Usage
Urofollitropin is prescribed for the treatment of infertility in women. Specifically, it is used for:
- Ovulation induction: Stimulating ovulation in women who have problems with ovulation, including those with polycystic ovary syndrome (PCOS) who have not responded to clomiphene citrate.
- Controlled ovarian stimulation: Used in assisted reproductive technologies (ART) such as in-vitro fertilization (IVF) to stimulate the ovaries to produce multiple eggs.
It is classified as a gonadotropin, a type of hormone that affects the ovaries or testicles.
Urofollitropin mimics the action of follicle-stimulating hormone (FSH), a naturally occurring hormone. It works by stimulating the growth and development of ovarian follicles, which contain eggs, ultimately leading to the maturation and release of eggs.
Alternate Names
Urofollitropin is also known as uFSH (purified urofollitropin).
Some brand names include Bravelle® (discontinued in the US), Fertinex®, and Metrodin®.
How It Works
Pharmacodynamics: Urofollitropin binds to FSH receptors on granulosa cells in the ovaries. This binding triggers a cascade of intracellular events, leading to follicular growth and development, increased estrogen production, and ultimately, the maturation and release of one or more mature eggs.
Pharmacokinetics:
- Absorption: Urofollitropin is administered subcutaneously (SC) or intramuscularly (IM). SC administration results in slower absorption compared to IM.
- Metabolism: The metabolism of urofollitropin is not fully characterized.
- Elimination: Limited information is available on the elimination of urofollitropin.
Dosage
Standard Dosage
Adults:
Ovulation induction:
Starting dose is typically 75-150 IU daily, administered SC or IM. The dose may be adjusted based on individual response and monitoring. The maximum dose is usually 225 IU daily for this indication.
Controlled ovarian stimulation (ART):
Initial dose of 150-225 IU daily, SC or IM, starting on day 2 or 3 of the menstrual cycle. Dosages are titrated upwards in increments of 75-150 IU every two days or more based on ovarian response and estradiol levels, up to a maximum of 450 IU per day. Treatment generally should not exceed 12 days. Once adequate follicular development is achieved, human chorionic gonadotropin (hCG) is administered to trigger final maturation and release of the eggs.
Children: Use is not recommended.
Special Cases:
- Elderly Patients: Limited data. Use with caution.
- Patients with Renal Impairment: No specific dosage adjustment guidelines are available. Careful monitoring is recommended.
- Patients with Hepatic Dysfunction: No specific dosage adjustment guidelines are available. Careful monitoring is recommended.
- Patients with Comorbid Conditions: Caution in patients with a history of thromboembolic events or risk factors for them.
Clinical Use Cases
Urofollitropin is not typically used in settings like intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations. Its use is limited to infertility treatment in specific clinical settings under careful monitoring by fertility specialists.
Side Effects
Common Side Effects:
- Headache
- Abdominal pain, bloating, or cramping
- Nausea, vomiting, diarrhea
- Breast tenderness or pain
- Hot flashes
- Injection site reactions (pain, redness, swelling)
Rare but Serious Side Effects:
- Ovarian Hyperstimulation Syndrome (OHSS): Symptoms can include severe abdominal pain, bloating, nausea, vomiting, rapid weight gain, decreased urination, and shortness of breath. This condition can be life-threatening and requires immediate medical attention.
- Multiple pregnancies: Urofollitropin increases the risk of twins, triplets, or higher-order multiple pregnancies.
- Ectopic pregnancy
- Thromboembolic events (blood clots)
- Allergic reactions, including anaphylaxis
Long-Term Effects:
The long-term effects of urofollitropin use are not well-established.
Contraindications
- Hypersensitivity to urofollitropin
- Primary ovarian failure
- Uncontrolled thyroid or adrenal dysfunction
- Pituitary tumors
- Sex hormone-dependent tumors (e.g., of the breast, uterus, or ovary)
- Undiagnosed abnormal vaginal bleeding
- Ovarian cysts or enlargement not due to PCOS
- Pregnancy
Drug Interactions
Limited information is available regarding specific drug interactions with urofollitropin. Concomitant use with clomiphene citrate may enhance the follicular response.
Pregnancy and Breastfeeding
Urofollitropin is contraindicated in pregnancy (Pregnancy Category X). Although used to induce pregnancy, it can cause fetal harm if used during pregnancy. It is unknown if it is excreted in breast milk. Use with caution while breastfeeding.
Drug Profile Summary
- Mechanism of Action: Stimulates follicular growth and development in the ovaries, leading to egg maturation and release.
- Side Effects: Common: Headache, abdominal pain, nausea, breast tenderness. Serious: OHSS, multiple pregnancies, thromboembolic events.
- Contraindications: Pregnancy, primary ovarian failure, uncontrolled thyroid or adrenal dysfunction, pituitary tumors, sex hormone-dependent tumors.
- Drug Interactions: Limited information available.
- Pregnancy & Breastfeeding: Contraindicated in pregnancy. Use with caution during breastfeeding.
- Dosage: Varies based on indication and individual response. See detailed dosage section.
- Monitoring Parameters: Ovarian response via ultrasound and serum estradiol levels.
Popular Combinations
Urofollitropin is sometimes used in combination with menotropins (hMG) in ART protocols, particularly for controlled ovarian stimulation.
Precautions
- Thorough pre-treatment evaluation to exclude contraindications and assess baseline hormonal levels.
- Close monitoring of ovarian response to avoid OHSS.
- Patient counseling regarding the risk of multiple pregnancies and other potential complications.
- Use with caution in patients with risk factors for thromboembolism.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Urofollitropin?
A: The dosage is individualized based on the patient’s response and the indication (ovulation induction vs. controlled ovarian stimulation for ART). See the detailed dosage section above.
Q2: What are the most serious side effects of Urofollitropin?
A: Ovarian Hyperstimulation Syndrome (OHSS), multiple pregnancies, and thromboembolic events (blood clots).
Q3: Can Urofollitropin be used in patients with PCOS?
A: Yes, urofollitropin can be used for ovulation induction in women with PCOS who haven’t responded to clomiphene citrate.
Q4: What monitoring is required during Urofollitropin treatment?
A: Regular monitoring of ovarian response via ultrasound and serum estradiol levels is essential.
Q5: Is Urofollitropin safe to use during pregnancy?
A: No, urofollitropin is contraindicated during pregnancy. It can cause fetal harm.
Q6: What are the signs and symptoms of OHSS?
A: Severe abdominal pain, bloating, nausea, vomiting, rapid weight gain, decreased urination, shortness of breath.
Q7: How is Urofollitropin administered?
A: It is administered by subcutaneous (under the skin) or intramuscular (into a muscle) injection.
Q8: What is the difference between Urofollitropin and other gonadotropins like hMG?
A: Urofollitropin is a purified form of FSH, while hMG contains both FSH and LH.
Q9: What are the contraindications for using Urofollitropin?
A: See the contraindications section for a detailed list, including hypersensitivity, primary ovarian failure, certain tumors, and pregnancy.
