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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
|Body as a whole||Abdominal cramps||13||3|
|Injection site pain + reaction||17||3.9|
|Injection site inflammation||10||2.3|
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.
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
Skin and subcutaneous tissue disorders: acne, rash
Vascular disorders: hot flush
Read the Menopur (menotropins injection) Side Effects Center for a complete guide to possible side effects
No drug/drug interaction studies in humans have been conducted for MENOPUR® .This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 2/28/2014
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