Follistim AQ Cartg 900iu Inj 1.08ml
It is used to help people get pregnant. It is used to help make sperm.
Drug Class
Gonadotropin; Infertility Agent
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 that contains a hormone called FSH (Follicle-Stimulating Hormone). It is used to help women who are having trouble getting pregnant by stimulating their ovaries to produce eggs. It can also be used in men to help with sperm production. 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. This medication is administered via injection. If you will be self-administering the injection, 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 skin irritation.
If the medication is stored in the refrigerator, allow it to reach room temperature before administering a dose. Inspect the solution before use; do not administer if it appears cloudy, is leaking, or contains particles. Additionally, do not use the medication if the solution has changed color.
Avoid injecting the medication into skin that is tender, bruised, red, or hard. When preparing the dose, you may hear a clicking sound, but do not rely on the number of clicks to determine the correct dose. 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 needle/sharp disposal box. Do not reuse needles or other items, and follow local regulations for disposing of the box 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 another person, even if the needle has been changed, as this can transmit infections from one person to another, including infections that may not be apparent.
Storage and Disposal
Follow the storage instructions provided for this medication.
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. This medication is administered via injection. If you will be self-administering the injection, 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 skin irritation.
If the medication is stored in the refrigerator, allow it to reach room temperature before administering a dose. Inspect the solution before use; do not administer if it appears cloudy, is leaking, or contains particles. Additionally, do not use the medication if the solution has changed color.
Avoid injecting the medication into skin that is tender, bruised, red, or hard. When preparing the dose, you may hear a clicking sound, but do not rely on the number of clicks to determine the correct dose. 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 needle/sharp disposal box. Do not reuse needles or other items, and follow local regulations for disposing of the box 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 another person, even if the needle has been changed, as this can transmit infections from one person to another, including infections that may not be apparent.
Storage and Disposal
Follow the storage instructions provided 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.
- Maintain a healthy weight.
- Attend all scheduled appointments for blood tests and ultrasounds, as these are crucial for safe and effective treatment.
- Report any unusual symptoms immediately to your healthcare provider.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Varies significantly by indication and patient response. For ovulation induction: Initial 50 IU/day for 7 days, then adjust by 25-50 IU at weekly intervals. For controlled ovarian hyperstimulation (COH) in ART: Initial 150-225 IU/day for 5-7 days, then adjust based on response. For spermatogenesis in males: 150 IU 3 times weekly (in conjunction with hCG).
Dose Range:
50 - 450 mg
Condition-Specific Dosing:
Ovulation Induction (Anovulatory Infertility):
Initial 50 IU/day for 7 days, then adjust by 25-50 IU at weekly intervals. Max 225 IU/day. Administer hCG after adequate follicular development.
Controlled Ovarian Hyperstimulation (COH) for ART:
Initial 150-225 IU/day for 5-7 days, then adjust based on ovarian response. Max 450 IU/day. Administer hCG after adequate follicular development.
Spermatogenesis (Hypogonadotropic Hypogonadism in Males):
150 IU 3 times weekly, typically administered with hCG (e.g., 1000-2000 IU 2-3 times weekly) until adequate spermatogenesis is achieved (often 3-6 months).
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (Safety and efficacy not established in pediatric patients. Not indicated for use in children.)
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. Monitor closely.
Dialysis:
Considerations: Data limited. Monitor closely.
Hepatic 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. Monitor closely.
Pharmacology
Mechanism of Action
Follitropin beta is a recombinant human follicle-stimulating hormone (rFSH). It binds to FSH receptors on granulosa cells in the ovarian follicles, stimulating follicular growth and development in women. In men, it acts on Sertoli cells in the testes to stimulate spermatogenesis.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 77% (subcutaneous)
Tmax:
10-16 hours (subcutaneous)
FoodEffect:
Not applicable (parenteral administration)
Distribution:
Vd:
Approximately 8-10 L (in women)
ProteinBinding:
Not extensively protein bound
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 12-70 hours (terminal half-life, highly variable)
Clearance:
Approximately 0.6 L/hour (in women)
ExcretionRoute:
Primarily renal (approximately 10% excreted unchanged in urine)
Unchanged:
Approximately 10%
Pharmacodynamics
OnsetOfAction:
Days (requires multiple doses for follicular development)
PeakEffect:
Varies with treatment cycle and individual response, typically observed with peak follicular growth and estradiol levels.
DurationOfAction:
Effects persist for several days after the last dose due to the half-life.
Confidence:
Medium
Safety & Warnings
BLACK BOX WARNING
Ovarian Hyperstimulation Syndrome (OHSS): Follistim AQ can cause Ovarian Hyperstimulation Syndrome (OHSS), a syndrome of sudden ovarian enlargement, ascites with or without pleural effusion, and/or thromboembolic events. OHSS can be severe and life-threatening. Multiple Births: Follistim AQ can cause multiple births. The risk of multiple births is increased with increasing numbers of follicles.
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 immediately or seek emergency medical attention:
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
Pale skin
Severe lung problems, which can be life-threatening. Watch for:
+ Shortness of breath or other breathing difficulties
+ Cough
+ Fever
Blood clots, which can be deadly. Seek help if you experience:
+ 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
Additional Urgent Side Effects for Females:
Unusual vaginal bleeding
Ovarian hyperstimulation syndrome (OHSS), a severe side effect that can occur in some individuals. Seek help if you experience:
+ Severe stomach pain or bloating
+ Very upset stomach, vomiting, or diarrhea
+ Significant weight gain
+ Shortness of breath
+ Change in urine output
Additional Urgent Side Effects for Males:
Enlarged breasts
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Irritation at the injection site
Upset stomach
Acne (pimples)
Headache
Feeling tired or weak
Additional Side Effects for Females:
Pelvic pain
Stomach pain
Reporting Side Effects
This list is not exhaustive, and you may experience other 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 or seek emergency medical attention:
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
Pale skin
Severe lung problems, which can be life-threatening. Watch for:
+ Shortness of breath or other breathing difficulties
+ Cough
+ Fever
Blood clots, which can be deadly. Seek help if you experience:
+ 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
Additional Urgent Side Effects for Females:
Unusual vaginal bleeding
Ovarian hyperstimulation syndrome (OHSS), a severe side effect that can occur in some individuals. Seek help if you experience:
+ Severe stomach pain or bloating
+ Very upset stomach, vomiting, or diarrhea
+ Significant weight gain
+ Shortness of breath
+ Change in urine output
Additional Urgent Side Effects for Males:
Enlarged breasts
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor:
Irritation at the injection site
Upset stomach
Acne (pimples)
Headache
Feeling tired or weak
Additional Side Effects for Females:
Pelvic pain
Stomach pain
Reporting Side Effects
This list is not exhaustive, and you may experience other 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 2 pounds in 24 hours)
- Decreased urination
- Shortness of breath or difficulty breathing
- Pain, swelling, or redness in your legs (signs of blood clot)
- Sudden, 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, 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 inability to produce sperm
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 determine whether it is safe to take this medication with your other treatments and health issues. Never start, stop, or adjust 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. 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, 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 inability to produce sperm
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 determine whether it is safe to take this medication with your other treatments and health issues. Never start, stop, or adjust 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 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
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) in individuals with certain health conditions, leading 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, or pale, sweaty, or clammy skin
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 during ovarian stimulation and discuss any concerns with your doctor.
Additional Risks and Considerations
The rate of pregnancy loss (miscarriage) may be higher with this medication compared to natural pregnancy; however, it is unclear whether the medication is the cause
Rarely, ovarian tumors have been reported in patients who have undergone repeated treatments with this medication to achieve pregnancy; the relationship between the medication and tumor development is unknown
* If you are breastfeeding, consult your doctor to discuss potential risks to your baby and determine the best course of action.
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 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
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) in individuals with certain health conditions, leading 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, or pale, sweaty, or clammy skin
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 during ovarian stimulation and discuss any concerns with your doctor.
Additional Risks and Considerations
The rate of pregnancy loss (miscarriage) may be higher with this medication compared to natural pregnancy; however, it is unclear whether the medication is the cause
Rarely, ovarian tumors have been reported in patients who have undergone repeated treatments with this medication to achieve pregnancy; the relationship between the medication and tumor development is unknown
* If you are breastfeeding, consult your doctor to discuss potential risks to your baby and determine the best course of action.
Overdose Information
Overdose Symptoms:
- Signs and symptoms of Ovarian Hyperstimulation Syndrome (OHSS)
- Severe abdominal pain
- Nausea and vomiting
- Diarrhea
- Rapid weight gain
- Shortness of breath
What to Do:
There is no specific antidote for follitropin beta overdose. Management is supportive and symptomatic, primarily focused on managing Ovarian Hyperstimulation Syndrome (OHSS). Seek immediate medical attention or call 1-800-222-1222 (Poison Control).
Drug Interactions
Monitoring
Baseline Monitoring
Complete fertility workup (including hormone levels like FSH, LH, Estradiol, Prolactin, Thyroid function)
Rationale: To assess baseline reproductive status and identify underlying causes of infertility.
Timing: Prior to initiation of treatment
Pelvic ultrasound
Rationale: To assess ovarian morphology, rule out cysts, and establish baseline follicular status.
Timing: Prior to initiation of treatment
Semen analysis (for male factor infertility)
Rationale: To assess male fertility potential if treating male hypogonadotropic hypogonadism.
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 treatment protocol and desired response (e.g., for COH, typically >1000-2000 pg/mL before hCG administration)
Action Threshold: Rapidly rising E2 levels or excessively high levels may indicate risk of OHSS; dose adjustment or cycle cancellation may be required.
Transvaginal ultrasound for follicular development
Frequency: Daily or every other day during stimulation phase
Target: Number and size of mature follicles (e.g., 1-3 follicles >18 mm for ovulation induction; multiple follicles >16-18 mm for COH)
Action Threshold: Excessive number of follicles or rapid growth may indicate risk of OHSS or multiple gestations; dose adjustment or cycle cancellation may be required.
Signs and symptoms of Ovarian Hyperstimulation Syndrome (OHSS)
Frequency: Daily during treatment and for 1-2 weeks post-hCG
Target: Absence of symptoms
Action Threshold: Abdominal pain, bloating, nausea, vomiting, diarrhea, weight gain, decreased urine output, shortness of breath. Seek immediate medical attention.
Symptom Monitoring
- Abdominal pain or discomfort
- Abdominal bloating or distension
- Nausea
- Vomiting
- Diarrhea
- Rapid weight gain
- Decreased urine output
- Shortness of breath
- Pain, redness, or swelling at injection site
Special Patient Groups
Pregnancy
Contraindicated in pregnant women. Follitropin beta is used to achieve pregnancy, not during pregnancy. There is no indication for use in pregnancy, and its use could harm the fetus.
Trimester-Specific Risks:
First Trimester:
Contraindicated. Potential for fetal harm.
Second Trimester:
Contraindicated. Potential for fetal harm.
Third Trimester:
Contraindicated. Potential for fetal harm.
Lactation
Contraindicated. It is not known whether follitropin beta is excreted in human milk. However, use is not recommended during lactation as it may suppress milk production and is not indicated for use in nursing mothers.
Infant Risk:
High (Potential for adverse effects on the infant and suppression of milk production in the mother.)
Pediatric Use
Safety and efficacy have not been established in pediatric patients. Not indicated for use in children.
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 for women in this age group. For male hypogonadotropic hypogonadism, use should be individualized and monitored.
Clinical Information
Clinical Pearls
- Follistim AQ is a highly purified recombinant FSH, reducing the risk of viral transmission compared to urine-derived products.
- Careful monitoring of follicular development via ultrasound and serum estradiol levels is critical to minimize the risk of OHSS and multiple gestations.
- Patients should be thoroughly educated on the signs and symptoms of OHSS and instructed to seek immediate medical attention if they occur.
- The 900 IU cartridge is designed for multiple doses and requires proper storage and handling, including refrigeration and protection from light.
- Patients should be trained on proper subcutaneous injection technique and needle disposal.
Alternative Therapies
- Follitropin alfa (e.g., Gonal-f)
- Urofollitropin (purified FSH from urine, e.g., Bravelle)
- Menotropins (hMG, contains FSH and LH, e.g., Menopur)
- Clomiphene citrate (oral ovulation stimulant)
- Letrozole (aromatase inhibitor, off-label for ovulation induction)
Cost & Coverage
Average Cost:
Price varies significantly by pharmacy and dosage. Typically several hundred to over a thousand dollars per cartridge. per 900 IU/1.08 mL cartridge
Insurance Coverage:
Specialty Tier (often requires prior authorization and is covered under medical or pharmacy benefits depending on plan)
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 emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.