Brand Name
Reclast
Generic Name
Zoledronic
View Brand Information FDA approval date: April 01, 2007
Classification: Bisphosphonate
Form: Injection
What is Reclast (Zoledronic)?
Zoledronic Acid Injection is a bisphosphonate indicated for the treatment of: Hypercalcemia of malignancy.
Approved To Treat
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Brand Information
Reclast (zoledronic acid)
1DOSAGE FORMS AND STRENGTHS
5 mg in a 100 mL ready to infuse solution.
2CONTRAINDICATIONS
Reclast is contraindicated in patients with the following conditions:
- Hypocalcemia
- Creatinine clearance less than 35 mL/min and in those with evidence of acute renal impairment due to an increased risk of renal failure
- Known hypersensitivity to zoledronic acid or any components of Reclast. Hypersensitivity reactions, including urticaria, angioedema, and anaphylactic reaction/shock have been reported
3DRUG INTERACTIONS
- No
3.1Aminoglycosides
Caution is advised when bisphosphonates, including zoledronic acid, are administered with aminoglycosides, since these agents may have an additive effect to lower serum calcium level for prolonged periods. This effect has not been reported in zoledronic acid clinical trials.
3.2Loop Diuretics
Caution should also be exercised when Reclast is used in combination with loop diuretics due to an increased risk of hypocalcemia.
3.3Nephrotoxic Drugs
Caution is indicated when Reclast is used with other potentially nephrotoxic drugs, such as nonsteroidal anti-inflammatory drugs (NSAIDs).
3.4Drugs Primarily Excreted by the Kidney
Renal impairment has been observed following the administration of zoledronic acid in patients with preexisting renal compromise or other risk factors
4OVERDOSAGE
Clinical experience with acute overdosage of zoledronic acid (Reclast) solution for intravenous infusion is limited. Patients who have received doses higher than those recommended should be carefully monitored. Overdosage may cause clinically significant renal impairment, hypocalcemia, hypophosphatemia, and hypomagnesemia. Clinically relevant reductions in serum levels of calcium, phosphorus, and magnesium should be corrected by intravenous administration of calcium gluconate, potassium or sodium phosphate, and magnesium sulfate, respectively.
Single doses of Reclast should not exceed 5 mg and the duration of the intravenous infusion should be no less than 15 minutes
5DESCRIPTION
Reclast contains zoledronic acid, a bisphosphonic acid which is an inhibitor of osteoclastic bone resorption. Zoledronic acid is designated chemically as (1-Hydroxy-2-imidazol-1-yl-phosphonoethyl) phosphonic acid monohydrate and its structural formula is:
Zoledronic acid monohydrate is a white crystalline powder. Its molecular formula is C
- 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.
6HOW SUPPLIED/STORAGE AND HANDLING
- Each bottle contains 5 mg per 100 mL NDC 66758-155-46
Handling
After opening the solution, it is stable for 24 hours at 2°C to 8°C (36°F to 46°F).
If refrigerated, allow the refrigerated solution to reach room temperature before administration.
Storage
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C and 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
7PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Information for Patients
Patients should be made aware that Reclast contains the same active ingredient (zoledronic acid) found in Zometa
Reclast is contraindicated in patients with creatinine clearance less than 35 mL/min
Before being given Reclast, patients should tell their doctor if they have kidney problems and what medications they are taking
Reclast should not be given if the patient is pregnant or plans to become pregnant, or if she is breastfeeding
There have been reports of bronchoconstriction in aspirin-sensitive patients receiving bisphosphonates, including Reclast. Before being given Reclast, patients should tell their doctor if they are aspirin-sensitive.
If the patient had surgery to remove some or all of the parathyroid glands in their neck, or had sections of their intestine removed, or are unable to take calcium supplements they should tell their doctor.
Reclast is given as an infusion into a vein by a nurse or a doctor, and the infusion time must not be less than 15 minutes.
On the day of treatment the patient should eat and drink normally, which includes drinking at least 2 glasses of fluid, such as water within a few hours prior to the infusion, as directed by their doctor, before receiving Reclast.
After getting Reclast it is strongly recommended patients with Paget’s disease take calcium in divided doses (for example, 2 to 4 times a day) for a total of 1500 mg calcium a day to prevent low blood calcium levels. This is especially important for the two weeks after getting Reclast
Adequate calcium and vitamin D intake is important in patients with osteoporosis and the current recommended daily intake of calcium is 1200 mg and vitamin D is 800 international units to 1000 international units daily. All patients should be instructed on the importance of calcium and vitamin D supplementation in maintaining serum calcium levels.
Patients should be aware of the most commonly associated side effects of therapy. Patients may experience one or more side effects that could include: fever, flu-like symptoms, myalgia, arthralgia, and headache. Most of these side effects occur within the first 3 days following the dose of Reclast. They usually resolve within 3 days of onset but may last for up to 7 to 14 days. Patients should consult their physician if they have questions or if these symptoms persist. The incidence of these symptoms decreased markedly with subsequent doses of Reclast.
Administration of acetaminophen following Reclast administration may reduce the incidence of these symptoms.
Physicians should inform their patients that there have been reports of persistent pain and/or a non-healing sore of the mouth or jaw, primarily in patients treated with bisphosphonates for other illnesses. During treatment with zoledronic acid, patients should be instructed to maintain good oral hygiene and undergo routine dental check-ups. If they experience any oral symptoms, they should immediately report them to their physician or dentist.
Severe and occasionally incapacitating bone, joint, and/or muscle pain have been infrequently reported in patients taking bisphosphonates, including Reclast. Consider withholding future Reclast treatment if severe symptoms develop.
Atypical femur fractures in patients on bisphosphonate therapy have been reported; patients with thigh or groin pain should be evaluated to rule out a femoral fracture.
8PRINCIPAL DISPLAY PANEL
NDC 66758-155-46
Rx only
Reclast
(zoledronic acid) injection
5 mg/100 mL
Solution for Intravenous Infusion
Dispense the accompanying Medication Guide to each patient.
1 bottle – Sterile Solution
Do not mix with calcium-containing solutions. Administer as a single intravenous
SANDOZ
