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Menopur

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SIDE EFFECTS

The safety of Menopur® (menotropins injection) was examined in 3 clinical studies that enrolled a total of 575 patients receiving Menopur® (menotropins injection) in the IVF and 01 studies. All adverse events (without regard to causality assessment) occurring at an incidence of > 2 % in women treated with Menopur® (menotropins injection) are listed in Table 3.

Table 3: HIGHLY PURIFIED MENOTROPIN SC AND IM IN FEMALE PATIENTS UNDERGOING IVF AND 01 ADVERSE EVENTS WITH ONSET ON OR AFTER GnRH ADMINISTRATION, COSTART CLASSIFICATION (FOR INCIDENCE OF 2% OR GREATER)

BODY SYSTEM/PREFERRED TERM IVF*
n=499		 01**
n=76
N % N %
BODY AS A WHOLE
    Abdomen Enlarged 12 2.4 0 0.0
    Abdominal cramps 30 6.0 5 6.6
    Abdominal fullness 16 3.2 7 9.2
    Abdominal pain 88 17.6 7 9.2
    Back pain 16 3.2 0 0.0
    Elevated estradiol 12 2.4 0 0.0
    Flu syndrome 13 2.6 1 1.3
    Flushing 12 2.4 0 0.0
    Headache 170 34.1 12 15.8
    Injection site pain 27 5.4 0 0.0
    Injection site reaction 48 9.6 9 11.8
    Malaise 14 2.8 2 2.6
    Pain 16 3.2 2 2.6
CARDIOVASCULAR
    Migraine 12 2.4 0 0.0
DIGESTIVE
    Constipation 8 1.6 0 0.0
    Diarrhea 14 2.8 2 2.6
    Nausea 60 12.0 6 7.9
    Vomitinq 21 4.2 2 2.6
NERVOUS
    Dizziness 13 2.6 0 0.0
RESPIRATORY
    Cough increased 8 1.6 2 2.6
    Respiratory disorder 29 5.8 3 3.9
UROGENITAL
    Breast tenderness 9 1.8 2 2.6
    Hot flash 3 0.6 2 2.6
    Menstrual disorder 16 3.2 0 0.0
    OHSS 19 3.8 10 13.2
    Pelvic cramps 0 0.0 3 3.9
    Pelvic discomfort 2 0.4 2 2.6
    Post retrieval pain 32 6.4 0 0.0
    Uterine spasm 8 1.6 3 3.9
* INCLUDES IM AND SC SUBJECTS FROM PROTOCOLS MFK/IVF/0399E AND MENOPUR (menotropins injection) 2000-02.
**INCLUDES IM AND SC SUBJECTS FROM PROTOCOL MENOPUR (menotropins injection) 2000-01.

Drug Abuse And Dependence

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

DRUG INTERACTIONS

No information provided.

Last reviewed on RxList: 2/25/2009
This monograph has been modified to include the generic and brand name in many instances.

Additional Menopur Information

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