Frequently Asked Questions and Answers

• Why is my doctor recommending Serostim^® [somatropin (rDNA origin) for injection] treatment?

  Your doctor is prescribing Serostim^® because you are losing weight, lean body mass and possibly physical endurance. This condition is sometimes referred to as HIV-associated wasting or cachexia, and Serostim^® can help increase weight and lean body mass and improve physical endurance.

• What is Serostim^® [somatropin (rDNA origin) for injection]?

  Serostim^® [somatropin (rDNA origin) for injection] is a human growth hormone and is the only therapy for HIV-wasting FDA-approved to increase weight and lean body mass, and improve physical endurance.

• How does Serostim^® [somatropin (rDNA origin) for injection] work?

  Serostim^® helps your body build and maintain weight and lean body mass. It allows your metabolism to function appropriately, using fat for energy instead of lean body mass. Studies have shown that patients with HIV wasting who were given Serostim^® for 12 weeks increased their weight and lean body mass and improved physical endurance. Increases in weight, lean body mass and improvements in physical endurance were maintained or improved through 24 weeks of treatment in an open label extension phase.

• How can Serostim^® [somatropin (rDNA origin) for injection] help me?

  If you have problems with HIV-associated wasting in spite of good diet, and your doctor has ruled out other possible causes, Serostim^® may be right for you. Serostim^® has been shown to increase weight, increase LBM and improve physical endurance. Patients treated with Serostim^® reported improvements in their perceptions of their HIV-associated wasting symptoms. These perceptions were reported after 12 weeks at both doses of Serostim^® and included:

  • Better appetite and more enjoyment in eating
  • Favorable change in appearance
  • Improvements in how they feel and change in weight has significantly improved health

• Should I continue to take my usual HIV drugs during Serostim^® [somatropin (rDNA origin) for injection] treatment?

  Yes - you must continue to take all of your usual HIV medications. Serostim^® [somatropin (rDNA origin) for injection] only helps control HIV wasting. Your other medications help control the HIV virus. Please be sure to consult with your doctor or healthcare provider regarding any questions you might have about your HIV medications.

• Is there anything else I should do while taking Serostim^® [somatropin (rDNA origin) for injection]?

  Yes - in addition to taking Serostim^®, there are other things you can do to stay healthy, including taking all other medications as prescribed by your doctor, eating a well-balanced diet, and exercising regularly. Always be sure to consult with your doctor or healthcare provider about diet and exercise.

• Is there any reason I should not use Serostim^® [somatropin (rDNA origin) for injection]?

  You should not use Serostim^®[somatropin (rDNA origin) for injection] if

  • You are in the hospital with a serious illness, or following an accident, or if you are on a respirator.
  • You are having surgery on your heart, abdomen, intestines, or bowel.
  • You have an active cancer.
  
  You should tell your doctor if:
  • You are pregnant or breastfeeding before you start Serostim^® treatment.
  • You are not using HAART medication
  • You develop glucose problems during Serostim^® treatment.

• Are there any side effects I should know about?

  Bodily pain increased and was attributed to musculoskeletal discomfort and increased tissue turgor observed in approximately 1/3 of patients treated with Serostim^®. Most of these side effects diminish or disappear within a few weeks of treatment. In the meantime, your doctor can recommend something to make you more comfortable. If the side effects do not go away, your doctor may want to lower your Serostim^® dose or reduce the number of injections during the week. Some patients report having fevers, diarrhea, upset stomach, stomach pain, or headache. It's difficult to know if these symptoms are caused by Serostim^®, other medications, you might be taking, or are related to the HIV virus itself, so be sure to tell your doctor if you feel any pain or discomfort while taking Serostim^®.

• Could I have an allergic reaction?

  Yes - it is possible to have an allergic reaction. Make sure to tell your doctor if you experience a skin rash.

• Is there anything else my doctor needs to know?

  Make sure your doctor knows about any of the following:

  • A diagnosis of any form of cancer
  • You become pregnant or start breastfeeding
  • Continued weight loss
  • Any infection - caused by a virus, bacteria, or fungus
  • Any tingling, or "needles and pins" feeling in your hands or wrists
  • Dizziness
  • Increased thirst
  • Increased urination
  • Swelling in your face, head, hands, or feet
  • Headaches
  • Vision problems
  • Nausea or vomiting

• How do I take Serostim^® [somatropin (rDNA origin) for injection]?

  Serostim^® is injected under the skin each day, usually at bedtime. This type of injection is simpler and less penetrating than injections that are given directly to the muscle or vein. Depending on your weight, your doctor will prescribe one of three dose strengths for you - 4mg, 5mg, or 6mg. Packages contain vials of Serostim^® powder and diluent for mixing. You will also need sterile subcutaneous and mixing needles or a special SeroJet^® needle-free delivery device.

• How do I get Serostim^® [somatropin (rDNA origin) for injection]?

  Serostim^® is a prescription medication. Once your doctor or healthcare provider has determined that you are experiencing HIV wasting, he or she can write you a prescription.

• Will my insurance cover Serostim^® [somatropin (rDNA origin) for injection]?

  EMD Serono offers a support team called SeroCare^SM that can assist you with verifying your insurance benefits, determining coverage options and locating pharmacies in your area. You can reach the SeroCare^SM support team at (800) 714-2437, or at www.serocare.com.

• How do I get my prescription filled?

  Once you have your prescription, your prescription for Serostim^® [somatropin (rDNA origin) for injection] can be filled through a network of pharmacies called the Serostim^® Secured Distribution Program. Found in 300 locations throughout the country, chances are there is a pharmacy near you. If not, you can fill your prescription through the network's mail-order pharmacy. For more information about this program, call (800) 714-2437, or visit www.serostim.com.

• What do I need for Serostim^® [somatropin (rDNA origin) for injection] injection?

  Prior to injecting Serostim^®[somatropin (rDNA origin) for injection] , you will need the Serostim^® vial, diluent, a syringe, two needles, alcohol swabs, a bandage or gauze pad, and a sharps container. See Administering Serostim^® for more detailed information.

• How do I inject Serostim^® [somatropin (rDNA origin) for injection]?

  A healthcare professional should provide injection training. Before each injection, you should gather all the tools previously outlined and consult the Administering Serostim^® section for more detailed information.

• What is SeroJet^®?

  SeroJet^® is a needle-free device for mixing and injecting Serostim^®. SeroJet^® is easy to use, and eliminates the risk of accidental needle sticks. Your healthcare provider will teach you how to use SeroJet^® and give you a set of instructions to follow when using the device.

• What do I need for SeroJet^® [somatropin (rDNA origin) for injection] injection?

  To administer Serostim^® using the SeroJet^® needle-free deliver device, you need the SeroJet^® device, Clear View™ nozzle and stem tip set, alcohol swabs, sterile gauze pad or cotton ball, and the vial connector and reconstitution kit. See the Injecting Serostim^® with SeroJet^® section for more detailed information.

• How do I use SeroJet^®?

  Before you start administering Serostim^® with SeroJet^® you must be trained by a certified healthcare provider. You can find more information here and with SeroCare^SM at (800) 714-2437.

• What do the Clinical Study Results Show for Serostim^® [somatropin (rDNA origin) for injection]?

  Since the introduction of highly active antiretroviral therapies (ARV), EMD Serono sponsored a large 12-week study that looked at the benefits of Serostim in treating 757 patients with HIV wasting.

  Serostim^® increased lean body mass (LBM) by over (12) lbs in patients who received Serostim^® 6 mg per every other day, and over (8) lbs in those who received the same dose of Serostim^® every day. Meanwhile, the placebo group gained only (2) lbs during the 12 weeks.

  Serostim^® also improved the patient's ability to perform exercise as a result of the increase in LBM. Patient's ability to perform on an exercise bicycle improved ~ 9%, while there was a 2% decline in the placebo group.

• Are there any Precautions with the Use of Serostim^® [somatropin (rDNA origin) for injection]?

  Serostim^® [somatropin (rDNA origin) for injection] can cause fluid to collect in the skin and joints, which can build up pressure in these tissues. These adverse events often resolve with continued treatment, pain medication or after lowering the dose of the drug.

  Patients with a history of elevated blood sugar, such as diabetes, or other risk factors for glucose intolerance should be monitored closely during Serostim^® therapy. There have been cases of diabetes occurring in patients receiving Serostim^®.

  Growth hormone products have the potential to increase HIV virus load or increase the spread of cancer. As a precaution, patients taking Serostim^® should use antiretroviral therapy. Patients should inform their doctor of a history of cancer before starting Serostim^® treatment.

• Who should not take Serostim^® [somatropin (rDNA origin) for injection]?

  Serostim^® should not be used in patients with active cancer or in patients hospitalized in intensive care.