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Reclast (Zoledronic Acid) Autoimmune Disease Considerations

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At a glance

  • Approved use / glucocorticoid-induced osteoporosis in adults on prednisone-equivalent 7.5 mg/day or more for 12 months or longer [1]
  • Dose / 5 mg IV over at least 15 minutes once a year [1]
  • Rheumatoid arthritis risk / increased osteoporotic fracture risk; no RA-specific osteoporosis guidelines [2]
  • Renal limit / contraindicated if creatinine clearance is below 35 mL/min or acute renal impairment is present [1]
  • Jaw risk / routine oral exam before treatment; rare in osteoporosis trials [1]
  • Acute-phase reaction / fever 18%, myalgia 9%, flu-like symptoms 8%, headache 7%, arthralgia 7% in the 3-year trial [1]

Does Reclast Have an Autoimmune Disease Indication?

No. The Reclast label lists postmenopausal osteoporosis, osteoporosis in men, glucocorticoid-induced osteoporosis, and Paget's disease of bone [1]. Autoimmune disease itself is not an indication [1]. The relevant use is glucocorticoid-induced osteoporosis: treatment and prevention in men and women starting or continuing prednisone-equivalent 7.5 mg/day or more, with expected treatment of 12 months or longer [1]. Rheumatoid arthritis is associated with increased osteoporotic fracture risk, and no evidence-based guidelines specific to osteoporosis in RA exist; treatment is based on general osteoporosis guidelines plus RA-specific risk factors [2].

Who With an Autoimmune Condition Fits the Label?

A patient on chronic glucocorticoids at that dose and duration. For glucocorticoid-induced osteoporosis, Reclast is 5 mg IV over at least 15 minutes once a year [1]. The Reclast prescribing information recommends an average of at least 1,200 mg of calcium and 800 to 1,000 international units of vitamin D daily for osteoporosis patients, with supplementation when dietary intake is insufficient [1]. The label says to check serum creatinine and calculate creatinine clearance by Cockcroft-Gault with actual body weight before every dose, and to do a routine oral exam before starting [1]. The label also states that patients being treated with Zometa should not also receive Reclast because both products contain zoledronic acid [1].

What About Autoimmune Flares and DMARDs?

The Reclast label's warnings include hypocalcemia, renal impairment, osteonecrosis of the jaw, atypical femoral fractures, and severe bone, joint and muscle pain; autoimmune flares are not among them [1]. The label states no in vivo drug interaction studies were performed [1]. Its interaction section addresses aminoglycosides, loop diuretics, nephrotoxic drugs such as NSAIDs, and drugs primarily excreted by the kidney [1]. It gives no specific interaction entry for methotrexate or biologic DMARDs [1].

What Safety Issues Matter Most?

In the 3-year Reclast osteoporosis trial, acute-phase symptoms included fever 18%, myalgia 9%, flu-like symptoms 8%, headache 7%, and arthralgia 7%; most occurred in the first 3 days and usually resolved within 3 days, up to 7 to 14 days [1]. Acetaminophen after the infusion may reduce acute-phase symptoms [1]. A transient creatinine rise within 10 days occurred in 1.8% on Reclast vs 0.8% on placebo [1]. Acute renal failure has followed a single dose, with rare hospitalization, dialysis or fatal outcomes in patients with moderate to severe renal impairment or risk factors such as advanced age, dehydration, diuretics and nephrotoxic drugs [1]. Osteonecrosis of the jaw was rare in the osteoporosis trials (see the FAQ below) [1].

How Long Is Reclast Used in This Setting?

Reclast's efficacy and safety data are for three years; optimal duration has not been determined [1]. The label says low-fracture-risk patients should be considered for discontinuation after 3 to 5 years, and patients who stop need periodic fracture risk re-evaluation [1]. In the HORIZON extension, 1,233 women who had 3 years of zoledronic acid were randomized to 3 more years (n=616) or placebo (n=617); new morphometric vertebral fractures were 14 vs 30 (OR 0.51), and other fractures did not differ [3]. The authors concluded many patients may discontinue for up to 3 years, but those at high fracture risk, particularly vertebral fracture, may benefit from continuing [3]. The ASBMR task force suggests reassessing risk after 3 years of intravenous bisphosphonate; high-risk women may continue up to 6 years, and a 2-to-3-year drug holiday can be considered for women not at high risk after 3 to 5 years [4]. The task force says the approach may be applicable to patients with glucocorticoid-induced osteoporosis, with some adaptations [4].

Frequently asked questions

Does Reclast cause autoimmune flares?
The Reclast label lists no autoimmune flare warning; its warnings include hypocalcemia, renal impairment, osteonecrosis of the jaw, atypical femoral fractures, and severe bone, joint and muscle pain [1].
Is Reclast safe with methotrexate?
The Reclast label reports no in vivo drug interaction studies and gives no specific interaction entry for methotrexate [1]. It advises caution with nephrotoxic drugs such as NSAIDs [1].
Does Reclast interact with biologic DMARDs?
The Reclast label's interaction section addresses aminoglycosides, loop diuretics, nephrotoxic drugs, and renally excreted drugs; it gives no specific entry for biologic DMARDs [1]. No in vivo drug interaction studies were performed [1].
Can Reclast be used in lupus nephritis?
Reclast is contraindicated when creatinine clearance is below 35 mL/min or acute renal impairment is present [1]. The label gives no lupus nephritis-specific recommendation and says to calculate creatinine clearance before every dose [1].
What is the ONJ risk in osteoporosis?
The Reclast label says most ONJ cases are in cancer patients on intravenous bisphosphonates after dental procedures, with some in postmenopausal osteoporosis patients on oral or IV bisphosphonates [1]. In the 7,736-woman trial, one placebo patient and one Reclast patient had symptoms consistent with ONJ; none occurred in the 2,127-patient hip-fracture trial [1].
Is Reclast approved for men with autoimmune disease and osteoporosis?
Reclast is approved to increase bone mass in men with osteoporosis and for glucocorticoid-induced osteoporosis in men and women [1]. The approval is not specific to autoimmune disease; it applies when the patient meets the label's osteoporosis or glucocorticoid criteria [1].

References

  1. U.S. National Library of Medicine, DailyMed. Reclast (zoledronic acid) injection 5 mg/100 mL prescribing information. Reclast (zoledronic acid) injection 5 mg/100 mL label
  2. Wysham KD, Baker JF, Shoback DM. Osteoporosis and fractures in rheumatoid arthritis. Curr Opin Rheumatol. 2021;33(3):270-276. Osteoporosis and fractures in rheumatoid arthritis
  3. Black DM, Reid IR, Boonen S, Bucci-Rechtweg C, Cauley JA, Cosman F, et al. The effect of 3 versus 6 years of zoledronic acid treatment of osteoporosis: a randomized extension to the HORIZON-Pivotal Fracture Trial (PFT). J Bone Miner Res. 2012;27(2):243-54. The effect of 3 versus 6 years of zoledronic acid treatment of osteoporosis: a randomized extension to the HORIZON-Pivotal Fracture Trial (PFT)
  4. Adler RA, El-Hajj Fuleihan G, Bauer DC, Camacho PM, Clarke BL, Clines GA, et al. Managing Osteoporosis in Patients on Long-Term Bisphosphonate Treatment: Report of a Task Force of the American Society for Bone and Mineral Research. J Bone Miner Res. 2016;31(1):16-35. Managing Osteoporosis in Patients on Long-Term Bisphosphonate Treatment: Report of a Task Force of the American Society for Bone and Mineral Research
Evidence overview for Reclast (Zoledronic Acid) Autoimmune Disease Considerations