Our products support the health of patients in the areas of maternal and women’s health, anemia management and cancer supportive care.
We also help families preserve newborn stem cells, which are used today in transplant medicine for certain cancers and blood, immune and metabolic disorders, and have the potential to play a valuable role in the ongoing development of regenerative medicine.
INTRAROSATM (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 INTRAROSATM
INTRAROSATM 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 INTRAROSATM (prasterone).
Please See patient information for INTRAROSATM
Makena helps reduce the risk of preterm birth in the indicated patient population.1
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.1
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.1
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 hypertension1
- Makena should be discontinued if thrombosis or thromboembolism occurs1
- Allergic reactions, including urticaria, pruritus and angioedema, have been reported with use of Makena or with other products containing castor oil.1
- 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 hypertension1
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%).1
The most common adverse reactions reported in ≥2% of subjects and at a higher rate in the Makena group than in the control group were injection site reactions pain [35% vs. 33%], swelling [17% vs. 8%], pruritus [6% vs. 3%], and nodule [5% vs. 2%]), urticaria (12% vs. 11%), pruritus (8% vs. 6%), nausea (6% vs. 5%), and diarrhea (2% vs. 1%).1
Please see patient information for Makena.
Indication and Dosing
Feraheme is indicated for the treatment of iron deficiency anemia in adult patients with chronic kidney disease (CKD).2
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.2
Important Information about Feraheme® (ferumoxytol) Injection
Fatal and serious hypersensitivity reactions including anaphylaxis have occurred in patients receiving Feraheme.2 Initial symptoms may include hypotension, syncope, unresponsiveness, cardiac/cardiorespiratory arrest.2
- Only administer Feraheme when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions.2
- 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.2
- Hypersensitivity reactions have occurred in patients in whom a previous Feraheme dose was tolerated.2
Feraheme is contraindicated in patients with:
- Known hypersensitivity to Feraheme or any of its components
- History of allergic reaction to any intravenous iron product2
Warnings and Precautions
- Fatal and serious hypersensitivity reactions including anaphylaxis, presenting with cardiac/ cardiorespiratory arrest, clinically significant hypotension, syncope, or unresponsiveness have occurred in patients receiving Feraheme. Other adverse reactions potentially associated with hypersensitivity have occurred (pruritus, rash, urticaria, and wheezing). These reactions have occurred following the first dose or subsequent doses in patients in whom a previous Feraheme dose was tolerated.2
- 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.2
- Only administer Feraheme when personnel and therapies are immediately available for the treatment of anaphylaxis and other hypersensitivity reactions. Closely observe patients for signs and symptoms of hypersensitivity including monitoring of blood pressure and pulse during and after Feraheme administration for at least 30 minutes and until clinically stable following completion of each infusion.2
- In clinical studies predominantly in patients with CKD, serious hypersensitivity reactions were reported in 0.2% (3/1,726) of subjects receiving Feraheme. Other adverse reactions potentially associated with hypersensitivity (e.g., pruritus, rash, urticaria or wheezing) were reported in 3.7% (63/1,726) of these subjects. In other trials excluding patients with Stages 4 and 5 CKD, moderate to severe hypersensitivity reactions were reported in 2.6% (26/1014) of patients treated with Feraheme.2
- In the post-marketing experience, fatal and serious anaphylactic type reactions presenting with cardiac/ cardiorespiratory arrest, clinically significant hypotension, syncope, and unresponsiveness have been reported. Elderly patients with multiple or serious co-morbidities who experience hypersensitivity reactions and/or hypotension following administration of Feraheme may have more severe outcomes.2
- Severe adverse reactions of clinically significant hypotension have been reported in the post-marketing experience. In clinical studies, hypotension was reported in 1.9% (33/1,726) of subjects, including three patients with serious hypotensive reactions. Monitor for signs and symptoms of hypotension following each Feraheme administration.2
- Excessive therapy with parenteral iron can lead to excess storage of iron with the possibility of iatrogenic hemosiderosis. Patients should be regularly monitored for hematologic response during parenteral iron therapy, noting that lab assays may overestimate serum iron and transferrin bound iron values in the 24 hours following administration of Feraheme.2
- As a superparamagnetic iron oxide, Feraheme may transiently affect magnetic resonance diagnostic imaging studies for up to 3 months following the last Feraheme dose. Feraheme will not affect X-ray, CT, PET, SPECT, ultrasound, or nuclear imaging.2
- The most common adverse reactions (≥ 2%) following the administration of Feraheme are diarrhea, nausea, dizziness, hypotension, constipation, and peripheral edema.2
- In clinical trials, adverse reactions leading to treatment discontinuation and occurring in ≥ 2 Feraheme-treated patients included hypotension, infusion site swelling, increased serum ferritin level, chest pain, diarrhea, dizziness, ecchymosis, pruritus, chronic renal failure, and urticaria.2
- The following additional serious adverse reactions have been reported from the post-marketing experience with Feraheme: tachycardia/rhythm abnormalities, angioedema, ischemic myocardial events, congestive heart failure, pulse absent, and cyanosis. These adverse reactions have usually occurred within 30 minutes after the administration of Feraheme. Reactions have occurred following the first dose or subsequent doses of Feraheme.2
Please see full prescribing information for Feraheme, 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.3
MuGard is contraindicated in patients with known hypersensitivity to any of the ingredients in the formulation.3
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.3
Please see full prescribing information for MuGard.