FDA

Menopur

Approved 29 Oct 2004SubcutaneousInjectable

Indications

MENOPUR ® (menotropins for injection) is a gonadotropin indicated for: Development of multiple follicles and pregnancy in ovulatory women as part of an Assisted Reproductive Technology (ART) cycle ( 1 ) Development of Multiple Follicles and Pregnancy in Ovulatory Women as Part of an Assisted Reproductive Technology (ART) Cycle Prior to initiation of treatment with MENOPUR ® (menotropins for injection): Perform a complete gynecologic and endocrinologic evaluation, and diagnose the cause of infertility Exclude the possibility of pregnancy Evaluate the fertility status of the male partner Exclude a diagnosis of primary ovarian failure

Contraindications

MENOPUR is contraindicated in women who exhibit: Prior hypersensitivity to MENOPUR or menotropins products or one of their excipients High levels of FSH indicating primary ovarian failure [see Indications and Usage (1) ] Pregnancy MENOPUR may cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1) ]. MENOPUR is contraindicated in women who are pregnant. If this drug is used during pregnancy, or if the woman becomes pregnant while taking this drug, the woman should be apprised of the potential hazard to a fetus.

Presence of uncontrolled non-gonadal endocrinopathies (e.g., thyroid, adrenal, or pituitary disorders) [see Indications and Usage (1) ] Sex hormone dependent tumors of the reproductive tract and accessory organs Tumors of pituitary gland or hypothalamus Abnormal uterine bleeding of undetermined origin Ovarian cyst or enlargement of undetermined origin, not due to polycystic ovary syndrome MENOPUR is contraindicated in women who exhibit: Prior hypersensitivity to MENOPUR or menotropins products or one of their excipients ( 4 ) High levels of FSH indicating primary ovarian failure ( 4 ) Pregnancy ( 4 ) Presence of uncontrolled non-gonadal endocrinopathies ( 4 ) Sex hormone dependent tumors of the reproductive tract and accessory organ ( 4 ) Tumors of pituitary gland or hypothalamus ( 4 ) Abnormal uterine bleeding of undetermined origin ( 4 ) Ovarian cyst or enlargement of undetermined origin, not due to polycystic ovary syndrome ( 4 )

Warnings and precautions

MENOPUR should only be used by physicians who are experienced in infertility treatment. MENOPUR contains gonadotropic substances capable of causing in women, Ovarian Hyperstimulation Syndrome (OHSS) with or without pulmonary or vascular complications [see Warnings and Precautions (5.2 , 5.3) ] and multiple births [see Warnings and Precautions (5.5) ] . Gonadotropin therapy requires the availability of appropriate monitoring facilities [see Warnings and Precautions (5.10) ] .

At a glance

Brand name: Menopur
Active substance: menotropins (fsh
Route: Subcutaneous
Dosage form: Injectable
Applicant: Ferring
Status: Prescription
FDA approval: 29 Oct 2004
Application: BLA021663-001

Indications

Contraindications

Warnings and precautions

Adverse reactions

The following serious adverse reactions are discussed elsewhere in the labeling: Abnormal Ovarian Enlargement [see Warnings and Precautions (5.1) ] Ovarian Hyperstimulation Syndrome [see Warnings and Precautions (5.2) ] Atelectasis, acute respiratory distress syndrome and exacerbation of asthma [see Warnings and Precautions (5.3) ] Thromboembolic events [see Warnings and Precautions (5.3) ] Ovarian Torsion [see Warnings and Precautions (5.4) ] Multi-fetal Gestation and Birth [see Warnings and Precautions (5.5) ] Congenital Malformations [see Warnings and Precautions (5.6) ] Ectopic Pregnancy [see Warnings and Precautions (5.7) ] Spontaneous Abortion [see Warnings and Precautions (5.8) ] Ovarian Neoplasms [see Warnings and Precautions (5.9) ] The most common adverse reactions (≥2%) in ART include: abdominal cramps; abdomen enlarged; abdominal pain; headache; injection site pain and reaction; injection site inflammation; OHSS ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Ferring Pharmaceuticals Inc. at 1-888-FERRING (1-888-337-7464) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical 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 Ovarian Hyperstimulation Syndrome (OHSS) 27

6.2 In addition, thrombophlebitis was reported in less than 1% of subjects. In an open label, US, 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 another 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.

6.2Postmarketing 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 (5.2) ] , 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

Menopur

Indications

Contraindications

Warnings and precautions

At a glance

Two medicines in one question?

Menopur

Indications

Contraindications

Warnings and precautions

At a glance

Two medicines in one question?

5.1Abnormal Ovarian Enlargement

5.2Ovarian Hyperstimulation Syndrome (OHSS)

5.3Pulmonary and Vascular Complications

5.4Ovarian Torsion

5.5Multi-fetal Gestation and Birth

Interactions

Pregnancy and breastfeeding

8.1Pregnancy

Adverse reactions

6.1Clinical Trial Experience

6.2Postmarketing Experience

Composition

Official product information