Ovidrel 250mcg/0.5ml Inj(1 Syringe)
It is used to help people get pregnant. It may be given to you for other reasons. Talk with the doctor.
Drug Class
Gonadotropin
Pharmacologic Class
Recombinant Human Chorionic Gonadotropin (hCG) Analog
Pregnancy Category
Category X
FDA Approved
Sep 2000
DEA Schedule
Not Controlled
Overview
What is this medicine?
Ovidrel is a medication used in fertility treatments to help mature eggs in the ovaries and trigger their release (ovulation). It acts like a natural hormone in your body that signals the final step of egg development.
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 into the fatty tissue of the skin in the abdominal area. If you are self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
Before and after handling the medication, wash your hands thoroughly. Do not use the medication if the solution appears cloudy, is leaking, or contains particles. Additionally, do not use the solution if it has changed color.
Each prefilled syringe or pen is intended for single use only. Dispose of used needles in a designated needle/sharp disposal container. Do not reuse needles or any other components. When the disposal container is full, follow local regulations for proper disposal. If you have any questions or concerns, consult your doctor or pharmacist.
Storage and Disposal
Prefilled syringes or pens should be stored as directed. If you are unsure about storage or disposal procedures, consult your doctor or pharmacist.
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 into the fatty tissue of the skin in the abdominal area. If you are self-administering the injection, your doctor or nurse will provide guidance on the proper technique.
Before and after handling the medication, wash your hands thoroughly. Do not use the medication if the solution appears cloudy, is leaking, or contains particles. Additionally, do not use the solution if it has changed color.
Each prefilled syringe or pen is intended for single use only. Dispose of used needles in a designated needle/sharp disposal container. Do not reuse needles or any other components. When the disposal container is full, follow local regulations for proper disposal. If you have any questions or concerns, consult your doctor or pharmacist.
Storage and Disposal
Prefilled syringes or pens should be stored as directed. If you are unsure about storage or disposal procedures, 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 your doctor's instructions precisely regarding the timing of the injection and subsequent procedures (e.g., egg retrieval or intercourse).
- Report any signs of ovarian hyperstimulation syndrome (OHSS) immediately.
- Avoid strenuous exercise and sexual intercourse if you experience abdominal discomfort or are at high risk for OHSS.
- Maintain adequate hydration.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
250 mcg (0.5 mL) subcutaneously as a single dose
Dose Range:
250 - 250 mg
Condition-Specific Dosing:
ovulationInduction:
Administer 24-48 hours after the last dose of FSH, or when optimal follicular development is achieved.
assistedReproductiveTechnology:
Administer 24-48 hours after the last dose of FSH, or when optimal follicular development is achieved, typically 34-36 hours prior to oocyte retrieval.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended, use with caution.
Moderate:
No specific dose adjustment recommended, use with caution due to potential for accumulation.
Severe:
No specific dose adjustment recommended, use with caution due to potential for accumulation.
Dialysis:
Not studied; use with caution.
Hepatic Impairment:
Mild:
No specific dose adjustment recommended, use with caution.
Moderate:
No specific dose adjustment recommended, use with caution.
Severe:
No specific dose adjustment recommended, use with caution.
Pharmacology
Mechanism of Action
Choriogonadotropin alfa is a recombinant human chorionic gonadotropin (hCG) that binds to the luteinizing hormone (LH)/hCG receptor of granulosa and theca cells in the ovary. It mimics the natural LH surge, triggering final follicular maturation, resumption of meiosis in the oocyte, and rupture of the mature follicle (ovulation). In males, it stimulates Leydig cells to produce androgens.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 40%
Tmax:
Approximately 12-24 hours (single dose)
FoodEffect:
Not applicable (injectable)
Distribution:
Vd:
Approximately 6.0 L
ProteinBinding:
Not extensively studied, but generally low for peptide hormones.
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 29-30 hours
Clearance:
Not precisely quantified, primarily renal excretion.
ExcretionRoute:
Renal (urine)
Unchanged:
Significant portion excreted unchanged or as active metabolites.
Pharmacodynamics
OnsetOfAction:
Ovulation typically occurs 36-40 hours post-injection.
PeakEffect:
Peak serum levels achieved around 12-24 hours post-injection, leading to ovulation around 36-40 hours.
DurationOfAction:
Effects on ovulation are acute, leading to follicular rupture within 36-40 hours. The hormonal effects (e.g., progesterone production) persist for several days due to the half-life.
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 or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Neurological symptoms, such as:
+ Weakness on one side of the body
+ Trouble speaking or thinking
+ Change in balance
+ Drooping on one side of the face
+ Blurred eyesight
Signs of a blood clot, such as:
+ Chest pain or pressure
+ Coughing up blood
+ Shortness of breath
+ Swelling, warmth, numbness, change of color, or pain in a leg or arm
+ Trouble speaking or swallowing
Ovarian hyperstimulation syndrome (OHSS), a severe side effect that may occur in some individuals, characterized by:
+ Severe stomach pain or bloating
+ Very upset stomach, throwing up, or diarrhea
+ Significant weight gain
+ Shortness of breath
+ Change in urine output
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:
Pain at the injection site
Bruising at the injection site
Reporting Side Effects
This list is not exhaustive, and you may experience other 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 notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Neurological symptoms, such as:
+ Weakness on one side of the body
+ Trouble speaking or thinking
+ Change in balance
+ Drooping on one side of the face
+ Blurred eyesight
Signs of a blood clot, such as:
+ Chest pain or pressure
+ Coughing up blood
+ Shortness of breath
+ Swelling, warmth, numbness, change of color, or pain in a leg or arm
+ Trouble speaking or swallowing
Ovarian hyperstimulation syndrome (OHSS), a severe side effect that may occur in some individuals, characterized by:
+ Severe stomach pain or bloating
+ Very upset stomach, throwing up, or diarrhea
+ Significant weight gain
+ Shortness of breath
+ Change in urine output
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical help:
Pain at the injection site
Bruising at the injection site
Reporting Side Effects
This list is not exhaustive, and you may experience other 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 and vomiting
- Rapid weight gain (e.g., 2 pounds in 24 hours)
- Decreased urination
- Shortness of breath
- Pain or swelling in your legs
- Dizziness or faintness
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:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
Certain medical conditions, such as:
+ Adrenal gland disease
+ Brain tumor
+ Pituitary gland disease
+ Thyroid gland disease
Female reproductive health issues, including:
+ Tumors in the female organs
+ Enlarged ovaries or ovarian cysts
+ Unexplained vaginal bleeding
Primary ovarian failure, a condition where the ovaries no longer produce eggs
Pregnancy or potential pregnancy. Do not take this medication if you are pregnant, as it may cause harm.
Additionally, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Natural products and vitamins you are using
Any existing health problems
This information is crucial to ensure your safety while taking this medication. Do not start, stop, or modify the dosage of any medication without consulting your doctor first. It is your responsibility to verify that it is safe to take this medication with your other medications and health conditions.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
Certain medical conditions, such as:
+ Adrenal gland disease
+ Brain tumor
+ Pituitary gland disease
+ Thyroid gland disease
Female reproductive health issues, including:
+ Tumors in the female organs
+ Enlarged ovaries or ovarian cysts
+ Unexplained vaginal bleeding
Primary ovarian failure, a condition where the ovaries no longer produce eggs
Pregnancy or potential pregnancy. Do not take this medication if you are pregnant, as it may cause harm.
Additionally, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Natural products and vitamins you are using
Any existing health problems
This information is crucial to ensure your safety while taking this medication. Do not start, stop, or modify the dosage of any medication without consulting your doctor first. It is your responsibility to verify that it is safe to take this medication with your other medications and health conditions.
Precautions & Cautions
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 condition. Additionally, you will need to undergo ultrasounds while using this drug, and it is important to discuss the schedule and details with your doctor.
This medication may interfere with certain laboratory tests, so it is vital to notify all your healthcare providers and laboratory personnel that you are taking this drug. Furthermore, be aware that this medication may increase the risk of multiple pregnancies.
There is a risk of blood clots associated with this medication. If you have a history of blood clots, inform your doctor promptly and discuss the potential risks. This medication may also increase the risk of severe side effects, including ovarian enlargement and ovarian cyst rupture, which can be life-threatening in rare cases. Discuss these risks with your doctor to understand the potential consequences.
In some individuals with pre-existing health conditions, this medication may increase the risk of ovarian torsion, a condition where the ovary twists, cutting off blood flow. It is crucial to discuss this risk with your doctor, especially if you have any underlying health issues.
While undergoing ovarian stimulation with this medication, it is recommended to limit strenuous exercise. Consult with your doctor to determine a safe level of physical activity.
If you become pregnant or suspect you are pregnant while taking this medication, contact your doctor immediately, as it may harm the unborn baby. Additionally, if you are breastfeeding, inform your doctor to discuss the potential risks to your baby and determine the best course of action.
This medication may interfere with certain laboratory tests, so it is vital to notify all your healthcare providers and laboratory personnel that you are taking this drug. Furthermore, be aware that this medication may increase the risk of multiple pregnancies.
There is a risk of blood clots associated with this medication. If you have a history of blood clots, inform your doctor promptly and discuss the potential risks. This medication may also increase the risk of severe side effects, including ovarian enlargement and ovarian cyst rupture, which can be life-threatening in rare cases. Discuss these risks with your doctor to understand the potential consequences.
In some individuals with pre-existing health conditions, this medication may increase the risk of ovarian torsion, a condition where the ovary twists, cutting off blood flow. It is crucial to discuss this risk with your doctor, especially if you have any underlying health issues.
While undergoing ovarian stimulation with this medication, it is recommended to limit strenuous exercise. Consult with your doctor to determine a safe level of physical activity.
If you become pregnant or suspect you are pregnant while taking this medication, contact your doctor immediately, as it may harm the unborn baby. Additionally, if you are breastfeeding, inform your doctor to discuss the potential risks to your baby and determine the best course of action.
Overdose Information
Overdose Symptoms:
- Symptoms of severe Ovarian Hyperstimulation Syndrome (OHSS) such as severe abdominal pain, ascites, pleural effusion, oliguria, dyspnea, hypovolemia, electrolyte imbalance, hemoconcentration, and thromboembolic events.
What to Do:
Seek immediate medical attention. Management is supportive and may include hospitalization, fluid and electrolyte management, pain control, and monitoring for complications. Call 1-800-222-1222 (Poison Control) for advice.
Drug Interactions
Monitoring
Baseline Monitoring
Pregnancy test
Rationale: To rule out existing pregnancy before initiating treatment.
Timing: Prior to administration
Ovarian ultrasound
Rationale: To assess follicular development and rule out ovarian cysts or other abnormalities.
Timing: Prior to administration and during FSH stimulation
Routine Monitoring
Ovarian ultrasound
Frequency: Daily or every other day during FSH stimulation
Target: Follicles reaching appropriate size (e.g., >17-18 mm)
Action Threshold: Administer Ovidrel when criteria for follicular maturity are met.
Serum estradiol (E2) levels
Frequency: Daily or every other day during FSH stimulation
Target: Levels consistent with appropriate follicular development (e.g., 200-300 pg/mL per mature follicle)
Action Threshold: High levels may indicate risk of OHSS; adjust FSH dose or withhold Ovidrel.
Signs and symptoms of Ovarian Hyperstimulation Syndrome (OHSS)
Frequency: Daily monitoring during treatment and for 1-2 weeks post-injection
Target: Absence of symptoms
Action Threshold: If symptoms develop (e.g., abdominal pain, bloating, nausea, vomiting, weight gain, decreased urination), seek immediate medical attention.
Symptom Monitoring
- Abdominal pain or discomfort
- Abdominal bloating or distension
- Nausea
- Vomiting
- Diarrhea
- Rapid weight gain (more than 2 pounds in 24 hours)
- Decreased urination
- Shortness of breath
- Pain or swelling in the legs
- Dizziness or faintness
Special Patient Groups
Pregnancy
Contraindicated in pregnant women. Ovidrel is used to achieve pregnancy, not during pregnancy. If pregnancy occurs, discontinue use.
Trimester-Specific Risks:
First Trimester:
Contraindicated
Second Trimester:
Contraindicated
Third Trimester:
Contraindicated
Lactation
It is not known whether choriogonadotropin alfa is excreted in human milk. Caution should be exercised when Ovidrel is administered to a nursing woman. The decision to discontinue nursing or to discontinue the drug should take into account the importance of the drug to the mother.
Infant Risk:
Unknown, potential for hormonal effects on infant.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established. Not indicated for pediatric use.
Geriatric Use
Safety and effectiveness in geriatric patients have not been established. Not indicated for geriatric use in fertility treatments.
Clinical Information
Clinical Pearls
- The timing of Ovidrel administration is critical for successful ovulation induction or oocyte retrieval. It must be given precisely as instructed by the physician.
- Patients should be thoroughly counseled on the signs and symptoms of Ovarian Hyperstimulation Syndrome (OHSS) and instructed to seek immediate medical attention if they occur.
- Ovidrel can increase the risk of multiple gestations (e.g., twins, triplets), which carries higher risks for both mother and babies.
- This medication is for subcutaneous injection only. Patients should be trained on proper self-injection technique.
- False positive pregnancy tests can occur if tested too soon after Ovidrel administration due to the presence of hCG from the medication itself.
Alternative Therapies
- Other human chorionic gonadotropin (hCG) products (e.g., Novarel, Pregnyl - derived from human urine)
- GnRH agonists (e.g., leuprolide) used as an ovulation trigger in specific ART protocols (e.g., GnRH antagonist cycles to reduce OHSS risk).
Cost & Coverage
Average Cost:
$200 - $400 per 250 mcg syringe
Generic Available:
Yes
Insurance Coverage:
Tier 3 or Specialty Tier (requires prior authorization)
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 your 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 medication taken, the amount, and the time it occurred.