Menotropins

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

This medicine is injected under the skin. You may be shown how to use injections at home. Do not self-inject this medicine if you do not understand how to give the injection and properly dispose of used needles and syringes.

Menotropins come in a powder medicine that must be mixed with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medicine.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Gently swirl the medicine after mixing. Do not shake the mixed medicine or it may foam. Prepare your dose only when you are ready to give an injection, do not save it for later use. Do not use if the mixture has changed colors or has particles in it. Call your pharmacist for new medicine.

You may need to use more than 1 vial of menotropins for your entire dose.

After giving the injection, throw away any portion of the mixed medicine that is not used right away. Do not save it for later use.

For the best results from your fertility treatments, follow your doctor's instructions very carefully.

Use a disposable needle and syringe only once. Follow any state or local laws about throwing away used needles and syringes. Use a puncture-proof "sharps" disposal container (ask your pharmacist where to get one and how to throw it away). Keep this container out of the reach of children and pets.

To be sure the medicine is effective, you will need frequent blood tests and ultrasound exams. You may also need to record your temperature on a daily chart.

Store unmixed powder medicine at room temperature away from moisture, heat, and light.

You may also store the powder in a refrigerator. Do not freeze.

Infertility is often treated with a combination of drugs. Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.

Call your doctor for instructions if you miss a dose of menotropins.

Menopur: For multiple follicle development and pregnancy in ovulatory women as part of an assisted reproductive technology (ART) cycle

Repronex: In conjunction with hCG to for multiple follicular development (controlled ovarian stimulation) and ovulation induction in women who have previously received GnRH agonist or antagonist for pituitary suppression

Limitations of use: Prior to therapy, preform a complete gynecologic exam and endocrinologic evaluation to diagnose the cause of infertility; exclude the possibility of pregnancy; evaluate the fertility status of the male partner; exclude a diagnosis of primary ovarian failure.

Ovulation induction (females): Repronex: IM, SubQ: Initial: 150 units once daily for the first 5 days of treatment. Adjustments should not be made more frequently than once every 2 days and should not exceed 75-150 units per adjustment based on ultrasound monitoring of ovarian response and/or measurement of serum estradiol levels. Maximum daily dose: 450 units; treatment >12 days is not recommended. If patient's response is appropriate, administer hCG one day following the last dose of Repronex. Hold dose if serum estradiol is >2000 pg/mL, if the ovaries are abnormally enlarged, or if abdominal pain occurs; the patient should also be advised to refrain from intercourse. May repeat process if follicular development is inadequate or if pregnancy does not occur.

Assisted reproductive technologies (ART) (females):

Menopur: SubQ: Initial: 225 units once daily beginning on cycle day 2 or 3; Menotropins may be administered together with urofollitropin and the total initial dose of both products combined should not exceed 225 units (menotropins 150 units and urofollitropin 75 units; or menotropins 75 units and urofollitropin 150 units). Dose should be adjusted after 5 days based on ultrasound monitoring of ovarian response and/or measurement of serum estradiol levels. Do not make additional adjustments more frequently than once every 2 days or by >150 units. Maximum daily dose: 450 units (of menotropins, or menotropins plus urofollitropin); treatment >20 days is not recommended. Once adequate follicular development is evident, hCG should be administered. Withhold the hCG dose if ovarian monitoring suggests an increased risk of ovarian hyperstimulation syndrome (OHSS).

Repronex: IM, SubQ: Initial: 225 units once daily; adjustments in dose based on ultrasound monitoring of ovarian response and/or measurement of serum estradiol levels should not be made more frequently than once every 2 days and should not exceed more than 75-150 units per adjustment. Maximum daily dose: 450 units; treatment >12 days is not recommended. Once adequate follicular development is evident, hCG should be administered to induce final follicular maturation in preparation for oocyte retrieval. Withhold the hCG dose if ovarian monitoring suggests an increased risk of OHSS.

Spermatogenesis (males) (off-label use): IM: Following pretreatment with hCG: 75 units 3 times per week with hCG twice weekly until sperm is detected in the ejaculate (4-6 months); if response is inadequate after 6 months, may increase menotropins dosage to 150 units 3 times per week for another 6 months (AACE, 2002)

Menopur: Reconstitute with sodium chloride 0.9% for injection (provided); gently swirl to dissolve, do not shake to avoid formation of bubbles. Use immediately after reconstitution. May also be mixed with Bravelle (urofollitropin for injection).

Repronex: Reconstitute with sodium chloride 0.9% injection (provided).

If more than 1 vial of menotropins is required for a single dose, up to 6 vials can be reconstituted and administered as a single injection. This is done by first reconstituting 1 vial with sodium chloride 0.9% injection as previously described, withdrawing the entire contents of the reconstituted vial, and (using this as the diluent for the second vial) injecting into the second vial, etc. Use immediately after reconstitution.

After reconstitution inject immediately; discard any unused portion.

There are no known significant interactions.

Concerns related to adverse effects:

• Hypersensitivity: Hypersensitivity and anaphylactic reactions have been reported; discontinue use for serious reactions and treat appropriately.

• Ovarian enlargement: May be accompanied by abdominal distention and/or abdominal pain and generally regresses without treatment within 2-3 weeks. If ovaries are abnormally enlarged on the last day of treatment, withhold hCG to reduce the risk of ovarian hyperstimulation syndrome (OHSS). Intercourse should be avoided with significant ovarian enlargement.

• Ovarian hyperstimulation syndrome: Ovarian hyperstimulation syndrome (OHSS) is a rare exaggerated response to ovulation induction therapy (Corbett 2014; Fiedler 2012). This syndrome may begin within 24 hours of treatment but may become most severe 7 to 10 days after therapy (Corbett 2014). Symptoms of mild/moderate OHSS may include abdominal distention/discomfort, diarrhea, nausea, and/or vomiting. Severe OHSS symptoms may include severe abdominal pain, anuria/oliguria, ascites, severe dyspnea, hypotension, or nausea/vomiting (intractable). Decreased creatinine clearance, hemoconcentration, hypoproteinemia, elevated liver enzymes, elevated WBC, and electrolyte imbalances may also be present (ASRM 2016; Corbett 2014; Fiedler 2012). Treatment is primarily symptomatic and includes fluid and electrolyte management, analgesics, and prevention of thromboembolic complications (ASRM 2016; SOGC-CFAS 2011). Therapy with gonadotropins should be stopped.

• Ovarian neoplasms: Benign and malignant neoplasms have been reported (infrequently) in women receiving multiple-drug therapy for controlled ovarian stimulation; causal effect has not been established.

• Ovarian torsion: Has been reported following gonadotropin treatment; may be related to OHSS, prior ovarian torsion, prior or current ovarian cyst, polycystic ovaries, pregnancy, or prior abdominal surgery. Early diagnosis and prompt detorsion may limit the extent of ovarian damage.

• Pulmonary effects: Serious pulmonary conditions (atelectasis, acute respiratory distress syndrome, and exacerbation of asthma) have been reported.

• Thromboembolism: In association with and separate from ovarian hyperstimulation syndrome (OHSS), thromboembolic events have been reported. Use caution in women with personal or family risk factors for thrombosis.

Disease-related concerns:

• Hepatic impairment: Use with caution in patients with hepatic impairment; safety and efficacy have not been established.

• Renal impairment: Use with caution in patients with renal impairment; safety and efficacy have not been established.

Other warnings/precautions:

• Appropriate use: To minimize risks, use only at the lowest effective dose. Monitor ovarian response with serum estradiol and vaginal ultrasound on a regular basis.

• Experienced physician: These medications should only be used by physicians who are thoroughly familiar with infertility problems and their management.

• Multiple births: May result from the use of these medications; advise patients of the potential risk of multi-fetal gestation and multiple births before starting the treatment.

Applies to menotropins: injection solution reconstituted, subcutaneous solution reconstituted

Data not available

-The first injection should be performed under direct medical supervision.

Storage requirements:
-Refrigerate or keep at room temperature, protect from light.

Reconstitution/preparation techniques:
-Use immediately after reconstitution.
-Discard unused material.

Monitoring:
-Withhold hCG if serum estradiol is greater than 2000 pg/mL, if the ovaries are abnormally enlarged, or if abdominal pain occurs; advise the patient to refrain from intercourse.
-Follow patients closely for at least 2 weeks after hCG administration.

Patient advice:
-Ovulation induction: Encourage daily intercourse, beginning on the day prior to hCG administration until ovulation becomes apparent.
-If a dose is missed, do not double the next dose.
-Inform women of the risk of ovarian hyperstimulation syndrome (OHSS) and OHSS-associated symptoms including lung and blood vessel problems and ovarian torsion.