Medical Editor: John P. Cunha, DO, FACOEP
Menopur (menotropins) injection is an equal mixture of the naturally occurring follicle-stimulating hormone (FSH) and luteinizing hormone (LH) used to stimulate ovulation (the release of an egg) when a woman's ovaries can produce a follicle but hormonal stimulation is deficient. Menopur is also used to stimulate the development of multiple eggs for in vitro fertilization, and is likewise used to stimulate the production of sperm in men who have functioning testes but in whom hormonal stimulation is deficient. Common side effects of Menopur include:
- headache,
- drowsiness,
- stomach or abdominal pain,
- bloating,
- injection site reactions (pain, swelling, irritation, redness),
- breast enlargement or tenderness,
- dizziness,
- nausea,
- vomiting,
- diarrhea,
- shortness of breath,
- pain/warmth/tenderness centralized in an arm or leg,
- fever,
- chills,
- weakness or aching of muscles or joints, or
- rash.
Menopur may increase the likelihood of multiple births. Tell your doctor if you have unlikely but serious side effects of Menopur including flu-like symptoms (e.g., fever, chills, joint pain, muscle ache, or tiredness).
Menopur is administered through a subcutaneous (under the skin) injection. The recommended initial dose of Menopur for patients who have received a GnRH agonist for pituitary suppression is 225 IU. The maximum daily dose should not exceed 450 IU and dosing beyond 20 days is not recommended. It is unknown if other medications will interact with Menopur. Tell your doctor all prescription or over-the-counter medicines or supplements you use. Stop using Menopur when you become pregnant. Menopur 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 Menopur (menotropins 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.
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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.
Read the entire detailed patient monograph for Menopur (Menotropins Injection)
SLIDESHOW
Fertility Options: Types, Treatments, and Costs See SlideshowSIDE EFFECTS
The following serious adverse reactions are discussed elsewhere in the labeling:
- Abnormal Ovarian Enlargement [see WARNINGS AND PRECAUTIONS]
- Ovarian Hyperstimulation Syndrome [see WARNINGS AND PRECAUTIONS]
- Atelectasis, acute respiratory distress syndrome and exacerbation of asthma [see WARNINGS AND PRECAUTIONS]
- Thromboembolic events [see WARNINGS AND PRECAUTIONS]
- Ovarian Torsion [see WARNINGS AND PRECAUTIONS]
- Multi-fetal Gestation and Birth [see WARNINGS AND PRECAUTIONS]
- Congenital Malformations [see WARNINGS AND PRECAUTIONS]
- Ectopic Pregnancy [see WARNINGS AND PRECAUTIONS]
- Spontaneous Abortion [see WARNINGS AND PRECAUTIONS]
- Ovarian Neoplasms [see WARNINGS AND PRECAUTIONS]
Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trial of another drug and may not reflect the rates observed in practice.
In two single cycle, open label, multinational, multicenter, comparative trials, a total of 434 normal ovulatory infertile women were randomized and received subcutaneously administered MENOPUR® as part of an in vitro fertilization (IVF) cycle (both trials) or intracytoplasmic sperm injection (ICSI)] cycle (one of the two trials). All women received pituitary down-regulation with gonadotropin releasing hormone (GnRH) agonist before stimulation. Adverse Reactions occurring at an incidence of ≥ 2% in women receiving MENOPUR® are shown in Table 1.
Table 1: MENOPUR Administered subcutaneously in Women Undergoing
IVF and ICSI. Adverse Reactions with Incidence of 2% or Greater Occurring on or
After GnRH Administration.
| Body System/Preferred Term | IVF n=434 |
||
| N | % | ||
| Body as a whole | Abdominal cramps | 13 | 3.0 |
| Abdomen enlarged | 10 | 2.3 | |
| Abdominal pain | 29 | 6.7 | |
| Headache | 27 | 6.2 | |
| Injection site pain + reaction | 17 | 3.9 | |
| Injection site inflammation | 10 | 2.3 | |
| Urogenital | OHSS | 27 | 6.2 |
In addition, thrombophlebitis was reported in less than 1% of subjects.
In a second open label, multinational, multicenter, comparative IVF and ICSI trial, MENOPUR® and BRAVELLE® were administered in the same syringe to 60 normal ovulatory infertile women. OHSS, post retrieval cramping and nausea and spontaneous abortion were the most common adverse reactions occurring at an incidence of ≥ 5% in women receiving the combination of MENOPUR® and BRAVELLE®.
In a third open label, US multicenter, comparative trial for ovulation induction in anovulatory or oligovulatory infertile women, 76 subjects received subcutaneous or intramuscular injections of MENOPUR®. The most common adverse reactions occurring at an incidence of ≥ 5% in women receiving MENOPUR® were: headache; OHSS; injection site reaction, abdominal cramps, fullness and pain; and nausea.
Postmarketing Experience
The following adverse reactions have been reported during postmarketing use of gonadotropins. Because these reactions were reported voluntarily from a population of uncertain size, the frequency or a causal relationship to MENOPUR® cannot be reliably determined.
Gastrointestinal disorders: abdominal pain, abdominal pain lower, abdominal distension, nausea, vomiting, abdominal discomfort
General disorders and administration site conditions: injection site reactions (most frequently reported injection site reaction was injection site pain), fatigue
Nervous system disorders: headache, dizziness
Reproductive system disorders: OHSS [see WARNINGS AND PRECAUTIONS], pelvic pain, ovarian cyst, breast complaints (including breast pain, breast tenderness, breast discomfort and breast swelling)
Skin and subcutaneous tissue disorders: acne, rash
Vascular disorders: hot flush
Read the entire FDA prescribing information for Menopur (Menotropins Injection)
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