Milestones in Hemophilia, Hemostasis, and Growth Hormone Disorders

ACTIVELLA^® 0.5 mg/0.1 mg and ACTIVELLA^® 1.0 mg/0.5 mg

Indications and Usage:

Activella® 0.5 mg/0.1 mg (estradiol/norethindrone acetate) tablets is used after menopause in women who have a uterus to reduce moderate to severe hot flashes and help reduce your chances of getting osteoporosis (thin weak bones). If you use Activella® only to prevent osteoporosis, talk to your health care provider about whether a different treatment or medicine without estrogens might be better for you.

Important Safety Information:

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT Activella® (a combination of estrogen and progestin hormones)?

Do not use estrogens with or without progestins to prevent heart disease, heart attacks, or strokes.  Using estrogens with or without progestins may increase your chance of getting heart attacks, strokes, breast cancer, and blood clots. 

Do not use estrogens with or without progestins to prevent dementia. Using estrogens with or without progestins may increase your risk of dementia. 

You and your health care provider should talk regularly about whether you still need treatment with Activella®.

Do not take Activella® if you have had your uterus removed (hysterectomy).  Do not start taking Activella® if you have unusual vaginal bleeding, currently have or have had certain cancers (including cancer of the breast or uterus), had a stroke or heart attack in the past year, currently have or have had blood clots, currently have or have had liver problems, are allergic to Activella® or any of its ingredients, think you may be pregnant, or are breast feeding.

In woman with a uterus, the use of estrogen alone may increase the chance of getting cancer of the tissue lining the uterus. Therefore, contact your doctor right away if you have unusual vaginal bleeding.

In a clinical trial, the most commonly reported adverse events (reported at a frequency of ≥5%) were back pain, pain in arms and legs, headache, nausea, diarrhea, upper respiratory tract infection, uterine thickening and vaginal bleeding.

Estrogens and progestins should be used at the lowest dose possible for your treatment only as long as needed.

Please click here for Activella® 0.5 mg/0.1 mg and Activella® 1.0 mg/0.5 mg Prescribing Information.

Indications and Usage:

Vagifem® (estradiol) vaginal tablet is indicated for the treatment of atrophic vaginitis.

Important Safety Information:

ESTROGENS HAVE BEEN REPORTED TO INCREASE THE RISK OF ENDOMETRIAL CARCINOMA (cancer of the uterus). 

Vagifem® should not be used by women who are pregnant or who think they may be pregnant.  It should not be used immediately after childbirth or while breast-feeding.  It also should not be used by women who have unusual vaginal bleeding, a history of breast or uterine cancer, or a history of blood clots.

Vagifem® may cause some side effects that are generally mild.  Those commonly reported in clinical studies include headache, abdominal pain, back pain, upper respiratory tract infection, vaginal itching, and vaginal yeast infection.  Vagifem® is designed to work only where it is applied in the vagina, and has not been shown to have a significant effect on other organs or tissues (such as the breasts or bones).  If you experience side effects while taking Vagifem®, be sure to tell your doctor.

Be sure to check with your doctor to make sure Vagifem® or any other hormone product is right for you.

Please click here for Vagifem^® Prescribing Information.

Remember, your doctor is the main source of information about you and your health. Please consult your doctor if you have any questions about your health or your medication.

Do not use Norditropin^® if you have any of the following conditions: an allergy to phenol or any other ingredients in the medicine; active cancer or other forms of tumor; acute critical illness due to certain types of heart or abdomen surgery, trauma, or acute respiratory failure.

Children should not use somatropin if they have any of the following conditions: closed epiphyses (closed bone growth plates), Prader-Willi syndrome with severe obesity, or Prader-Willi syndrome with significant respiratory impairment.

Be sure to tell your doctor if you have diabetes mellitus; have had cancer or other forms of tumor; are pregnant, planning to be pregnant or are breastfeeding; or if you have had a kidney transplant.

Be sure to tell your doctor about all medications you are taking especially if they are: a glucocorticoid medication such as hydrocortisone or cortisone acetate, thyroid hormone, insulin and/or oral diabetes medicines, drugs metabolized by the liver (for example, corticosteroids, sex steroids, anticonvulsants, cyclosporine), or oral estrogen replacement.

Adult height can be influenced if you are on Norditropin^® for growth failure and at the same time using glucocorticoids or thyroid hormone.

If you are treated with insulin and/or oral diabetes medicines, the dose of your insulin/oral diabetes medicines may need to be adjusted.

Side effects are usually mild and temporary. Side effects may include headaches, muscle pain, joint stiffness, weakness, high blood sugar (hyperglycemia), sugar in your urine (glucosuria), swollen hands and feet due to fluid retention, and redness and itching in the area you inject.

If you have any of these symptoms, discuss them with your doctor.

If you have headaches, eyesight problems, nausea and/or vomiting, these may be symptoms of raised pressure in the brain. Contact your doctor right away.

In very rare cases children treated with somatropin have experienced pain in the hip or knee or a limp. These symptoms may be caused by a slippage of the growth plate in the hip (slipped capital femoral epiphysis).

Scoliosis (curvature of the spine) can occur in children who experience rapid growth. Because growth hormone increases growth rate, children should be monitored for progression of scoliosis.

Thyroid function tests should be performed periodically.

Skin lesions should be checked carefully for any unusual changes.

Somatropin treatment can increase the chances of developing middle ear infections in patients with Turner syndrome.

Congenital heart disease is a common finding in Noonan syndrome and patients should be closely monitored.

Talk to your doctor if you think you have any of these conditions.

Please click here for Norditropin® Prescribing Information.

Indications and Usage:NovoSeven® RT (Coagulation Factor VIIa [Recombinant] Room Temperature Stable) is indicated for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to FVIII or FIX and in patients with acquired hemophilia; prevention of bleeding in surgical interventions or invasive procedures in hemophilia A or B patients with inhibitors to FVIII or FIX and in patients with acquired hemophilia; treatment of bleeding episodes in patients with congenital Factor VII deficiency and prevention of bleeding in surgical interventions or invasive procedures in patients with congenital FVII deficiency.

Important Safety Information:

Warning: Serious thrombotic side effects are associated with the use of NovoSeven® RT outside of the uses approved by the FDA. These thrombotic side effects are blood clots that form in arteries and veins and can cause harm and may lead to death. Your doctor should discuss the risks and explain the signs and symptoms of thrombotic side effects to you. Your doctor should monitor you for blood clots during treatment with NovoSeven® RT.

Thrombotic side effects following the use of NovoSeven® RT occurred in 0.28% of all bleeds that were treated for FDA-approved uses. The rate of 0.20% was observed in hemophilia patients with inhibitors, and the rate was higher in patients with acquired hemophilia (4%). Thrombotic events (fatal and non-fatal) have been reported following use of NovoSeven® RT for all FDA-approved uses.

Some patients have conditions that may increase the risk of thrombotic side effects. These include clogged arteries, blood clots that form throughout the body instead of at the place of injury (called disseminated intravascular coagulation), a type of blood poisoning called septicemia, and crush injury, which is when a body part is crushed or squeezed between heavy or immobile objects. Also, people taking aPCCs/PCCs (activated or nonactivated prothrombin complex concentrates) at the same time that they are taking NovoSeven® RT may be at increased risk for thrombotic side effects. NovoSeven® RT should be used with caution in patients who have an increased risk for thrombotic side effects. These include, but are not limited to, patients with a history of heart disease, liver disease, patients who have limited movement following surgery, elderly patients, and neonates (babies who are 4 weeks old or younger). In each of these situations, the potential benefit of treatment with NovoSeven® RT should be weighed against the risk of these complications.

Some patients with Factor VII deficiency have developed resistance (antibodies) to Factor VII after treatment with NovoSeven® RT. Factor VII-deficient patients should be monitored for antibody formation before and after administration of NovoSeven® RT.

People who have ever had a bad reaction to NovoSeven® RT or to proteins from mice, hamsters, or “bovines” (such as an ox or cow) should consult their physician prior to using NovoSeven® RT.

The most common side effects during clinical trials in people taking NovoSeven® RT were fever, bleeding, injection site reaction, joint pain, headache, high or low blood pressure, nausea, vomiting, pain, swelling, and rash.

Please click here for NovoSeven^® RT Prescribing Information.