Menotropins (Menopur)

Trade Name	Menopur
Active Ingredient
Power
Type / form	Tablets
Status
Manufacturer	Ferring Pharmaceuticals Inc.

Storage and handling for Menopur

Disclaimer

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Menotropins (Menopur) which is also known as Menopur and Manufactured by Ferring Pharmaceuticals Inc.. It is available in strength of per ml. Read more

Menotropins (Menopur) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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About GNH

GNH India a Global Orphan Drug specialist renowned for its adherence to stringent quality standards. GNH India holds ISO 9001:2015 certification and WHO Good Storage and Distribution Practices (GSDP) compliance, ensuring the highest levels of safety and reliability in our operations.

No data

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):
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 ()

No data

Initial starting dose of the first cycle - 225 International Units per day, administered subcutaneously ()
Dosage adjustments after 5 days and by no more than 150 International Units at each adjustment ()
Do not administer doses greater than 450 International Units per day ()
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. ()

Lyophilized powder for Injection containing 75 International Units FSH and 75 International Units of LH activity, supplied as lyophilized powder or pellet in sterile vials with diluent vials and Qu2022Cap vial adapters.
Lyophilized powder for injection: containing 75 IU FSH and 75 IU of LH activity, supplied as lyophilized powder or pellet in sterile vials with diluent vials and Qu2022Cap vial adapters. ()

MENOPUR is contraindicated in women who exhibit:
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 ()
Pregnancy ()
Presence of uncontrolled non-gonadal endocrinopathies ()
Sex hormone dependent tumors of the reproductive tract and accessory organ ()
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 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 and multiple births . Gonadotropin therapy requires the availability of appropriate monitoring facilities . Use the lowest effective dose.

Abnormal Ovarian Enlargement ()
Ovarian Hyperstimulation Syndrome (OHSS) ()
Pulmonary and Vascular Complications ()
Ovarian Torsion ()
Multi-fetal Gestation and Birth ()
Congenital Malformation ()
Ectopic Pregnancy ()
Spontaneous Abortion ()
Ovarian Neoplasms ()

The following serious adverse reactions are discussed elsewhere in the labeling:
The most common adverse reactions (u22652%) in ART include: abdominal cramps; abdomen enlarged; abdominal pain; headache; injection site pain and reaction; injection site inflammation; OHSS ()n n n n

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

No data

Pregnancy Category X. Do not use MENOPUR in pregnant women. (, )
Nursing Mothers: It is not known whether this drug is excreted in human milk. ()
Pediatric Use: Safety and efficacy not established. ()
Renal and Hepatic Insufficiency: Safety, efficacy, and pharmacokinetics of MENOPUR in women with renal or hepatic insufficiency have not been established. ()

Aside from possible OHSS and multiple gestations , there is no additional information on the consequences of acute overdosage with MENOPUR.

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. Each vial of MENOPUR contains 75 International Units of follicle-stimulating hormone (FSH) activity and 75 International Units of luteinizing hormone (LH) activity, plus 21 mg lactose monohydrate and 0.005 mg Polysorbate 20 and Sodium Phosphate Buffer (Sodium Phosphate Dibasic, Heptahydrate and Phosphoric Acid).
The biological activity of MENOPUR is determined using the bioassays for FSH (ovarian weight gain assay in female rats) and LH (seminal vesicle weight gain assay in male rats), modified to increase the accuracy and reproducibility of these assays. The FSH and LH activity assays are standardized using the Fourth International Standard for Urinary FSH and Urinary LH, November 2000, by the Expert Committee on Biological Standardization of the World Health Organization (WHO ECBS). Both FSH and LH are glycoproteins that are acidic and water-soluble. Human Chorionic Gonadotropin (hCG) is detected in MENOPUR.
MENOPUR has been mixed with BRAVELLE with no evidence of aggregation.
Therapeutic class: Infertility

No data

Long-term toxicity studies in animals have not been performed to evaluate the carcinogenic potential of menotropins.

The efficacy of MENOPUR was established in one randomized, open-label, multicenter, multinational (in Europe and Israel), comparative clinical trial of women undergoing in vitro fertilization (IVF) or IVF plus intracytoplasmic injection (ICSI) to achieve pregnancy.
All women began ovarian stimulation as part of an IVF cycle following pituitary suppression with a GnRH agonist. A total of 373 patients were randomized to the MENOPUR arm. Randomization was stratified by insemination technique [conventional IVF vs. ICSI]. Efficacy was assessed based on the primary efficacy parameter of continuing pregnancy. The initial daily dose of MENOPUR was 225 International Units administered subcutaneously for five days. Thereafter, the dose was individualized according to each patient's response, up to a maximum of 450 IU/day for a total maximum duration of stimulation of 20 days. Treatment outcomes are summarized in Table 3.

No data

See FDA-approved patient labeling ( and ).

MANUFACTURED FOR:FERRING PHARMACEUTICALS INC.PARSIPPANY, NJ 07054
8109000033 Rev: 05/2018

MENOPUR (Men-oh-pyoor)(menotropins for injection)for subcutaneous use
Read this Patient Information before you start using MENOPUR (menotropins for injection) and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.
What is MENOPUR?
MENOPUR is a prescription medicine that contains follicle stimulating hormone (FSH) and luteinizing hormone (LH). MENOPUR causes your ovaries to make multiple (more than 1) eggs as part of an Assisted Reproductive Technology (ART) cycle.
Who should not use MENOPUR?
Do not use MENOPUR if you:
What should I tell my healthcare provider before using MENOPUR?
Before you use MENOPUR, tell your healthcare provider if you:
Tell your healthcare provider about all the medicines you take
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
How should I use MENOPUR?
What are possible side effects of MENOPUR?
MENOPUR may cause serious side effects, including:
The most common side effects of MENOPUR include:
These are not all the possible side effects of MENOPUR. For more information, ask your healthcare provider or pharmacist.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
How should I store MENOPUR?
Keep MENOPUR and all medicines out of the reach of children.
General Information about the safe and effective use of MENOPUR.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use MENOPUR for a condition for which it was not prescribed. Do not give MENOPUR to other people, even if they have the same condition you have. It may harm them.
This Patient Information summarizes the most important information about MENOPUR. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about MENOPUR that is written for health professionals.
For more information go to www.menopur.com, or call .
What are the ingredients in MENOPUR?
Active ingredient: menotropins
Inactive ingredients: lactose monohydrate, polysorbate, sodium phosphate buffer (sodium phosphate dibasic, heptahydrate and phosphoric acid)

MENOPUR (Men-oh-pyoor)
(menotropins for injection)
for subcutaneous use
Your healthcare provider should show you how to mix and inject (menotropins for injection) (urofollitropin for injection, purified) before you do it for the first time. Before using MENOPUR or MENOPUR mixed with BRAVELLE for the first time, read this carefully. Keep this leaflet in a safe place and read it when you have questions.
Supplies you will need to give your injection of MENOPUR or MENOPUR mixed with BRAVELLE. See .
Step 1. Preparing your MENOPUR or MENOPUR mixed with BRAVELLE.
If your healthcare provider tells you to use more than 1 vial of MENOPUR or tells you to mix your MENOPUR with BRAVELLE in the same syringe:
Step 2. Removing the Qu2022Cap and adding your needle for injection.
Step 3. Prepare Injection site for MENOPUR or MENOPUR mixed with BRAVELLE.
Step 4: Injection
Step 5. After your injection.
Step 6. Disposing of your used needles and syringes.
Do not dispose of your used sharps disposal container in your household trash unless your community guidelines permit this. Do not recycle your used sharps disposal container.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.

MANUFACTURED FOR:FERRING PHARMACEUTICALS INC.PARSIPPANY, NJ 07054
8109000033Rev: 05/2018

NDC 55566-7501-2
Menopur 75 IU (menotropins for injection)
5 single dose vials of Menotropins for Injection 5 single dose vials of 0.9% Sodium Chloride Injection, USP, 2 mL 5 Qu2022Cap Vial Adapters
FOR SUBCUTANEOUS INJECTION ONLY
Rx only
Qu2022Capn Vial Adapters for Needle-Free Reconstitution
For exclusive use withReproductive Medicine andMaternal Health products
FERRINGPHARMACEUTICALS