Follistim AQ Cartg 600iu Inj 0.72ml
It is used to help people get pregnant. It is used to help make sperm.
Drug Class
Infertility agent; Gonadotropin
Pharmacologic Class
Recombinant Human Follicle-Stimulating Hormone (r-hFSH)
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 is given as an injection under the skin.
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 the injection, your doctor or nurse will provide guidance on the proper technique.
Preparation and Administration
1. Wash your hands before and after handling the medication.
2. Rotate the injection site as directed by your doctor to minimize the risk of adverse reactions.
3. If the medication has been refrigerated, allow it to reach room temperature before administering a dose.
4. Inspect the solution for cloudiness, leakage, or particles, and do not use if any of these conditions are present. Additionally, do not use the medication if the solution has changed color.
5. Avoid injecting the medication into skin that is tender, bruised, red, or hard.
Important Safety Precautions
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 dose being administered.
Remove all pen needle covers before injecting a dose (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.
Dispose of used 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.
Sharing and Storage
Do not share pen or cartridge devices with another person, even if the needle has been changed, as this can increase the risk of transmitting infections.
* Store the medication according to the manufacturer's instructions and dispose of it properly when it is no longer needed.
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 the injection, your doctor or nurse will provide guidance on the proper technique.
Preparation and Administration
1. Wash your hands before and after handling the medication.
2. Rotate the injection site as directed by your doctor to minimize the risk of adverse reactions.
3. If the medication has been refrigerated, allow it to reach room temperature before administering a dose.
4. Inspect the solution for cloudiness, leakage, or particles, and do not use if any of these conditions are present. Additionally, do not use the medication if the solution has changed color.
5. Avoid injecting the medication into skin that is tender, bruised, red, or hard.
Important Safety Precautions
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 dose being administered.
Remove all pen needle covers before injecting a dose (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.
Dispose of used 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.
Sharing and Storage
Do not share pen or cartridge devices with another person, even if the needle has been changed, as this can increase the risk of transmitting infections.
* Store the medication according to the manufacturer's instructions and dispose of it properly when it is no longer needed.
Missed Dose
If you miss a dose, contact your doctor to determine the best course of action.
Lifestyle & Tips
- Follow your doctor's instructions carefully regarding dose and timing of injections.
- Attend all scheduled appointments for blood tests and ultrasounds, as these are crucial for monitoring your response and preventing complications.
- Avoid sexual intercourse or use barrier contraception during treatment and for several days after hCG administration to reduce the risk of multiple pregnancies and ovarian hyperstimulation syndrome (OHSS).
- Report any unusual symptoms immediately to your healthcare provider.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Highly individualized based on patient response. For anovulation (WHO Group II): Initial 75 IU/day SC for 7-14 days. For Assisted Reproductive Technology (ART): Initial 150-225 IU/day SC for 5 days.
Dose Range:
75 - 450 mg
Condition-Specific Dosing:
anovulation:
Initial 75 IU/day SC for 7-14 days. Dose adjustments of 37.5-75 IU may be made at 7-day intervals. Max daily dose 225 IU. Once response is achieved, administer hCG.
assisted_reproductive_technology:
Initial 150-225 IU/day SC for 5 days. Dose adjustments of 37.5-75 IU may be made based on ovarian response, not more frequently than every 2 days. Max daily dose 450 IU. Once sufficient follicular development is achieved, administer hCG.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (not indicated for pediatric use for fertility treatment)
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:
Not available
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 (r-hFSH) that stimulates ovarian follicular growth in women who do not have primary ovarian failure. It binds to FSH receptors on granulosa cells, leading to follicular maturation, estrogen production, and ovulation when followed by human chorionic gonadotropin (hCG) administration.
Pharmacokinetics
Absorption:
Bioavailability:
77% (subcutaneous)
Tmax:
10-16 hours (subcutaneous)
FoodEffect:
Not applicable (parenteral administration)
Distribution:
Vd:
Not available (complex distribution kinetics)
ProteinBinding:
Not significantly protein bound
CnssPenetration:
Limited
Elimination:
HalfLife:
12-70 hours (terminal half-life, highly variable)
Clearance:
Not available (complex elimination kinetics)
ExcretionRoute:
Primarily renal (approximately 10% excreted unchanged in urine)
Unchanged:
Approximately 10%
Pharmacodynamics
OnsetOfAction:
Days (requires multiple doses for follicular development)
PeakEffect:
Variable, depends on follicular response and estradiol levels
DurationOfAction:
Variable, depends on follicular response and estradiol levels
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
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 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. 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
Most people do not experience severe side effects, but some may occur. If you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
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 is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, 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
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 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. 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
Most people do not experience severe side effects, but some may occur. If you experience any of the following side effects, contact your doctor or seek medical attention if they bother you or do not go away:
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 is not a comprehensive list of all possible side effects. If you have questions or concerns about side effects, 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)
- Decreased urination
- Shortness of breath or difficulty breathing
- Pain, swelling, or redness in your leg or arm
- Sudden chest pain
- 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:
For All Patients:
- Any known allergies to this drug, its components, or other substances, including foods and medications. Describe the allergic reaction and its symptoms.
- Presence of certain health conditions, including:
- Adrenal gland disease
- Brain tumor
- Breast cancer or other cancers that are hormone-sensitive
- Pituitary gland disease
- Thyroid gland disease
For Female Patients:
- Presence of tumors in the female reproductive organs
- Enlarged ovaries or ovarian cysts
- Unexplained vaginal bleeding
- Primary ovarian failure (when the ovaries no longer produce eggs)
- Infertility due to reproductive organ issues
- Pregnancy or suspected pregnancy. This medication is contraindicated during pregnancy, and a pregnancy test will be conducted before initiating treatment to confirm that you are not pregnant.
For Male Patients:
- Inability to produce sperm
- Presence of tumors in the male reproductive organs
General Considerations:
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. Ensure that it is safe to take this medication alongside your other treatments and health conditions. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following conditions before starting this medication:
For All Patients:
- Any known allergies to this drug, its components, or other substances, including foods and medications. Describe the allergic reaction and its symptoms.
- Presence of certain health conditions, including:
- Adrenal gland disease
- Brain tumor
- Breast cancer or other cancers that are hormone-sensitive
- Pituitary gland disease
- Thyroid gland disease
For Female Patients:
- Presence of tumors in the female reproductive organs
- Enlarged ovaries or ovarian cysts
- Unexplained vaginal bleeding
- Primary ovarian failure (when the ovaries no longer produce eggs)
- Infertility due to reproductive organ issues
- Pregnancy or suspected pregnancy. This medication is contraindicated during pregnancy, and a pregnancy test will be conducted before initiating treatment to confirm that you are not pregnant.
For Male Patients:
- Inability to produce sperm
- Presence of tumors in the male reproductive organs
General Considerations:
This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. Ensure that it is safe to take this medication alongside your other treatments and health conditions. Never start, stop, or adjust the dosage of any medication without first 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. 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 regular ultrasound examinations as directed by your doctor. Be aware that this medication may increase your chances of becoming pregnant with multiple babies. It may also increase the risk of severe side effects, including enlarged ovaries and ovarian cysts that can rupture, which in rare cases can be life-threatening. Discuss these risks with your doctor.
If your ovaries become enlarged, your doctor may advise you to avoid sexual intercourse, as it may cause an ovarian cyst to rupture. Talk to your doctor about this risk.
This medication may also increase the risk of ovarian torsion (twisting of the ovaries) in individuals with certain health conditions, which can cut off blood flow to the ovary. Discuss this risk with your doctor.
Furthermore, the risk of ectopic pregnancy (pregnancy outside the uterus) may be increased in some individuals. If you have questions or concerns, discuss them with your doctor. Seek immediate medical attention if you experience symptoms such as vaginal bleeding, nausea or vomiting, stomach pain, pelvic or rectal pain, shoulder or neck pain, dizziness, fainting, rapid heartbeat, pale, sweaty, or clammy skin, confusion, or other severe or unusual effects.
Additional Precautions
While undergoing ovarian stimulation with this medication, limit your physical activity and discuss any concerns with your doctor.
Pregnancy Loss and Other Risks
The rate of pregnancy loss (miscarriage) is higher with medications like this one compared to natural pregnancies. However, it is unclear whether this medication is the cause of this increased risk. If you have questions, discuss them with your doctor.
Rarely, ovarian tumors have been reported in patients who have undergone repeated treatments with medications like this one to become pregnant. The relationship between this medication and ovarian tumors is unclear. If you have questions, discuss them with your doctor.
Breastfeeding
If you are breastfeeding, inform your doctor, as you will need to discuss any potential risks to your baby.
It is essential to 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 regular ultrasound examinations as directed by your doctor. Be aware that this medication may increase your chances of becoming pregnant with multiple babies. It may also increase the risk of severe side effects, including enlarged ovaries and ovarian cysts that can rupture, which in rare cases can be life-threatening. Discuss these risks with your doctor.
If your ovaries become enlarged, your doctor may advise you to avoid sexual intercourse, as it may cause an ovarian cyst to rupture. Talk to your doctor about this risk.
This medication may also increase the risk of ovarian torsion (twisting of the ovaries) in individuals with certain health conditions, which can cut off blood flow to the ovary. Discuss this risk with your doctor.
Furthermore, the risk of ectopic pregnancy (pregnancy outside the uterus) may be increased in some individuals. If you have questions or concerns, discuss them with your doctor. Seek immediate medical attention if you experience symptoms such as vaginal bleeding, nausea or vomiting, stomach pain, pelvic or rectal pain, shoulder or neck pain, dizziness, fainting, rapid heartbeat, pale, sweaty, or clammy skin, confusion, or other severe or unusual effects.
Additional Precautions
While undergoing ovarian stimulation with this medication, limit your physical activity and discuss any concerns with your doctor.
Pregnancy Loss and Other Risks
The rate of pregnancy loss (miscarriage) is higher with medications like this one compared to natural pregnancies. However, it is unclear whether this medication is the cause of this increased risk. If you have questions, discuss them with your doctor.
Rarely, ovarian tumors have been reported in patients who have undergone repeated treatments with medications like this one to become pregnant. The relationship between this medication and ovarian tumors is unclear. If you have questions, discuss them with your doctor.
Breastfeeding
If you are breastfeeding, inform your doctor, as you will need to discuss any potential risks to your baby.
Overdose Information
Overdose Symptoms:
- Ovarian Hyperstimulation Syndrome (OHSS) with severe symptoms (e.g., severe abdominal pain, ascites, pleural effusion, oliguria, hypovolemia, electrolyte imbalance, thromboembolism)
- Multiple gestations
What to Do:
There is no specific antidote. Management is supportive and symptomatic, primarily focusing on managing OHSS. This may include hospitalization, fluid and electrolyte management, pain control, and monitoring for complications like thromboembolism. Call 1-800-222-1222 (Poison Control) or seek immediate medical attention.
Drug Interactions
Monitoring
Baseline Monitoring
Serum FSH, LH, Estradiol (E2)
Rationale: To assess baseline ovarian function and rule out primary ovarian failure.
Timing: Prior to initiation of treatment
Transvaginal Ultrasound
Rationale: To assess baseline ovarian morphology and rule out ovarian cysts.
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
Prolactin Levels
Rationale: To rule out hyperprolactinemia.
Timing: Prior to initiation of treatment
Routine Monitoring
Serum Estradiol (E2) levels
Frequency: Every 1-3 days during stimulation phase
Target: Increases with follicular growth, specific targets vary by protocol and clinic (e.g., 200-600 pg/mL per mature follicle for ART)
Action Threshold: Rapid rise or excessively high levels (e.g., >4000 pg/mL) may indicate risk of OHSS; consider withholding hCG.
Transvaginal Ultrasound (Follicular Monitoring)
Frequency: Every 1-3 days during stimulation phase
Target: Follicles reaching 16-20 mm in diameter (for mature follicles)
Action Threshold: Excessive number of mature follicles (e.g., >20) or rapid growth may indicate risk of OHSS; consider withholding hCG.
Symptom Monitoring
- Signs and symptoms of Ovarian Hyperstimulation Syndrome (OHSS): abdominal pain, bloating, nausea, vomiting, diarrhea, rapid weight gain, decreased urination, shortness of breath.
- Signs of injection site reactions: pain, redness, swelling, bruising.
- Symptoms of thromboembolic events: pain, swelling, warmth, redness in an extremity; sudden chest pain, shortness of breath.
Special Patient Groups
Pregnancy
Contraindicated in pregnant women. This drug is used to achieve pregnancy, not during pregnancy. Use during pregnancy may cause fetal harm.
Trimester-Specific Risks:
First Trimester:
Contraindicated
Second Trimester:
Contraindicated
Third Trimester:
Contraindicated
Lactation
Not recommended during lactation. It is not known if follitropin beta is excreted in human milk. However, gonadotropins are large proteins and unlikely to pass into milk in significant amounts. The potential for adverse effects on the infant or interference with lactation is unknown. Given its use in fertility, it is generally not used in breastfeeding women.
Infant Risk:
Risk L5 (Contraindicated/Hazardous)
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Not indicated for use in pediatric patients.
Geriatric Use
Safety and effectiveness in geriatric patients have not been established. Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Not indicated for use in geriatric patients.
Clinical Information
Clinical Pearls
- Follitropin beta is a highly purified recombinant FSH, generally well-tolerated with a low risk of allergic reactions compared to urinary-derived gonadotropins.
- Dosing is highly individualized and requires careful monitoring of ovarian response (estradiol levels and follicular ultrasound) to optimize outcomes and minimize the risk of Ovarian Hyperstimulation Syndrome (OHSS) and multiple gestations.
- Patients should be thoroughly counseled on the risks of OHSS and multiple pregnancies before starting treatment.
- The Follistim AQ Cartridge is designed for use with the Follistim Pen, allowing for precise and convenient self-administration.
- Refrigeration is required for storage, but the cartridge can be stored at room temperature for a limited time after first use (up to 28 days).
Alternative Therapies
- Follitropin alfa (Gonal-f)
- Urofollitropin (Bravelle, Fertinex)
- Menotropins (Menopur, Repronex) - contain both FSH and LH activity
- Clomiphene citrate (Clomid, Serophene) - oral ovulation stimulant
- Letrozole (Femara) - aromatase inhibitor, off-label for ovulation induction
Cost & Coverage
Average Cost:
$1000 - $2000+ per 600 IU cartridge
Insurance Coverage:
Specialty Tier (requires prior authorization, often limited to specific fertility diagnoses)
General Drug Facts
If your symptoms or health issues persist or worsen, it'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.