Follistim AQ Cartg 300iu Inj0.36ml
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 1997
DEA Schedule
Not Controlled
Overview
What is this medicine?
Follistim AQ is a medicine used to help women get pregnant by stimulating their ovaries to produce eggs. It's a man-made version of a natural hormone called FSH (follicle-stimulating hormone). It can also be used in men to help produce sperm.
How to Use This Medicine
Proper Administration of This Medication
To ensure safe and effective use, follow your doctor's instructions and read all accompanying information carefully. This medication is administered via injection. If you will be self-administering, your doctor or nurse will provide guidance on the proper technique.
Before and after handling the medication, wash your hands thoroughly. Rotate the injection site as directed by your doctor to minimize the risk of adverse reactions.
If the medication is stored in the refrigerator, allow it to reach room temperature before administering a dose. Inspect the solution for any visible particles, cloudiness, or leakage, and do not use if you notice any of these issues or if the solution has changed color. Avoid injecting into skin that is tender, bruised, red, or hard.
When preparing the dose, you may hear a clicking sound. However, do not rely on the number of clicks to determine the correct dose, as this could lead to an incorrect dosage. Remove all pen needle covers before injecting (note that there may be two covers). If you are unsure about the type of pen needle you are using or how to use it, consult your doctor.
After use, dispose of needles in a designated sharps disposal container. Do not reuse needles or other materials, and follow local regulations for disposing of the container when it is full. If you have any questions or concerns, consult your doctor or pharmacist.
Important Safety Precaution
Do not share pen or cartridge devices with others, even if the needle has been changed, as this can facilitate the transmission of infections, including those that may be asymptomatic.
Storage and Disposal
Follow the recommended storage instructions for this medication.
Missed Dose
If you miss a dose, contact your doctor to determine the best course of action.
To ensure safe and effective use, follow your doctor's instructions and read all accompanying information carefully. This medication is administered via injection. If you will be self-administering, your doctor or nurse will provide guidance on the proper technique.
Before and after handling the medication, wash your hands thoroughly. Rotate the injection site as directed by your doctor to minimize the risk of adverse reactions.
If the medication is stored in the refrigerator, allow it to reach room temperature before administering a dose. Inspect the solution for any visible particles, cloudiness, or leakage, and do not use if you notice any of these issues or if the solution has changed color. Avoid injecting into skin that is tender, bruised, red, or hard.
When preparing the dose, you may hear a clicking sound. However, do not rely on the number of clicks to determine the correct dose, as this could lead to an incorrect dosage. Remove all pen needle covers before injecting (note that there may be two covers). If you are unsure about the type of pen needle you are using or how to use it, consult your doctor.
After use, dispose of needles in a designated sharps disposal container. Do not reuse needles or other materials, and follow local regulations for disposing of the container when it is full. If you have any questions or concerns, consult your doctor or pharmacist.
Important Safety Precaution
Do not share pen or cartridge devices with others, even if the needle has been changed, as this can facilitate the transmission of infections, including those that may be asymptomatic.
Storage and Disposal
Follow the recommended storage instructions for this medication.
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 diet, exercise, and sexual activity.
- Avoid alcohol and smoking as they can negatively impact fertility.
- Report any unusual symptoms immediately, especially severe abdominal pain or bloating.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Varies significantly by indication and patient response. For ovulation induction: Initial 50-100 IU/day SC for 7-14 days. For controlled ovarian hyperstimulation (COH) for ART: Initial 150-225 IU/day SC for 5-7 days. For spermatogenesis in men: 450 IU/week (e.g., 150 IU 3 times a week) SC, in conjunction with hCG.
Dose Range:
50 - 450 mg
Condition-Specific Dosing:
Ovulation Induction:
Initial 50-100 IU/day SC for 7-14 days, adjusted based on ovarian response (estradiol levels and follicular ultrasound). Max 225 IU/day.
Controlled Ovarian Hyperstimulation (COH) for ART:
Initial 150-225 IU/day SC for 5-7 days, adjusted based on ovarian response. Max 450 IU/day.
Spermatogenesis (male hypogonadotropic hypogonadism):
450 IU/week (e.g., 150 IU 3 times a week) SC, in conjunction with hCG (e.g., 1500 IU 3 times a week). Treatment duration typically 3-6 months or longer.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (not indicated for pediatric use for fertility)
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 beta is primarily eliminated renally.
Dialysis:
No specific recommendations. Use with caution and close monitoring.
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 beta is a recombinant human follicle-stimulating hormone (rFSH). It stimulates ovarian follicular growth in women who do not have primary ovarian failure. FSH is essential for normal follicular growth, maturation, and gonadal steroid production. In men, FSH acts on the Sertoli cells of the seminiferous tubules to stimulate spermatogenesis.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 77% (subcutaneous)
Tmax:
Approximately 7-10 hours (subcutaneous)
FoodEffect:
Not applicable (parenteral administration)
Distribution:
Vd:
Approximately 8-10 L
ProteinBinding:
Not extensively protein bound
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 12-70 hours (variable, often cited as 12-24 hours for SC administration)
Clearance:
Approximately 0.6 L/hour
ExcretionRoute:
Primarily renal (approximately 10% 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 of treatment, leading up to hCG administration.
DurationOfAction:
Effects persist as long as treatment continues, with a half-life allowing for once-daily dosing.
Safety & Warnings
Side Effects
Serious 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 immediately:
Signs of an allergic reaction, including:
+ 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
Pale skin
Severe lung problems, which can be life-threatening. Watch for:
+ Shortness of breath
+ Trouble breathing
+ Cough
+ Fever
Blood clots, which can be deadly. Seek help if you have:
+ Chest, arm, back, neck, or jaw pain or pressure
+ Coughing up blood
+ Numbness or weakness on one side of your body
+ Trouble speaking or thinking
+ Change in balance
+ Change in eyesight
+ Shortness of breath
+ Swelling, warmth, or pain in the leg or arm
Female Patients:
Unusual vaginal bleeding
Ovarian hyperstimulation syndrome (OHSS), a severe side effect that can occur. Seek help if you have:
+ Severe stomach pain or bloating
+ Very upset stomach, throwing up, or diarrhea
+ Significant weight gain
+ Shortness of breath
+ Change in urine output
Male Patients:
Enlarged breasts
Other Side Effects
Most people taking this medication will not experience serious side effects, but some may occur. If you have any of the following side effects, or if they bother you or do not go away, contact your doctor:
Irritation at the injection site
Upset stomach
Pimples (acne)
Headache
Feeling tired or weak
Female Patients:
Pelvic pain
Stomach pain
This is not a complete list of possible side effects. If you have questions or concerns, 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, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor immediately:
Signs of an allergic reaction, including:
+ 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
Pale skin
Severe lung problems, which can be life-threatening. Watch for:
+ Shortness of breath
+ Trouble breathing
+ Cough
+ Fever
Blood clots, which can be deadly. Seek help if you have:
+ Chest, arm, back, neck, or jaw pain or pressure
+ Coughing up blood
+ Numbness or weakness on one side of your body
+ Trouble speaking or thinking
+ Change in balance
+ Change in eyesight
+ Shortness of breath
+ Swelling, warmth, or pain in the leg or arm
Female Patients:
Unusual vaginal bleeding
Ovarian hyperstimulation syndrome (OHSS), a severe side effect that can occur. Seek help if you have:
+ Severe stomach pain or bloating
+ Very upset stomach, throwing up, or diarrhea
+ Significant weight gain
+ Shortness of breath
+ Change in urine output
Male Patients:
Enlarged breasts
Other Side Effects
Most people taking this medication will not experience serious side effects, but some may occur. If you have any of the following side effects, or if they bother you or do not go away, contact your doctor:
Irritation at the injection site
Upset stomach
Pimples (acne)
Headache
Feeling tired or weak
Female Patients:
Pelvic pain
Stomach pain
This is not a complete list of possible side effects. If you have questions or concerns, 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 5 pounds in 24 hours)
- Decreased urination
- Shortness of breath or difficulty breathing
- Pain, swelling, or redness in your legs (signs of blood clot)
- Severe headache or vision changes
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. Describe the symptoms you experienced during an allergic reaction.
Certain health conditions, such as:
+ Adrenal gland disease
+ Brain tumor
+ Breast cancer or other hormone-sensitive cancers
+ Pituitary gland disease
+ Thyroid gland disease
For Female Patients:
Inform your doctor if you have:
+ A tumor in your female reproductive organs
+ Enlarged ovaries or ovarian cysts
+ Unexplained vaginal bleeding
+ Primary ovarian failure (when your ovaries no longer produce eggs)
+ Infertility due to reproductive organ problems
If you are pregnant or think you might be pregnant, please note that this medication is not intended for use during pregnancy. A pregnancy test will be conducted to confirm that you are not pregnant before initiating treatment.
For Male Patients:
* Inform your doctor if you have:
+ A tumor in your male reproductive organs
+ Infertility or low sperm count
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help you determine whether it is safe to take this medication with your existing treatments and health status. Do not modify your medication regimen 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. Describe the symptoms you experienced during an allergic reaction.
Certain health conditions, such as:
+ Adrenal gland disease
+ Brain tumor
+ Breast cancer or other hormone-sensitive cancers
+ Pituitary gland disease
+ Thyroid gland disease
For Female Patients:
Inform your doctor if you have:
+ A tumor in your female reproductive organs
+ Enlarged ovaries or ovarian cysts
+ Unexplained vaginal bleeding
+ Primary ovarian failure (when your ovaries no longer produce eggs)
+ Infertility due to reproductive organ problems
If you are pregnant or think you might be pregnant, please note that this medication is not intended for use during pregnancy. A pregnancy test will be conducted to confirm that you are not pregnant before initiating treatment.
For Male Patients:
* Inform your doctor if you have:
+ A tumor in your male reproductive organs
+ Infertility or low sperm count
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help you determine whether it is safe to take this medication with your existing treatments and health status. Do not modify your medication regimen without consulting your doctor.
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, as directed by your doctor, are crucial to monitor your health.
Special Considerations for Female Patients
While using this medication, you will need to undergo regular ultrasound examinations, as advised by your doctor. It is crucial to discuss the following potential risks with your doctor:
Increased chance of multiple pregnancies
Higher risk of severe side effects, including enlarged ovaries and ovarian cysts that can rupture, which can be life-threatening
Potential for ovarian torsion (twisting of the ovaries), particularly in individuals with pre-existing health conditions, which can disrupt blood flow to the ovary
Elevated risk of ectopic pregnancy (pregnancy outside the uterus), which requires immediate medical attention if symptoms occur, such as:
+ Vaginal bleeding
+ Nausea or vomiting
+ Abdominal or pelvic pain
+ Shoulder or neck pain
+ Dizziness or fainting
+ Rapid heartbeat
+ Pale, sweaty, or clammy skin
+ Confusion or other severe effects
To minimize risks, it is recommended to limit strenuous exercise during ovarian stimulation, as advised by your doctor.
Additional Risks and Considerations
The rate of pregnancy loss (miscarriage) is higher with medications like this one compared to natural pregnancies, although it is unclear if the medication is the cause. Discuss any concerns with your doctor.
Rarely, ovarian tumors have been reported in patients who have undergone repeated treatments with this medication to conceive. The relationship between the medication and tumor development is unknown, and you should discuss any questions or concerns with your doctor.
Breastfeeding Considerations
If you are breastfeeding, inform your doctor to discuss potential risks to your baby and determine the best course of action.
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, as directed by your doctor, are crucial to monitor your health.
Special Considerations for Female Patients
While using this medication, you will need to undergo regular ultrasound examinations, as advised by your doctor. It is crucial to discuss the following potential risks with your doctor:
Increased chance of multiple pregnancies
Higher risk of severe side effects, including enlarged ovaries and ovarian cysts that can rupture, which can be life-threatening
Potential for ovarian torsion (twisting of the ovaries), particularly in individuals with pre-existing health conditions, which can disrupt blood flow to the ovary
Elevated risk of ectopic pregnancy (pregnancy outside the uterus), which requires immediate medical attention if symptoms occur, such as:
+ Vaginal bleeding
+ Nausea or vomiting
+ Abdominal or pelvic pain
+ Shoulder or neck pain
+ Dizziness or fainting
+ Rapid heartbeat
+ Pale, sweaty, or clammy skin
+ Confusion or other severe effects
To minimize risks, it is recommended to limit strenuous exercise during ovarian stimulation, as advised by your doctor.
Additional Risks and Considerations
The rate of pregnancy loss (miscarriage) is higher with medications like this one compared to natural pregnancies, although it is unclear if the medication is the cause. Discuss any concerns with your doctor.
Rarely, ovarian tumors have been reported in patients who have undergone repeated treatments with this medication to conceive. The relationship between the medication and tumor development is unknown, and you should discuss any questions or concerns with your doctor.
Breastfeeding Considerations
If you are breastfeeding, inform your doctor to discuss potential risks to your baby and determine the best course of action.
Overdose Information
Overdose Symptoms:
- Ovarian Hyperstimulation Syndrome (OHSS) - symptoms include severe abdominal pain, bloating, nausea, vomiting, diarrhea, rapid weight gain, decreased urination, shortness of breath.
- Multiple pregnancies (though not a direct symptom of overdose, it's a risk of excessive ovarian stimulation).
What to Do:
Seek immediate medical attention. Management of OHSS is supportive and may involve hospitalization, fluid management, and monitoring of vital signs and electrolytes. Call 1-800-222-1222 (Poison Control) or emergency services.
Drug Interactions
Monitoring
Baseline Monitoring
Complete gynecological and endocrinological evaluation (women)
Rationale: To rule out primary ovarian failure, assess ovarian reserve, and identify other causes of infertility.
Timing: Prior to initiation of treatment
Semen analysis (male partner)
Rationale: To assess male factor infertility.
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 and rule out ovarian cysts.
Timing: Prior to initiation of treatment
Routine Monitoring
Serum Estradiol (E2) levels
Frequency: Daily or every other day during stimulation phase
Target: Varies based on protocol and number of developing follicles; rapid rise or very high levels may indicate risk of OHSS.
Action Threshold: Rapidly rising E2 levels or levels exceeding protocol-specific thresholds may require dose reduction, cycle cancellation, or withholding hCG.
Transvaginal Ultrasound (follicular monitoring)
Frequency: Daily or every other day during stimulation phase
Target: Follicles typically reach 17-20 mm diameter before hCG administration.
Action Threshold: Excessive number of developing follicles (>10-15 follicles >10mm) or rapid growth may indicate risk of OHSS and require intervention.
Signs and symptoms of Ovarian Hyperstimulation Syndrome (OHSS)
Frequency: Daily during stimulation and for 2 weeks post-hCG
Target: Absence of symptoms
Action Threshold: Abdominal pain, bloating, nausea, vomiting, diarrhea, weight gain, decreased urine output, shortness of breath. Requires immediate medical evaluation.
Symptom Monitoring
- Abdominal pain
- Abdominal bloating
- Nausea
- Vomiting
- Diarrhea
- Weight gain
- Decreased urine output
- Shortness of breath
- Pain, bruising, swelling, or irritation at injection site
Special Patient Groups
Pregnancy
Contraindicated in pregnant women. Follitropin beta is used to achieve pregnancy, but once pregnancy is confirmed, it should be discontinued.
Trimester-Specific Risks:
First Trimester:
Contraindicated. No indication for use.
Second Trimester:
Contraindicated. No indication for use.
Third Trimester:
Contraindicated. No indication for use.
Lactation
Not recommended during breastfeeding. It is not known if follitropin beta is excreted in human milk. However, administration of gonadotropins may suppress lactation.
Infant Risk:
L5 (Contraindicated/Hazardous). Potential for adverse effects on the infant and suppression of milk production.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Not indicated for use in children.
Geriatric Use
Not indicated for use in geriatric patients for fertility treatment. 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
- Follistim AQ is a highly purified recombinant FSH, reducing the risk of viral transmission compared to urine-derived products.
- Patients must be carefully monitored with serum estradiol levels and transvaginal ultrasounds to minimize the risk of Ovarian Hyperstimulation Syndrome (OHSS) and multiple gestations.
- Patients should be instructed on proper subcutaneous injection technique and needle disposal.
- The Follistim AQ Cartridge is designed for use with the Follistim Pen, allowing for precise dose adjustments.
- For male infertility, treatment with follitropin beta (in conjunction with hCG) is typically long-term (months to years) to achieve spermatogenesis.
Alternative Therapies
- Follitropin alfa (e.g., Gonal-F)
- Menotropins (hMG, e.g., Menopur, Repronex) - contain both FSH and LH activity
- Urofollitropin (purified FSH from urine, e.g., Bravelle)
- Clomiphene citrate (oral ovulation stimulant)
- Letrozole (aromatase inhibitor, used off-label for ovulation induction)
Cost & Coverage
Average Cost:
$500 - $1500+ per 300 IU cartridge (highly variable based on pharmacy and quantity)
Insurance Coverage:
Specialty Tier (often requires prior authorization and may have high co-pays or be excluded by some plans for fertility treatment)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.