Reclast: Anti-Osteoporosis medicine

From: www.reclast.com

1 INDICATIONS AND USAGE
1.1 Treatment of Osteoporosis in Postmenopausal Women
Reclast is indicated for treatment of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis, diagnosed by bone mineral density (BMD)
or prevalent vertebral fracture, Reclast reduces the incidence of fractures (hip, vertebral and non-vertebral osteoporosis-related fractures). In patients at high risk of
fracture, defined as a recent low-trauma hip fracture, Reclast reduces the incidence of new clinical fractures [see Clinical Studies (14.1)].

1.2 Prevention of Osteoporosis in Postmenopausal Women
Reclast is indicated for prevention of osteoporosis in postmenopausal women [see Clinical Studies (14.2)].

1.3 Osteoporosis in Men
Reclast is indicated for treatment to increase bone mass in men with osteoporosis [see Clinical Studies (14.3)].

1.4 Glucocorticoid-Induced Osteoporosis
Reclast is indicated for the treatment and prevention of glucocorticoid-induced osteoporosis in men and women who are either initiating or continuing systemic
glucocorticoids in a daily dosage equivalent to 7.5 mg or greater of prednisone and who are expected to remain on glucocorticoids for at least 12 months. [See Clinical
Studies (14.4)].

1.5 Paget's Disease of Bone
Reclast is indicated for treatment of Paget's disease of bone in men and women. Treatment is indicated in patients with Paget’s disease of bone with elevations in serum
alkaline phosphatase of two times or higher than the upper limit of the age-specific normal reference range, or those who are symptomatic, or those at risk for
complications from their disease [see Clinical Studies (14.5)].

2 DOSAGE AND ADMINISTRATION
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Patients must be appropriately hydrated prior to administration of Reclast [see Warnings and Precautions (5.3)].
Administration of acetaminophen following Reclast administration may reduce the incidence of acute-phase reaction symptoms.
A 5 mg dose of Reclast administered intravenously is recommended for patients with creatinine clearance >35 mL/min [see Warnings and Precautions (5.3)].
2.1 Treatment of Osteoporosis in Postmenopausal Women
The recommended regimen is a 5 mg infusion once a year given intravenously over no less than 15 minutes. For osteoporosis treatment, and to reduce the risk of
hypocalcemia, patients must be adequately supplemented with calcium and vitamin D if dietary intake is not sufficient. Postmenopausal women require an average of at
least 1200 mg calcium and 800-1000 IU vitamin D daily.
2.2 Prevention of Osteoporosis in Postmenopausal Women
The recommended regimen is a 5 mg infusion given once every 2 years intravenously over no less than 15 minutes. Patients must be adequately supplemented with
calcium and vitamin D if dietary intake is not sufficient. Postmenopausal women require an average of 1200 mg calcium and 800-1000 IU vitamin D daily.
2.3 Osteoporosis in Men
The recommended regimen is a 5 mg infusion once a year given intravenously over no less than 15 minutes. Patients must be adequately supplemented with calcium
and vitamin D if dietary intake is not sufficient. An average of at least 1200 mg calcium and 800-1000 IU vitamin D daily is recommended.
2.4 Treatment and Prevention of Glucocorticoid-Induced Osteoporosis
The recommended regimen is a 5mg infusion once a year given intravenously over no less than 15 minutes. Patients must be adequately supplemented with calcium
and vitamin D if dietary intake is not sufficient. An average of at least 1200 mg calcium and 800-1000 IU vitamin D daily is recommended.
2.5 Treatment of Paget’s Disease of Bone
The recommended dose is a 5 mg infusion. The infusion time must not be less than 15 minutes given over a constant infusion rate.
To reduce the risk of hypocalcemia, all patients with Paget’s disease should receive 1500 mg elemental calcium daily in divided doses (750 mg two times a day, or
500 mg three times a day) and 800 IU vitamin D daily, particularly in the 2 weeks following Reclast administration. All patients should be instructed on the importance
of calcium and vitamin D supplementation in maintaining serum calcium levels, and on the symptoms of hypocalcemia [see Warnings and Precautions (5.2)].
Re-treatment of Paget’s Disease
After a single treatment with Reclast in Paget’s disease an extended remission period is observed. Specific re-treatment data are not available. However, re-treatment
with Reclast may be considered in patients who have relapsed, based on increases in serum alkaline phosphatase, or in those patients who failed to achieve
normalization of their serum alkaline phosphatase, or in those patients with symptoms, as dictated by medical practice.
2.6 Method of Administration
The Reclast infusion time must not be less than 15 minutes given over a constant infusion rate.
Reclast solution for infusion must not be allowed to come in contact with any calcium or other divalent cation-containing solutions, and should be administered as a
single intravenous solution through a separate vented infusion line.
If refrigerated, allow the refrigerated solution to reach room temperature before administration. After opening, the solution is stable for 24 hours at 2°C–8°C (36°F -
46°F) [see How Supplied/Storage and Handling (16)].

3 DOSAGE FORMS AND STRENGTHS
5 mg in a 100 mL ready to infuse solution.

4 CONTRAINDICATIONS
4.1 Hypocalcemia
[See Warnings and Precautions (5.2)].
4.2 Hypersensitivity to zoledronic acid or any components of Reclast
Hypersensitivity reactions including rare cases of urticaria, angioedema, and anaphylactic reaction/shock have been reported [see Post-Marketing Experience (6.2)].

5 WARNINGS AND PRECAUTIONS
5.1 Drug Products with Same Active Ingredient
Reclast contains the same active ingredient found in Zometa, used for oncology indications, and a patient being treated with Zometa should not be treated with Reclast.
5.2 Hypocalcemia and Mineral Metabolism
Pre-existing hypocalcemia and disturbances of mineral metabolism (e.g., hypoparathyroidism, thyroid surgery, parathyroid surgery; malabsorption syndromes, excision of small intestine) must be effectively treated before initiating therapy with Reclast. Clinical monitoring of calcium and mineral levels (phosphorus and magnesium) is highly recommended for these patients [see Contraindications (4)].
Hypocalcemia following Reclast administration is a significant risk in Paget’s disease. All patients should be instructed about the symptoms of hypocalcemia and the
importance of calcium and vitamin D supplementation in maintaining serum calcium levels [see Dosage and Administration (2), Adverse Reactions (6.1), Information
for Patients (17.1)].
All osteoporosis patients should be instructed on the importance of calcium and vitamin D supplementation in maintaining serum calcium levels [see Dosage and
Administration (2), Adverse Reactions (6.1), Information for Patients (17.1)].
5.3 Renal Impairment
A single dose of Reclast should not exceed 5 mg and the duration of infusion should be no less than 15 minutes [see Dosage and Administration (2.1)].
Reclast should not be used in patients with severe renal impairment (creatinine clearance <35 mL/min) due to lack of adequate clinical experience in this population
[see Adverse Reactions (6.1)].
Renal impairment has been observed following the administration of zoledronic acid, especially in patients with pre-existing renal compromise or other risk factors
including concomitant nephrotoxic medications, concomitant diuretic therapy, or severe dehydration occurring before or after Reclast administration. Renal impairment
has been observed in patients after a single administration. Rare reports of hospitalization and/or dialysis occurred in patients with underlying moderate to severe renal impairment [see Post-Marketing Experience (6.2)]. Renal impairment may lead to increased exposure of concomitant medications that are primarily renally excreted [see Drug Interactions (7.4)].
Serum creatinine should be measured before each Reclast dose. Transient increase in serum creatinine may be greater in patients with impaired renal function; consider
interim monitoring of serum creatinine in at-risk patients. Patients, especially those receiving diuretic therapy, should be appropriately hydrated prior to administration of Reclast. Reclast should be used with caution with other nephrotoxic drugs [see Drug Interactions (7.3)]. Consider monitoring serum creatinine in patients at risk for renal impairment who are taking concomitant medications that are primarily excreted by the kidney [see Drug Interactions (7.4)].
5.4 Osteonecrosis of the Jaw Osteonecrosis of the jaw (ONJ) has been reported in patients treated with bisphosphonates, including zoledronic acid. Most cases have been in cancer patients treated with intravenous bisphosphonates undergoing dental procedures. Some cases have occurred in patients with postmenopausal osteoporosis treated with either oral or intravenous bisphosphonates. A routine oral examination should be performed by the prescriber prior to initiation of bisphosphonate treatment. A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with a history of concomitant risk factors (e.g., cancer,chemotherapy, radiotherapy, corticosteroids, poor oral hygiene, pre-existing dental disease or infection, anemia, coagulopathy).
While on treatment, patients with concomitant risk factors should avoid invasive dental procedures if possible. For patients who develop ONJ while on bisphosphonate
therapy, dental surgery may exacerbate the condition. For patients requiring dental procedures, there are no data available to suggest whether discontinuation of
bisphosphonate treatment reduces the risk of ONJ. The clinical judgment of the treating physician should guide the management plan of each patient based on
individual benefit/risk assessment [see Adverse Reactions (6.1)].
5.5 Pregnancy
RECLAST SHOULD NOT BE USED DURING PREGNANCY. Reclast may cause fetal harm when administered to a pregnant woman. If the patient becomes
pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus. Women of childbearing potential should be advised to avoid becoming
pregnant while on Reclast therapy [see Use in Specific Populations (8.1)].
5.6 Musculoskeletal Pain
In post-marketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain have been infrequently reported in patients taking bisphosphonates, including Reclast. The time to onset of symptoms varied from one day to several months after starting the drug. Consider withholding future Reclast treatment if severe symptoms develop. Most patients had relief of symptoms after stopping. A subset had recurrence of symptoms when rechallenged with the same drug or another bisphosphonate [see Adverse Reactions (6.2)].
5.7 Patients with Asthma
While not observed in clinical trials with Reclast, there have been reports of bronchoconstriction in aspirin-sensitive patients receiving bisphosphonates. Use Reclast with caution in aspirin-sensitive patients.