How do you make an informed decision about taking Reclast?
Reclast History and Evidence
Novartis received FDA approval for Reclast (zoledronic acid) in August 2007, for the treatment of post-menopausal osteoporosis, with an initial FDA approval in 2001 for Paget's disease.
"The FDA decision is based on safety and efficacy data from the landmark Recurrent Fracture Trial, published in The New England Journal of Medicine, showing a significant 35% reduction in the risk of new clinical fractures in patients treated with Reclast (Novartis, June 5, 2008, Reclast Press Release))
This study stands out because the patients included had previous hip, vertebral, or other fractures. The results showed a 70% reduction of vertebral fractures and 41% reduction in hip fractures, compared to placebo, over a three year period. Reclast is the only osteoporosis drug approved to protect you from fracture in more places, including hip spine and other bones (Novartis, 2008, Patient Safety Guide).
Figures on other Reclast-related fractures results, increases in bone mineral density, bone metabolism markers, and noteworthy benefits and side effects are available in this May 2007 New England Journal of Medicine article, "Once-Yearly Zoledronic Acid for Treatment of Post-Menopausal Osteoporosis."
In the European Union, zoledronic acid is marketed under the name Aclasta.
How is Reclast Administered?
Reclast is given once a year in a fifteen minute infusion for yearlong bone protection. Novartis recommends taking 1200 mg of calcium and 400-800 IU of vitamin D daily, in addition to your dose of Reclast.
Should I Consider Reclast?
If you've taken oral bisphosphonates, like Boniva, Fosamax, or Actonel, etc., and had gastrointestinal or esophageal issues, Reclast may be an option for you. Your health professional will administer Reclast through an infusion, because this medication doesn't travel through your intestinal tract you don't usually have gastrointestinal issues.
Novartis say's that the majority of the drug goes to your bones, and the rest flushes from your body within days, (Novartis, 2008, Patient Safety Guide). When deciding whether this medication is right for you, be sure you evaluate all the possible side effects and benefits listed in the article above, the FDA literature and Novartis' recommendations below, so you can make a truly informed decision.
Currently Medicare covers Reclast, as do most other insurance plans. Check with your insurance provider prior to administration to be sure that it's covered. Your doctor, nurse or infusion center can administer this drug. An infusion center is usually located at a hospital or clinic staffed with doctors and nurses who administer IV medications.
Who Shouldn't Take Reclast?
If you have low blood calcium levels (hypocalcemia), are taking Zometa, have kidney problems, or are allergic to any ingredient in Reclast, you should not take Reclast. Also if you are pregnant, nursing, or plan on becoming pregnant, you shouldn't take Reclast. If you are currently on Zometa you can't take Reclast because it contains the same ingredient (zoledronic acid) in a different strength (Novartis, 2008, Patient Safety Guide).
The FDA notified doctors of the potential for atrial fibrillation with Reclast. Also mentioned in the NEJM study, there is a small risk of contracting osteonecrosis of the jaw. If you are concerned about this discuss it with your health provider and also your oral surgeon or dentist, to evaluate your risks versus benefits. The most common side effect is flu-like symptoms, fever, headache, and joint or muscle pain. The links below explain the adverse events related to Reclast seen in some individuals.
FDA alert on atrial fibrillation.
FDA alert on bisphosphonate joint pain.
Novartis offers a yearly reminder service, for women on the go. You can sign up for this reminder service at www.MeetReclast.com.
Need help finding an infusion center? Call 1-866-Reclast or visit www.reclast.com
If you don't have insurance log on to www.pap.novartis.com or call 1-800-245-5356 (Novartis, 2008, Patient Safety Guide).