Repronex

Name: Repronex

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.

Adverse Effects

>10%

Heachache (34%)

Abdominal pain (18%)

Nausea (12%)

OHSS (13%-dose related)

Injection site pain (4-12%)

1-10%

Flushing (2.4%)

Dizziness (2.6%)

Malaise (2.8%)

Migraine (2.4%)

Breast tenderness (1.8%)

Hot flashes (0.6-2.6%)

Menstrual irregularities (3.2%)

Abdominal cramping/fullness (6%)

Constipation (1.6%)

Diarrhea (2.8%)

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%)

<1%

Ovarian enlargement & hyperstimulation

Frequency Not Defined

Arterial thromboembolism (rare but potentially fatal)

Gynecomastia in males

Hemoperitoneum

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.

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:

Allergies

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.

Pediatric

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.

Geriatric

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.

Adverse Reactions

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, and 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® IM or Repronex® 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.

Package label - kiel carton

Repronex 75 IU

(menotropins for injection, USP)

75 IU FSH, 75 IU LH

6296-02

Manufactured for:

Ferring Pharmaceuticals Inc., Parsippany, NJ 07054

By: Ferring GmbH, Kiel, Germany

Diluent manufactured for Ferring Pharmaceuticals Inc.

Rx only

NDC 55566-7185-2

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.

Contents:

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

Repronex 
menotropins kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:55566-7185
Packaging
# Item Code Package Description
1 NDC:55566-7185-2 5 CARTON in 1 CARTON
1 NDC:55566-7185-0 1 KIT in 1 CARTON
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 5 VIAL, SINGLE-USE 10 mL
Part 2 5 VIAL, SINGLE-USE 10 mL
Part 1 of 2
Repronex 
menotropins injection, powder, lyophilized, for solution
Product Information
Route of Administration SUBCUTANEOUS, INTRAMUSCULAR DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FOLLITROPIN (FOLLITROPIN) FOLLITROPIN 75 [iU]  in 2 mL
LUTEINIZING HORMONE (LUTEINIZING HORMONE) LUTEINIZING HORMONE 75 [iU]  in 2 mL
Inactive Ingredients
Ingredient Name Strength
LACTOSE MONOHYDRATE 20 mg  in 2 mL
SODIUM PHOSPHATE, DIBASIC  
Packaging
# Item Code Package Description
1 2 mL in 1 VIAL, SINGLE-USE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021289 05/06/2002 12/31/2014
Part 2 of 2
DILUENT 
sodium chloride injection
Product Information
Route of Administration SUBCUTANEOUS, INTRAMUSCULAR DEA Schedule     
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 9 mg  in 2 mL
Packaging
# Item Code Package Description
1 2 mL in 1 VIAL, SINGLE-USE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021289 05/06/2002 12/31/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021047 08/27/1999 12/31/2014
Labeler - Ferring Pharmaceuticals (103722955)
Establishment
Name Address ID/FEI Operations
Ferring GmbH - Kiel 328609615 manufacture(55566-7185)
Establishment
Name Address ID/FEI Operations
Jubilant HollisterStier General Partnership 246762764 manufacture(55566-7185), pack(55566-7185)
Establishment
Name Address ID/FEI Operations
F. M. Howell & Company 962888116 pack(55566-7185)
Revised: 06/2013   Ferring Pharmaceuticals

In Summary

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.

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