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• actonel • aredia • boniva • didronel • evista • Forteo • fosamax • miacalcin • zometa • vivelle • reclast •
Reclast is a medicine used to treat:
• Osteoporosis in women after menopause
• Men and women with Paget’s disease of the bone
your bones by increasing bone mass and lowers the chance of breaking
IMPORTANT: You should not receive Reclast if you are already receiving
Reclast and Zometa are the same medicine. They both contain zoledronic
Facts about Reclast:
- receives US FDA approval as first and only once-yearly treatment for
women with postmenopausal osteoporosis
- Shown to be highly effective in strengthening bones and protecting
against osteoporosis-related fractures, including spine and hip
- Reclast reduced spine fractures by 70% and hip fractures by 41% compared
to placebo in study published in New England Journal of Medicine
- Unique once-yearly dosing provides potential for significant compliance
- Osteoporotic fractures affect one in two women over 501 and are
associated with increased morbidity, mortality and healthcare costs
What are the possible
side effects of Reclast?
- Low blood calcium (hypocalcemia).
- Kidney problems. Your doctor may do a blood test to check your
kidney function before each dose of Reclast. It is important for
you to drink at least 2 glasses of fluid (such as water), within a
few hours before receiving Reclast, as directed by your doctor.
- Jaw-bone problems (Osteonecrosis of the jaw). Jaw-bone problems
may occur in some people and include: infection, delayed
healing after teeth are pulled.
- Severe muscle, bone and joint pain. Tell your doctor if you have
severe muscle, bone, or joint pain after receiving Reclast.
- The most common side effects of Reclast include: flu-like illness,
fever, pain in your muscles or joints, and headache that can happen
in the days after you get Reclast. A mild pain reliever such as
ibuprofen or acetaminophen may reduce these symptoms. The
chance of getting these side effects goes down with repeat dosing
Tell your doctor about any side effect that bothers you or does not
What is the most
important information I should know about Reclast?
- Low blood calcium should be corrected prior to receiving Reclast.
- You should take calcium and vitamin D daily as recommended by your
health care professional.
- Patients with severe kidney problems should not receive Reclast
Reclast may not be right for you. Tell your
doctor about all your medical conditions, including if you:
- have kidney problems
- have a history of low blood calcium
- are not able to take daily calcium and vitamin D supplements
- had parathyroid or thyroid surgery (these glands are located in your
- have a malabsorption syndrome
- had sections of your intestine removed
- have asthma (wheezing) from taking aspirin
- have a planned dental surgery such as tooth extraction
- are pregnant or plan to become pregnant, Reclast may harm your unborn
- are breast feeding or planning to breast feed. It is not known if
Reclast passes into breast milk
your doctor about all the medicines you take, including prescription and
nonprescription drugs, herbal supplements, and vitamins.
Some medicines may increase your chance for low blood calcium levels or kidney
problems when used with Reclast.
Especially tell your doctor if you are taking:
- a diuretic or water pill
- an antibiotic--certain antibiotics called aminoglycosides may increase
the effect of Reclast in lowering your blood calcium for a long period of
Know the medicines you take. Keep a list of your medicines and show it
to your doctor and pharmacist each time you get a new medication
How will I receive
- Reclast is given by infusion into a vein (IV) that takes at least 15
minutes time. Reclast is always infused by your doctor or nurse
- Drink at least 2 glasses of fluid such as water, within a few hours
before receiving Reclast as directed by your doctor, You may eat
normally before your infusion.
East Hanover, NJ, August 17, 2007 – Reclast® (zoledronic acid) Injection has
been approved by the US Food and Drug Administration as the first and only
medicine for postmenopausal osteoporosis, offering an important new approach to
the treatment of a bone disease affecting eight million women in the US1.
Unlike oral bisphosphonate therapies that have to be taken daily, weekly or
monthly, Reclast is given as a once-yearly 15-minute intravenous (IV) infusion.
This means with a single treatment a patient can receive a full year’s
protection against the effects of osteoporosis – a disorder that causes bones to
break easily. “The fact that Reclast is highly effective and can be administered
once-yearly represents a major milestone in the treatment of postmenopausal
osteoporosis,” said Felicia Cosman, MD, Professor of Clinical Medicine, Columbia
University. “For the first time we can ensure women receive a full year of the
treatment they need to protect their bones,” said Dr. Cosman.
The US approval comes a few weeks after the Committee for Medicinal Products for
Human Use (CHMP) issued a positive opinion recommending approval for the
medicine in the European Union, under the brand name Aclasta®. The European
Commission generally follows the CHMP’s recommendations and is expected to issue
a final decision within three months.
The regulatory submissions were based on efficacy and safety data from a
Pivotal Fracture Trial, showing that Reclast increases bone strength and reduces
fractures in areas of the body typically affected by osteoporosis, including the
hip, spine and nonspine (i.e. hip, wrist, arm, leg, rib). Reclast is the only
treatment proven to reduce fractures across all of these key sites.2/4 In this
study involving more than 7,700 women, Reclast reduced the risk of spine
fractures by 70% and hip fractures by 41% (The New England Journal of Medicine,
May 3, 2007) 2. The reduction in spine fractures was sustained over three years
(60% in year one, 71% in year two, and 70% in year three). Bone mineral density
increased significantly in the spine by 6.7% and the hip by 6% in women on
Reclast compared to placebo2.“Reclast has shown significant efficacy in
protecting women against fractures in all the common osteoporotic fracture
sites, while demonstrating a favorable safety profile,” said James Shannon, MD,
Global Head of Development at Novartis Pharma AG. “It is our hope that this
innovative once-yearly dosing regimen will have a positive impact on the
management of this potentially devastating condition.”
The need for effective treatments is pressing, with one out of every two women
over the age of 50 suffering an osteoporotic fracture in her lifetime1. The
disease is responsible for 1.5 million fractures in the US every year1, some of
which can have severe consequences. Approximately 20% of women over the age of
50 who suffer a hip fracture will die within one year1.
Osteoporotic fractures are responsible for an estimated 800,000 emergency room
visits, 500,000 hospitalizations, 180,000 nursing home placements, and 2.6
million physician visits in the US each year3, costing the healthcare system
approximately $12.2 to 17.9 billion annually3. “Osteoporosis is a serious
disease affecting millions of people in this country,” said Leo Schargorodski,
executive director of the National Osteoporosis Foundation (NOF). “NOF welcomes
new FDA approved treatment options, such as Reclast, that give patients a choice
when it comes to taking their osteoporosis therapy.” Reclast/Aclasta is approved
in more than 60 countries, including the US, Canada and the EU for the treatment
of Paget’s disease, the second most common metabolic bone disorder.
Additional studies are ongoing to examine the use of Reclast to prevent
fractures following a hip fracture in men and women, treatment of
corticosteroid-induced osteoporosis, and male osteoporosis. The active
ingredient in Reclast is zoledronic acid, which is also available in a different
dosage under the brand name Zometa® (zoledronic acid 4 mg) Injection for use in
certain oncology indications.
Reclast is contraindicated in patients with hypocalcemia (low blood calcium) and
those who are allergic to zoledronic acid. Reclast contains the same active
ingredient found in
Zometa. Patients already being treated with Zometa should not be treated with
Reclast. Reclast should not be used during pregnancy because of potential harm
to the fetus. Reclast is not recommended for use in patients with severe renal
impairment (creatinine clearance <35 mL/min) and infusion time should not be
less than 15 minutes. 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 3 to 4 days of onset but resolution
could take up to 7 to 14 days. Patients have reported severe bone, joint and/or
muscle pain after using bisphosphonates. Osteonecrosis of the jaw (ONJ) has been
reported rarely in postmenopausal osteoporosis patients treated with
bisphosphonates. A routine oral examination should be performed by the
prescriber prior to initiation of ¾ bisphosphonate treatment. Hypocalcemia may
occur with Reclast therapy. In the Pivotal Fracture Trial an increased number of
cases of serious atrial fibrillation were observed in women given Reclast
compared to those on placebo (1.3% vs. 0.4% respectively)2. The timing of these
events suggest that they were not related to the acute infusion. This finding
has not been observed in other zoledronic acid clinical studies and in
post-marketing experience from more than 1.5 million patients treated with
Zometa. All patients with Paget’s disease should receive 1500 mg of calcium in
divided doses and 800 IU of vitamin D daily, particularly in the two weeks
following Reclast administration.It is recommended that patients with
postmenopausal osteoporosis take calcium and vitamin D supplements, if dietary
intake is not sufficient.
For more information about Reclast, visit www.reclast.com or call 866-RECLAST
1 National Osteoporosis Foundation. About Osteoporosis: Fast Facts. Available
http://www.nof.org/osteoporosis/diseasefacts.htm Accessed on June 7, 2007.
2 Black D, Delmas, S, Eastell R et al for the HORIZON Pivotal Fracture Trial.
Once-Yearly Zoledronic Acid
for Treatment of Postmenopausal Osteoporosis. NEJM 2007; 356(18):1809-22.
3 U.S. Department of Health and Human Services. Bone Health and Osteoporosis: A
Report of the Surgeon