Menotropins

Generic Name: menotropins

Over-the-Counter (OTC)

Brand Names:

Menopur

11 DESCRIPTION MENOPUR is a preparation of gonadotropins (FSH and LH activity), extracted from the urine of postmenopausal women, which has undergone additional steps for purification. MENOPUR is a sterile, lyophilized powder intended for subcutaneous (SC) injection after reconstitution with sterile 0.9% Sodium Chloride Injection, USP.

Overview

11 DESCRIPTION MENOPUR is a preparation of gonadotropins (FSH and LH activity), extracted from the urine of postmenopausal women, which has undergone additional steps for purification. MENOPUR is a sterile, lyophilized powder intended for subcutaneous (SC) injection after reconstitution with sterile 0.9% Sodium Chloride Injection, USP.

Uses

1 INDICATIONS AND USAGE 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

Dosage

2 DOSAGE AND ADMINISTRATION Initial starting dose of the first cycle - 225 International Units per day, administered subcutaneously ( 2.2 ) Dosage adjustments after 5 days and by no more than 150 International Units at each adjustment ( 2.2 ) Do not administer doses greater than 450 International Units per day ( 2.2 ) MENOPUR may be administered together with BRAVELLE ® (urofollitropin for injection, purified). Only the total starting dose of 225 International Units (150 International Units of MENOPUR and 75 International Units of BRAVELLE or 75 International Units of MENOPUR and 150 International Units of BRAVELLE) was studied in a clinical trial.

Side Effects

6 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 reac...

Interactions

7 DRUG INTERACTIONS No drug/drug interaction studies in humans have been conducted for MENOPUR. No drug/drug interaction studies have been conducted for MENOPUR in humans. ( 7 )

Warnings

5 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) ] . Use the lowest effective dose. 4 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) ].

Pregnancy

8.1 Pregnancy Teratogenic effects Pregnancy Category X [see Contraindications (4) ] .

Storage

16.2 Storage and Handling Lyophilized powder may be stored refrigerated or at room temperature (3° to 25° C/37° to 77°F) until dispensed. Protect from light. Use immediately after reconstitution. Discard unused material.

Frequently Asked Questions

What is Menotropins used for?

1 INDICATIONS AND USAGE 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

What are the side effects of Menotropins?

6 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 reac...

Can I take Menotropins during pregnancy?

8.1 Pregnancy Teratogenic effects Pregnancy Category X [see Contraindications (4) ] .

What are the important warnings for Menotropins?

5 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) ] . Use the lowest effective dose. 4 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) ].

Related Medications

Medical Disclaimer

This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.