Answers to Common Questions About Our Products
We know it’s important for you to understand what your medications do, and how to take them correctly. We’ve provided some more information about Ferring fertility products to help aspiring parents understand the purpose of these products and what to expect on the treatment journey.
MENOPUR is a prescription gonadotropin treatment that contains follicle stimulating hormone (FSH) and luteinizing hormone (LH). MENOPUR causes your ovaries to make multiple (more than 1) eggs as part of an Assisted Reproductive Technology (ART) cycle.
MENOPUR is taken by injection. Your healthcare provider will tell you how to use MENOPUR, how much to use, and when to use it.
See how to use MENOPUR, step by step:
MENOPUR should not be used if you:
- are allergic to menotropins or any of the ingredients in MENOPUR
- have ovaries that no longer make eggs (primary ovarian failure)
- are pregnant or think you may be pregnant. If MENOPUR is taken while you are pregnant, it may harm your baby
- have problems with your thyroid gland, adrenal gland or pituitary gland that are not controlled by taking medicine
- have a tumor in your female organs, including your ovaries, breast, or uterus that may get worse with high levels of estrogen
- have a tumor of your pituitary gland or hypothalamus
- have abnormal bleeding from your uterus or vagina and the cause is not known
- have ovarian cysts
MENOPUR can cause ovarian hyperstimulation syndrome (OHSS), which is a serious condition that can happen when the ovaries produce too many eggs (hyperstimulation).
Stop using MENOPUR and call your healthcare provider or go to the nearest hospital emergency room right away if you have any of the following symptoms of OHSS:
- severe pelvic or stomach pain
- sudden weight gain
- swollen stomach
- trouble breathing
- decreased or no urine
Other serious adverse reactions that may occur with MENOPUR include:
- Abnormally large ovaries that can cause bloating or pain in your lower stomach (pelvic) area. If your ovaries become too large your healthcare provider may tell you that you should not have intercourse (sex) so you do not rupture an ovarian cyst
- Lung problems
- Blood clots
- Ovarian torsion (twisting)
- Ovarian tumors
- Multiple pregnancies, miscarriage, birth defects and ectopic pregnancies (pregnancy outside the womb)
The most common side effects of MENOPUR include:
- stomach cramps, fullness or pain
- injection site swelling, heat, redness and pain
These are not all the possible side effects of MENOPUR. For more information, ask your healthcare provider or pharmacist. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
- Before mixing, store MENOPUR powder in the refrigerator or at room temperature between 37ºF to 77ºF (3ºC to 25ºC)
- Protect MENOPUR from light
- MENOPUR should be used right after mixing
- Throw away any unused MENOPUR
FYREMADEL is used to inhibit premature luteinizing hormone (LH) surges in women who are undergoing controlled ovarian hyperstimulation.
It comes in disposable, ready-to-use, single-dose prefilled syringes that you can self-administer at home. Your provider will show you how to administer the injection.
Don’t use FYREMADEL if you are:
- Allergic to the ingredients in FYREMADEL (ganirelix acetate) or to any of its components
- Allergic to GnRH or any other GnRH analog
- Pregnant or suspect you may be pregnant
In clinical studies, the most common side effects (experienced by at least 1% of women taking FYREMADEL) were:
- abdominal pain
- fetal death
- ovarian hyperstimulation syndrome
- vaginal bleeding
- injection site reaction
Store the prefilled syringes at 20° to 25°C (68° to 77°F). FYREMADEL can be kept between 15° and 30°C (59° and 86°F) for brief periods. Keep the syringes in a dark place to protect the them from light.
NOVAREL is a hormone called human chorionic gonadotropin (hCG). It’s used to trigger ovulation in women whose infertility is not due to primary ovulation failure, and who has been pretreated with human menotropins.
NOVAREL comes in a vial as a sterile powder that needs to be mixed with Bacteriostatic Water for Injection preserved with benzyl alcohol 0.9%. Your provider will show you how to mix and self-inject NOVAREL.
See how to use NOVAREL, step by step:
Don’t take NOVAREL if you’ve previously had an allergic reaction to human chorionic gonadotropin (HCG). HCG may cause fetal harm if given during pregnancy.
Adverse reactions include headache, irritability, restlessness, depression, fatigue, edema, early puberty, enlarged breast tissue in men, and pain at the site of injection. Hypersensitivity reactions both localized and systemic in nature, including redness, itching, rash, swelling, and shortness of breath have been reported. The relationship of these allergic-like events to the polypeptide hormone or the diluent containing benzyl alcohol is not clear.
Serious adverse reactions when using NOVAREL include:
- Ovarian hyperstimulation, a syndrome of sudden ovarian enlargement, fluid buildup in the abdomen, with or without pain, and/or excess fluid around the lungs
- Enlargement of preexisting ovarian cysts or rupture of ovarian cysts with internal bleeding
- Multiple births
- Blood clots in the arteries
Store NOVAREL at room temperature at 20° to 25°C (68° to 77°F). You may briefly leave NOVAREL between 15° and 30°C (between 59° and 86°F).
After mixing NOVAREL with Bacteriostatic Water, refrigerate at 2° to 8°C (36° to 46°F) and use it within 30 days.
ENDOMETRIN is a vaginal insert that contains the hormone progesterone. ENDOMETRIN is for women who need extra progesterone while undergoing treatment in an Assisted Reproductive Technology (ART) program.
ENDOMETRIN is delivered through a disposable applicator you insert in your vagina.
See how to use ENDOMETRIN, step by step:
Do not use ENDOMETRIN if you:
- Are allergic to anything in ENDOMETRIN. See the end of this leaflet for a complete list of ingredients
- Have unusual vaginal bleeding that has not been evaluated by a doctor
- Currently have or have had liver problems or cancer of the breast or genital organs
- Have or have had blood clots in the legs, lungs, eyes, or elsewhere in your body
ENDOMETRIN may not be right for you. Before starting ENDOMETRIN, tell your doctor about all your health problems.
Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vaginal products, vitamins, and herbal supplements.
Common side effects seen with ART and ENDOMETRIN included pelvic pain after surgery, abdominal pain, nausea, and swollen ovaries (ovarian hyperstimulation syndrome).
Other reported side effects included abdominal bloating, headache, urinary infections, uterine cramping, constipation, vomiting, tiredness, and vaginal bleeding.
Vaginal products with progesterone may also cause vaginal irritation, burning, and discharge.
Serious Risks of Progesterone
Progesterone can increase your chance of getting blood clots. Blood clots can be serious and lead to death. Serious blood clots include those in the:
- legs (thrombophlebitis)
- lungs (pulmonary embolus)
- eyes (blindness)
- heart (heart attack)
- brain (stroke)
Call your doctor or get medical help right away if you have:
- persistent pain in the lower leg (calf)
- sudden shortness of breath
- coughing up blood
- sudden blindness, partial or complete
- severe chest pain
- sudden, severe headache, vomiting, dizziness, or fainting
- weakness in an arm or leg, or trouble speaking
- yellowing of the skin and/or white of the eyes indicating possible liver problem
Other risks of progesterone use include:
- breast tenderness
- bloating or fluid retention
- mood swings and depression
Store ENDOMETRIN at room temperature, 20 ‐ 25°C (68 ‐ 77°F); ENDOMETRIN may be stored briefly between 15 ‐ 30˚C (59 ‐ 86˚F).
• Do not use ENDOMETRIN after the expiration date that is printed on the carton
MENOPUR® (menotropins for injection)
Indication for Use
- MENOPUR® (menotropins for injection), administered subcutaneously, is indicated for the development of multiple follicles and pregnancy in the ovulatory patients participating in an Assisted Reproductive Technology (ART) program.
Important Safety Information
- MENOPUR is contraindicated in women who have: a high FSH level indicating primary ovarian failure, presence of uncontrolled non-gonadal endocrinopathies, tumors of the pituitary gland or hypothalamus, sex hormone dependent tumors of the reproductive tract and accessory organs, abnormal uterine bleeding of undetermined origin, ovarian cysts or enlargement of undetermined origin, not due to polycystic ovary syndrome, or prior hypersensitivity to menotropins or MENOPUR. MENOPUR is not indicated in women who are pregnant and may cause fetal harm when administered to a pregnant woman
- MENOPUR should only be used by physicians who are thoroughly familiar with infertility problems. MENOPUR is a potent gonadotropic substance capable of causing Ovarian Hyperstimulation Syndrome (OHSS), with or without pulmonary or vascular complications, in women undergoing therapy for infertility. Ovarian torsion has been reported after gonadotropin treatment. Serious pulmonary conditions and thromboembolic events have been reported with MENOPUR. There have been infrequent reports of ovarian neoplasms with MENOPUR. Multiple pregnancies, spontaneous abortion, congenital malformations and ectopic pregnancies have occurred following treatment with MENOPUR.
- The most common adverse reactions (≥2%) in ART include: abdominal cramps; abdomen enlarged; abdominal pain; headache; injection site pain and reaction; injection site inflammation; OHSS.
FYREMADEL® (ganirelix acetate) injection
Indication for Use
- FYREMADEL® (ganirelix acetate) injection is indicated for the inhibition of premature LH surges in women undergoing controlled ovarian hyperstimulation.
Important Safety Information
- Ganirelix acetate injection is contraindicated under the following conditions: Known hypersensitivity to ganirelix acetate or to any of its components, Known hypersensitivity to GnRH or any other GnRH analog, Known or suspected pregnancy.
- Ganirelix acetate injection should be prescribed by physicians who are experienced in infertility treatment. Before starting treatment with ganirelix acetate, pregnancy must be excluded. Safe use of ganirelix acetate during pregnancy has not been established.
- Special care should be taken in women with signs and symptoms of active allergic conditions.
- Cases of hypersensitivity reactions, including anaphylactoid reactions, have been reported, as early as with the first dose, during postmarketing surveillance. In the absence of clinical experience, ganirelix acetate treatment is not advised in women with severe allergic conditions.
- The packaging of this product contains natural rubber latex which may cause allergic reactions.
- Most commonly reported adverse reactions (≥ 1%) reported in clinical trials were: Abdominal Pain (gynecological), Fetal Death, Headache, Ovarian Hyperstimulation Syndrome, Vaginal Bleeding, Injection Site Reaction, Nausea, Abdominal Pain (gastrointestinal).
- During post marketing surveillance, rare cases of hypersensitivity reactions, including anaphylactoid reactions, have been reported, as early as with the first dose.
- Major and minor congenital abnormalities have been reported in clinical follow-up studies of newborns of women administered ganirelix acetate injection. The causal relationship between these congenital anomalies and ganirelix acetate is unknown.
NOVAREL® (chorionic gonadotropin for injection, USP)
Indication for Use
- NOVAREL is indicated for the induction of ovulation and pregnancy in the anovulatory, infertile woman in whom the cause of anovulation is secondary and not due to primary ovarian failure, and who has been appropriately pre-treated with human menotropins.
Important Safety Information
- NOVAREL should not be used in patients with prior allergic reaction to HCG. HCG may cause fetal harm when administered to a pregnant woman.
- NOVAREL should be used in conjunction with human menopausal gonadotropins only by physicians experienced with infertility problems who are familiar with the criteria for patient selection, contraindications, warnings, precautions, and adverse reactions described in the package insert for menotropins. The principal serious adverse reactions during this use are: (1) Ovarian hyperstimulation, a syndrome of sudden ovarian enlargement, ascites with or without pain, and/or pleural effusion; (2) Enlargement of preexisting ovarian cysts or rupture of ovarian cysts with resultant hemoperitoneum; (3) Multiple births, and (4) Arterial thromboembolism.
- Anaphylaxis has been reported with urinary-derived HCG products.
- Since androgens may cause fluid retention, HCG should be used with caution in patients with cardiac or renal disease, epilepsy, migraine, or asthma.
- HCG can cross react in the radioimmunoassay of gonadotropins, especially luteinizing hormone. Each individual laboratory should establish the degree of cross reactivity with their gonadotropin assay. Physicians should make the laboratory aware of patients on HCG if gonadotropin levels are requested.
- Defects of forelimbs and of the central nervous system, as well as alterations in sex ratio, have been reported in mice on combined gonadotropin and HCG regimens. The dose of gonadotropin used was intended to induce superovulation. No mutagenic effect has been clearly established in humans.
- It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk caution should be exercised when HCG is administered to a nursing woman.
- Adverse reactions include headache, irritability, restlessness, depression, fatigue, edema, precocious puberty, gynecomastia, pain at the site of injection. Hypersensitivity reactions both localized and systemic in nature, including erythema, urticaria, rash, angioedema, dyspnea and shortness of breath, have been reported. The relationship of these allergic-like events to the polypeptide hormone or the diluent containing benzyl alcohol is not clear.
ENDOMETRIN® (progesterone) Vaginal Insert
Indication for Use
- ENDOMETRIN® (progesterone) Vaginal Insert is indicated to support embryo implantation and early pregnancy by supplementation of corpus luteal function as part of an Assisted Reproductive Technology (ART) treatment program for infertile women.
Important Safety Information
- ENDOMETRIN should not be used in individuals with any of the following conditions: previous allergic reactions to progesterone or any of the ingredients of ENDOMETRIN, undiagnosed vaginal bleeding, known missed abortion or ectopic pregnancy, liver disease, known or suspected breast cancer, active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events.
- The physician should be alert to earliest signs of myocardial infarction, cerebrovascular disorders, arterial or venous thromboembolism (venous thromboembolism or pulmonary embolism), thrombophlebitis, or retinal thrombosis. ENDOMETRIN should be discontinued if any of these are suspected.
- Patients with a history of depression need to be closely observed. Consider discontinuation if symptoms worsen.
- ENDOMETRIN should not be recommended for use with other vaginal products (such as antifungal products) as this may alter progesterone release and absorption from the vaginal insert.
- The most common adverse reactions reported (greater than 5%) were post-oocyte retrieval pain, abdominal pain, nausea, and ovarian hyperstimulation syndrome.