Reclast

Reclast™ (zoledronic acid) is a prescription medication used to treat the following conditions:

*Paget's disease of the bone
*Osteoporosis in postmenopausal women
*Osteoporosis treatment in men.

According to the manufacturer (Novartis), Reclast increases bone strength and reduces fractures in areas of the body typically affected by osteoporosis, including the hip, spine and other areas such as the wrist, arm, leg, or rib. Reclast is given by infusion.

The drug belongs to a class of medications called bisphosphonates, which also includes the osteoporosis drugs Actonel and Fosamax, which are usually taken once a week, and Boniva, which is taken monthly. All are in pill form.

Reclast is given as a once-yearly 15-minute intravenous (IV) infusion.



"Osteoporosis is a serious disease affecting millions of people in this country," says Leo Schargorodski, executive director of the National Osteoporosis Foundation (NOF), in a Novartis news release. "NOF welcomes new FDA approved treatment options, such as Reclast, that give patients a choice when it comes to taking their osteoporosis therapy."

Reclast is not intended for patients with hypocalcemia (low blood calcium) and those who are allergic to zoledronic acid. Patients already being treated with Zometa should not be treated with Reclast.

Reclast should also not be used during pregnancy because of potential harm to the fetus. And Reclast is not recommended for use in patients with severe kidney impairment.

The most common side effects associated with Reclast are fever; pain in the muscles, bones, or joints; flu-like symptoms; and headache. These symptoms usually occur within the first three days following Reclast administration and usually resolve within three to four days of onset, but resolution could take up to seven to 14 days.

Some patients have reported severe bone, joint, and/or muscle pain after using bisphosphonates. Osteonecrosis of the jaw (damage to the bone) has been reported rarely in postmenopausal osteoporosis patients treated with bisphosphonates. A routine oral examination should be performed by the doctor prior to initiation of treatment, according to the manufacturer.

Reclast contains zoledronic acid, a bisphosphonic acid which is an inhibitor of osteoclastic bone resorption. Zoledronic acid monohydrate is a white crystalline powder. Its molecular formula is C5H10N2O7P2•H2O and a molar mass of 290.1 g/Mol. Zoledronic acid monohydrate is highly soluble in 0.1N sodium hydroxide solution, sparingly soluble in water and 0.1N hydrochloric acid, and practically insoluble in organic solvents. The pH of the Reclast solution for infusion is approximately 6.0 – 7.0.

Reclast Injection is available as a sterile solution in bottles for intravenous infusion. One bottle with 100 mL solution contains 5.330 mg of zoledronic acid monohydrate, equivalent to 5 mg zoledronic acid on an anhydrous basis.

Inactive Ingredients: 4950 mg of mannitol, USP; and 30 mg of sodium citrate, USP.