Our products offer innovative options to help patients managing under-recognized health conditions such as anemia, pregnancy complications, women’s sexual function and menopause-related issues.
We devote our expertise and resources to developing and bringing to market innovative treatments that help address unmet medical needs for patients.
VYLEESI is indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD), as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is NOT due to:
- A co-existing medical or psychiatric condition,
- Problems with the relationship, or
- The effects of a medication or drug substance.
Acquired HSDD refers to HSDD that develops in a patient who previously had no problems with sexual desire. Generalized HSDD refers to HSDD that occurs regardless of the type of stimulation, situation or partner.
Limitations of Use
- VYLEESI is not indicated for the treatment of HSDD in postmenopausal women or in men.
- VYLEESI is not indicated to enhance sexual performance.
Vyleesi (bremelanotide injection) Important Safety Information
VYLEESI is contraindicated in patients who have uncontrolled hypertension or known cardiovascular disease.
Warnings and Precautions
Transient Increase in Blood Pressure and Decrease in Heart Rate: VYLEESI transiently increases blood pressure and reduces heart rate after each dose. Advise patients that these changes usually resolve within 12 hours. VYLEESI is not recommended in patients at high risk for cardiovascular disease. Consider the patient’s cardiovascular risk before initiating VYLEESI and periodically during treatment and ensure blood pressure is well-controlled. To minimize the risk of more pronounced blood pressure effects, patients should not take more than one VYLEESI dose within 24 hours. Patients should not use more than 8 VYLEESI doses per month.
Focal Hyperpigmentation: Reported by 1% of patients who received up to 8 doses per month, including involvement of the face, gingiva and breasts. Patients are at higher risk of developing focal hyperpigmentation if they have darker skin and with daily dosing. Resolution of the focal hyperpigmentation was not confirmed in all patients after discontinuation of VYLEESI. Consider discontinuing VYLEESI if hyperpigmentation develops.
Nausea: Reported by 40% of patients who received up to 8 monthly doses, requiring anti-emetic therapy in 13% of patients and leading to premature discontinuation for 8% of patients. Nausea improves for most patients with the second dose. Consider discontinuing VYLEESI or initiating anti-emetic therapy for persistent or severe nausea.
Most common adverse reactions (incidence >4%) are nausea, flushing, injection site reactions, headache, and vomiting.
VYLEESI may slow gastric emptying and impact absorption of concomitantly administered oral medications. VYLEESI may significantly decrease the systemic exposure of orally-administered naltrexone; avoid use with orally administered naltrexone-containing products intended to treat alcohol or opioid addiction.
Advise patients to discontinue VYLEESI if pregnancy is suspected. Advise patients to use effective contraception while taking VYLEESI.
There will be a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to VYLEESI during pregnancy. Pregnant women exposed to VYLEESI and healthcare providers are encouraged to call the VYLEESI Pregnancy Exposure Registry at 1-877-411-2510.
INTRAROSA® (prasterone) vaginal inserts is a steroid indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.
Important Safety Information for INTRAROSA®
INTRAROSA® is contraindicated in women with undiagnosed abnormal genital bleeding. Estrogen is a metabolite of prasterone. Use of estrogen in contraindicated in women with a known or suspected history of breast cancer. Intrarosa® has not been studied in women with a history of breast cancer.
In four 12-week randomized, placebo-controlled clinical trials, the most common adverse reaction with an incidence ≥ 2 percent was vaginal discharge. In one 52-week open-label clinical trial, the most common adverse reactions with an incidence ≥ 2 percent were vaginal discharge and abnormal Pap smear
Please see Full Prescribing Information for INTRAROSA® (prasterone).
Please See patient information for INTRAROSA®
Makena helps reduce the risk of preterm birth in the indicated patient population.
Makena is a progestin indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. The effectiveness of Makena is based on improvement in the proportion of women who delivered <37 weeks of gestation. There are no controlled trials demonstrating a direct clinical benefit such as improvement in neonatal mortality and morbidity.
Limitation of use: While there are many risk factors for preterm birth, safety and efficacy of Makena has been demonstrated only in women with a prior spontaneous singleton preterm birth. It is not intended for use in women with multiple gestations or other risk factors for preterm birth.
Important Safety Information for Makena® (hydroxyprogesterone caproate injection)
- Do not use Makena (hydroxyprogesterone caproate injection) in women with any of the following conditions:
- Current or history of thrombosis or thromboembolic disorders
- Known or suspected breast cancer, other hormone-sensitive cancer, or history of these conditions
- Undiagnosed abnormal vaginal bleeding unrelated to pregnancy
- Cholestatic jaundice of pregnancy
- Liver tumors, benign or malignant, or active liver disease
- Uncontrolled hypertension
- Makena should be discontinued if thrombosis or thromboembolism occurs
- Allergic reactions, including urticaria, pruritus and angioedema, have been reported with use of Makena or with other products containing castor oil.
- Women receiving Makena should be monitored if they:
- Are prediabetic or diabetic
- Have conditions that may be affected by fluid retention, such as preeclampsia, epilepsy, cardiac or renal dysfunction
- Develop jaundice: consider whether benefit of use warrants continuation
- Develop hypertension
Certain pregnancy-related fetal and maternal complications or events were numerically increased in Makena-treated subjects as compared to placebo subjects, including miscarriage (2.4% vs. 0%) and stillbirth (2% vs. 1.3%), admission for preterm labor (16% vs. 13.8%), preeclampsia or gestational hypertension (8.8% vs. 4.6%), gestational diabetes (5.6% vs. 4.6%), and oligohydramnios (3.6% vs. 1.3%).
In a study where the Makena intramuscular injection was compared with placebo, the most common adverse reactions reported with Makena intramuscular injection (reported incidence in ≥2% of subjects and higher than in the control group) were: injection site reactions (pain [35%], swelling [17%], pruritus [6%], nodule [5%]), urticaria (12%), pruritus (8%), nausea (6%), and diarrhea (2%)
In studies where the Makena subcutaneous injection using auto-injector was compared with Makena intramuscular injection, the most common adverse reaction reported with Makena Auto-Injector use (and higher than with Makena intramuscular injection) was injection site pain (10% in one study and 34% in another)
Please see patient information for Makena.
Indication and Dosing
Feraheme is indicated for the treatment of iron deficiency anemia (IDA) in adult patients:
- who have intolerance to oral iron or have had unsatisfactory response to oral iron or
- who have chronic kidney disease (CKD).
The recommended dose of Feraheme is an initial 510 mg dose followed by a second 510 mg dose 3 to 8 days later, each dose infused over at least 15 minutes while the patient is in a reclined or semi-reclined position.
Feraheme® (ferumoxytol injection) Important Safety Information
Fatal and serious hypersensitivity reactions including anaphylaxis have occurred in patients receiving Feraheme. Initial symptoms may include hypotension, syncope, unresponsiveness, cardiac/cardiorespiratory arrest.
- Only administer Feraheme as an intravenous infusion over at least 15 minutes and only when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions.
- Observe for signs or symptoms of hypersensitivity reactions during and for at least 30 minutes following Feraheme infusion including monitoring of blood pressure and pulse during and after Feraheme administration.
- Hypersensitivity reactions have occurred in patients in whom a previous Feraheme dose was tolerated.
Feraheme is contraindicated in patients with known hypersensitivity to Feraheme or any of its components or a history of allergic reaction to any intravenous iron product.
Warnings and Precautions
Hypersensitivity: In addition to the fatal and serious adverse reactions in the Boxed Warning, other adverse reactions associated with hypersensitivity have occurred (pruritus, rash, urticaria, and wheezing). Allergic reactions have occurred following the first dose or subsequent doses in patients in whom a previous dose was tolerated. Patients with a history of multiple drug allergies may have a greater risk of anaphylaxis with parenteral iron products. Carefully consider the potential risks and benefits before administering Feraheme to these patients. Elderly patients with multiple or serious co-morbidities who experience hypersensitivity reactions and/or hypotension following administration of Feraheme may have more severe outcomes.
Hypotension: Feraheme may cause clinically significant hypotension. Monitor patients for signs and symptoms of hypotension following each Feraheme administration.
Iron Overload: Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. Regularly monitor the hematologic response during parenteral iron therapy. Do not administer Feraheme to patients with iron overload.
Magnetic Resonance (MR) Imaging Test Interference: Administration of Feraheme may transiently affect the diagnostic ability of MR imaging. Alteration of MR imaging studies may persist for up to 3 months following the last Feraheme dose. Maximum alteration of vascular MR imaging is anticipated to be evident for 1 – 2 days following Feraheme administration.
The most common adverse reactions (≥ 2%) are diarrhea, headache, nausea, dizziness, hypotension, constipation, and peripheral edema.
You may report an adverse event related to AMAG Pharmaceuticals’ products by calling 1-877-411-2510 or emailing firstname.lastname@example.org. If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly at fda.gov/medwatch or call 1-800-FDA-1088
Please click here to see full Prescribing Information, including Boxed Warning.
MuGard® Oral Mucoadhesive provides effective management of oral mucositis (OM).
MuGard® Oral Mucoadhesive is indicated for the management of oral mucositis/stomatitis (that may be caused by radiotherapy and/or chemotherapy) and all types of oral wounds (mouth sores and injuries), including aphthous ulcers/canker sores and traumatic ulcers, such as those caused by oral surgery or ill-fitting dentures or braces.
MuGard is contraindicated in patients with known hypersensitivity to any of the ingredients in the formulation.
Special Precautions for Use
Patients should avoid eating or drinking for at least one hour after using MuGard. After use, patients should replace the bottle cap and tightly seal the bottle. This product should not be used after the expiration date shown on the carton and product label. Do not use this product in patients with known sensitivity to any of the product’s ingredients. Dilution of the product prior to use is not recommended.
Please see full prescribing information for MuGard.