Approval status FDA approved
Company Amgen
Advantages It is an injection usually given once every month, or less often in some cases, with a low rate of side effects. It may be usable at any time in men with HRPC to improve bone health and reduce the risk of skeletal-related events (SREs). In a phase-3 study, it beat Zometa in terms of preventing SREs and, perhaps, at reducing the risk of metastatic bone disease.
The catch Calcium (at least 500 mg or more) and vitamin D (at least 400 IU or more) supplements are strongly recommended for patients getting Xgeva. The precise amount to take depends on how much calcium you get from food and the results of a vitamin D blood test. Discuss these supplements with your doctor to determine the right amount for your situation. There seems to be a rare increased risk of osteonecrosis of the jaw (ONJ), similar or even slightly greater to what has been observed with Zometa, and a higher risk of causing low blood calcium (hypocalcemia). Approximately 80 percent of patients with ONJ had a previous tooth removal, were using a dental appliance, or had poor oral hygiene.
What else do I need to know? Xgeva is an antibody that is injected monthly or less frequently. It basically blocks a signal that allows bone loss to occur and prevents SREs. Ask your doctor if it is available and can be used after or instead of Zometa.
ZOMETA
Also known as Zoledronic acid
How is it taken? IV
Approval status FDA approved
Company Novartis
Information www.us.zometa.com
Zometa belongs to a class of drugs called bisphosphonates that are generally prescribed for bone health. It is not an FDA-approved treatment for cancer, but it is an FDA-approved treatment for preventing or delaying problems associated with hormone-reducing drugs or from cancer itself, such as bone loss. Both Zometa and Xgeva can be used for patients with metastatic prostate cancer to prevent or delay a skeletal-related event (SRE). Some of these SREs can be serious enough to change the way your cancer is treated overall, causing serious delays in treatment, changes in the treatment itself, or cessation of the treatment to alleviate the bone pain.
Zometa significantly reduces the risk of all the earlier mentioned SREs to some degree, but has been most effective at reducing the risk of bone fractures, making it a popular osteoporosis drug in both cancer situations and general medicine. It also has been shown to have an impact on reducing bone pain long-term.
Dosage Given intravenously (IV) in the oncology or urology office, clinic, or hospital to prevent bone loss and skeletal problems associated with HRPC. Total amount given per visit is generally 4 mg. It is used every 3 to 4 weeks in many cases, but can be used once every few months or even once a year in some rare cases. Your physician will decide the frequency of the IV infusions of this drug based on your situation.
Advantages This drug improves quality of life. It takes only 15 to 30 minutes to administer and prevents bone loss from hormone therapy (ADT). It may also prevent or delay harm to the bone that can be caused by prostate cancer that has become metastatic. The earlier Zometa is used in HRPC, the more it can do to prevent these problems.
The catch Calcium and vitamin D supplements should be used daily while on and off this medication (their dosages should be determined by a doctor). If your doctor encourages you to do some weight lifting because you have minimal or no bone disease, you should consider that as well to improve your bone health. Many men and women do not get the full bone health benefit because they do not undertake the lifestyle and dietary supplement changes that can improve the positive impact of the drug itself (see the side effects chapter for more information on bone health).
What else do I need to know? Although there are lots of osteoporosis drugs on the market, Zometa was the first one the FDA approved for metastatic HRPC. However, this does not mean that other osteoporosis-prevention pills are not an option for some patients to prevent bone loss.
Speaking just in terms of bisphosphonate or other osteoporosis pills available to prevent bone loss in men and women, there are medications that can be taken once a day, once a week (alendronate and risedronate, for example), twice a month (risedronate), or just once a month (ibandronate and risedronate, for example). All of them require that you take the medication on an empty stomach, sitting or standing, with a full glass of water at least 30 minutes before you eat anything. All of them have the ability to irritate your esophagus, which is why you need the glass of water to get the pill all the way down into the stomach. These pills do not absorb well with food in the stomach; hence the recommendation to take them on an empty stomach. The good news about the pills is that they allow flexibility and, unlike the IV bisphosphonates, do not require an office visit. However, for people who have issues swallowing pills and esophageal (throat) problems (such as Barrett’s esophagus), or simply for most patients with HRPC and bone metastasis, these oral drugs are not as effective as Xgeva or Zometa. Remember, none of these other bone loss pills are FDA approved for HRPC metastatic prostate cancer to reduce skeletal-related events.
Zoledronic acid (Zometa) is the most powerful bisphosphonate medication, which is probably why it is often used for HRPC. However, this powerful drug comes with powerful side effects, so always weigh the risk-to-benefit options with your doctor.
Question: What should I know about the common and not-so-common side effects of Xgeva and Zometa?
Answer: Most of the side effects of these drugs are mild and rare. For example, the most common side effect is a short-duration fever soon after the treatment. Other side effects include gastrointestinal problems (constipation), anemia, nausea, fatigue, and loss of appetite. A collection of flu-like symptoms can also occur (fever; chills; weakness; and muscle, bone, and joint aches) after the drugs are given.
If you have a kidney problem or an irregular heartbeat, Xgeva or Zometa can make it worse in some rare cases. A complete review of your current and recent medications with your doctor is important before you receive Xgeva or Zometa to prevent or reduce the risk of any side effects. It is very important that your doctor know if you have been taking any over-the-counter or prescription drug that can affect (reduce) your kidney function, such as aspirin, non-steroidal anti-inflammatories (ibuprofen, naproxen, or celecoxib), diuretics, and angiotensin-converting enzyme (ACE) inhibitors for blood pressure. Your doctor needs to know if you have been taking any prescription aminoglycoside medications (used to treat some infections), because the combination of these drugs can reduce your blood calcium to abnormally low levels (hypocalcemia), causing all sorts of health issues. Some examples of aminoglycosides include gentamycin sulfate, streptomycin sulfate, and tobramycin sulfate. Kidney function and blood levels of certain compounds (creatinine and calcium, in particular) will also be monitored over time by your doctor.
Also, if you have any dental problems or dental procedures planned for the near future, please talk to your doctor about them. Xgeva and Zometa are getting some attention for a rare side effect known as osteonecrosis of the jaw (ONJ). This problem occurs when an upper or lower area of the teeth or jaw becomes infected, and this infection becomes difficult to cure while you are on these drugs. One way to reduce the risk of this problem is to get dental clearance or a clean bill of health from a dentist before you start Xgeva or Zometa. Also, ask your doctor if your bone imaging test indicates that you might be at higher risk for ONJ.
The majority of cases of ONJ are in patients who have been treated for a longer duration, and commonly ONJ patients reported a previous dental procedure. If you develop any of the following symptoms, be sure to check with your physician right away:
• Mouth or facial pain that resembles a toothache
• Chronic sinusitis (inflammation of the sinuses)
• Foul-smelling drainage in the jaw area
• Numbness in either