Follistim AQ (dlvring 900iu) 1.08ml
It is used to help people get pregnant. It is used to help make sperm.
Drug Class
Gonadotropin
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 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 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.
Preparation and Administration
1. Wash your hands before and after handling the medication.
2. Rotate the injection site as directed by your doctor.
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 solution if it has changed color.
5. Avoid injecting into skin that is tender, bruised, red, or hard.
Important Administration Notes
You may hear a clicking sound when preparing the dose. Do not rely on the number of clicks to determine the dose, as this could result in an incorrect dose.
Remove all pen needle covers before injecting a dose (you may have two covers).
If you are unsure about the type of pen needle you have or how to use it, consult your doctor.
Disposal and Safety Precautions
Dispose of used needles in a designated needle/sharp disposal box. Do not reuse needles or other items.
When the disposal box is full, follow local regulations for proper disposal.
Consult your doctor or pharmacist if you have any questions or concerns.
* Do not share pen or cartridge devices with others, even if the needle has been changed, as this can transmit infections, including those you may not be aware of.
Storage and Disposal
Follow the storage instructions provided with the medication. If you have any questions or concerns, consult your doctor or pharmacist.
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.
Preparation and Administration
1. Wash your hands before and after handling the medication.
2. Rotate the injection site as directed by your doctor.
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 solution if it has changed color.
5. Avoid injecting into skin that is tender, bruised, red, or hard.
Important Administration Notes
You may hear a clicking sound when preparing the dose. Do not rely on the number of clicks to determine the dose, as this could result in an incorrect dose.
Remove all pen needle covers before injecting a dose (you may have two covers).
If you are unsure about the type of pen needle you have or how to use it, consult your doctor.
Disposal and Safety Precautions
Dispose of used needles in a designated needle/sharp disposal box. Do not reuse needles or other items.
When the disposal box is full, follow local regulations for proper disposal.
Consult your doctor or pharmacist if you have any questions or concerns.
* Do not share pen or cartridge devices with others, even if the needle has been changed, as this can transmit infections, including those you may not be aware of.
Storage and Disposal
Follow the storage instructions provided with the medication. If you have any questions or concerns, consult your doctor or pharmacist.
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 dosing and administration.
- Learn proper self-injection technique from a healthcare professional.
- Keep all appointments for monitoring (blood tests and ultrasounds) as these are crucial for safe and effective treatment.
- Avoid sexual intercourse or use barrier contraception during the treatment cycle and for a few days after hCG administration to reduce the risk of multiple pregnancies or if OHSS is a concern.
- Report any signs of Ovarian Hyperstimulation Syndrome (OHSS) immediately.
- Store the medication as directed (refrigerated, protect from light).
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Highly individualized based on patient response and indication.
Dose Range:
50 - 450 mg
Condition-Specific Dosing:
Ovulation Induction (anovulatory infertility):
Initial: 50 IU/day subcutaneously for 7 days. Adjust dose by 25-50 IU at weekly intervals based on ovarian response (estradiol levels and follicular development). Max daily dose: 200 IU. Administer hCG when adequate follicular development is achieved.
Controlled Ovarian Hyperstimulation (COH) for ART:
Initial: 150-225 IU/day subcutaneously for the first 5-7 days of stimulation. Adjust dose based on ovarian response. Max daily dose: 450 IU. Administer hCG when adequate follicular development is achieved.
Spermatogenesis Induction (male hypogonadotropic hypogonadism):
450 IU/week subcutaneously, usually divided into 3 doses per week (e.g., 150 IU three times weekly), in conjunction with hCG (e.g., 1500 IU three times weekly). 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)
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, but monitor response closely.
Moderate:
No specific dose adjustment recommended, but monitor response closely.
Severe:
No specific dose adjustment recommended, but monitor response closely. Caution advised due to primary renal excretion.
Dialysis:
No specific recommendations. Caution advised.
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) that binds to FSH receptors on granulosa cells of the ovarian follicle and Sertoli cells of the testis. In women, it stimulates follicular growth and maturation in the ovary. In men, in conjunction with human chorionic gonadotropin (hCG), it stimulates spermatogenesis in individuals with primary or secondary hypogonadotropic hypogonadism.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 77% (subcutaneous)
Tmax:
10-16 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 12-70 hours (terminal half-life, highly variable)
Clearance:
Approximately 0.6 L/hour (after IV administration)
ExcretionRoute:
Primarily renal (approximately 10% of administered dose excreted unchanged in urine)
Unchanged:
Approximately 10%
Pharmacodynamics
OnsetOfAction:
Not acutely measurable; effects on follicular growth are observed over days to weeks.
PeakEffect:
Peak follicular response and estradiol levels are typically observed after several days to a week of treatment.
DurationOfAction:
Effects persist as long as treatment continues and for a period after cessation, depending on the half-life and follicular development stage.
Safety & Warnings
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 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, characterized by:
+ Shortness of breath
+ Other breathing difficulties
+ Cough
+ Fever
Blood clots, which may cause:
+ Chest, arm, back, neck, or jaw pain or pressure
+ Coughing up blood
+ Numbness or weakness on one side of the body
+ Trouble speaking or thinking
+ Change in balance
+ Change in eyesight
+ Shortness of breath
+ Swelling, warmth, or pain in the leg or arm
Sex-Specific Side Effects:
Females:
+ Unusual vaginal bleeding
+ Ovarian hyperstimulation syndrome (OHSS), a severe side effect that may 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 Possible Side Effects
Most people taking this medication will not experience severe side effects. However, some may occur. If you experience any of the following side effects, contact your doctor if they bother you or do not go away:
Injection site irritation
Upset stomach
Acne (pimples)
Headache
Fatigue or weakness
Females:
+ Pelvic pain
+ Stomach pain
Reporting Side Effects
This is not an exhaustive list of 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, 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 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, characterized by:
+ Shortness of breath
+ Other breathing difficulties
+ Cough
+ Fever
Blood clots, which may cause:
+ Chest, arm, back, neck, or jaw pain or pressure
+ Coughing up blood
+ Numbness or weakness on one side of the body
+ Trouble speaking or thinking
+ Change in balance
+ Change in eyesight
+ Shortness of breath
+ Swelling, warmth, or pain in the leg or arm
Sex-Specific Side Effects:
Females:
+ Unusual vaginal bleeding
+ Ovarian hyperstimulation syndrome (OHSS), a severe side effect that may 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 Possible Side Effects
Most people taking this medication will not experience severe side effects. However, some may occur. If you experience any of the following side effects, contact your doctor if they bother you or do not go away:
Injection site irritation
Upset stomach
Acne (pimples)
Headache
Fatigue or weakness
Females:
+ Pelvic pain
+ Stomach pain
Reporting Side Effects
This is not an exhaustive list of 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 that doesn't go away
- Sudden weight gain (more than 2 pounds in a day)
- Shortness of breath or difficulty breathing
- Decreased urination
- Pain, redness, or swelling at the injection site that worsens
- Signs of an allergic reaction (rash, itching, hives, swelling of the face/lips/tongue/throat, severe dizziness, trouble breathing)
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following conditions before starting this medication:
Any allergies you have, including allergies to this drug, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
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 other medications and health conditions. Do not start, stop, or adjust the dosage of any medication without consulting your doctor first.
It is essential to inform your doctor about the following conditions before starting this medication:
Any allergies you have, including allergies to this drug, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
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 other medications and health conditions. Do not start, stop, or adjust the dosage of any medication without consulting your doctor first.
Precautions & Cautions
Important Information for All Patients Taking This Medication
It is 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 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 crucial to discuss the following potential risks with your doctor:
Increased chance of multiple pregnancies (e.g., twins, triplets)
Elevated risk of severe side effects, including ovarian enlargement and rupture of ovarian cysts, which can be life-threatening
Potential for ovarian torsion (twisting of the ovaries), particularly in individuals with certain health conditions, which can disrupt 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 to limit strenuous exercise during ovarian stimulation; consult your doctor for guidance.
Additional Risks and Considerations
The rate of pregnancy loss (miscarriage) is higher with medications like this one compared to natural pregnancies; however, it is unclear whether this medication is the cause
Rarely, ovarian tumors have been reported in patients who have undergone repeated treatments with medications like this one to conceive; it is uncertain whether this medication is the cause
* If you are breastfeeding, consult 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. 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 crucial to discuss the following potential risks with your doctor:
Increased chance of multiple pregnancies (e.g., twins, triplets)
Elevated risk of severe side effects, including ovarian enlargement and rupture of ovarian cysts, which can be life-threatening
Potential for ovarian torsion (twisting of the ovaries), particularly in individuals with certain health conditions, which can disrupt 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 to limit strenuous exercise during ovarian stimulation; consult your doctor for guidance.
Additional Risks and Considerations
The rate of pregnancy loss (miscarriage) is higher with medications like this one compared to natural pregnancies; however, it is unclear whether this medication is the cause
Rarely, ovarian tumors have been reported in patients who have undergone repeated treatments with medications like this one to conceive; it is uncertain whether this medication is the cause
* 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:
- Severe Ovarian Hyperstimulation Syndrome (OHSS)
- Multiple pregnancies (including high-order multiples)
What to Do:
Seek immediate medical attention. Management of OHSS is supportive and may require hospitalization. There is no specific antidote. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Monitoring
Baseline Monitoring
Complete gynecological examination (women)
Rationale: To rule out primary ovarian failure, uterine/tubal abnormalities, or other contraindications.
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 tests
Rationale: To rule out underlying 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
Ovarian reserve assessment (e.g., FSH, AMH, antral follicle count)
Rationale: To predict ovarian response and guide initial dosing.
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 (e.g., 200-600 pg/mL per mature follicle for COH)
Action Threshold: Rapid rise or excessively high levels may indicate risk of OHSS; slow rise may indicate inadequate response.
Transvaginal Ultrasound (follicular monitoring)
Frequency: Daily or every other day during stimulation phase
Target: Follicles typically 17-20 mm in diameter for mature follicles
Action Threshold: Excessive number of developing follicles or rapid growth may indicate risk of OHSS; inadequate growth may indicate need for dose adjustment.
Signs and symptoms of Ovarian Hyperstimulation Syndrome (OHSS)
Frequency: Daily during stimulation and for 1-2 weeks post-hCG
Target: Absence of symptoms
Action Threshold: Abdominal pain, bloating, nausea, vomiting, diarrhea, weight gain, dyspnea, oliguria. Requires immediate medical evaluation.
Symptom Monitoring
- Abdominal pain or discomfort
- Bloating
- Nausea
- Vomiting
- Diarrhea
- Weight gain
- Shortness of breath
- Decreased urination
- Injection site reactions (pain, redness, swelling, bruising)
- Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
Special Patient Groups
Pregnancy
Contraindicated in pregnant women. Follitropin beta is used to achieve pregnancy, but once pregnancy is confirmed, treatment should be discontinued.
Trimester-Specific Risks:
First Trimester:
Contraindicated. No known benefit, potential risk of fetal harm.
Second Trimester:
Contraindicated.
Third Trimester:
Contraindicated.
Lactation
Not recommended during breastfeeding. It is not known if follitropin beta is excreted in human milk. However, gonadotropins may suppress lactation.
Infant Risk:
L5 (Contraindicated/Hazardous - potential for adverse effects on the infant and/or milk production).
Pediatric Use
Not indicated for pediatric use. Safety and effectiveness in pediatric patients have not been established.
Geriatric Use
Not indicated for geriatric use. Clinical studies did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Fertility treatment is generally not applicable to this age group.
Clinical Information
Clinical Pearls
- Follistim AQ is a highly potent gonadotropin; careful monitoring of ovarian response (estradiol levels and ultrasound) is critical to minimize the risk of Ovarian Hyperstimulation Syndrome (OHSS) and multiple gestations.
- The 900 IU/1.08 mL pen is designed for multiple doses. Patients must be carefully instructed on proper storage, handling, and self-injection technique, including dose dialing.
- Patients should be advised on the increased risk of multiple pregnancies (including high-order multiples) and the associated risks to both mother and fetuses.
- Treatment cycles should be cancelled if ovarian response is excessive to prevent severe OHSS.
- In male patients, treatment for spermatogenesis induction is prolonged, often requiring 3-6 months or more to see results, and requires concomitant hCG administration.
Alternative Therapies
- Other recombinant FSH products (e.g., Gonal-f [follitropin alfa])
- Urinary-derived gonadotropins (e.g., Menopur [menotropins], Bravelle [urofollitropin])
- Clomiphene citrate (oral ovulation stimulant)
- Letrozole (aromatase inhibitor, used off-label for ovulation induction)
- Human Chorionic Gonadotropin (hCG) for ovulation trigger or male hypogonadism (often used in conjunction with FSH)
Cost & Coverage
Average Cost:
Highly variable, typically $1000 - $5000+ per 900 IU/1.08 mL pen
Insurance Coverage:
Specialty Tier (requires prior authorization, often subject to high co-pays or co-insurance)
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.