Follistim AQ (dlvring 600iu) 0.72ml
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
Oct 1997
DEA Schedule
Not Controlled
Overview
What is this medicine?
Follistim AQ is a medicine that contains a hormone called FSH (follicle-stimulating hormone). In women, it helps the ovaries produce and mature eggs. In men, it helps the testes produce sperm. It is used to treat certain types of infertility.
How to Use This Medicine
Proper Administration of This Medication
To ensure safe and effective use, follow your doctor's instructions and the information provided with this medication. 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.
3. If the medication is stored in the refrigerator, allow it to reach room temperature before administering a dose.
4. Inspect the solution before use; do not administer if it appears cloudy, is leaking, or contains particles. Additionally, do not use the solution if it has changed color.
5. Avoid injecting into skin that is tender, bruised, red, or hard.
6. Note that the device may produce a clicking sound while preparing the dose. However, do not rely on the number of clicks to determine the correct dose.
7. Remove all pen needle covers before injecting a dose (you may have two covers).
8. If you are unsure about the type of pen needle or how to use it, consult your doctor.
Disposal and Safety Precautions
1. Dispose of used needles in a designated needle/sharp disposal box.
2. Do not reuse needles or other items.
3. When the disposal box is full, follow local regulations for proper disposal.
4. If you have questions or concerns, consult your doctor or pharmacist.
5. Do not share the pen or cartridge devices with another person, even if the needle has been changed, as this can transmit infections.
Storage and Disposal
Follow the storage instructions provided with the medication.
Missed Dose
If you miss a dose, contact your doctor for guidance on what to do next.
To ensure safe and effective use, follow your doctor's instructions and the information provided with this medication. 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.
3. If the medication is stored in the refrigerator, allow it to reach room temperature before administering a dose.
4. Inspect the solution before use; do not administer if it appears cloudy, is leaking, or contains particles. Additionally, do not use the solution if it has changed color.
5. Avoid injecting into skin that is tender, bruised, red, or hard.
6. Note that the device may produce a clicking sound while preparing the dose. However, do not rely on the number of clicks to determine the correct dose.
7. Remove all pen needle covers before injecting a dose (you may have two covers).
8. If you are unsure about the type of pen needle or how to use it, consult your doctor.
Disposal and Safety Precautions
1. Dispose of used needles in a designated needle/sharp disposal box.
2. Do not reuse needles or other items.
3. When the disposal box is full, follow local regulations for proper disposal.
4. If you have questions or concerns, consult your doctor or pharmacist.
5. Do not share the pen or cartridge devices with another person, even if the needle has been changed, as this can transmit infections.
Storage and Disposal
Follow the storage instructions provided with the medication.
Missed Dose
If you miss a dose, contact your doctor for guidance on what to do next.
Lifestyle & Tips
- Learn proper self-injection technique from your healthcare provider.
- Store Follistim AQ in the refrigerator (2°C to 8°C / 36°F to 46°F) and protect from light. Do not freeze.
- Once opened, the Follistim AQ pen can be stored for up to 28 days at room temperature (2°C to 25°C / 36°F to 77°F) or in the refrigerator.
- Follow your doctor's instructions for monitoring appointments (blood tests and ultrasounds) very closely, as these are crucial for safe and effective treatment.
- Avoid sexual intercourse or use barrier contraception during treatment and for a few days after the last injection to reduce the risk of multiple pregnancies, especially if hCG is administered.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Highly individualized based on indication and patient response. Examples: Ovulation Induction: Initial 50 IU/day for 7 days, adjusted by 25-50 IU/day weekly. Controlled Ovarian Hyperstimulation (ART): Initial 150-225 IU/day for 5-7 days, adjusted based on response. Spermatogenesis Induction (males): 450 IU/week (e.g., 150 IU 3 times a week) with hCG.
Dose Range:
50 - 450 mg
Condition-Specific Dosing:
Ovulation Induction:
Initial 50 IU/day for 7 days, adjust by 25-50 IU/day at weekly intervals. Max 250 IU/day.
Controlled Ovarian Hyperstimulation (ART):
Initial 150-225 IU/day for 5-7 days, adjust based on ovarian response. Max 450 IU/day.
Spermatogenesis Induction (males with hypogonadotropic hypogonadism):
450 IU/week (e.g., 150 IU 3 times a week) in combination with hCG.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (safety and efficacy not established for pediatric patients)
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.
Dialysis:
Considerations: No specific data, but caution advised due to potential for altered pharmacokinetics.
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.
Pharmacology
Mechanism of Action
Follitropin beta is a recombinant human follicle-stimulating hormone (rFSH). It binds to FSH receptors on the granulosa cells of the ovarian follicle in women and Sertoli cells in the testes in men, stimulating follicular growth and maturation in women, and spermatogenesis in men.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 77% (subcutaneous)
Tmax:
Approximately 10 hours (subcutaneous)
FoodEffect:
Not applicable (administered by injection)
Distribution:
Vd:
Approximately 8-10 L
ProteinBinding:
Not significantly protein bound
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 12-70 hours (average 24-48 hours)
Clearance:
Approximately 0.6 L/hour
ExcretionRoute:
Primarily renal (small amount of intact hormone)
Unchanged:
< 3% (renal)
Pharmacodynamics
OnsetOfAction:
Not acutely measurable; effects are seen over days to weeks (follicular growth, estradiol increase).
PeakEffect:
Peak follicular response and estradiol levels are typically observed after several days of treatment, guided by monitoring.
DurationOfAction:
Effects persist as long as treatment continues and for a period after discontinuation, depending on the half-life and physiological response.
Safety & Warnings
BLACK BOX WARNING
Ovarian Hyperstimulation Syndrome (OHSS): Follistim AQ can cause severe OHSS, a syndrome of sudden ovarian enlargement, ascites with or without pain, and/or pleural effusion. OHSS can be life-threatening. Multiple Births: Follistim AQ can result in multiple births, including triplet or more, which carries increased risks for both the mother and the fetuses.
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 can be identified by:
+ 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
Female Patients:
Abnormal 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
Male Patients:
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 or seek medical attention if they bother you or do not go away:
Irritation at the injection site
Upset stomach
Acne (pimples)
Headache
Fatigue or weakness
Female Patients:
Pelvic pain
Stomach pain
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 can be identified by:
+ 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
Female Patients:
Abnormal 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
Male Patients:
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 or seek medical attention if they bother you or do not go away:
Irritation at the injection site
Upset stomach
Acne (pimples)
Headache
Fatigue or weakness
Female Patients:
Pelvic pain
Stomach pain
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
- Rapid weight gain (more than 2 pounds in a day)
- Decreased urination
- Difficulty breathing or shortness of breath
- Pain, warmth, redness, or swelling in your leg (signs of a blood clot)
- Sudden severe headache or vision changes
- Signs of an allergic reaction: rash, itching, hives, swelling of the face, lips, tongue, or throat, 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 to ensure safe treatment:
For All Patients:
- Any known allergies to this medication, its components, or other substances, including foods and drugs. Describe the allergic reaction and its symptoms.
- Presence of certain health conditions, such as adrenal gland disease, brain tumor, breast cancer, cancers that are hormone-sensitive, pituitary gland disease, or thyroid gland disease.
For Female Patients:
- Health issues related to female organs, including tumors, enlarged ovaries, ovarian cysts, or unexplained vaginal bleeding.
- Primary ovarian failure, where the ovaries no longer produce eggs.
- Infertility due to reproductive organ problems.
- Pregnancy or potential pregnancy. This medication is contraindicated during pregnancy. A pregnancy test will be required before initiating treatment to confirm that you are not pregnant.
For Male Patients:
- Inability to produce sperm or 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. This will help determine the safety of taking this medication alongside your other treatments and health conditions. Never 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 to ensure safe treatment:
For All Patients:
- Any known allergies to this medication, its components, or other substances, including foods and drugs. Describe the allergic reaction and its symptoms.
- Presence of certain health conditions, such as adrenal gland disease, brain tumor, breast cancer, cancers that are hormone-sensitive, pituitary gland disease, or thyroid gland disease.
For Female Patients:
- Health issues related to female organs, including tumors, enlarged ovaries, ovarian cysts, or unexplained vaginal bleeding.
- Primary ovarian failure, where the ovaries no longer produce eggs.
- Infertility due to reproductive organ problems.
- Pregnancy or potential pregnancy. This medication is contraindicated during pregnancy. A pregnancy test will be required before initiating treatment to confirm that you are not pregnant.
For Male Patients:
- Inability to produce sperm or 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. This will help determine the safety of taking this medication alongside your other treatments and health conditions. Never 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. 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 may rupture, which can be life-threatening
Potential for ovarian torsion (twisting of the ovaries), particularly in individuals with certain health conditions, which can disrupt blood flow to the ovary
Increased risk of ectopic pregnancy (pregnancy outside the uterus), 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. Additionally, it is recommended to limit strenuous exercise during ovarian stimulation, as directed by your doctor.
Pregnancy and Breastfeeding 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 this medication to conceive, but it is unknown whether the medication is the cause. If you have questions or concerns, discuss them with your doctor.
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. 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 may rupture, which can be life-threatening
Potential for ovarian torsion (twisting of the ovaries), particularly in individuals with certain health conditions, which can disrupt blood flow to the ovary
Increased risk of ectopic pregnancy (pregnancy outside the uterus), 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. Additionally, it is recommended to limit strenuous exercise during ovarian stimulation, as directed by your doctor.
Pregnancy and Breastfeeding 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 this medication to conceive, but it is unknown whether the medication is the cause. If you have questions or concerns, discuss them with your doctor.
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) characterized by severe abdominal pain, bloating, nausea, vomiting, diarrhea, rapid weight gain, decreased urine output, and potentially fluid accumulation in the abdomen and chest.
- Multiple gestations (pregnancy with more than one fetus).
What to Do:
Seek immediate medical attention. Management of OHSS is supportive and may include hospitalization, fluid and electrolyte management, pain control, and monitoring for complications like thromboembolism. Call 1-800-222-1222 (Poison Control) for further guidance if needed.
Drug Interactions
Monitoring
Baseline Monitoring
Pregnancy test
Rationale: To rule out existing pregnancy before starting treatment.
Timing: Prior to initiation of therapy
Thyroid and adrenal function tests
Rationale: To rule out underlying endocrine disorders that may affect fertility.
Timing: Prior to initiation of therapy
Prolactin levels
Rationale: To rule out hyperprolactinemia.
Timing: Prior to initiation of therapy
Pelvic ultrasound
Rationale: To assess ovarian morphology and rule out ovarian cysts.
Timing: Prior to initiation of therapy
Semen analysis (for male factor infertility)
Rationale: To assess male fertility status.
Timing: Prior to initiation of therapy
Routine Monitoring
Serum estradiol (E2) levels
Frequency: Daily or every other day during stimulation phase
Target: Varies based on protocol and desired response (e.g., typically 150-300 pg/mL per mature follicle for ART)
Action Threshold: Rapid rise or excessively high levels may indicate risk of OHSS; low levels may indicate inadequate response.
Transvaginal ultrasound (follicular development and endometrial thickness)
Frequency: Daily or every other day during stimulation phase
Target: Follicles typically 17-20 mm for ovulation induction; endometrial thickness > 7 mm
Action Threshold: Excessive number of large follicles or rapid growth may indicate risk of OHSS or multiple gestation; inadequate growth indicates poor response.
Symptom Monitoring
- Signs and symptoms of Ovarian Hyperstimulation Syndrome (OHSS): abdominal pain, bloating, nausea, vomiting, diarrhea, rapid weight gain, decreased urine output, dyspnea, calf pain, chest pain.
- Signs of allergic reactions: rash, itching, swelling, severe dizziness, trouble breathing.
- Symptoms of thromboembolic events: pain, warmth, redness, numbness, or tingling in an arm or leg; sudden severe headache or fainting; vision changes; chest pain; shortness of breath; sudden cough; coughing up blood.
Special Patient Groups
Pregnancy
Follistim AQ is contraindicated in pregnant women. It is used to achieve pregnancy, but once pregnancy is confirmed, treatment should be discontinued.
Trimester-Specific Risks:
First Trimester:
Contraindicated. Potential for adverse effects on fetal development if continued.
Second Trimester:
Contraindicated.
Third Trimester:
Contraindicated.
Lactation
It is not known if follitropin beta is excreted in human milk. However, use of Follistim AQ is not recommended during lactation as it may suppress milk production and is not indicated for use in nursing mothers.
Infant Risk:
Risk L5 (Contraindicated) - potential for adverse effects on infant and milk production.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Not indicated for use in children.
Geriatric Use
Safety and effectiveness in geriatric patients have not been established. Not indicated for use in geriatric patients for fertility treatment.
Clinical Information
Clinical Pearls
- Follistim AQ is a highly potent gonadotropin; careful monitoring of ovarian response (serum estradiol and ultrasound) is essential to minimize the risk of OHSS and multiple gestations.
- Patients should be thoroughly counseled on the risks of OHSS and multiple births before starting treatment.
- The 600 IU/0.72 mL pen is designed for multiple doses; patients must be instructed on proper storage and handling after first use.
- Individualized dosing is critical; starting doses and adjustments should be based on patient's clinical profile, previous response to gonadotropins, and ovarian reserve markers.
- In male patients with hypogonadotropic hypogonadism, Follistim AQ must be administered concurrently with hCG for spermatogenesis induction.
Alternative Therapies
- Other recombinant FSH products (e.g., Gonal-f [follitropin alfa])
- Human Menopausal Gonadotropin (hMG) products (e.g., Menopur, Repronex - contain FSH and LH activity)
- Urinary-derived FSH products (e.g., Bravelle - discontinued in US, but similar products exist)
- Clomiphene citrate (oral ovulation stimulant)
- Letrozole (aromatase inhibitor, oral ovulation stimulant)
Cost & Coverage
Average Cost:
Varies widely, typically several hundred to over a thousand USD per pen/cartridge per 600 IU/0.72 mL pen
Insurance Coverage:
Specialty Tier (Tier 3 or 4) or requires prior authorization; often covered under fertility benefits if available.
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 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.