/throat, severe dizziness.
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 list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins.
You must verify that it is safe to take this medication with all your other medications and health conditions.
* Do not initiate, stop, or modify the dosage of any medication without consulting 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 list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins.
You must verify that it is safe to take this medication with all your other medications and health conditions.
* Do not initiate, stop, or modify the dosage of any medication without consulting your doctor.
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 risk 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 medical attention immediately.
Additional Precautions
To minimize risks, limit your physical activity while undergoing ovarian stimulation, and consult with your doctor for guidance. It is also important to note that the risk of pregnancy loss (miscarriage) is higher with medications like this one compared to natural pregnancies, although it is unclear whether these medications are the cause. 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.
Ovarian Enlargement and Sex
If your ovaries become enlarged, your doctor may advise you to avoid sexual intercourse to prevent the risk of ovarian cyst rupture. Discuss this with your doctor to understand the necessary precautions.
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 risk 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 medical attention immediately.
Additional Precautions
To minimize risks, limit your physical activity while undergoing ovarian stimulation, and consult with your doctor for guidance. It is also important to note that the risk of pregnancy loss (miscarriage) is higher with medications like this one compared to natural pregnancies, although it is unclear whether these medications are the cause. 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.
Ovarian Enlargement and Sex
If your ovaries become enlarged, your doctor may advise you to avoid sexual intercourse to prevent the risk of ovarian cyst rupture. Discuss this with your doctor to understand the necessary precautions.
Overdose Information
Overdose Symptoms:
- Ovarian Hyperstimulation Syndrome (OHSS) with or without pulmonary or vascular complications (e.g., ascites, pleural effusion, acute respiratory distress syndrome, thromboembolism).
- Multiple pregnancies (including high-order multiple pregnancies).
What to Do:
There is no specific antidote for follitropin alfa overdose. Management is supportive and symptomatic, primarily focused on managing OHSS. This may include hospitalization, fluid and electrolyte management, pain control, and monitoring for complications. Call 1-800-222-1222 (Poison Control) or seek immediate medical attention.
Drug Interactions
Moderate Interactions
- Clomiphene citrate (may potentiate ovarian response, requiring lower follitropin alfa doses)
- GnRH agonists/antagonists (used in conjunction, may require dose adjustments of follitropin alfa)
Monitoring
Baseline Monitoring
Serum FSH, LH, Estradiol (E2)
Rationale: To assess baseline hormonal status and rule out primary ovarian failure.
Timing: Prior to initiation of treatment.
Thyroid and Adrenal function
Rationale: To rule out other endocrine disorders that may affect fertility.
Timing: Prior to initiation of treatment.
Pelvic Ultrasound
Rationale: To assess baseline ovarian morphology, rule out ovarian cysts, and count antral follicles.
Timing: Prior to initiation of treatment.
Semen analysis (for male factor infertility)
Rationale: To assess male fertility potential.
Timing: Prior to initiation of treatment.
Routine Monitoring
Serum Estradiol (E2) levels
Frequency: Every 1-3 days during stimulation phase, or as clinically indicated.
Target: Varies based on protocol and desired response (e.g., for ART, often aiming for 1500-3000 pg/mL on day of hCG).
Action Threshold: Rapidly rising E2 levels or very high E2 levels may indicate risk of Ovarian Hyperstimulation Syndrome (OHSS) and warrant dose reduction or cycle cancellation.
Transvaginal Ultrasound
Frequency: Every 1-3 days during stimulation phase, or as clinically indicated.
Target: Follicle size (e.g., dominant follicle(s) 17-20 mm for ovulation induction; multiple follicles >16 mm for ART). Endometrial thickness.
Action Threshold: Excessive number of follicles or rapid growth may indicate risk of OHSS. Insufficient follicular growth may indicate need for dose increase.
Symptom Monitoring
- Signs and symptoms of Ovarian Hyperstimulation Syndrome (OHSS): abdominal pain, bloating, nausea, vomiting, diarrhea, rapid weight gain, decreased urine output, 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
Gonal-F is contraindicated in pregnant women. It is used to achieve pregnancy, not during pregnancy. There is no indication for use in pregnancy.
Trimester-Specific Risks:
First Trimester:
Contraindicated
Second Trimester:
Contraindicated
Third Trimester:
Contraindicated
Lactation
It is not known whether follitropin alfa is excreted in human milk. However, the use of Gonal-F is not recommended during lactation as it may suppress milk production and is not indicated for use in nursing mothers.
Infant Risk:
Risk cannot be ruled out. Potential for adverse effects on infant and milk production.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Generally not indicated for fertility treatment in this population, except for specific cases of hypogonadotropic hypogonadism in males under specialist supervision.
Geriatric Use
Safety and effectiveness in geriatric patients have not been established. Gonal-F 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.
Clinical Information
Clinical Pearls
- Gonal-F treatment requires close monitoring by a healthcare professional experienced in infertility treatment. Patients must commit to frequent blood tests (estradiol levels) and ultrasound examinations.
- The risk of Ovarian Hyperstimulation Syndrome (OHSS) is a significant concern. Patients should be educated on its symptoms and instructed to report them immediately.
- The risk of multiple pregnancies (including high-order multiples) is increased with gonadotropin therapy. This risk should be discussed with patients prior to treatment.
- Proper injection technique is crucial for subcutaneous administration. Patients should be trained and demonstrate proficiency.
- Individualized dosing is key. Starting doses and adjustments depend on the patient's specific condition, ovarian response, and protocol.
- For male hypogonadotropic hypogonadism, follitropin alfa is typically used after hCG pre-treatment to normalize testosterone levels and stimulate Leydig cell function.
Alternative Therapies
- Other recombinant FSH products (e.g., Follistim AQ, Elonva)
- Urinary-derived gonadotropins (e.g., Menopur, Repronex - contain FSH and LH activity)
- Clomiphene citrate (oral ovulation induction agent for anovulatory infertility)
- Letrozole (aromatase inhibitor, used for ovulation induction)
- Human Chorionic Gonadotropin (hCG) - used to trigger ovulation/spermatogenesis after FSH stimulation (e.g., Ovidrel, Pregnyl)
- GnRH agonists/antagonists (used in ART cycles to prevent premature ovulation)
Cost & Coverage
Average Cost:
Highly variable, typically $1,000 - $5,000+ per cycle depending on dosage and duration. per vial/pen
Insurance Coverage:
Specialty Tier (requires prior authorization, often not covered for fertility treatment by all plans).
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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.