Follistim AQ (dlvring 300iu) 0.36ml
It is used to help people get pregnant. It is used to help make sperm.
Drug Class
Gonadotropin
Pharmacologic Class
Follicle-stimulating hormone (FSH) analog
Pregnancy Category
Category X
FDA Approved
Sep 1997
DEA Schedule
Not Controlled
Overview
What is this medicine?
Follistim AQ is a medication that contains a hormone called FSH (follicle-stimulating hormone). It is used to help women's ovaries produce eggs, either for pregnancy through natural conception or with assisted reproductive technologies like IVF. It works by stimulating the growth of follicles (sacs containing eggs) in the ovaries.
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 instruct you 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 stored in the refrigerator, allow it to reach room temperature before administering a dose.
4. Inspect the solution before use; do not use if it appears cloudy, is leaking, or contains particles. Additionally, do not use if the solution has changed color.
5. Avoid injecting into skin that is tender, bruised, red, or hard.
Important Administration Notes
This product may produce a clicking sound when preparing the dose. However, do not rely on the clicks to determine the correct 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 another person, even if the needle has been changed, as this can transmit infections from one person to another, including infections you may not be aware of.
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 instruct you 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 stored in the refrigerator, allow it to reach room temperature before administering a dose.
4. Inspect the solution before use; do not use if it appears cloudy, is leaking, or contains particles. Additionally, do not use if the solution has changed color.
5. Avoid injecting into skin that is tender, bruised, red, or hard.
Important Administration Notes
This product may produce a clicking sound when preparing the dose. However, do not rely on the clicks to determine the correct 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 another person, even if the needle has been changed, as this can transmit infections from one person to another, including infections you may not be aware of.
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 during treatment.
- Avoid alcohol and smoking as they can negatively impact fertility.
- Maintain a healthy weight.
- Report any unusual symptoms immediately to your healthcare provider.
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:
anovulatoryInfertility:
Initial: 50 IU/day for 7 days. Adjust by 25-50 IU at weekly intervals based on ovarian response (estradiol levels and follicular development). Max daily dose: 225 IU. Treatment duration typically up to 35 days.
controlledOvarianHyperstimulationART:
Initial: 150-225 IU/day for 5-7 days. Adjust based on ovarian response. Max daily dose: 450 IU. Treatment duration typically 10-12 days. Once adequate follicular development is achieved, hCG is administered.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (not indicated for pediatric use for fertility)
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, but monitor response closely.
Moderate:
No specific dose adjustment recommended, but monitor response closely.
Severe:
No specific dose adjustment recommended, but monitor response closely. Excretion is primarily renal, so caution is advised.
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 (FSH) that stimulates ovarian follicular growth in women who do not have primary ovarian failure. It binds to FSH receptors on the granulosa cells of the ovarian follicle, promoting follicular maturation, and stimulating estrogen production. In men, it stimulates spermatogenesis in the presence of adequate endogenous or exogenous luteinizing hormone (LH).
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 77% (subcutaneous)
Tmax:
Approximately 10 hours (after subcutaneous administration)
FoodEffect:
Not applicable (parenteral administration)
Distribution:
Vd:
Approximately 8 L
ProteinBinding:
Not significantly protein bound
CnssPenetration:
No
Elimination:
HalfLife:
Approximately 12-70 hours (variable, often cited as 12-24 hours after single dose, longer with multiple doses)
Clearance:
Approximately 0.6 L/hour
ExcretionRoute:
Renal (primarily)
Unchanged:
Approximately 10-15% (renal excretion)
Pharmacodynamics
OnsetOfAction:
Gradual, with follicular development typically observed within days of initiation.
PeakEffect:
Peak estradiol levels and follicular size are typically observed after several days of treatment, leading to ovulation or oocyte retrieval.
DurationOfAction:
Dependent on continued administration and half-life; effects persist for several days after discontinuation.
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 notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction, including:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Pale skin
Severe lung problems, 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
Female Patients:
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
Male Patients:
Enlarged breasts (gynecomastia)
Other Possible Side Effects
Most people experience few or no side effects while taking this medication. However, some individuals may encounter mild or moderate side effects. If you experience any of the following symptoms, contact your doctor if they bother you or persist:
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, consult 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 notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction, including:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Pale skin
Severe lung problems, 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
Female Patients:
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
Male Patients:
Enlarged breasts (gynecomastia)
Other Possible Side Effects
Most people experience few or no side effects while taking this medication. However, some individuals may encounter mild or moderate side effects. If you experience any of the following symptoms, contact your doctor if they bother you or persist:
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, consult 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 (e.g., more than 2 pounds in a day)
- Shortness of breath or difficulty breathing
- Decreased urination
- Pain or swelling in your legs or arms
- Dizziness or faintness
- Unusual vaginal bleeding
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, 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. 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. 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 first consulting 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, 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. 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. 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 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. 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 (e.g., twins, triplets)
Higher risk of severe side effects, including:
+ Enlarged ovaries (ovarian hyperstimulation syndrome)
+ Ovarian cysts that may rupture, which can be life-threatening in rare cases
If your ovaries become overstimulated, your doctor may advise you to avoid sexual intercourse to prevent the risk of an ovarian cyst rupture
Potential increased risk of ovarian torsion (twisting of the ovaries), which can cut off blood flow to the ovary, particularly in individuals with pre-existing health conditions
Higher chance 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 or vomiting
+ Abdominal or pelvic pain
+ Shoulder or neck pain
+ Dizziness or fainting
+ Rapid heartbeat
+ Pale, sweaty, or clammy skin
+ Confusion or other severe or unusual effects
Additional Precautions
Limit strenuous exercise while undergoing ovarian stimulation, as advised by your doctor
Be aware that the risk of pregnancy loss (miscarriage) may be higher with this medication compared to natural pregnancy; however, it is unclear if the medication is the cause of this increased risk
Rarely, ovarian tumors have been reported in patients who have undergone repeated fertility treatments; it is uncertain if this medication is the cause, and you should discuss any concerns with your doctor
Breastfeeding Considerations
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 (e.g., twins, triplets)
Higher risk of severe side effects, including:
+ Enlarged ovaries (ovarian hyperstimulation syndrome)
+ Ovarian cysts that may rupture, which can be life-threatening in rare cases
If your ovaries become overstimulated, your doctor may advise you to avoid sexual intercourse to prevent the risk of an ovarian cyst rupture
Potential increased risk of ovarian torsion (twisting of the ovaries), which can cut off blood flow to the ovary, particularly in individuals with pre-existing health conditions
Higher chance 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 or vomiting
+ Abdominal or pelvic pain
+ Shoulder or neck pain
+ Dizziness or fainting
+ Rapid heartbeat
+ Pale, sweaty, or clammy skin
+ Confusion or other severe or unusual effects
Additional Precautions
Limit strenuous exercise while undergoing ovarian stimulation, as advised by your doctor
Be aware that the risk of pregnancy loss (miscarriage) may be higher with this medication compared to natural pregnancy; however, it is unclear if the medication is the cause of this increased risk
Rarely, ovarian tumors have been reported in patients who have undergone repeated fertility treatments; it is uncertain if this medication is the cause, and you should discuss any concerns with your doctor
Breastfeeding Considerations
If you are breastfeeding, inform your doctor, as you will need to discuss any potential risks to your baby.
Overdose Information
Overdose Symptoms:
- Severe Ovarian Hyperstimulation Syndrome (OHSS)
- Multiple gestations (though not a direct symptom of overdose, it's a significant risk of excessive stimulation)
What to Do:
There is no specific antidote. Management is supportive, primarily for Ovarian Hyperstimulation Syndrome (OHSS). Seek immediate medical attention. Call 1-800-222-1222 (Poison Control).
Drug Interactions
Monitoring
Baseline Monitoring
Serum FSH, LH, Estradiol (E2), Prolactin, TSH
Rationale: To assess baseline hormonal status and rule out primary ovarian failure or other endocrine disorders.
Timing: Prior to initiation of treatment
Pelvic ultrasound
Rationale: To assess baseline ovarian morphology, rule out ovarian cysts, and evaluate endometrial thickness.
Timing: Prior to initiation of treatment
Semen analysis (male partner)
Rationale: To assess male factor infertility.
Timing: Prior to initiation of treatment
Routine Monitoring
Serum Estradiol (E2) levels
Frequency: Daily or every other day during stimulation phase
Target: Increases indicative of follicular growth; specific targets vary by protocol and clinic.
Action Threshold: Rapidly rising E2 levels or very high E2 levels may indicate risk of Ovarian Hyperstimulation Syndrome (OHSS) or multiple gestations, requiring dose adjustment or cycle cancellation.
Transvaginal ultrasound
Frequency: Daily or every other day during stimulation phase
Target: Follicular size (e.g., dominant follicle(s) 17-20 mm for ovulation induction, multiple follicles 16-18 mm for ART); endometrial thickness (e.g., >7-8 mm).
Action Threshold: Insufficient follicular growth, excessive number of follicles, or signs of OHSS may require dose adjustment or cycle cancellation.
Symptom Monitoring
- Abdominal pain or discomfort
- Abdominal bloating or distension
- Nausea
- Vomiting
- Diarrhea
- Rapid weight gain (more than 2 lbs/day)
- Decreased urine output
- Shortness of breath or difficulty breathing
- Pain or swelling in the legs
- Dizziness or faintness
Special Patient Groups
Pregnancy
Contraindicated in pregnant women. This drug is used to achieve pregnancy, not during pregnancy. Discontinue immediately if pregnancy occurs.
Trimester-Specific Risks:
First Trimester:
Contraindicated
Second Trimester:
Contraindicated
Third Trimester:
Contraindicated
Lactation
Not recommended during lactation. Follitropin beta may suppress milk production and is not indicated for use in nursing mothers.
Infant Risk:
Low direct risk to infant, but potential for reduced milk supply.
Pediatric Use
Not indicated for pediatric use. Safety and efficacy have not been established in pediatric patients.
Geriatric Use
Not indicated for geriatric patients. 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
- Follitropin beta dosing is highly individualized and requires careful monitoring of ovarian response (serum estradiol levels and transvaginal ultrasound) to 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 pen is a pre-filled, multi-dose device designed for ease of use, but proper injection technique must be taught to the patient.
- Consider cycle cancellation if ovarian response is excessive (e.g., too many large follicles, rapidly rising estradiol levels) to prevent severe OHSS.
- This medication is often used in conjunction with other fertility drugs, such as GnRH agonists/antagonists and hCG.
Alternative Therapies
- Follitropin alfa (e.g., Gonal-f, Ovidrel)
- Menotropins (hMG, e.g., Menopur, Repronex) - contain both FSH and LH activity
- Urofollitropin (purified FSH, e.g., Bravelle)
- Clomiphene citrate (oral ovulation stimulant)
- Letrozole (aromatase inhibitor, off-label for ovulation induction)
Cost & Coverage
Average Cost:
Varies significantly, typically $500-$1500+ per 300 IU pen
Insurance Coverage:
Tier 3 or Specialty Tier (requires prior authorization, often not covered by all plans for fertility treatment)
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, 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 discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek 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.