|
Product
Anti-cancer Products (Zoldria)
|
Anti-cancer Products (Zoldria)
|
|
| |
|
Zoldria
Zoldria Injection
COMPOSITION
Each vial contains Zoledronic acid monohydrate equivalent to Zoledronic
acid anhydrous 4 mg as sterile freeze dried powder for reconstitution with
5ml of Sterile Water for Injection IP
Indications and Usage
Hypercalcemia of Malignancy - Zoldria (zoledronic acid) Injection is
indicated for the treatment of hypercalcemia of malignancy.
Multiple Myeloma and Bone Metastases of Solid Tumors - Zoldria is
indicated for the treatment of patients with multiple myeloma and patients
with documented bone metastases from solid tumors, in conjunction with
standard antineoplastic therapy. Prostate cancer should have progressed
after treatment with at least one hormonal therapy.
Dosage and Administration
Hypercalcemia of Malignancy
Consideration should be given to the severity of as well as the symptoms of
tumor-induced hypercalcemia when considering use of Zoldria (zoledronic
acid) Injection. Vigorous saline hydration alone may be sufficient to treat
mild, asymptomatic hypercalcemia. |
The maximum recommended dose of Zoldria in hypercalcemia of
malignancy (albumin-corrected serum calcium* ≥ 12 mg/dL [3.0 mmol/L])
is 4 mg. The 4-mg dose must be given as a single-dose intravenous infusion
over no less than 15 minutes.
Patients should be adequately rehydrated prior to administration of Zoldria.
(See Warnings and Precautions).
Retreatment with Zoldria 4 mg may be considered if serum calcium does
not return to normal or remain normal after initial treatment. It is
recommended that a minimum of 7 days elapse before retreatment, to
allow for full response to the initial dose. Renal function must be carefully
monitored in all patients receiving Zoldria and possible deterioration in
renal function must be assessed prior to treatment with Zoldria. (See
Warnings and Precautions).
* Albumin-corrected serum calcium (Cca, mg/dL) = Ca + 0.8 (mid-range
albumin-measured albumin in mg/dL).
Multiple Myeloma and Metastatic Bone Lesions From Solid Tumors
The recommended dose of Zoldria in patients with multiple myeloma and
metastatic bone lesions from solid tumors is 4 mg infused over 15 minutes
every three or four weeks. Duration of treatment in the clinical studies was
15 months for prostate cancer, 12 months for breast cancer and multiple
myeloma, and 9 months for other solid tumors. Patients should also be
administered an oral calcium supplement of 500 mg and a multiple vitamin
containing 400 IU of Vitamin D daily.
Serum creatinine should be measured before each Zoldria dose and
treatment should be withheld for renal deterioration. In the clinical studies,
renal deterioration was defined as follows:
• For patients with normal baseline creatinine, increase of 0.5 mg/dL
• For patients with abnormal baseline creatinine, increase of
1.0 mg/dL
In the clinical studies, Zoldria treatment was resumed only when the
creatinine returned to within 10% of the baseline value.
Preparation of the solution
Vials of Zoldria concentrate for infusion contain overfill allowing for the
withdrawal of 5 mL of concentrate (equivalent to 4 mg zoledronic acid).
This concentrate should immediately be diluted in 100 mL of sterile 0.9%
of Sodium Chloride, USP, or 5% Dextrose Injection, USP.
Do not store undiluted concentrate in a syringe, to avoid inadvertent
injection. The dose must be given as a single intravenous infusion over no
less than 15 minutes.
If not used immediately after dilution with infusion media, for microbiological
integrity, the solution should be refrigerated at 2 o C - 8 o C (36 o F- 46 o F). The
refrigerated solution should then be equilibrated to room temperature prior
to administration. The total time between dilution, storage in the refrigerator,
and end of administration must not exceed 24 hours.
Zoldria must not be mixed with calcium-containing infusion solutions, such
as Lactated Ringer’s solution, and should be administered as a single
intravenous solution in a line separate from all other drugs
Method of administration
Due to the risk of clinically significant deterioration in renal function, which
may progress to renal failure, single doses of Zoldria should not exceed 4
mg and the duration of infusion should be no less than 15 minutes (See Warnings).
There must be strict adherence to the intravenous administration
recommendations for Zoldria in order to decrease the risk of deterioration
in renal function.
Note: Parenteral drug products should be inspected visually for
particulate matter and discoloration prior to administration, whenever
solution and container permit.
Contraindications
Zoldria injection is contraindicated in patients with clinically significant
hypersensitivity to zoledronic acid or other bisphosphonates, or any of the
excipients in the formulations of Zoldria.
Presentation
Zoldria Vial of 10 ml
|
|
