What is Serostim?

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Tweet• Serostim is a drug that mimics human growth hormone, a chemical produced by the body to help maintain and build bone, muscle, and organ tissue.
• Serostim is marketed by Serono Laboratories. The drug has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of AIDS-related wasting syndrome and weight loss. It is also being studied in clinical trials for the treatment of lipodystrophy, a side effect of anti-HIV drug therapy. It may also work as an immune-based therapy by helping the thymus gland to produce new T-cells.
• Serostim can be used to treat wasting syndrome, an AIDS-related illness defined as a loss of more than 10% of body weight, along with more than 30 days of either diarrhea or weakness and fever. Left untreated, wasting syndrome is associated disease progression and death.
• In people with wasting syndrome, both fat and muscle are lost. While losing fat is not harmful to the body, losing too much muscle can be a very serious problem. Serostim works by protecting muscle in the body and helps form new muscle.
• Serostim is also being studied as a possible treated for lipodystrophy. Lipodystrophy is believed to be a side effect of anti-HIV drug therapy and can cause a buildup of fat around the gut, the breasts, or the back of the neck. Early studies of Serostim have shown that it can reduce fat in these areas of the body.
• Serostim may also help the thymus to produce new T-cells. The thymus, a gland located above the heart that is responsible for producing T-cells during childhood, usually becomes filled with fat after a person has finished puberty. In HIV-positive adults, the thymus can become active again to help replace T-cells that are killed by the virus. Serostim is being studied for its ability to reduce fat in the thymus and to help the gland to produce the T-cells needed to keep the immune system healthy.


What is already known about Serostim?

• There are a number of possible causes of wasting syndrome in people with HIV. While Serostim can help improve the way the body makes use of proteins and other nutrients, it is important for all people with wasting syndrome to determine if they are eating enough of the right foods and if they are absorbing them properly. HIV-related problems that affect appetite (e.g., depression, mouth or throat infection) or absorption (e.g., diarrhea or an infection of the gut) must be treated first. It is also a good idea to consult with a nutritionist or dietitian to make sure that the right amount and types of food are being eaten both before and during Serostim therapy.
• In test tube studies, Serostim increased HIV reproduction. Serostim must be used in combination with an anti-HIV drug combination that is able to keep viral load undetectable.


How well did Serostim work in clinical trials?

• There have been three clinical trials of Serostim for the treatment of wasting syndrome. Not all studies demonstrated that Serostim increased weight in people with wasting syndrome. However, Serostim increased muscle mass and exercise performance and decreased fat mass, benefits that can't accurately be measured using a weight scale.
• A few small studies have found that Serostim may help control some of the body-shape problems caused by lipodystrophy. Some people who took the drug saw a decrease in the amount of fat around their gut, breasts, and the neck. Serostim did not have any effect on cholesterol, triglyceride, or glucose levels. The manufacturer is currently conducting a large clinical trial of Serostim involving people with lipodystrophy.


How is Serostim administered?

• Serostim is always injected subcutaneously (under the skin). There are now two ways to do this: 1) with the use of a traditional hypodermic needle, or 2) with the use of a needle-free pump-like gadget that pushes the drug directly under the skin (SeroJet). SeroJet is recommended for people who have a fear of needles or do not like having sharp medical instruments at home. Even though SeroJet does not use needles, using it might not be painless -- some people say that they feel a rubber band-like "snap" at the site of the injection.

• Whether you use hypodermic needles or SeroJet to administer Serostim, your doctor or a nurse will need to show you how to inject the drug correctly.

• People taking Serostim should also rotate the site on their body where they give themselves injections.
• Serostim is taken once a day at bedtime. For people who weigh more than 121 pounds, the Serostim dose should be 6mg every day; for people who weigh between 99 pounds and 120 pounds, the correct dose is 5 mg ever day; for people who weight less than 99 pounds, the correct dose is 4mg every day
• Each vial of powdered Serostim should be mixed with 1 mL sterile water before injection. Ask your doctor for directions on how to prepare your Serostim solution.
• Serostim can be stored at room temperature before mixing and is good for 24 hours after mixing if it is stored under refrigeration.
• Do not inject any medication that is cloudy, discolored, or that has particles in it.
• There are no restrictions on food, beverages, or activity during therapy with Serostim unless otherwise directed by your doctor.


What is known about side effects?

• The most common side effects include muscle/bone pain and/or swelling in the hands and feet. Some people taking Serostim develop carpal tunnel syndrome, a painful condition in the forearms or wrists. If these side effects do not decrease over time, it is recommended that Serostim therapy be stopped.
• Notify your doctor immediately if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives). These symptoms could indicate that you need a lower dose of Serostim or that you need to stop using it.
• Serostim can increase glucose (sugar) levels in the bloodstream, which can lead to diabetes or worsen diabetes in people who already have this condition (which can lead to diabetic coma). This is important for HIV-positive people to know, given that many HIV-positive people taking anti-HIV drugs have abnormally high glucose levels. If you have diabetes or your doctor has told you that your glucose levels are elevated as a result of the anti-HIV drugs you are taking, it is very important that you and your doctor monitor your glucose levels closely while taking Serostim.
• Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.


Who should not use Serostim?

• Do not take Serostim if you have ever had an allergic reaction to it in the past.
• Serostim should not be used by patients who are in intensive care units (ICUs) and are recovering from complications related to recent open-heart surgery or abdominal surgery. It should also not be used by people who are recovering from acute respiratory failure.
• Do not take Serostim if you have an active form of cancer (cancer that has not yet been successfully treated), including lymphoma, breast cancer, prostate cancer, testicular cancer, ovarian cancer, or prostate cancer.
• Serostim is in the FDA pregnancy category B. This means that it is not expected to harm an unborn baby. There are, however, no adequate and well controlled studies in pregnant women. Therefore, this drug should be used during pregnancy only if clearly needed.
• It is not known whether Serostim passes into breast milk and what effect it may have on a nursing baby. To prevent transmission of the virus to uninfected babies, it is recommended that HIV-positive mothers not breast-feed.


What other drugs will affect Serostim?

• Formal drug interaction studies have not been conducted. No data are available on drug interactions between Serostim and HIV protease inhibitors or the non-nucleoside reverse transcriptase inhibitors.
• Drugs other than those listed here may interact with Serostim. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.


Where can I learn more about clinical trials of Serostim?

• Serono Laboratories has initiated a 200-person clinical trial of Serostim for the treatment of lipodystrophy. Information about this study, which officially started in February 2001, can be found by clicking here.
• Two other web sites may also contain information about clinical trials involving Serostim. One site is run by the American Foundation for AIDS Research (amfAR); the second web site is AIDSinfo.nih.gov, a site run by the U.S. National Institutes of Health

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TweetSerostim (HGH) on Black Market for Body Builders



Daily News (New York City) (06.02.03)::Thomas Zambito

Serostim, a drug used to counteract wasting in AIDS patients, has become one of the hottest sellers on New York's multimillion-dollar black market in prescription drugs. Especially popular among bodybuilders, Serostim - one of the most expensive AIDS drugs on the market - works by mimicking natural human growth hormone and adds pounds of muscle in a few months.

"Drug diversion schemes are a nationwide problem that not only robs the city, the state and federal government of millions of dollars each year but places the public in jeopardy," said New

York Attorney General Eliot Spitzer. According to estimates by Spitzer's office, fraudulent sales of Serostim and other prescription drugs amounted to 10 percent of the state's $3 billion Medicaid drug tab last year. "If you were to make a list of the top 10 diverted drugs, Serostim would be at the top and it would make up 40 to 50 percent of the cost of all diverted drugs," said Ken Karp, an investigator with Spitzer's Medicaid fraud control unit.

Despite efforts by Serostim's maker and law enforcement to ensure it only goes to patients who need it, the drug remains plentiful in the city's gyms. "Every topnotch bodybuilder in the world uses it," said Dave Palumbo, editor-in-chief of the muscle magazine RxMuscle and a champion bodybuilder. And AIDS patients are often the suppliers, according to some of New York's leading AIDS doctors. One Manhattan physician told of an AIDS patient who sold his supply to pay the rent.

Investigators with the US attorney's office in Boston are questioning whether the maker of Serostim, Swiss-based Serono Laboratories, promoted the drug for AIDS patients who were losing weight but may not have been experiencing AIDS wasting, which causes the body to consume muscle and organ tissue rather than stored fat. In response to complaints that doctors were incorrectly prescribing the drug, the New York Health Department began requiring physicians last year to get state approval prior to prescribing it. To counter fraud, Serono revamped its distribution network to track the drug from the warehouse to the patient, resulting in a drop in sales from $124 million in 2001 to $95 million in 2002.