Patient Assistance Program

Hormone Therapy Patient Assistance Program Application

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	NORDITROPIN^® Indications and Usage: Norditropin^® (somatropin [rDNA origin] injection) is used to treat children with growth failure caused by very low or no production of growth hormone. It is also used to treat children who have short stature associated with Noonan syndrome or Turner syndrome and to treat adults who do not make enough growth hormone. Important Safety 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.


	NOVOSEVEN^®RT INDICATIONS NovoSeven^® RT 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 The most common side effects 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. The most serious side effects observed during NovoSeven^® RT therapy are thrombotic events, which is when clots form in blood vessels and cause harm. After taking NovoSeven^® RT, some patients have more of a risk of thrombotic events. Although the extent of this risk is not known, it is thought to be small. Some patients have conditions that may increase this risk. These include clogged arteries, blood clots that form throughout the body instead of at the place of injury, 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 events. People who have ever had a bad reaction to proteins from mice, hamsters, or “bovines” (such as an ox or cow) should consult their physician prior to using NovoSeven^® RT. Serious adverse events which may have been related to the use of NovoSeven^® RT occurred in 14 of the 298 patients in the initial clinical program. Some patients with Factor VII deficiency have developed resistance (antibodies) to Factor VII after treatment with NovoSeven^® RT. These patients had been previously treated with human plasma and/or plasma-derived Factor VII. Factor VII-deficient patients should be monitored for antibody formation before and after administration of NovoSeven^® RT. Concomitant use of NovoSeven^® RT with other formulations of NovoSeven^® is not recommended due to potential dosing errors based on different concentrations. Please click here for NovoSeven^® RT Prescribing Information.

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