- Repronex injection
- Repronex effects of
- Repronex the effects of
- Repronex drug
- Repronex 20 mg
- Repronex side effects
- Repronex side effects of repronex
- Repronex effects of repronex
- Repronex adverse effects
Abdominal pain (18%)
OHSS (13%-dose related)
Injection site pain (4-12%)
Breast tenderness (1.8%)
Hot flashes (0.6-2.6%)
Menstrual irregularities (3.2%)
Abdominal cramping/fullness (6%)
Ovarian disease (3.8%)
Vaginal hemorrhage (3.2%)
Back pain (3.2%)
Cough increased (1.6-2.6%)
Respiratory disorder (3.9-5.8%)
Flu-like syndrome (1.3-2.6%)
Ovarian enlargement & hyperstimulation
Frequency Not Defined
Arterial thromboembolism (rare but potentially fatal)
Gynecomastia in males
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.
What should i avoid while using menotropins (menopur, repronex)?
There are no restrictions on food, beverages, or activity during therapy with menotropins unless your doctor directs otherwise.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Before Using Repronex
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Appropriate studies have not been performed on the relationship of age to the effects of menotropins injection in the pediatric population. Safety and efficacy have not been established.
Appropriate studies on the relationship of age to the effects of menotropins injection have not been performed in the geriatric population.
Interactions with Medicines
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Interactions with Food/Tobacco/Alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Abnormal or unusual vaginal bleeding or
- Adrenal gland problems, uncontrolled or
- Cysts in the ovaries or enlarged ovaries or
- High levels of FSH or
- Pituitary gland problems, uncontrolled or
- Thyroid gland problems, uncontrolled or
- Tumor in the brain (hypothalamus area or pituitary gland) or
- Tumor in the breast or
- Tumor in the ovary or uterus—Should not be used in patients with these conditions.
- Blood clots (eg, pulmonary embolism, venous thromboembolism), or history of or
- Blood vessel problems or
- Lung or breathing problems or
- Ovarian torsion (twisting of the ovary), history of or
- Stroke, or history of—Use with caution. May make these conditions worse.
Uses of Repronex
- It is used to help women get pregnant.
- It may be given to you for other reasons. Talk with the doctor.
The following adverse reactions, reported during menotropins therapy, are listed in decreasing order of potential severity:
- Pulmonary and vascular complications (see WARNINGS)
- Ovarian Hyperstimulation Syndrome (see WARNINGS)
- Adnexal torsion (as a complication of ovarian enlargement)
- Mild to moderate ovarian enlargement
- Ovarian cysts
- Abdominal pain
- 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).
- Gastrointestinal symptoms (nausea, vomiting, diarrhea, abdominal cramps, bloating)
- Pain, rash, swelling and/or irritation at the site of injection
- Body rashes
- Dizziness, tachycardia, dyspnea, and tachypnea
The following medical events have been reported subsequent to pregnancies resulting from menotropins therapy:
- Ectopic pregnancy
- 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® IM or Repronex® SC are described in Table 4.
|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)*|
|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)|
|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.
Package label - kiel carton
Repronex 75 IU
(menotropins for injection, USP)
75 IU FSH, 75 IU LH
Ferring Pharmaceuticals Inc., Parsippany, NJ 07054
By: Ferring GmbH, Kiel, Germany
Diluent manufactured for Ferring Pharmaceuticals Inc.
Repronex 75 IU
(menotropins for injection, USP)
75 IU FSH, 75 IU LH
5 single dose vials of menotropins for Injection, USP, and
5 single dose vials of 0.9% Sodium Chloride Injection, USP, 2 mL.
Each single dose vial of sterile, lyophilized monotrpins contains:
75 IU of FSH
75 IU of LH
lactose monohydrate 20 mg.
May contain sodium phosphate buffer (sodium phosphate tribasic and phosphoric acide).
Each single dose vial of diluent contains 2 mL 0.9%
Sodium Chloride Injection, USP.
FOR SUBCUTANEOUS AND
INTRAMUSCULAR INJECTION ONLY
|Labeler - Ferring Pharmaceuticals (103722955)|
|Ferring GmbH - Kiel||328609615||manufacture(55566-7185)|
|Jubilant HollisterStier General Partnership||246762764||manufacture(55566-7185), pack(55566-7185)|
|F. M. Howell & Company||962888116||pack(55566-7185)|
Common side effects of Repronex include: ovarian hyperstimulation syndrome, abdominal pain, headache, injection site reaction, and nausea. Other side effects include: respiratory tract disease, abdominal cramps, increased cough, vomiting, epigastric fullness, pain at injection site, and postoperative pain. See below for a comprehensive list of adverse effects.