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Name:Menopur
Manufacturer:Ferring Pharmaceuticals Inc.
Category:Prescription Marketed Drugs


These highlights do not include all the information needed to use MENOPUR safely and effectively.  See full prescribing information for MENOPUR.MENOPUR (menotropins for injection, USP) Initial U.S. Approval: 1975

MENOPUR - follicle stimulating hormone beta polypeptide and lutropin alfa injection 
Ferring Pharmaceuticals Inc.

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HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use MENOPUR safely and effectively.  See full prescribing information for MENOPUR.

MENOPUR (menotropins for injection, USP) Initial U.S. Approval: 1975


INDICATIONS AND USAGE

MENOPUR is indicated for the development of multiple follicles and pregnancy in the ovulatory patients participating in an ART program. (1)


DOSAGE AND ADMINISTRATION

Dosing (2.2)

  • Recommended initial dose: 225 IU
  • Adjustments < 150 IU at least 2 days apart
  • Maximum dosage: 450 IU/day, up to 20 days
  • Administration (2.3): subcutaneouslyin lower abdomen

DOSAGE FORMS AND STRENGTHS

75 IU FSH and 75 IU of LH activity, supplied as lyophilized powder or pellet in sterile vials with diluent vials and Q-Cap® vial adapters. (3)


CONTRAINDICATIONS

MENOPUR is contraindicated in women who have:

  • A high FSH level indicating primary ovarian failure (4)

  • Uncontrolled thyroid and adrenal dysfunction (4)

  • An organic intracranial lesion such as a pituitary tumor (4)

  • Sex hormone dependent tumors of the reproductive tract and accessory organs (4)

  • Abnormal uterine bleeding of undetermined origin (4)

  • Ovarian cysts or enlargement not due to polycystic ovary syndrome (4)

  • Prior hypersensitivity to menotropins or MENOPUR (4)


WARNINGS AND PRECAUTIONS

  • Overstimulation of the ovary can lead to enlargement or OHSS (5.1)

  • Pulmonary complications and thromboembolic events have been reported following therapy (5.2)

  • There is a potential risk for multiple pregnancies (5.3)

  • Careful attention should be given to the diagnosis of infertility in the selection of candidates (5.4)


ADVERSE REACTIONS

The most commonly observed adverse reactions (>2% incidence) are abdominal cramps, fullness, or pain, injection site reaction, nausea, respiratory disorder, OHSS, and post retrieval pain. (6.1)

To report SUSPECTED ADVERSE REACTIONS, contact Ferring at 1-800-822-8214 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.


DRUG INTERACTIONS

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


USE IN SPECIFIC POPULATIONS

  • MENOPUR is not indicated in women who are pregnant (4, 8.1)

  • Caution should be exercised if administered to a nursing woman (8.2)



Revised: 10/2010

FULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed

1 INDICATIONS AND USAGE

2 DOSAGE AND ADMINISTRATION

2.1 Selection of Patients

2.2 Dosage

2.3 Administration

3 DOSAGE FORMS AND STRENGTHS

4 CONTRAINDICATIONS

5 WARNINGS AND PRECAUTIONS

5.1 Overstimulation of the Ovary during MENOPUR Therapy

5.2 Pulmonary and Vascular Complications

5.3 Multiple Pregnancies

5.4 General Precautions

5.5 Laboratory Tests

6 ADVERSE REACTIONS

6.1 Clinical Study Experience

7 DRUG INTERACTIONS

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy (Category X)

8.2 Nursing Mothers

8.3 Pediatric Patients

8.4 Geriatric Patients

10 OVERDOSAGE

11 DESCRIPTION

12 CLINICAL PHARMACOLOGY

12.2 Pharmacokinetics

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

14 CLINICAL STUDIES

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 Storage and Handling

16.2 Directions for Using MENOPUR

16.3 Disposing of Needles and Syringes

17 PATIENT COUNSELING INFORMATION

17.1 Duration and Monitoring Required

17.2 Overstimulation of the Ovary

17.3 Multiple Pregnancies

17.4 Instructions for Self-Administration and Proper Disposal of Sharps

PACKAGE LABEL - DRAXIS VIAL LABEL

PACKAGE LABEL - KIEL VIAL LABEL

PACKAGE LABEL - KIEL CARTON

PACKAGE LABEL.- DRAXIS CARTON

PACKAGE LABEL - OUTER CARTON


FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

MENOPUR administered subcutaneously is indicated for the development of multiple follicles and pregnancy in the ovulatory patients participating in an ART program.

2 DOSAGE AND ADMINISTRATION

2.1 Selection of Patients

  • A thorough gynecologic and endocrinologic evaluation, including an assessment of pelvic anatomy must be performed before treatment with MENOPUR. Patients with tubal obstruction should receive MENOPUR only if enrolled in an IVF program.

  • Primary ovarian failure should be excluded by the determination of gonadotropin levels.

  • Careful examination should be made to rule out the presence of an early pregnancy.

  • Patients in late reproductive life have a greater predilection to endometrial carcinoma as well as a higher incidence of anovulatory disorders. A thorough diagnostic evaluation should always be performed in patients who demonstrate abnormal uterine bleeding or other signs of endometrial abnormalities before starting MENOPUR therapy.

  • Evaluation of the partner's fertility potential should be included in the workup.

2.2 Dosage

Assisted Reproductive Technologies

The recommended initial dose of MENOPUR for patients who have received a GnRH agonist for pituitary suppression is 225 IU. Based on clinical monitoring (including serum estradiol levels and vaginal ultrasound results) subsequent dosing should be adjusted according to individual patient response. Adjustments in dose should not be made more frequently than once every two days and should not exceed 150 IU per adjustment. The maximum daily dose of MENOPUR given should not exceed 450 IU and dosing beyond 20 days is not recommended.

Once adequate follicular development is evident, hCG should be administered to induce final follicular maturation in preparation for oocyte retrieval. The administration of hCG must be withheld in cases where the ovaries are abnormally enlarged on the last day of therapy. This should reduce the chance of developing OHSS.

2.3 Administration

Dissolve the contents of one to six vials of MENOPUR in one mL of sterile saline and ADMINISTER SUBCUTANEOUSLY immediately. Any unused reconstituted material should be discarded.

Parenteral drug products should be visually inspected for particulate matter and discoloration prior to administration, whenever solution and container permit.

The lower abdomen (alternating sides) should be used for subcutaneous administration.

3 DOSAGE FORMS AND STRENGTHS

75 IU FSH and 75 IU of LH activity, supplied as lyophilized powder or pellet in sterile vials with diluent vials and Q-Cap® vial adapters.

4 CONTRAINDICATIONS

MENOPUR is contraindicated in women who have:

  • A high FSH level indicating primary ovarian failure.

  • Uncontrolled thyroid and adrenal dysfunction.

  • An organic intracranial lesion such as a pituitary tumor.

  • Sex hormone dependent tumors of the reproductive tract and accessory organs.

  • Abnormal uterine bleeding of undetermined origin.

  • Ovarian cysts or enlargement not due to polycystic ovary syndrome.

  • Prior hypersensitivity to menotropins or MENOPUR.

  • MENOPUR is not indicated in women who are pregnant. There are limited human data on the affects of menotropins when administered during pregnancy

. 1


1

5 WARNINGS AND PRECAUTIONS

MENOPUR is a drug that should only be used by physicians who are thoroughly familiar with infertility problems. It is a potent gonadotropic substance capable of Ovarian Hyperstimulation Syndrome (OHSS) in women with or without pulmonary or vascular complications. Gonadotropin therapy requires a certain time commitment by physicians and supportive health professionals, and its use requires the availability of appropriate monitoring facilities [see Warnings and Precautions(5.5)]

5.1 Overstimulation of the Ovary during MENOPUR Therapy

Ovarian Enlargement: Mild to moderate uncomplicated ovarian enlargement which may be accompanied by abdominal distension and/or abdominal pain occurs in approximately 5 to 10% of women treated with menotropins and hCG, and generally regresses without treatment within two or three weeks. The lowest dose consistent with expectation of good results and careful monitoring of ovarian response can further minimize the risk of overstimulation.

If the ovaries are abnormally enlarged on the last day of MENOPUR therapy, hCG should not be administered in this course of treatment; this will reduce the chances of development of the Ovarian Hyperstimulation Syndrome (OHSS).

OHSS: OHSS is a medical event distinct from uncomplicated ovarian enlargement. OHSS may progress rapidly to become a serious medical event. It is characterized by an apparent dramatic increase in vascular permeability which can result in a rapid accumulation of fluid in the peritoneal cavity, thorax, and potentially, the pericardium. The early warning signs of development of OHSS are severe pelvic pain, nausea, vomiting, and weight gain. The following symptomatology has been seen with cases of OHSS: abdominal pain, abdominal distension, gastrointestinal symptoms including nausea, vomiting and diarrhea, severe ovarian enlargement, weight gain, dyspnea, and oliguria. Clinical evaluation may reveal hypovolemia, hemoconcentration, electrolyte imbalances, ascites, hernoperitoneum, pleural effusions, hydrothorax, acute pulmonary distress, and thromboembolic events [see Warnings and Precautions (5.2)]. Transient liver function test abnormalities suggestive of hepatic dysfunction, which may be accompanied by morphologic changes on liver biopsy, have been reported in association with the OHSS.

In the IVF clinical study, 0399E, OHSS occurred in 7.2% of the 373 MENOPUR treated women.

Cases of OHSS are more common, more severe and more protracted if pregnancy occurs. OHSS develops rapidly; therefore patients should be followed for at least two weeks after hCG administration. Most often, OHSS occurs after treatment has been discontinued and reaches its maximum at about seven to ten days following treatment. Usually, OHSS resolves spontaneously with the onset of menses. If there is evidence that OHSS may be developing prior to hCG administration [see Warnings and Precautions(5.5)], the hCG should be withheld. If severe OHSS occurs, treatment must be stopped and the patient should be hospitalized.

A physician experienced in the management of the syndrome, or who is experienced in the management of fluid and electrolyte imbalances, should be consulted.

5.2 Pulmonary and Vascular Complications

Serious pulmonary conditions (e.g., atelectasis, acute respiratory distress syndrome) have been reported. In addition, thromboembolic events both in association with, and separate from, the OHSS have been reported following menotropins therapy. Intravascular thrombosis and embolism, which may originate in venous or arterial vessels, can result in reduced blood flow to critical organs or the extremities. Sequelae of such events have included venous thrombophlebitis, pulmonary embolism, pulmonary infarction, cerebral vascular occlusion (stroke), and arterial occlusion resulting in loss of limb. In rare cases, pulmonary complications and/or thromboembolic events have resulted in death.

5.3 Multiple Pregnancies

In the clinical trial multiple pregnancy as diagnosed by ultrasound occurred in 35.3% (n=30) of 85 total pregnancies.

The patient and her partner should be advised of the potential risk of multiple births before starting treatment.

5.4 General Precautions

Careful attention should be given to the diagnosis of infertility in the selection of candidates for MENOPUR therapy [see Dosage and Administration(2.1)]

5.5 Laboratory Tests

The combination of both estradiol levels and ultrasonography are useful for monitoring the growth and development of follicles, timing hCG administration, as well as minimizing the risk of the OHSS and multiple gestations.

The clinical confirmation of ovulation, is determined by:

  • A rise in basal body temperature;

  • Increase in serum progesterone; and

  • Menstruation following the shift in basal body temperature.

When used in conjunction with indices of progesterone production, sonographic visualization of the ovaries will assist in determining if ovulation has occurred. Sonographic evidence of ovulation may include the following:

  • Fluid in the cul-de-sac;

  • Ovarian stigmata; and

  • Collapsed follicle.

Because of the subjectivity of the various tests for the determination of follicular maturation and ovulation, it cannot be overemphasized that the physician should choose tests with which he/she is thoroughly familiar.

6 ADVERSE REACTIONS

6.1 Clinical Study Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observes in practice.The safety of MENOPUR was examined in 3 clinical studies that enrolled a total of 575 patients receiving MENOPUR in the IVF and OI studies. All adverse events (without regard to causality assessment) occurring at an incidence of >2% in women treated with MENOPUR are listed in Table 1

Table 1: Highly Purified Menotropin SC and IM in Female Patients Undergoing IVF and OI Adverse Events With Onset on or After GnRH Administration, COSTART Classification (for Incidence of 2% or Greater)

 Body System/Preferred Term IVF*n=499 OI**n=76
N % N %
Body as a whole Abdomen enlarged 12 2.4 0 0.0
Abdominal cramps 30 6.0 5 6.6
Abdominal fullness 16 3.2 7 9.2
Abdominal pain 88 17.6 7 9.2
Back pain 16 3.2 0 0.0
Elevated estradiol 12 2.4 0 0.0
Flu syndrome 13 2.6 1 1.3
Flushing 12 2.4 0 0.0
Headache 170 34.1 12 15.8
Injection site pain 27 5.4 0 0.0
Injection site reaction 48 9.6 9 11.8
Malaise 14 2.8 2 2.6
Pain 16 3.2 2 2.6
Cardiovascular Migraine 12 2.4 0 0.0
Digestive Constipation 8 1.6 0 0.0
Diarrhea 14 2.8 2 2.6
Nausea 60 12.0 6 7.9
Vomiting 21 4.2 2 2.6
Nervous Dizziness 13 2.6 0 0.0
Respiratory Cough increased 8 1.6 2 2.6
Respiratory disorder 29 5.8 3 3.9
Urogenital Breast tenderness 9 1.8 2 2.6
Hot flash 3 0.6 2 2.6
Menstrual disorder 16 3.2 0 0.0
OHSS 19 3.8 10 13.2
Pelvic cramps 0 0.0 3 3.9
Pelvic discomfort 2 0.4 2 2.6
Post retrieval pain 32 6.4 0 0.0
Uterine spasm 8 1.6 3 3.9

 * Includes IM and SC subjects from Protocols MFK/IVF/0399E and MENOPUR 2000-02.

** Includes IM and SC subjects from Protocol MENOPUR 2000-01

7 DRUG INTERACTIONS

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

8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy (Category X)

MENOPUR is not indicated in women who are pregnant. There are limited human data on the effects of menotropins when administered during pregnancy [see Contraindication (4)]

8.2 Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised if menotropins are administered to a nursing woman.

8.3 Pediatric Patients

Safety and effectiveness in pediatric patients have not been established.

8.4 Geriatric Patients

10 OVERDOSAGE

Aside from possible ovarian hyperstimulation [see Warnings and Precautions(5.1)], little is known concerning the consequences of acute overdosage with MENOPUR.

11 DESCRIPTION

MENOPUR (menotropins for injection, USP) is a preparation of gonadotropins, extracted from the urine of postmenopausal women, which has undergone additional steps for purification. Each vial of MENOPUR contains 75 International Units (IU) of follicle-stimulating hormone (FSH) activity and 75 IU 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) in a sterile, lyophilized form intended for reconstitution with sterile 0.9% Sodium Chloride Injection, USP. MENOPUR is administered by subcutaneous (SC) injection.

The biological activity of MENOPUR is determined using the USP 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). Human Chorionic Gonadotropin (hCG) is detected in MENOPUR.

Both FSH and LH are glycoproteins that are acidic and water soluble.

12 CLINICAL PHARMACOLOGY

MENOPUR, administered for 7 to 20 days, produces ovarian follicular growth and maturation in women who do not have primary ovarian failure. In order to produce final follicular maturation and ovulation in the absence of an endogenous LH surge, hCG must be administered following MENOPUR treatment, at a time when patient monitoring indicates sufficient follicular development has occurred.

12.2 Pharmacokinetics

Two open-label, randomized, controlled trials were conducted to assess the pharmacokinetics of MENOPUR. Study 2003-02 compared single doses of SC administration of the US and European (EU) formulations of MENOPUR in 57 healthy, pre-menopausal females who had undergone pituitary suppression. The study established that the two formulations are bioequivalent. Study 2000-03 assessed single and multiple doses of MENOPUR administered SC and IM in a 3 phase cross-over design in 33 healthy, pre-menopausal females who had undergone pituitary suppression. The primary pharmacokinetic endpoints were FSH AUC and Cmax values. The results are summarized in Table 2.

Table 2: Mean (±SD) FSH Pharmacokinetic ParametersFollowing MENOPUR Administration (Study 2000-03)

PK Parameters Single Dose(225 IU) Multiple Dose
(225 IU x 1 day then
150 IU x 6 days)
SC IM SC IM
Cmax†(mIU/mL) 8.5 (2.5) 7.8 (2.4) 15.0 (3.6) 12.5 (2.3)
Tmax (hr) 17.9 (5.8) 27.5 (25.4) 8.0 (3.0) 9.0 (7.0)
AUC (hr-mIU/mL) 726.2 (243.0) 656.1 (233.7) 622.7 (153.0) 546.2 (91.2)

Single dose Cmax AUC120 and multiple dose Cmaxss and AUCss

Absorption

The SC route of administration trends toward greater bioavailability than the IM route for single and multiple doses of MENOPUR.

Distribution

Human tissue or organ distribution of FSH and LH has not been studied for MENOPUR.

Metabolism

Metabolism of FSH and LH has not been studied for MENOPUR in humans.

Elimination

The elimination half-lives for FSH in the multiple-dose phase were similar (11-13 hours) for MENOPUR SC and MENOPUR IM.

Special Populations

Pregnancy (Category X)

MENOPUR is not indicated in women who are pregnant. There are limited human data on the effects of menotropins when administered during pregnancy [see Contraindications(4)].

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised if menotropins are administered to a nursing woman.

Pediatric Use

MENOPUR has not been studied in the pediatric population.

Geriatric Use

MENOPUR has not been studied in the geriatric population.

Renal Impairment

The safety and efficacy of MENOPUR in renal insufficiency have not been studied.

Hepatic Impairment

The safety and efficacy of MENOPUR in hepatic insufficiency have not been studied.

Drug Interactions

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

13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

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

14 CLINICAL STUDIES

The efficacy and safety of MENOPUR have been established in one randomized, controlled clinical study, 0399E, of women undergoing in vitro fertilization (IVF) or IVF plus intracytoplasmic injection to achieve pregnancy. Study 0399E was a Phase 3, randomized, open-label, multicenter, multinational (in Europe and Israel), comparative clinical trial of ovulatory, infertile females undergoing ovarian stimulation to produce multiple follicles for IVF and embryo transfer (IVF/ET) after pituitary suppression with a GnRH agonist. A total of 373 patients were randomized to the MENOPUR arm. Randomization was stratified by insemination technique [conventional in-vitro fertilization (IVF) vs. intra-cytoplasmic sperm injection (ICSI)]. Efficacy was assessed based on the primary efficacy parameter of continuing pregnancy. The initial daily dose of MENOPUR was 225 IU SC 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.

Table 3: Efficacy Outcomes for IVF Study 0399E (one cycle of treatment)

 Parameter MENOPUR SC
n=373
Continuing Pregnancy (%)a 87 (23)b
Clinical Pregnancy (%) 98 (26)c

a Continuing pregnancy was defined as ultrasound visualization of gestational sac with fetal heartbeat at ≥10 weeks after ET

b Non-inferior to comparator recombinant human FSH based on a two-sided 95% confidence interval, intent-to-treat analysis

c Secondary efficacy parameter. Study 0399E was not powered to demonstrate differences in this parameter

16 HOW SUPPLIED/STORAGE AND HANDLING

MENOPUR (menotropins for injection, USP) is supplied in sterile vials as a lyophilized, white to off-white powder or pellet.

Each vial of MENOPUR is accompanied by a vial of sterile diluent containing 2 mL of 0.9% Sodium Chloride Injection, USP:

75 IU FSH and 75 IU of LH activity, supplied as:

NDC 55566-7501-1 : Box of 5 vials + 5 vials diluent.

NDC 55566-7501-2 : Box of 5 vials + 5 vials diluent + 5 Q•Cap vial adapters.

16.1 Storage and Handling

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

16.2 Directions for Using MENOPUR

  1. Wash hands thoroughly with soap and water.

  2. Before injections, the septum tops of the vials should be wiped with an aseptic solution to prevent contamination of the contents.

  3. To prepare the MENOPUR solution, inject 1 mL of Sterile Saline for Injection, USP into the vial of MENOPUR. DO NOT SHAKE, but gently swirl until the solution is clear. Generally, the MENOPUR dissolves immediately. Check the liquid in the container. If it is not clear or has particles in it, DO NOT USE IT.

  4. For patients requiring a single injection from multiple vials of MENOPUR, up to 6 vials can be reconstituted with 1 mL of Sterile Saline for Injection, USP. This can be accomplished by reconstituting a single vial as described above (see step 3). Then draw the entire contents of the first vial into a syringe, and inject the contents into a second vial of lyophilized MENOPUR. Gently swirl the second vial, as described above, once again checking to make sure the solution is clear and free of particles. This step can be repeated with 4 additional vials for a total of up to 6 vials of lyophilized MENOPUR into 1 mL of diluent.

  5. Draw the reconstituted MENOPUR into an empty, sterile syringe.

  6. Hold the syringe pointing upwards and gently tap the side to force any air bubbles to the top; then squeeze the plunger gently until all the air has been expelled and only MENOPUR solution is left in the syringe.

  7. MENOPUR works if it is injected SC. The recommended sites for SC injection are either side of the lower abdomen alternating between left and right sides of the lower abdomen below the naval. SC injection of MENOPUR into the thigh is not recommended unless the lower abdomen is not usable because of scarring, surgical deformity or other medical conditions.

  8. The injection site should be swabbed with alcohol. Clean about two inches around the point where the needle will go in and let the alcohol dry for at least one minute before proceeding.

  9. For SC injection, the needle should be inserted at a 90° angle to the skin surface.


    InjectionSite2 

  10. If the needle is incorrectly positioned, it will be difficult to draw back on the plunger. Any blood drawn into the syringe means the needle tip has penetrated a vein or artery. If this happens, the needle should be withdrawn, cover the injection site with a swab containing alcohol and apply pressure; the site should stop bleeding in a minute or two. After withdrawing the needle, replace with a sterile needle and administer the injection.

  11. Once the needle is properly placed, depress the plunger slowly and steadily, so the solution is correctly injected and the skin or muscle tissue is not damaged.

  12. Withdraw the needle quickly and apply pressure to the site with a swab. If bleeding does not stop within a few minutes, place a clean piece of gauze and/or adhesive bandage over the site.

  13. Use the disposable syringe only once and dispose of it properly. Discard the used needle and syringe into your safety container. Do not reuse your injection materials.

16.3 Disposing of Needles and Syringes

To safely dispose of medical sharps, place used needles and syringes in a closeable, puncture-resistant container, such as a red biohazard sharps container.  Sharps containers should then be taken to a collection center for proper disposal. Ask your physician or pharmacist or reference our website for more information about safely disposing used sharps.

State Laws: In some states, it is illegal to throw away medical sharps in household garbage, recycling, and compost bins. Needles and other sharps must be placed in an approved sharps container and disposed of at an approved drop-off site.

More information and options for sharps disposal can be found at our website www.ferringusa.com/sharps.

17 PATIENT COUNSELING INFORMATION

See 17 for PATIENT COUNSELING INFORMATION

17.1 Duration and Monitoring Required

Prior to therapy with MENOPUR, patients should be informed of the duration of treatment and the monitoring of their condition that will be required.

17.2 Overstimulation of the Ovary

Inform patients that they should seek immediate medical attention if they notice symptoms of ovarian enlargement (e.g., severe pelvic pain, chest pain, abdominal pain, nausea, vomiting, sudden weight gain, bloating, or trouble breathing).

17.3 Multiple Pregnancies

The patient and her partner should be advised of the potential risk of multiple births before starting treatment.

17.4 Instructions for Self-Administration and Proper Disposal of Sharps

Instruct patient on how to properly self administer MENOPUR and properly dispose of needles [see How Supplied/Storage and Handling (16.3)]

MANUFACTURED FOR:

FerringLogo

FERRING PHARMACEUTICALS INC.Parsippany, NJ 07054

6314-01 Rev 06/2008

PACKAGE LABEL - DRAXIS VIAL LABEL

MenopurDraxisVialLabel 

Menopur® 75IU

(menotropins for injection USP)

75 IU FSH, 75 IU LH

FOR SUBCUTANEOUS INJECTION ONLY

DISCARD UNUSED PORTION

Rx only

Manufactured For:

Ferring Pharmaceuticals Inc., Parsippany, NJ 07054

By: DRAXIS Specialty Pharmaceuticals Inc,, Quebec, Canada

NDS 55566-7501-0

LOT/EXP.

225490 6245-02

PACKAGE LABEL - KIEL VIAL LABEL

MenopurKielVialLabel

MENOPUR® 75 IU

(menotrophins for injection, USP)

75 IU FSH, 75 IU LH

FOR SUBCUTANEOUS INJECTION ONLY

DISCARD UNUSED PORTION

Rx only

Manufactured For:

Ferring Pharmaceuticals Inc., Parsippany, NJ 07054

By: Ferring GmbH, Kiel Germany

NDC 55566-7501-0

LOT/EXP.

6225-02

PACKAGE LABEL - KIEL CARTON

MenopurKielCarton

MENOPUR® 75 IU

(menotrophins for injection, USP)

6309-01

Manufactured for:

Ferring Pharmaceuticals Inc., Parsippany, NJ 07054

By: Ferring GmbH, Kiel, Germany

Diluent manufactured for Ferring Pharmaceuticals Inc.

NDC 55566-7501-1

5 single-dose vials of Menotrophins for Injection, USP

5 single-dose vials of 0.9% Sodium Chloride Injection, USP, 2 mL

Reconstitute with 1 mL 0.9% Sodium Chloride Injection, USP

Administer SC immediately after reconstitution.

Discard unused portion.

Usual Dosage: See package insert for dosage and complete Prescribing Information.

Lyophilized powder may be stored refrigerated or at room temperature (3˚ to 25˚ C/ 37˚ to 77˚ F). Protect from light.

FOR SUBCUTANEOUS INJECTION ONLY

PACKAGE LABEL.- DRAXIS CARTON

MenopurDraxisCarton

Menopur® 75 IU

(menotropins for injection, USP)

6310-01

Manufactured for:

Ferring Pharmaceuticals Inc., Parsippany, NJ 07054

By: DRAXIS Specialty Pharmaceuticals Inc., Quebec, Canada

Diluent manufactured for Ferring Pharmaceuticals Inc.

NDC 55566-7501-1

Menopur® 75 IU

(menotropins for injection, USP)

5 single-dose vials of Menotropins for Injection, USP

5 single-dose vials of 0.9% Sodium Chloride Injection, USP, 2 mL

Reconstitute with 1 mL 0.9% Sodium Chloride Injection, USP.
Administer SC immediately after reconstitution.
Discard unused portion.
Usual Dosage: See package insert for dosage and complete Prescribing Information.
Lyophilized powder may be stored refrigerated or at room temperature (3˚ to 25˚ C/ 37˚ to 77˚ F). Protect from light.

FOR SUBCUTENEOUS INJECTION ONLY

PACKAGE LABEL - OUTER CARTON

MenopurOuterCarton

NDC 55566-7501-2

Menopur® 75 IU

(menotrophins for injection, USP)

5 single-dose vials of Menotropins for Injection, USP

5 single-dose vials of 0.9% Sodium Chloride Injection, USP, 2 mL

5 Q•Cap™ Vial Adapters

FOR SUBCUTANEOUS INJECTION ONLY

Rx only

Reconstitute with 1 mL 0.9% Sodium Chloride Injection, USP.

Administer SC immediately after reconstitution.

Discard unused portion.

Usual Dosage:See package insert for dosage and complete Prescribing Information.

Lyophilized powdermay be stored refrigerated or at roomtemperature (3˚ to 25˚C/37˚ to 77˚F). Protect from light.

6311-02

Each single-dose vial of diluent contains:

2 mL 0.9% Sodium Chloride Injection, USP.

Contents: Each single-dose vial of sterile, lyophilized menotropins contains: 75 IU ofFSH; 75 IU LH; Lactose Monohydrate 21 mg; Polysorbate 20 0.005 mg; SodiumPhosphate buffer (Sodium Phosphate Dibasic and Phosphoric Acid).


MENOPUR 
menotropins injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:55566-7501
Route of Administration SUBCUTANEOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
follicle stimulating hormone beta polypeptide (follicle stimulating hormone beta polypeptide) follicle stimulating hormone beta polypeptide 75 [iU]
lutropin alfa (lutropin alfa) lutropin alfa 75 [iU]
Inactive Ingredients
Ingredient Name Strength
lactose monohydrate 21 mg
polysorbate 20 0.005 mg
sodium chloride 2 mL
sodium phosphate, dibasic, heptahydrate 0.005 mg
Product Characteristics
Color WHITE Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:55566-7501-2 1 BOX (5 VIAL) in 1 CARTON contains a BOX (55566-7501-1)
1 NDC:55566-7501-1 1 INJECTION (5 VIAL) in 1 BOX This package is contained within the CARTON (55566-7501-2)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021663 10/29/2004

Labeler - Ferring Pharmaceuticals Inc. (103722955)
Establishment
Name Address ID/FEI Operations
DRAXIS Specialty Pharmaceuticals Inc. 243604761 manufacture, pack
Establishment
Name Address ID/FEI Operations
Ferring GmbH - Kiel 328609615 manufacture

Revised: 10/2010 Ferring Pharmaceuticals Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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