Repronex

DRUG DESCRIPTION

Repronex® (menotropins for injection, USP) is a purified preparation of gonadotropins extracted from the urine of postmenopausal women. Each vial of Repronex® (menotropins for injection) contains 75 International Units (IU) or 150 IU of follicle-stimulating hormone (FSH) activity and 75 IU or 150 IU of luteinizing hormone (LH) activity, respectively, plus 20 mg lactose monohydrate in a sterile, lyophilized form. The final product may contain sodium phosphate buffer (sodium phosphate tribasic and phosphoric acid). Repronex® (menotropins for injection) is administered by subcutaneous or intramuscular injection. Human Chorionic Gonadotropin (hCG), a naturally occurring hormone in post-menopausal urine, is detected in Repronex® (menotropins for injection) .

Repronex® (menotropins for injection) is biologically standardized for FSH and LH (ICSH) gonadotropin activities in terms of the Second International Reference Preparation for Human Menopausal Gonadotropins established in September, 1964 by the Expert Committee on Biological Standards of the World Health Organization.

Both FSH and LH are glycoproteins that are acidic and water soluble. Therapeutic class: Infertility.

What are the possible side effects of menotropins (Menopur, Repronex)?

Stop using menotropins and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Less than 2% of female patients treated with menotropins develop ovarian hyperstimulation syndrome (OHSS), especially after the first cycle of therapy. Symptoms of OHSS include swelling of the hands or legs, abdominal pain and swelling, shortness of breath, weight gain, and nausea or vomiting. OHSS can be fatal. Notify your doctor...

Read All Potential Side Effects and See Pictures of Repronex »

What are the precautions when taking menotropins for injection (Repronex)?

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other products containing FSH or LH; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: other fertility problems (e.g., primary ovarian failure), abnormal uterine/vaginal bleeding, thyroid or adrenal gland problems, cancer of the reproductive organs (breast, uterus, ovary), tumor in the brain (e.g., pituitary tumor), ovarian cysts or enlarged ovaries (not due to polycystic ovary syndrome).

Before using this...

Read All Potential Precautions of Repronex »


Repronex Consumer (continued)

SIDE EFFECTS: Headache, mild stomach pain/bloating, redness/pain at the injection site, breast tenderness, or dizziness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: vaginal bleeding, flu-like symptoms (e.g., fever, chills, joint pain, muscle ache, tiredness).

Seek immediate medical attention if any of these rare but very serious side effects occur: weakness on one side of the body, slurred speech, sudden vision changes or severe headache, pain/swelling of the calf muscles, chest pain, shortness of breath.

This medication may cause a condition known as Ovarian Hyperstimulation Syndrome (OHSS). This condition may occur during therapy and after treatment has been discontinued. Rarely, serious OHSS causes fluid to suddenly build up in the stomach, chest, and heart area. Seek immediate medical attention if you develop the following side effects: severe pain/swelling in the lower abdominal (pelvic) area, nausea/vomiting, sudden/rapid weight gain, or change in the amount of urine.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other products containing FSH or LH; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: other fertility problems (e.g., primary ovarian failure), abnormal uterine/vaginal bleeding, thyroid or adrenal gland problems, cancer of the reproductive organs (breast, uterus, ovary), tumor in the brain (e.g., pituitary tumor), ovarian cysts or enlarged ovaries (not due to polycystic ovary syndrome).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood clots, stroke, certain heart diseases (e.g., heart attack), lung problems (e.g., asthma).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Multiple births may occur because of this treatment. Consult your doctor for more details.

Stop using this medication when you become pregnant. This medication must not be used during pregnancy. If you think you may be pregnant, tell your doctor immediately.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.


Repronex Patient Information Including Side Effects

Brand Names: Menopur, Repronex

Generic Name: menotropins (injectable) (Pronunciation: MEN oh troe pins)

  • What are menotropins (Repronex)?
  • What are the possible side effects of menotropins (Repronex)?
  • What is the most important information I should know about menotropins (Repronex)?
  • What should I discuss with my healthcare provider before using menotropins (Repronex)?
  • How should I use menotropins (Repronex)?
  • What happens if I miss a dose (Repronex)?
  • What happens if I overdose (Repronex)?
  • What should I avoid while using menotropins (Repronex)?
  • What other drugs will affect menotropins (Repronex)?
  • Where can I get more information?

What are menotropins (Repronex)?

Menotropins are an equal mixture of the naturally occurring follicle-stimulating hormone (FSH) and luteinizing hormone (LH). FSH and LH are important for the development of follicles (eggs) produced by the ovaries and for the development of sperm.

Menotropins are used to stimulate ovulation (the release of an egg) when a woman's ovaries can produce a follicle but hormonal stimulation is deficient. Menotropins are also used to stimulate the development of multiple eggs for in vitro fertilization. Likewise, menotropins are used to stimulate the production of sperm in men who have functioning testes but in whom hormonal stimulation is deficient.

Menotropins may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of menotropins (Repronex)?

Stop using menotropins and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Less than 2% of female patients treated with menotropins develop ovarian hyperstimulation syndrome (OHSS), especially after the first cycle of therapy. Symptoms of OHSS include swelling of the hands or legs, abdominal pain and swelling, shortness of breath, weight gain, and nausea or vomiting. OHSS can be fatal. Notify your doctor immediately or seek emergency medical attention if you develop any of these side effects.

Serious pulmonary (lung and breathing) conditions have been reported in patients using menotropins. Seek medical attention if you experience any sudden changes in your breathing.

Other side effects may also occur. Notify your doctor if you experience

  • ovarian enlargement presenting as abdominal or pelvic pain, tenderness, pressure, or swelling;
  • nausea, vomiting, or diarrhea;
  • shortness of breath;
  • pain, warmth, or tenderness centralized in an arm or leg;
  • fever or chills;
  • headache or drowsiness;
  • weakness or aching of muscles or joints;
  • breast enlargement or tenderness;
  • pain, swelling, or irritation at the injection site; or
  • rash.

Menotropins may increase the likelihood of multiple births. Multiple births may carry additional risk both for the mother and for the fetuses.

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.

What is the most important information I should know about menotropins (Repronex)?

Menotropins may increase the likelihood of multiple births. Multiple births may carry additional risk both for the mother and for the fetuses.

Related Drug Centers
  • Menopur
  • Repronex


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