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Basic Drug Info
Drug Name:Reclast
Manufacturer:Novartis Pharmaceuticals Corporation
Other Info:

Reclast was studied in male and female patients with moderate to severe Paget’s disease of bone, defined as serum alkaline phosphatase level at least twice the upper limit of the age-specific normal reference range at the time of study entry.

Diagnosis was confirmed by radiographic evidence. The efficacy of one infusion of 5 mg Reclast vs.

oral daily doses of 30 mg risedronate for 2 months was demonstrated in two identically designed 6-month randomized, double blind trials.

The mean age of patients in the two trials was 70.

Ninety-three percent (93%) of patients were Caucasian.

Therapeutic response was defined as either normalization of serum alkaline phosphatase (SAP) or a reduction of at least 75% from baseline in total SAP excess at the end of 6 months.

SAP excess was defined as the difference between the measured level and midpoint of normal range.

In both trials Reclast demonstrated a superior and more rapid therapeutic response compared with risedronate and returned more patients to normal levels of bone turnover, as evidenced by biochemical markers of formation (SAP, serum N-terminal propeptide of type I collagen [P1NP]) and resorption (serum CTx 1 [cross-linked C-telopeptides of type I collagen] and urine ?-CTx).

The 6-month combined data from both trials showed that 96% (169/176) of Reclast-treated patients achieved a therapeutic response as compared with 74% (127/171) of patients treated with risedronate.

Most Reclast patients achieved a therapeutic response by the Day 63 visit.

In addition, at 6 months, 89% (156/176) of Reclast-treated patients achieved normalization of SAP levels, compared to 58% (99/171) of patients treated with risedronate (p<0.0001) (see Figure 2).

Figure 2.

Therapeutic Response/Serum Alkaline Phosphatase (SAP) Normalization Over Time The therapeutic response to Reclast was similar across demographic and disease-severity groups defined by gender, age, previous bisphosphonate use, and disease severity.

At 6 months, the percentage of Reclast-treated patients who achieved therapeutic response was 97% and 95%, respectively, in each of the baseline disease severity subgroups (baseline SAP < 3xULN, > 3xULN) compared to 75% and 74%, respectively, for the same disease severity subgroups of risedronate-treated patients.

In patients who had previously received treatment with oral bisphosphonates, therapeutic response rates were 96% and 55% for Reclast and risedronate, respectively.

The comparatively low risedronate response was due to the low response rate (7/23, 30%) in patients previously treated with risedronate.

In patients naïve to previous treatment, a greater therapeutic response was also observed with Reclast (98%) relative to risedronate (86%).

In patients with symptomatic pain at screening, therapeutic response rates were 94% and 70% for Reclast and risedronate respectively.

For patients without pain at screening, therapeutic response rates were 100% and 82% for Reclast and risedronate respectively.

Bone histology was evaluated in 7 patients with Paget’s disease 6 months after being treated with Reclast 5 mg.

Bone biopsy results showed bone of normal quality with no evidence of impaired bone remodeling and no evidence of mineralization defect.



Clinical Trials:


Indications and Usage
Reclast is a bisphosphonate indicated for:Treatment of osteoporosis in postmenopausal women (1.1)Treatment to increase bone mass in men with osteoporosis (1.2)Treatment of Paget’s disease of bone in men and women (1.3)
Osteoporosis -- Reduction of bone mass without alteration in the composition of bone, leading to fractures. Primary osteoporosis can be of two major types: postmenopausal osteoporosis (OSTEOPOROSIS, POSTMENOPAUSAL) and age-related or senile osteoporosis.

Osteitis Deformans -- A disease marked by repeated episodes of increased bone resorption followed by excessive attempts at repair, resulting in weakened, deformed bones of increased mass. The resultant architecture of the bone assumes a mosaic pattern in which the fibers take on a haphazard pattern instead of the normal parallel symmetry.

Paget's Disease -- A malignant neoplasm composed of large cells with large nuclei, prominent nucleoli, and abundant pale cytoplasm (Paget cells). Paget cell neoplasms include Paget disease of the nipple and extramammary Paget disease which may affect the vulva, penis, anus, skin and scrotum. -- 2004

Contraindications

Hypocalcemia (4.1)Hypersensitivity to any component of Reclast (4.2, 6.2)      -----------WARNINGS AND PRECAUTIONS------------Reclast contains the same active ingredient found in Zometa.

Patients receiving Zometa should not receive Reclast (5.1)Patients must be adequately supplemented with calcium and vitamin D (5.2)A single dose should not exceed 5 mg and the duration of infusion should be no less than 15 minutes (2.1, 2.2, 5.3)Renal toxicity may be greater in patients with renal impairment.

Treatment in patients with severe renal impairment (creatinine clearance <35 mL/min) is not recommended.

Monitor serum creatinine before each dose (5.3)Osteonecrosis of the jaw has been reported rarely in postmenopausal osteoporosis patients treated with bisphosphonates, including zoledronic acid.

All patients should have a routine oral exam by the prescriber prior to treatment (5.4)Reclast can cause fetal harm.

Women of childbearing potential should be advised of the potential hazard to the fetus and to avoid becoming pregnant (5.5, 8.1)Severe incapacitating bone, joint, and/or muscle pain may occur.

Withhold future doses of Reclast if severe symptoms occur (5.6)
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

TOXIC NEPHROPATHY --

Aseptic Necrosis of Bone --

Bone necrosis -- Death of a bone or part of a bone, either atraumatic or posttraumatic.

Osteoporosis, Postmenopausal -- Metabolic disorder associated with fractures of the femoral neck, vertebrae, and distal forearm. It occurs commonly in women within 15-20 years after menopause, and is caused by factors associated with menopause including estrogen deficiency.

Myalgia -- Myalgia: Pain or aching in a muscle or muscles.

Symptoms -- An indication that a person has a condition or disease. Some examples of symptoms are headache, fever, fatigue, nausea, vomiting, and pain.


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