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Repronex

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Repronex

Repronex

Repronex Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Repronex (menotropins for injection) used to stimulate ovulation (the release of an egg) when a woman's ovaries can produce a follicle but hormonal stimulation is deficient. It is also used to stimulate the development of multiple eggs for in vitro fertilization, and to stimulate the production of sperm in men who have functioning testes but in whom hormonal stimulation is deficient. It is a mixture of the naturally occurring follicle-stimulating hormone (FSH) and luteinizing hormone (LH). Common side effects include headache, mild stomach pain/bloating, redness/pain at the injection site, breast tenderness, or dizziness.

The dose of Repronex to stimulate development of ovarian follicles is individualized for each patient. The lowest dose to achieve results should be used. It is not known if other medications will interact with Repronex. Tell your doctor all medications and supplements you use. Stop using Repronex when you become pregnant. It must not be used during pregnancy. If you think you may be pregnant, tell your doctor. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Repronex (menotropins for injection) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

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 Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Repronex in Detail - Patient Information: Side Effects

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.

Read the entire detailed patient monograph for Repronex (Menotropins for Injection) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Repronex Overview - Patient Information: Side Effects

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.

Read the entire patient information overview for Repronex (Menotropins for Injection)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Repronex FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following adverse reactions, reported during menotropins therapy, are listed in decreasing order of potential severity:

  1. Pulmonary and vascular complications (see WARNINGS)
  2. Ovarian Hyperstimulation Syndrome (see WARNINGS)
  3. Hemoperitoneum
  4. Adnexal torsion (as a complication of ovarian enlargement)
  5. Mild to moderate ovarian enlargement
  6. Ovarian cysts
  7. Abdominal pain
  8. Sensitivity to menotropins (Febrile reactions suggestive of allergic response have been reported following the administration of menotropins. Reports of flu-like symptoms including fever, chills, musculoskeletal aches, joint pains, nausea, headaches, and malaise have also been reported).
  9. Gastrointestinal symptoms (nausea, vomiting, diarrhea, abdominal cramps, bloating)
  10. Pain, rash, swelling and/or irritation at the site of injection
  11. Body rashes
  12. Dizziness, tachycardia, dyspnea, tachypnea

The following medical events have been reported subsequent to pregnancies resulting from menotropins therapy:

  1. Ectopic pregnancy
  2. Congenital abnormalities

With menotropin therapy congenital abnormalities have been reported. One infant was shown to have multiple congenital anomalies consisting of aplasia of the sigmoid colon, cecovesicle fistula, bifid scrotum, meningocele, bilateral internal tibial torsion, and right metatarsus adductus. Other reported anomalies include imperforate anus, congenital heart lesions, supernumerary digits, hypospadias, extrophy of the bladder, Down's syndrome and hydrocephalus. The incidence of congenital abnormalities does not exceed that found in the general population.

There have been infrequent reports of ovarian neoplasms, both benign and malignant, in women who have undergone multiple drug regimens for ovulation induction; however, a causal relationship has not been established.

Adverse events occurring in ≥ 1% of patients exposed to Repronex® (menotropins for injection) IM or Repronex® (menotropins for injection) SC are described in Table 4.

Table 4: Patients with Adverse Events ≥ 1%

  Repronex®
IM (N=101)
Repronex®
SC (N=96)
Adverse Events n (%) n (%)
INJECTION SITE AEs
  Injection Site Edema 1 (1.0) 8 (8.3)*
  Injection Site Reaction 2 (2.0) 8 (8.3)*
GENITOURINARY/REPRODUCTIVE AEs
  OHSS 2 (2.0) 5 (5.2)
  Vaginal Hemorrhage 8 (7.9) 3 (3.1)
  Ovarian Disease 3 (3.0) 8 (8.3)
  Ectopic Pregnancy 1 (1.0) 1 (1.0)
  Pelvic Pain 3 (3.0) 1 (1.0)
  Breast Tenderness 2 (2.0) 2 (2.1)
GASTROINTESTINAL AEs
  Nausea 4 (4.0) 7 (7.3)
  Vomiting 0 (0) 3 (3.1)
  Diarrhea 0 (0) 2 (2.1)
  Abdominal Cramping 7(6.9) 5 (5.2)
  Abdominal Pain 5 (5.0) 7 (7.3)
  Enlarged Abdomen 6 (6.0) 2 (2.1)
OTHER BODY SYSTEM AEs
  Headache 6 (6.0) 5 (5.2)
  Infection 1 (1.0) 0 (0)
  Dyspnea 1 (1.0) 2 (2.1)
* Fisher's Exact/Chi-Squared Tests- significant for Repronex® SC vs.Repronex® IM.

Drug Abuse And Dependence

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

Read the entire FDA prescribing information for Repronex (Menotropins for Injection) »

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Repronex - User Reviews

Repronex User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Repronex sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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