Repronex

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.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some women using this medicine develop a condition called ovarian hyperstimulation syndrome (OHSS), especially after the first treatment. OHSS can be a life threatening condition. Stop using menotropins, do not have sexual intercourse, and call your doctor right away if you have any of the following symptoms of OHSS:

• stomach pain, bloating;

• nausea, vomiting, diarrhea;

• rapid weight gain, especially in your face and midsection;

• little or no urinating; or

• pain when you breathe, rapid heart rate, feeling short of breath (especially when lying down).

Also call your doctor at once if you have:

• chest pain, dry cough, feeling short of breath (especially when lying down);

• signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;

• signs of a blood clot in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; or

• signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs.

Common side effects may include:

• stomach cramps or bloating;

• headache; or

• pain, swelling, or warmth where the medicine was injected.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Menotropins injection is used to treat infertility in women. Menotropins are a mixture of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) that are produced in the body by the pituitary gland.

Menotropins injection is used in women with healthy ovaries who are enrolled in a fertility program called assisted reproductive technology (ART). ART uses procedures such as in vitro fertilization (IVF). Menotropins is used together with human chorionic gonadotropin (hCG) in these procedures.

Many women choosing treatment with menotropins have already tried clomiphene (eg, Serophene) and have not been able to conceive yet. Menotropins may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).

This medicine is available only with your doctor's prescription.

It is very important that your doctor check your progress at regular visits to make sure that the medicine is working properly and to check for unwanted effects. Blood and urine tests, and ultrasound examinations are needed to check for any unwanted effects caused by this medicine.

Call your doctor right away if you think you have become pregnant while you are using this medicine. You may have a higher risk of an ectopic pregnancy or miscarriage if you get pregnant while undergoing IVF procedures. An ectopic pregnancy can be a serious and life-threatening condition. It can also cause problems that may make it harder for you to become pregnant in the future.

If your doctor has asked you to record your basal body temperatures (BBTs) daily, make sure that you know how to do this. Carefully follow your doctor's instructions.

This medicine may increase your risk of having a problem with the ovaries called ovarian hyperstimulation syndrome (OHSS). OHSS is a serious problem that can be life-threatening. Call your doctor right away if you have severe pain in the lower stomach area, nausea, vomiting, weight gain, diarrhea, decreased urine output, or trouble breathing.

This medicine may increase your risk of having a blood clot, heart attack, or stroke. This is more likely in people who already have heart disease. Contact your doctor right away if you have chest pain, tightness in the chest, a fast or irregular heartbeat, unusual flushing or warmth of the skin, increased coughing, trouble with breathing, a sudden difficulty with breathing at night, or abnormal swelling in your ankles or legs. These could be symptoms of serious heart problems or blood clots.

This medicine may cause more than one egg to be released from your ovary at the same time. This means you may become pregnant with more than one baby. Talk with your doctor about this possibility before you start using this medicine.

This medicine may increase your risk of having ovarian cancer if you received it more than one time to get pregnant. Talk to your doctor about this risk.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Repronex, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Repronex. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Repronex (menotropins).

Review Date: October 4, 2017

Menotropins administered for 7 to 12 days produces ovarian follicular growth in women who do not have primary ovarian failure. Treatment with menotropins in most instances results only in follicular growth and maturation. When sufficient follicular maturation has occurred, hCG must be given to induce ovulation.

Single doses of 300 IU menotropins (Menogon® Ferring’s European formulation) were administered subcutaneously (SC) and intramuscularly (IM) in a 2-period crossover study to 16 healthy female subjects while their endogenous FSH and LH were being suppressed. Serum FSH concentrations were determined. Based on the ratio of FSH Cmax and AUC0-α, SC and IM administration of menotropins are not bioequivalent. Compared to IM administration, the SC administration of menotropins results in an increase of FSH Cmax and AUC0-α by 35 and 20%, respectively.

Based on two subjects who received either the highest SC or IM Repronex® dose, FSH pharmacokinetics (PK) appears to be linear up to 450 IU menotropins. The mean accumulation factors for FSH upon six doses of SC or IM 150 to 450 IU/day Repronex® are 1.6 and 1.4, respectively. Upon six doses of SC or IM 150 IU/day Repronex®, the observed serum FSH concentrations range from 1.7 to 15.9 mIU/mL and 0.5 to 10.1 mIU/mL, respectively. The FSH pharmacokinetic parameters from population modeling for these two studies are in Table 1.

† mean (CV%)

‡ Menogen® (Ferring's European formulation of menotropins)

¶ Repronex®

Serum LH concentrations upon multiple dose SC or IM Repronex® are low and variable. No recognizable trend in the increase in serum LH concentrations from SC or IM 150 to 450 IU/day Repronex® doses was observed. After the 6th dose of SC or IM 150 IU/day Repronex®, the range of baseline corrected serum LH concentrations is 0 to 0.2 mIU/mL for both routes of administration.

Absorption

The geometric mean of FSH Cmax and AUC0-α upon single dose SC administration of menotropins is 5.62 mIU/mL and 385.2 mIU·h/mL, respectively; the corresponding geometric median of FSH tmax is 12 hours. The geometric mean of FSH Cmax and AUC0-α upon single dose IM administration of menotropins is 4.15 mIU/mL and 320.1 mIU·h/mL, respectively; the corresponding geometric median of FSH tmax is 18 hours.

Distribution

Human tissue or organ distribution of FSH and LH have not been studied for Repronex®.

Metabolism

Metabolism of FSH and LH have not been studied for Repronex® in humans.

Excretion

The mean elimination half-lives of FSH upon single dose SC and IM administration of menotropins are 53.7 and 59.2 hours, respectively.

Pediatric Populations

Repronex® is not used in pediatric populations.
 
Geriatric Populations 
 
Repronex® is not used in geriatric populations.
 
Special Populations
 
The safety and efficacy of Repronex® is renal and hepatic insufficiency have not been studied.

Drug Interactions

No drug/drug interaction studies have been conducted for Repronex® in humans.

Repronex® is contraindicated in women who have:

1. A high FSH level indicating primary ovarian failure.
2. Uncontrolled thyroid and adrenal dysfunction.
3. An organic intracranial lesion such as a pituitary tumor.
4. The presence of any cause of infertility other than anovulation unless they are candidates for in vitro fertilization.
5. Abnormal bleeding of undetermined origin.
6. Ovarian cysts or enlargement not due to polycystic ovary syndrome.
7. Prior hypersensitivity to menotropins.
8. Repronex® is not indicated in women who are pregnant. There are limited human data on the effects of menotropins when administered during pregnancy.

There have been no reports of abuse or dependence with menotropins.

Aside from possible ovarian hyperstimulation (see WARNINGS), little is known concerning the consequences of acute overdosage with menotropins.

Applies to menotropins: injection solution reconstituted, subcutaneous solution reconstituted