MENOPUR SIDE EFFECTS

SIDE EFFECTS

The following serious adverse reactions are discussed elsewhere in the labeling:

• Abnormal Ovarian Enlargement
• Ovarian Hyperstimulation Syndrome
• Atelectasis, acute respiratory distress syndrome and exacerbation of asthma
• Thromboembolic events
• Ovarian Torsion
• Multi-fetal Gestation and Birth
• Congenital Malformations
• Ectopic Pregnancy
• Spontaneous Abortion
• Ovarian Neoplasms

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.

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, 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