Drugs Details

Drugs Info of Menopur, Repronex
Drugs Details
  • Drugs Type  : FDA
  • Date : 20th Mar 2015 03:53 am
  • Brand Name : Menopur, Repronex
  • Generic Name : menotropins (injectable) (Pronunciation: MEN oh troe pins)
Descriptions

Repronex® (menotropins for injection, USP) is a purified preparation of gonadotropins extracted from the urine of postmenopausal women. Each vial of Repronex® (menotropins for injection) contains 75 International Units (IU) or 150 IU of follicle-stimulating hormone (FSH) activity and 75 IU or 150 IU of luteinizing hormone (LH) activity, respectively, plus 20 mg lactose monohydrate in a sterile, lyophilized form. The final product may contain sodium phosphate buffer (sodium phosphate tribasic and phosphoric acid). Repronex® (menotropins for injection) is administered by subcutaneous or intramuscular injection. Human Chorionic Gonadotropin (hCG), a naturally occurring hormone in post-menopausal urine, is detected in Repronex® (menotropins for injection) .

Repronex® (menotropins for injection) is biologically standardized for FSH and LH (ICSH) gonadotropin activities in terms of the Second International Reference Preparation for Human Menopausal Gonadotropins established in September, 1964 by the Expert Committee on Biological Standards of the World Health Organization.

Both FSH and LH are glycoproteins that are acidic and water soluble. Therapeutic class: Infertility.

What are the possible side effects of menotropins (Menopur, Repronex)?

Stop using menotropins and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Less than 2% of female patients treated with menotropins develop ovarian hyperstimulation syndrome (OHSS), especially after the first cycle of therapy. Symptoms of OHSS include swelling of the hands or legs, abdominal pain and swelling, shortness of breath, weight gain, and nausea or vomiting. OHSS can be fatal. Notify your doctor immediately or seek emergency medical attention if...

Read All Potential Side Effects and See Pictures of Repronex »

What are the precautions when taking menotropins for injection (Repronex)?

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other products containing FSH or LH; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details

Before using this medication, tell your doctor or pharmacist your medical history, especially of: other fertility problems (e.g., primary ovarian failure), abnormal uterine/vaginal bleeding, thyroid or adrenal gland problems, cancer of the reproductive organs (breast, uterus, ovary), tumor in the brain (e.g., pituitary tumor), ovarian cysts or enlarged ovaries (not due to polycystic ovary syndrome), twisting of the ovary (ovarian torsion), personal/family history of blood...

Read All Potential Precautions of Repronex »

This monograph has been modified to include the generic and brand name in many instances.

Indications

Repronex® (menotropins for injection) , in conjunction with hCG, is indicated for multiple follicular development (controlled ovarian stimulation) and ovulation induction in patients who have previously received pituitary suppression.

Selection of Patients

  1. Before treatment with Repronex® (menotropins for injection) is instituted, a thorough gynecologic and endocrinologic evaluation must be performed. Except for those patients enrolled in an in vitrofertilization program, this should include a hysterosalpingogram (to rule out uterine and tubal pathology) and documentation of anovulation by means of basal body temperature, serial vaginal smears, examination of cervical mucus, determination of serum (or urine) progesterone, urinary pregnanediol and endometrial biopsy. Patients with tubal pathology should receive menotropins only if enrolled in an in vitro fertilization program.
  2. Primary ovarian failure should be excluded by the determination of gonadotropin levels.
  3. Careful examination should be made to rule out the presence of an early pregnancy.
  4. Patients in late reproductive life have a greater predilection to endometrial carcinoma as well as a higher incidence of anovulatory disorders. Cervical dilation and curettage should always be done for diagnosis before starting Repronex® (menotropins for injection) therapy in such patients who demonstrate abnormal uterine bleeding or other signs of endometrial abnormalities.
  5. Evaluation of the husband's fertility potential should be included in the workup.

Dosage Administration

Dosage

Infertile patients with oligo-anovulation

The dose of Repronex® (menotropins for injection) to stimulate development of ovarian follicles must be individualized for each patient. The lowest dose consistent with achieving good results based on clinical experience and reported clinical data should be used.

The recommended initial dose of Repronex® (menotropins for injection) for patients who have received GnRH agonist or antagonist pituitary suppression is 150 IU daily for the first 5 days of treatment. 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 2 days and should not exceed more than 75 to 150 IU per adjustment. The maximum daily dose of Repronex® (menotropins for injection) should not exceed 450 IU and dosing beyond 12 days is not recommended.

If patient response to Repronex® (menotropins for injection) is appropriate, hCG (5000 to 10,000 USP units) should be given 1 day following the last dose of Repronex® (menotropins for injection) . The hCG should be withheld if the serum estradiol is greater than 2000 pg/mL, if the ovaries are abnormally enlarged or if abdominal pain occurs, and the patient should be advised to refrain from intercourse. These precautions may reduce the risk of Ovarian Hyperstimulation Syndrome and multiple gestation. Patients should be followed closely for at least 2 weeks after hCG administration. If there is inadequate follicle development or ovulation without subsequent pregnancy, the course of treatment with Repronex® (menotropins for injection) may be repeated. The couple should be encouraged to have intercourse daily, beginning on the day prior to the administration of hCG until ovulation becomes apparent from the indices employed for the determination of progestational activity. In the light of the foregoing indices and parameters mentioned, it should become obvious that, unless a physician is willing to devote considerable time to these patients and be familiar with and conduct the necessary laboratory studies, he/she should not use Repronex® (menotropins for injection) .

Assisted Reproductive Technologies

The recommended initial dose of Repronex® (menotropins for injection) for patients who have received GnRH agonist or antagonist 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 2 days and should not exceed more than 75 to 150 IU per adjustment. The maximum daily dose of Repronex® (menotropins for injection) given should not exceed 450 IU and dosing beyond 12 days is not recommended.

Once adequate follicular development is evident, hCG (5000 - 10,000 USP units) 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.

Administration

Dissolve the contents of one to 6 vials of Repronex® (menotropins for injection) in one to two mL of sterile saline and ADMINISTER SUBCUTANEOUSLY OR INTRAMUSCULARLY immediately. Any unused reconstituted material should be discarded.

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

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

How Supplied

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

Each vial is available with an accompanying 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 55566-7185-1 - Box of 1 vial + 1 vial diluent.
NDC 55566-7185-2 - Box of 5 vials + 5 vials diluent.

150 IU FSH and 150 IU of LH activity, supplied as:

NDC 55566-7125-1 - Box of 1 vial + 1 vial diluent.

By biological assay, one IU of LH for the Second International Reference Preparation (2nd-IRP) for hMG is biologically equivalent to approximately 0.5 U of hCG.

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.

Vials of sterile diluent of 0.9% Sodium Chloride Injection, USP manufactured for Ferring Pharmaceuticals Inc.

Manufactured for: FERRING PHARMACEUTICALS INC. SUFFERN, NY 10901. By: CARDINAL HEALTH, Albuquerque, New Mexico 87107. 03/03. FDA Rev date: 10/23/2001

This monograph has been modified to include the generic and brand name in many instances.

Side Effects

The following adverse reactions, reported during menotropins therapy, are listed in decreasing order of potential severity:

  1. Pulmonary and vascular complications (see WARNINGS)
  2. Ovarian Hyperstimulation Syndrome (see WARNINGS)
  3. Hemoperitoneum
  4. Adnexal torsion (as a complication of ovarian enlargement)
  5. Mild to moderate ovarian enlargement
  6. Ovarian cysts
  7. Abdominal pain
  8. Sensitivity to menotropins (Febrile reactions suggestive of allergic response have been reported following the administration of menotropins. Reports of flu-like symptoms including fever, chills, musculoskeletal aches, joint pains, nausea, headaches, and malaise have also been reported).
  9. Gastrointestinal symptoms (nausea, vomiting, diarrhea, abdominal cramps, bloating)
  10. Pain, rash, swelling and/or irritation at the site of injection
  11. Body rashes
  12. Dizziness, tachycardia, dyspnea, tachypnea

The following medical events have been reported subsequent to pregnancies resulting from menotropins therapy:

  1. Ectopic pregnancy
  2. Congenital abnormalities

With menotropin therapy congenital abnormalities have been reported. One infant was shown to have multiple congenital anomalies consisting of aplasia of the sigmoid colon, cecovesicle fistula, bifid scrotum, meningocele, bilateral internal tibial torsion, and right metatarsus adductus. Other reported anomalies include imperforate anus, congenital heart lesions, supernumerary digits, hypospadias, extrophy of the bladder, Down's syndrome and hydrocephalus. The incidence of congenital abnormalities does not exceed that found in the general population.

There have been infrequent reports of ovarian neoplasms, both benign and malignant, in women who have undergone multiple drug regimens for ovulation induction; however, a causal relationship has not been established.

Adverse events occurring in ≥ 1% of patients exposed to Repronex® (menotropins for injection) IM or Repronex® (menotropins for injection) SC are described in Table 4.

Table 4: Patients with Adverse Events ≥ 1%

  Repronex®
IM (N=101)
Repronex®
SC (N=96)
Adverse Events n (%) n (%)
INJECTION SITE AEs
  Injection Site Edema 1 (1.0) 8 (8.3)*
  Injection Site Reaction 2 (2.0) 8 (8.3)*
GENITOURINARY/REPRODUCTIVE AEs
  OHSS 2 (2.0) 5 (5.2)
  Vaginal Hemorrhage 8 (7.9) 3 (3.1)
  Ovarian Disease 3 (3.0) 8 (8.3)
  Ectopic Pregnancy 1 (1.0) 1 (1.0)
  Pelvic Pain 3 (3.0) 1 (1.0)
  Breast Tenderness 2 (2.0) 2 (2.1)
GASTROINTESTINAL AEs
  Nausea 4 (4.0) 7 (7.3)
  Vomiting 0 (0) 3 (3.1)
  Diarrhea 0 (0) 2 (2.1)
  Abdominal Cramping 7(6.9) 5 (5.2)
  Abdominal Pain 5 (5.0) 7 (7.3)
  Enlarged Abdomen 6 (6.0) 2 (2.1)
OTHER BODY SYSTEM AEs
  Headache 6 (6.0) 5 (5.2)
  Infection 1 (1.0) 0 (0)
  Dyspnea 1 (1.0) 2 (2.1)
* Fisher's Exact/Chi-Squared Tests- significant for Repronex® SC vs.Repronex® IM.

Drug Abuse And Dependence

There have been no reports of abuse or dependence with menotropins.

Read the Repronex (menotropins for injection) Side Effects Center for a complete guide to possible side effects

Learn More »

Interactions

No information provided.

This monograph has been modified to include the generic and brand name in many instances.

Warnings

Repronex® (menotropins for injection) 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 causing mild to severe adverse reactions in women. Gonadotropin therapy requires a certain time commitment by physicians and supportive health professionals, and its use requires the availability of appropriate monitoring facilities (see PRECAUTIONS - Laboratory Tests). In female patients it must be used with a great deal of care.

Overstimulation of the Ovary During Repronex® (menotropins for injection) 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 those treated with Repronex® menotropins and hCG, and generally regresses without treatment within two or three weeks.

In order to minimize the hazard associated with the occasional abnormal ovarian enlargement which may occur with Repronex® (menotropins for injection) hCG therapy, the lowest dose consistent with expectation of good results, should be used. Careful monitoring of ovarian response can further minimize the risk of overstimulation.

If the ovaries are abnormally enlarged on the last day of Repronex® (menotropins for injection) therapy, hCG should not be administered in this course of therapy; this will reduce the chances of development of the Ovarian Hyperstimulation Syndrome.

The Ovarian Hyperstimulation Syndrome (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, hemoperitoneum, pleural effusions, hydrothorax, acute pulmonary distress, and thromboembolic events (see "Pulmonary and Vascular Complications" below). 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 Ovarian Hyperstimulation Syndrome (OHSS).

OHSS occured in 3 of 125 (2.4%) Repronex® (menotropins for injection) treated women during ART clinical studies. None of these cases was classified as severe. In Ovulation Induction clinical studies, 4 of 72 (5.5%) Repronex® (menotropins for injection) treated women developed OHSS and of this number one case was classified as severe (1.4%). 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 PRECAUTIONS - Laboratory Tests), the hCG should be withheld.

If OHSS occurs, treatment should be stopped and the patient hospitalized. Treatment is primarily symptomatic, consisting of bed rest, fluid and electrolyte management, and analgesics if needed. The phenomenon of hemoconcentration associated with fluid loss into the peritoneal cavity, pleural cavity, and the pericardial cavity has been seen to occur and should be thoroughly assessed in the following manner: 1) fluid intake and output, 2) weight, 3) hematocrit, 4) serum and urinary electrolytes, 5) urine specific gravity, 6) BUN and creatinine, and 7) abdominal girth. These determinations are to be performed daily or more often if the need arises.

With OHSS there is an increased risk of injury to the ovary. The ascitic, pleural, and pericardial fluid should not be removed unless absolutely necessary to relieve symptoms such as pulmonary distress or cardiac tamponade. Pelvic examination may cause rupture of an ovarian cyst, which may result in hemoperitoneum, and should therefore be avoided. If this does occur, and if bleeding becomes such that surgery is required, the surgical treatment should be designed to control bleeding and to retain as much ovarian tissue as possible. Intercourse should be prohibited in those patients in whom significant ovarian enlargement occurs after ovulation because of the danger of hemoperitoneum resulting from ruptured ovarian cysts.

The management of OHSS may be divided into three phases: the acute, the chronic, and the resolution phases. Because the use of diuretics can accentuate the diminished intravascular volume, diuretics should be avoided except in the late phase of resolution as described below.

Acute Phase: Management during the acute phase should be designed to prevent hemoconcentration due to loss of intravascular volume to the third space and to minimize the risk of thromboembolic phenomena and kidney damage. Treatment is designed to normalize electrolytes while maintaining an acceptable but somewhat reduced intravascular volume. Full correction of the intravascular volume deficit may lead to an unacceptable increase in the amount of third space fluid accumulation. Management includes administration of limited intravenous fluids, electrolytes, and human serum albumin. Monitoring for the development of hyperkalemia is recommended.

Chronic Phase: After stabilizing the patient during the acute phase, excessive fluid accumulation in the third space should be limited by instituting severe potassium, sodium, and fluid restriction.

Resolution Phase: A fall in hematocrit and an increasing urinary output without an increased intake are observed due to the return of third space fluid to the intravascular compartment. Peripheral and/or pulmonary edema may result if the kidneys are unable to excrete third space fluid as rapidly as it is mobilized. Diuretics may be indicated during the resolution phase if necessary to combat pulmonary edema.

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 Ovarian Hyperstimulation Syndrome 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.

Multiple Pregnancies

Multiple pregnancies have occurred following treatment with Repronex® (menotropins for injection) IM and SC. In a clinical trial for ovulation induction in which Repronex® (menotropins for injection) IM and Repronex® (menotropins for injection) SC were directly compared, the rates of multiple pregnancies were as follows. Of the four clinical pregnancies with Repronex® (menotropins for injection) IM, two were single and two were multiple pregnancies. Both multiple pregnancies were triplet pregnancies. Of the six clinical pregnancies with Repronex® (menotropins for injection) SC, three were single and three were multiple pregnancies. The three multiple pregnancies included one twin pregnancy and two quadruplet pregnancies.

In a clinical trial of IVF patients in which Repronex® (menotropins for injection) IM and Repronex® (menotropins for injection) SC were directly compared, the rates of multiple pregnancies were as follows. Of the 24 continuing pregnancies on Repronex® (menotropins for injection) IM, 14 were single and 10 were multiple pregnancies. The ten multiple pregnancies included three triplet and seven twin pregnancies. Of the 29 continuing pregnancies on Repronex® (menotropins for injection) SC, 14 were single and 15 were multiple pregnancies. The 15 multiple pregnancies included three quadruplet, three triplet and nine twin pregnancies. The patient and her partner should be advised of the potential risk of multiple births before starting treatment.

Hypersensitivity/Anaphylactic Reactions

Hypersensitivity/anaphylactic reactions associated with menotropins administration have been reported in some patients. These reactions presented as generalized urticaria, facial edema, angioneurotic edema, and/or dyspnea suggestive of laryngeal edema. The relationship of these symptoms to uncharacterized urinary proteins is uncertain.

Precautions

General

Careful attention should be given to diagnosis in the selection of candidates for menotropins therapy (see "INDICATIONS - Selection of Patients").

Laboratory Tests

Treatment for Induction of ovulation

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 Ovarian Hyperstimulation Syndrome and multiple gestation.

The clinical confirmation of ovulation, is determined by:

  1. A rise in basal body temperature;
  2. Increase in serum progesterone; and
  3. 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:

  1. Fluid in the cul-de-sac;
  2. Ovarian stigmata; and
  3. 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.

Carcinogenesis and Mutagenesis

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

Pregnancy

Pregnancy Category X: See CONTRAINDICATIONS section.

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 Patients

Safety and effectiveness in pediatric patients have not been established.

Geriatric Patients

Safety and effectiveness in geriatric patients have not been established.

This monograph has been modified to include the generic and brand name in many instances.

OverDose

Aside from possible ovarian hyperstimulation (see WARNINGS), little is known concerning the consequences of acute overdosage with menotropins.

ContrainDications

Repronex® (menotropins for injection) is contraindicated in women who have:

  1. A high FSH level indicating primary ovarian failure.
  2. Uncontrolled thyroid and adrenal dysfunction.
  3. An organic intracranial lesion such as a pituitary tumor.
  4. The presence of any cause of infertility other than anovulation unless they are candidates for in vitro-fertilization.
  5. Abnormal bleeding of undetermined origin.
  6. Ovarian cysts or enlargement not due to polycystic ovary syndrome.
  7. Prior hypersensitivity to menotropins.
  8. Repronex® (menotropins for injection) is not indicated in women who are pregnant. There are limited human data on the effects of menotropins when administered during pregnancy.

This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Menotropins administered for 7 to 12 days produces ovarian follicular growth in women who do not have primary ovarian failure. Treatment with menotropins in most instances results only in follicular growth and maturation. When sufficient follicular maturation has occurred, hCG must be given to induce ovulation.

Pharmacokinetics

Single doses of 300 IU menotropins (Menogon®, Ferring's European formulation) were administered subcutaneously (SC) and intramuscularly (IM) in a 2-period crossover study to 16 healthy female subjects while their endogenous FSH and LH were being suppressed. Serum FSH concentrations were determined. Based on the ratio of FSH Cmax and AUCo-oc, SC and IM administration of menotropins are not bioequivalent. Compared to IM administration, the SC administration of menotropins results in an increase of FSH Cmax and AUCo-oc by 35 and 20%, respectively.

Based on two subjects who received either the highest SC or IM Repronex® (menotropins for injection) dose, FSH pharmacokinetics (PK) appears to be linear up to 450 IU menotropins. The mean accumulation factors for FSH upon six doses of SC or IM 150 to 450 IU/day Repronex® (menotropins for injection) are 1.6 and 1.4, respectively. Upon six doses of SC or IM 150 IU/day Repronex® (menotropins for injection) , the observed serum FSH concentrations range from 1.7 to 15.9 mIU/mL and 0.5 to 10.1 mIU/mL, respectively. The FSH pharmacokinetic parameters from population modeling for these two studies are in Table 1.

Table 1. FSH Pharmacokinetic Parameters† Upon Menotropins Administration

Single Dose‡ Multiple Dose¶
FSH Parameter SC IM SC IM
Ka(h-1) 0.128 (42.1) 0.117 (21.3) 0.076 (46.3) 0.064 (63.2)
C1/F (L/h) 0.770 (17.1) 0.94 (6.9) 1.11 (39.5) 1.44 (43.5)
V/F (L) 39.37 (14.1) 57.68 (11.4) 23.09 (8.3) 23.5 (2.5)
†mean (CV%)
‡Menogon® (Ferring's European formulation of menotropins)
¶ Repronex® (menotropins for injection)

Serum LH concentrations upon multiple dose SC or IM Repronex® (menotropins for injection) are low and variable. No recognizable trend in the increase in serum LH concentrations from SC or IM 150 to 450 IU/day Repronex® (menotropins for injection) doses was observed. After the 6th dose of SC or IM 150 IU/day Repronex® (menotropins for injection) , the range of baseline-corrected serum LH concentrations is 0 to 3.2 mIU/mL for both routes of administration.

Absorption

The geometric mean of FSH Cmax and AUCo-oc upon single dose SC administration of menotropins is 5.62 mIU/mL and 385.2 mIU-h/mL, respectively; the corresponding geometric median of FSH tmax is 12 hours. The geometric mean of FSH Cmax and AUCo-oc upon single dose IM administration of menotropins is 4.15 mIU/mL and 320.1 mIU-h/mL, respectively; the corresponding geometric median of FSH tmax is 18 hours.

Distribution

Human tissue or organ distribution of FSH and LH have not been studied for Repronex® (menotropins for injection) .

Metabolism

Metabolism of FSH and LH have not been studied for Repronex® (menotropins for injection) in humans.

Excretion

The mean elimination half-lives of FSH upon single dose SC and IM administration of menotropins are 53.7 and 59.2 hours, respectively.

Pediatric Populations

Repronex® (menotropins for injection) is not used in pediatric populations.

Geriatric Populations

Repronex® (menotropins for injection) is not used in geriatric populations.

Special Populations

The safety and efficacy of Repronex® (menotropins for injection) in renal and hepatic insufficiency have not been studied.

Drug Interactions

No drug/drug interaction studies have been conducted for Repronex® (menotropins for injection) in humans.

Clinical Studies

Efficacy results from a clinical trial in in vitro fertilization (IVF) patients and a clinical trial in ovulation induction (OI) in anovulatory and oligovulatory patients are summarized in Tables 2 and 3 respectively. Both studies were multicenter, active control, randomized, parallel group designs. In addition, all patients in both studies underwent pituitary suppression with a GnRH agonist before starting treatment with Repronex® (menotropins for injection) or the control therapy. The IVF study evaluated 186 patients (125 patients received Repronex® (menotropins for injection) ). The patients treated with Repronex® (menotropins for injection) received 225 IU Repronex® (menotropins for injection) daily for 5 days. This was followed by individual titration of the dose from 75 to 450 IU daily based on ultrasound and estradiol (E2) levels. The total duration of dosing did not exceed 12 days. The OI study evaluated 108 patients (72 patients received Repronex® (menotropins for injection) ). The patients treated with Repronex® (menotropins for injection) received 150 IU Repronex® (menotropins for injection) daily for 5 days. This was followed by individual titration of the dose from 75 to 450 IU daily based on ultrasound and estradiol (E2) levels. The total duration of dosing did not exceed 12 days.

Table 2. Efficacy Outcomes by Treatment Group for IVF (one cycle of treatment)

Parameter Repronex® IM
N=65
Repronex® SC
N=60
Total oocytes Retrieved 13.6 12.7
Mature oocytes Retrieved 9.4 8.6
Pts. w/oocyte Retrieval (%) 61(93.8) 55 (91.7)
Pts. w/Embryo Transfer (%) 58(89.2) 51(85.0)
Pts. w/Chemical Pregnancy (%) 31(47.7) 35(58.3)
Pts. w/Clinical Pregnancy (%) 25(38.5) 30(50.0)
Pts. w/Continuing Pregnancy (%) 24(36.9)1 29(48.3)2
Pts. w/Live Births (%) 22(33.8)3 25(41.7)4
1. Continuing pregnancies included 14 single, 7 twins, and 3 triplet pregnancies.
2. Continuing pregnancies included 14 single, 9 twins, 3 triplets, and 3 quadruplet pregnancies.
3. Total of 34 live births. One spontaneous abortion. The follow-up data is not available for one patient.
4. Total of 39 live births. Two spontaneous abortions. The follow-up data is not available for two patients.

Table 3. Efficacy Outcomes by Treatment Groups in Ovulation Induction (one cycle of treatment)

Parameter Repronex® IM
N=36
Repronex® SC
N=36
Ovulation (%) 23 (63.9) 25 (69.4)
Received hCG (%) 25 (69.4) 27 (75.0)
Mean Peak Serum E2 (SD) 1158.5 (742.3) 1452.6* (1270.6)
Chemical Pregnancy (%) 4 (11.1) 11 (30.6)
Clinical Pregnancy (%) 4 (11.1) 6 (16.7)
Continuing Pregnancy (%) 4 (11.1)1 6 (16.7)2
Pts. w/Live Births (%) 4(11.1)3 4(11.1)4
* Fisher's Exact/Chi-Squared Tests -significant for Repronex® (menotropins for injection) SC vs. Repronex® (menotropins for injection) IM
1. Continuing pregnancies included 2 single and 2 triplet pregnancies.
2. Continuing pregnancies included 3 single, 1 twin and 2 quadruplet pregnancies.
3. Total 6 live births
4. Total of 6 live births. One spontaneous abortion. The follow-up data is not available for one patient.

This monograph has been modified to include the generic and brand name in many instances.

Patient Information

Prior to therapy with Repronex® (menotropins for injection) , patients should be informed of the duration of treatment and the monitoring of their condition that will be required. Possible adverse reactions (see ADVERSE REACTIONS section) and the risk of multiple births should also be discussed.

This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

MENOTROPINS - INJECTION

 

(men-oh-TROW-pins)

 

COMMON BRAND NAME(S): Repronex

 

USES: This medication is used to treat certain fertility problems in women. It provides follicle stimulating hormone (FSH) and luteinizing hormone (LH) that help stimulate healthy ovaries to make eggs. This medication is usually used in combination with another hormone (human chorionic gonadotropin-hCG) to help you become pregnant by bringing about the growth and release of a mature egg (ovulation).

This medication is not recommended for women whose ovaries no longer make eggs properly (primary ovarian failure).

 

HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before starting this medication and each time you get a refill. You will be trained by a healthcare professional on how to properly use this medication. Learn and understand all preparation and usage instructions. If you have any questions regarding this information, consult your doctor or pharmacist.

Inject under the skin (subcutaneously) or into a muscle (intramuscularly) exactly as directed by your doctor. The dosage and length of treatment are based on your medical condition, response to therapy, and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Be sure to keep all medical appointments so your doctor can closely monitor your response to determine the dosage that is right for you. The manufacturer recommends that your dose should not exceed 450 international units per day and that the medication should not be used for more than 12 days per treatment cycle. Do not change the dose or use this drug for a longer period than prescribed unless instructed by your doctor.

Follow all instructions for proper mixing with the correct fluid provided with this medication. Use the solution immediately after the medication is mixed. Before using, check the solution visually for particles or discoloration. If either is present, do not use the liquid. Discard any unused solution. If you have questions regarding the use of this medication, consult your pharmacist.

Wash hands with soap and water before using this medication. Before injecting each dose, clean the injection site with rubbing alcohol. It is important to change the location of the injection site daily to avoid discomfort or problem areas under the skin.

Learn how to store and discard needles and medical supplies safely. Consult your pharmacist for more information.

Use this medication exactly as directed by your doctor in order to get the most benefit from it. To help you remember, use it at the same time each day. Consult your doctor or pharmacist if you have any questions about your therapy.

Consumer Overview Side Effect

SIDE EFFECTS: Headache, mild stomach pain/bloating, redness/pain at the injection site, breast tenderness, or dizziness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: vaginal bleeding, flu-like symptoms (e.g., fever, chills, joint pain, muscle ache, tiredness).

Seek immediate medical attention if any of these rare but very serious side effects occur: weakness on one side of the body, slurred speech, sudden vision changes or severe headache, pain/swelling of the calf muscles, chest pain, shortness of breath.

This medication may cause a condition known as Ovarian Hyperstimulation Syndrome (OHSS). This condition may occur during therapy and after treatment has been discontinued. Rarely, serious OHSS causes fluid to suddenly build up in the stomach, chest, and heart area. Seek immediate medical attention if you develop the following side effects: severe pain/swelling in the lower abdominal (pelvic) area, nausea/vomiting, sudden/rapid weight gain, or change in the amount of urine.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Repronex (menotropins for injection) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other products containing FSH or LH; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details

Before using this medication, tell your doctor or pharmacist your medical history, especially of: other fertility problems (e.g., primary ovarian failure), abnormal uterine/vaginal bleeding, thyroid or adrenal gland problems, cancer of the reproductive organs (breast, uterus, ovary), tumor in the brain (e.g., pituitary tumor), ovarian cysts or enlarged ovaries (not due to polycystic ovary syndrome), twisting of the ovary (ovarian torsion), personal/family history of blood clots, blood clotting disorders (such as thrombophilia), obesity, stroke, certain heart diseases (e.g., heart attack), lung problems (e.g., asthma).

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Multiple births may occur because of this treatment. Consult your doctor for more details.

Stop using this medication when you become pregnant. This medication must not be used during pregnancy. If you think you may be pregnant, tell your doctor immediately.

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: gonadorelin.

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

 

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (e.g., blood hormone tests such as estradiol level, vaginal ultrasound) should be performed regularly to monitor your progress or check for side effects. Consult your doctor for more details.

It is important to keep all regular medical and laboratory appointments so your doctor can closely monitor your response to help reduce the risk of serious side effects and determine the timing of your hCG dose.

 

MISSED DOSE: It is important to give this medication on a fixed schedule. If you miss a dose, contact your doctor or pharmacist immediately for instructions. Do not double the dose to catch up.

 

STORAGE: Store the medication refrigerated or at room temperature between 37-77 degrees F (3-25 degrees C). Protect from light. Do not freeze. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

 

Information last revised February 2014. Copyright(c) 2014 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Menopur, Repronex

Generic Name: menotropins (injectable) (Pronunciation: MEN oh troe pins)

  • What are menotropins (Repronex)?
  • What are the possible side effects of menotropins (Repronex)?
  • What is the most important information I should know about menotropins (Repronex)?
  • What should I discuss with my healthcare provider before using menotropins (Repronex)?
  • How should I use menotropins (Repronex)?
  • What happens if I miss a dose (Repronex)?
  • What happens if I overdose (Repronex)?
  • What should I avoid while using menotropins (Repronex)?
  • What other drugs will affect menotropins (Repronex)?
  • Where can I get more information?

What are menotropins (Repronex)?

Menotropins are an equal mixture of the naturally occurring follicle-stimulating hormone (FSH) and luteinizing hormone (LH). FSH and LH are important for the development of follicles (eggs) produced by the ovaries and for the development of sperm.

Menotropins are used to stimulate ovulation (the release of an egg) when a woman's ovaries can produce a follicle but hormonal stimulation is deficient. Menotropins are also used to stimulate the development of multiple eggs for in vitro fertilization. Likewise, menotropins are used to stimulate the production of sperm in men who have functioning testes but in whom hormonal stimulation is deficient.

Menotropins may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of menotropins (Repronex)?

Stop using menotropins and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Less than 2% of female patients treated with menotropins develop ovarian hyperstimulation syndrome (OHSS), especially after the first cycle of therapy. Symptoms of OHSS include swelling of the hands or legs, abdominal pain and swelling, shortness of breath, weight gain, and nausea or vomiting. OHSS can be fatal. Notify your doctor immediately or seek emergency medical attention if you develop any of these side effects.

Serious pulmonary (lung and breathing) conditions have been reported in patients using menotropins. Seek medical attention if you experience any sudden changes in your breathing.

Other side effects may also occur. Notify your doctor if you experience

  • ovarian enlargement presenting as abdominal or pelvic pain, tenderness, pressure, or swelling;
  • nausea, vomiting, or diarrhea;
  • shortness of breath;
  • pain, warmth, or tenderness centralized in an arm or leg;
  • fever or chills;
  • headache or drowsiness;
  • weakness or aching of muscles or joints;
  • breast enlargement or tenderness;
  • pain, swelling, or irritation at the injection site; or
  • rash.

Menotropins may increase the likelihood of multiple births. Multiple births may carry additional risk both for the mother and for the fetuses.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Repronex (menotropins for injection) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about menotropins (Repronex)?

Menotropins may increase the likelihood of multiple births. Multiple births may carry additional risk both for the mother and for the fetuses.

Side Effects Centers
  • Repronex
  • Menopur

Patient Detailed How Take

What should I discuss with my healthcare provider before using menotropins (Repronex)?

Menotropins will not induce ovulation or sperm production if your ovaries or testes are not functioning properly.

Do not use menotropins without first taking to your doctor if you

  • might be pregnant;
  • have a thyroid problem;
  • have cancer or a tumor of the breast, ovary, uterus, hypothalamus, or pituitary gland;
  • have undiagnosed vaginal bleeding;
  • have ovarian cysts or enlargement; or
  • have any other serious or chronic medical illness.

You may not be able to use menotropins, or you may require a dosage adjustment or special monitoring if you have any of the conditions listed above.

Do not use menotropins if you are pregnant. Menotropins are in the FDA pregnancy category X. This means that they are known to cause birth defects.

It is not known whether menotropins pass into breast milk. Do not use menotropins without first talking to your doctor if you are breast-feeding a baby.

How should I use menotropins (Repronex)?

Use menotropins exactly as directed by your doctor. If you do not understand these directions, ask your doctor, nurse, or pharmacist to explain them to you.

Formulations of menotropins intended for intramuscular injection (an injection into muscle) must not be administered subcutaneously (under the skin), and vice versa. If you are administering this medication at home, your doctor will give you detailed instructions on how to mix the solution and give yourself the injection. Do not inject menotropins if you are not sure how.

Use the solution immediately after it is mixed. Throw away any medicine that is left over.

Never reuse a needle or syringe. Dispose of all needles and syringes in an appropriate, puncture-resistant disposal container.

Store menotropins at room temperature or in the refrigerator, away from direct light, moisture, and heat.

Side Effects Centers
  • Repronex
  • Menopur

Patient Detailed Avoid Taking

What happens if I miss a dose (Repronex)?

Contact your doctor if you miss a dose of menotropins. Do not use a double dose of this medication without first talking to your doctor.

What happens if I overdose (Repronex)?

An overdose of menotropins is unlikely to threaten life. Notify your doctor immediately or call an emergency room or poison control center for advice.

Symptoms of a menotropins overdose are not known. Ovarian hyperstimulation syndrome (OHSS) may result with an overdose of menotropins. Symptoms of OHSS include swelling of the hands or legs, abdominal pain and swelling, shortness of breath, weight gain, and nausea or vomiting. OHSS can be fatal.

What should I avoid while using menotropins (Repronex)?

There are no restrictions on food, beverages, or activity during therapy with menotropins unless your doctor directs otherwise.

What other drugs will affect menotropins (Repronex)?

It is not known whether other medications will interact with menotropins. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines including vitamins, minerals, and herbal products.

Where can I get more information?

Your pharmacist can provide more information about menotropins.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2013 Cerner Multum, Inc. Version: 4.02. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

Healthwise

Side Effects Centers
  • Repronex
  • Menopur

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